TDMS Study 99022-02 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Southern Research Inst AZT TRANSPLACENTAL CARCINOGENESIS STUDY DATE: 09/09/04
EXPERIMENT: 99022 TEST: 02 TIME: 14:02:01
TEST TYPE: PERINATAL EXPOS CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-15328 ROUTE: IN-UTERO NTP C#: C99022
PATHOLOGIST: HEATH, JAMES E. CAS: 30516-87-1
------------------------------------------------------------------------------------------------------------------------------------
FINAL #2; REVISION #1 MICE
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: MERGE 001 001,011 0 MG/KG/DY
MERGE 002 002,012 50 MG/KG/DY
MERGE 003 003,013 100 MG/KG/DY
MERGE 004 004,014 200 MG/KG/DY
MERGE 005 005,015 300 MG/KG/DY
MERGE 006 006,016 0 MG/KG/DY
MERGE 007 007,017 50 MG/KG/DY
MERGE 008 008,018 100 MG/KG/DY
MERGE 009 009,019 200 MG/KG/DY
MERGE 010 010,020 300 MG/KG/DY
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Southern Research Inst AZT TRANSPLACENTAL CARCINOGENESIS STUDY DATE: 09/09/04
EXPERIMENT: 99022 TEST: 02 TIME: 14:02:01
TEST TYPE: PERINATAL EXPOS CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-15328 ROUTE: IN-UTERO NTP C#: C99022
PATHOLOGIST: HEATH, JAMES E. CAS: 30516-87-1
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF AZT TRANSPLACENTAL CARCINOGENESIS
===============================================================
Male Mice
------------
Organ Morphology
----- ----------
Bone Marrow Hyperplasia
Bone: Femur Osteopetrosis
Heart Cardiomyopathy
Intestine Large, Cecum Edema
Kidney Amyloid Deposition
Cyst
Hydronephrosis
Infiltration Cellular Mixed Cell
Inflammation
Nephropathy
Kidney: Renal Tubule Dilatation
Liver Infiltration Cellular Mixed Cell
Liver: Hepatocyte Hypertrophy
Lung Edema
Infiltration Cellular Histiocyte
Lung: Alveolar Epithelium Hyperplasia
Lymph Node Hyperplasia
Lymph Node, Mandibular Hematopoietic Cell Proliferation
Hyperplasia
Lymph Node, Mesenteric Ectasia
Hematopoietic Cell Proliferation
Hemorrhage
Mesentery: Fat Necrosis
Penis Inflammation Chronic
Preputial Gland Inflammation Chronic
Salivary Glands Hyperplasia Lymphoid
Infiltration Cellular Lymphoid
Seminal Vesicle Dilatation
Skin Edema
Spleen: Lymphoid Follicle Hyperplasia
Stomach, Glandular: Glands Hyperplasia Cystic
Thymus Hyperplasia Lymphoid
Urethra Angiectasis
Inflammation Chronic
Urinary Bladder Edema
Hemorrhage
Inflammation Chronic
===============================================================
Female Mice
------------
Organ Morphology
----- ----------
Bone Fibrous Osteodystrophy
Bone Marrow Hyperplasia
Clitoral Gland Cyst
Heart Inflammation Chronic
Intestine Large, Cecum Edema
Intestine Small, Duodenum: Epithelium Hyperplasia
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Southern Research Inst AZT TRANSPLACENTAL CARCINOGENESIS STUDY DATE: 09/09/04
EXPERIMENT: 99022 TEST: 02 TIME: 14:02:01
TEST TYPE: PERINATAL EXPOS CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-15328 ROUTE: IN-UTERO NTP C#: C99022
PATHOLOGIST: HEATH, JAMES E. CAS: 30516-87-1
Islets, Pancreatic Hyperplasia
Kidney Cyst
Infiltration Cellular Mixed Cell
Inflammation Chronic
Nephropathy
Liver: Hepatocyte Hypertrophy
Lung Foreign Body
Infiltration Cellular Histiocyte
Lung: Alveolar Epithelium Hyperplasia
Lymph Node Hyperplasia
Lymph Node, Mandibular Hyperplasia
Infiltration Cellular Plasma Cell
Lymph Node: Inguinal Hyperplasia
Mesentery: Fat Necrosis
Nose Foreign Body
Inflammation Chronic
Ovary Angiectasis
Pancreas: Acinus Cytoplasmic Alteration
Pituitary Gland: Pars Distalis Angiectasis
Skin Cyst Epithelial Inclusion
Edema
Ulcer
Spleen Hematopoietic Cell Proliferation
Pigmentation
Stomach, Forestomach Erosion
Thyroid Gland Degeneration Cystic
Uterus: Endometrium Hyperplasia Cystic
===============================================================
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 1
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Accessory Adrenal Cortical Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 8/50 (16%) 9/50 (18%) 7/50 (14%) 6/37 (16%) 6/32 (19%) |
|POLY-3 RATE (b) | 8/35.78 9/33.66 7/31.13 6/24.16 6/20.28 |
|POLY-3 PERCENT (g) | 22.4% 26.7% 22.5% 24.8% 29.6% |
|TERMINAL (d) | 5/19 (26%) 5/21 (24%) 3/13 (23%) 1/7 (14%) 1/8 (13%) |
|FIRST INCIDENCE | 322 147 320 157 563 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.212 P=0.524 P=0.504 P=0.358 P=0.327 |
|POLY 3 | P=0.351 P=0.442 P=0.612 P=0.536 P=0.391 |
|POLY 1.5 | P=0.373 P=0.448 P=0.579N P=0.557 P=0.404 |
|POLY 6 | P=0.339 P=0.461 P=0.576 P=0.517 P=0.398 |
|LOGISTIC REGRESSION| P=0.432 P=0.514 P=0.526N P=0.592N P=0.448 |
|COCH-ARM / FISHERS | P=0.448 P=0.500 P=0.500N P=0.601 P=0.485 |
|ORDER RESTRICTED | P=0.502 (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Accessory Adrenal Cortical Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 10/50 (20%) 8/49 (16%) 11/50 (22%) 7/38 (18%) 6/42 (14%) |
|POLY-3 RATE (b) | 10/37.67 8/34.35 11/38.86 7/30.93 6/30.78 |
|POLY-3 PERCENT (g) | 26.6% 23.3% 28.3% 22.6% 19.5% |
|TERMINAL (d) | 4/20 (20%) 1/17 (6%) 5/24 (21%) 5/18 (28%) 3/19 (16%) |
|FIRST INCIDENCE | 287 219 460 359 43 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.210N P=0.534N P=0.569N P=0.394N P=0.322N |
|POLY 3 | P=0.269N P=0.481N P=0.533 P=0.463N P=0.344N |
|POLY 1.5 | P=0.276N P=0.442N P=0.518 P=0.468N P=0.334N |
|POLY 6 | P=0.273N P=0.528N P=0.563 P=0.479N P=0.357N |
|LOGISTIC REGRESSION| P=0.301N P=0.401N P=0.519 P=0.493N P=0.328N |
|COCH-ARM / FISHERS | P=0.303N P=0.416N P=0.500 P=0.538N P=0.331N |
|ORDER RESTRICTED | P=0.435N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 2
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hyperplasia Diffuse |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/37 (0%) 0/32 (0%) |
|POLY-3 RATE (b) | 0/33.13 0/30.37 0/29.15 0/20.93 0/19.14 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/19 (0%) 0/21 (0%) 0/13 (0%) 0/7 (0%) 0/8 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hyperplasia Diffuse |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 2/49 (4%) 0/50 (0%) 0/38 (0%) 1/42 (2%) |
|POLY-3 RATE (b) | 0/34.96 2/31.07 0/36.65 0/29.97 1/29.68 |
|POLY-3 PERCENT (g) | 0.0% 6.4% 0.0% 0.0% 3.4% |
|TERMINAL (d) | 0/20 (0%) 0/17 (0%) 0/24 (0%) 0/18 (0%) 0/19 (0%) |
|FIRST INCIDENCE | --- 500 --- --- 332 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.535 P=0.205 (e) (e) P=0.466 |
|POLY 3 | P=0.544 P=0.210 (e) (e) P=0.467 |
|POLY 1.5 | P=0.545 P=0.221 (e) (e) P=0.466 |
|POLY 6 | P=0.539 P=0.201 (e) (e) P=0.469 |
|LOGISTIC REGRESSION| P=0.523 P=0.238 (e) (e) P=0.508 |
|COCH-ARM / FISHERS | P=0.527 P=0.242 (e) (e) P=0.457 |
|ORDER RESTRICTED | P=0.273 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 3
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 5/50 (10%) 3/50 (6%) 2/37 (5%) 0/32 (0%) |
|POLY-3 RATE (b) | 2/33.95 5/31.08 3/29.72 2/21.52 0/19.14 |
|POLY-3 PERCENT (g) | 5.9% 16.1% 10.1% 9.3% 0.0% |
|TERMINAL (d) | 1/19 (5%) 3/21 (14%) 1/13 (8%) 0/7 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 373 523 536 580 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.275N P=0.229 P=0.388 P=0.470 P=0.405N |
|POLY 3 | P=0.207N P=0.176 P=0.439 P=0.522 P=0.372N |
|POLY 1.5 | P=0.194N P=0.181 P=0.462 P=0.541 P=0.366N |
|POLY 6 | P=0.225N P=0.184 P=0.412 P=0.501 P=0.380N |
|LOGISTIC REGRESSION| P=0.185N P=0.188 P=0.471 P=0.567 P=0.334N |
|COCH-ARM / FISHERS | P=0.158N P=0.218 P=0.500 P=0.571 P=0.369N |
|ORDER RESTRICTED | P=0.185N (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/38 (0%) 0/42 (0%) |
|POLY-3 RATE (b) | 0/34.96 0/30.04 0/36.65 0/29.97 0/28.81 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/20 (0%) 0/17 (0%) 0/24 (0%) 0/18 (0%) 0/19 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 4
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hypertrophy Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 6/50 (12%) 5/50 (10%) 4/50 (8%) 4/37 (11%) 4/32 (13%) |
|POLY-3 RATE (b) | 6/33.13 5/30.37 4/30.01 4/21.27 4/19.52 |
|POLY-3 PERCENT (g) | 18.1% 16.5% 13.3% 18.8% 20.5% |
|TERMINAL (d) | 6/19 (32%) 5/21 (24%) 2/13 (15%) 2/7 (29%) 3/8 (38%) |
|FIRST INCIDENCE | 668 (T) 668 (T) 490 625 569 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.155 P=0.424N P=0.587N P=0.294 P=0.357 |
|POLY 3 | P=0.423 P=0.563N P=0.430N P=0.615 P=0.560 |
|POLY 1.5 | P=0.436 P=0.556N P=0.408N P=0.630N P=0.563 |
|POLY 6 | P=0.404 P=0.552N P=0.458N P=0.581 P=0.559 |
|LOGISTIC REGRESSION| P=0.332 P=0.424N P=0.512N P=0.414 P=0.500 |
|COCH-ARM / FISHERS | P=0.477 P=0.500N P=0.370N P=0.571N P=0.602 |
|ORDER RESTRICTED | P=0.599 (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hypertrophy Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/38 (0%) 1/42 (2%) |
|POLY-3 RATE (b) | 0/34.96 0/30.04 0/36.65 0/29.97 1/28.81 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 3.5% |
|TERMINAL (d) | 0/20 (0%) 0/17 (0%) 0/24 (0%) 0/18 (0%) 1/19 (5%) |
|FIRST INCIDENCE | --- --- --- --- 668 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.125 (e) (e) (e) P=0.490 |
|POLY 3 | P=0.136 (e) (e) (e) P=0.461 |
|POLY 1.5 | P=0.130 (e) (e) (e) P=0.462 |
|POLY 6 | P=0.141 (e) (e) (e) P=0.461 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) P=0.490 |
|COCH-ARM / FISHERS | P=0.111 (e) (e) (e) P=0.457 |
|ORDER RESTRICTED | P=0.062 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 5
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Adrenal Cortex: Capsule |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 1/50 (2%) 3/37 (8%) 2/32 (6%) |
|POLY-3 RATE (b) | 2/33.13 2/30.37 1/29.15 3/21.18 2/20.07 |
|POLY-3 PERCENT (g) | 6.0% 6.6% 3.4% 14.2% 10.0% |
|TERMINAL (d) | 2/19 (11%) 2/21 (10%) 1/13 (8%) 2/7 (29%) 0/8 (0%) |
|FIRST INCIDENCE | 668 (T) 668 (T) 668 (T) 608 404 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.094 P=0.662N P=0.634N P=0.136 P=0.430 |
|POLY 3 | P=0.219 P=0.664 P=0.545N P=0.301 P=0.504 |
|POLY 1.5 | P=0.217 P=0.667 P=0.527N P=0.322 P=0.502 |
|POLY 6 | P=0.219 P=0.672 P=0.569N P=0.275 P=0.506 |
|LOGISTIC REGRESSION| P=0.182 P=0.662N P=0.634N P=0.201 P=0.496 |
|COCH-ARM / FISHERS | P=0.230 P=0.691N P=0.500N P=0.359 P=0.510 |
|ORDER RESTRICTED | P=0.343 (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Adrenal Cortex: Capsule |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 1/49 (2%) 0/50 (0%) 2/38 (5%) 2/42 (5%) |
|POLY-3 RATE (b) | 1/34.96 1/30.57 0/36.65 2/29.97 2/29.11 |
|POLY-3 PERCENT (g) | 2.9% 3.3% 0.0% 6.7% 6.9% |
|TERMINAL (d) | 1/20 (5%) 0/17 (0%) 0/24 (0%) 2/18 (11%) 1/19 (5%) |
|FIRST INCIDENCE | 668 (T) 521 --- 668 (T) 593 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.176 P=0.726 P=0.464N P=0.463 P=0.462 |
|POLY 3 | P=0.153 P=0.731 P=0.491N P=0.446 P=0.436 |
|POLY 1.5 | P=0.149 P=0.744 P=0.494N P=0.437 P=0.435 |
|POLY 6 | P=0.156 P=0.718 P=0.483N P=0.450 P=0.438 |
|LOGISTIC REGRESSION| P=0.154 P=0.743 (e) P=0.463 P=0.432 |
|COCH-ARM / FISHERS | P=0.142 P=0.747 P=0.500N P=0.397 P=0.434 |
|ORDER RESTRICTED | P=0.263 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 6
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/49 (2%) 0/37 (0%) 1/32 (3%) |
|POLY-3 RATE (b) | 2/33.72 0/30.37 1/28.71 0/20.93 1/19.75 |
|POLY-3 PERCENT (g) | 5.9% 0.0% 3.5% 0.0% 5.1% |
|TERMINAL (d) | 0/19 (0%) 0/21 (0%) 1/13 (8%) 0/7 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 567 --- 668 (T) --- 488 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.563N P=0.253N P=0.598N P=0.363N P=0.670N |
|POLY 3 | P=0.527N P=0.260N P=0.556N P=0.350N P=0.682N |
|POLY 1.5 | P=0.512N P=0.256N P=0.537N P=0.333N P=0.678N |
|POLY 6 | P=0.554N P=0.259N P=0.583N P=0.373N P=0.688N |
|LOGISTIC REGRESSION| P=0.524N P=0.251N P=0.554N P=0.331N P=0.666N |
|COCH-ARM / FISHERS | P=0.505N P=0.247N P=0.508N P=0.327N P=0.779 |
|ORDER RESTRICTED | P=0.391N (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 3/49 (6%) 1/50 (2%) 0/38 (0%) 0/42 (0%) |
|POLY-3 RATE (b) | 1/34.96 3/30.04 1/36.65 0/29.97 0/28.81 |
|POLY-3 PERCENT (g) | 2.9% 10.0% 2.7% 0.0% 0.0% |
|TERMINAL (d) | 1/20 (5%) 3/17 (18%) 1/24 (4%) 0/18 (0%) 0/19 (0%) |
|FIRST INCIDENCE | 668 (T) 668 (T) 668 (T) --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.072N P=0.244 P=0.722N P=0.521N P=0.510N |
|POLY 3 | P=0.098N P=0.251 P=0.751N P=0.531N P=0.539N |
|POLY 1.5 | P=0.097N P=0.273 P=0.755N P=0.536N P=0.538N |
|POLY 6 | P=0.101N P=0.227 P=0.743N P=0.528N P=0.539N |
|LOGISTIC REGRESSION| P=0.072N P=0.244 P=0.722N (e) (e) |
|COCH-ARM / FISHERS | P=0.098N P=0.301 P=0.753N P=0.568N P=0.543N |
|ORDER RESTRICTED | P=0.131N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 7
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Bone |
| Fibrous Osteodystrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/37 (3%) 1/32 (3%) |
|POLY-3 RATE (b) | 0/33.13 0/30.37 1/29.53 1/21.43 1/19.32 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 3.4% 4.7% 5.2% |
|TERMINAL (d) | 0/19 (0%) 0/21 (0%) 0/13 (0%) 0/7 (0%) 0/8 (0%) |
|FIRST INCIDENCE | --- --- 570 531 627 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.106 (e) P=0.469 P=0.428 P=0.415 |
|POLY 3 | P=0.100 (e) P=0.477 P=0.414 P=0.393 |
|POLY 1.5 | P=0.101 (e) P=0.486 P=0.422 P=0.395 |
|POLY 6 | P=0.098 (e) P=0.466 P=0.403 P=0.391 |
|LOGISTIC REGRESSION| P=0.102 (e) P=0.490 P=0.440 P=0.388 |
|COCH-ARM / FISHERS | P=0.109 (e) P=0.500 P=0.425 P=0.390 |
|ORDER RESTRICTED | P=0.219 (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Bone |
| Fibrous Osteodystrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 7/50 (14%) 9/50 (18%) 6/40 (15%) 4/42 (10%) |
|POLY-3 RATE (b) | 2/35.72 7/35.55 9/41.01 6/34.10 4/31.68 |
|POLY-3 PERCENT (g) | 5.6% 19.7% 22.0% 17.6% 12.6% |
|TERMINAL (d) | 0/20 (0%) 0/18 (0%) 0/24 (0%) 1/20 (5%) 0/19 (0%) |
|FIRST INCIDENCE | 443 326 328 359 207 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.417 P=0.070 P=0.048 * P=0.134 P=0.267 |
|POLY 3 | P=0.434 P=0.073 P=0.041 * P=0.113 P=0.280 |
|POLY 1.5 | P=0.401 P=0.077 P=0.034 * P=0.100 P=0.271 |
|POLY 6 | P=0.465 P=0.071 P=0.054 P=0.125 P=0.291 |
|LOGISTIC REGRESSION| P=0.314 P=0.088 P=0.024 * P=0.049 * P=0.281 |
|COCH-ARM / FISHERS | P=0.346 P=0.080 P=0.026 * P=0.074 P=0.259 |
|ORDER RESTRICTED | P=0.132 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 8
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Bone Marrow |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 43/50 (86%) 29/50 (58%) 35/50 (70%) 27/37 (73%) 24/32 (75%) |
|POLY-3 RATE (b) | 43/48.79 29/41.81 35/43.29 27/33.80 24/27.74 |
|POLY-3 PERCENT (g) | 88.1% 69.4% 80.9% 79.9% 86.5% |
|TERMINAL (d) | 15/19 (79%) 11/21 (52%) 10/13 (77%) 3/7 (43%) 5/8 (63%) |
|FIRST INCIDENCE | 104 147 147 157 192 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.149 P=0.050N P=0.530 P=0.313 P=0.466 |
|POLY 3 | P=0.460 P=0.020N* P=0.231N P=0.228N P=0.562N |
|POLY 1.5 | P=0.471 P=0.009N** P=0.130N P=0.172N P=0.501N |
|POLY 6 | P=0.452 P=0.037N* P=0.422N P=0.301N P=0.593N |
|LOGISTIC REGRESSION| P=0.459N P=0.002N** P=0.041N* P=0.068N P=0.193N |
|COCH-ARM / FISHERS | P=0.455N P=0.002N** P=0.045N* P=0.108N P=0.167N |
|ORDER RESTRICTED | P=0.262N (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Bone Marrow |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 33/50 (66%) 24/50 (48%) 30/50 (60%) 22/40 (55%) 26/42 (62%) |
|POLY-3 RATE (b) | 33/47.13 24/40.22 30/43.46 22/36.73 26/38.16 |
|POLY-3 PERCENT (g) | 70.0% 59.7% 69.0% 59.9% 68.1% |
|TERMINAL (d) | 11/20 (55%) 6/18 (33%) 13/24 (54%) 8/20 (40%) 10/19 (53%) |
|FIRST INCIDENCE | 105 207 182 414 43 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.314N P=0.283N P=0.220N P=0.105N P=0.404N |
|POLY 3 | P=0.451N P=0.208N P=0.551N P=0.225N P=0.520N |
|POLY 1.5 | P=0.482N P=0.134N P=0.501N P=0.211N P=0.495N |
|POLY 6 | P=0.424N P=0.271N P=0.551N P=0.232N P=0.523N |
|LOGISTIC REGRESSION| P=0.489 P=0.043N* P=0.345N P=0.303N P=0.404N |
|COCH-ARM / FISHERS | P=0.501 P=0.053N P=0.339N P=0.199N P=0.424N |
|ORDER RESTRICTED | P=0.478N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 9
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Bone: Femur |
| Osteopetrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/37 (0%) 2/32 (6%) |
|POLY-3 RATE (b) | 0/33.13 1/30.76 0/29.15 0/20.93 2/19.14 |
|POLY-3 PERCENT (g) | 0.0% 3.3% 0.0% 0.0% 10.5% |
|TERMINAL (d) | 0/19 (0%) 0/21 (0%) 0/13 (0%) 0/7 (0%) 2/8 (25%) |
|FIRST INCIDENCE | --- 567 --- --- 668 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.033 * P=0.493 (e) (e) P=0.076 |
|POLY 3 | P=0.054 P=0.485 (e) (e) P=0.126 |
|POLY 1.5 | P=0.057 P=0.486 (e) (e) P=0.129 |
|POLY 6 | P=0.050 P=0.491 (e) (e) P=0.122 |
|LOGISTIC REGRESSION| P=0.054 P=0.492 (e) (e) P=0.076 |
|COCH-ARM / FISHERS | P=0.064 P=0.500 (e) (e) P=0.149 |
|ORDER RESTRICTED | P=0.015 * (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Bone: Femur |
| Osteopetrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/40 (0%) 0/42 (0%) |
|POLY-3 RATE (b) | 0/34.96 0/31.04 0/36.65 0/31.97 0/28.81 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/20 (0%) 0/18 (0%) 0/24 (0%) 0/20 (0%) 0/19 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 10
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | |
|POLY-3 RATE (b) | |
|POLY-3 PERCENT (g) | |
|TERMINAL (d) | |
|FIRST INCIDENCE | |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | |
|POLY 3 | |
|POLY 1.5 | |
|POLY 6 | |
|LOGISTIC REGRESSION| |
|COCH-ARM / FISHERS | |
|ORDER RESTRICTED | |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 22/50 (44%) 18/50 (36%) 25/50 (50%) 14/40 (35%) 12/42 (29%) |
|POLY-3 RATE (b) | 22/39.10 18/34.48 25/42.10 14/34.07 12/29.74 |
|POLY-3 PERCENT (g) | 56.3% 52.2% 59.4% 41.1% 40.4% |
|TERMINAL (d) | 10/20 (50%) 10/18 (56%) 12/24 (50%) 7/20 (35%) 10/19 (53%) |
|FIRST INCIDENCE | 443 412 332 497 479 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.025N* P=0.521N P=0.557N P=0.116N P=0.078N |
|POLY 3 | P=0.044N* P=0.452N P=0.476 P=0.136N P=0.134N |
|POLY 1.5 | P=0.047N* P=0.347N P=0.424 P=0.152N P=0.111N |
|POLY 6 | P=0.053N P=0.586N P=0.543 P=0.138N P=0.187N |
|LOGISTIC REGRESSION| P=0.033N* P=0.425N P=0.382 P=0.134N P=0.093N |
|COCH-ARM / FISHERS | P=0.068N P=0.270N P=0.344 P=0.258N P=0.095N |
|ORDER RESTRICTED | P=0.154N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 11
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | |
|POLY-3 RATE (b) | |
|POLY-3 PERCENT (g) | |
|TERMINAL (d) | |
|FIRST INCIDENCE | |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | |
|POLY 3 | |
|POLY 1.5 | |
|POLY 6 | |
|LOGISTIC REGRESSION| |
|COCH-ARM / FISHERS | |
|ORDER RESTRICTED | |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 23/50 (46%) 19/50 (38%) 17/50 (34%) 14/40 (35%) 16/42 (38%) |
|POLY-3 RATE (b) | 23/39.22 19/34.35 17/39.14 14/33.17 16/32.10 |
|POLY-3 PERCENT (g) | 58.7% 55.3% 43.4% 42.2% 49.8% |
|TERMINAL (d) | 11/20 (55%) 11/18 (61%) 9/24 (38%) 8/20 (40%) 10/19 (53%) |
|FIRST INCIDENCE | 443 500 332 539 453 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.120N P=0.550N P=0.084N P=0.081N P=0.256N |
|POLY 3 | P=0.167N P=0.478N P=0.123N P=0.113N P=0.300N |
|POLY 1.5 | P=0.197N P=0.362N P=0.126N P=0.119N P=0.295N |
|POLY 6 | P=0.165N P=0.593 P=0.121N P=0.129N P=0.328N |
|LOGISTIC REGRESSION| P=0.173N P=0.453N P=0.113N P=0.081N P=0.305N |
|COCH-ARM / FISHERS | P=0.270N P=0.272N P=0.154N P=0.201N P=0.291N |
|ORDER RESTRICTED | P=0.198N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 12
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Epididymis |
| Atypia Cellular |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) 3/50 (6%) 3/37 (8%) 3/32 (9%) |
|POLY-3 RATE (b) | 1/33.13 3/31.36 3/30.69 3/21.41 3/19.67 |
|POLY-3 PERCENT (g) | 3.0% 9.6% 9.8% 14.0% 15.3% |
|TERMINAL (d) | 1/19 (5%) 2/21 (10%) 0/13 (0%) 1/7 (14%) 1/8 (13%) |
|FIRST INCIDENCE | 668 (T) 157 147 607 563 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.051 P=0.332 P=0.246 P=0.090 P=0.102 |
|POLY 3 | P=0.079 P=0.283 P=0.276 P=0.163 P=0.139 |
|POLY 1.5 | P=0.083 P=0.285 P=0.288 P=0.176 P=0.141 |
|POLY 6 | P=0.075 P=0.290 P=0.261 P=0.149 P=0.138 |
|LOGISTIC REGRESSION| P=0.094 P=0.301 P=0.318 P=0.132 P=0.129 |
|COCH-ARM / FISHERS | P=0.104 P=0.309 P=0.309 P=0.204 P=0.162 |
|ORDER RESTRICTED | P=0.141 (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Epididymis |
| Atypia Cellular |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | |
|POLY-3 RATE (b) | |
|POLY-3 PERCENT (g) | |
|TERMINAL (d) | |
|FIRST INCIDENCE | |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | |
|POLY 3 | |
|POLY 1.5 | |
|POLY 6 | |
|LOGISTIC REGRESSION| |
|COCH-ARM / FISHERS | |
|ORDER RESTRICTED | |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 13
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Epididymis |
| Spermatocele |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/37 (0%) 1/32 (3%) |
|POLY-3 RATE (b) | 0/33.13 0/30.37 2/29.77 0/20.93 1/19.14 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 6.7% 0.0% 5.2% |
|TERMINAL (d) | 0/19 (0%) 0/21 (0%) 0/13 (0%) 0/7 (0%) 1/8 (13%) |
|FIRST INCIDENCE | --- --- 544 --- 668 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.204 (e) P=0.193 (e) P=0.328 |
|POLY 3 | P=0.224 (e) P=0.213 (e) P=0.391 |
|POLY 1.5 | P=0.233 (e) P=0.221 (e) P=0.394 |
|POLY 6 | P=0.210 (e) P=0.202 (e) P=0.387 |
|LOGISTIC REGRESSION| P=0.235 (e) P=0.219 (e) P=0.328 |
|COCH-ARM / FISHERS | P=0.256 (e) P=0.247 (e) P=0.390 |
|ORDER RESTRICTED | P=0.216 (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Epididymis |
| Spermatocele |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | |
|POLY-3 RATE (b) | |
|POLY-3 PERCENT (g) | |
|TERMINAL (d) | |
|FIRST INCIDENCE | |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | |
|POLY 3 | |
|POLY 1.5 | |
|POLY 6 | |
|LOGISTIC REGRESSION| |
|COCH-ARM / FISHERS | |
|ORDER RESTRICTED | |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 14
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Harderian Gland |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/49 (2%) 1/37 (3%) 1/32 (3%) |
|POLY-3 RATE (b) | 2/33.40 0/30.37 1/28.48 1/21.68 1/19.32 |
|POLY-3 PERCENT (g) | 6.0% 0.0% 3.5% 4.6% 5.2% |
|TERMINAL (d) | 1/19 (5%) 0/21 (0%) 0/13 (0%) 0/7 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 601 --- 651 419 627 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.428 P=0.250N P=0.617N P=0.715N P=0.712N |
|POLY 3 | P=0.507 P=0.258N P=0.556N P=0.648N P=0.686N |
|POLY 1.5 | P=0.510 P=0.255N P=0.537N P=0.633N P=0.680N |
|POLY 6 | P=0.498 P=0.255N P=0.580N P=0.668N P=0.692N |
|LOGISTIC REGRESSION| P=0.492 P=0.253N P=0.581N P=0.624N P=0.693N |
|COCH-ARM / FISHERS | P=0.517 P=0.247N P=0.508N P=0.613N P=0.779 |
|ORDER RESTRICTED | P=0.530N (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Harderian Gland |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/49 (0%) 0/49 (0%) 1/50 (2%) 2/40 (5%) 1/41 (2%) |
|POLY-3 RATE (b) | 0/34.94 0/30.96 1/36.65 2/31.97 1/28.81 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 2.7% 6.3% 3.5% |
|TERMINAL (d) | 0/20 (0%) 0/18 (0%) 1/24 (4%) 2/20 (10%) 1/19 (5%) |
|FIRST INCIDENCE | --- --- 668 (T) 668 (T) 668 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.129 (e) P=0.536 P=0.237 P=0.490 |
|POLY 3 | P=0.111 (e) P=0.510 P=0.216 P=0.461 |
|POLY 1.5 | P=0.107 (e) P=0.506 P=0.210 P=0.462 |
|POLY 6 | P=0.116 (e) P=0.517 P=0.220 P=0.461 |
|LOGISTIC REGRESSION| (e) (e) P=0.536 P=0.237 P=0.490 |
|COCH-ARM / FISHERS | P=0.102 (e) P=0.505 P=0.199 P=0.456 |
|ORDER RESTRICTED | P=0.177 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 15
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Heart |
| Cardiomyopathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 12/50 (24%) 7/50 (14%) 19/50 (38%) 13/37 (35%) 7/32 (22%) |
|POLY-3 RATE (b) | 12/35.85 7/30.49 19/35.38 13/25.36 7/20.85 |
|POLY-3 PERCENT (g) | 33.5% 23.0% 53.7% 51.3% 33.6% |
|TERMINAL (d) | 6/19 (32%) 6/21 (29%) 3/13 (23%) 3/7 (43%) 1/8 (13%) |
|FIRST INCIDENCE | 322 640 147 298 329 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.077 P=0.134N P=0.032 * P=0.029 * P=0.469 |
|POLY 3 | P=0.205 P=0.248N P=0.060 P=0.120 P=0.612 |
|POLY 1.5 | P=0.213 P=0.222N P=0.068 P=0.136 P=0.602N |
|POLY 6 | P=0.193 P=0.262N P=0.063 P=0.104 P=0.606 |
|LOGISTIC REGRESSION| P=0.198 P=0.195N P=0.065 P=0.128 P=0.592N |
|COCH-ARM / FISHERS | P=0.267 P=0.154N P=0.097 P=0.185 P=0.523N |
|ORDER RESTRICTED | P=0.138 (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Heart |
| Cardiomyopathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/50 (6%) 2/49 (4%) 6/50 (12%) 1/40 (3%) 2/42 (5%) |
|POLY-3 RATE (b) | 3/36.19 2/31.43 6/37.61 1/31.97 2/29.97 |
|POLY-3 PERCENT (g) | 8.3% 6.4% 16.0% 3.1% 6.7% |
|TERMINAL (d) | 1/20 (5%) 0/18 (0%) 2/24 (8%) 1/20 (5%) 0/19 (0%) |
|FIRST INCIDENCE | 255 560 514 668 (T) 453 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.292N P=0.571N P=0.316 P=0.328N P=0.577N |
|POLY 3 | P=0.296N P=0.565N P=0.257 P=0.349N P=0.586N |
|POLY 1.5 | P=0.317N P=0.538N P=0.249 P=0.357N P=0.588N |
|POLY 6 | P=0.278N P=0.592N P=0.278 P=0.345N P=0.583N |
|LOGISTIC REGRESSION| P=0.342N P=0.507N P=0.247 P=0.433N P=0.567N |
|COCH-ARM / FISHERS | P=0.348N P=0.510N P=0.243 P=0.397N P=0.583N |
|ORDER RESTRICTED | P=0.362N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 16
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Heart |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 5/50 (10%) 3/50 (6%) 2/37 (5%) 1/32 (3%) |
|POLY-3 RATE (b) | 1/33.13 5/31.97 3/29.40 2/21.67 1/19.75 |
|POLY-3 PERCENT (g) | 3.0% 15.6% 10.2% 9.2% 5.1% |
|TERMINAL (d) | 1/19 (5%) 2/21 (10%) 2/13 (15%) 0/7 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 668 (T) 157 608 501 488 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.518 P=0.110 P=0.185 P=0.275 P=0.608 |
|POLY 3 | P=0.507N P=0.089 P=0.261 P=0.354 P=0.641 |
|POLY 1.5 | P=0.497N P=0.089 P=0.278 P=0.367 P=0.641 |
|POLY 6 | P=0.520N P=0.096 P=0.240 P=0.339 P=0.642 |
|LOGISTIC REGRESSION| P=0.479N P=0.096 P=0.210 P=0.351 P=0.647 |
|COCH-ARM / FISHERS | P=0.450N P=0.102 P=0.309 P=0.387 P=0.631 |
|ORDER RESTRICTED | P=0.325 (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Heart |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 7/50 (14%) 1/49 (2%) 2/50 (4%) 2/40 (5%) 2/42 (5%) |
|POLY-3 RATE (b) | 7/37.15 1/31.02 2/36.65 2/32.23 2/29.43 |
|POLY-3 PERCENT (g) | 18.8% 3.2% 5.5% 6.2% 6.8% |
|TERMINAL (d) | 3/20 (15%) 0/18 (0%) 2/24 (8%) 1/20 (5%) 1/19 (5%) |
|FIRST INCIDENCE | 255 655 668 (T) 603 482 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.113N P=0.061N P=0.063N P=0.104N P=0.133N |
|POLY 3 | P=0.113N P=0.051N P=0.078N P=0.111N P=0.141N |
|POLY 1.5 | P=0.127N P=0.041N* P=0.078N P=0.117N P=0.138N |
|POLY 6 | P=0.102N P=0.066N P=0.075N P=0.109N P=0.147N |
|LOGISTIC REGRESSION| P=0.139N P=0.036N* P=0.078N P=0.146N P=0.129N |
|COCH-ARM / FISHERS | P=0.149N P=0.032N* P=0.080N P=0.144N P=0.128N |
|ORDER RESTRICTED | P=0.035N* (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 17
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Heart |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/50 (2%) 1/37 (3%) 0/32 (0%) |
|POLY-3 RATE (b) | 0/33.13 2/31.49 1/29.88 1/21.92 0/19.14 |
|POLY-3 PERCENT (g) | 0.0% 6.4% 3.4% 4.6% 0.0% |
|TERMINAL (d) | 0/19 (0%) 0/21 (0%) 0/13 (0%) 0/7 (0%) 0/8 (0%) |
|FIRST INCIDENCE | --- 432 434 157 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.524N P=0.224 P=0.490 P=0.448 (e) |
|POLY 3 | P=0.548N P=0.225 P=0.479 P=0.418 (e) |
|POLY 1.5 | P=0.540N P=0.223 P=0.487 P=0.426 (e) |
|POLY 6 | P=0.561N P=0.233 P=0.469 P=0.406 (e) |
|LOGISTIC REGRESSION| P=0.458N P=0.246 P=0.521 P=0.441 (e) |
|COCH-ARM / FISHERS | P=0.505N P=0.247 P=0.500 P=0.425 (e) |
|ORDER RESTRICTED | P=0.403 (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Heart |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 3/49 (6%) 2/50 (4%) 1/40 (3%) 2/42 (5%) |
|POLY-3 RATE (b) | 2/35.82 3/32.81 2/38.05 1/32.44 2/30.54 |
|POLY-3 PERCENT (g) | 5.6% 9.1% 5.3% 3.1% 6.6% |
|TERMINAL (d) | 1/20 (5%) 0/18 (0%) 0/24 (0%) 0/20 (0%) 0/19 (0%) |
|FIRST INCIDENCE | 352 417 322 541 207 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.459N P=0.463 P=0.674N P=0.531N P=0.641 |
|POLY 3 | P=0.452N P=0.460 P=0.673N P=0.535N P=0.637 |
|POLY 1.5 | P=0.461N P=0.476 P=0.682N P=0.545N P=0.634 |
|POLY 6 | P=0.446N P=0.445 P=0.658N P=0.526N P=0.641 |
|LOGISTIC REGRESSION| P=0.487N P=0.498 P=0.677 P=0.664N P=0.674 |
|COCH-ARM / FISHERS | P=0.483N P=0.490 P=0.691N P=0.584N P=0.623 |
|ORDER RESTRICTED | P=0.577N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 18
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Heart |
| Thrombosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 4/50 (8%) 5/50 (10%) 3/37 (8%) 3/32 (9%) |
|POLY-3 RATE (b) | 2/34.18 4/32.17 5/30.52 3/21.52 3/19.44 |
|POLY-3 PERCENT (g) | 5.9% 12.4% 16.4% 13.9% 15.4% |
|TERMINAL (d) | 0/19 (0%) 2/21 (10%) 0/13 (0%) 0/7 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 104 236 544 563 635 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.165 P=0.340 P=0.140 P=0.230 P=0.232 |
|POLY 3 | P=0.192 P=0.306 P=0.167 P=0.295 P=0.254 |
|POLY 1.5 | P=0.209 P=0.306 P=0.181 P=0.315 P=0.261 |
|POLY 6 | P=0.174 P=0.316 P=0.155 P=0.273 P=0.248 |
|LOGISTIC REGRESSION| P=0.249 P=0.393 P=0.215 P=0.371 P=0.299 |
|COCH-ARM / FISHERS | P=0.268 P=0.339 P=0.218 P=0.359 P=0.296 |
|ORDER RESTRICTED | P=0.296 (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Heart |
| Thrombosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 3/50 (6%) 0/40 (0%) 1/42 (2%) |
|POLY-3 RATE (b) | 0/34.96 0/30.96 3/39.34 0/31.97 1/29.09 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 7.6% 0.0% 3.4% |
|TERMINAL (d) | 0/20 (0%) 0/18 (0%) 0/24 (0%) 0/20 (0%) 0/19 (0%) |
|FIRST INCIDENCE | --- --- 181 --- 598 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.388 (e) P=0.128 (e) P=0.445 |
|POLY 3 | P=0.449 (e) P=0.140 (e) P=0.463 |
|POLY 1.5 | P=0.424 (e) P=0.133 (e) P=0.463 |
|POLY 6 | P=0.475 (e) P=0.150 (e) P=0.465 |
|LOGISTIC REGRESSION| P=0.424 (e) P=0.063 (e) P=0.462 |
|COCH-ARM / FISHERS | P=0.380 (e) P=0.121 (e) P=0.457 |
|ORDER RESTRICTED | P=0.265 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 19
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Intestine Large, Cecum |
| Edema |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 13/49 (27%) 11/49 (22%) 8/48 (17%) 14/35 (40%) 2/30 (7%) |
|POLY-3 RATE (b) | 13/35.52 11/32.02 8/31.58 14/24.03 2/19.56 |
|POLY-3 PERCENT (g) | 36.6% 34.4% 25.3% 58.3% 10.2% |
|TERMINAL (d) | 8/19 (42%) 8/21 (38%) 2/13 (15%) 4/7 (57%) 1/8 (13%) |
|FIRST INCIDENCE | 392 385 147 341 495 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.503N P=0.372N P=0.372N P=0.019 * P=0.073N |
|POLY 3 | P=0.254N P=0.525N P=0.228N P=0.073 P=0.033N* |
|POLY 1.5 | P=0.234N P=0.503N P=0.200N P=0.092 P=0.032N* |
|POLY 6 | P=0.298N P=0.528N P=0.266N P=0.060 P=0.037N* |
|LOGISTIC REGRESSION| P=0.246N P=0.490N P=0.209N P=0.073 P=0.033N* |
|COCH-ARM / FISHERS | P=0.213N P=0.407N P=0.176N P=0.143 P=0.025N* |
|ORDER RESTRICTED | P=0.039N* (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Intestine Large, Cecum |
| Edema |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/47 (6%) 3/48 (6%) 4/45 (9%) 4/38 (11%) 8/40 (20%) |
|POLY-3 RATE (b) | 3/34.13 3/31.75 4/36.01 4/32.38 8/31.32 |
|POLY-3 PERCENT (g) | 8.8% 9.5% 11.1% 12.4% 25.5% |
|TERMINAL (d) | 1/20 (5%) 1/18 (6%) 1/24 (4%) 1/20 (5%) 2/19 (11%) |
|FIRST INCIDENCE | 588 500 362 530 467 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.027 * P=0.546 P=0.539 P=0.457 P=0.065 |
|POLY 3 | P=0.026 * P=0.631 P=0.530 P=0.471 P=0.066 |
|POLY 1.5 | P=0.021 * P=0.653 P=0.509 P=0.448 P=0.060 |
|POLY 6 | P=0.031 * P=0.603 P=0.556 P=0.490 P=0.074 |
|LOGISTIC REGRESSION| P=0.014 * P=0.648 P=0.470 P=0.410 P=0.057 |
|COCH-ARM / FISHERS | P=0.015 * P=0.651N P=0.475 P=0.381 P=0.057 |
|ORDER RESTRICTED | P=0.031 * (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 20
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Intestine Large, Colon |
| Edema |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/48 (0%) 0/50 (0%) 2/49 (4%) 1/37 (3%) 0/32 (0%) |
|POLY-3 RATE (b) | 0/31.88 0/30.37 2/28.73 1/21.28 0/19.14 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 7.0% 4.7% 0.0% |
|TERMINAL (d) | 0/18 (0%) 0/21 (0%) 0/13 (0%) 0/7 (0%) 0/8 (0%) |
|FIRST INCIDENCE | --- --- 605 580 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.445 (e) P=0.194 P=0.423 (e) |
|POLY 3 | P=0.439 (e) P=0.213 P=0.420 (e) |
|POLY 1.5 | P=0.445 (e) P=0.224 P=0.429 (e) |
|POLY 6 | P=0.430 (e) P=0.202 P=0.409 (e) |
|LOGISTIC REGRESSION| P=0.454 (e) P=0.212 P=0.430 (e) |
|COCH-ARM / FISHERS | P=0.475 (e) P=0.253 P=0.435 (e) |
|ORDER RESTRICTED | P=0.302 (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Intestine Large, Colon |
| Edema |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 1/49 (2%) 1/49 (2%) 0/39 (0%) 1/42 (2%) |
|POLY-3 RATE (b) | 0/34.96 1/31.54 1/37.21 0/31.44 1/29.45 |
|POLY-3 PERCENT (g) | 0.0% 3.2% 2.7% 0.0% 3.4% |
|TERMINAL (d) | 0/20 (0%) 0/18 (0%) 0/24 (0%) 0/20 (0%) 0/19 (0%) |
|FIRST INCIDENCE | --- 500 460 --- 474 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.438 P=0.478 P=0.505 (e) P=0.467 |
|POLY 3 | P=0.464 P=0.479 P=0.512 (e) P=0.466 |
|POLY 1.5 | P=0.452 P=0.488 P=0.506 (e) P=0.464 |
|POLY 6 | P=0.474 P=0.470 P=0.522 (e) P=0.468 |
|LOGISTIC REGRESSION| P=0.421 P=0.499 P=0.478 (e) P=0.475 |
|COCH-ARM / FISHERS | P=0.421 P=0.495 P=0.495 (e) P=0.457 |
|ORDER RESTRICTED | P=0.276 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 21
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Intestine Small, Duodenum |
| Erosion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/36 (0%) 0/32 (0%) |
|POLY-3 RATE (b) | 0/32.39 0/30.37 0/28.72 0/19.93 0/19.14 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/19 (0%) 0/21 (0%) 0/13 (0%) 0/6 (0%) 0/8 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Intestine Small, Duodenum |
| Erosion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 0/48 (0%) 0/40 (0%) 2/42 (5%) |
|POLY-3 RATE (b) | 1/34.96 1/31.04 0/36.41 0/31.97 2/29.78 |
|POLY-3 PERCENT (g) | 2.9% 3.2% 0.0% 0.0% 6.7% |
|TERMINAL (d) | 1/20 (5%) 1/18 (6%) 0/24 (0%) 0/20 (0%) 0/19 (0%) |
|FIRST INCIDENCE | 668 (T) 668 (T) --- --- 530 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.323 P=0.740 P=0.464N P=0.500N P=0.437 |
|POLY 3 | P=0.330 P=0.735 P=0.492N P=0.518N P=0.444 |
|POLY 1.5 | P=0.322 P=0.748 P=0.498N P=0.524N P=0.439 |
|POLY 6 | P=0.333 P=0.720 P=0.484N P=0.513N P=0.452 |
|LOGISTIC REGRESSION| P=0.300 P=0.740 (e) (e) P=0.436 |
|COCH-ARM / FISHERS | P=0.293 P=0.753N P=0.510N P=0.556N P=0.434 |
|ORDER RESTRICTED | P=0.145 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 22
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Intestine Small, Duodenum |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/36 (0%) 0/32 (0%) |
|POLY-3 RATE (b) | 0/32.39 0/30.37 0/28.72 0/19.93 0/19.14 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/19 (0%) 0/21 (0%) 0/13 (0%) 0/6 (0%) 0/8 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Intestine Small, Duodenum |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/48 (4%) 0/40 (0%) 1/42 (2%) |
|POLY-3 RATE (b) | 0/34.96 0/31.04 2/36.97 0/31.97 1/28.81 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 5.4% 0.0% 3.5% |
|TERMINAL (d) | 0/20 (0%) 0/18 (0%) 0/24 (0%) 0/20 (0%) 1/19 (5%) |
|FIRST INCIDENCE | --- --- 537 --- 668 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.345 (e) P=0.262 (e) P=0.490 |
|POLY 3 | P=0.379 (e) P=0.249 (e) P=0.461 |
|POLY 1.5 | P=0.358 (e) P=0.241 (e) P=0.462 |
|POLY 6 | P=0.400 (e) P=0.261 (e) P=0.461 |
|LOGISTIC REGRESSION| P=0.330 (e) P=0.233 (e) P=0.490 |
|COCH-ARM / FISHERS | P=0.319 (e) P=0.237 (e) P=0.457 |
|ORDER RESTRICTED | P=0.269 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 23
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Intestine Small, Duodenum: Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/49 (6%) 4/50 (8%) 4/49 (8%) 1/36 (3%) 1/32 (3%) |
|POLY-3 RATE (b) | 3/32.98 4/31.97 4/28.72 1/20.16 1/19.44 |
|POLY-3 PERCENT (g) | 9.1% 12.5% 13.9% 5.0% 5.1% |
|TERMINAL (d) | 2/19 (11%) 1/21 (5%) 4/13 (31%) 0/6 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 497 467 668 (T) 612 593 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.356N P=0.497 P=0.317 P=0.611N P=0.574N |
|POLY 3 | P=0.252N P=0.483 P=0.423 P=0.493N P=0.507N |
|POLY 1.5 | P=0.232N P=0.479 P=0.454 P=0.466N P=0.500N |
|POLY 6 | P=0.283N P=0.502 P=0.381 P=0.527N P=0.515N |
|LOGISTIC REGRESSION| P=0.232N P=0.484 P=0.386 P=0.489N P=0.501N |
|COCH-ARM / FISHERS | P=0.194N P=0.511 P=0.500 P=0.432N P=0.482N |
|ORDER RESTRICTED | P=0.404N (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Intestine Small, Duodenum: Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 12/50 (24%) 7/50 (14%) 12/48 (25%) 4/40 (10%) 9/42 (21%) |
|POLY-3 RATE (b) | 12/37.69 7/34.28 12/36.78 4/31.97 9/29.70 |
|POLY-3 PERCENT (g) | 31.8% 20.4% 32.6% 12.5% 30.3% |
|TERMINAL (d) | 7/20 (35%) 2/18 (11%) 8/24 (33%) 4/20 (20%) 7/19 (37%) |
|FIRST INCIDENCE | 372 341 631 668 (T) 530 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.220N P=0.247N P=0.430N P=0.032N* P=0.419N |
|POLY 3 | P=0.308N P=0.200N P=0.570 P=0.047N* P=0.552N |
|POLY 1.5 | P=0.321N P=0.172N P=0.565 P=0.050N P=0.529N |
|POLY 6 | P=0.306N P=0.232N P=0.584 P=0.048N* P=0.576N |
|LOGISTIC REGRESSION| P=0.299N P=0.164N P=0.557N P=0.047N* P=0.501N |
|COCH-ARM / FISHERS | P=0.354N P=0.154N P=0.547 P=0.072N P=0.484N |
|ORDER RESTRICTED | P=0.270N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 24
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Intestine Small, Jejunum: Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/49 (8%) 2/50 (4%) 0/46 (0%) 1/36 (3%) 1/29 (3%) |
|POLY-3 RATE (b) | 4/33.56 2/31.21 0/28.05 1/20.92 1/18.70 |
|POLY-3 PERCENT (g) | 11.9% 6.4% 0.0% 4.8% 5.4% |
|TERMINAL (d) | 1/19 (5%) 1/21 (5%) 0/13 (0%) 1/7 (14%) 0/8 (0%) |
|FIRST INCIDENCE | 413 363 --- 668 (T) 488 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.281N P=0.354N P=0.106N P=0.453N P=0.391N |
|POLY 3 | P=0.221N P=0.369N P=0.083N P=0.345N P=0.389N |
|POLY 1.5 | P=0.213N P=0.363N P=0.076N P=0.318N P=0.385N |
|POLY 6 | P=0.237N P=0.368N P=0.095N P=0.387N P=0.397N |
|LOGISTIC REGRESSION| P=0.214N P=0.341N P=0.075N P=0.317N P=0.372N |
|COCH-ARM / FISHERS | P=0.208N P=0.329N P=0.067N P=0.291N P=0.381N |
|ORDER RESTRICTED | P=0.191N (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Intestine Small, Jejunum: Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/46 (0%) 1/49 (2%) 1/46 (2%) 0/40 (0%) 1/40 (3%) |
|POLY-3 RATE (b) | 0/32.73 1/31.06 1/35.55 0/31.97 1/29.37 |
|POLY-3 PERCENT (g) | 0.0% 3.2% 2.8% 0.0% 3.4% |
|TERMINAL (d) | 0/20 (0%) 0/18 (0%) 1/24 (4%) 0/20 (0%) 0/19 (0%) |
|FIRST INCIDENCE | --- 644 668 (T) --- 332 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.449 P=0.464 P=0.536 (e) P=0.466 |
|POLY 3 | P=0.467 P=0.490 P=0.516 (e) P=0.478 |
|POLY 1.5 | P=0.457 P=0.500 P=0.510 (e) P=0.476 |
|POLY 6 | P=0.473 P=0.477 P=0.525 (e) P=0.480 |
|LOGISTIC REGRESSION| P=0.421 P=0.475 P=0.536 (e) P=0.516 |
|COCH-ARM / FISHERS | P=0.428 P=0.516 P=0.500 (e) P=0.465 |
|ORDER RESTRICTED | P=0.287 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 25
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 15/50 (30%) 13/50 (26%) 12/50 (24%) 6/36 (17%) 6/31 (19%) |
|POLY-3 RATE (b) | 15/38.90 13/34.71 12/33.74 6/22.28 6/20.45 |
|POLY-3 PERCENT (g) | 38.6% 37.5% 35.6% 26.9% 29.3% |
|TERMINAL (d) | 4/19 (21%) 6/21 (29%) 1/13 (8%) 1/6 (17%) 1/8 (13%) |
|FIRST INCIDENCE | 322 236 320 341 473 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.263N P=0.448N P=0.567N P=0.359N P=0.348N |
|POLY 3 | P=0.177N P=0.557N P=0.492N P=0.262N P=0.338N |
|POLY 1.5 | P=0.141N P=0.529N P=0.429N P=0.202N P=0.305N |
|POLY 6 | P=0.237N P=0.563N P=0.558N P=0.348N P=0.381N |
|LOGISTIC REGRESSION| P=0.104N P=0.438N P=0.343N P=0.132N P=0.230N |
|COCH-ARM / FISHERS | P=0.089N P=0.412N P=0.326N P=0.121N P=0.213N |
|ORDER RESTRICTED | P=0.399N (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 5/49 (10%) 6/49 (12%) 7/40 (18%) 10/41 (24%) |
|POLY-3 RATE (b) | 2/35.26 5/31.54 6/38.30 7/32.22 10/31.73 |
|POLY-3 PERCENT (g) | 5.7% 15.9% 15.7% 21.7% 31.5% |
|TERMINAL (d) | 1/20 (5%) 4/18 (22%) 3/24 (13%) 6/20 (30%) 4/19 (21%) |
|FIRST INCIDENCE | 593 500 425 608 453 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.005 ** P=0.162 P=0.176 P=0.075 P=0.010 * |
|POLY 3 | P=0.003 ** P=0.168 P=0.158 P=0.053 P=0.005 ** |
|POLY 1.5 | P=0.002 ** P=0.189 P=0.145 P=0.049 * P=0.004 ** |
|POLY 6 | P=0.004 ** P=0.146 P=0.177 P=0.055 P=0.007 ** |
|LOGISTIC REGRESSION| P=0.002 ** P=0.153 P=0.133 P=0.063 P=0.005 ** |
|COCH-ARM / FISHERS | P=0.002 ** P=0.210 P=0.128 P=0.038 * P=0.005 ** |
|ORDER RESTRICTED | P=0.004 ** (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 26
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Kidney |
| Amyloid Deposition |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) 0/50 (0%) 0/37 (0%) 0/32 (0%) |
|POLY-3 RATE (b) | 3/35.36 0/30.37 0/29.15 0/20.93 0/19.14 |
|POLY-3 PERCENT (g) | 8.5% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/19 (0%) 0/21 (0%) 0/13 (0%) 0/7 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 373 --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.057N P=0.148N P=0.134N P=0.210N P=0.240N |
|POLY 3 | P=0.044N* P=0.146N P=0.155N P=0.231N P=0.250N |
|POLY 1.5 | P=0.043N* P=0.140N P=0.140N P=0.210N P=0.239N |
|POLY 6 | P=0.048N* P=0.148N P=0.177N P=0.258N P=0.263N |
|LOGISTIC REGRESSION| P=0.043N* P=0.087N P=0.098N P=0.140N P=0.159N |
|COCH-ARM / FISHERS | P=0.050N P=0.121N P=0.121N P=0.185N P=0.221N |
|ORDER RESTRICTED | P=0.042N* (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Kidney |
| Amyloid Deposition |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) 0/40 (0%) 2/42 (5%) |
|POLY-3 RATE (b) | 2/34.96 0/31.04 1/37.53 0/31.97 2/30.57 |
|POLY-3 PERCENT (g) | 5.7% 0.0% 2.7% 0.0% 6.5% |
|TERMINAL (d) | 2/20 (10%) 0/18 (0%) 0/24 (0%) 0/20 (0%) 0/19 (0%) |
|FIRST INCIDENCE | 668 (T) --- 328 --- 43 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.459 P=0.260N P=0.455N P=0.237N P=0.656 |
|POLY 3 | P=0.491 P=0.263N P=0.475N P=0.255N P=0.647 |
|POLY 1.5 | P=0.469 P=0.250N P=0.485N P=0.263N P=0.642 |
|POLY 6 | P=0.509 P=0.279N P=0.461N P=0.250N P=0.653 |
|LOGISTIC REGRESSION| P=0.429 (e) P=0.503N (e) P=0.659 |
|COCH-ARM / FISHERS | P=0.425 P=0.247N P=0.500N P=0.306N P=0.623 |
|ORDER RESTRICTED | P=0.267 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 27
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Kidney |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 27/50 (54%) 23/50 (46%) 26/50 (52%) 24/37 (65%) 17/32 (53%) |
|POLY-3 RATE (b) | 27/38.88 23/33.16 26/35.47 24/26.73 17/23.92 |
|POLY-3 PERCENT (g) | 69.5% 69.4% 73.3% 89.8% 71.1% |
|TERMINAL (d) | 15/19 (79%) 17/21 (81%) 9/13 (69%) 7/7 (100%) 4/8 (50%) |
|FIRST INCIDENCE | 322 432 229 301 229 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.015 * P=0.229N P=0.185 P=0.006 ** P=0.255 |
|POLY 3 | P=0.171 P=0.607N P=0.451 P=0.028 * P=0.563 |
|POLY 1.5 | P=0.165 P=0.512N P=0.524 P=0.057 P=0.537 |
|POLY 6 | P=0.225 P=0.596 P=0.424 P=0.022 * P=0.628N |
|LOGISTIC REGRESSION| P=0.096 P=0.430N P=0.475 P=0.050 P=0.480 |
|COCH-ARM / FISHERS | P=0.247 P=0.274N P=0.500N P=0.213 P=0.559N |
|ORDER RESTRICTED | P=0.238 (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Kidney |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 7/50 (14%) 5/50 (10%) 7/40 (18%) 5/42 (12%) |
|POLY-3 RATE (b) | 2/35.79 7/35.16 5/37.71 7/32.90 5/31.34 |
|POLY-3 PERCENT (g) | 5.6% 19.9% 13.3% 21.3% 16.0% |
|TERMINAL (d) | 1/20 (5%) 2/18 (11%) 3/24 (13%) 4/20 (20%) 1/19 (5%) |
|FIRST INCIDENCE | 372 219 432 497 43 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.207 P=0.078 P=0.266 P=0.080 P=0.168 |
|POLY 3 | P=0.170 P=0.069 P=0.235 P=0.055 P=0.160 |
|POLY 1.5 | P=0.158 P=0.076 P=0.226 P=0.050 P=0.156 |
|POLY 6 | P=0.187 P=0.062 P=0.252 P=0.060 P=0.168 |
|LOGISTIC REGRESSION| P=0.130 P=0.086 P=0.219 P=0.047 * P=0.164 |
|COCH-ARM / FISHERS | P=0.139 P=0.080 P=0.218 P=0.038 * P=0.152 |
|ORDER RESTRICTED | P=0.109 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 28
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Kidney |
| Hydronephrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 30/50 (60%) 20/50 (40%) 17/50 (34%) 16/37 (43%) 14/32 (44%) |
|POLY-3 RATE (b) | 30/42.16 20/37.16 17/36.51 16/25.32 14/24.87 |
|POLY-3 PERCENT (g) | 71.2% 53.8% 46.6% 63.2% 56.3% |
|TERMINAL (d) | 12/19 (63%) 10/21 (48%) 2/13 (15%) 4/7 (57%) 4/8 (50%) |
|FIRST INCIDENCE | 104 168 315 329 41 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.426 P=0.075N P=0.154N P=0.482 P=0.433N |
|POLY 3 | P=0.230N P=0.074N P=0.016N* P=0.333N P=0.152N |
|POLY 1.5 | P=0.209N P=0.066N P=0.013N* P=0.239N P=0.145N |
|POLY 6 | P=0.265N P=0.075N P=0.020N* P=0.425N P=0.169N |
|LOGISTIC REGRESSION| P=0.205N P=0.045N* P=0.010N* P=0.142N P=0.121N |
|COCH-ARM / FISHERS | P=0.173N P=0.036N* P=0.008N** P=0.092N P=0.113N |
|ORDER RESTRICTED | P=0.137N (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Kidney |
| Hydronephrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 7/50 (14%) 5/50 (10%) 5/40 (13%) 3/42 (7%) |
|POLY-3 RATE (b) | 2/34.96 7/33.14 5/39.05 5/32.78 3/30.44 |
|POLY-3 PERCENT (g) | 5.7% 21.1% 12.8% 15.3% 9.9% |
|TERMINAL (d) | 2/20 (10%) 3/18 (17%) 0/24 (0%) 2/20 (10%) 0/19 (0%) |
|FIRST INCIDENCE | 668 (T) 326 432 541 332 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.528N P=0.053 P=0.266 P=0.213 P=0.449 |
|POLY 3 | P=0.531 P=0.061 P=0.261 P=0.185 P=0.436 |
|POLY 1.5 | P=0.508 P=0.070 P=0.241 P=0.171 P=0.428 |
|POLY 6 | P=0.549N P=0.055 P=0.292 P=0.201 P=0.447 |
|LOGISTIC REGRESSION| P=0.472 P=0.065 P=0.216 P=0.181 P=0.421 |
|COCH-ARM / FISHERS | P=0.470 P=0.080 P=0.218 P=0.136 P=0.417 |
|ORDER RESTRICTED | P=0.241 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 29
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Kidney |
| Infarct |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/37 (3%) 1/32 (3%) |
|POLY-3 RATE (b) | 1/33.13 0/30.37 0/29.15 1/21.51 1/19.44 |
|POLY-3 PERCENT (g) | 3.0% 0.0% 0.0% 4.7% 5.1% |
|TERMINAL (d) | 1/19 (5%) 0/21 (0%) 0/13 (0%) 0/7 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 668 (T) --- --- 501 593 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.210 P=0.480N P=0.576N P=0.613 P=0.595 |
|POLY 3 | P=0.256 P=0.517N P=0.526N P=0.661 P=0.637 |
|POLY 1.5 | P=0.254 P=0.516N P=0.515N P=0.671 P=0.639 |
|POLY 6 | P=0.256 P=0.514N P=0.539N P=0.648 P=0.636 |
|LOGISTIC REGRESSION| P=0.242 (e) (e) P=0.673 P=0.633 |
|COCH-ARM / FISHERS | P=0.256 P=0.500N P=0.500N P=0.673 P=0.631 |
|ORDER RESTRICTED | P=0.325 (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Kidney |
| Infarct |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 3/50 (6%) 2/40 (5%) 0/42 (0%) |
|POLY-3 RATE (b) | 0/34.96 1/31.04 3/37.71 2/32.58 0/28.81 |
|POLY-3 PERCENT (g) | 0.0% 3.2% 8.0% 6.1% 0.0% |
|TERMINAL (d) | 0/20 (0%) 1/18 (6%) 1/24 (4%) 1/20 (5%) 0/19 (0%) |
|FIRST INCIDENCE | --- 668 (T) 514 488 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.571N P=0.479 P=0.137 P=0.237 (e) |
|POLY 3 | P=0.567 P=0.476 P=0.131 P=0.220 (e) |
|POLY 1.5 | P=0.554 P=0.488 P=0.126 P=0.211 (e) |
|POLY 6 | P=0.581 P=0.464 P=0.142 P=0.227 (e) |
|LOGISTIC REGRESSION| P=0.549 P=0.479 P=0.120 P=0.181 (e) |
|COCH-ARM / FISHERS | P=0.542 P=0.500 P=0.121 P=0.195 (e) |
|ORDER RESTRICTED | P=0.251 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 30
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Kidney |
| Infiltration Cellular Mixed Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 9/50 (18%) 11/50 (22%) 17/50 (34%) 9/37 (24%) 12/32 (38%) |
|POLY-3 RATE (b) | 9/35.03 11/30.84 17/31.57 9/22.37 12/23.36 |
|POLY-3 PERCENT (g) | 25.7% 35.7% 53.9% 40.2% 51.4% |
|TERMINAL (d) | 5/19 (26%) 9/21 (43%) 9/13 (69%) 4/7 (57%) 3/8 (38%) |
|FIRST INCIDENCE | 322 580 538 531 329 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.002 ** P=0.445 P=0.007 ** P=0.062 P=0.017 * |
|POLY 3 | P=0.031 * P=0.267 P=0.013 * P=0.190 P=0.035 * |
|POLY 1.5 | P=0.030 * P=0.295 P=0.022 * P=0.231 P=0.031 * |
|POLY 6 | P=0.032 * P=0.261 P=0.007 ** P=0.154 P=0.041 * |
|LOGISTIC REGRESSION| P=0.017 * P=0.317 P=0.015 * P=0.198 P=0.030 * |
|COCH-ARM / FISHERS | P=0.046 * P=0.402 P=0.055 P=0.324 P=0.044 * |
|ORDER RESTRICTED | P=0.031 * (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Kidney |
| Infiltration Cellular Mixed Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 10/50 (20%) 20/50 (40%) 15/50 (30%) 14/40 (35%) 15/42 (36%) |
|POLY-3 RATE (b) | 10/37.52 20/39.54 15/38.49 14/35.56 15/33.38 |
|POLY-3 PERCENT (g) | 26.7% 50.6% 39.0% 39.4% 44.9% |
|TERMINAL (d) | 4/20 (20%) 5/18 (28%) 9/24 (38%) 7/20 (35%) 7/19 (37%) |
|FIRST INCIDENCE | 372 326 425 359 332 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.309 P=0.021 * P=0.314 P=0.223 P=0.110 |
|POLY 3 | P=0.230 P=0.022 * P=0.180 P=0.177 P=0.081 |
|POLY 1.5 | P=0.192 P=0.023 * P=0.177 P=0.149 P=0.072 |
|POLY 6 | P=0.270 P=0.024 * P=0.194 P=0.201 P=0.094 |
|LOGISTIC REGRESSION| P=0.156 P=0.025 * P=0.197 P=0.091 P=0.069 |
|COCH-ARM / FISHERS | P=0.148 P=0.024 * P=0.178 P=0.087 P=0.073 |
|ORDER RESTRICTED | P=0.088 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 31
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Kidney |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/50 (8%) 0/50 (0%) 0/50 (0%) 0/37 (0%) 0/32 (0%) |
|POLY-3 RATE (b) | 4/35.28 0/30.37 0/29.15 0/20.93 0/19.14 |
|POLY-3 PERCENT (g) | 11.3% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/19 (0%) 0/21 (0%) 0/13 (0%) 0/7 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 104 --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.032N* P=0.078N P=0.091N P=0.154N P=0.161N |
|POLY 3 | P=0.019N* P=0.080N P=0.086N P=0.149N P=0.166N |
|POLY 1.5 | P=0.018N* P=0.076N P=0.076N P=0.132N P=0.158N |
|POLY 6 | P=0.021N* P=0.080N P=0.103N P=0.173N P=0.177N |
|LOGISTIC REGRESSION| P=0.020N* P=0.044N* P=0.049N* P=0.080N P=0.097N |
|COCH-ARM / FISHERS | P=0.024N* P=0.059N P=0.059N P=0.103N P=0.132N |
|ORDER RESTRICTED | P=0.018N* (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Kidney |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/40 (0%) 0/42 (0%) |
|POLY-3 RATE (b) | 0/34.96 0/31.04 0/36.65 0/31.97 0/28.81 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/20 (0%) 0/18 (0%) 0/24 (0%) 0/20 (0%) 0/19 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 32
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Kidney |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 1/50 (2%) 2/37 (5%) 0/32 (0%) |
|POLY-3 RATE (b) | 1/34.03 2/32.27 1/30.05 2/22.75 0/19.14 |
|POLY-3 PERCENT (g) | 2.9% 6.2% 3.3% 8.8% 0.0% |
|TERMINAL (d) | 0/19 (0%) 0/21 (0%) 0/13 (0%) 0/7 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 308 147 308 298 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.482N P=0.474 P=0.747 P=0.372 P=0.607N |
|POLY 3 | P=0.518N P=0.481 P=0.734 P=0.361 P=0.613N |
|POLY 1.5 | P=0.507N P=0.482 P=0.744 P=0.373 P=0.608N |
|POLY 6 | P=0.530N P=0.489 P=0.719 P=0.343 P=0.618N |
|LOGISTIC REGRESSION| P=0.332N P=0.677 P=0.738N P=0.498 P=0.499N |
|COCH-ARM / FISHERS | P=0.465N P=0.500 P=0.753N P=0.387 P=0.610N |
|ORDER RESTRICTED | P=0.378N (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Kidney |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) 0/50 (0%) 0/40 (0%) 0/42 (0%) |
|POLY-3 RATE (b) | 3/35.88 0/31.04 0/36.65 0/31.97 0/28.81 |
|POLY-3 PERCENT (g) | 8.4% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/20 (10%) 0/18 (0%) 0/24 (0%) 0/20 (0%) 0/19 (0%) |
|FIRST INCIDENCE | 287 --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.035N* P=0.132N P=0.100N P=0.130N P=0.138N |
|POLY 3 | P=0.033N* P=0.145N P=0.113N P=0.137N P=0.159N |
|POLY 1.5 | P=0.036N* P=0.132N P=0.116N P=0.143N P=0.158N |
|POLY 6 | P=0.030N* P=0.159N P=0.108N P=0.133N P=0.160N |
|LOGISTIC REGRESSION| P=0.045N* P=0.118N P=0.123N P=0.183N P=0.151N |
|COCH-ARM / FISHERS | P=0.043N* P=0.121N P=0.121N P=0.167N P=0.156N |
|ORDER RESTRICTED | P=0.009N** (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 33
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Kidney |
| Metaplasia Osseous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 1/50 (2%) 0/37 (0%) 0/32 (0%) |
|POLY-3 RATE (b) | 1/33.13 1/30.37 1/29.53 0/20.93 0/19.14 |
|POLY-3 PERCENT (g) | 3.0% 3.3% 3.4% 0.0% 0.0% |
|TERMINAL (d) | 1/19 (5%) 1/21 (5%) 0/13 (0%) 0/7 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 668 (T) 668 (T) 570 --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.298N P=0.741N P=0.700 P=0.699N P=0.672N |
|POLY 3 | P=0.246N P=0.742 P=0.736 P=0.590N P=0.608N |
|POLY 1.5 | P=0.235N P=0.744 P=0.745 P=0.580N P=0.605N |
|POLY 6 | P=0.263N P=0.747 P=0.723 P=0.604N P=0.612N |
|LOGISTIC REGRESSION| P=0.246N P=0.741N P=0.732 (e) (e) |
|COCH-ARM / FISHERS | P=0.218N P=0.753N P=0.753N P=0.575N P=0.610N |
|ORDER RESTRICTED | P=0.424N (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Kidney |
| Metaplasia Osseous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/40 (0%) 2/42 (5%) |
|POLY-3 RATE (b) | 1/35.25 0/31.04 0/36.65 0/31.97 2/28.91 |
|POLY-3 PERCENT (g) | 2.8% 0.0% 0.0% 0.0% 6.9% |
|TERMINAL (d) | 0/20 (0%) 0/18 (0%) 0/24 (0%) 0/20 (0%) 1/19 (5%) |
|FIRST INCIDENCE | 598 --- --- --- 645 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.174 P=0.564N P=0.480N P=0.514N P=0.446 |
|POLY 3 | P=0.191 P=0.525N P=0.492N P=0.520N P=0.430 |
|POLY 1.5 | P=0.179 P=0.513N P=0.495N P=0.525N P=0.432 |
|POLY 6 | P=0.200 P=0.539N P=0.487N P=0.517N P=0.428 |
|LOGISTIC REGRESSION| P=0.163 P=0.514N P=0.496N P=0.536N P=0.432 |
|COCH-ARM / FISHERS | P=0.153 P=0.500N P=0.500N P=0.556N P=0.434 |
|ORDER RESTRICTED | P=0.052 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 34
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 40/50 (80%) 40/50 (80%) 42/50 (84%) 30/37 (81%) 23/32 (72%) |
|POLY-3 RATE (b) | 40/44.84 40/42.51 42/43.51 30/31.20 23/24.60 |
|POLY-3 PERCENT (g) | 89.2% 94.1% 96.5% 96.2% 93.5% |
|TERMINAL (d) | 17/19 (90%) 20/21 (95%) 13/13 (100%) 7/7 (100%) 7/8 (88%) |
|FIRST INCIDENCE | 111 157 147 301 404 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.120 P=0.551 P=0.076 P=0.047 * P=0.361 |
|POLY 3 | P=0.208 P=0.311 P=0.142 P=0.226 P=0.432 |
|POLY 1.5 | P=0.338 P=0.367 P=0.201 P=0.275 P=0.536 |
|POLY 6 | P=0.194 P=0.297 P=0.127 P=0.232 P=0.425 |
|LOGISTIC REGRESSION| P=0.400N P=0.396 P=0.248 P=0.339 P=0.497N |
|COCH-ARM / FISHERS | P=0.238N P=0.598N P=0.398 P=0.562 P=0.278N |
|ORDER RESTRICTED | P=0.222 (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 29/50 (58%) 31/50 (62%) 41/50 (82%) 26/40 (65%) 33/42 (79%) |
|POLY-3 RATE (b) | 29/43.26 31/45.61 41/47.70 26/38.11 33/40.07 |
|POLY-3 PERCENT (g) | 67.0% 68.0% 86.0% 68.2% 82.4% |
|TERMINAL (d) | 12/20 (60%) 7/18 (39%) 20/24 (83%) 11/20 (55%) 14/19 (74%) |
|FIRST INCIDENCE | 248 207 237 359 43 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.310 P=0.244 P=0.152 P=0.458N P=0.134 |
|POLY 3 | P=0.111 P=0.555 P=0.022 * P=0.551 P=0.077 |
|POLY 1.5 | P=0.080 P=0.525 P=0.012 * P=0.486 P=0.056 |
|POLY 6 | P=0.156 P=0.595 P=0.046 * P=0.590N P=0.116 |
|LOGISTIC REGRESSION| P=0.033 * P=0.459 P=0.009 ** P=0.321 P=0.031 * |
|COCH-ARM / FISHERS | P=0.038 * P=0.419 P=0.008 ** P=0.324 P=0.030 * |
|ORDER RESTRICTED | P=0.074 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 35
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Accumulation, Hyaline Droplet |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/37 (0%) 0/32 (0%) |
|POLY-3 RATE (b) | 0/33.13 0/30.37 0/29.15 0/20.93 0/19.14 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/19 (0%) 0/21 (0%) 0/13 (0%) 0/7 (0%) 0/8 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Accumulation, Hyaline Droplet |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 2/50 (4%) 3/40 (8%) 3/42 (7%) |
|POLY-3 RATE (b) | 1/35.38 2/31.50 2/37.65 3/32.64 3/29.94 |
|POLY-3 PERCENT (g) | 2.8% 6.4% 5.3% 9.2% 10.0% |
|TERMINAL (d) | 0/20 (0%) 0/18 (0%) 0/24 (0%) 1/20 (5%) 0/19 (0%) |
|FIRST INCIDENCE | 558 577 524 510 530 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.138 P=0.402 P=0.497 P=0.288 P=0.225 |
|POLY 3 | P=0.133 P=0.459 P=0.522 P=0.274 P=0.245 |
|POLY 1.5 | P=0.124 P=0.479 P=0.513 P=0.263 P=0.242 |
|POLY 6 | P=0.141 P=0.439 P=0.537 P=0.283 P=0.251 |
|LOGISTIC REGRESSION| P=0.113 P=0.478 P=0.494 P=0.236 P=0.243 |
|COCH-ARM / FISHERS | P=0.112 P=0.500 P=0.500 P=0.229 P=0.245 |
|ORDER RESTRICTED | P=0.212 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 36
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Dilatation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 5/50 (10%) 2/37 (5%) 1/32 (3%) |
|POLY-3 RATE (b) | 0/33.13 1/31.13 5/32.45 2/21.97 1/19.62 |
|POLY-3 PERCENT (g) | 0.0% 3.2% 15.4% 9.1% 5.1% |
|TERMINAL (d) | 0/19 (0%) 0/21 (0%) 0/13 (0%) 0/7 (0%) 0/8 (0%) |
|FIRST INCIDENCE | --- 418 376 434 539 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.244 P=0.480 P=0.033 * P=0.150 P=0.402 |
|POLY 3 | P=0.215 P=0.488 P=0.027 * P=0.151 P=0.396 |
|POLY 1.5 | P=0.221 P=0.487 P=0.028 * P=0.157 P=0.397 |
|POLY 6 | P=0.206 P=0.493 P=0.025 * P=0.144 P=0.395 |
|LOGISTIC REGRESSION| P=0.278 P=0.536 P=0.039 * P=0.179 P=0.409 |
|COCH-ARM / FISHERS | P=0.258 P=0.500 P=0.028 * P=0.178 P=0.390 |
|ORDER RESTRICTED | P=0.124 (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Dilatation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) 0/50 (0%) 1/40 (3%) 0/42 (0%) |
|POLY-3 RATE (b) | 1/34.96 3/32.90 0/36.65 1/32.58 0/28.81 |
|POLY-3 PERCENT (g) | 2.9% 9.1% 0.0% 3.1% 0.0% |
|TERMINAL (d) | 1/20 (5%) 0/18 (0%) 0/24 (0%) 0/20 (0%) 0/19 (0%) |
|FIRST INCIDENCE | 668 (T) 417 --- 488 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.173N P=0.273 P=0.464N P=0.757 P=0.510N |
|POLY 3 | P=0.199N P=0.282 P=0.491N P=0.746 P=0.539N |
|POLY 1.5 | P=0.196N P=0.294 P=0.494N P=0.737 P=0.538N |
|POLY 6 | P=0.203N P=0.272 P=0.483N P=0.754 P=0.539N |
|LOGISTIC REGRESSION| P=0.198N P=0.312 (e) P=0.712 (e) |
|COCH-ARM / FISHERS | P=0.190N P=0.309 P=0.500N P=0.694 P=0.543N |
|ORDER RESTRICTED | P=0.146N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 37
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) 0/50 (0%) 1/37 (3%) 0/32 (0%) |
|POLY-3 RATE (b) | 3/34.31 0/30.37 0/29.15 1/21.09 0/19.14 |
|POLY-3 PERCENT (g) | 8.7% 0.0% 0.0% 4.7% 0.0% |
|TERMINAL (d) | 0/19 (0%) 0/21 (0%) 0/13 (0%) 0/7 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 392 --- --- 631 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.209N P=0.148N P=0.169N P=0.558N P=0.263N |
|POLY 3 | P=0.155N P=0.140N P=0.148N P=0.491N P=0.242N |
|POLY 1.5 | P=0.154N P=0.136N P=0.136N P=0.464N P=0.234N |
|POLY 6 | P=0.160N P=0.140N P=0.168N P=0.525N P=0.253N |
|LOGISTIC REGRESSION| P=0.171N P=0.122N P=0.122N P=0.440N P=0.211N |
|COCH-ARM / FISHERS | P=0.162N P=0.121N P=0.121N P=0.429N P=0.221N |
|ORDER RESTRICTED | P=0.070N (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/40 (3%) 0/42 (0%) |
|POLY-3 RATE (b) | 0/34.96 0/31.04 1/36.85 1/32.73 0/28.81 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 2.7% 3.1% 0.0% |
|TERMINAL (d) | 0/20 (0%) 0/18 (0%) 0/24 (0%) 0/20 (0%) 0/19 (0%) |
|FIRST INCIDENCE | --- --- 619 414 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.503 (e) P=0.551 P=0.485 (e) |
|POLY 3 | P=0.502 (e) P=0.511 P=0.487 (e) |
|POLY 1.5 | P=0.491 (e) P=0.506 P=0.479 (e) |
|POLY 6 | P=0.516 (e) P=0.519 P=0.493 (e) |
|LOGISTIC REGRESSION| P=0.474 (e) P=0.507 P=0.293 (e) |
|COCH-ARM / FISHERS | P=0.479 (e) P=0.500 P=0.444 (e) |
|ORDER RESTRICTED | P=0.413 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 38
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 2/50 (4%) 2/37 (5%) 0/32 (0%) |
|POLY-3 RATE (b) | 0/33.13 1/30.37 2/29.86 2/21.81 0/19.14 |
|POLY-3 PERCENT (g) | 0.0% 3.3% 6.7% 9.2% 0.0% |
|TERMINAL (d) | 0/19 (0%) 1/21 (5%) 0/13 (0%) 0/7 (0%) 0/8 (0%) |
|FIRST INCIDENCE | --- 668 (T) 544 434 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.366 P=0.520 P=0.202 P=0.124 (e) |
|POLY 3 | P=0.383 P=0.483 P=0.213 P=0.150 (e) |
|POLY 1.5 | P=0.390 P=0.484 P=0.222 P=0.157 (e) |
|POLY 6 | P=0.372 P=0.486 P=0.204 P=0.142 (e) |
|LOGISTIC REGRESSION| P=0.409 P=0.520 P=0.224 P=0.172 (e) |
|COCH-ARM / FISHERS | P=0.428 P=0.500 P=0.247 P=0.178 (e) |
|ORDER RESTRICTED | P=0.290 (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 1/50 (2%) 2/40 (5%) 2/42 (5%) |
|POLY-3 RATE (b) | 1/35.26 1/31.40 1/37.13 2/32.61 2/29.41 |
|POLY-3 PERCENT (g) | 2.8% 3.2% 2.7% 6.1% 6.8% |
|TERMINAL (d) | 0/20 (0%) 0/18 (0%) 0/24 (0%) 0/20 (0%) 0/19 (0%) |
|FIRST INCIDENCE | 593 577 537 565 593 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.207 P=0.675 P=0.753N P=0.466 P=0.422 |
|POLY 3 | P=0.205 P=0.735 P=0.750N P=0.472 P=0.436 |
|POLY 1.5 | P=0.196 P=0.748 P=0.754N P=0.460 P=0.435 |
|POLY 6 | P=0.215 P=0.721 P=0.742N P=0.484 P=0.440 |
|LOGISTIC REGRESSION| P=0.183 P=0.753 P=0.762 P=0.426 P=0.435 |
|COCH-ARM / FISHERS | P=0.180 P=0.753N P=0.753N P=0.416 P=0.434 |
|ORDER RESTRICTED | P=0.386 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 39
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Liver |
| Basophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 4/50 (8%) 2/50 (4%) 2/37 (5%) 0/32 (0%) |
|POLY-3 RATE (b) | 2/33.13 4/30.37 2/29.39 2/21.55 0/19.14 |
|POLY-3 PERCENT (g) | 6.0% 13.2% 6.8% 9.3% 0.0% |
|TERMINAL (d) | 2/19 (11%) 4/21 (19%) 0/13 (0%) 0/7 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 668 (T) 668 (T) 633 580 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.363N P=0.380 P=0.557 P=0.423 P=0.442N |
|POLY 3 | P=0.231N P=0.294 P=0.652 P=0.532 P=0.366N |
|POLY 1.5 | P=0.223N P=0.299 P=0.668 P=0.548 P=0.362N |
|POLY 6 | P=0.242N P=0.300 P=0.631 P=0.515 P=0.371N |
|LOGISTIC REGRESSION| P=0.257N P=0.380 P=0.595 P=0.503 (e) |
|COCH-ARM / FISHERS | P=0.195N P=0.339 P=0.691N P=0.571 P=0.369N |
|ORDER RESTRICTED | P=0.208N (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Liver |
| Basophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/40 (0%) 1/42 (2%) |
|POLY-3 RATE (b) | 0/34.96 0/31.04 1/36.66 0/31.97 1/28.81 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 2.7% 0.0% 3.5% |
|TERMINAL (d) | 0/20 (0%) 0/18 (0%) 0/24 (0%) 0/20 (0%) 1/19 (5%) |
|FIRST INCIDENCE | --- --- 666 --- 668 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.267 (e) P=0.545 (e) P=0.490 |
|POLY 3 | P=0.281 (e) P=0.509 (e) P=0.461 |
|POLY 1.5 | P=0.266 (e) P=0.506 (e) P=0.462 |
|POLY 6 | P=0.295 (e) P=0.517 (e) P=0.461 |
|LOGISTIC REGRESSION| P=0.260 (e) P=0.537 (e) P=0.490 |
|COCH-ARM / FISHERS | P=0.235 (e) P=0.500 (e) P=0.457 |
|ORDER RESTRICTED | P=0.183 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 40
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Liver |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 1/37 (3%) 0/32 (0%) |
|POLY-3 RATE (b) | 0/33.13 0/30.37 2/29.85 1/21.38 0/19.14 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 6.7% 4.7% 0.0% |
|TERMINAL (d) | 0/19 (0%) 0/21 (0%) 0/13 (0%) 0/7 (0%) 0/8 (0%) |
|FIRST INCIDENCE | --- --- 510 549 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.442 (e) P=0.194 P=0.422 (e) |
|POLY 3 | P=0.432 (e) P=0.213 P=0.413 (e) |
|POLY 1.5 | P=0.437 (e) P=0.222 P=0.422 (e) |
|POLY 6 | P=0.423 (e) P=0.203 P=0.403 (e) |
|LOGISTIC REGRESSION| P=0.456 (e) P=0.225 P=0.434 (e) |
|COCH-ARM / FISHERS | P=0.467 (e) P=0.247 P=0.425 (e) |
|ORDER RESTRICTED | P=0.306 (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Liver |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) 1/40 (3%) 0/42 (0%) |
|POLY-3 RATE (b) | 2/35.19 0/31.04 1/36.65 1/31.97 0/28.81 |
|POLY-3 PERCENT (g) | 5.7% 0.0% 2.7% 3.1% 0.0% |
|TERMINAL (d) | 1/20 (5%) 0/18 (0%) 1/24 (4%) 1/20 (5%) 0/19 (0%) |
|FIRST INCIDENCE | 612 --- 668 (T) 668 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.218N P=0.276N P=0.429N P=0.500N P=0.265N |
|POLY 3 | P=0.248N P=0.265N P=0.486N P=0.534N P=0.282N |
|POLY 1.5 | P=0.258N P=0.251N P=0.491N P=0.543N P=0.281N |
|POLY 6 | P=0.240N P=0.282N P=0.476N P=0.528N P=0.283N |
|LOGISTIC REGRESSION| P=0.230N P=0.275N P=0.468N P=0.521N P=0.280N |
|COCH-ARM / FISHERS | P=0.261N P=0.247N P=0.500N P=0.584N P=0.293N |
|ORDER RESTRICTED | P=0.122N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 41
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Liver |
| Eosinophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/50 (6%) 2/50 (4%) 2/50 (4%) 1/37 (3%) 2/32 (6%) |
|POLY-3 RATE (b) | 3/34.22 2/30.37 2/29.84 1/21.09 2/19.44 |
|POLY-3 PERCENT (g) | 8.8% 6.6% 6.7% 4.7% 10.3% |
|TERMINAL (d) | 1/19 (5%) 2/21 (10%) 0/13 (0%) 0/7 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 446 668 (T) 490 631 627 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.444 P=0.494N P=0.589N P=0.557N P=0.593 |
|POLY 3 | P=0.543 P=0.555N P=0.563N P=0.490N P=0.617 |
|POLY 1.5 | P=0.557 P=0.544N P=0.538N P=0.463N P=0.626 |
|POLY 6 | P=0.521 P=0.557N P=0.595N P=0.523N P=0.608 |
|LOGISTIC REGRESSION| P=0.545 P=0.532N P=0.518N P=0.448N P=0.638 |
|COCH-ARM / FISHERS | P=0.540N P=0.500N P=0.500N P=0.429N P=0.652 |
|ORDER RESTRICTED | P=0.583 (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Liver |
| Eosinophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 3/50 (6%) 1/40 (3%) 3/42 (7%) |
|POLY-3 RATE (b) | 1/34.96 2/31.46 3/37.39 1/32.58 3/29.89 |
|POLY-3 PERCENT (g) | 2.9% 6.4% 8.0% 3.1% 10.0% |
|TERMINAL (d) | 1/20 (5%) 1/18 (6%) 1/24 (4%) 0/20 (0%) 1/19 (5%) |
|FIRST INCIDENCE | 668 (T) 559 514 488 453 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.283 P=0.446 P=0.363 P=0.757 P=0.267 |
|POLY 3 | P=0.288 P=0.463 P=0.328 P=0.746 P=0.248 |
|POLY 1.5 | P=0.269 P=0.481 P=0.318 P=0.737 P=0.244 |
|POLY 6 | P=0.306 P=0.445 P=0.347 P=0.754 P=0.254 |
|LOGISTIC REGRESSION| P=0.239 P=0.446 P=0.317 P=0.712 P=0.241 |
|COCH-ARM / FISHERS | P=0.233 P=0.500 P=0.309 P=0.694 P=0.245 |
|ORDER RESTRICTED | P=0.196 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 42
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Liver |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 9/50 (18%) 7/50 (14%) 12/50 (24%) 6/37 (16%) 5/32 (16%) |
|POLY-3 RATE (b) | 9/37.84 7/35.33 12/35.05 6/24.88 5/21.68 |
|POLY-3 PERCENT (g) | 23.8% 19.8% 34.2% 24.1% 23.1% |
|TERMINAL (d) | 1/19 (5%) 0/21 (0%) 2/13 (15%) 0/7 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 111 157 229 298 192 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.470 P=0.459N P=0.199 P=0.537 P=0.587N |
|POLY 3 | P=0.508 P=0.449N P=0.230 P=0.607 P=0.599N |
|POLY 1.5 | P=0.531N P=0.443N P=0.263 P=0.594N P=0.581N |
|POLY 6 | P=0.454 P=0.447N P=0.183 P=0.553 P=0.625N |
|LOGISTIC REGRESSION| P=0.375N P=0.274N P=0.375 P=0.417N P=0.434N |
|COCH-ARM / FISHERS | P=0.456N P=0.393N P=0.312 P=0.531N P=0.515N |
|ORDER RESTRICTED | P=0.534 (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Liver |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 8/50 (16%) 5/50 (10%) 5/50 (10%) 5/40 (13%) 8/42 (19%) |
|POLY-3 RATE (b) | 8/38.10 5/34.04 5/38.64 5/33.23 8/31.44 |
|POLY-3 PERCENT (g) | 21.0% 14.7% 12.9% 15.0% 25.4% |
|TERMINAL (d) | 1/20 (5%) 0/18 (0%) 1/24 (4%) 2/20 (10%) 3/19 (16%) |
|FIRST INCIDENCE | 179 207 182 414 453 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.355 P=0.379N P=0.226N P=0.324N P=0.474 |
|POLY 3 | P=0.317 P=0.348N P=0.261N P=0.365N P=0.439 |
|POLY 1.5 | P=0.295 P=0.312N P=0.266N P=0.378N P=0.437 |
|POLY 6 | P=0.332 P=0.387N P=0.253N P=0.363N P=0.445 |
|LOGISTIC REGRESSION| P=0.250 P=0.252N P=0.291N P=0.510N P=0.459 |
|COCH-ARM / FISHERS | P=0.265 P=0.277N P=0.277N P=0.437N P=0.455 |
|ORDER RESTRICTED | P=0.262 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 43
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Liver |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/37 (0%) 0/32 (0%) |
|POLY-3 RATE (b) | 0/33.13 0/30.37 1/29.15 0/20.93 0/19.14 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 3.4% 0.0% 0.0% |
|TERMINAL (d) | 0/19 (0%) 0/21 (0%) 1/13 (8%) 0/7 (0%) 0/8 (0%) |
|FIRST INCIDENCE | --- --- 668 (T) --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.663 (e) P=0.424 (e) (e) |
|POLY 3 | P=0.680N (e) P=0.474 (e) (e) |
|POLY 1.5 | P=0.665N (e) P=0.485 (e) (e) |
|POLY 6 | P=0.700N (e) P=0.461 (e) (e) |
|LOGISTIC REGRESSION| (e) (e) P=0.424 (e) (e) |
|COCH-ARM / FISHERS | P=0.647N (e) P=0.500 (e) (e) |
|ORDER RESTRICTED | P=0.512 (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Liver |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 3/40 (8%) 0/42 (0%) |
|POLY-3 RATE (b) | 0/34.96 0/31.04 0/36.65 3/32.44 0/28.81 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 9.3% 0.0% |
|TERMINAL (d) | 0/20 (0%) 0/18 (0%) 0/24 (0%) 2/20 (10%) 0/19 (0%) |
|FIRST INCIDENCE | --- --- --- 541 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.174 (e) (e) P=0.113 (e) |
|POLY 3 | P=0.133 (e) (e) P=0.103 (e) |
|POLY 1.5 | P=0.134 (e) (e) P=0.097 (e) |
|POLY 6 | P=0.133 (e) (e) P=0.108 (e) |
|LOGISTIC REGRESSION| P=0.161 (e) (e) P=0.101 (e) |
|COCH-ARM / FISHERS | P=0.153 (e) (e) P=0.084 (e) |
|ORDER RESTRICTED | P=0.119 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 44
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Liver |
| Infiltration Cellular Mixed Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 10/50 (20%) 7/50 (14%) 2/50 (4%) 5/37 (14%) 2/32 (6%) |
|POLY-3 RATE (b) | 10/35.49 7/30.89 2/29.65 5/21.36 2/19.75 |
|POLY-3 PERCENT (g) | 28.2% 22.7% 6.8% 23.4% 10.1% |
|TERMINAL (d) | 6/19 (32%) 6/21 (29%) 0/13 (0%) 3/7 (43%) 1/8 (13%) |
|FIRST INCIDENCE | 308 523 606 608 488 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.243N P=0.264N P=0.052N P=0.527 P=0.180N |
|POLY 3 | P=0.086N P=0.407N P=0.026N* P=0.467N P=0.111N |
|POLY 1.5 | P=0.080N P=0.384N P=0.020N* P=0.407N P=0.105N |
|POLY 6 | P=0.095N P=0.408N P=0.034N* P=0.539N P=0.118N |
|LOGISTIC REGRESSION| P=0.099N P=0.356N P=0.021N* P=0.412N P=0.097N |
|COCH-ARM / FISHERS | P=0.072N P=0.298N P=0.014N* P=0.310N P=0.077N |
|ORDER RESTRICTED | P=0.093N (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Liver |
| Infiltration Cellular Mixed Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 7/50 (14%) 6/50 (12%) 6/50 (12%) 9/40 (23%) 9/42 (21%) |
|POLY-3 RATE (b) | 7/35.41 6/33.58 6/37.69 9/33.46 9/29.89 |
|POLY-3 PERCENT (g) | 19.8% 17.9% 15.9% 26.9% 30.1% |
|TERMINAL (d) | 4/20 (20%) 1/18 (6%) 4/24 (17%) 4/20 (20%) 5/19 (26%) |
|FIRST INCIDENCE | 588 369 460 530 539 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.142 P=0.605N P=0.392N P=0.385 P=0.305 |
|POLY 3 | P=0.088 P=0.543N P=0.451N P=0.338 P=0.245 |
|POLY 1.5 | P=0.079 P=0.518N P=0.471N P=0.302 P=0.243 |
|POLY 6 | P=0.099 P=0.566N P=0.419N P=0.375 P=0.253 |
|LOGISTIC REGRESSION| P=0.086 P=0.555N P=0.455N P=0.317 P=0.229 |
|COCH-ARM / FISHERS | P=0.071 P=0.500N P=0.500N P=0.220 P=0.254 |
|ORDER RESTRICTED | P=0.198 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 45
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Liver |
| Necrosis Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 8/50 (16%) 9/50 (18%) 7/50 (14%) 4/37 (11%) 3/32 (9%) |
|POLY-3 RATE (b) | 8/34.88 9/33.08 7/31.07 4/22.82 3/19.74 |
|POLY-3 PERCENT (g) | 22.9% 27.2% 22.5% 17.5% 15.2% |
|TERMINAL (d) | 3/19 (16%) 3/21 (14%) 2/13 (15%) 1/7 (14%) 1/8 (13%) |
|FIRST INCIDENCE | 463 254 243 157 538 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.325N P=0.487 P=0.496 P=0.582N P=0.434N |
|POLY 3 | P=0.190N P=0.449 P=0.601N P=0.436N P=0.370N |
|POLY 1.5 | P=0.172N P=0.450 P=0.558N P=0.401N P=0.355N |
|POLY 6 | P=0.225N P=0.468 P=0.575 P=0.485N P=0.392N |
|LOGISTIC REGRESSION| P=0.163N P=0.446 P=0.571N P=0.390N P=0.352N |
|COCH-ARM / FISHERS | P=0.138N P=0.500 P=0.500N P=0.357N P=0.305N |
|ORDER RESTRICTED | P=0.382N (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Liver |
| Necrosis Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 6/50 (12%) 8/50 (16%) 5/50 (10%) 4/40 (10%) 6/42 (14%) |
|POLY-3 RATE (b) | 6/36.84 8/34.89 5/37.43 4/33.22 6/29.23 |
|POLY-3 PERCENT (g) | 16.3% 22.9% 13.4% 12.0% 20.5% |
|TERMINAL (d) | 3/20 (15%) 1/18 (6%) 2/24 (8%) 1/20 (5%) 4/19 (21%) |
|FIRST INCIDENCE | 255 369 524 414 585 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.431N P=0.292 P=0.416N P=0.418N P=0.530 |
|POLY 3 | P=0.504N P=0.339 P=0.489N P=0.434N P=0.451 |
|POLY 1.5 | P=0.512N P=0.360 P=0.496N P=0.453N P=0.463 |
|POLY 6 | P=0.502N P=0.330 P=0.468N P=0.419N P=0.442 |
|LOGISTIC REGRESSION| P=0.517N P=0.396 P=0.491N P=0.562N P=0.484 |
|COCH-ARM / FISHERS | P=0.528N P=0.387 P=0.500N P=0.519N P=0.492 |
|ORDER RESTRICTED | P=0.550N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 46
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Liver: Centrilobular |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) 0/37 (0%) 0/32 (0%) |
|POLY-3 RATE (b) | 2/33.99 0/30.37 1/29.77 0/20.93 0/19.14 |
|POLY-3 PERCENT (g) | 5.9% 0.0% 3.4% 0.0% 0.0% |
|TERMINAL (d) | 0/19 (0%) 0/21 (0%) 0/13 (0%) 0/7 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 475 --- 482 --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.159N P=0.266N P=0.548N P=0.364N P=0.363N |
|POLY 3 | P=0.151N P=0.262N P=0.546N P=0.352N P=0.373N |
|POLY 1.5 | P=0.145N P=0.257N P=0.528N P=0.335N P=0.365N |
|POLY 6 | P=0.164N P=0.262N P=0.571N P=0.376N P=0.383N |
|LOGISTIC REGRESSION| P=0.143N P=0.240N P=0.495N P=0.309N P=0.343N |
|COCH-ARM / FISHERS | P=0.143N P=0.247N P=0.500N P=0.327N P=0.369N |
|ORDER RESTRICTED | P=0.163N (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Liver: Centrilobular |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/40 (0%) 0/42 (0%) |
|POLY-3 RATE (b) | 0/34.96 0/31.04 0/36.65 0/31.97 0/28.81 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/20 (0%) 0/18 (0%) 0/24 (0%) 0/20 (0%) 0/19 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 47
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 15/50 (30%) 15/50 (30%) 9/50 (18%) 6/37 (16%) 15/32 (47%) |
|POLY-3 RATE (b) | 15/35.89 15/33.83 9/33.41 6/22.46 15/23.78 |
|POLY-3 PERCENT (g) | 41.8% 44.3% 26.9% 26.7% 63.1% |
|TERMINAL (d) | 8/19 (42%) 10/21 (48%) 1/13 (8%) 0/7 (0%) 6/8 (75%) |
|FIRST INCIDENCE | 322 254 229 563 329 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.038 * P=0.561N P=0.336N P=0.417N P=0.027 * |
|POLY 3 | P=0.118 P=0.511 P=0.140N P=0.184N P=0.076 |
|POLY 1.5 | P=0.130 P=0.516 P=0.128N P=0.155N P=0.070 |
|POLY 6 | P=0.106 P=0.521 P=0.166N P=0.217N P=0.081 |
|LOGISTIC REGRESSION| P=0.140 P=0.493 P=0.146N P=0.179N P=0.054 |
|COCH-ARM / FISHERS | P=0.190 P=0.586N P=0.121N P=0.108N P=0.095 |
|ORDER RESTRICTED | P=0.023 * (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 6/50 (12%) 3/50 (6%) 2/40 (5%) 2/42 (5%) |
|POLY-3 RATE (b) | 1/35.32 6/35.10 3/37.76 2/32.44 2/29.28 |
|POLY-3 PERCENT (g) | 2.8% 17.1% 7.9% 6.2% 6.8% |
|TERMINAL (d) | 0/20 (0%) 0/18 (0%) 0/24 (0%) 0/20 (0%) 1/19 (5%) |
|FIRST INCIDENCE | 577 326 362 608 539 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.413N P=0.047 * P=0.347 P=0.478 P=0.435 |
|POLY 3 | P=0.434N P=0.051 P=0.328 P=0.470 P=0.434 |
|POLY 1.5 | P=0.440N P=0.055 P=0.319 P=0.458 P=0.434 |
|POLY 6 | P=0.430N P=0.048 * P=0.343 P=0.480 P=0.435 |
|LOGISTIC REGRESSION| P=0.468N P=0.060 P=0.302 P=0.438 P=0.435 |
|COCH-ARM / FISHERS | P=0.453N P=0.056 P=0.309 P=0.416 P=0.434 |
|ORDER RESTRICTED | P=0.286 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 48
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 2/50 (4%) 0/37 (0%) 1/32 (3%) |
|POLY-3 RATE (b) | 1/33.32 1/30.37 2/30.05 0/20.93 1/19.79 |
|POLY-3 PERCENT (g) | 3.0% 3.3% 6.7% 0.0% 5.1% |
|TERMINAL (d) | 0/19 (0%) 1/21 (5%) 1/13 (8%) 0/7 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 621 668 (T) 315 --- 473 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.519 P=0.754N P=0.416 P=0.622N P=0.652 |
|POLY 3 | P=0.571 P=0.741 P=0.464 P=0.591N P=0.640 |
|POLY 1.5 | P=0.580 P=0.743 P=0.479 P=0.580N P=0.641 |
|POLY 6 | P=0.556 P=0.744 P=0.442 P=0.606N P=0.639 |
|LOGISTIC REGRESSION| P=0.581N P=0.749 P=0.500 P=0.597N P=0.656 |
|COCH-ARM / FISHERS | P=0.572N P=0.753N P=0.500 P=0.575N P=0.631 |
|ORDER RESTRICTED | P=0.616 (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 3/50 (6%) 0/40 (0%) 2/42 (5%) |
|POLY-3 RATE (b) | 0/34.96 1/31.32 3/37.67 0/31.97 2/29.97 |
|POLY-3 PERCENT (g) | 0.0% 3.2% 8.0% 0.0% 6.7% |
|TERMINAL (d) | 0/20 (0%) 0/18 (0%) 1/24 (4%) 0/20 (0%) 0/19 (0%) |
|FIRST INCIDENCE | --- 600 514 --- 332 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.275 P=0.457 P=0.137 (e) P=0.192 |
|POLY 3 | P=0.305 P=0.478 P=0.131 (e) P=0.202 |
|POLY 1.5 | P=0.287 P=0.489 P=0.126 (e) P=0.200 |
|POLY 6 | P=0.322 P=0.467 P=0.141 (e) P=0.205 |
|LOGISTIC REGRESSION| P=0.245 P=0.485 P=0.121 (e) P=0.210 |
|COCH-ARM / FISHERS | P=0.249 P=0.500 P=0.121 (e) P=0.206 |
|ORDER RESTRICTED | P=0.126 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 49
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Liver: Kupffer Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 1/37 (3%) 1/32 (3%) |
|POLY-3 RATE (b) | 2/33.47 0/30.37 0/29.15 1/20.96 1/19.28 |
|POLY-3 PERCENT (g) | 6.0% 0.0% 0.0% 4.8% 5.2% |
|TERMINAL (d) | 0/19 (0%) 0/21 (0%) 0/13 (0%) 0/7 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 619 --- --- 662 635 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.406 P=0.254N P=0.326N P=0.701 P=0.687N |
|POLY 3 | P=0.498 P=0.258N P=0.268N P=0.659N P=0.687N |
|POLY 1.5 | P=0.497 P=0.255N P=0.255N P=0.639N P=0.681N |
|POLY 6 | P=0.495 P=0.256N P=0.287N P=0.685N P=0.695N |
|LOGISTIC REGRESSION| P=0.451 P=0.254N P=0.273N P=0.690N P=0.692N |
|COCH-ARM / FISHERS | P=0.495 P=0.247N P=0.247N P=0.613N P=0.779 |
|ORDER RESTRICTED | P=0.394N (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Liver: Kupffer Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 1/40 (3%) 2/42 (5%) |
|POLY-3 RATE (b) | 1/34.96 0/31.04 1/36.65 1/32.49 2/30.40 |
|POLY-3 PERCENT (g) | 2.9% 0.0% 2.7% 3.1% 6.6% |
|TERMINAL (d) | 1/20 (5%) 0/18 (0%) 1/24 (4%) 0/20 (0%) 0/19 (0%) |
|FIRST INCIDENCE | 668 (T) --- 668 (T) 523 207 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.170 P=0.521N P=0.722N P=0.751 P=0.447 |
|POLY 3 | P=0.187 P=0.524N P=0.751N P=0.746 P=0.451 |
|POLY 1.5 | P=0.173 P=0.512N P=0.755N P=0.737 P=0.446 |
|POLY 6 | P=0.201 P=0.536N P=0.743N P=0.754 P=0.457 |
|LOGISTIC REGRESSION| P=0.146 (e) P=0.722N P=0.723 P=0.461 |
|COCH-ARM / FISHERS | P=0.148 P=0.500N P=0.753N P=0.694 P=0.434 |
|ORDER RESTRICTED | P=0.200 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 50
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Liver: Kupffer Cell |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) 0/50 (0%) 2/37 (5%) 3/32 (9%) |
|POLY-3 RATE (b) | 2/33.19 3/30.37 0/29.15 2/22.07 3/19.89 |
|POLY-3 PERCENT (g) | 6.0% 9.9% 0.0% 9.1% 15.1% |
|TERMINAL (d) | 1/19 (5%) 3/21 (14%) 0/13 (0%) 0/7 (0%) 1/8 (13%) |
|FIRST INCIDENCE | 654 668 (T) --- 157 488 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.087 P=0.537 P=0.338N P=0.416 P=0.211 |
|POLY 3 | P=0.166 P=0.459 P=0.266N P=0.541 P=0.273 |
|POLY 1.5 | P=0.170 P=0.464 P=0.254N P=0.557 P=0.274 |
|POLY 6 | P=0.162 P=0.466 P=0.282N P=0.519 P=0.273 |
|LOGISTIC REGRESSION| P=0.162 P=0.500 P=0.309N P=0.587 P=0.258 |
|COCH-ARM / FISHERS | P=0.184 P=0.500 P=0.247N P=0.571 P=0.296 |
|ORDER RESTRICTED | P=0.184 (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Liver: Kupffer Cell |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/50 (8%) 4/50 (8%) 2/50 (4%) 6/40 (15%) 6/42 (14%) |
|POLY-3 RATE (b) | 4/36.27 4/32.56 2/37.00 6/33.02 6/30.88 |
|POLY-3 PERCENT (g) | 11.0% 12.3% 5.4% 18.2% 19.4% |
|TERMINAL (d) | 1/20 (5%) 1/18 (6%) 0/24 (0%) 3/20 (15%) 3/19 (16%) |
|FIRST INCIDENCE | 248 500 621 523 207 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.116 P=0.550 P=0.285N P=0.349 P=0.289 |
|POLY 3 | P=0.091 P=0.584 P=0.326N P=0.306 P=0.266 |
|POLY 1.5 | P=0.084 P=0.611 P=0.332N P=0.288 P=0.263 |
|POLY 6 | P=0.097 P=0.561 P=0.311N P=0.323 P=0.271 |
|LOGISTIC REGRESSION| P=0.074 P=0.644N P=0.336N P=0.242 P=0.269 |
|COCH-ARM / FISHERS | P=0.073 P=0.643N P=0.339N P=0.237 P=0.264 |
|ORDER RESTRICTED | P=0.189 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 51
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lung |
| Edema |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 2/50 (4%) 4/37 (11%) 0/32 (0%) |
|POLY-3 RATE (b) | 0/33.13 1/30.37 2/29.55 4/21.96 0/19.14 |
|POLY-3 PERCENT (g) | 0.0% 3.3% 6.8% 18.2% 0.0% |
|TERMINAL (d) | 0/19 (0%) 1/21 (5%) 0/13 (0%) 0/7 (0%) 0/8 (0%) |
|FIRST INCIDENCE | --- 668 (T) 606 580 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.166 P=0.520 P=0.179 P=0.020 * (e) |
|POLY 3 | P=0.166 P=0.483 P=0.211 P=0.019 * (e) |
|POLY 1.5 | P=0.172 P=0.484 P=0.221 P=0.022 * (e) |
|POLY 6 | P=0.155 P=0.486 P=0.200 P=0.018 * (e) |
|LOGISTIC REGRESSION| P=0.176 P=0.520 P=0.204 P=0.020 * (e) |
|COCH-ARM / FISHERS | P=0.205 P=0.500 P=0.247 P=0.030 * (e) |
|ORDER RESTRICTED | P=0.125 (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lung |
| Edema |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 3/49 (6%) 4/50 (8%) 1/40 (3%) 3/42 (7%) |
|POLY-3 RATE (b) | 1/35.82 3/32.64 4/37.37 1/32.81 3/31.17 |
|POLY-3 PERCENT (g) | 2.8% 9.2% 10.7% 3.1% 9.6% |
|TERMINAL (d) | 0/20 (0%) 0/18 (0%) 0/24 (0%) 0/20 (0%) 0/19 (0%) |
|FIRST INCIDENCE | 352 417 585 359 207 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.389 P=0.282 P=0.229 P=0.737 P=0.249 |
|POLY 3 | P=0.409 P=0.271 P=0.189 P=0.743 P=0.254 |
|POLY 1.5 | P=0.389 P=0.285 P=0.184 P=0.735 P=0.250 |
|POLY 6 | P=0.425 P=0.258 P=0.204 P=0.748 P=0.260 |
|LOGISTIC REGRESSION| P=0.335 P=0.296 P=0.179 P=0.453 P=0.284 |
|COCH-ARM / FISHERS | P=0.345 P=0.301 P=0.181 P=0.694 P=0.245 |
|ORDER RESTRICTED | P=0.238 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 52
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lung |
| Foreign Body |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 1/37 (3%) 1/32 (3%) |
|POLY-3 RATE (b) | 1/33.19 0/30.37 1/29.79 1/21.33 1/20.14 |
|POLY-3 PERCENT (g) | 3.0% 0.0% 3.4% 4.7% 5.0% |
|TERMINAL (d) | 0/19 (0%) 0/21 (0%) 0/13 (0%) 0/7 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 654 --- 474 563 41 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.272 P=0.500N P=0.708 P=0.605 P=0.624 |
|POLY 3 | P=0.306 P=0.518N P=0.737 P=0.658 P=0.646 |
|POLY 1.5 | P=0.307 P=0.516N P=0.746 P=0.670 P=0.648 |
|POLY 6 | P=0.300 P=0.515N P=0.725 P=0.644 P=0.643 |
|LOGISTIC REGRESSION| P=0.333 P=0.510N P=0.755 P=0.661 P=0.753 |
|COCH-ARM / FISHERS | P=0.305 P=0.500N P=0.753N P=0.673 P=0.631 |
|ORDER RESTRICTED | P=0.443 (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lung |
| Foreign Body |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/50 (6%) 0/49 (0%) 0/50 (0%) 0/40 (0%) 0/42 (0%) |
|POLY-3 RATE (b) | 3/35.75 0/30.96 0/36.65 0/31.97 0/28.81 |
|POLY-3 PERCENT (g) | 8.4% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/20 (0%) 0/18 (0%) 0/24 (0%) 0/20 (0%) 0/19 (0%) |
|FIRST INCIDENCE | 577 --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.039N* P=0.191N P=0.113N P=0.153N P=0.171N |
|POLY 3 | P=0.034N* P=0.145N P=0.113N P=0.137N P=0.158N |
|POLY 1.5 | P=0.037N* P=0.132N P=0.115N P=0.141N P=0.156N |
|POLY 6 | P=0.031N* P=0.162N P=0.109N P=0.135N P=0.162N |
|LOGISTIC REGRESSION| P=0.040N* P=0.134N P=0.116N P=0.148N P=0.155N |
|COCH-ARM / FISHERS | P=0.042N* P=0.125N P=0.121N P=0.167N P=0.156N |
|ORDER RESTRICTED | P=0.009N** (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 53
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lung |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/50 (10%) 3/50 (6%) 7/50 (14%) 5/37 (14%) 2/32 (6%) |
|POLY-3 RATE (b) | 5/34.44 3/32.15 7/32.61 5/22.33 2/20.67 |
|POLY-3 PERCENT (g) | 14.5% 9.3% 21.5% 22.4% 9.7% |
|TERMINAL (d) | 2/19 (11%) 1/21 (5%) 1/13 (8%) 0/7 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 475 322 147 501 329 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.445 P=0.372N P=0.263 P=0.256 P=0.501N |
|POLY 3 | P=0.513 P=0.392N P=0.335 P=0.344 P=0.459N |
|POLY 1.5 | P=0.519 P=0.389N P=0.355 P=0.372 P=0.456N |
|POLY 6 | P=0.495 P=0.388N P=0.309 P=0.318 P=0.467N |
|LOGISTIC REGRESSION| P=0.532N P=0.357N P=0.385 P=0.358 P=0.428N |
|COCH-ARM / FISHERS | P=0.534N P=0.357N P=0.380 P=0.429 P=0.436N |
|ORDER RESTRICTED | P=0.460N (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lung |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 7/50 (14%) 6/49 (12%) 6/50 (12%) 2/40 (5%) 8/42 (19%) |
|POLY-3 RATE (b) | 7/37.57 6/33.99 6/37.25 2/32.44 8/32.68 |
|POLY-3 PERCENT (g) | 18.6% 17.7% 16.1% 6.2% 24.5% |
|TERMINAL (d) | 2/20 (10%) 1/18 (6%) 3/24 (13%) 1/20 (5%) 3/19 (16%) |
|FIRST INCIDENCE | 372 207 585 539 49 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.491 P=0.606N P=0.415N P=0.107N P=0.385 |
|POLY 3 | P=0.481 P=0.579N P=0.507N P=0.113N P=0.379 |
|POLY 1.5 | P=0.462 P=0.543N P=0.505N P=0.117N P=0.377 |
|POLY 6 | P=0.492 P=0.616N P=0.495N P=0.111N P=0.381 |
|LOGISTIC REGRESSION| P=0.390 P=0.501N P=0.489N P=0.165N P=0.375 |
|COCH-ARM / FISHERS | P=0.405 P=0.516N P=0.500N P=0.144N P=0.355 |
|ORDER RESTRICTED | P=0.233 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 54
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lung |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/37 (3%) 1/32 (3%) |
|POLY-3 RATE (b) | 1/33.13 0/30.37 0/29.15 1/21.09 1/19.54 |
|POLY-3 PERCENT (g) | 3.0% 0.0% 0.0% 4.7% 5.1% |
|TERMINAL (d) | 1/19 (5%) 0/21 (0%) 0/13 (0%) 0/7 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 668 (T) --- --- 631 563 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.206 P=0.480N P=0.576N P=0.557 P=0.602 |
|POLY 3 | P=0.259 P=0.517N P=0.526N P=0.656 P=0.639 |
|POLY 1.5 | P=0.256 P=0.516N P=0.515N P=0.668 P=0.640 |
|POLY 6 | P=0.260 P=0.514N P=0.539N P=0.640 P=0.638 |
|LOGISTIC REGRESSION| P=0.233 (e) (e) P=0.622 P=0.637 |
|COCH-ARM / FISHERS | P=0.256 P=0.500N P=0.500N P=0.673 P=0.631 |
|ORDER RESTRICTED | P=0.326 (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lung |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 1/49 (2%) 3/50 (6%) 4/40 (10%) 1/42 (2%) |
|POLY-3 RATE (b) | 1/34.96 1/31.54 3/37.40 4/32.19 1/28.81 |
|POLY-3 PERCENT (g) | 2.9% 3.2% 8.0% 12.4% 3.5% |
|TERMINAL (d) | 1/20 (5%) 0/18 (0%) 1/24 (4%) 3/20 (15%) 1/19 (5%) |
|FIRST INCIDENCE | 668 (T) 500 460 614 668 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.348 P=0.736 P=0.361 P=0.180 P=0.752 |
|POLY 3 | P=0.294 P=0.738 P=0.329 P=0.150 P=0.718 |
|POLY 1.5 | P=0.286 P=0.748 P=0.319 P=0.142 P=0.718 |
|POLY 6 | P=0.303 P=0.728 P=0.346 P=0.157 P=0.718 |
|LOGISTIC REGRESSION| P=0.307 P=0.751 P=0.315 P=0.163 P=0.752 |
|COCH-ARM / FISHERS | P=0.286 P=0.747 P=0.309 P=0.119 P=0.707 |
|ORDER RESTRICTED | P=0.334 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 55
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lung |
| Infiltration Cellular Histiocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 12/50 (24%) 16/50 (32%) 13/50 (26%) 16/37 (43%) 14/32 (44%) |
|POLY-3 RATE (b) | 12/36.08 16/35.72 13/32.37 16/25.52 14/22.06 |
|POLY-3 PERCENT (g) | 33.3% 44.8% 40.2% 62.7% 63.5% |
|TERMINAL (d) | 3/19 (16%) 6/21 (29%) 6/13 (46%) 4/7 (57%) 4/8 (50%) |
|FIRST INCIDENCE | 446 322 376 341 376 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.002 ** P=0.258 P=0.245 P=0.008 ** P=0.024 * |
|POLY 3 | P=0.003 ** P=0.219 P=0.364 P=0.016 * P=0.018 * |
|POLY 1.5 | P=0.005 ** P=0.206 P=0.417 P=0.021 * P=0.022 * |
|POLY 6 | P=0.002 ** P=0.251 P=0.294 P=0.013 * P=0.017 * |
|LOGISTIC REGRESSION| P=0.006 ** P=0.198 P=0.389 P=0.018 * P=0.023 * |
|COCH-ARM / FISHERS | P=0.016 * P=0.252 P=0.500 P=0.048 * P=0.052 |
|ORDER RESTRICTED | P=0.020 * (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lung |
| Infiltration Cellular Histiocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 12/50 (24%) 11/49 (22%) 21/50 (42%) 12/40 (30%) 10/42 (24%) |
|POLY-3 RATE (b) | 12/37.09 11/35.32 21/43.08 12/33.52 10/30.37 |
|POLY-3 PERCENT (g) | 32.4% 31.1% 48.8% 35.8% 32.9% |
|TERMINAL (d) | 4/20 (20%) 2/18 (11%) 9/24 (38%) 7/20 (35%) 7/19 (37%) |
|FIRST INCIDENCE | 497 369 181 539 412 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.387N P=0.494 P=0.129 P=0.540 P=0.548N |
|POLY 3 | P=0.519N P=0.557N P=0.099 P=0.478 P=0.585 |
|POLY 1.5 | P=0.530N P=0.530N P=0.076 P=0.450 P=0.592 |
|POLY 6 | P=0.532N P=0.588N P=0.130 P=0.490 P=0.565 |
|LOGISTIC REGRESSION| P=0.520N P=0.562N P=0.046 * P=0.480 P=0.588 |
|COCH-ARM / FISHERS | P=0.508 P=0.522N P=0.044 * P=0.344 P=0.590N |
|ORDER RESTRICTED | P=0.419 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 56
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lung |
| Infiltration Cellular Mixed Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/37 (0%) 0/32 (0%) |
|POLY-3 RATE (b) | 0/33.13 0/30.37 0/29.15 0/20.93 0/19.14 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/19 (0%) 0/21 (0%) 0/13 (0%) 0/7 (0%) 0/8 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lung |
| Infiltration Cellular Mixed Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 0/49 (0%) 0/50 (0%) 1/40 (3%) 1/42 (2%) |
|POLY-3 RATE (b) | 2/35.32 0/30.96 0/36.65 1/31.97 1/28.81 |
|POLY-3 PERCENT (g) | 5.7% 0.0% 0.0% 3.1% 3.5% |
|TERMINAL (d) | 1/20 (5%) 0/18 (0%) 0/24 (0%) 1/20 (5%) 1/19 (5%) |
|FIRST INCIDENCE | 577 --- --- 668 (T) 668 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.577N P=0.295N P=0.220N P=0.527N P=0.543N |
|POLY 3 | P=0.604 P=0.266N P=0.228N P=0.535N P=0.571N |
|POLY 1.5 | P=0.589 P=0.253N P=0.232N P=0.544N P=0.568N |
|POLY 6 | P=0.599N P=0.283N P=0.222N P=0.530N P=0.575N |
|LOGISTIC REGRESSION| P=0.595 P=0.265N P=0.228N P=0.529N P=0.568N |
|COCH-ARM / FISHERS | P=0.567 P=0.253N P=0.247N P=0.584N P=0.566N |
|ORDER RESTRICTED | P=0.257N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 57
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lung |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 5/50 (10%) 2/37 (5%) 1/32 (3%) |
|POLY-3 RATE (b) | 2/33.19 1/30.37 5/31.01 2/22.71 1/19.26 |
|POLY-3 PERCENT (g) | 6.0% 3.3% 16.1% 8.8% 5.2% |
|TERMINAL (d) | 1/19 (5%) 1/21 (5%) 0/13 (0%) 0/7 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 654 668 (T) 474 298 640 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.421 P=0.477N P=0.135 P=0.439 P=0.713 |
|POLY 3 | P=0.496 P=0.531N P=0.183 P=0.552 P=0.685N |
|POLY 1.5 | P=0.507 P=0.528N P=0.194 P=0.562 P=0.680N |
|POLY 6 | P=0.474 P=0.526N P=0.174 P=0.534 P=0.691N |
|LOGISTIC REGRESSION| P=0.521 P=0.506N P=0.180 P=0.610 P=0.709N |
|COCH-ARM / FISHERS | P=0.537 P=0.500N P=0.218 P=0.571 P=0.779 |
|ORDER RESTRICTED | P=0.403 (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lung |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 0/49 (0%) 0/50 (0%) 2/40 (5%) 2/42 (5%) |
|POLY-3 RATE (b) | 1/35.01 0/30.96 0/36.65 2/33.37 2/29.44 |
|POLY-3 PERCENT (g) | 2.9% 0.0% 0.0% 6.0% 6.8% |
|TERMINAL (d) | 0/20 (0%) 0/18 (0%) 0/24 (0%) 0/20 (0%) 1/19 (5%) |
|FIRST INCIDENCE | 658 --- --- 359 479 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.085 P=0.531N P=0.465N P=0.488 P=0.460 |
|POLY 3 | P=0.084 P=0.525N P=0.491N P=0.483 P=0.439 |
|POLY 1.5 | P=0.078 P=0.514N P=0.495N P=0.467 P=0.437 |
|POLY 6 | P=0.090 P=0.537N P=0.484N P=0.497 P=0.442 |
|LOGISTIC REGRESSION| P=0.071 P=0.540N P=0.474N P=0.320 P=0.434 |
|COCH-ARM / FISHERS | P=0.072 P=0.505N P=0.500N P=0.416 P=0.434 |
|ORDER RESTRICTED | P=0.147 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 58
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lung: Alveolar Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 6/50 (12%) 3/50 (6%) 0/50 (0%) 1/37 (3%) 4/32 (13%) |
|POLY-3 RATE (b) | 6/34.31 3/31.86 0/29.15 1/21.41 4/19.78 |
|POLY-3 PERCENT (g) | 17.5% 9.4% 0.0% 4.7% 20.2% |
|TERMINAL (d) | 2/19 (11%) 1/21 (5%) 0/13 (0%) 0/7 (0%) 2/8 (25%) |
|FIRST INCIDENCE | 538 418 --- 539 488 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.402 P=0.260N P=0.043N* P=0.236N P=0.452 |
|POLY 3 | P=0.538 P=0.274N P=0.024N* P=0.164N P=0.545 |
|POLY 1.5 | P=0.555 P=0.273N P=0.020N* P=0.146N P=0.557 |
|POLY 6 | P=0.508 P=0.268N P=0.031N* P=0.192N P=0.525 |
|LOGISTIC REGRESSION| P=0.533 P=0.268N P=0.025N* P=0.154N P=0.548 |
|COCH-ARM / FISHERS | P=0.537N P=0.243N P=0.013N* P=0.118N P=0.602 |
|ORDER RESTRICTED | P=0.163 (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lung: Alveolar Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 2/49 (4%) 10/50 (20%) 3/40 (8%) 2/42 (5%) |
|POLY-3 RATE (b) | 2/35.32 2/30.96 10/37.79 3/32.09 2/29.68 |
|POLY-3 PERCENT (g) | 5.7% 6.5% 26.5% 9.4% 6.7% |
|TERMINAL (d) | 1/20 (5%) 2/18 (11%) 8/24 (33%) 2/20 (10%) 1/19 (5%) |
|FIRST INCIDENCE | 577 668 (T) 181 641 332 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.434N P=0.631 P=0.029 * P=0.479 P=0.644 |
|POLY 3 | P=0.462N P=0.647 P=0.016 * P=0.456 P=0.632 |
|POLY 1.5 | P=0.495N P=0.669 P=0.015 * P=0.443 P=0.630 |
|POLY 6 | P=0.434N P=0.621 P=0.018 * P=0.464 P=0.632 |
|LOGISTIC REGRESSION| P=0.506N P=0.628 P=0.017 * P=0.467 P=0.631 |
|COCH-ARM / FISHERS | P=0.539N P=0.684 P=0.014 * P=0.394 P=0.623 |
|ORDER RESTRICTED | P=0.194 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 59
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lymph Node |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/12 (25%) 2/10 (20%) 1/15 (7%) 0/6 (0%) 0/2 (0%) |
|POLY-3 RATE (b) | 3/6.80 2/6.23 1/9.95 0/2.81 0/0.97 |
|POLY-3 PERCENT (g) | 44.1% 32.1% 10.1% 0.0% 0.0% |
|TERMINAL (d) | 0/1 (0%) 0/1 (0%) 0/3 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 308 322 243 --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.051N P=0.558N P=0.335N P=0.206N P=0.237N |
|POLY 3 | P=0.067N P=0.551N P=0.148N P=0.283N P=0.603N |
|POLY 1.5 | P=0.073N P=0.540N P=0.168N P=0.262N P=0.576N |
|POLY 6 | P=0.060N P=0.619N P=0.140N P=0.314N P=0.637N |
|LOGISTIC REGRESSION| P=0.099N P=0.651 P=0.327N P=0.284N P=0.601N |
|COCH-ARM / FISHERS | P=0.075N P=0.594N P=0.216N P=0.270N P=0.604N |
|ORDER RESTRICTED | P=0.560N (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lymph Node |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/14 (7%) 1/23 (4%) 2/16 (13%) 0/12 (0%) 0/16 (0%) |
|POLY-3 RATE (b) | 1/6.20 1/12.90 2/10.85 0/9.59 0/11.87 |
|POLY-3 PERCENT (g) | 16.1% 7.8% 18.4% 0.0% 0.0% |
|TERMINAL (d) | 0/0 (0%) 0/4 (0%) 1/4 (25%) 0/6 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 460 475 654 --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.098N P=0.749 P=0.734N P=0.510N P=0.538N |
|POLY 3 | P=0.097N P=0.590N P=0.694 P=0.416N P=0.376N |
|POLY 1.5 | P=0.123N P=0.610N P=0.637 P=0.459N P=0.411N |
|POLY 6 | P=0.070N P=0.567N P=0.710N P=0.364N P=0.337N |
|LOGISTIC REGRESSION| P=0.133N P=0.673N P=0.762N P=0.644N P=0.576N |
|COCH-ARM / FISHERS | P=0.178N P=0.620N P=0.552 P=0.538N P=0.467N |
|ORDER RESTRICTED | P=0.256N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 60
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lymph Node |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/12 (25%) 0/10 (0%) 0/15 (0%) 0/6 (0%) 2/2 (100%) |
|POLY-3 RATE (b) | 3/6.80 0/4.46 0/9.00 0/2.81 2/2.00 |
|POLY-3 PERCENT (g) | 44.1% 0.0% 0.0% 0.0% 100.0% |
|TERMINAL (d) | 0/1 (0%) 0/1 (0%) 0/3 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 308 --- --- --- 329 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.474 P=0.148N P=0.140N P=0.206N P=0.609 |
|POLY 3 | P=0.040 * P=0.161N P=0.045N* P=0.283N P=0.213 |
|POLY 1.5 | P=0.054 P=0.134N P=0.051N P=0.262N P=0.142 |
|POLY 6 | P=0.045 * P=0.238N P=0.042N* P=0.314N P=0.317 |
|LOGISTIC REGRESSION| P=0.191 P=0.192N P=0.112N P=0.284N P=0.092 |
|COCH-ARM / FISHERS | P=0.219 P=0.143N P=0.075N P=0.270N P=0.110 |
|ORDER RESTRICTED | P=0.028 * (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lymph Node |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/14 (14%) 0/23 (0%) 0/16 (0%) 0/12 (0%) 1/16 (6%) |
|POLY-3 RATE (b) | 2/6.48 0/12.26 0/10.79 0/9.59 1/12.56 |
|POLY-3 PERCENT (g) | 30.9% 0.0% 0.0% 0.0% 8.0% |
|TERMINAL (d) | 0/0 (0%) 0/4 (0%) 0/4 (0%) 0/6 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 460 --- --- --- 453 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.444N P=0.274N P=0.214N P=0.250N P=0.557N |
|POLY 3 | P=0.493N P=0.095N P=0.123N P=0.145N P=0.277N |
|POLY 1.5 | P=0.481N P=0.105N P=0.149N P=0.185N P=0.337N |
|POLY 6 | P=0.506N P=0.088N P=0.097N P=0.109N P=0.220N |
|LOGISTIC REGRESSION| P=0.527N P=0.103N P=0.163N P=0.220N P=0.510N |
|COCH-ARM / FISHERS | P=0.459N P=0.137N P=0.209N P=0.280N P=0.448N |
|ORDER RESTRICTED | P=0.018N* (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 61
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lymph Node |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/12 (8%) 3/10 (30%) 2/15 (13%) 2/6 (33%) 0/2 (0%) |
|POLY-3 RATE (b) | 1/5.02 3/6.89 2/10.84 2/4.57 0/0.97 |
|POLY-3 PERCENT (g) | 19.9% 43.6% 18.5% 43.8% 0.0% |
|TERMINAL (d) | 0/1 (0%) 0/1 (0%) 0/3 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 453 322 243 329 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.396N P=0.269 P=0.479 P=0.357 P=0.600N |
|POLY 3 | P=0.612 P=0.409 P=0.710N P=0.460 P=0.844N |
|POLY 1.5 | P=0.558 P=0.344 P=0.695 P=0.373 P=0.841N |
|POLY 6 | P=0.656 P=0.445 P=0.675N P=0.532 P=0.851N |
|LOGISTIC REGRESSION| P=0.364 P=0.152 P=0.460 P=0.203 P=0.850N |
|COCH-ARM / FISHERS | P=0.451 P=0.226 P=0.586 P=0.245 P=0.857N |
|ORDER RESTRICTED | P=0.644N (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lymph Node |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/14 (7%) 3/23 (13%) 0/16 (0%) 1/12 (8%) 0/16 (0%) |
|POLY-3 RATE (b) | 1/6.11 3/14.27 0/10.79 1/10.20 0/11.87 |
|POLY-3 PERCENT (g) | 16.4% 21.0% 0.0% 9.8% 0.0% |
|TERMINAL (d) | 0/0 (0%) 0/4 (0%) 0/4 (0%) 0/6 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 497 219 --- 488 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.183N P=0.263 P=0.505N P=0.749 P=0.559N |
|POLY 3 | P=0.108N P=0.634 P=0.390N P=0.637N P=0.374N |
|POLY 1.5 | P=0.128N P=0.583 P=0.422N P=0.704N P=0.409N |
|POLY 6 | P=0.089N P=0.697 P=0.352N P=0.551N P=0.335N |
|LOGISTIC REGRESSION| P=0.317N P=0.422 P=0.485N P=0.710 P=0.517N |
|COCH-ARM / FISHERS | P=0.176N P=0.509 P=0.467N P=0.720 P=0.467N |
|ORDER RESTRICTED | P=0.215N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 62
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/49 (2%) 3/37 (8%) 0/32 (0%) |
|POLY-3 RATE (b) | 0/33.13 0/30.37 1/29.14 3/23.31 0/19.14 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 3.4% 12.9% 0.0% |
|TERMINAL (d) | 0/19 (0%) 0/21 (0%) 0/12 (0%) 0/7 (0%) 0/8 (0%) |
|FIRST INCIDENCE | --- --- 147 157 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.156 (e) P=0.508 P=0.072 (e) |
|POLY 3 | P=0.128 (e) P=0.474 P=0.061 (e) |
|POLY 1.5 | P=0.133 (e) P=0.484 P=0.064 (e) |
|POLY 6 | P=0.121 (e) P=0.461 P=0.057 (e) |
|LOGISTIC REGRESSION| P=0.228 (e) P=0.371 P=0.104 (e) |
|COCH-ARM / FISHERS | P=0.157 (e) P=0.495 P=0.073 (e) |
|ORDER RESTRICTED | P=0.144 (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/49 (4%) 2/47 (4%) 1/49 (2%) 0/40 (0%) 4/42 (10%) |
|POLY-3 RATE (b) | 2/35.09 2/30.36 1/36.48 0/31.97 4/30.87 |
|POLY-3 PERCENT (g) | 5.7% 6.6% 2.7% 0.0% 13.0% |
|TERMINAL (d) | 0/20 (0%) 0/17 (0%) 0/24 (0%) 0/20 (0%) 0/19 (0%) |
|FIRST INCIDENCE | 443 536 490 --- 332 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.229 P=0.611 P=0.496N P=0.270N P=0.263 |
|POLY 3 | P=0.253 P=0.642 P=0.486N P=0.256N P=0.276 |
|POLY 1.5 | P=0.245 P=0.661 P=0.492N P=0.261N P=0.272 |
|POLY 6 | P=0.255 P=0.622 P=0.476N P=0.255N P=0.281 |
|LOGISTIC REGRESSION| P=0.209 P=0.686 P=0.512N P=0.333N P=0.277 |
|COCH-ARM / FISHERS | P=0.216 P=0.676 P=0.500N P=0.300N P=0.268 |
|ORDER RESTRICTED | P=0.075 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 63
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/49 (2%) 1/37 (3%) 2/32 (6%) |
|POLY-3 RATE (b) | 2/34.92 0/30.37 1/28.76 1/21.09 2/20.90 |
|POLY-3 PERCENT (g) | 5.7% 0.0% 3.5% 4.7% 9.6% |
|TERMINAL (d) | 0/19 (0%) 0/21 (0%) 0/12 (0%) 0/7 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 308 --- 490 631 329 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.224 P=0.267N P=0.524N P=0.675N P=0.499 |
|POLY 3 | P=0.232 P=0.268N P=0.568N P=0.670N P=0.499 |
|POLY 1.5 | P=0.233 P=0.263N P=0.545N P=0.648N P=0.501 |
|POLY 6 | P=0.225 P=0.268N P=0.594N P=0.694N P=0.496 |
|LOGISTIC REGRESSION| P=0.277 P=0.153N P=0.452N P=0.548N P=0.695 |
|COCH-ARM / FISHERS | P=0.233 P=0.247N P=0.508N P=0.613N P=0.510 |
|ORDER RESTRICTED | P=0.232 (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/49 (4%) 1/47 (2%) 0/49 (0%) 3/40 (8%) 2/42 (5%) |
|POLY-3 RATE (b) | 2/34.50 1/30.07 0/35.88 3/32.00 2/30.15 |
|POLY-3 PERCENT (g) | 5.8% 3.3% 0.0% 9.4% 6.6% |
|TERMINAL (d) | 0/20 (0%) 0/17 (0%) 0/24 (0%) 2/20 (10%) 0/19 (0%) |
|FIRST INCIDENCE | 577 475 --- 662 453 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.266 P=0.568N P=0.221N P=0.488 P=0.632 |
|POLY 3 | P=0.252 P=0.548N P=0.227N P=0.465 P=0.647 |
|POLY 1.5 | P=0.242 P=0.530N P=0.231N P=0.453 P=0.641 |
|POLY 6 | P=0.261 P=0.569N P=0.221N P=0.471 P=0.652 |
|LOGISTIC REGRESSION| P=0.232 P=0.520N P=0.229N P=0.480 P=0.642 |
|COCH-ARM / FISHERS | P=0.230 P=0.516N P=0.247N P=0.404 P=0.631 |
|ORDER RESTRICTED | P=0.302 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 64
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 7/50 (14%) 0/50 (0%) 6/49 (12%) 4/37 (11%) 5/32 (16%) |
|POLY-3 RATE (b) | 7/36.88 0/30.37 6/31.19 4/23.16 5/21.09 |
|POLY-3 PERCENT (g) | 19.0% 0.0% 19.2% 17.3% 23.7% |
|TERMINAL (d) | 1/19 (5%) 0/21 (0%) 1/12 (8%) 0/7 (0%) 1/8 (13%) |
|FIRST INCIDENCE | 308 --- 229 298 329 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.136 P=0.015N* P=0.587 P=0.582N P=0.451 |
|POLY 3 | P=0.178 P=0.015N* P=0.611 P=0.569N P=0.464 |
|POLY 1.5 | P=0.185 P=0.012N* P=0.582N P=0.527N P=0.481 |
|POLY 6 | P=0.162 P=0.016N* P=0.547 P=0.623N P=0.444 |
|LOGISTIC REGRESSION| P=0.214 P=0.007N** P=0.458N P=0.390N P=0.578 |
|COCH-ARM / FISHERS | P=0.195 P=0.006N** P=0.516N P=0.459N P=0.540 |
|ORDER RESTRICTED | P=0.162 (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 7/49 (14%) 3/47 (6%) 2/49 (4%) 4/40 (10%) 6/42 (14%) |
|POLY-3 RATE (b) | 7/36.00 3/31.46 2/35.94 4/32.49 6/30.97 |
|POLY-3 PERCENT (g) | 19.4% 9.5% 5.6% 12.3% 19.4% |
|TERMINAL (d) | 3/20 (15%) 0/17 (0%) 1/24 (4%) 3/20 (15%) 3/19 (16%) |
|FIRST INCIDENCE | 460 207 654 523 332 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.402 P=0.249N P=0.064N P=0.297N P=0.605N |
|POLY 3 | P=0.394 P=0.211N P=0.075N P=0.317N P=0.619N |
|POLY 1.5 | P=0.372 P=0.187N P=0.076N P=0.328N P=0.619N |
|POLY 6 | P=0.408 P=0.242N P=0.072N P=0.317N P=0.622 |
|LOGISTIC REGRESSION| P=0.336 P=0.170N P=0.074N P=0.340N P=0.615 |
|COCH-ARM / FISHERS | P=0.336 P=0.176N P=0.080N P=0.391N P=0.616 |
|ORDER RESTRICTED | P=0.286N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 65
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 3/49 (6%) 0/37 (0%) 0/32 (0%) |
|POLY-3 RATE (b) | 0/33.13 0/30.37 3/30.02 0/20.93 0/19.14 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 10.0% 0.0% 0.0% |
|TERMINAL (d) | 0/19 (0%) 0/21 (0%) 1/12 (8%) 0/7 (0%) 0/8 (0%) |
|FIRST INCIDENCE | --- --- 187 --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.588N (e) P=0.093 (e) (e) |
|POLY 3 | P=0.589N (e) P=0.099 (e) (e) |
|POLY 1.5 | P=0.568N (e) P=0.106 (e) (e) |
|POLY 6 | P=0.619N (e) P=0.090 (e) (e) |
|LOGISTIC REGRESSION| P=0.490N (e) P=0.139 (e) (e) |
|COCH-ARM / FISHERS | P=0.532N (e) P=0.117 (e) (e) |
|ORDER RESTRICTED | P=0.297 (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/49 (6%) 4/47 (9%) 5/49 (10%) 5/40 (13%) 7/42 (17%) |
|POLY-3 RATE (b) | 3/34.07 4/30.41 5/37.31 5/32.32 7/30.42 |
|POLY-3 PERCENT (g) | 8.8% 13.2% 13.4% 15.5% 23.0% |
|TERMINAL (d) | 3/20 (15%) 2/17 (12%) 0/24 (0%) 2/20 (10%) 4/19 (21%) |
|FIRST INCIDENCE | 668 (T) 500 460 608 332 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.083 P=0.399 P=0.446 P=0.361 P=0.124 |
|POLY 3 | P=0.071 P=0.437 P=0.406 P=0.323 P=0.106 |
|POLY 1.5 | P=0.063 P=0.459 P=0.384 P=0.304 P=0.102 |
|POLY 6 | P=0.078 P=0.417 P=0.442 P=0.341 P=0.111 |
|LOGISTIC REGRESSION| P=0.059 P=0.404 P=0.375 P=0.344 P=0.097 |
|COCH-ARM / FISHERS | P=0.051 P=0.476 P=0.357 P=0.250 P=0.103 |
|ORDER RESTRICTED | P=0.084 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 66
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 11/50 (22%) 9/50 (18%) 6/49 (12%) 3/37 (8%) 4/32 (13%) |
|POLY-3 RATE (b) | 11/40.21 9/34.75 6/31.16 3/22.91 4/22.76 |
|POLY-3 PERCENT (g) | 27.4% 25.9% 19.3% 13.1% 17.6% |
|TERMINAL (d) | 0/19 (0%) 3/21 (14%) 0/12 (0%) 0/7 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 308 147 229 298 192 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.133N P=0.476N P=0.242N P=0.138N P=0.276N |
|POLY 3 | P=0.111N P=0.548N P=0.303N P=0.165N P=0.287N |
|POLY 1.5 | P=0.091N P=0.508N P=0.236N P=0.123N P=0.263N |
|POLY 6 | P=0.149N P=0.576N P=0.390N P=0.229N P=0.327N |
|LOGISTIC REGRESSION| P=0.041N* P=0.300N P=0.102N P=0.034N* P=0.093N |
|COCH-ARM / FISHERS | P=0.070N P=0.402N P=0.154N P=0.071N P=0.216N |
|ORDER RESTRICTED | P=0.244N (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/49 (10%) 0/47 (0%) 0/49 (0%) 0/40 (0%) 3/42 (7%) |
|POLY-3 RATE (b) | 5/35.69 0/29.43 0/35.88 0/31.97 3/30.15 |
|POLY-3 PERCENT (g) | 14.0% 0.0% 0.0% 0.0% 10.0% |
|TERMINAL (d) | 1/20 (5%) 0/17 (0%) 0/24 (0%) 0/20 (0%) 1/19 (5%) |
|FIRST INCIDENCE | 460 --- --- --- 453 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.423N P=0.053N P=0.029N* P=0.040N* P=0.445N |
|POLY 3 | P=0.386N P=0.048N* P=0.029N* P=0.038N* P=0.451N |
|POLY 1.5 | P=0.412N P=0.040N* P=0.029N* P=0.040N* P=0.450N |
|POLY 6 | P=0.365N P=0.059N P=0.027N* P=0.038N* P=0.455N |
|LOGISTIC REGRESSION| P=0.461N P=0.038N* P=0.033N* P=0.052N P=0.443N |
|COCH-ARM / FISHERS | P=0.458N P=0.031N* P=0.028N* P=0.046N* P=0.447N |
|ORDER RESTRICTED | P=0.018N* (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 67
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 11/50 (22%) 7/50 (14%) 9/49 (18%) 6/37 (16%) 9/32 (28%) |
|POLY-3 RATE (b) | 11/36.87 7/32.62 9/31.66 6/24.31 9/22.72 |
|POLY-3 PERCENT (g) | 29.8% 21.5% 28.4% 24.7% 39.6% |
|TERMINAL (d) | 4/19 (21%) 4/21 (19%) 4/12 (33%) 1/7 (14%) 2/8 (25%) |
|FIRST INCIDENCE | 111 322 243 167 329 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.096 P=0.233N P=0.523 P=0.574 P=0.223 |
|POLY 3 | P=0.220 P=0.299N P=0.556N P=0.441N P=0.308 |
|POLY 1.5 | P=0.223 P=0.289N P=0.504N P=0.408N P=0.298 |
|POLY 6 | P=0.211 P=0.294N P=0.590 P=0.489N P=0.325 |
|LOGISTIC REGRESSION| P=0.251 P=0.223N P=0.408N P=0.298N P=0.359 |
|COCH-ARM / FISHERS | P=0.250 P=0.218N P=0.421N P=0.348N P=0.354 |
|ORDER RESTRICTED | P=0.226 (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 9/49 (18%) 10/47 (21%) 17/49 (35%) 10/40 (25%) 4/42 (10%) |
|POLY-3 RATE (b) | 9/36.43 10/33.94 17/38.21 10/33.69 4/30.17 |
|POLY-3 PERCENT (g) | 24.7% 29.5% 44.5% 29.7% 13.3% |
|TERMINAL (d) | 5/20 (25%) 2/17 (12%) 11/24 (46%) 7/20 (35%) 1/19 (5%) |
|FIRST INCIDENCE | 179 207 425 488 455 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.100N P=0.392 P=0.125 P=0.460 P=0.187N |
|POLY 3 | P=0.127N P=0.427 P=0.055 P=0.420 P=0.192N |
|POLY 1.5 | P=0.146N P=0.449 P=0.049 * P=0.386 P=0.196N |
|POLY 6 | P=0.107N P=0.409 P=0.072 P=0.452 P=0.183N |
|LOGISTIC REGRESSION| P=0.141N P=0.477 P=0.061 P=0.322 P=0.184N |
|COCH-ARM / FISHERS | P=0.152N P=0.459 P=0.054 P=0.308 P=0.184N |
|ORDER RESTRICTED | P=0.054N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 68
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Infiltration Cellular Plasma Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/37 (0%) 0/32 (0%) |
|POLY-3 RATE (b) | 0/33.13 0/30.37 0/28.15 0/20.93 0/19.14 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/19 (0%) 0/21 (0%) 0/12 (0%) 0/7 (0%) 0/8 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Infiltration Cellular Plasma Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/49 (4%) 0/47 (0%) 0/49 (0%) 0/40 (0%) 0/42 (0%) |
|POLY-3 RATE (b) | 2/34.14 0/29.43 0/35.88 0/31.97 0/28.81 |
|POLY-3 PERCENT (g) | 5.9% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/20 (5%) 0/17 (0%) 0/24 (0%) 0/20 (0%) 0/19 (0%) |
|FIRST INCIDENCE | 651 --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.083N P=0.274N P=0.202N P=0.240N P=0.262N |
|POLY 3 | P=0.088N P=0.270N P=0.225N P=0.250N P=0.275N |
|POLY 1.5 | P=0.092N P=0.257N P=0.230N P=0.258N P=0.275N |
|POLY 6 | P=0.085N P=0.286N P=0.217N P=0.245N P=0.275N |
|LOGISTIC REGRESSION| P=0.082N P=0.286N P=0.203N P=0.236N P=0.267N |
|COCH-ARM / FISHERS | P=0.096N P=0.258N P=0.247N P=0.300N P=0.287N |
|ORDER RESTRICTED | P=0.026N* (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 69
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/49 (2%) 0/37 (0%) 0/32 (0%) |
|POLY-3 RATE (b) | 0/33.13 1/30.37 1/28.53 0/20.93 0/19.14 |
|POLY-3 PERCENT (g) | 0.0% 3.3% 3.5% 0.0% 0.0% |
|TERMINAL (d) | 0/19 (0%) 1/21 (5%) 0/12 (0%) 0/7 (0%) 0/8 (0%) |
|FIRST INCIDENCE | --- 668 (T) 570 --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.504N P=0.520 P=0.469 (e) (e) |
|POLY 3 | P=0.481N P=0.483 P=0.470 (e) (e) |
|POLY 1.5 | P=0.465N P=0.484 P=0.480 (e) (e) |
|POLY 6 | P=0.502N P=0.486 P=0.458 (e) (e) |
|LOGISTIC REGRESSION| P=0.457N P=0.520 P=0.484 (e) (e) |
|COCH-ARM / FISHERS | P=0.434N P=0.500 P=0.495 (e) (e) |
|ORDER RESTRICTED | P=0.492N (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/49 (10%) 4/47 (9%) 2/49 (4%) 4/40 (10%) 6/42 (14%) |
|POLY-3 RATE (b) | 5/34.72 4/30.01 2/35.94 4/32.31 6/28.81 |
|POLY-3 PERCENT (g) | 14.4% 13.3% 5.6% 12.4% 20.8% |
|TERMINAL (d) | 3/20 (15%) 1/17 (6%) 1/24 (4%) 2/20 (10%) 6/19 (32%) |
|FIRST INCIDENCE | 573 559 654 608 668 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.284 P=0.626N P=0.165N P=0.523N P=0.432 |
|POLY 3 | P=0.243 P=0.593N P=0.198N P=0.546N P=0.366 |
|POLY 1.5 | P=0.232 P=0.558N P=0.205N P=0.564N P=0.375 |
|POLY 6 | P=0.247 P=0.631N P=0.187N P=0.535N P=0.352 |
|LOGISTIC REGRESSION| P=0.257 P=0.617N P=0.183N P=0.533N P=0.384 |
|COCH-ARM / FISHERS | P=0.211 P=0.527N P=0.218N P=0.646 P=0.391 |
|ORDER RESTRICTED | P=0.208 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 70
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 0/49 (0%) 2/49 (4%) 3/36 (8%) 0/32 (0%) |
|POLY-3 RATE (b) | 1/33.27 0/30.28 2/30.60 3/22.31 0/19.14 |
|POLY-3 PERCENT (g) | 3.0% 0.0% 6.5% 13.5% 0.0% |
|TERMINAL (d) | 0/19 (0%) 0/21 (0%) 0/13 (0%) 0/6 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 635 --- 147 157 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.354 P=0.509N P=0.456 P=0.158 P=0.614N |
|POLY 3 | P=0.332 P=0.519N P=0.471 P=0.172 P=0.609N |
|POLY 1.5 | P=0.341 P=0.518N P=0.481 P=0.181 P=0.605N |
|POLY 6 | P=0.316 P=0.516N P=0.455 P=0.159 P=0.614N |
|LOGISTIC REGRESSION| P=0.447 P=0.515N P=0.531 P=0.253 P=0.614N |
|COCH-ARM / FISHERS | P=0.374 P=0.505N P=0.492 P=0.196 P=0.610N |
|ORDER RESTRICTED | P=0.327 (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 4/48 (8%) 2/46 (4%) 1/40 (3%) 5/42 (12%) |
|POLY-3 RATE (b) | 2/35.99 4/32.87 2/35.54 1/32.56 5/31.91 |
|POLY-3 PERCENT (g) | 5.6% 12.2% 5.6% 3.1% 15.7% |
|TERMINAL (d) | 0/20 (0%) 0/18 (0%) 0/22 (0%) 0/20 (0%) 0/19 (0%) |
|FIRST INCIDENCE | 443 417 328 497 207 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.206 P=0.266 P=0.687N P=0.537N P=0.157 |
|POLY 3 | P=0.229 P=0.293 P=0.691 P=0.535N P=0.165 |
|POLY 1.5 | P=0.219 P=0.307 P=0.681 P=0.544N P=0.159 |
|POLY 6 | P=0.234 P=0.281 P=0.688N P=0.530N P=0.171 |
|LOGISTIC REGRESSION| P=0.182 P=0.325 P=0.642 P=0.680N P=0.165 |
|COCH-ARM / FISHERS | P=0.190 P=0.319 P=0.659 P=0.584N P=0.152 |
|ORDER RESTRICTED | P=0.101 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 71
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 7/49 (14%) 3/49 (6%) 6/36 (17%) 2/32 (6%) |
|POLY-3 RATE (b) | 2/33.83 7/31.16 3/31.13 6/22.60 2/19.93 |
|POLY-3 PERCENT (g) | 5.9% 22.5% 9.6% 26.6% 10.0% |
|TERMINAL (d) | 1/19 (5%) 6/21 (29%) 0/13 (0%) 0/6 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 446 329 229 329 488 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.200 P=0.088 P=0.426 P=0.025 * P=0.476 |
|POLY 3 | P=0.288 P=0.055 P=0.462 P=0.034 * P=0.493 |
|POLY 1.5 | P=0.296 P=0.057 P=0.475 P=0.038 * P=0.495 |
|POLY 6 | P=0.282 P=0.056 P=0.440 P=0.029 * P=0.492 |
|LOGISTIC REGRESSION| P=0.342 P=0.062 P=0.535 P=0.052 P=0.513 |
|COCH-ARM / FISHERS | P=0.353 P=0.075 P=0.490 P=0.053 P=0.510 |
|ORDER RESTRICTED | P=0.185 (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 3/48 (6%) 2/46 (4%) 3/40 (8%) 1/42 (2%) |
|POLY-3 RATE (b) | 2/35.30 3/30.60 2/34.41 3/31.97 1/28.81 |
|POLY-3 PERCENT (g) | 5.7% 9.8% 5.8% 9.4% 3.5% |
|TERMINAL (d) | 0/20 (0%) 3/18 (17%) 0/22 (0%) 3/20 (15%) 1/19 (5%) |
|FIRST INCIDENCE | 612 668 (T) 621 668 (T) 668 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.374N P=0.435 P=0.621N P=0.496 P=0.547N |
|POLY 3 | P=0.453N P=0.434 P=0.686 P=0.454 P=0.571N |
|POLY 1.5 | P=0.454N P=0.460 P=0.677 P=0.443 P=0.568N |
|POLY 6 | P=0.456N P=0.404 P=0.692N P=0.460 P=0.575N |
|LOGISTIC REGRESSION| P=0.400N P=0.407 P=0.686 P=0.475 P=0.568N |
|COCH-ARM / FISHERS | P=0.450N P=0.480 P=0.659 P=0.394 P=0.566N |
|ORDER RESTRICTED | P=0.454N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 72
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 12/50 (24%) 3/49 (6%) 8/49 (16%) 3/36 (8%) 4/32 (13%) |
|POLY-3 RATE (b) | 12/40.25 3/31.56 8/33.78 3/21.09 4/21.42 |
|POLY-3 PERCENT (g) | 29.8% 9.5% 23.7% 14.2% 18.7% |
|TERMINAL (d) | 1/19 (5%) 1/21 (5%) 1/13 (8%) 0/6 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 308 322 229 298 329 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.227N P=0.028N* P=0.349N P=0.129N P=0.229N |
|POLY 3 | P=0.203N P=0.034N* P=0.370N P=0.157N P=0.263N |
|POLY 1.5 | P=0.174N P=0.025N* P=0.317N P=0.108N P=0.234N |
|POLY 6 | P=0.248N P=0.041N* P=0.442N P=0.233N P=0.296N |
|LOGISTIC REGRESSION| P=0.112N P=0.008N** P=0.172N P=0.033N* P=0.105N |
|COCH-ARM / FISHERS | P=0.142N P=0.013N* P=0.242N P=0.052N P=0.160N |
|ORDER RESTRICTED | P=0.200N (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 6/50 (12%) 6/48 (13%) 2/46 (4%) 3/40 (8%) 8/42 (19%) |
|POLY-3 RATE (b) | 6/35.74 6/32.04 2/34.11 3/32.19 8/31.07 |
|POLY-3 PERCENT (g) | 16.8% 18.7% 5.9% 9.3% 25.8% |
|TERMINAL (d) | 4/20 (20%) 3/18 (17%) 1/22 (5%) 2/20 (10%) 3/19 (16%) |
|FIRST INCIDENCE | 460 207 654 614 453 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.302 P=0.541 P=0.106N P=0.246N P=0.302 |
|POLY 3 | P=0.264 P=0.544 P=0.143N P=0.291N P=0.273 |
|POLY 1.5 | P=0.247 P=0.575 P=0.150N P=0.306N P=0.261 |
|POLY 6 | P=0.280 P=0.509 P=0.132N P=0.279N P=0.297 |
|LOGISTIC REGRESSION| P=0.233 P=0.554 P=0.135N P=0.282N P=0.247 |
|COCH-ARM / FISHERS | P=0.216 P=0.591 P=0.163N P=0.367N P=0.259 |
|ORDER RESTRICTED | P=0.103 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 73
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 7/50 (14%) 14/49 (29%) 17/49 (35%) 8/36 (22%) 9/32 (28%) |
|POLY-3 RATE (b) | 7/34.41 14/32.00 17/33.70 8/21.62 9/20.50 |
|POLY-3 PERCENT (g) | 20.4% 43.7% 50.5% 37.0% 43.9% |
|TERMINAL (d) | 3/19 (16%) 10/21 (48%) 5/13 (39%) 2/6 (33%) 2/8 (25%) |
|FIRST INCIDENCE | 463 418 481 483 539 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.045 * P=0.081 P=0.005 ** P=0.059 P=0.045 * |
|POLY 3 | P=0.103 P=0.032 * P=0.006 ** P=0.142 P=0.056 |
|POLY 1.5 | P=0.126 P=0.035 * P=0.007 ** P=0.171 P=0.061 |
|POLY 6 | P=0.087 P=0.034 * P=0.006 ** P=0.117 P=0.054 |
|LOGISTIC REGRESSION| P=0.118 P=0.037 * P=0.006 ** P=0.127 P=0.055 |
|COCH-ARM / FISHERS | P=0.221 P=0.063 P=0.015 * P=0.240 P=0.100 |
|ORDER RESTRICTED | P=0.060 (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 12/50 (24%) 10/48 (21%) 9/46 (20%) 9/40 (23%) 11/42 (26%) |
|POLY-3 RATE (b) | 12/36.87 10/32.31 9/34.98 9/33.36 11/31.98 |
|POLY-3 PERCENT (g) | 32.5% 31.0% 25.7% 27.0% 34.4% |
|TERMINAL (d) | 7/20 (35%) 5/18 (28%) 4/22 (18%) 4/20 (20%) 5/19 (26%) |
|FIRST INCIDENCE | 372 500 514 510 332 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.517 P=0.545N P=0.225N P=0.335N P=0.551 |
|POLY 3 | P=0.491 P=0.547N P=0.352N P=0.401N P=0.538 |
|POLY 1.5 | P=0.442 P=0.496N P=0.369N P=0.433N P=0.514 |
|POLY 6 | P=0.528N P=0.592N P=0.318N P=0.369N P=0.576 |
|LOGISTIC REGRESSION| P=0.420 P=0.546N P=0.336N P=0.419N P=0.485 |
|COCH-ARM / FISHERS | P=0.371 P=0.447N P=0.391N P=0.535N P=0.499 |
|ORDER RESTRICTED | P=0.541 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 74
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 15/50 (30%) 16/49 (33%) 9/49 (18%) 10/36 (28%) 6/32 (19%) |
|POLY-3 RATE (b) | 15/38.25 16/35.08 9/32.05 10/24.29 6/22.30 |
|POLY-3 PERCENT (g) | 39.2% 45.6% 28.1% 41.2% 26.9% |
|TERMINAL (d) | 6/19 (32%) 8/21 (38%) 3/13 (23%) 2/6 (33%) 1/8 (13%) |
|FIRST INCIDENCE | 329 157 308 298 329 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.421N P=0.493 P=0.317N P=0.315 P=0.348N |
|POLY 3 | P=0.180N P=0.373 P=0.229N P=0.545 P=0.243N |
|POLY 1.5 | P=0.169N P=0.387 P=0.185N P=0.594 P=0.235N |
|POLY 6 | P=0.210N P=0.381 P=0.295N P=0.477 P=0.260N |
|LOGISTIC REGRESSION| P=0.154N P=0.438 P=0.146N P=0.528N P=0.190N |
|COCH-ARM / FISHERS | P=0.139N P=0.473 P=0.132N P=0.509N P=0.190N |
|ORDER RESTRICTED | P=0.210N (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 6/50 (12%) 7/48 (15%) 9/46 (20%) 10/40 (25%) 7/42 (17%) |
|POLY-3 RATE (b) | 6/35.39 7/32.39 9/35.76 10/32.80 7/30.78 |
|POLY-3 PERCENT (g) | 17.0% 21.6% 25.2% 30.5% 22.7% |
|TERMINAL (d) | 4/20 (20%) 3/18 (17%) 6/22 (27%) 8/20 (40%) 4/19 (21%) |
|FIRST INCIDENCE | 577 341 332 488 453 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.300 P=0.411 P=0.354 P=0.191 P=0.424 |
|POLY 3 | P=0.242 P=0.429 P=0.287 P=0.146 P=0.389 |
|POLY 1.5 | P=0.215 P=0.455 P=0.264 P=0.132 P=0.375 |
|POLY 6 | P=0.269 P=0.397 P=0.320 P=0.157 P=0.404 |
|LOGISTIC REGRESSION| P=0.213 P=0.409 P=0.257 P=0.154 P=0.353 |
|COCH-ARM / FISHERS | P=0.189 P=0.468 P=0.230 P=0.093 P=0.366 |
|ORDER RESTRICTED | P=0.297 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 75
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 1/49 (2%) 3/49 (6%) 0/36 (0%) 0/32 (0%) |
|POLY-3 RATE (b) | 1/33.13 1/31.27 3/30.44 0/19.93 0/19.14 |
|POLY-3 PERCENT (g) | 3.0% 3.2% 9.9% 0.0% 0.0% |
|TERMINAL (d) | 1/19 (5%) 0/21 (0%) 1/13 (8%) 0/6 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 668 (T) 157 308 --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.309N P=0.749N P=0.235 P=0.729N P=0.672N |
|POLY 3 | P=0.294N P=0.749 P=0.273 P=0.599N P=0.608N |
|POLY 1.5 | P=0.275N P=0.747 P=0.282 P=0.587N P=0.605N |
|POLY 6 | P=0.324N P=0.755 P=0.259 P=0.615N P=0.612N |
|LOGISTIC REGRESSION| P=0.219N P=0.732N P=0.297 (e) (e) |
|COCH-ARM / FISHERS | P=0.240N P=0.747 P=0.301 P=0.581N P=0.610N |
|ORDER RESTRICTED | P=0.322N (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/48 (0%) 0/46 (0%) 0/40 (0%) 0/42 (0%) |
|POLY-3 RATE (b) | 0/34.96 0/30.60 0/34.05 0/31.97 0/28.81 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/20 (0%) 0/18 (0%) 0/22 (0%) 0/20 (0%) 0/19 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 76
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 1/49 (2%) 1/49 (2%) 0/36 (0%) 1/32 (3%) |
|POLY-3 RATE (b) | 1/33.92 1/30.28 1/28.97 0/19.93 1/19.62 |
|POLY-3 PERCENT (g) | 3.0% 3.3% 3.5% 0.0% 5.1% |
|TERMINAL (d) | 0/19 (0%) 1/21 (5%) 1/13 (8%) 0/6 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 392 668 (T) 668 (T) --- 538 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.495 P=0.755 P=0.707 P=0.593N P=0.639 |
|POLY 3 | P=0.557 P=0.736 P=0.726 P=0.604N P=0.633 |
|POLY 1.5 | P=0.567 P=0.738 P=0.738 P=0.590N P=0.637 |
|POLY 6 | P=0.543 P=0.739 P=0.708 P=0.621N P=0.631 |
|LOGISTIC REGRESSION| P=0.578 P=0.760 P=0.761 P=0.523N P=0.690 |
|COCH-ARM / FISHERS | P=0.593 P=0.747 P=0.747 P=0.581N P=0.631 |
|ORDER RESTRICTED | P=0.552 (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 7/48 (15%) 3/46 (7%) 2/40 (5%) 4/42 (10%) |
|POLY-3 RATE (b) | 2/34.96 7/32.05 3/34.05 2/31.97 4/29.20 |
|POLY-3 PERCENT (g) | 5.7% 21.8% 8.8% 6.3% 13.7% |
|TERMINAL (d) | 2/20 (10%) 5/18 (28%) 3/22 (14%) 2/20 (10%) 3/19 (16%) |
|FIRST INCIDENCE | 668 (T) 341 668 (T) 668 (T) 565 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.493N P=0.058 P=0.545 P=0.699 P=0.295 |
|POLY 3 | P=0.544 P=0.054 P=0.488 P=0.664 P=0.253 |
|POLY 1.5 | P=0.531 P=0.062 P=0.477 P=0.651 P=0.253 |
|POLY 6 | P=0.553 P=0.046 * P=0.505 P=0.673 P=0.256 |
|LOGISTIC REGRESSION| P=0.543 P=0.054 P=0.545 P=0.699 P=0.250 |
|COCH-ARM / FISHERS | P=0.498 P=0.070 P=0.460 P=0.603 P=0.259 |
|ORDER RESTRICTED | P=0.268 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 77
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lymph Node: Iliac |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/12 (0%) 0/10 (0%) 1/15 (7%) 1/6 (17%) 0/2 (0%) |
|POLY-3 RATE (b) | 0/4.33 0/4.46 1/9.00 1/2.90 0/0.97 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 11.1% 34.5% 0.0% |
|TERMINAL (d) | 0/1 (0%) 0/1 (0%) 1/3 (33%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- 668 (T) 647 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.219 (e) P=0.718 P=0.331 (e) |
|POLY 3 | P=0.291 (e) P=0.636 P=0.409 (e) |
|POLY 1.5 | P=0.263 (e) P=0.599 P=0.384 (e) |
|POLY 6 | P=0.338 (e) P=0.667 P=0.445 (e) |
|LOGISTIC REGRESSION| P=0.163 (e) P=0.718 P=0.387 (e) |
|COCH-ARM / FISHERS | P=0.226 (e) P=0.556 P=0.333 (e) |
|ORDER RESTRICTED | P=0.589 (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lymph Node: Iliac |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/14 (0%) 2/23 (9%) 2/16 (13%) 0/12 (0%) 0/16 (0%) |
|POLY-3 RATE (b) | 0/5.53 2/13.28 2/11.79 0/9.59 0/11.87 |
|POLY-3 PERCENT (g) | 0.0% 15.1% 17.0% 0.0% 0.0% |
|TERMINAL (d) | 0/0 (0%) 0/4 (0%) 0/4 (0%) 0/6 (0%) 0/8 (0%) |
|FIRST INCIDENCE | --- 207 460 --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.238N P=0.239 P=0.253 (e) (e) |
|POLY 3 | P=0.099N P=0.447 P=0.421 (e) (e) |
|POLY 1.5 | P=0.145N P=0.410 P=0.351 (e) (e) |
|POLY 6 | P=0.062N P=0.501 P=0.515 (e) (e) |
|LOGISTIC REGRESSION| P=0.345N P=0.299 P=0.262 (e) (e) |
|COCH-ARM / FISHERS | P=0.248N P=0.380 P=0.276 (e) (e) |
|ORDER RESTRICTED | P=0.387N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 78
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lymph Node: Inguinal |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/12 (17%) 0/10 (0%) 0/15 (0%) 0/6 (0%) 0/2 (0%) |
|POLY-3 RATE (b) | 2/6.22 0/4.46 0/9.00 0/2.81 0/0.97 |
|POLY-3 PERCENT (g) | 32.2% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/1 (0%) 0/1 (0%) 0/3 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 111 --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.116N P=0.252N P=0.250N P=0.319N P=0.356N |
|POLY 3 | P=0.111N P=0.294N P=0.139N P=0.417N P=0.704N |
|POLY 1.5 | P=0.122N P=0.277N P=0.159N P=0.413N P=0.692N |
|POLY 6 | P=0.095N P=0.350N P=0.125N P=0.427N P=0.720N |
|LOGISTIC REGRESSION| P=0.172N P=0.591N P=0.221N P=0.540N P=0.853N |
|COCH-ARM / FISHERS | P=0.135N P=0.286N P=0.188N P=0.431N P=0.725N |
|ORDER RESTRICTED | P=0.516N (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lymph Node: Inguinal |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/14 (7%) 0/23 (0%) 0/16 (0%) 0/12 (0%) 0/16 (0%) |
|POLY-3 RATE (b) | 1/6.08 0/12.26 0/10.79 0/9.59 0/11.87 |
|POLY-3 PERCENT (g) | 16.5% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/0 (0%) 0/4 (0%) 0/4 (0%) 0/6 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 510 --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.244N P=0.541N P=0.505N P=0.522N P=0.554N |
|POLY 3 | P=0.308N P=0.360N P=0.389N P=0.412N P=0.373N |
|POLY 1.5 | P=0.281N P=0.373N P=0.421N P=0.457N P=0.409N |
|POLY 6 | P=0.351N P=0.347N P=0.351N P=0.361N P=0.334N |
|LOGISTIC REGRESSION| P=0.255N P=0.384N P=0.471N P=0.560N P=0.495N |
|COCH-ARM / FISHERS | P=0.245N P=0.378N P=0.467N P=0.538N P=0.467N |
|ORDER RESTRICTED | P=0.029N* (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 79
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lymph Node: Inguinal |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/12 (17%) 1/10 (10%) 6/15 (40%) 1/6 (17%) 0/2 (0%) |
|POLY-3 RATE (b) | 2/6.02 1/4.46 6/11.42 1/3.72 0/0.97 |
|POLY-3 PERCENT (g) | 33.2% 22.4% 52.6% 26.9% 0.0% |
|TERMINAL (d) | 0/1 (0%) 1/1 (100%) 1/3 (33%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 111 668 (T) 243 298 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.356N P=0.513N P=0.139 P=0.622N P=0.354N |
|POLY 3 | P=0.502N P=0.622N P=0.399 P=0.695N P=0.699N |
|POLY 1.5 | P=0.558N P=0.582N P=0.294 P=0.715N P=0.687N |
|POLY 6 | P=0.450N P=0.725N P=0.492 P=0.690N P=0.717N |
|LOGISTIC REGRESSION| P=0.567 P=0.619N P=0.151 P=0.693 P=0.780N |
|COCH-ARM / FISHERS | P=0.581 P=0.571N P=0.186 P=0.730 P=0.725N |
|ORDER RESTRICTED | P=0.607N (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lymph Node: Inguinal |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/14 (14%) 4/23 (17%) 2/16 (13%) 1/12 (8%) 2/16 (13%) |
|POLY-3 RATE (b) | 2/7.16 4/14.28 2/12.19 1/9.59 2/13.18 |
|POLY-3 PERCENT (g) | 28.0% 28.0% 16.4% 10.4% 15.2% |
|TERMINAL (d) | 0/0 (0%) 1/4 (25%) 0/4 (0%) 0/6 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 287 207 432 667 453 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.300N P=0.468 P=0.689N P=0.519N P=0.629 |
|POLY 3 | P=0.224N P=0.692 P=0.491N P=0.393N P=0.460N |
|POLY 1.5 | P=0.277N P=0.653 P=0.557N P=0.456N P=0.533N |
|POLY 6 | P=0.172N P=0.669N P=0.408N P=0.313N P=0.372N |
|LOGISTIC REGRESSION| P=0.487 P=0.498 P=0.584 P=0.733N P=0.446 |
|COCH-ARM / FISHERS | P=0.379N P=0.593 P=0.648N P=0.560N P=0.648N |
|ORDER RESTRICTED | P=0.419N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 80
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lymph Node: Mediastinal |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/12 (8%) 0/10 (0%) 0/15 (0%) 0/6 (0%) 0/2 (0%) |
|POLY-3 RATE (b) | 1/4.61 0/4.46 0/9.00 0/2.81 0/0.97 |
|POLY-3 PERCENT (g) | 21.7% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/1 (0%) 0/1 (0%) 0/3 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 601 --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.288N P=0.532N P=0.541N P=0.604N P=0.617N |
|POLY 3 | P=0.372N P=0.507N P=0.370N P=0.607N P=0.838N |
|POLY 1.5 | P=0.358N P=0.508N P=0.403N P=0.618N P=0.838N |
|POLY 6 | P=0.375N P=0.540N P=0.349N P=0.604N P=0.842N |
|LOGISTIC REGRESSION| P=0.275N P=0.510N P=0.340N P=0.577N P=0.799N |
|COCH-ARM / FISHERS | P=0.328N P=0.545N P=0.444N P=0.667N P=0.857N |
|ORDER RESTRICTED | P=0.548N (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lymph Node: Mediastinal |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/14 (7%) 1/23 (4%) 2/16 (13%) 0/12 (0%) 1/16 (6%) |
|POLY-3 RATE (b) | 1/6.47 1/12.74 2/11.14 0/9.59 1/11.87 |
|POLY-3 PERCENT (g) | 15.5% 7.9% 18.0% 0.0% 8.4% |
|TERMINAL (d) | 0/0 (0%) 0/4 (0%) 0/4 (0%) 0/6 (0%) 1/8 (13%) |
|FIRST INCIDENCE | 248 536 612 --- 668 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.353N P=0.746 P=0.543 P=0.532N P=0.537N |
|POLY 3 | P=0.338N P=0.605N P=0.688 P=0.423N P=0.616N |
|POLY 1.5 | P=0.389N P=0.622N P=0.628 P=0.467N P=0.665N |
|POLY 6 | P=0.282N P=0.577N P=0.698N P=0.368N P=0.548N |
|LOGISTIC REGRESSION| P=0.475N P=0.730N P=0.532 P=0.983N P=0.719 |
|COCH-ARM / FISHERS | P=0.475N P=0.620N P=0.552 P=0.538N P=0.724N |
|ORDER RESTRICTED | P=0.452N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 81
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lymph Node: Mediastinal |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/12 (0%) 0/10 (0%) 3/15 (20%) 0/6 (0%) 0/2 (0%) |
|POLY-3 RATE (b) | 0/4.33 0/4.46 3/9.49 0/2.81 0/0.97 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 31.6% 0.0% 0.0% |
|TERMINAL (d) | 0/1 (0%) 0/1 (0%) 1/3 (33%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- 607 --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.597 (e) P=0.148 (e) (e) |
|POLY 3 | P=0.648 (e) P=0.284 (e) (e) |
|POLY 1.5 | P=0.580 (e) P=0.216 (e) (e) |
|POLY 6 | P=0.652N (e) P=0.360 (e) (e) |
|LOGISTIC REGRESSION| P=0.626 (e) P=0.301 (e) (e) |
|COCH-ARM / FISHERS | P=0.510 (e) P=0.156 (e) (e) |
|ORDER RESTRICTED | P=0.642 (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lymph Node: Mediastinal |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/14 (7%) 2/23 (9%) 0/16 (0%) 1/12 (8%) 0/16 (0%) |
|POLY-3 RATE (b) | 1/6.51 2/13.39 0/10.79 1/9.59 0/11.87 |
|POLY-3 PERCENT (g) | 15.4% 14.9% 0.0% 10.4% 0.0% |
|TERMINAL (d) | 0/0 (0%) 0/4 (0%) 0/4 (0%) 1/6 (17%) 0/8 (0%) |
|FIRST INCIDENCE | 179 472 --- 668 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.158N P=0.482 P=0.500N P=0.540N P=0.540N |
|POLY 3 | P=0.187N P=0.731N P=0.401N P=0.670N P=0.384N |
|POLY 1.5 | P=0.208N P=0.712 P=0.433N P=0.728N P=0.420N |
|POLY 6 | P=0.169N P=0.693N P=0.359N P=0.584N P=0.340N |
|LOGISTIC REGRESSION| P=0.368N P=0.577 (e) P=0.570 (e) |
|COCH-ARM / FISHERS | P=0.248N P=0.772N P=0.467N P=0.720 P=0.467N |
|ORDER RESTRICTED | P=0.262N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 82
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lymph Node: Renal |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/12 (0%) 0/10 (0%) 0/15 (0%) 0/6 (0%) 0/2 (0%) |
|POLY-3 RATE (b) | 0/4.33 0/4.46 0/9.00 0/2.81 0/0.97 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/1 (0%) 0/1 (0%) 0/3 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lymph Node: Renal |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/14 (0%) 2/23 (9%) 1/16 (6%) 0/12 (0%) 0/16 (0%) |
|POLY-3 RATE (b) | 0/5.53 2/13.10 1/10.87 0/9.59 0/11.87 |
|POLY-3 PERCENT (g) | 0.0% 15.3% 9.2% 0.0% 0.0% |
|TERMINAL (d) | 0/0 (0%) 0/4 (0%) 0/4 (0%) 0/6 (0%) 0/8 (0%) |
|FIRST INCIDENCE | --- 549 650 --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.253N P=0.177 P=0.550 (e) (e) |
|POLY 3 | P=0.130N P=0.443 P=0.626 (e) (e) |
|POLY 1.5 | P=0.170N P=0.404 P=0.586 (e) (e) |
|POLY 6 | P=0.094N P=0.506 P=0.675 (e) (e) |
|LOGISTIC REGRESSION| P=0.173N P=0.410 P=0.895 (e) (e) |
|COCH-ARM / FISHERS | P=0.256N P=0.380 P=0.533 (e) (e) |
|ORDER RESTRICTED | P=0.411N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 83
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lymph Node: Renal |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/12 (8%) 0/10 (0%) 0/15 (0%) 1/6 (17%) 0/2 (0%) |
|POLY-3 RATE (b) | 1/4.61 0/4.46 0/9.00 1/2.90 0/0.97 |
|POLY-3 PERCENT (g) | 21.7% 0.0% 0.0% 34.5% 0.0% |
|TERMINAL (d) | 0/1 (0%) 0/1 (0%) 0/3 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 601 --- --- 647 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.626N P=0.532N P=0.541N P=0.602 P=0.617N |
|POLY 3 | P=0.596 P=0.507N P=0.370N P=0.681 P=0.838N |
|POLY 1.5 | P=0.586 P=0.508N P=0.403N P=0.646 P=0.838N |
|POLY 6 | P=0.614 P=0.540N P=0.349N P=0.714 P=0.842N |
|LOGISTIC REGRESSION| P=0.660 P=0.510N P=0.340N P=0.728 P=0.799N |
|COCH-ARM / FISHERS | P=0.569 P=0.545N P=0.444N P=0.569 P=0.857N |
|ORDER RESTRICTED | P=0.620N (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lymph Node: Renal |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/14 (0%) 3/23 (13%) 2/16 (13%) 0/12 (0%) 0/16 (0%) |
|POLY-3 RATE (b) | 0/5.53 3/14.15 2/11.54 0/9.59 0/11.87 |
|POLY-3 PERCENT (g) | 0.0% 21.2% 17.3% 0.0% 0.0% |
|TERMINAL (d) | 0/0 (0%) 0/4 (0%) 0/4 (0%) 0/6 (0%) 0/8 (0%) |
|FIRST INCIDENCE | --- 207 460 --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.171N P=0.123 P=0.270 (e) (e) |
|POLY 3 | P=0.055N P=0.329 P=0.415 (e) (e) |
|POLY 1.5 | P=0.088N P=0.283 P=0.348 (e) (e) |
|POLY 6 | P=0.030N* P=0.398 P=0.507 (e) (e) |
|LOGISTIC REGRESSION| P=0.289N P=0.144 P=0.310 (e) (e) |
|COCH-ARM / FISHERS | P=0.176N P=0.228 P=0.276 (e) (e) |
|ORDER RESTRICTED | P=0.338N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 84
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Mammary Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/37 (0%) 0/32 (0%) |
|POLY-3 RATE (b) | 0/33.13 0/30.37 0/29.15 0/20.93 0/19.14 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/19 (0%) 0/21 (0%) 0/13 (0%) 0/7 (0%) 0/8 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Mammary Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 9/50 (18%) 9/50 (18%) 8/49 (16%) 6/40 (15%) 7/42 (17%) |
|POLY-3 RATE (b) | 9/37.83 9/34.73 8/39.31 6/32.95 7/31.10 |
|POLY-3 PERCENT (g) | 23.8% 25.9% 20.4% 18.2% 22.5% |
|TERMINAL (d) | 2/20 (10%) 1/18 (6%) 1/24 (4%) 2/20 (10%) 2/19 (11%) |
|FIRST INCIDENCE | 391 369 425 488 482 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.326N P=0.466 P=0.425N P=0.321N P=0.544N |
|POLY 3 | P=0.376N P=0.525 P=0.464N P=0.389N P=0.564N |
|POLY 1.5 | P=0.391N P=0.565 P=0.485N P=0.399N P=0.562N |
|POLY 6 | P=0.367N P=0.488 P=0.433N P=0.389N P=0.560N |
|LOGISTIC REGRESSION| P=0.412N P=0.598 P=0.519N P=0.438N P=0.549N |
|COCH-ARM / FISHERS | P=0.417N P=0.602N P=0.518N P=0.465N P=0.545N |
|ORDER RESTRICTED | P=0.567N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 85
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Mesentery: Fat |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/1 (0%) 1/2 (50%) 0/0 (0%) 3/3 (100%) 0/1 (0%) |
|POLY-3 RATE (b) | 0/1.00 1/2.00 0/0.00 3/3.00 0/1.00 |
|POLY-3 PERCENT (g) | 0.0% 50.0% 0.0% 100.0% 0.0% |
|TERMINAL (d) | 0/1 (0%) 0/1 (0%) 0/0 (0%) 0/0 (0%) 0/1 (0%) |
|FIRST INCIDENCE | --- 363 --- 434 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.185 P=0.479 (e) P=0.039 * (e) |
|POLY 3 | (e) P=0.614 (e) P=0.250N (e) |
|POLY 1.5 | (e) P=0.614 (e) P=0.250N (e) |
|POLY 6 | (e) P=0.614 (e) P=0.250N (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.415 P=0.667 (e) P=0.250 (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Mesentery: Fat |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/4 (0%) 5/8 (63%) 4/7 (57%) 2/3 (67%) 3/5 (60%) |
|POLY-3 RATE (b) | 0/2.87 5/6.55 4/6.33 2/2.74 3/5.00 |
|POLY-3 PERCENT (g) | 0.0% 76.4% 63.2% 73.1% 60.0% |
|TERMINAL (d) | 0/0 (0%) 3/3 (100%) 2/3 (67%) 1/1 (100%) 2/4 (50%) |
|FIRST INCIDENCE | --- 500 362 488 412 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.389N P=0.184 P=0.251 P=0.495 P=0.475 |
|POLY 3 | P=0.397 P=0.030 * P=0.121 P=0.116 P=0.172 |
|POLY 1.5 | P=0.277 P=0.034 * P=0.099 P=0.101 P=0.126 |
|POLY 6 | P=0.613N P=0.047 * P=0.187 P=0.158 P=0.276 |
|LOGISTIC REGRESSION| P=0.176 P=0.057 P=0.113 P=0.145 P=0.102 |
|COCH-ARM / FISHERS | P=0.182 P=0.071 P=0.106 P=0.143 P=0.119 |
|ORDER RESTRICTED | P=0.070 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 86
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Nose |
| Foreign Body |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 1/50 (2%) 0/36 (0%) 0/32 (0%) |
|POLY-3 RATE (b) | 1/33.19 1/30.56 1/29.79 0/20.80 0/19.14 |
|POLY-3 PERCENT (g) | 3.0% 3.3% 3.4% 0.0% 0.0% |
|TERMINAL (d) | 0/19 (0%) 0/21 (0%) 0/13 (0%) 0/7 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 654 624 474 --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.259N P=0.760 P=0.708 P=0.692N P=0.648N |
|POLY 3 | P=0.245N P=0.743 P=0.737 P=0.592N P=0.609N |
|POLY 1.5 | P=0.235N P=0.744 P=0.746 P=0.583N P=0.605N |
|POLY 6 | P=0.261N P=0.749 P=0.725 P=0.605N P=0.613N |
|LOGISTIC REGRESSION| P=0.232N P=0.748 P=0.755 P=0.635N P=0.622N |
|COCH-ARM / FISHERS | P=0.220N P=0.753N P=0.753N P=0.581N P=0.610N |
|ORDER RESTRICTED | P=0.426N (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Nose |
| Foreign Body |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/40 (0%) 0/42 (0%) |
|POLY-3 RATE (b) | 2/35.04 0/31.04 0/36.65 0/31.97 0/28.81 |
|POLY-3 PERCENT (g) | 5.7% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/20 (5%) 0/18 (0%) 0/24 (0%) 0/20 (0%) 0/19 (0%) |
|FIRST INCIDENCE | 651 --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.083N P=0.268N P=0.202N P=0.240N P=0.262N |
|POLY 3 | P=0.089N P=0.264N P=0.226N P=0.256N P=0.281N |
|POLY 1.5 | P=0.093N P=0.250N P=0.231N P=0.263N P=0.280N |
|POLY 6 | P=0.086N P=0.280N P=0.219N P=0.251N P=0.281N |
|LOGISTIC REGRESSION| P=0.084N P=0.280N P=0.205N P=0.242N P=0.272N |
|COCH-ARM / FISHERS | P=0.099N P=0.247N P=0.247N P=0.306N P=0.293N |
|ORDER RESTRICTED | P=0.028N* (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 87
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Nose |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/50 (10%) 5/50 (10%) 5/50 (10%) 3/36 (8%) 4/32 (13%) |
|POLY-3 RATE (b) | 5/33.58 5/30.56 5/30.25 3/21.07 4/19.49 |
|POLY-3 PERCENT (g) | 14.9% 16.4% 16.5% 14.2% 20.5% |
|TERMINAL (d) | 3/19 (16%) 4/21 (19%) 3/13 (23%) 1/7 (14%) 1/8 (13%) |
|FIRST INCIDENCE | 565 624 474 607 627 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.195 P=0.591N P=0.430 P=0.474 P=0.340 |
|POLY 3 | P=0.391 P=0.572 P=0.566 P=0.626N P=0.442 |
|POLY 1.5 | P=0.410 P=0.579 P=0.591 P=0.598N P=0.451 |
|POLY 6 | P=0.362 P=0.581 P=0.531 P=0.641 P=0.433 |
|LOGISTIC REGRESSION| P=0.356 P=0.597 P=0.531 P=0.622 P=0.420 |
|COCH-ARM / FISHERS | P=0.458 P=0.630N P=0.630N P=0.552N P=0.495 |
|ORDER RESTRICTED | P=0.535 (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Nose |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 11/50 (22%) 2/50 (4%) 7/50 (14%) 2/40 (5%) 4/42 (10%) |
|POLY-3 RATE (b) | 11/35.72 2/31.69 7/38.60 2/32.58 4/29.55 |
|POLY-3 PERCENT (g) | 30.8% 6.3% 18.1% 6.1% 13.5% |
|TERMINAL (d) | 7/20 (35%) 1/18 (6%) 2/24 (8%) 1/20 (5%) 2/19 (11%) |
|FIRST INCIDENCE | 577 472 182 488 565 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.051N P=0.018N* P=0.137N P=0.010N* P=0.077N |
|POLY 3 | P=0.044N* P=0.010N* P=0.155N P=0.008N** P=0.083N |
|POLY 1.5 | P=0.057N P=0.008N** P=0.175N P=0.011N* P=0.087N |
|POLY 6 | P=0.035N* P=0.013N* P=0.129N P=0.007N** P=0.078N |
|LOGISTIC REGRESSION| P=0.069N P=0.016N* P=0.193N P=0.011N* P=0.090N |
|COCH-ARM / FISHERS | P=0.085N P=0.007N** P=0.218N P=0.021N* P=0.090N |
|ORDER RESTRICTED | P=0.013N* (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 88
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Ovary |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | |
|POLY-3 RATE (b) | |
|POLY-3 PERCENT (g) | |
|TERMINAL (d) | |
|FIRST INCIDENCE | |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | |
|POLY 3 | |
|POLY 1.5 | |
|POLY 6 | |
|LOGISTIC REGRESSION| |
|COCH-ARM / FISHERS | |
|ORDER RESTRICTED | |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Ovary |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 4/49 (8%) 3/40 (8%) 4/42 (10%) |
|POLY-3 RATE (b) | 1/34.96 1/31.44 4/36.89 3/32.69 4/29.41 |
|POLY-3 PERCENT (g) | 2.9% 3.2% 10.8% 9.2% 13.6% |
|TERMINAL (d) | 1/20 (5%) 0/18 (0%) 2/24 (8%) 1/20 (5%) 2/19 (11%) |
|FIRST INCIDENCE | 668 (T) 565 612 539 593 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.071 P=0.706 P=0.243 P=0.297 P=0.146 |
|POLY 3 | P=0.063 P=0.738 P=0.193 P=0.279 P=0.126 |
|POLY 1.5 | P=0.056 P=0.749 P=0.185 P=0.265 P=0.125 |
|POLY 6 | P=0.072 P=0.726 P=0.208 P=0.293 P=0.129 |
|LOGISTIC REGRESSION| P=0.053 P=0.739 P=0.206 P=0.262 P=0.123 |
|COCH-ARM / FISHERS | P=0.047 * P=0.753N P=0.175 P=0.229 P=0.131 |
|ORDER RESTRICTED | P=0.090 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 89
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Ovary |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | |
|POLY-3 RATE (b) | |
|POLY-3 PERCENT (g) | |
|TERMINAL (d) | |
|FIRST INCIDENCE | |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | |
|POLY 3 | |
|POLY 1.5 | |
|POLY 6 | |
|LOGISTIC REGRESSION| |
|COCH-ARM / FISHERS | |
|ORDER RESTRICTED | |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Ovary |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 38/50 (76%) 35/50 (70%) 37/49 (76%) 29/40 (73%) 29/42 (69%) |
|POLY-3 RATE (b) | 38/43.53 35/44.59 37/45.21 29/36.51 29/34.65 |
|POLY-3 PERCENT (g) | 87.3% 78.5% 81.9% 79.4% 83.7% |
|TERMINAL (d) | 18/20 (90%) 10/18 (56%) 20/24 (83%) 16/20 (80%) 16/19 (84%) |
|FIRST INCIDENCE | 179 326 181 497 332 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.127N P=0.421 P=0.239N P=0.140N P=0.276N |
|POLY 3 | P=0.434N P=0.193N P=0.329N P=0.240N P=0.444N |
|POLY 1.5 | P=0.386N P=0.226N P=0.399N P=0.268N P=0.399N |
|POLY 6 | P=0.521N P=0.158N P=0.269N P=0.243N P=0.516N |
|LOGISTIC REGRESSION| P=0.237N P=0.380N P=0.510N P=0.186N P=0.320N |
|COCH-ARM / FISHERS | P=0.306N P=0.326N P=0.570N P=0.445N P=0.304N |
|ORDER RESTRICTED | P=0.385N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 90
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Ovary |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | |
|POLY-3 RATE (b) | |
|POLY-3 PERCENT (g) | |
|TERMINAL (d) | |
|FIRST INCIDENCE | |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | |
|POLY 3 | |
|POLY 1.5 | |
|POLY 6 | |
|LOGISTIC REGRESSION| |
|COCH-ARM / FISHERS | |
|ORDER RESTRICTED | |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Ovary |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 7/49 (14%) 5/40 (13%) 4/42 (10%) |
|POLY-3 RATE (b) | 2/35.30 2/32.42 7/38.54 5/32.69 4/28.81 |
|POLY-3 PERCENT (g) | 5.7% 6.2% 18.2% 15.3% 13.9% |
|TERMINAL (d) | 1/20 (5%) 0/18 (0%) 3/24 (13%) 3/20 (15%) 4/19 (21%) |
|FIRST INCIDENCE | 581 395 432 539 668 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.182 P=0.634 P=0.118 P=0.202 P=0.294 |
|POLY 3 | P=0.142 P=0.665 P=0.098 P=0.180 P=0.244 |
|POLY 1.5 | P=0.133 P=0.680 P=0.088 P=0.169 P=0.249 |
|POLY 6 | P=0.149 P=0.647 P=0.113 P=0.191 P=0.238 |
|LOGISTIC REGRESSION| P=0.133 P=0.690N P=0.080 P=0.175 P=0.251 |
|COCH-ARM / FISHERS | P=0.123 P=0.691N P=0.075 P=0.136 P=0.259 |
|ORDER RESTRICTED | P=0.178 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 91
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Ovary |
| Thrombosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | |
|POLY-3 RATE (b) | |
|POLY-3 PERCENT (g) | |
|TERMINAL (d) | |
|FIRST INCIDENCE | |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | |
|POLY 3 | |
|POLY 1.5 | |
|POLY 6 | |
|LOGISTIC REGRESSION| |
|COCH-ARM / FISHERS | |
|ORDER RESTRICTED | |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Ovary |
| Thrombosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/49 (4%) 1/40 (3%) 1/42 (2%) |
|POLY-3 RATE (b) | 0/34.96 0/31.04 2/36.54 1/31.97 1/29.11 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 5.5% 3.1% 3.4% |
|TERMINAL (d) | 0/20 (0%) 0/18 (0%) 2/24 (8%) 0/20 (0%) 0/19 (0%) |
|FIRST INCIDENCE | --- --- 668 (T) 667 593 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.257 (e) P=0.278 P=0.510 P=0.455 |
|POLY 3 | P=0.252 (e) P=0.246 P=0.482 P=0.463 |
|POLY 1.5 | P=0.238 (e) P=0.241 P=0.476 P=0.463 |
|POLY 6 | P=0.268 (e) P=0.255 P=0.487 P=0.465 |
|LOGISTIC REGRESSION| P=0.235 (e) P=0.278 P=0.506 P=0.463 |
|COCH-ARM / FISHERS | P=0.216 (e) P=0.242 P=0.444 P=0.457 |
|ORDER RESTRICTED | P=0.257 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 92
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Pancreas |
| Edema |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 2/50 (4%) 2/37 (5%) 0/31 (0%) |
|POLY-3 RATE (b) | 1/33.77 0/30.37 2/29.55 2/21.66 0/18.96 |
|POLY-3 PERCENT (g) | 3.0% 0.0% 6.8% 9.2% 0.0% |
|TERMINAL (d) | 0/19 (0%) 0/21 (0%) 0/13 (0%) 0/7 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 475 --- 607 531 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.484 P=0.523N P=0.425 P=0.345 P=0.604N |
|POLY 3 | P=0.489 P=0.521N P=0.453 P=0.348 P=0.614N |
|POLY 1.5 | P=0.490 P=0.518N P=0.471 P=0.363 P=0.611N |
|POLY 6 | P=0.480 P=0.520N P=0.431 P=0.330 P=0.618N |
|LOGISTIC REGRESSION| P=0.495 P=0.483N P=0.482 P=0.391 P=0.578N |
|COCH-ARM / FISHERS | P=0.509 P=0.500N P=0.500 P=0.387 P=0.617N |
|ORDER RESTRICTED | P=0.405N (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Pancreas |
| Edema |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 2/49 (4%) 1/49 (2%) 0/40 (0%) 1/41 (2%) |
|POLY-3 RATE (b) | 0/34.96 2/32.33 1/37.21 0/31.97 1/29.32 |
|POLY-3 PERCENT (g) | 0.0% 6.2% 2.7% 0.0% 3.4% |
|TERMINAL (d) | 0/20 (0%) 0/18 (0%) 0/24 (0%) 0/20 (0%) 0/19 (0%) |
|FIRST INCIDENCE | --- 326 460 --- 482 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.581 P=0.228 P=0.505 (e) P=0.454 |
|POLY 3 | P=0.599 P=0.219 P=0.512 (e) P=0.465 |
|POLY 1.5 | P=0.591 P=0.227 P=0.506 (e) P=0.462 |
|POLY 6 | P=0.603 P=0.210 P=0.522 (e) P=0.468 |
|LOGISTIC REGRESSION| P=0.556 P=0.223 P=0.478 (e) P=0.466 |
|COCH-ARM / FISHERS | P=0.562 P=0.242 P=0.495 (e) P=0.451 |
|ORDER RESTRICTED | P=0.335 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 93
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Pancreas: Acinus |
| Cytoplasmic Alteration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 1/50 (2%) 1/37 (3%) 1/31 (3%) |
|POLY-3 RATE (b) | 1/33.40 2/31.54 1/29.31 1/21.21 1/19.14 |
|POLY-3 PERCENT (g) | 3.0% 6.3% 3.4% 4.7% 5.2% |
|TERMINAL (d) | 0/19 (0%) 0/21 (0%) 0/13 (0%) 0/7 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 601 168 631 599 627 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.495 P=0.475 P=0.699 P=0.638 P=0.639 |
|POLY 3 | P=0.494 P=0.480 P=0.732 P=0.655 P=0.632 |
|POLY 1.5 | P=0.499 P=0.481 P=0.744 P=0.668 P=0.633 |
|POLY 6 | P=0.485 P=0.487 P=0.716 P=0.638 P=0.629 |
|LOGISTIC REGRESSION| P=0.520 P=0.535 P=0.734 P=0.665 P=0.635 |
|COCH-ARM / FISHERS | P=0.526 P=0.500 P=0.753N P=0.673 P=0.622 |
|ORDER RESTRICTED | P=0.622 (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Pancreas: Acinus |
| Cytoplasmic Alteration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 4/49 (8%) 0/49 (0%) 2/40 (5%) 4/41 (10%) |
|POLY-3 RATE (b) | 0/34.96 4/33.58 0/36.54 2/33.10 4/31.19 |
|POLY-3 PERCENT (g) | 0.0% 11.9% 0.0% 6.0% 12.8% |
|TERMINAL (d) | 0/20 (0%) 0/18 (0%) 0/24 (0%) 0/20 (0%) 0/19 (0%) |
|FIRST INCIDENCE | --- 326 --- 488 207 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.060 P=0.062 (e) P=0.228 P=0.043 * |
|POLY 3 | P=0.061 P=0.053 (e) P=0.223 P=0.044 * |
|POLY 1.5 | P=0.057 P=0.057 (e) P=0.213 P=0.041 * |
|POLY 6 | P=0.064 P=0.049 * (e) P=0.233 P=0.048 * |
|LOGISTIC REGRESSION| P=0.045 * P=0.053 (e) P=0.119 P=0.043 * |
|COCH-ARM / FISHERS | P=0.049 * P=0.056 (e) P=0.195 P=0.038 * |
|ORDER RESTRICTED | P=0.019 * (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 94
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Penis |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/0 (0%) 2/2 (100%) 1/1 (100%) 1/3 (33%) 0/1 (0%) |
|POLY-3 RATE (b) | 0/0.00 2/2.00 1/1.00 1/1.64 0/0.70 |
|POLY-3 PERCENT (g) | 0.0% 100.0% 100.0% 61.2% 0.0% |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- 479 631 599 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.554N (e) (e) P=0.370 (e) |
|POLY 3 | (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.040N* (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.057N (e) (e) P=1.000 (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Penis |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | |
|POLY-3 RATE (b) | |
|POLY-3 PERCENT (g) | |
|TERMINAL (d) | |
|FIRST INCIDENCE | |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | |
|POLY 3 | |
|POLY 1.5 | |
|POLY 6 | |
|LOGISTIC REGRESSION| |
|COCH-ARM / FISHERS | |
|ORDER RESTRICTED | |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 95
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/48 (0%) 0/49 (0%) 0/49 (0%) 0/36 (0%) 0/31 (0%) |
|POLY-3 RATE (b) | 0/32.18 0/30.26 0/28.40 0/20.80 0/18.74 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/19 (0%) 0/21 (0%) 0/13 (0%) 0/7 (0%) 0/8 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 1/50 (2%) 1/40 (3%) 2/42 (5%) |
|POLY-3 RATE (b) | 0/34.96 0/31.01 1/36.73 1/31.97 2/29.20 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 2.7% 3.1% 6.9% |
|TERMINAL (d) | 0/20 (0%) 0/18 (0%) 0/24 (0%) 1/20 (5%) 1/19 (5%) |
|FIRST INCIDENCE | --- --- 650 668 (T) 565 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.051 (e) P=0.541 P=0.500 P=0.206 |
|POLY 3 | P=0.052 (e) P=0.510 P=0.482 P=0.196 |
|POLY 1.5 | P=0.048 * (e) P=0.506 P=0.476 P=0.196 |
|POLY 6 | P=0.055 (e) P=0.517 P=0.487 P=0.198 |
|LOGISTIC REGRESSION| P=0.045 * (e) P=0.519 P=0.500 P=0.196 |
|COCH-ARM / FISHERS | P=0.042 * (e) P=0.500 P=0.444 P=0.206 |
|ORDER RESTRICTED | P=0.061 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 96
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/48 (2%) 2/49 (4%) 3/49 (6%) 2/36 (6%) 1/31 (3%) |
|POLY-3 RATE (b) | 1/32.66 2/30.78 3/29.02 2/21.38 1/19.04 |
|POLY-3 PERCENT (g) | 3.1% 6.5% 10.3% 9.4% 5.3% |
|TERMINAL (d) | 0/19 (0%) 1/21 (5%) 2/13 (15%) 1/7 (14%) 0/8 (0%) |
|FIRST INCIDENCE | 538 523 482 501 593 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.326 P=0.489 P=0.229 P=0.313 P=0.642 |
|POLY 3 | P=0.391 P=0.479 P=0.261 P=0.354 P=0.635 |
|POLY 1.5 | P=0.398 P=0.479 P=0.279 P=0.368 P=0.637 |
|POLY 6 | P=0.382 P=0.487 P=0.241 P=0.335 P=0.635 |
|LOGISTIC REGRESSION| P=0.412 P=0.490 P=0.277 P=0.379 P=0.652 |
|COCH-ARM / FISHERS | P=0.443 P=0.508 P=0.316 P=0.392 P=0.634 |
|ORDER RESTRICTED | P=0.416 (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/50 (6%) 0/49 (0%) 0/50 (0%) 3/40 (8%) 0/42 (0%) |
|POLY-3 RATE (b) | 3/35.88 0/31.01 0/36.65 3/31.97 0/28.81 |
|POLY-3 PERCENT (g) | 8.4% 0.0% 0.0% 9.4% 0.0% |
|TERMINAL (d) | 2/20 (10%) 0/18 (0%) 0/24 (0%) 2/20 (10%) 0/19 (0%) |
|FIRST INCIDENCE | 287 --- --- 667 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.325N P=0.132N P=0.100N P=0.656 P=0.138N |
|POLY 3 | P=0.387N P=0.145N P=0.113N P=0.610 P=0.159N |
|POLY 1.5 | P=0.394N P=0.133N P=0.116N P=0.598 P=0.158N |
|POLY 6 | P=0.381N P=0.159N P=0.108N P=0.619 P=0.160N |
|LOGISTIC REGRESSION| P=0.367N P=0.122N P=0.123N P=0.588 P=0.151N |
|COCH-ARM / FISHERS | P=0.380N P=0.125N P=0.121N P=0.550 P=0.156N |
|ORDER RESTRICTED | P=0.057N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 97
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/48 (0%) 0/49 (0%) 0/49 (0%) 0/36 (0%) 0/31 (0%) |
|POLY-3 RATE (b) | 0/32.18 0/30.26 0/28.40 0/20.80 0/18.74 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/19 (0%) 0/21 (0%) 0/13 (0%) 0/7 (0%) 0/8 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/50 (6%) 4/49 (8%) 1/50 (2%) 2/40 (5%) 4/42 (10%) |
|POLY-3 RATE (b) | 3/35.30 4/31.12 1/36.65 2/32.22 4/29.43 |
|POLY-3 PERCENT (g) | 8.5% 12.9% 2.7% 6.2% 13.6% |
|TERMINAL (d) | 1/20 (5%) 3/18 (17%) 1/24 (4%) 1/20 (5%) 3/19 (16%) |
|FIRST INCIDENCE | 612 644 668 (T) 608 482 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.433 P=0.422 P=0.245N P=0.504N P=0.439 |
|POLY 3 | P=0.390 P=0.430 P=0.290N P=0.542N P=0.399 |
|POLY 1.5 | P=0.377 P=0.463 P=0.296N P=0.556N P=0.399 |
|POLY 6 | P=0.396 P=0.392 P=0.281N P=0.533N P=0.399 |
|LOGISTIC REGRESSION| P=0.391 P=0.388 P=0.272N P=0.536N P=0.394 |
|COCH-ARM / FISHERS | P=0.348 P=0.489 P=0.309N P=0.606N P=0.402 |
|ORDER RESTRICTED | P=0.330 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 98
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Preputial Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 6/50 (12%) 7/50 (14%) 6/50 (12%) 6/37 (16%) 2/32 (6%) |
|POLY-3 RATE (b) | 6/34.00 7/32.33 6/31.18 6/22.31 2/19.37 |
|POLY-3 PERCENT (g) | 17.7% 21.7% 19.2% 26.9% 10.3% |
|TERMINAL (d) | 3/19 (16%) 4/21 (19%) 1/13 (8%) 2/7 (29%) 0/8 (0%) |
|FIRST INCIDENCE | 497 329 481 382 627 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.520 P=0.510 P=0.433 P=0.133 P=0.447N |
|POLY 3 | P=0.413N P=0.459 P=0.561 P=0.310 P=0.375N |
|POLY 1.5 | P=0.389N P=0.456 P=0.582 P=0.340 P=0.364N |
|POLY 6 | P=0.449N P=0.479 P=0.538 P=0.275 P=0.389N |
|LOGISTIC REGRESSION| P=0.384N P=0.446 P=0.548 P=0.291 P=0.372N |
|COCH-ARM / FISHERS | P=0.327N P=0.500 P=0.620N P=0.398 P=0.326N |
|ORDER RESTRICTED | P=0.338N (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Preputial Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | |
|POLY-3 RATE (b) | |
|POLY-3 PERCENT (g) | |
|TERMINAL (d) | |
|FIRST INCIDENCE | |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | |
|POLY 3 | |
|POLY 1.5 | |
|POLY 6 | |
|LOGISTIC REGRESSION| |
|COCH-ARM / FISHERS | |
|ORDER RESTRICTED | |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 99
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Preputial Gland |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 11/50 (22%) 11/50 (22%) 18/50 (36%) 8/37 (22%) 9/32 (28%) |
|POLY-3 RATE (b) | 11/34.90 11/32.88 18/35.14 8/23.90 9/21.47 |
|POLY-3 PERCENT (g) | 31.5% 33.5% 51.2% 33.5% 41.9% |
|TERMINAL (d) | 5/19 (26%) 5/21 (24%) 6/13 (46%) 2/7 (29%) 2/8 (25%) |
|FIRST INCIDENCE | 308 329 147 382 329 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.126 P=0.584N P=0.024 * P=0.260 P=0.193 |
|POLY 3 | P=0.295 P=0.536 P=0.066 P=0.551 P=0.303 |
|POLY 1.5 | P=0.303 P=0.530 P=0.074 P=0.565 P=0.299 |
|POLY 6 | P=0.281 P=0.572 P=0.060 P=0.535 P=0.314 |
|LOGISTIC REGRESSION| P=0.295 P=0.517 P=0.062 P=0.522 P=0.274 |
|COCH-ARM / FISHERS | P=0.367 P=0.595N P=0.093 P=0.590N P=0.354 |
|ORDER RESTRICTED | P=0.339 (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Preputial Gland |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | |
|POLY-3 RATE (b) | |
|POLY-3 PERCENT (g) | |
|TERMINAL (d) | |
|FIRST INCIDENCE | |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | |
|POLY 3 | |
|POLY 1.5 | |
|POLY 6 | |
|LOGISTIC REGRESSION| |
|COCH-ARM / FISHERS | |
|ORDER RESTRICTED | |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 100
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Prostate |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 8/50 (16%) 3/50 (6%) 12/50 (24%) 6/37 (16%) 5/32 (16%) |
|POLY-3 RATE (b) | 8/36.18 3/31.26 12/33.45 6/22.27 5/20.74 |
|POLY-3 PERCENT (g) | 22.1% 9.6% 35.9% 26.9% 24.1% |
|TERMINAL (d) | 1/19 (5%) 2/21 (10%) 4/13 (31%) 0/7 (0%) 1/8 (13%) |
|FIRST INCIDENCE | 104 322 413 580 376 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.204 P=0.123N P=0.125 P=0.381 P=0.526 |
|POLY 3 | P=0.275 P=0.144N P=0.153 P=0.459 P=0.561 |
|POLY 1.5 | P=0.292 P=0.134N P=0.171 P=0.504 P=0.571 |
|POLY 6 | P=0.253 P=0.150N P=0.134 P=0.416 P=0.550 |
|LOGISTIC REGRESSION| P=0.322 P=0.099N P=0.214 P=0.568 P=0.612N |
|COCH-ARM / FISHERS | P=0.359 P=0.100N P=0.227 P=0.601 P=0.633 |
|ORDER RESTRICTED | P=0.222 (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Prostate |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | |
|POLY-3 RATE (b) | |
|POLY-3 PERCENT (g) | |
|TERMINAL (d) | |
|FIRST INCIDENCE | |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | |
|POLY 3 | |
|POLY 1.5 | |
|POLY 6 | |
|LOGISTIC REGRESSION| |
|COCH-ARM / FISHERS | |
|ORDER RESTRICTED | |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 101
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Salivary Glands |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/37 (0%) 1/32 (3%) |
|POLY-3 RATE (b) | 0/33.13 0/30.37 0/29.15 0/20.93 1/19.14 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 5.2% |
|TERMINAL (d) | 0/19 (0%) 0/21 (0%) 0/13 (0%) 0/7 (0%) 1/8 (13%) |
|FIRST INCIDENCE | --- --- --- --- 668 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.048 * (e) (e) (e) P=0.328 |
|POLY 3 | P=0.082 (e) (e) (e) P=0.391 |
|POLY 1.5 | P=0.083 (e) (e) (e) P=0.394 |
|POLY 6 | P=0.081 (e) (e) (e) P=0.387 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) P=0.328 |
|COCH-ARM / FISHERS | P=0.086 (e) (e) (e) P=0.390 |
|ORDER RESTRICTED | P=0.037 * (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Salivary Glands |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 6/49 (12%) 3/49 (6%) 1/40 (3%) 4/42 (10%) |
|POLY-3 RATE (b) | 2/35.24 6/33.81 3/36.00 1/31.97 4/30.13 |
|POLY-3 PERCENT (g) | 5.7% 17.7% 8.3% 3.1% 13.3% |
|TERMINAL (d) | 1/20 (5%) 1/18 (6%) 2/24 (8%) 1/20 (5%) 1/19 (5%) |
|FIRST INCIDENCE | 599 369 640 668 (T) 482 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.534N P=0.109 P=0.578 P=0.500N P=0.264 |
|POLY 3 | P=0.550 P=0.114 P=0.510 P=0.534N P=0.263 |
|POLY 1.5 | P=0.535 P=0.122 P=0.502 P=0.544N P=0.259 |
|POLY 6 | P=0.550N P=0.106 P=0.526 P=0.529N P=0.272 |
|LOGISTIC REGRESSION| P=0.502 P=0.130 P=0.532 P=0.524N P=0.254 |
|COCH-ARM / FISHERS | P=0.494 P=0.128 P=0.490 P=0.584N P=0.259 |
|ORDER RESTRICTED | P=0.259 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 102
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Salivary Glands |
| Infiltration Cellular Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/37 (0%) 5/32 (16%) |
|POLY-3 RATE (b) | 1/33.13 0/30.37 0/29.15 0/20.93 5/20.04 |
|POLY-3 PERCENT (g) | 3.0% 0.0% 0.0% 0.0% 25.0% |
|TERMINAL (d) | 1/19 (5%) 0/21 (0%) 0/13 (0%) 0/7 (0%) 3/8 (38%) |
|FIRST INCIDENCE | 668 (T) --- --- --- 495 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.480N P=0.576N P=0.699N P=0.010 * |
|POLY 3 | P<0.001 ** P=0.517N P=0.526N P=0.590N P=0.020 * |
|POLY 1.5 | P<0.001 ** P=0.516N P=0.515N P=0.580N P=0.020 * |
|POLY 6 | P<0.001 ** P=0.514N P=0.539N P=0.604N P=0.019 * |
|LOGISTIC REGRESSION| P<0.001 ** (e) (e) (e) P=0.019 * |
|COCH-ARM / FISHERS | P<0.001 ** P=0.500N P=0.500N P=0.575N P=0.031 * |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Salivary Glands |
| Infiltration Cellular Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/40 (0%) 0/42 (0%) |
|POLY-3 RATE (b) | 0/34.96 0/30.96 0/35.88 0/31.97 0/28.81 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/20 (0%) 0/18 (0%) 0/24 (0%) 0/20 (0%) 0/19 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 103
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Salivary Glands |
| Infiltration Cellular Mixed Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 2/37 (5%) 0/32 (0%) |
|POLY-3 RATE (b) | 1/33.13 0/30.37 1/29.15 2/21.09 0/19.14 |
|POLY-3 PERCENT (g) | 3.0% 0.0% 3.4% 9.5% 0.0% |
|TERMINAL (d) | 1/19 (5%) 0/21 (0%) 1/13 (8%) 1/7 (14%) 0/8 (0%) |
|FIRST INCIDENCE | 668 (T) --- 668 (T) 631 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.354 P=0.480N P=0.676 P=0.204 P=0.672N |
|POLY 3 | P=0.482 P=0.517N P=0.733 P=0.345 P=0.608N |
|POLY 1.5 | P=0.480 P=0.516N P=0.744 P=0.362 P=0.605N |
|POLY 6 | P=0.481 P=0.514N P=0.717 P=0.324 P=0.612N |
|LOGISTIC REGRESSION| P=0.413 (e) P=0.676 P=0.264 (e) |
|COCH-ARM / FISHERS | P=0.495 P=0.500N P=0.753N P=0.387 P=0.610N |
|ORDER RESTRICTED | P=0.442N (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Salivary Glands |
| Infiltration Cellular Mixed Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/40 (0%) 0/42 (0%) |
|POLY-3 RATE (b) | 0/34.96 0/30.96 0/35.88 0/31.97 0/28.81 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/20 (0%) 0/18 (0%) 0/24 (0%) 0/20 (0%) 0/19 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 104
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Seminal Vesicle |
| Dilatation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/37 (0%) 3/32 (9%) |
|POLY-3 RATE (b) | 2/33.72 0/30.37 0/29.15 0/20.93 3/19.32 |
|POLY-3 PERCENT (g) | 5.9% 0.0% 0.0% 0.0% 15.5% |
|TERMINAL (d) | 0/19 (0%) 0/21 (0%) 0/13 (0%) 0/7 (0%) 2/8 (25%) |
|FIRST INCIDENCE | 538 --- --- --- 627 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.056 P=0.256N P=0.298N P=0.384N P=0.218 |
|POLY 3 | P=0.087 P=0.260N P=0.270N P=0.350N P=0.256 |
|POLY 1.5 | P=0.092 P=0.256N P=0.256N P=0.333N P=0.266 |
|POLY 6 | P=0.079 P=0.259N P=0.290N P=0.373N P=0.245 |
|LOGISTIC REGRESSION| P=0.080 P=0.251N P=0.255N P=0.329N P=0.255 |
|COCH-ARM / FISHERS | P=0.097 P=0.247N P=0.247N P=0.327N P=0.296 |
|ORDER RESTRICTED | P=0.012 * (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Seminal Vesicle |
| Dilatation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | |
|POLY-3 RATE (b) | |
|POLY-3 PERCENT (g) | |
|TERMINAL (d) | |
|FIRST INCIDENCE | |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | |
|POLY 3 | |
|POLY 1.5 | |
|POLY 6 | |
|LOGISTIC REGRESSION| |
|COCH-ARM / FISHERS | |
|ORDER RESTRICTED | |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 105
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Seminal Vesicle |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) 0/50 (0%) 3/37 (8%) 0/32 (0%) |
|POLY-3 RATE (b) | 2/34.47 3/30.49 0/29.15 3/21.21 0/19.14 |
|POLY-3 PERCENT (g) | 5.8% 9.8% 0.0% 14.2% 0.0% |
|TERMINAL (d) | 0/19 (0%) 2/21 (10%) 0/13 (0%) 0/7 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 418 640 --- 631 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.512N P=0.498 P=0.255N P=0.234 P=0.368N |
|POLY 3 | P=0.412N P=0.444 P=0.275N P=0.286 P=0.376N |
|POLY 1.5 | P=0.400N P=0.455 P=0.259N P=0.314 P=0.368N |
|POLY 6 | P=0.429N P=0.443 P=0.297N P=0.256 P=0.387N |
|LOGISTIC REGRESSION| P=0.403N P=0.476 P=0.218N P=0.334 P=0.306N |
|COCH-ARM / FISHERS | P=0.368N P=0.500 P=0.247N P=0.359 P=0.369N |
|ORDER RESTRICTED | P=0.247N (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Seminal Vesicle |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | |
|POLY-3 RATE (b) | |
|POLY-3 PERCENT (g) | |
|TERMINAL (d) | |
|FIRST INCIDENCE | |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | |
|POLY 3 | |
|POLY 1.5 | |
|POLY 6 | |
|LOGISTIC REGRESSION| |
|COCH-ARM / FISHERS | |
|ORDER RESTRICTED | |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 106
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Skin |
| Cyst Epithelial Inclusion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 1/37 (3%) 0/32 (0%) |
|POLY-3 RATE (b) | 0/33.13 2/31.03 0/29.15 1/21.11 0/19.14 |
|POLY-3 PERCENT (g) | 0.0% 6.5% 0.0% 4.7% 0.0% |
|TERMINAL (d) | 0/19 (0%) 1/21 (5%) 0/13 (0%) 0/7 (0%) 0/8 (0%) |
|FIRST INCIDENCE | --- 467 --- 625 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.590N P=0.241 (e) P=0.370 (e) |
|POLY 3 | P=0.570N P=0.221 (e) P=0.411 (e) |
|POLY 1.5 | P=0.562N P=0.222 (e) P=0.421 (e) |
|POLY 6 | P=0.578N P=0.227 (e) P=0.399 (e) |
|LOGISTIC REGRESSION| P=0.550N P=0.228 (e) P=0.400 (e) |
|COCH-ARM / FISHERS | P=0.533N P=0.247 (e) P=0.425 (e) |
|ORDER RESTRICTED | P=0.433N (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Skin |
| Cyst Epithelial Inclusion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/49 (0%) 1/40 (3%) 2/42 (5%) |
|POLY-3 RATE (b) | 0/34.96 0/31.04 0/36.54 1/32.58 2/29.92 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 3.1% 6.7% |
|TERMINAL (d) | 0/20 (0%) 0/18 (0%) 0/24 (0%) 0/20 (0%) 0/19 (0%) |
|FIRST INCIDENCE | --- --- --- 488 412 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.019 * (e) (e) P=0.495 P=0.201 |
|POLY 3 | P=0.021 * (e) (e) P=0.486 P=0.201 |
|POLY 1.5 | P=0.020 * (e) (e) P=0.478 P=0.199 |
|POLY 6 | P=0.023 * (e) (e) P=0.493 P=0.205 |
|LOGISTIC REGRESSION| P=0.018 * (e) (e) P=0.374 P=0.206 |
|COCH-ARM / FISHERS | P=0.017 * (e) (e) P=0.444 P=0.206 |
|ORDER RESTRICTED | P=0.032 * (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 107
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Skin |
| Edema |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 10/50 (20%) 2/50 (4%) 7/50 (14%) 7/37 (19%) 1/32 (3%) |
|POLY-3 RATE (b) | 10/38.55 2/31.55 7/30.92 7/22.84 1/19.92 |
|POLY-3 PERCENT (g) | 25.9% 6.3% 22.6% 30.7% 5.0% |
|TERMINAL (d) | 0/19 (0%) 0/21 (0%) 1/13 (8%) 0/7 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 322 322 536 531 404 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.264N P=0.032N* P=0.463N P=0.465 P=0.059N |
|POLY 3 | P=0.225N P=0.030N* P=0.485N P=0.459 P=0.058N |
|POLY 1.5 | P=0.201N P=0.024N* P=0.409N P=0.527 P=0.048N* |
|POLY 6 | P=0.270N P=0.035N* P=0.566N P=0.400 P=0.074N |
|LOGISTIC REGRESSION| P=0.181N P=0.011N* P=0.301N P=0.566N P=0.022N* |
|COCH-ARM / FISHERS | P=0.170N P=0.014N* P=0.298N P=0.562N P=0.026N* |
|ORDER RESTRICTED | P=0.051N (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Skin |
| Edema |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/50 (6%) 7/50 (14%) 7/49 (14%) 6/40 (15%) 5/42 (12%) |
|POLY-3 RATE (b) | 3/37.45 7/35.64 7/40.09 6/34.17 5/32.19 |
|POLY-3 PERCENT (g) | 8.0% 19.6% 17.5% 17.6% 15.5% |
|TERMINAL (d) | 0/20 (0%) 0/18 (0%) 0/24 (0%) 1/20 (5%) 0/19 (0%) |
|FIRST INCIDENCE | 248 290 362 414 43 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.337 P=0.140 P=0.186 P=0.209 P=0.271 |
|POLY 3 | P=0.331 P=0.132 P=0.183 P=0.193 P=0.272 |
|POLY 1.5 | P=0.319 P=0.144 P=0.167 P=0.179 P=0.273 |
|POLY 6 | P=0.347 P=0.124 P=0.210 P=0.209 P=0.277 |
|LOGISTIC REGRESSION| P=0.229 P=0.157 P=0.112 P=0.040 * P=0.303 |
|COCH-ARM / FISHERS | P=0.280 P=0.159 P=0.151 P=0.145 P=0.264 |
|ORDER RESTRICTED | P=0.236 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 108
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Skin |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 14/50 (28%) 14/50 (28%) 13/50 (26%) 7/37 (19%) 6/32 (19%) |
|POLY-3 RATE (b) | 14/41.05 14/37.73 13/36.82 7/26.13 6/22.90 |
|POLY-3 PERCENT (g) | 34.1% 37.1% 35.3% 26.8% 26.2% |
|TERMINAL (d) | 3/19 (16%) 4/21 (19%) 1/13 (8%) 0/7 (0%) 1/8 (13%) |
|FIRST INCIDENCE | 111 147 229 167 192 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.251N P=0.523 P=0.506 P=0.410N P=0.370N |
|POLY 3 | P=0.187N P=0.483 P=0.552 P=0.359N P=0.355N |
|POLY 1.5 | P=0.157N P=0.499 P=0.589N P=0.310N P=0.326N |
|POLY 6 | P=0.243N P=0.482 P=0.496 P=0.430N P=0.399N |
|LOGISTIC REGRESSION| P=0.057N P=0.462N P=0.371N P=0.101N P=0.136N |
|COCH-ARM / FISHERS | P=0.110N P=0.588N P=0.500N P=0.235N P=0.248N |
|ORDER RESTRICTED | P=0.417N (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Skin |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 8/50 (16%) 5/50 (10%) 1/49 (2%) 5/40 (13%) 3/42 (7%) |
|POLY-3 RATE (b) | 8/37.53 5/33.53 1/36.54 5/33.47 3/30.15 |
|POLY-3 PERCENT (g) | 21.3% 14.9% 2.7% 14.9% 10.0% |
|TERMINAL (d) | 3/20 (15%) 0/18 (0%) 1/24 (4%) 2/20 (10%) 1/19 (5%) |
|FIRST INCIDENCE | 255 207 668 (T) 488 453 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.173N P=0.371N P=0.014N* P=0.319N P=0.160N |
|POLY 3 | P=0.196N P=0.348N P=0.016N* P=0.349N P=0.175N |
|POLY 1.5 | P=0.207N P=0.311N P=0.016N* P=0.368N P=0.173N |
|POLY 6 | P=0.187N P=0.386N P=0.015N* P=0.333N P=0.177N |
|LOGISTIC REGRESSION| P=0.227N P=0.264N P=0.019N* P=0.472N P=0.162N |
|COCH-ARM / FISHERS | P=0.219N P=0.277N P=0.017N* P=0.437N P=0.164N |
|ORDER RESTRICTED | P=0.104N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 109
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Skin: Epidermis |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 13/50 (26%) 12/50 (24%) 12/50 (24%) 8/37 (22%) 5/32 (16%) |
|POLY-3 RATE (b) | 13/40.05 12/35.83 12/36.82 8/26.31 5/22.76 |
|POLY-3 PERCENT (g) | 32.5% 33.5% 32.6% 30.4% 22.0% |
|TERMINAL (d) | 3/19 (16%) 4/21 (19%) 0/13 (0%) 0/7 (0%) 1/8 (13%) |
|FIRST INCIDENCE | 308 254 229 167 192 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.297N P=0.553N P=0.520 P=0.578 P=0.318N |
|POLY 3 | P=0.211N P=0.560 P=0.593 P=0.537N P=0.277N |
|POLY 1.5 | P=0.185N P=0.583 P=0.559N P=0.486N P=0.254N |
|POLY 6 | P=0.264N P=0.554 P=0.545 P=0.604N P=0.317N |
|LOGISTIC REGRESSION| P=0.097N P=0.437N P=0.388N P=0.278N P=0.118N |
|COCH-ARM / FISHERS | P=0.153N P=0.500N P=0.500N P=0.416N P=0.204N |
|ORDER RESTRICTED | P=0.348N (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Skin: Epidermis |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 7/50 (14%) 5/50 (10%) 3/49 (6%) 4/40 (10%) 3/42 (7%) |
|POLY-3 RATE (b) | 7/36.86 5/33.53 3/37.13 4/32.61 3/30.15 |
|POLY-3 PERCENT (g) | 19.0% 14.9% 8.1% 12.3% 10.0% |
|TERMINAL (d) | 2/20 (10%) 0/18 (0%) 2/24 (8%) 2/20 (10%) 1/19 (5%) |
|FIRST INCIDENCE | 460 207 495 488 453 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.169N P=0.493N P=0.127N P=0.279N P=0.238N |
|POLY 3 | P=0.194N P=0.445N P=0.149N P=0.330N P=0.245N |
|POLY 1.5 | P=0.205N P=0.408N P=0.154N P=0.342N P=0.243N |
|POLY 6 | P=0.190N P=0.487N P=0.143N P=0.330N P=0.250N |
|LOGISTIC REGRESSION| P=0.219N P=0.377N P=0.156N P=0.361N P=0.240N |
|COCH-ARM / FISHERS | P=0.219N P=0.380N P=0.167N P=0.405N P=0.239N |
|ORDER RESTRICTED | P=0.236N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 110
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 31/49 (63%) 29/50 (58%) 27/50 (54%) 18/37 (49%) 20/32 (63%) |
|POLY-3 RATE (b) | 31/47.16 29/41.27 27/41.65 18/29.69 20/26.79 |
|POLY-3 PERCENT (g) | 65.7% 70.3% 64.8% 60.6% 74.7% |
|TERMINAL (d) | 7/18 (39%) 12/21 (57%) 5/13 (39%) 0/7 (0%) 6/8 (75%) |
|FIRST INCIDENCE | 104 147 147 167 41 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.266 P=0.474N P=0.508 P=0.549N P=0.324 |
|POLY 3 | P=0.390 P=0.409 P=0.554N P=0.416N P=0.293 |
|POLY 1.5 | P=0.498 P=0.504 P=0.430N P=0.310N P=0.387 |
|POLY 6 | P=0.265 P=0.351 P=0.498 P=0.522N P=0.198 |
|LOGISTIC REGRESSION| P=0.330N P=0.313N P=0.142N P=0.064N P=0.482N |
|COCH-ARM / FISHERS | P=0.368N P=0.371N P=0.232N P=0.128N P=0.564N |
|ORDER RESTRICTED | P=0.391 (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 31/50 (62%) 21/50 (42%) 32/49 (65%) 26/40 (65%) 29/42 (69%) |
|POLY-3 RATE (b) | 31/43.75 21/38.39 32/43.18 26/37.62 29/36.68 |
|POLY-3 PERCENT (g) | 70.9% 54.7% 74.1% 69.1% 79.1% |
|TERMINAL (d) | 13/20 (65%) 7/18 (39%) 17/24 (71%) 11/20 (55%) 14/19 (74%) |
|FIRST INCIDENCE | 179 207 182 359 49 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.305 P=0.204N P=0.388N P=0.337N P=0.429 |
|POLY 3 | P=0.110 P=0.087N P=0.459 P=0.530N P=0.271 |
|POLY 1.5 | P=0.078 P=0.054N P=0.452 P=0.564N P=0.267 |
|POLY 6 | P=0.153 P=0.137N P=0.491 P=0.509N P=0.291 |
|LOGISTIC REGRESSION| P=0.065 P=0.041N* P=0.484 P=0.505 P=0.294 |
|COCH-ARM / FISHERS | P=0.056 P=0.036N* P=0.447 P=0.472 P=0.314 |
|ORDER RESTRICTED | P=0.083 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 111
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Spleen |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/49 (4%) 3/50 (6%) 4/50 (8%) 2/37 (5%) 0/32 (0%) |
|POLY-3 RATE (b) | 2/32.24 3/30.89 4/30.90 2/22.05 0/19.14 |
|POLY-3 PERCENT (g) | 6.2% 9.7% 12.9% 9.1% 0.0% |
|TERMINAL (d) | 1/18 (6%) 2/21 (10%) 2/13 (15%) 0/7 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 641 523 147 320 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.377N P=0.529 P=0.239 P=0.426 P=0.427N |
|POLY 3 | P=0.275N P=0.480 P=0.314 P=0.552 P=0.359N |
|POLY 1.5 | P=0.267N P=0.479 P=0.329 P=0.564 P=0.356N |
|POLY 6 | P=0.293N P=0.494 P=0.292 P=0.534 P=0.364N |
|LOGISTIC REGRESSION| P=0.243N P=0.481 P=0.346 P=0.573 P=0.368N |
|COCH-ARM / FISHERS | P=0.235N P=0.510 P=0.349 P=0.579 P=0.363N |
|ORDER RESTRICTED | P=0.224N (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Spleen |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 13/50 (26%) 24/50 (48%) 12/49 (24%) 10/40 (25%) 12/42 (29%) |
|POLY-3 RATE (b) | 13/38.73 24/39.56 12/40.21 10/33.81 12/32.91 |
|POLY-3 PERCENT (g) | 33.6% 60.7% 29.9% 29.6% 36.5% |
|TERMINAL (d) | 7/20 (35%) 11/18 (61%) 5/24 (21%) 6/20 (30%) 5/19 (26%) |
|FIRST INCIDENCE | 248 290 328 488 207 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.135N P=0.014 * P=0.380N P=0.362N P=0.541 |
|POLY 3 | P=0.170N P=0.010 * P=0.454N P=0.455N P=0.497 |
|POLY 1.5 | P=0.190N P=0.013 * P=0.487N P=0.480N P=0.482 |
|POLY 6 | P=0.147N P=0.009 ** P=0.401N P=0.425N P=0.526 |
|LOGISTIC REGRESSION| P=0.231N P=0.019 * P=0.530N P=0.552N P=0.486 |
|COCH-ARM / FISHERS | P=0.227N P=0.019 * P=0.523N P=0.555N P=0.482 |
|ORDER RESTRICTED | P=0.138N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 112
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Spleen: Lymphoid Follicle |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/49 (8%) 5/50 (10%) 5/50 (10%) 7/37 (19%) 2/32 (6%) |
|POLY-3 RATE (b) | 4/34.81 5/34.01 5/31.51 7/25.40 2/19.67 |
|POLY-3 PERCENT (g) | 11.5% 14.7% 15.9% 27.6% 10.2% |
|TERMINAL (d) | 0/18 (0%) 0/21 (0%) 0/13 (0%) 0/7 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 104 45 474 157 539 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.336 P=0.462 P=0.420 P=0.081 P=0.624N |
|POLY 3 | P=0.298 P=0.485 P=0.436 P=0.101 P=0.615N |
|POLY 1.5 | P=0.319 P=0.484 P=0.458 P=0.108 P=0.603N |
|POLY 6 | P=0.274 P=0.505 P=0.418 P=0.094 P=0.625N |
|LOGISTIC REGRESSION| P=0.477 P=0.598N P=0.559 P=0.197 P=0.481N |
|COCH-ARM / FISHERS | P=0.401 P=0.513 P=0.513 P=0.125 P=0.555N |
|ORDER RESTRICTED | P=0.398 (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Spleen: Lymphoid Follicle |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/50 (8%) 6/50 (12%) 5/49 (10%) 6/40 (15%) 4/42 (10%) |
|POLY-3 RATE (b) | 4/37.45 6/34.60 5/40.25 6/33.38 4/31.30 |
|POLY-3 PERCENT (g) | 10.7% 17.3% 12.4% 18.0% 12.8% |
|TERMINAL (d) | 1/20 (5%) 0/18 (0%) 0/24 (0%) 1/20 (5%) 0/19 (0%) |
|FIRST INCIDENCE | 248 412 237 488 207 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.466 P=0.322 P=0.512 P=0.354 P=0.557 |
|POLY 3 | P=0.434 P=0.317 P=0.546 P=0.294 P=0.543 |
|POLY 1.5 | P=0.423 P=0.338 P=0.523 P=0.280 P=0.541 |
|POLY 6 | P=0.444 P=0.305 P=0.577 P=0.310 P=0.548 |
|LOGISTIC REGRESSION| P=0.371 P=0.393 P=0.410 P=0.147 P=0.590 |
|COCH-ARM / FISHERS | P=0.406 P=0.370 P=0.487 P=0.237 P=0.541 |
|ORDER RESTRICTED | P=0.503 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 113
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Spleen: Lymphoid Follicle |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/49 (0%) 6/50 (12%) 5/50 (10%) 2/37 (5%) 1/32 (3%) |
|POLY-3 RATE (b) | 0/32.13 6/30.37 5/29.30 2/21.09 1/19.14 |
|POLY-3 PERCENT (g) | 0.0% 19.8% 17.1% 9.5% 5.2% |
|TERMINAL (d) | 0/18 (0%) 6/21 (29%) 4/13 (31%) 1/7 (14%) 1/8 (13%) |
|FIRST INCIDENCE | --- 668 (T) 633 631 668 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.340 P=0.023 * P=0.011 * P=0.083 P=0.338 |
|POLY 3 | P=0.552 P=0.011 * P=0.021 * P=0.150 P=0.397 |
|POLY 1.5 | P=0.542N P=0.012 * P=0.025 * P=0.158 P=0.400 |
|POLY 6 | P=0.530 P=0.011 * P=0.017 * P=0.139 P=0.394 |
|LOGISTIC REGRESSION| P=0.452 P=0.023 * P=0.012 * P=0.117 P=0.338 |
|COCH-ARM / FISHERS | P=0.475N P=0.014 * P=0.030 * P=0.182 P=0.395 |
|ORDER RESTRICTED | P=0.108 (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Spleen: Lymphoid Follicle |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 7/50 (14%) 3/50 (6%) 7/49 (14%) 6/40 (15%) 7/42 (17%) |
|POLY-3 RATE (b) | 7/36.24 3/32.79 7/37.23 6/32.44 7/30.09 |
|POLY-3 PERCENT (g) | 19.3% 9.2% 18.8% 18.5% 23.3% |
|TERMINAL (d) | 3/20 (15%) 1/18 (6%) 5/24 (21%) 5/20 (25%) 5/19 (26%) |
|FIRST INCIDENCE | 510 326 574 541 467 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.293 P=0.230N P=0.511N P=0.532N P=0.513 |
|POLY 3 | P=0.244 P=0.194N P=0.595N P=0.588N P=0.464 |
|POLY 1.5 | P=0.223 P=0.172N P=0.607N P=0.603N P=0.465 |
|POLY 6 | P=0.260 P=0.228N P=0.577N P=0.587N P=0.458 |
|LOGISTIC REGRESSION| P=0.221 P=0.165N P=0.580N P=0.573N P=0.460 |
|COCH-ARM / FISHERS | P=0.196 P=0.159N P=0.597 P=0.563 P=0.472 |
|ORDER RESTRICTED | P=0.307 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 114
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Edema |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/49 (2%) 0/50 (0%) 2/50 (4%) 1/37 (3%) 0/32 (0%) |
|POLY-3 RATE (b) | 1/32.92 0/30.37 2/30.24 1/21.18 0/19.14 |
|POLY-3 PERCENT (g) | 3.0% 0.0% 6.6% 4.7% 0.0% |
|TERMINAL (d) | 0/18 (0%) 0/21 (0%) 0/13 (0%) 0/7 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 392 --- 490 607 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.520N P=0.530N P=0.474 P=0.651 P=0.616N |
|POLY 3 | P=0.533N P=0.516N P=0.470 P=0.658 P=0.607N |
|POLY 1.5 | P=0.522N P=0.513N P=0.483 P=0.672 P=0.602N |
|POLY 6 | P=0.552N P=0.514N P=0.455 P=0.642 P=0.612N |
|LOGISTIC REGRESSION| P=0.496N P=0.453N P=0.530 P=0.712 P=0.537N |
|COCH-ARM / FISHERS | P=0.501N P=0.495N P=0.508 P=0.678 P=0.605N |
|ORDER RESTRICTED | P=0.446N (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Edema |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 5/50 (10%) 3/49 (6%) 2/40 (5%) 4/42 (10%) |
|POLY-3 RATE (b) | 1/35.79 5/33.87 3/36.77 2/32.44 4/28.92 |
|POLY-3 PERCENT (g) | 2.8% 14.8% 8.2% 6.2% 13.8% |
|TERMINAL (d) | 0/20 (0%) 0/18 (0%) 2/24 (8%) 1/20 (5%) 3/19 (16%) |
|FIRST INCIDENCE | 372 395 612 541 641 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.296 P=0.088 P=0.361 P=0.469 P=0.155 |
|POLY 3 | P=0.260 P=0.086 P=0.314 P=0.465 P=0.116 |
|POLY 1.5 | P=0.255 P=0.093 P=0.307 P=0.455 P=0.120 |
|POLY 6 | P=0.264 P=0.081 P=0.326 P=0.474 P=0.113 |
|LOGISTIC REGRESSION| P=0.243 P=0.109 P=0.300 P=0.346 P=0.126 |
|COCH-ARM / FISHERS | P=0.239 P=0.102 P=0.301 P=0.416 P=0.131 |
|ORDER RESTRICTED | P=0.103 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 115
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Erosion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/37 (0%) 0/32 (0%) |
|POLY-3 RATE (b) | 0/32.13 0/30.37 0/29.15 0/20.93 0/19.14 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/18 (0%) 0/21 (0%) 0/13 (0%) 0/7 (0%) 0/8 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Erosion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/40 (0%) 2/42 (5%) |
|POLY-3 RATE (b) | 0/34.96 0/31.04 0/36.54 0/31.97 2/29.77 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 6.7% |
|TERMINAL (d) | 0/20 (0%) 0/18 (0%) 0/24 (0%) 0/20 (0%) 0/19 (0%) |
|FIRST INCIDENCE | --- --- --- --- 479 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.022 * (e) (e) (e) P=0.192 |
|POLY 3 | P=0.025 * (e) (e) (e) P=0.200 |
|POLY 1.5 | P=0.024 * (e) (e) (e) P=0.198 |
|POLY 6 | P=0.026 * (e) (e) (e) P=0.204 |
|LOGISTIC REGRESSION| P=0.020 * (e) (e) (e) P=0.202 |
|COCH-ARM / FISHERS | P=0.020 * (e) (e) (e) P=0.206 |
|ORDER RESTRICTED | P=0.010 * (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 116
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Stomach, Forestomach: Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/49 (4%) 0/50 (0%) 1/50 (2%) 1/37 (3%) 1/32 (3%) |
|POLY-3 RATE (b) | 2/32.13 0/30.37 1/29.41 1/21.82 1/19.52 |
|POLY-3 PERCENT (g) | 6.2% 0.0% 3.4% 4.6% 5.1% |
|TERMINAL (d) | 2/18 (11%) 0/21 (0%) 0/13 (0%) 0/7 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 668 (T) --- 605 320 569 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.433 P=0.203N P=0.595N P=0.721 P=0.731 |
|POLY 3 | P=0.517 P=0.248N P=0.531N P=0.634N P=0.671N |
|POLY 1.5 | P=0.517 P=0.248N P=0.517N P=0.621N P=0.669N |
|POLY 6 | P=0.512 P=0.242N P=0.549N P=0.651N P=0.671N |
|LOGISTIC REGRESSION| P=0.507 (e) P=0.570N P=0.610N P=0.683N |
|COCH-ARM / FISHERS | P=0.521 P=0.242N P=0.492N P=0.605N P=0.657N |
|ORDER RESTRICTED | P=0.504N (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Stomach, Forestomach: Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/50 (8%) 3/50 (6%) 0/49 (0%) 2/40 (5%) 4/42 (10%) |
|POLY-3 RATE (b) | 4/36.11 3/32.31 0/36.54 2/32.34 4/31.57 |
|POLY-3 PERCENT (g) | 11.1% 9.3% 0.0% 6.2% 12.7% |
|TERMINAL (d) | 2/20 (10%) 0/18 (0%) 0/24 (0%) 1/20 (5%) 0/19 (0%) |
|FIRST INCIDENCE | 372 500 --- 572 207 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.415 P=0.593N P=0.054N P=0.379N P=0.544 |
|POLY 3 | P=0.419 P=0.561N P=0.057N P=0.387N P=0.569 |
|POLY 1.5 | P=0.404 P=0.533N P=0.059N P=0.399N P=0.560 |
|POLY 6 | P=0.428 P=0.587N P=0.054N P=0.378N P=0.580 |
|LOGISTIC REGRESSION| P=0.357 P=0.508N P=0.065N P=0.434N P=0.567 |
|COCH-ARM / FISHERS | P=0.369 P=0.500N P=0.061N P=0.450N P=0.541 |
|ORDER RESTRICTED | P=0.296 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 117
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/37 (0%) 0/32 (0%) |
|POLY-3 RATE (b) | 0/32.88 0/30.37 0/29.15 0/20.93 0/19.14 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/19 (0%) 0/21 (0%) 0/13 (0%) 0/7 (0%) 0/8 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/49 (0%) 0/40 (0%) 0/42 (0%) |
|POLY-3 RATE (b) | 0/34.96 2/31.52 0/36.54 0/31.97 0/28.81 |
|POLY-3 PERCENT (g) | 0.0% 6.3% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/20 (0%) 1/18 (6%) 0/24 (0%) 0/20 (0%) 0/19 (0%) |
|FIRST INCIDENCE | --- 536 --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.248N P=0.212 (e) (e) (e) |
|POLY 3 | P=0.290N P=0.214 (e) (e) (e) |
|POLY 1.5 | P=0.279N P=0.225 (e) (e) (e) |
|POLY 6 | P=0.304N P=0.203 (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.261N P=0.219 (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.268N P=0.247 (e) (e) (e) |
|ORDER RESTRICTED | P=0.240N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 118
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Edema |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/49 (0%) 1/50 (2%) 2/50 (4%) 2/37 (5%) 0/32 (0%) |
|POLY-3 RATE (b) | 0/32.88 1/30.37 2/29.86 2/21.27 0/19.14 |
|POLY-3 PERCENT (g) | 0.0% 3.3% 6.7% 9.4% 0.0% |
|TERMINAL (d) | 0/19 (0%) 1/21 (5%) 0/13 (0%) 0/7 (0%) 0/8 (0%) |
|FIRST INCIDENCE | --- 668 (T) 544 625 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.368 P=0.520 P=0.197 P=0.106 (e) |
|POLY 3 | P=0.385 P=0.484 P=0.215 P=0.147 (e) |
|POLY 1.5 | P=0.393 P=0.487 P=0.225 P=0.157 (e) |
|POLY 6 | P=0.374 P=0.487 P=0.204 P=0.137 (e) |
|LOGISTIC REGRESSION| P=0.396 P=0.520 P=0.227 P=0.134 (e) |
|COCH-ARM / FISHERS | P=0.432 P=0.505 P=0.253 P=0.182 (e) |
|ORDER RESTRICTED | P=0.288 (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Edema |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/49 (2%) 0/40 (0%) 2/42 (5%) |
|POLY-3 RATE (b) | 0/34.96 2/32.51 1/37.21 0/31.97 2/29.57 |
|POLY-3 PERCENT (g) | 0.0% 6.2% 2.7% 0.0% 6.8% |
|TERMINAL (d) | 0/20 (0%) 0/18 (0%) 0/24 (0%) 0/20 (0%) 0/19 (0%) |
|FIRST INCIDENCE | --- 326 460 --- 474 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.292 P=0.232 P=0.505 (e) P=0.207 |
|POLY 3 | P=0.305 P=0.220 P=0.512 (e) P=0.199 |
|POLY 1.5 | P=0.297 P=0.229 P=0.506 (e) P=0.198 |
|POLY 6 | P=0.308 P=0.211 P=0.522 (e) P=0.201 |
|LOGISTIC REGRESSION| P=0.268 P=0.231 P=0.478 (e) P=0.200 |
|COCH-ARM / FISHERS | P=0.270 P=0.247 P=0.495 (e) P=0.206 |
|ORDER RESTRICTED | P=0.093 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 119
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Erosion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/49 (4%) 2/50 (4%) 1/50 (2%) 0/37 (0%) 1/32 (3%) |
|POLY-3 RATE (b) | 2/34.35 2/31.41 1/29.91 0/20.93 1/19.62 |
|POLY-3 PERCENT (g) | 5.8% 6.4% 3.3% 0.0% 5.1% |
|TERMINAL (d) | 0/19 (0%) 0/21 (0%) 0/13 (0%) 0/7 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 392 432 413 --- 539 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.339N P=0.648 P=0.523N P=0.341N P=0.677N |
|POLY 3 | P=0.357N P=0.663 P=0.548N P=0.355N P=0.689N |
|POLY 1.5 | P=0.335N P=0.668 P=0.526N P=0.335N P=0.680N |
|POLY 6 | P=0.389N P=0.668 P=0.576N P=0.381N P=0.697N |
|LOGISTIC REGRESSION| P=0.285N P=0.655N P=0.450N P=0.260N P=0.608N |
|COCH-ARM / FISHERS | P=0.305N P=0.684N P=0.492N P=0.322N P=0.657N |
|ORDER RESTRICTED | P=0.491N (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Erosion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 1/49 (2%) 0/40 (0%) 0/42 (0%) |
|POLY-3 RATE (b) | 1/35.91 2/31.10 1/37.49 0/31.97 0/28.81 |
|POLY-3 PERCENT (g) | 2.8% 6.4% 2.7% 0.0% 0.0% |
|TERMINAL (d) | 0/20 (0%) 1/18 (6%) 0/24 (0%) 0/20 (0%) 0/19 (0%) |
|FIRST INCIDENCE | 255 655 237 --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.119N P=0.479 P=0.760 P=0.532N P=0.537N |
|POLY 3 | P=0.135N P=0.450 P=0.752N P=0.523N P=0.544N |
|POLY 1.5 | P=0.134N P=0.473 P=0.757N P=0.528N P=0.542N |
|POLY 6 | P=0.138N P=0.426 P=0.744N P=0.520N P=0.545N |
|LOGISTIC REGRESSION| P=0.140N P=0.508 P=0.706 P=0.931N P=0.461N |
|COCH-ARM / FISHERS | P=0.132N P=0.500 P=0.747 P=0.556N P=0.543N |
|ORDER RESTRICTED | P=0.215N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 120
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Stomach, Glandular: Glands |
| Hyperplasia Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 9/49 (18%) 13/50 (26%) 10/50 (20%) 15/37 (41%) 6/32 (19%) |
|POLY-3 RATE (b) | 9/33.42 13/32.85 10/30.42 15/25.57 6/20.17 |
|POLY-3 PERCENT (g) | 26.9% 39.6% 32.9% 58.7% 29.8% |
|TERMINAL (d) | 6/19 (32%) 9/21 (43%) 7/13 (54%) 5/7 (71%) 2/8 (25%) |
|FIRST INCIDENCE | 601 147 510 320 539 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.026 * P=0.270 P=0.197 P<0.001 ** P=0.348 |
|POLY 3 | P=0.160 P=0.196 P=0.401 P=0.009 ** P=0.537 |
|POLY 1.5 | P=0.171 P=0.200 P=0.448 P=0.011 * P=0.539 |
|POLY 6 | P=0.150 P=0.210 P=0.343 P=0.007 ** P=0.541 |
|LOGISTIC REGRESSION| P=0.153 P=0.170 P=0.290 P=0.006 ** P=0.485 |
|COCH-ARM / FISHERS | P=0.244 P=0.251 P=0.520 P=0.022 * P=0.593 |
|ORDER RESTRICTED | P=0.148 (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Stomach, Glandular: Glands |
| Hyperplasia Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 6/50 (12%) 12/50 (24%) 8/49 (16%) 10/40 (25%) 6/42 (14%) |
|POLY-3 RATE (b) | 6/36.78 12/34.62 8/38.19 10/34.09 6/30.06 |
|POLY-3 PERCENT (g) | 16.3% 34.7% 21.0% 29.3% 20.0% |
|TERMINAL (d) | 0/20 (0%) 6/18 (33%) 4/24 (17%) 5/20 (25%) 4/19 (21%) |
|FIRST INCIDENCE | 443 326 362 488 479 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.468N P=0.061 P=0.481 P=0.191 P=0.507 |
|POLY 3 | P=0.488 P=0.060 P=0.413 P=0.149 P=0.474 |
|POLY 1.5 | P=0.477 P=0.076 P=0.400 P=0.133 P=0.480 |
|POLY 6 | P=0.487 P=0.047 * P=0.429 P=0.159 P=0.462 |
|LOGISTIC REGRESSION| P=0.488 P=0.082 P=0.387 P=0.108 P=0.486 |
|COCH-ARM / FISHERS | P=0.462 P=0.096 P=0.371 P=0.093 P=0.492 |
|ORDER RESTRICTED | P=0.301 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/09/04 EXPERIMENT: 99022 TEST: 02 Page 121
Statistical Analysis of Non-neoplastic Lesions in Mice(SWISS) - AZT TRANSPLACENTAL CARCINOGENESIS
Terminal Sacrifice at 96 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 50 100 200 300 |
| | MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Testes: Germinal Epithelium |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- |