TDMS Study 99022-02 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst AZT TRANSPLACENTAL CARCINOGENESIS STUDY DATE: 10/08/03
EXPERIMENT: 99022 TEST: 02 TIME: 15:46:56
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/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 PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst AZT TRANSPLACENTAL CARCINOGENESIS STUDY DATE: 10/08/03
EXPERIMENT: 99022 TEST: 02 TIME: 15:46:56
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
Mice(SWISS)
-----------------------------
FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE
BASED ON NUMBER OF TISSUES EXAMINED. IN OTHER TISSUES/ORGANS RATES
ARE BASED ON THE NUMBER OF ANIMALS NECROPSIED.
---------------
Adrenal Cortex
Adrenal Medulla
Bone Marrow
Brain
Heart
Islets, Pancreatic
Kidney
Liver
Lung
Ovary
Parathyroid Gland
Pituitary Gland
Salivary Glands
Spleen
Testes
Thymus
Thyroid Gland
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst AZT TRANSPLACENTAL CARCINOGENESIS STUDY DATE: 10/08/03
EXPERIMENT: 99022 TEST: 02 TIME: 15:46:56
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
----- ----------
Lung Alveolar/Bronchiolar Adenoma
Alveolar/Bronchiolar Carcinoma
Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
All Organs Malignant Tumors
Malignant and Benign Tumors
===============================================================
Female Mice
------------
Organ Morphology
----- ----------
Islets, Pancreatic Adenoma
===============================================================
Date: 10/08/03 EXPERIMENT: 99022 TEST: 02 Page 1
Statistical Analysis of Primary Tumors 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 |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) 3/37 (8%) 0/32 (0%) |
|POLY-3 RATE (b) | 2/33.13 0/30.37 1/29.40 3/20.93 0/19.14 |
|POLY-3 PERCENT (g) | 6.0% 0.0% 3.4% 14.3% 0.0% |
|TERMINAL (d) | 2/19 (11%) 0/21 (0%) 0/13 (0%) 3/7 (43%) 0/8 (0%) |
|FIRST INCIDENCE | 668 (T) --- 608 668 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.349 P=0.215N P=0.623N P=0.102 P=0.442N |
|POLY 3 | P=0.528 P=0.256N P=0.542N P=0.296 P=0.366N |
|POLY 1.5 | P=0.523 P=0.254N P=0.526N P=0.320 P=0.362N |
|POLY 6 | P=0.528 P=0.251N P=0.562N P=0.265 P=0.371N |
|LOGISTIC REGRESSION| P=0.438 (e) P=0.585N P=0.102 (e) |
|COCH-ARM / FISHERS | P=0.535 P=0.247N P=0.500N P=0.359 P=0.369N |
|ORDER RESTRICTED | P=0.297N (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 |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 1/49 (2%) 0/50 (0%) 0/38 (0%) 0/42 (0%) |
|POLY-3 RATE (b) | 1/35.30 1/30.04 0/36.65 0/29.97 0/28.81 |
|POLY-3 PERCENT (g) | 2.8% 3.3% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/20 (0%) 1/17 (6%) 0/24 (0%) 0/18 (0%) 0/19 (0%) |
|FIRST INCIDENCE | 581 668 (T) --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.156N P=0.691 P=0.494N P=0.540N P=0.555N |
|POLY 3 | P=0.178N P=0.725 P=0.493N P=0.533N P=0.541N |
|POLY 1.5 | P=0.176N P=0.741 P=0.495N P=0.537N P=0.539N |
|POLY 6 | P=0.182N P=0.705 P=0.487N P=0.532N P=0.543N |
|LOGISTIC REGRESSION| P=0.162N P=0.726 P=0.498N P=0.556N P=0.537N |
|COCH-ARM / FISHERS | P=0.172N P=0.747 P=0.500N P=0.568N P=0.543N |
|ORDER RESTRICTED | P=0.235N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 99022 TEST: 02 Page 2
Statistical Analysis of Primary Tumors 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 |
| Osteosarcoma or Osteoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR 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 |
|=================================================================================================================================|
| |
|Bone |
| Osteosarcoma or Osteoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 1/40 (3%) 0/42 (0%) |
|POLY-3 RATE (b) | 0/34.96 2/31.79 0/36.65 1/31.97 0/28.81 |
|POLY-3 PERCENT (g) | 0.0% 6.3% 0.0% 3.1% 0.0% |
|TERMINAL (d) | 0/20 (0%) 0/18 (0%) 0/24 (0%) 1/20 (5%) 0/19 (0%) |
|FIRST INCIDENCE | --- 565 --- 668 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.444N P=0.160 (e) P=0.500 (e) |
|POLY 3 | P=0.504N P=0.215 (e) P=0.482 (e) |
|POLY 1.5 | P=0.493N P=0.226 (e) P=0.476 (e) |
|POLY 6 | P=0.516N P=0.206 (e) P=0.487 (e) |
|LOGISTIC REGRESSION| P=0.461N P=0.231 (e) P=0.500 (e) |
|COCH-ARM / FISHERS | P=0.471N P=0.247 (e) P=0.444 (e) |
|ORDER RESTRICTED | P=0.334N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 99022 TEST: 02 Page 3
Statistical Analysis of Primary Tumors 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 |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 11/50 (22%) 8/50 (16%) 9/50 (18%) 3/37 (8%) 4/32 (13%) |
|POLY-3 RATE (b) | 11/35.25 8/31.68 9/31.45 3/21.67 4/19.78 |
|POLY-3 PERCENT (g) | 31.2% 25.3% 28.6% 13.9% 20.2% |
|TERMINAL (d) | 5/19 (26%) 4/21 (19%) 3/13 (23%) 1/7 (14%) 2/8 (25%) |
|FIRST INCIDENCE | 453 523 413 501 488 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.283N P=0.302N P=0.521 P=0.291N P=0.418N |
|POLY 3 | P=0.119N P=0.393N P=0.515N P=0.122N P=0.287N |
|POLY 1.5 | P=0.103N P=0.381N P=0.472N P=0.101N P=0.270N |
|POLY 6 | P=0.151N P=0.377N P=0.563N P=0.155N P=0.310N |
|LOGISTIC REGRESSION| P=0.114N P=0.371N P=0.507N P=0.112N P=0.267N |
|COCH-ARM / FISHERS | P=0.082N P=0.306N P=0.402N P=0.071N P=0.216N |
|ORDER RESTRICTED | P=0.228N (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 |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 4/50 (8%) 6/50 (12%) 9/50 (18%) 4/40 (10%) 7/42 (17%) |
|POLY-3 RATE (b) | 4/35.91 6/31.40 9/37.13 4/32.36 7/30.54 |
|POLY-3 PERCENT (g) | 11.1% 19.1% 24.2% 12.4% 22.9% |
|TERMINAL (d) | 1/20 (5%) 5/18 (28%) 8/24 (33%) 3/20 (15%) 3/19 (16%) |
|FIRST INCIDENCE | 558 577 537 565 453 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.335 P=0.260 P=0.182 P=0.608 P=0.190 |
|POLY 3 | P=0.294 P=0.283 P=0.121 P=0.587 P=0.167 |
|POLY 1.5 | P=0.266 P=0.325 P=0.119 P=0.573 P=0.165 |
|POLY 6 | P=0.318 P=0.237 P=0.126 P=0.593 P=0.172 |
|LOGISTIC REGRESSION| P=0.268 P=0.267 P=0.137 P=0.584 P=0.162 |
|COCH-ARM / FISHERS | P=0.221 P=0.370 P=0.117 P=0.512 P=0.170 |
|ORDER RESTRICTED | P=0.175 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 99022 TEST: 02 Page 4
Statistical Analysis of Primary Tumors 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 |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 11/50 (22%) 8/50 (16%) 10/50 (20%) 3/37 (8%) 5/32 (16%) |
|POLY-3 RATE (b) | 11/35.25 8/31.68 10/31.45 3/21.67 5/20.60 |
|POLY-3 PERCENT (g) | 31.2% 25.3% 31.8% 13.9% 24.3% |
|TERMINAL (d) | 5/19 (26%) 4/21 (19%) 4/13 (31%) 1/7 (14%) 2/8 (25%) |
|FIRST INCIDENCE | 453 523 413 501 376 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.416N P=0.302N P=0.411 P=0.291N P=0.563N |
|POLY 3 | P=0.196N P=0.393N P=0.586 P=0.122N P=0.402N |
|POLY 1.5 | P=0.176N P=0.381N P=0.579N P=0.101N P=0.392N |
|POLY 6 | P=0.236N P=0.377N P=0.540 P=0.155N P=0.420N |
|LOGISTIC REGRESSION| P=0.195N P=0.371N P=0.583 P=0.112N P=0.398N |
|COCH-ARM / FISHERS | P=0.147N P=0.306N P=0.500N P=0.071N P=0.340N |
|ORDER RESTRICTED | P=0.291N (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 |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 4/50 (8%) 6/50 (12%) 10/50 (20%) 4/40 (10%) 8/42 (19%) |
|POLY-3 RATE (b) | 4/35.91 6/31.40 10/37.49 4/32.36 8/30.54 |
|POLY-3 PERCENT (g) | 11.1% 19.1% 26.7% 12.4% 26.2% |
|TERMINAL (d) | 1/20 (5%) 5/18 (28%) 8/24 (33%) 3/20 (15%) 4/19 (21%) |
|FIRST INCIDENCE | 558 577 537 565 453 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.248 P=0.260 P=0.125 P=0.608 P=0.125 |
|POLY 3 | P=0.211 P=0.283 P=0.078 P=0.587 P=0.098 |
|POLY 1.5 | P=0.188 P=0.325 P=0.075 P=0.573 P=0.098 |
|POLY 6 | P=0.231 P=0.237 P=0.084 P=0.593 P=0.101 |
|LOGISTIC REGRESSION| P=0.187 P=0.267 P=0.087 P=0.584 P=0.097 |
|COCH-ARM / FISHERS | P=0.151 P=0.370 P=0.074 P=0.512 P=0.105 |
|ORDER RESTRICTED | P=0.091 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 99022 TEST: 02 Page 5
Statistical Analysis of Primary Tumors 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 |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/36 (0%) 0/31 (0%) |
|POLY-3 RATE (b) | 1/33.89 0/30.37 0/29.15 0/19.93 0/18.96 |
|POLY-3 PERCENT (g) | 3.0% 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 | 413 --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.284N P=0.525N P=0.515N P=0.588N P=0.620N |
|POLY 3 | P=0.282N P=0.522N P=0.530N P=0.603N P=0.614N |
|POLY 1.5 | P=0.272N P=0.518N P=0.518N P=0.590N P=0.611N |
|POLY 6 | P=0.300N P=0.521N P=0.545N P=0.621N P=0.619N |
|LOGISTIC REGRESSION| P=0.257N P=0.462N P=0.477N P=0.528N P=0.555N |
|COCH-ARM / FISHERS | P=0.273N P=0.500N P=0.500N P=0.581N P=0.617N |
|ORDER RESTRICTED | P=0.230N (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 |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 0/49 (0%) 1/40 (3%) 2/41 (5%) |
|POLY-3 RATE (b) | 0/34.96 0/30.96 0/36.54 1/31.97 2/29.09 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 3.1% 6.9% |
|TERMINAL (d) | 0/20 (0%) 0/18 (0%) 0/24 (0%) 1/20 (5%) 1/19 (5%) |
|FIRST INCIDENCE | --- --- --- 668 (T) 565 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.022 * (e) (e) P=0.500 P=0.206 |
|POLY 3 | P=0.020 * (e) (e) P=0.482 P=0.195 |
|POLY 1.5 | P=0.019 * (e) (e) P=0.476 P=0.194 |
|POLY 6 | P=0.021 * (e) (e) P=0.487 P=0.197 |
|LOGISTIC REGRESSION| P=0.018 * (e) (e) P=0.500 P=0.194 |
|COCH-ARM / FISHERS | P=0.017 * (e) (e) P=0.444 P=0.200 |
|ORDER RESTRICTED | P=0.030 * (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 99022 TEST: 02 Page 6
Statistical Analysis of Primary Tumors 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 |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 7/50 (14%) 4/50 (8%) 3/50 (6%) 1/37 (3%) 3/32 (9%) |
|POLY-3 RATE (b) | 7/36.30 4/31.83 3/30.02 1/21.18 3/20.40 |
|POLY-3 PERCENT (g) | 19.3% 12.6% 10.0% 4.7% 14.7% |
|TERMINAL (d) | 1/19 (5%) 1/21 (5%) 1/13 (8%) 0/7 (0%) 1/8 (13%) |
|FIRST INCIDENCE | 373 385 482 607 404 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.293N P=0.316N P=0.261N P=0.148N P=0.494N |
|POLY 3 | P=0.241N P=0.337N P=0.240N P=0.131N P=0.472N |
|POLY 1.5 | P=0.217N P=0.321N P=0.204N P=0.107N P=0.454N |
|POLY 6 | P=0.281N P=0.339N P=0.290N P=0.166N P=0.496N |
|LOGISTIC REGRESSION| P=0.200N P=0.263N P=0.162N P=0.076N P=0.384N |
|COCH-ARM / FISHERS | P=0.188N P=0.262N P=0.159N P=0.072N P=0.398N |
|ORDER RESTRICTED | P=0.282N (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 |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/40 (0%) 0/42 (0%) |
|POLY-3 RATE (b) | 1/34.96 0/31.04 1/36.65 0/31.97 0/28.81 |
|POLY-3 PERCENT (g) | 2.9% 0.0% 2.7% 0.0% 0.0% |
|TERMINAL (d) | 1/20 (5%) 0/18 (0%) 1/24 (4%) 0/20 (0%) 0/19 (0%) |
|FIRST INCIDENCE | 668 (T) --- 668 (T) --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.234N P=0.521N P=0.722N P=0.500N P=0.510N |
|POLY 3 | P=0.253N P=0.524N P=0.751N P=0.518N P=0.539N |
|POLY 1.5 | P=0.261N P=0.512N P=0.755N P=0.524N P=0.538N |
|POLY 6 | P=0.245N P=0.536N P=0.743N P=0.513N P=0.539N |
|LOGISTIC REGRESSION| P=0.234N (e) P=0.722N (e) (e) |
|COCH-ARM / FISHERS | P=0.268N P=0.500N P=0.753N P=0.556N P=0.543N |
|ORDER RESTRICTED | P=0.269N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 99022 TEST: 02 Page 7
Statistical Analysis of Primary Tumors 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 |
| Hepatoblastoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 2/50 (4%) 0/37 (0%) 0/32 (0%) |
|POLY-3 RATE (b) | 1/33.74 0/30.37 2/30.16 0/20.93 0/19.14 |
|POLY-3 PERCENT (g) | 3.0% 0.0% 6.6% 0.0% 0.0% |
|TERMINAL (d) | 0/19 (0%) 0/21 (0%) 0/13 (0%) 0/7 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 488 --- 413 --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.330N P=0.524N P=0.458 P=0.575N P=0.593N |
|POLY 3 | P=0.346N P=0.521N P=0.461 P=0.594N P=0.611N |
|POLY 1.5 | P=0.330N P=0.518N P=0.476 P=0.581N P=0.607N |
|POLY 6 | P=0.372N P=0.520N P=0.441 P=0.609N P=0.617N |
|LOGISTIC REGRESSION| P=0.306N P=0.487N P=0.514 P=0.546N P=0.575N |
|COCH-ARM / FISHERS | P=0.311N P=0.500N P=0.500 P=0.575N P=0.610N |
|ORDER RESTRICTED | P=0.425N (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 |
| Hepatoblastoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR 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: 10/08/03 EXPERIMENT: 99022 TEST: 02 Page 8
Statistical Analysis of Primary Tumors 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 |
| Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 14/50 (28%) 11/50 (22%) 10/50 (20%) 8/37 (22%) 4/32 (13%) |
|POLY-3 RATE (b) | 14/35.88 11/30.85 10/31.07 8/22.35 4/19.37 |
|POLY-3 PERCENT (g) | 39.0% 35.7% 32.2% 35.8% 20.7% |
|TERMINAL (d) | 8/19 (42%) 9/21 (43%) 4/13 (31%) 3/7 (43%) 2/8 (25%) |
|FIRST INCIDENCE | 446 595 505 483 627 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.377N P=0.284N P=0.530N P=0.406 P=0.214N |
|POLY 3 | P=0.124N P=0.488N P=0.369N P=0.512N P=0.137N |
|POLY 1.5 | P=0.107N P=0.442N P=0.314N P=0.445N P=0.119N |
|POLY 6 | P=0.159N P=0.515N P=0.440N P=0.593N P=0.164N |
|LOGISTIC REGRESSION| P=0.127N P=0.403N P=0.355N P=0.490N P=0.111N |
|COCH-ARM / FISHERS | P=0.082N P=0.322N P=0.241N P=0.337N P=0.081N |
|ORDER RESTRICTED | P=0.160N (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 |
| Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 3/50 (6%) 4/50 (8%) 5/50 (10%) 2/40 (5%) 4/42 (10%) |
|POLY-3 RATE (b) | 3/35.01 4/31.04 5/37.87 2/32.58 4/29.20 |
|POLY-3 PERCENT (g) | 8.6% 12.9% 13.2% 6.1% 13.7% |
|TERMINAL (d) | 2/20 (10%) 4/18 (22%) 2/24 (8%) 1/20 (5%) 3/19 (16%) |
|FIRST INCIDENCE | 658 668 (T) 514 488 565 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.539 P=0.437 P=0.439 P=0.498N P=0.452 |
|POLY 3 | P=0.511 P=0.433 P=0.399 P=0.533N P=0.400 |
|POLY 1.5 | P=0.485 P=0.467 P=0.380 P=0.551N P=0.399 |
|POLY 6 | P=0.534 P=0.397 P=0.432 P=0.519N P=0.403 |
|LOGISTIC REGRESSION| P=0.486 P=0.415 P=0.379 P=0.545N P=0.396 |
|COCH-ARM / FISHERS | P=0.436 P=0.500 P=0.357 P=0.606N P=0.402 |
|ORDER RESTRICTED | P=0.452 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 99022 TEST: 02 Page 9
Statistical Analysis of Primary Tumors 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 |
| Hepatocellular Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 6/50 (12%) 6/50 (12%) 6/50 (12%) 4/37 (11%) 2/32 (6%) |
|POLY-3 RATE (b) | 6/35.11 6/31.38 6/31.52 4/22.29 2/20.40 |
|POLY-3 PERCENT (g) | 17.1% 19.1% 19.0% 17.9% 9.8% |
|TERMINAL (d) | 2/19 (11%) 4/21 (19%) 1/13 (8%) 0/7 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 392 444 413 483 473 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.387N P=0.615 P=0.474 P=0.514 P=0.402N |
|POLY 3 | P=0.287N P=0.542 P=0.545 P=0.607 P=0.365N |
|POLY 1.5 | P=0.275N P=0.556 P=0.573 P=0.635N P=0.359N |
|POLY 6 | P=0.307N P=0.543 P=0.513 P=0.573 P=0.374N |
|LOGISTIC REGRESSION| P=0.267N P=0.575 P=0.596 P=0.612N P=0.325N |
|COCH-ARM / FISHERS | P=0.237N P=0.620N P=0.620N P=0.571N P=0.326N |
|ORDER RESTRICTED | P=0.390N (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 |
| Hepatocellular Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/40 (0%) 2/42 (5%) |
|POLY-3 RATE (b) | 2/34.96 1/31.04 0/36.65 0/31.97 2/29.43 |
|POLY-3 PERCENT (g) | 5.7% 3.2% 0.0% 0.0% 6.8% |
|TERMINAL (d) | 2/20 (10%) 1/18 (6%) 0/24 (0%) 0/20 (0%) 1/19 (5%) |
|FIRST INCIDENCE | 668 (T) 668 (T) --- --- 482 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.567 P=0.537N P=0.198N P=0.237N P=0.660 |
|POLY 3 | P=0.562 P=0.542N P=0.226N P=0.255N P=0.632 |
|POLY 1.5 | P=0.548 P=0.521N P=0.230N P=0.263N P=0.629 |
|POLY 6 | P=0.571 P=0.564N P=0.218N P=0.250N P=0.637 |
|LOGISTIC REGRESSION| P=0.535 P=0.537N (e) (e) P=0.625 |
|COCH-ARM / FISHERS | P=0.510 P=0.500N P=0.247N P=0.306N P=0.623 |
|ORDER RESTRICTED | P=0.251 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 99022 TEST: 02 Page 10
Statistical Analysis of Primary Tumors 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 |
| Hepatocellular Carcinoma or Hepatoblastoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 7/50 (14%) 6/50 (12%) 6/50 (12%) 4/37 (11%) 2/32 (6%) |
|POLY-3 RATE (b) | 7/35.72 6/31.38 6/31.52 4/22.29 2/20.40 |
|POLY-3 PERCENT (g) | 19.6% 19.1% 19.0% 17.9% 9.8% |
|TERMINAL (d) | 2/19 (11%) 4/21 (19%) 1/13 (8%) 0/7 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 392 444 413 483 473 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.306N P=0.509N P=0.585 P=0.614 P=0.307N |
|POLY 3 | P=0.219N P=0.603N P=0.599N P=0.573N P=0.282N |
|POLY 1.5 | P=0.206N P=0.580N P=0.562N P=0.532N P=0.273N |
|POLY 6 | P=0.241N P=0.611N P=0.606 P=0.618N P=0.294N |
|LOGISTIC REGRESSION| P=0.197N P=0.545N P=0.522N P=0.491N P=0.234N |
|COCH-ARM / FISHERS | P=0.174N P=0.500N P=0.500N P=0.459N P=0.236N |
|ORDER RESTRICTED | P=0.337N (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 |
| Hepatocellular Carcinoma or Hepatoblastoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/40 (0%) 2/42 (5%) |
|POLY-3 RATE (b) | 2/34.96 1/31.04 0/36.65 0/31.97 2/29.43 |
|POLY-3 PERCENT (g) | 5.7% 3.2% 0.0% 0.0% 6.8% |
|TERMINAL (d) | 2/20 (10%) 1/18 (6%) 0/24 (0%) 0/20 (0%) 1/19 (5%) |
|FIRST INCIDENCE | 668 (T) 668 (T) --- --- 482 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.567 P=0.537N P=0.198N P=0.237N P=0.660 |
|POLY 3 | P=0.562 P=0.542N P=0.226N P=0.255N P=0.632 |
|POLY 1.5 | P=0.548 P=0.521N P=0.230N P=0.263N P=0.629 |
|POLY 6 | P=0.571 P=0.564N P=0.218N P=0.250N P=0.637 |
|LOGISTIC REGRESSION| P=0.535 P=0.537N (e) (e) P=0.625 |
|COCH-ARM / FISHERS | P=0.510 P=0.500N P=0.247N P=0.306N P=0.623 |
|ORDER RESTRICTED | P=0.251 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 99022 TEST: 02 Page 11
Statistical Analysis of Primary Tumors 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 |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 18/50 (36%) 16/50 (32%) 16/50 (32%) 10/37 (27%) 6/32 (19%) |
|POLY-3 RATE (b) | 18/37.65 16/31.86 16/33.44 10/22.91 6/20.63 |
|POLY-3 PERCENT (g) | 47.8% 50.2% 47.9% 43.7% 29.1% |
|TERMINAL (d) | 9/19 (47%) 12/21 (57%) 5/13 (39%) 3/7 (43%) 2/8 (25%) |
|FIRST INCIDENCE | 392 444 413 483 473 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.328N P=0.390N P=0.410 P=0.451 P=0.225N |
|POLY 3 | P=0.083N P=0.517 P=0.596 P=0.480N P=0.130N |
|POLY 1.5 | P=0.069N P=0.584 P=0.532N P=0.392N P=0.114N |
|POLY 6 | P=0.110N P=0.472 P=0.542 P=0.578N P=0.154N |
|LOGISTIC REGRESSION| P=0.076N P=0.538N P=0.540N P=0.388N P=0.104N |
|COCH-ARM / FISHERS | P=0.050N P=0.417N P=0.417N P=0.258N P=0.075N |
|ORDER RESTRICTED | P=0.133N (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 |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 5/50 (10%) 5/50 (10%) 5/50 (10%) 2/40 (5%) 6/42 (14%) |
|POLY-3 RATE (b) | 5/35.01 5/31.04 5/37.87 2/32.58 6/29.83 |
|POLY-3 PERCENT (g) | 14.3% 16.1% 13.2% 6.1% 20.1% |
|TERMINAL (d) | 4/20 (20%) 5/18 (28%) 2/24 (8%) 1/20 (5%) 4/19 (21%) |
|FIRST INCIDENCE | 658 668 (T) 514 488 482 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.526 P=0.563 P=0.532N P=0.215N P=0.436 |
|POLY 3 | P=0.501 P=0.555 P=0.582N P=0.241N P=0.385 |
|POLY 1.5 | P=0.469 P=0.594 P=0.603N P=0.260N P=0.377 |
|POLY 6 | P=0.527 P=0.510 P=0.544N P=0.225N P=0.398 |
|LOGISTIC REGRESSION| P=0.462 P=0.544 P=0.598N P=0.245N P=0.362 |
|COCH-ARM / FISHERS | P=0.406 P=0.630N P=0.630N P=0.320N P=0.377 |
|ORDER RESTRICTED | P=0.329 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 99022 TEST: 02 Page 12
Statistical Analysis of Primary Tumors 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 |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, |
| or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 18/50 (36%) 16/50 (32%) 16/50 (32%) 10/37 (27%) 6/32 (19%) |
|POLY-3 RATE (b) | 18/37.65 16/31.86 16/33.44 10/22.91 6/20.63 |
|POLY-3 PERCENT (g) | 47.8% 50.2% 47.9% 43.7% 29.1% |
|TERMINAL (d) | 9/19 (47%) 12/21 (57%) 5/13 (39%) 3/7 (43%) 2/8 (25%) |
|FIRST INCIDENCE | 392 444 413 483 473 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.328N P=0.390N P=0.410 P=0.451 P=0.225N |
|POLY 3 | P=0.083N P=0.517 P=0.596 P=0.480N P=0.130N |
|POLY 1.5 | P=0.069N P=0.584 P=0.532N P=0.392N P=0.114N |
|POLY 6 | P=0.110N P=0.472 P=0.542 P=0.578N P=0.154N |
|LOGISTIC REGRESSION| P=0.076N P=0.538N P=0.540N P=0.388N P=0.104N |
|COCH-ARM / FISHERS | P=0.050N P=0.417N P=0.417N P=0.258N P=0.075N |
|ORDER RESTRICTED | P=0.133N (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 |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, |
| or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 5/50 (10%) 5/50 (10%) 5/50 (10%) 2/40 (5%) 6/42 (14%) |
|POLY-3 RATE (b) | 5/35.01 5/31.04 5/37.87 2/32.58 6/29.83 |
|POLY-3 PERCENT (g) | 14.3% 16.1% 13.2% 6.1% 20.1% |
|TERMINAL (d) | 4/20 (20%) 5/18 (28%) 2/24 (8%) 1/20 (5%) 4/19 (21%) |
|FIRST INCIDENCE | 658 668 (T) 514 488 482 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.526 P=0.563 P=0.532N P=0.215N P=0.436 |
|POLY 3 | P=0.501 P=0.555 P=0.582N P=0.241N P=0.385 |
|POLY 1.5 | P=0.469 P=0.594 P=0.603N P=0.260N P=0.377 |
|POLY 6 | P=0.527 P=0.510 P=0.544N P=0.225N P=0.398 |
|LOGISTIC REGRESSION| P=0.462 P=0.544 P=0.598N P=0.245N P=0.362 |
|COCH-ARM / FISHERS | P=0.406 P=0.630N P=0.630N P=0.320N P=0.377 |
|ORDER RESTRICTED | P=0.329 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 99022 TEST: 02 Page 13
Statistical Analysis of Primary Tumors 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/Bronchiolar Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 10/50 (20%) 13/50 (26%) 8/50 (16%) 9/37 (24%) 11/32 (34%) |
|POLY-3 RATE (b) | 10/34.53 13/34.83 8/31.51 9/24.48 11/23.96 |
|POLY-3 PERCENT (g) | 29.0% 37.3% 25.4% 36.8% 45.9% |
|TERMINAL (d) | 5/19 (26%) 5/21 (24%) 3/13 (23%) 2/7 (29%) 3/8 (38%) |
|FIRST INCIDENCE | 560 229 322 167 229 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.028 * P=0.332 P=0.540 P=0.138 P=0.053 |
|POLY 3 | P=0.109 P=0.311 P=0.480N P=0.361 P=0.137 |
|POLY 1.5 | P=0.102 P=0.288 P=0.446N P=0.377 P=0.118 |
|POLY 6 | P=0.105 P=0.356 P=0.532N P=0.336 P=0.149 |
|LOGISTIC REGRESSION| P=0.084 P=0.255 P=0.502N P=0.327 P=0.092 |
|COCH-ARM / FISHERS | P=0.105 P=0.318 P=0.398N P=0.410 P=0.116 |
|ORDER RESTRICTED | P=0.150 (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/Bronchiolar Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 7/50 (14%) 6/49 (12%) 8/50 (16%) 4/40 (10%) 7/42 (17%) |
|POLY-3 RATE (b) | 7/35.71 6/31.12 8/37.89 4/33.04 7/30.14 |
|POLY-3 PERCENT (g) | 19.6% 19.3% 21.1% 12.1% 23.2% |
|TERMINAL (d) | 4/20 (20%) 4/18 (22%) 4/24 (17%) 2/20 (10%) 5/19 (26%) |
|FIRST INCIDENCE | 573 644 432 359 453 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.480N P=0.614 P=0.586N P=0.288N P=0.535 |
|POLY 3 | P=0.522N P=0.609N P=0.551 P=0.301N P=0.478 |
|POLY 1.5 | P=0.523 P=0.559N P=0.530 P=0.324N P=0.473 |
|POLY 6 | P=0.498N P=0.579 P=0.585 P=0.287N P=0.480 |
|LOGISTIC REGRESSION| P=0.508 P=0.587 P=0.543 P=0.334N P=0.458 |
|COCH-ARM / FISHERS | P=0.454 P=0.516N P=0.500 P=0.405N P=0.472 |
|ORDER RESTRICTED | P=0.523 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 99022 TEST: 02 Page 14
Statistical Analysis of Primary Tumors 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/Bronchiolar Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 5/50 (10%) 11/50 (22%) 6/50 (12%) 11/37 (30%) 8/32 (25%) |
|POLY-3 RATE (b) | 5/33.64 11/33.29 6/30.23 11/24.41 8/20.69 |
|POLY-3 PERCENT (g) | 14.9% 33.0% 19.9% 45.1% 38.7% |
|TERMINAL (d) | 2/19 (11%) 5/21 (24%) 4/13 (31%) 3/7 (43%) 3/8 (38%) |
|FIRST INCIDENCE | 619 363 482 341 376 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.004 ** P=0.100 P=0.291 P=0.003 ** P=0.028 * |
|POLY 3 | P=0.014 * P=0.068 P=0.422 P=0.009 ** P=0.043 * |
|POLY 1.5 | P=0.016 * P=0.064 P=0.452 P=0.010 * P=0.045 * |
|POLY 6 | P=0.012 * P=0.082 P=0.380 P=0.008 ** P=0.041 * |
|LOGISTIC REGRESSION| P=0.015 * P=0.060 P=0.381 P=0.008 ** P=0.038 * |
|COCH-ARM / FISHERS | P=0.028 * P=0.086 P=0.500 P=0.020 * P=0.068 |
|ORDER RESTRICTED | P=0.026 * (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/Bronchiolar Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 5/50 (10%) 6/49 (12%) 8/50 (16%) 8/40 (20%) 5/42 (12%) |
|POLY-3 RATE (b) | 5/35.35 6/32.12 8/37.19 8/33.10 5/29.11 |
|POLY-3 PERCENT (g) | 14.2% 18.7% 21.5% 24.2% 17.2% |
|TERMINAL (d) | 3/20 (15%) 3/18 (17%) 7/24 (29%) 5/20 (25%) 4/19 (21%) |
|FIRST INCIDENCE | 599 560 514 539 593 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.445 P=0.369 P=0.388 P=0.263 P=0.566 |
|POLY 3 | P=0.356 P=0.431 P=0.304 P=0.225 P=0.504 |
|POLY 1.5 | P=0.337 P=0.461 P=0.292 P=0.203 P=0.506 |
|POLY 6 | P=0.372 P=0.403 P=0.325 P=0.246 P=0.503 |
|LOGISTIC REGRESSION| P=0.378 P=0.389 P=0.329 P=0.218 P=0.509 |
|COCH-ARM / FISHERS | P=0.317 P=0.486 P=0.277 P=0.149 P=0.514 |
|ORDER RESTRICTED | P=0.424 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 99022 TEST: 02 Page 15
Statistical Analysis of Primary Tumors 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/Bronchiolar Carcinoma or Alveolar/Bronchiolar |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 14/50 (28%) 20/50 (40%) 13/50 (26%) 18/37 (49%) 18/32 (56%) |
|POLY-3 RATE (b) | 14/34.86 20/36.71 13/32.14 18/27.17 18/24.68 |
|POLY-3 PERCENT (g) | 40.2% 54.5% 40.5% 66.3% 72.9% |
|TERMINAL (d) | 7/19 (37%) 9/21 (43%) 7/13 (54%) 5/7 (71%) 6/8 (75%) |
|FIRST INCIDENCE | 560 229 322 167 229 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.178 P=0.323 P=0.002 ** P=0.003 ** |
|POLY 3 | P=0.002 ** P=0.156 P=0.592 P=0.027 * P=0.007 ** |
|POLY 1.5 | P=0.002 ** P=0.127 P=0.565N P=0.028 * P=0.005 ** |
|POLY 6 | P=0.002 ** P=0.212 P=0.528 P=0.027 * P=0.009 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.087 P=0.521 P=0.014 * P=0.003 ** |
|COCH-ARM / FISHERS | P=0.003 ** P=0.146 P=0.500N P=0.040 * P=0.010 * |
|ORDER RESTRICTED | P=0.008 ** (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/Bronchiolar Carcinoma or Alveolar/Bronchiolar |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 10/50 (20%) 11/49 (22%) 14/50 (28%) 12/40 (30%) 11/42 (26%) |
|POLY-3 RATE (b) | 10/36.09 11/32.28 14/38.44 12/34.17 11/30.44 |
|POLY-3 PERCENT (g) | 27.7% 34.1% 36.4% 35.1% 36.1% |
|TERMINAL (d) | 5/20 (25%) 6/18 (33%) 9/24 (38%) 7/20 (35%) 8/19 (42%) |
|FIRST INCIDENCE | 573 560 432 359 453 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.379 P=0.324 P=0.402 P=0.376 P=0.391 |
|POLY 3 | P=0.296 P=0.377 P=0.286 P=0.338 P=0.315 |
|POLY 1.5 | P=0.260 P=0.432 P=0.266 P=0.298 P=0.315 |
|POLY 6 | P=0.323 P=0.319 P=0.319 P=0.370 P=0.311 |
|LOGISTIC REGRESSION| P=0.268 P=0.313 P=0.281 P=0.292 P=0.297 |
|COCH-ARM / FISHERS | P=0.213 P=0.479 P=0.241 P=0.197 P=0.324 |
|ORDER RESTRICTED | P=0.410 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 99022 TEST: 02 Page 16
Statistical Analysis of Primary Tumors 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 |
| Plasma Cell Tumor Malignant |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR 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 |
|=================================================================================================================================|
| |
|Lymph Node |
| Plasma Cell Tumor Malignant |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/50 (2%) 0/40 (0%) 0/42 (0%) |
|POLY-3 RATE (b) | 0/34.96 2/32.17 1/37.63 0/31.97 0/28.81 |
|POLY-3 PERCENT (g) | 0.0% 6.2% 2.7% 0.0% 0.0% |
|TERMINAL (d) | 0/20 (0%) 0/18 (0%) 0/24 (0%) 0/20 (0%) 0/19 (0%) |
|FIRST INCIDENCE | --- 441 182 --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.259N P=0.204 P=0.504 (e) (e) |
|POLY 3 | P=0.272N P=0.218 P=0.515 (e) (e) |
|POLY 1.5 | P=0.269N P=0.227 P=0.510 (e) (e) |
|POLY 6 | P=0.275N P=0.209 P=0.523 (e) (e) |
|LOGISTIC REGRESSION| P=0.264N P=0.244 P=0.381 (e) (e) |
|COCH-ARM / FISHERS | P=0.267N P=0.247 P=0.500 (e) (e) |
|ORDER RESTRICTED | P=0.336N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 99022 TEST: 02 Page 17
Statistical Analysis of Primary Tumors 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 |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR 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 |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 2/50 (4%) 1/40 (3%) 1/42 (2%) |
|POLY-3 RATE (b) | 2/35.44 2/31.04 2/37.47 1/32.07 1/29.15 |
|POLY-3 PERCENT (g) | 5.6% 6.4% 5.3% 3.1% 3.4% |
|TERMINAL (d) | 0/20 (0%) 2/18 (11%) 0/24 (0%) 0/20 (0%) 0/19 (0%) |
|FIRST INCIDENCE | 573 668 (T) 425 646 580 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.299N P=0.619 P=0.661N P=0.535N P=0.582N |
|POLY 3 | P=0.322N P=0.647 P=0.675N P=0.535N P=0.568N |
|POLY 1.5 | P=0.330N P=0.671 P=0.682N P=0.544N P=0.567N |
|POLY 6 | P=0.316N P=0.618 P=0.663N P=0.530N P=0.570N |
|LOGISTIC REGRESSION| P=0.325N P=0.634 P=0.694N P=0.542N P=0.566N |
|COCH-ARM / FISHERS | P=0.343N P=0.691N P=0.691N P=0.584N P=0.566N |
|ORDER RESTRICTED | P=0.534N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 99022 TEST: 02 Page 18
Statistical Analysis of Primary Tumors 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 |
| Cystadenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR 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 |
| Cystadenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 2/49 (4%) 0/40 (0%) 1/42 (2%) |
|POLY-3 RATE (b) | 2/35.80 1/31.04 2/36.60 0/31.97 1/28.91 |
|POLY-3 PERCENT (g) | 5.6% 3.2% 5.5% 0.0% 3.5% |
|TERMINAL (d) | 0/20 (0%) 1/18 (6%) 1/24 (4%) 0/20 (0%) 0/19 (0%) |
|FIRST INCIDENCE | 510 668 (T) 654 --- 645 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.267N P=0.569N P=0.647N P=0.254N P=0.579N |
|POLY 3 | P=0.278N P=0.550N P=0.687N P=0.261N P=0.575N |
|POLY 1.5 | P=0.290N P=0.525N P=0.692N P=0.266N P=0.570N |
|POLY 6 | P=0.271N P=0.578N P=0.680N P=0.259N P=0.580N |
|LOGISTIC REGRESSION| P=0.288N P=0.521N P=0.690N P=0.305N P=0.564N |
|COCH-ARM / FISHERS | P=0.310N P=0.500N P=0.684 P=0.306N P=0.566N |
|ORDER RESTRICTED | P=0.357N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 99022 TEST: 02 Page 19
Statistical Analysis of Primary Tumors 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 |
| Granulosa Cell Tumor Malignant |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR 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 |
| Granulosa Cell Tumor Malignant |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/49 (0%) 2/40 (5%) 1/42 (2%) |
|POLY-3 RATE (b) | 0/34.96 0/31.04 0/36.54 2/32.46 1/28.81 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 6.2% 3.5% |
|TERMINAL (d) | 0/20 (0%) 0/18 (0%) 0/24 (0%) 0/20 (0%) 1/19 (5%) |
|FIRST INCIDENCE | --- --- --- 565 668 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.068 (e) (e) P=0.219 P=0.490 |
|POLY 3 | P=0.059 (e) (e) P=0.219 P=0.461 |
|POLY 1.5 | P=0.058 (e) (e) P=0.211 P=0.462 |
|POLY 6 | P=0.061 (e) (e) P=0.226 P=0.461 |
|LOGISTIC REGRESSION| P=0.061 (e) (e) P=0.201 P=0.490 |
|COCH-ARM / FISHERS | P=0.058 (e) (e) P=0.195 P=0.457 |
|ORDER RESTRICTED | P=0.125 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 99022 TEST: 02 Page 20
Statistical Analysis of Primary Tumors 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 |
| Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, |
| or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/37 (3%) 0/32 (0%) |
|POLY-3 RATE (b) | 0/33.13 1/31.33 0/29.15 1/20.93 0/19.14 |
|POLY-3 PERCENT (g) | 0.0% 3.2% 0.0% 4.8% 0.0% |
|TERMINAL (d) | 0/19 (0%) 0/21 (0%) 0/13 (0%) 1/7 (14%) 0/8 (0%) |
|FIRST INCIDENCE | --- 229 --- 668 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.502 P=0.492 (e) P=0.301 (e) |
|POLY 3 | P=0.548 P=0.489 (e) P=0.409 (e) |
|POLY 1.5 | P=0.544 P=0.489 (e) P=0.420 (e) |
|POLY 6 | P=0.555 P=0.494 (e) P=0.395 (e) |
|LOGISTIC REGRESSION| P=0.584 P=0.607 (e) P=0.301 (e) |
|COCH-ARM / FISHERS | P=0.566 P=0.500 (e) P=0.425 (e) |
|ORDER RESTRICTED | P=0.444 (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 |
| Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, |
| or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) 1/40 (3%) 0/42 (0%) |
|POLY-3 RATE (b) | 2/35.19 1/31.15 0/36.65 1/32.49 0/28.81 |
|POLY-3 PERCENT (g) | 5.7% 3.2% 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 | 612 644 --- 523 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.165N P=0.559N P=0.194N P=0.510N P=0.265N |
|POLY 3 | P=0.192N P=0.543N P=0.227N P=0.528N P=0.282N |
|POLY 1.5 | P=0.194N P=0.522N P=0.231N P=0.540N P=0.281N |
|POLY 6 | P=0.192N P=0.566N P=0.221N P=0.519N P=0.283N |
|LOGISTIC REGRESSION| P=0.178N P=0.562N P=0.222N P=0.560N P=0.280N |
|COCH-ARM / FISHERS | P=0.190N P=0.500N P=0.247N P=0.584N P=0.293N |
|ORDER RESTRICTED | P=0.122N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 99022 TEST: 02 Page 21
Statistical Analysis of Primary Tumors 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 |
| Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/37 (3%) 0/32 (0%) |
|POLY-3 RATE (b) | 0/33.13 1/31.33 0/29.15 1/20.93 0/19.14 |
|POLY-3 PERCENT (g) | 0.0% 3.2% 0.0% 4.8% 0.0% |
|TERMINAL (d) | 0/19 (0%) 0/21 (0%) 0/13 (0%) 1/7 (14%) 0/8 (0%) |
|FIRST INCIDENCE | --- 229 --- 668 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.502 P=0.492 (e) P=0.301 (e) |
|POLY 3 | P=0.548 P=0.489 (e) P=0.409 (e) |
|POLY 1.5 | P=0.544 P=0.489 (e) P=0.420 (e) |
|POLY 6 | P=0.555 P=0.494 (e) P=0.395 (e) |
|LOGISTIC REGRESSION| P=0.584 P=0.607 (e) P=0.301 (e) |
|COCH-ARM / FISHERS | P=0.566 P=0.500 (e) P=0.425 (e) |
|ORDER RESTRICTED | P=0.444 (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 |
| Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) 1/40 (3%) 0/42 (0%) |
|POLY-3 RATE (b) | 2/35.19 1/31.15 0/36.65 1/32.49 0/28.81 |
|POLY-3 PERCENT (g) | 5.7% 3.2% 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 | 612 644 --- 523 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.165N P=0.559N P=0.194N P=0.510N P=0.265N |
|POLY 3 | P=0.192N P=0.543N P=0.227N P=0.528N P=0.282N |
|POLY 1.5 | P=0.194N P=0.522N P=0.231N P=0.540N P=0.281N |
|POLY 6 | P=0.192N P=0.566N P=0.221N P=0.519N P=0.283N |
|LOGISTIC REGRESSION| P=0.178N P=0.562N P=0.222N P=0.560N P=0.280N |
|COCH-ARM / FISHERS | P=0.190N P=0.500N P=0.247N P=0.584N P=0.293N |
|ORDER RESTRICTED | P=0.122N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 99022 TEST: 02 Page 22
Statistical Analysis of Primary Tumors 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 |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 3/49 (6%) 2/50 (4%) 1/50 (2%) 0/37 (0%) 1/32 (3%) |
|POLY-3 RATE (b) | 3/34.14 2/30.72 1/29.15 0/20.93 1/19.92 |
|POLY-3 PERCENT (g) | 8.8% 6.5% 3.4% 0.0% 5.0% |
|TERMINAL (d) | 0/18 (0%) 1/21 (5%) 1/13 (8%) 0/7 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 373 580 668 (T) --- 404 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.253N P=0.519N P=0.366N P=0.214N P=0.519N |
|POLY 3 | P=0.215N P=0.549N P=0.362N P=0.222N P=0.511N |
|POLY 1.5 | P=0.201N P=0.538N P=0.336N P=0.203N P=0.502N |
|POLY 6 | P=0.239N P=0.547N P=0.398N P=0.247N P=0.522N |
|LOGISTIC REGRESSION| P=0.184N P=0.482N P=0.283N P=0.145N P=0.400N |
|COCH-ARM / FISHERS | P=0.184N P=0.490N P=0.301N P=0.180N P=0.482N |
|ORDER RESTRICTED | P=0.295N (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 |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/49 (0%) 0/40 (0%) 0/42 (0%) |
|POLY-3 RATE (b) | 1/35.24 0/31.04 0/36.54 0/31.97 0/28.81 |
|POLY-3 PERCENT (g) | 2.8% 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 | 599 --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.234N P=0.550N P=0.466N P=0.500N P=0.550N |
|POLY 3 | P=0.251N P=0.525N P=0.493N P=0.520N P=0.540N |
|POLY 1.5 | P=0.254N P=0.513N P=0.497N P=0.525N P=0.539N |
|POLY 6 | P=0.248N P=0.539N P=0.487N P=0.517N P=0.542N |
|LOGISTIC REGRESSION| P=0.246N P=0.515N P=0.499N P=0.536N P=0.538N |
|COCH-ARM / FISHERS | P=0.251N P=0.500N P=0.505N P=0.556N P=0.543N |
|ORDER RESTRICTED | P=0.126N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 99022 TEST: 02 Page 23
Statistical Analysis of Primary Tumors 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 |
|=================================================================================================================================|
| |
|Thymus |
| Plasma Cell Tumor Malignant |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/48 (0%) 0/45 (0%) 0/47 (0%) 0/33 (0%) 0/32 (0%) |
|POLY-3 RATE (b) | 0/31.39 0/26.53 0/27.78 0/19.03 0/19.14 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/19 (0%) 0/18 (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 |
|=================================================================================================================================|
| |
|Thymus |
| Plasma Cell Tumor Malignant |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/49 (0%) 2/44 (5%) 1/46 (2%) 0/36 (0%) 0/42 (0%) |
|POLY-3 RATE (b) | 0/34.91 2/29.92 1/35.73 0/29.65 0/28.81 |
|POLY-3 PERCENT (g) | 0.0% 6.7% 2.8% 0.0% 0.0% |
|TERMINAL (d) | 0/20 (0%) 0/17 (0%) 0/23 (0%) 0/19 (0%) 0/19 (0%) |
|FIRST INCIDENCE | --- 441 182 --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.259N P=0.204 P=0.504 (e) (e) |
|POLY 3 | P=0.270N P=0.202 P=0.505 (e) (e) |
|POLY 1.5 | P=0.267N P=0.210 P=0.498 (e) (e) |
|POLY 6 | P=0.273N P=0.195 P=0.514 (e) (e) |
|LOGISTIC REGRESSION| P=0.231N P=0.207 P=0.397 (e) (e) |
|COCH-ARM / FISHERS | P=0.263N P=0.221 P=0.484 (e) (e) |
|ORDER RESTRICTED | P=0.320N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 99022 TEST: 02 Page 24
Statistical Analysis of Primary Tumors 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 |
|=================================================================================================================================|
| |
|All Organs |
| Hemangioma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/37 (0%) 0/32 (0%) |
|POLY-3 RATE (b) | 0/33.13 1/30.37 1/29.15 0/20.93 0/19.14 |
|POLY-3 PERCENT (g) | 0.0% 3.3% 3.4% 0.0% 0.0% |
|TERMINAL (d) | 0/19 (0%) 1/21 (5%) 1/13 (8%) 0/7 (0%) 0/8 (0%) |
|FIRST INCIDENCE | --- 668 (T) 668 (T) --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.556N P=0.520 P=0.424 (e) (e) |
|POLY 3 | P=0.481N P=0.483 P=0.474 (e) (e) |
|POLY 1.5 | P=0.465N P=0.484 P=0.485 (e) (e) |
|POLY 6 | P=0.502N P=0.486 P=0.461 (e) (e) |
|LOGISTIC REGRESSION| (e) P=0.520 P=0.424 (e) (e) |
|COCH-ARM / FISHERS | P=0.434N P=0.500 P=0.500 (e) (e) |
|ORDER RESTRICTED | P=0.495N (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 |
|=================================================================================================================================|
| |
|All Organs |
| Hemangioma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 2/50 (4%) 2/40 (5%) 0/42 (0%) |
|POLY-3 RATE (b) | 0/34.96 1/31.45 2/36.80 2/32.09 0/28.81 |
|POLY-3 PERCENT (g) | 0.0% 3.2% 5.4% 6.2% 0.0% |
|TERMINAL (d) | 0/20 (0%) 0/18 (0%) 1/24 (4%) 0/20 (0%) 0/19 (0%) |
|FIRST INCIDENCE | --- 560 631 646 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.559 P=0.441 P=0.281 P=0.250 (e) |
|POLY 3 | P=0.520 P=0.479 P=0.248 P=0.216 (e) |
|POLY 1.5 | P=0.513 P=0.489 P=0.243 P=0.209 (e) |
|POLY 6 | P=0.528 P=0.469 P=0.257 P=0.222 (e) |
|LOGISTIC REGRESSION| P=0.536 P=0.498 P=0.256 P=0.225 (e) |
|COCH-ARM / FISHERS | P=0.510 P=0.500 P=0.247 P=0.195 (e) |
|ORDER RESTRICTED | P=0.306 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 99022 TEST: 02 Page 25
Statistical Analysis of Primary Tumors 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 |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 7/50 (14%) 6/50 (12%) 4/50 (8%) 2/37 (5%) 3/32 (9%) |
|POLY-3 RATE (b) | 7/36.30 6/31.83 4/30.11 2/21.18 3/20.40 |
|POLY-3 PERCENT (g) | 19.3% 18.9% 13.3% 9.4% 14.7% |
|TERMINAL (d) | 1/19 (5%) 3/21 (14%) 1/13 (8%) 1/7 (14%) 1/8 (13%) |
|FIRST INCIDENCE | 373 385 482 607 404 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.334N P=0.536N P=0.399N P=0.315N P=0.494N |
|POLY 3 | P=0.247N P=0.604N P=0.374N P=0.274N P=0.472N |
|POLY 1.5 | P=0.220N P=0.582N P=0.326N P=0.232N P=0.454N |
|POLY 6 | P=0.290N P=0.610N P=0.435N P=0.332N P=0.496N |
|LOGISTIC REGRESSION| P=0.204N P=0.523N P=0.274N P=0.182N P=0.384N |
|COCH-ARM / FISHERS | P=0.181N P=0.500N P=0.262N P=0.173N P=0.398N |
|ORDER RESTRICTED | P=0.434N (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 |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) 2/50 (4%) 1/40 (3%) 2/42 (5%) |
|POLY-3 RATE (b) | 3/35.60 1/31.04 2/36.71 1/32.73 2/29.43 |
|POLY-3 PERCENT (g) | 8.4% 3.2% 5.5% 3.1% 6.8% |
|TERMINAL (d) | 1/20 (5%) 1/18 (6%) 1/24 (4%) 0/20 (0%) 1/19 (5%) |
|FIRST INCIDENCE | 577 668 (T) 654 414 482 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.450N P=0.385N P=0.433N P=0.335N P=0.576N |
|POLY 3 | P=0.460N P=0.354N P=0.486N P=0.334N P=0.587N |
|POLY 1.5 | P=0.481N P=0.329N P=0.491N P=0.346N P=0.586N |
|POLY 6 | P=0.444N P=0.385N P=0.476N P=0.327N P=0.590N |
|LOGISTIC REGRESSION| P=0.497N P=0.355N P=0.475N P=0.409N P=0.586N |
|COCH-ARM / FISHERS | P=0.513N P=0.309N P=0.500N P=0.397N P=0.583N |
|ORDER RESTRICTED | P=0.443N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 99022 TEST: 02 Page 26
Statistical Analysis of Primary Tumors 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 |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma or Hemangioma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 7/50 (14%) 7/50 (14%) 5/50 (10%) 2/37 (5%) 3/32 (9%) |
|POLY-3 RATE (b) | 7/36.30 7/31.83 5/30.11 2/21.18 3/20.40 |
|POLY-3 PERCENT (g) | 19.3% 22.0% 16.6% 9.4% 14.7% |
|TERMINAL (d) | 1/19 (5%) 4/21 (19%) 2/13 (15%) 1/7 (14%) 1/8 (13%) |
|FIRST INCIDENCE | 373 385 482 607 404 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.316N P=0.579 P=0.541N P=0.315N P=0.494N |
|POLY 3 | P=0.218N P=0.510 P=0.515N P=0.274N P=0.472N |
|POLY 1.5 | P=0.191N P=0.532 P=0.460N P=0.232N P=0.454N |
|POLY 6 | P=0.262N P=0.505 P=0.584N P=0.332N P=0.496N |
|LOGISTIC REGRESSION| P=0.175N P=0.584 P=0.405N P=0.182N P=0.384N |
|COCH-ARM / FISHERS | P=0.150N P=0.613N P=0.380N P=0.173N P=0.398N |
|ORDER RESTRICTED | P=0.387N (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 |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma or Hemangioma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 3/50 (6%) 2/50 (4%) 4/50 (8%) 3/40 (8%) 2/42 (5%) |
|POLY-3 RATE (b) | 3/35.60 2/31.45 4/36.87 3/32.85 2/29.43 |
|POLY-3 PERCENT (g) | 8.4% 6.4% 10.9% 9.1% 6.8% |
|TERMINAL (d) | 1/20 (5%) 1/18 (6%) 2/24 (8%) 0/20 (0%) 1/19 (5%) |
|FIRST INCIDENCE | 577 560 631 414 482 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.476N P=0.602N P=0.585 P=0.643 P=0.576N |
|POLY 3 | P=0.514N P=0.557N P=0.519 P=0.627 P=0.587N |
|POLY 1.5 | P=0.533N P=0.529N P=0.512 P=0.611 P=0.586N |
|POLY 6 | P=0.500N P=0.588N P=0.534 P=0.637 P=0.590N |
|LOGISTIC REGRESSION| P=0.529N P=0.550N P=0.534 P=0.574 P=0.586N |
|COCH-ARM / FISHERS | P=0.547 P=0.500N P=0.500 P=0.550 P=0.583N |
|ORDER RESTRICTED | P=0.658N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 99022 TEST: 02 Page 27
Statistical Analysis of Primary Tumors 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 |
|=================================================================================================================================|
| |
|All Organs |
| Histiocytic Sarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR 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 |
|=================================================================================================================================|
| |
|All Organs |
| Histiocytic Sarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 1/50 (2%) 2/40 (5%) 2/42 (5%) |
|POLY-3 RATE (b) | 1/34.96 1/31.46 1/36.80 2/32.09 2/28.81 |
|POLY-3 PERCENT (g) | 2.9% 3.2% 2.7% 6.2% 6.9% |
|TERMINAL (d) | 1/20 (5%) 0/18 (0%) 0/24 (0%) 1/20 (5%) 2/19 (11%) |
|FIRST INCIDENCE | 668 (T) 556 631 641 668 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.225 P=0.720 P=0.719N P=0.500 P=0.482 |
|POLY 3 | P=0.201 P=0.738 P=0.750N P=0.470 P=0.432 |
|POLY 1.5 | P=0.193 P=0.749 P=0.755N P=0.458 P=0.433 |
|POLY 6 | P=0.206 P=0.726 P=0.741N P=0.479 P=0.431 |
|LOGISTIC REGRESSION| P=0.202 P=0.741 P=0.744N P=0.489 P=0.482 |
|COCH-ARM / FISHERS | P=0.180 P=0.753N P=0.753N P=0.416 P=0.434 |
|ORDER RESTRICTED | P=0.379 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 99022 TEST: 02 Page 28
Statistical Analysis of Primary Tumors 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 |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, |
| NOS, or Undifferentiated Cell Type |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 6/50 (12%) 9/50 (18%) 7/50 (14%) 4/37 (11%) 3/32 (9%) |
|POLY-3 RATE (b) | 6/35.21 9/33.67 7/32.43 4/21.95 3/19.77 |
|POLY-3 PERCENT (g) | 17.0% 26.7% 21.6% 18.2% 15.2% |
|TERMINAL (d) | 1/19 (5%) 2/21 (10%) 1/13 (8%) 0/7 (0%) 1/8 (13%) |
|FIRST INCIDENCE | 413 322 187 589 495 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.405N P=0.269 P=0.370 P=0.527 P=0.625N |
|POLY 3 | P=0.358N P=0.246 P=0.434 P=0.595 P=0.578N |
|POLY 1.5 | P=0.321N P=0.242 P=0.461 P=0.630 P=0.559N |
|POLY 6 | P=0.411N P=0.271 P=0.398 P=0.557 P=0.603N |
|LOGISTIC REGRESSION| P=0.273N P=0.263 P=0.504 P=0.624N P=0.533N |
|COCH-ARM / FISHERS | P=0.249N P=0.288 P=0.500 P=0.571N P=0.505N |
|ORDER RESTRICTED | P=0.514N (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 |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, |
| NOS, or Undifferentiated Cell Type |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 19/50 (38%) 19/50 (38%) 20/50 (40%) 16/40 (40%) 17/42 (40%) |
|POLY-3 RATE (b) | 19/39.41 19/37.75 20/38.78 16/35.35 17/31.65 |
|POLY-3 PERCENT (g) | 48.2% 50.3% 51.6% 45.3% 53.7% |
|TERMINAL (d) | 8/20 (40%) 8/18 (44%) 15/24 (63%) 8/20 (40%) 11/19 (58%) |
|FIRST INCIDENCE | 352 341 425 359 325 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.395N P=0.362 P=0.447N P=0.415N P=0.552 |
|POLY 3 | P=0.463 P=0.517 P=0.471 P=0.491N P=0.409 |
|POLY 1.5 | P=0.446 P=0.561 P=0.487 P=0.525N P=0.439 |
|POLY 6 | P=0.458 P=0.460 P=0.454 P=0.479N P=0.363 |
|LOGISTIC REGRESSION| P=0.475 P=0.534 P=0.552 P=0.578N P=0.464 |
|COCH-ARM / FISHERS | P=0.411 P=0.582N P=0.500 P=0.509 P=0.488 |
|ORDER RESTRICTED | P=0.555 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 99022 TEST: 02 Page 29
Statistical Analysis of Primary Tumors 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 |
|=================================================================================================================================|
| |
|All Organs |
| Osteosarcoma or Osteoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR 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 |
|=================================================================================================================================|
| |
|All Organs |
| Osteosarcoma or Osteoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 1/40 (3%) 0/42 (0%) |
|POLY-3 RATE (b) | 0/34.96 2/31.79 0/36.65 1/31.97 0/28.81 |
|POLY-3 PERCENT (g) | 0.0% 6.3% 0.0% 3.1% 0.0% |
|TERMINAL (d) | 0/20 (0%) 0/18 (0%) 0/24 (0%) 1/20 (5%) 0/19 (0%) |
|FIRST INCIDENCE | --- 565 --- 668 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.444N P=0.160 (e) P=0.500 (e) |
|POLY 3 | P=0.504N P=0.215 (e) P=0.482 (e) |
|POLY 1.5 | P=0.493N P=0.226 (e) P=0.476 (e) |
|POLY 6 | P=0.516N P=0.206 (e) P=0.487 (e) |
|LOGISTIC REGRESSION| P=0.461N P=0.231 (e) P=0.500 (e) |
|COCH-ARM / FISHERS | P=0.471N P=0.247 (e) P=0.444 (e) |
|ORDER RESTRICTED | P=0.334N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 99022 TEST: 02 Page 30
Statistical Analysis of Primary Tumors 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 |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 27/50 (54%) 23/50 (46%) 27/50 (54%) 18/37 (49%) 16/32 (50%) |
|POLY-3 RATE (b) | 27/38.82 23/35.83 27/35.35 18/25.42 16/24.75 |
|POLY-3 PERCENT (g) | 69.6% 64.2% 76.4% 70.8% 64.6% |
|TERMINAL (d) | 11/19 (58%) 12/21 (57%) 11/13 (85%) 7/7 (100%) 5/8 (63%) |
|FIRST INCIDENCE | 413 229 322 167 229 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.113 P=0.311N P=0.146 P=0.140 P=0.359 |
|POLY 3 | P=0.451N P=0.398N P=0.330 P=0.573 P=0.444N |
|POLY 1.5 | P=0.443N P=0.378N P=0.430 P=0.543N P=0.463N |
|POLY 6 | P=0.542N P=0.394N P=0.233 P=0.425 P=0.476N |
|LOGISTIC REGRESSION| P=0.469 P=0.413N P=0.355 P=0.581 P=0.577N |
|COCH-ARM / FISHERS | P=0.438N P=0.274N P=0.579N P=0.391N P=0.449N |
|ORDER RESTRICTED | P=0.545N (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 |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 17/50 (34%) 17/50 (34%) 23/50 (46%) 14/40 (35%) 16/42 (38%) |
|POLY-3 RATE (b) | 17/38.06 17/32.74 23/39.33 14/34.17 16/31.28 |
|POLY-3 PERCENT (g) | 44.7% 51.9% 58.5% 41.0% 51.2% |
|TERMINAL (d) | 7/20 (35%) 11/18 (61%) 14/24 (58%) 8/20 (40%) 10/19 (53%) |
|FIRST INCIDENCE | 510 560 432 359 453 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.376N P=0.337 P=0.354 P=0.389N P=0.487 |
|POLY 3 | P=0.492N P=0.349 P=0.153 P=0.468N P=0.380 |
|POLY 1.5 | P=0.520 P=0.470 P=0.151 P=0.494N P=0.394 |
|POLY 6 | P=0.480N P=0.222 P=0.162 P=0.480N P=0.353 |
|LOGISTIC REGRESSION| P=0.512N P=0.347 P=0.179 P=0.484N P=0.391 |
|COCH-ARM / FISHERS | P=0.418 P=0.583N P=0.154 P=0.548 P=0.424 |
|ORDER RESTRICTED | P=0.504 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 99022 TEST: 02 Page 31
Statistical Analysis of Primary Tumors 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 |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 19/50 (38%) 27/50 (54%) 20/50 (40%) 20/37 (54%) 17/32 (53%) |
|POLY-3 RATE (b) | 19/39.22 27/39.79 20/36.28 20/27.27 17/24.12 |
|POLY-3 PERCENT (g) | 48.4% 67.9% 55.1% 73.3% 70.5% |
|TERMINAL (d) | 5/19 (26%) 10/21 (48%) 6/13 (46%) 4/7 (57%) 5/8 (63%) |
|FIRST INCIDENCE | 373 157 187 341 376 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.026 * P=0.117 P=0.229 P=0.019 * P=0.063 |
|POLY 3 | P=0.036 * P=0.056 P=0.358 P=0.030 * P=0.064 |
|POLY 1.5 | P=0.044 * P=0.050 P=0.414 P=0.041 * P=0.066 |
|POLY 6 | P=0.031 * P=0.078 P=0.293 P=0.027 * P=0.066 |
|LOGISTIC REGRESSION| P=0.076 P=0.058 P=0.443 P=0.054 P=0.084 |
|COCH-ARM / FISHERS | P=0.120 P=0.080 P=0.500 P=0.102 P=0.132 |
|ORDER RESTRICTED | P=0.049 * (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 |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 30/50 (60%) 28/50 (56%) 31/50 (62%) 25/40 (63%) 27/42 (64%) |
|POLY-3 RATE (b) | 30/40.73 28/39.76 31/41.49 25/37.56 27/33.48 |
|POLY-3 PERCENT (g) | 73.7% 70.4% 74.7% 66.6% 80.6% |
|TERMINAL (d) | 15/20 (75%) 12/18 (67%) 19/24 (79%) 11/20 (55%) 17/19 (90%) |
|FIRST INCIDENCE | 352 341 182 359 325 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.419N P=0.382 P=0.361N P=0.332N P=0.523 |
|POLY 3 | P=0.374 P=0.468N P=0.560 P=0.323N P=0.318 |
|POLY 1.5 | P=0.330 P=0.418N P=0.556 P=0.410N P=0.353 |
|POLY 6 | P=0.387 P=0.542N P=0.559 P=0.278N P=0.254 |
|LOGISTIC REGRESSION| P=0.362 P=0.543N P=0.566 P=0.498N P=0.363 |
|COCH-ARM / FISHERS | P=0.274 P=0.420N P=0.500 P=0.491 P=0.419 |
|ORDER RESTRICTED | P=0.307 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/08/03 EXPERIMENT: 99022 TEST: 02 Page 32
Statistical Analysis of Primary Tumors 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 |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 35/50 (70%) 35/50 (70%) 34/50 (68%) 25/37 (68%) 26/32 (81%) |
|POLY-3 RATE (b) | 35/42.09 35/41.72 34/39.18 25/28.41 26/27.62 |
|POLY-3 PERCENT (g) | 83.2% 83.9% 86.8% 88.0% 94.1% |
|TERMINAL (d) | 14/19 (74%) 15/21 (71%) 12/13 (92%) 7/7 (100%) 8/8 (100%) |
|FIRST INCIDENCE | 373 157 187 167 229 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.019 * P=0.536 P=0.163 P=0.077 P=0.063 |
|POLY 3 | P=0.070 P=0.585 P=0.434 P=0.404 P=0.137 |
|POLY 1.5 | P=0.087 P=0.541 P=0.551 P=0.525 P=0.110 |
|POLY 6 | P=0.049 * P=0.589N P=0.302 P=0.291 P=0.160 |
|LOGISTIC REGRESSION| P=0.079 P=0.400 P=0.487 P=0.455 P=0.062 |
|COCH-ARM / FISHERS | P=0.206 P=0.586N P=0.500N P=0.495N P=0.190 |
|ORDER RESTRICTED | P=0.130 (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 |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 35/50 (70%) 33/50 (66%) 38/50 (76%) 31/40 (78%) 33/42 (79%) |
|POLY-3 RATE (b) | 35/41.62 33/39.81 38/42.65 31/38.17 33/35.51 |
|POLY-3 PERCENT (g) | 84.1% 82.9% 89.1% 81.2% 92.9% |
|TERMINAL (d) | 16/20 (80%) 16/18 (89%) 23/24 (96%) 16/20 (80%) 19/19 (100%) |
|FIRST INCIDENCE | 352 341 182 359 325 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.515 P=0.343 P=0.435N P=0.402N P=0.399 |
|POLY 3 | P=0.207 P=0.568N P=0.347 P=0.481N P=0.167 |
|POLY 1.5 | P=0.140 P=0.447N P=0.357 P=0.586N P=0.175 |
|POLY 6 | P=0.257 P=0.538 P=0.324 P=0.451N P=0.141 |
|LOGISTIC REGRESSION| P=0.158 P=0.595 P=0.364 P=0.575 P=0.162 |
|COCH-ARM / FISHERS | P=0.101 P=0.415N P=0.326 P=0.289 P=0.245 |
|ORDER RESTRICTED | P=0.150 (e) (e) (e) (e) |
|=================================================================================================================================|
(a) Number of tumor-bearing animals / number of animals examined at site.
(b) Number of tumor-bearing animals / Poly-3 number
(d) Observed incidence at terminal kill.
(f) Beneath the control incidence are the P-values associated with the trend
test. Beneath the dosed group incidence are the P-values corresponding to
pairwise comparisons between the controls and that dosed group. The life
table analysis regards tumors in animals dying prior to terminal kill as
being (directly or indirectly) the cause of death.
Logistic regression is an alternative
method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage
and Fishers exact tests compare directly the overall incidence rates
For all tests a negative trend is indicated by N
(e) Value of Statistic cannot be computed.
(g) Poly-3 adjusted lifetime tumor incidence.
(I) Interim sacrifice
(T) Terminal sacrifice
# Tumor rates based on number of animals necropsied.
* To the right of any statistical result, indicates significance at (P<=0.05).
** To the right of any statistical result, indicates significance at (P<=0.01).