TDMS Study 05161-06 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Southern Research Inst RIDDELLIINE DATE: 12/12/00
EXPERIMENT: 05161 TEST: 06 TIME: 09:46:32
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-55393 ROUTE: GAVAGE NTP C#: 61358C
PATHOLOGIST: FARNELL, D. CAS: 23246-96-0
------------------------------------------------------------------------------------------------------------------------------------
FEMALE MICE/FINAL#1
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE 002 0 MG/KG/DY
INCLUDE 007 3.0 MG/KG/DY
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Southern Research Inst RIDDELLIINE DATE: 12/12/00
EXPERIMENT: 05161 TEST: 06 TIME: 09:46:32
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-55393 ROUTE: GAVAGE NTP C#: 61358C
PATHOLOGIST: FARNELL, D. CAS: 23246-96-0
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF RIDDELLIINE
===============================================================
Female Mice
------------
Organ Morphology
----- ----------
Adrenal Cortex Cytoplasmic Alteration Focal
Inflammation Chronic Focal
Bone: Vertebra Hyperostosis Focal
Brain Hemorrhage Focal
Intestine Large, Cecum Edema
Hemorrhage Focal
Intestine Large, Cecum: Artery Inflammation Chronic Focal
Intestine Large, Cecum: Epithelium Erosion Focal
Intestine Small, Duodenum: Artery Inflammation Chronic
Kidney Metaplasia Focal Osseous
Nephropathy
Kidney: Artery Inflammation Chronic
Kidney: Glomerulus Glomerulosclerosis
Kidney: Renal Tubule Accumulation, Hyaline Droplet
Pigmentation
Liver Infiltration Cellular Mixed Cell
Liver: Bile Duct Hyperplasia
Liver: Hepatocyte Cytomegaly
Karyomegaly
Necrosis Focal
Vacuolization Cytoplasmic Diffuse
Liver: Hepatocyte, Midzonal Vacuolization Cytoplasmic
Lung Hyperplasia
Lung: Alveolar Epithelium Hyperplasia
Lymph Node, Mesenteric Hematopoietic Cell Proliferation
Mesentery: Artery Inflammation Chronic Focal
Mesentery: Fat Necrosis
Ovary Cyst
Ovary: Artery Inflammation Chronic
Spleen Hematopoietic Cell Proliferation
Spleen: Artery Inflammation Chronic Focal
Thyroid Gland Degeneration Cystic Focal
Uterus: Artery Inflammation Chronic Focal
Uterus: Endometrium Hyperplasia Cystic
===============================================================
Date: 12/12/00 EXPERIMENT: 05161 TEST: 06 Page 1
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Accessory Adrenal Cortical Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/42.06 2/41.80 |
|POLY-3 PERCENT (g) | 0.0% 4.8% |
|TERMINAL (d) | 0/34 (0%) 1/17 (6%) |
|FIRST INCIDENCE | --- 637 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.171 P=0.171 |
|POLY 3 | P=0.236 P=0.236 |
|POLY 1.5 | P=0.238 P=0.238 |
|POLY 6 | P=0.231 P=0.231 |
|LOGISTIC REGRESSION| P=0.238 P=0.238 |
|COCH-ARM / FISHERS | P=0.238 P=0.247 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Cytoplasmic Alteration Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 25/50 (50%) |
|POLY-3 RATE (b) | 1/42.06 25/43.78 |
|POLY-3 PERCENT (g) | 2.4% 57.1% |
|TERMINAL (d) | 1/34 (3%) 9/17 (53%) |
|FIRST INCIDENCE | 729 (T) 587 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
Date: 12/12/00 EXPERIMENT: 05161 TEST: 06 Page 2
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Inflammation Chronic Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 6/50 (12%) |
|POLY-3 RATE (b) | 0/42.06 6/41.99 |
|POLY-3 PERCENT (g) | 0.0% 14.3% |
|TERMINAL (d) | 0/34 (0%) 1/17 (6%) |
|FIRST INCIDENCE | --- 675 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.006 ** P=0.006 ** |
|POLY 3 | P=0.015 * P=0.015 * |
|POLY 1.5 | P=0.016 * P=0.016 * |
|POLY 6 | P=0.013 * P=0.013 * |
|LOGISTIC REGRESSION| P=0.015 * P=0.015 * |
|COCH-ARM / FISHERS | P=0.018 * P=0.013 * |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Bone Marrow |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 6/50 (12%) |
|POLY-3 RATE (b) | 2/42.27 6/43.85 |
|POLY-3 PERCENT (g) | 4.7% 13.7% |
|TERMINAL (d) | 1/34 (3%) 0/17 (0%) |
|FIRST INCIDENCE | 675 489 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.112 P=0.112 |
|POLY 3 | P=0.142 P=0.142 |
|POLY 1.5 | P=0.143 P=0.143 |
|POLY 6 | P=0.135 P=0.135 |
|LOGISTIC REGRESSION| P=0.109 P=0.109 |
|COCH-ARM / FISHERS | P=0.134 P=0.134 |
|=================================================================================================================================|
Date: 12/12/00 EXPERIMENT: 05161 TEST: 06 Page 3
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Bone: Vertebra |
| Hyperostosis Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 40/50 (80%) 33/50 (66%) |
|POLY-3 RATE (b) | 40/44.60 33/44.35 |
|POLY-3 PERCENT (g) | 89.7% 74.4% |
|TERMINAL (d) | 34/34 (100%) 14/17 (82%) |
|FIRST INCIDENCE | 545 587 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.025 * P=0.025 * |
|POLY 3 | P=0.034N* P=0.034N* |
|POLY 1.5 | P=0.040N* P=0.040N* |
|POLY 6 | P=0.037N* P=0.037N* |
|LOGISTIC REGRESSION| P=0.033N* P=0.033N* |
|COCH-ARM / FISHERS | P=0.088N P=0.088N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Brain |
| Hemorrhage Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 4/50 (8%) |
|POLY-3 RATE (b) | 0/42.06 4/41.73 |
|POLY-3 PERCENT (g) | 0.0% 9.6% |
|TERMINAL (d) | 0/34 (0%) 2/17 (12%) |
|FIRST INCIDENCE | --- 669 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.020 * P=0.020 * |
|POLY 3 | P=0.059 P=0.059 |
|POLY 1.5 | P=0.061 P=0.061 |
|POLY 6 | P=0.054 P=0.054 |
|LOGISTIC REGRESSION| P=0.052 P=0.052 |
|COCH-ARM / FISHERS | P=0.063 P=0.059 |
|=================================================================================================================================|
Date: 12/12/00 EXPERIMENT: 05161 TEST: 06 Page 4
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Degeneration Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/49 (0%) 2/49 (4%) |
|POLY-3 RATE (b) | 0/41.64 2/41.31 |
|POLY-3 PERCENT (g) | 0.0% 4.8% |
|TERMINAL (d) | 0/34 (0%) 0/17 (0%) |
|FIRST INCIDENCE | --- 700 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.161 P=0.161 |
|POLY 3 | P=0.236 P=0.236 |
|POLY 1.5 | P=0.238 P=0.238 |
|POLY 6 | P=0.231 P=0.231 |
|LOGISTIC REGRESSION| P=0.223 P=0.223 |
|COCH-ARM / FISHERS | P=0.237 P=0.247 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Gallbladder |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/45 (2%) 2/45 (4%) |
|POLY-3 RATE (b) | 1/39.48 2/37.52 |
|POLY-3 PERCENT (g) | 2.5% 5.3% |
|TERMINAL (d) | 1/33 (3%) 1/16 (6%) |
|FIRST INCIDENCE | 729 (T) 709 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.297 P=0.297 |
|POLY 3 | P=0.488 P=0.488 |
|POLY 1.5 | P=0.497 P=0.497 |
|POLY 6 | P=0.474 P=0.474 |
|LOGISTIC REGRESSION| P=0.402 P=0.402 |
|COCH-ARM / FISHERS | P=0.500 P=0.500 |
|=================================================================================================================================|
Date: 12/12/00 EXPERIMENT: 05161 TEST: 06 Page 5
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Heart |
| Infiltration Cellular Mixed Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/50 (6%) 6/50 (12%) |
|POLY-3 RATE (b) | 3/42.57 6/43.19 |
|POLY-3 PERCENT (g) | 7.1% 13.9% |
|TERMINAL (d) | 2/34 (6%) 2/17 (12%) |
|FIRST INCIDENCE | 577 489 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.123 P=0.123 |
|POLY 3 | P=0.247 P=0.247 |
|POLY 1.5 | P=0.252 P=0.252 |
|POLY 6 | P=0.230 P=0.230 |
|LOGISTIC REGRESSION| P=0.226 P=0.226 |
|COCH-ARM / FISHERS | P=0.242 P=0.243 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Heart |
| Inflammation Chronic Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/42.06 2/41.53 |
|POLY-3 PERCENT (g) | 0.0% 4.8% |
|TERMINAL (d) | 0/34 (0%) 1/17 (6%) |
|FIRST INCIDENCE | --- 713 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.128 P=0.128 |
|POLY 3 | P=0.235 P=0.235 |
|POLY 1.5 | P=0.238 P=0.238 |
|POLY 6 | P=0.230 P=0.230 |
|LOGISTIC REGRESSION| P=0.190 P=0.190 |
|COCH-ARM / FISHERS | P=0.238 P=0.247 |
|=================================================================================================================================|
Date: 12/12/00 EXPERIMENT: 05161 TEST: 06 Page 6
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Heart |
| Mineralization Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 4/50 (8%) |
|POLY-3 RATE (b) | 0/42.06 4/42.59 |
|POLY-3 PERCENT (g) | 0.0% 9.4% |
|TERMINAL (d) | 0/34 (0%) 0/17 (0%) |
|FIRST INCIDENCE | --- 618 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.067 P=0.067 |
|POLY 3 | P=0.061 P=0.061 |
|POLY 1.5 | P=0.062 P=0.062 |
|POLY 6 | P=0.058 P=0.058 |
|LOGISTIC REGRESSION| P=0.058 P=0.058 |
|COCH-ARM / FISHERS | P=0.063 P=0.059 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Intestine Large, Cecum |
| Edema |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/48 (0%) 5/47 (11%) |
|POLY-3 RATE (b) | 0/40.80 5/40.42 |
|POLY-3 PERCENT (g) | 0.0% 12.4% |
|TERMINAL (d) | 0/34 (0%) 2/17 (12%) |
|FIRST INCIDENCE | --- 530 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.009 ** P=0.009 ** |
|POLY 3 | P=0.029 * P=0.029 * |
|POLY 1.5 | P=0.030 * P=0.030 * |
|POLY 6 | P=0.026 * P=0.026 * |
|LOGISTIC REGRESSION| P=0.032 * P=0.032 * |
|COCH-ARM / FISHERS | P=0.031 * P=0.026 * |
|=================================================================================================================================|
Date: 12/12/00 EXPERIMENT: 05161 TEST: 06 Page 7
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Intestine Large, Cecum |
| Hemorrhage Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/48 (0%) 6/47 (13%) |
|POLY-3 RATE (b) | 0/40.80 6/40.55 |
|POLY-3 PERCENT (g) | 0.0% 14.8% |
|TERMINAL (d) | 0/34 (0%) 2/17 (12%) |
|FIRST INCIDENCE | --- 530 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.005 ** P=0.005 ** |
|POLY 3 | P=0.014 * P=0.014 * |
|POLY 1.5 | P=0.015 * P=0.015 * |
|POLY 6 | P=0.013 * P=0.013 * |
|LOGISTIC REGRESSION| P=0.017 * P=0.017 * |
|COCH-ARM / FISHERS | P=0.016 * P=0.012 * |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Intestine Large, Cecum: Artery |
| Inflammation Chronic Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/48 (0%) 18/47 (38%) |
|POLY-3 RATE (b) | 0/40.80 18/42.21 |
|POLY-3 PERCENT (g) | 0.0% 42.6% |
|TERMINAL (d) | 0/34 (0%) 4/17 (24%) |
|FIRST INCIDENCE | --- 530 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
Date: 12/12/00 EXPERIMENT: 05161 TEST: 06 Page 8
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Intestine Large, Cecum: Epithelium |
| Erosion Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/48 (0%) 6/47 (13%) |
|POLY-3 RATE (b) | 0/40.80 6/40.55 |
|POLY-3 PERCENT (g) | 0.0% 14.8% |
|TERMINAL (d) | 0/34 (0%) 2/17 (12%) |
|FIRST INCIDENCE | --- 530 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.005 ** P=0.005 ** |
|POLY 3 | P=0.014 * P=0.014 * |
|POLY 1.5 | P=0.015 * P=0.015 * |
|POLY 6 | P=0.013 * P=0.013 * |
|LOGISTIC REGRESSION| P=0.017 * P=0.017 * |
|COCH-ARM / FISHERS | P=0.016 * P=0.012 * |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Intestine Small, Duodenum |
| Hemorrhage Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/47 (0%) 2/46 (4%) |
|POLY-3 RATE (b) | 0/40.38 2/39.57 |
|POLY-3 PERCENT (g) | 0.0% 5.1% |
|TERMINAL (d) | 0/34 (0%) 0/17 (0%) |
|FIRST INCIDENCE | --- 696 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.207 P=0.207 |
|POLY 3 | P=0.234 P=0.234 |
|POLY 1.5 | P=0.236 P=0.236 |
|POLY 6 | P=0.230 P=0.230 |
|LOGISTIC REGRESSION| P=0.233 P=0.233 |
|COCH-ARM / FISHERS | P=0.233 P=0.242 |
|=================================================================================================================================|
Date: 12/12/00 EXPERIMENT: 05161 TEST: 06 Page 9
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Intestine Small, Duodenum |
| Necrosis Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/47 (0%) 2/46 (4%) |
|POLY-3 RATE (b) | 0/40.38 2/39.57 |
|POLY-3 PERCENT (g) | 0.0% 5.1% |
|TERMINAL (d) | 0/34 (0%) 0/17 (0%) |
|FIRST INCIDENCE | --- 696 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.207 P=0.207 |
|POLY 3 | P=0.234 P=0.234 |
|POLY 1.5 | P=0.236 P=0.236 |
|POLY 6 | P=0.230 P=0.230 |
|LOGISTIC REGRESSION| P=0.233 P=0.233 |
|COCH-ARM / FISHERS | P=0.233 P=0.242 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Intestine Small, Duodenum: Artery |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/47 (0%) 13/46 (28%) |
|POLY-3 RATE (b) | 0/40.38 13/40.50 |
|POLY-3 PERCENT (g) | 0.0% 32.1% |
|TERMINAL (d) | 0/34 (0%) 3/17 (18%) |
|FIRST INCIDENCE | --- 656 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
Date: 12/12/00 EXPERIMENT: 05161 TEST: 06 Page 10
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Kidney |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/49 (6%) 2/50 (4%) |
|POLY-3 RATE (b) | 3/41.79 2/42.07 |
|POLY-3 PERCENT (g) | 7.2% 4.8% |
|TERMINAL (d) | 3/34 (9%) 1/17 (6%) |
|FIRST INCIDENCE | 729 (T) 532 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.627 P=0.627 |
|POLY 3 | P=0.496N P=0.496N |
|POLY 1.5 | P=0.485N P=0.485N |
|POLY 6 | P=0.523N P=0.523N |
|LOGISTIC REGRESSION| P=0.493N P=0.493N |
|COCH-ARM / FISHERS | P=0.491N P=0.490N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Kidney |
| Metaplasia Focal Osseous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/49 (2%) 8/50 (16%) |
|POLY-3 RATE (b) | 1/41.79 8/42.09 |
|POLY-3 PERCENT (g) | 2.4% 19.0% |
|TERMINAL (d) | 1/34 (3%) 3/17 (18%) |
|FIRST INCIDENCE | 729 (T) 675 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.003 ** P=0.003 ** |
|POLY 3 | P=0.015 * P=0.015 * |
|POLY 1.5 | P=0.017 * P=0.017 * |
|POLY 6 | P=0.013 * P=0.013 * |
|LOGISTIC REGRESSION| P=0.013 * P=0.013 * |
|COCH-ARM / FISHERS | P=0.019 * P=0.017 * |
|=================================================================================================================================|
Date: 12/12/00 EXPERIMENT: 05161 TEST: 06 Page 11
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 18/49 (37%) 47/50 (94%) |
|POLY-3 RATE (b) | 18/45.32 47/47.93 |
|POLY-3 PERCENT (g) | 39.7% 98.1% |
|TERMINAL (d) | 11/34 (32%) 17/17 (100%) |
|FIRST INCIDENCE | 27 489 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Kidney: Artery |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/49 (2%) 16/50 (32%) |
|POLY-3 RATE (b) | 1/41.79 16/42.44 |
|POLY-3 PERCENT (g) | 2.4% 37.7% |
|TERMINAL (d) | 1/34 (3%) 8/17 (47%) |
|FIRST INCIDENCE | 729 (T) 637 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
Date: 12/12/00 EXPERIMENT: 05161 TEST: 06 Page 12
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Kidney: Glomerulus |
| Glomerulosclerosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/49 (0%) 40/50 (80%) |
|POLY-3 RATE (b) | 0/41.79 40/46.73 |
|POLY-3 PERCENT (g) | 0.0% 85.6% |
|TERMINAL (d) | 0/34 (0%) 14/17 (82%) |
|FIRST INCIDENCE | --- 489 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Accumulation, Hyaline Droplet |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/49 (4%) 14/50 (28%) |
|POLY-3 RATE (b) | 2/42.01 14/43.25 |
|POLY-3 PERCENT (g) | 4.8% 32.4% |
|TERMINAL (d) | 0/34 (0%) 5/17 (29%) |
|FIRST INCIDENCE | 675 530 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P=0.002 ** P<0.001 ** |
|=================================================================================================================================|
Date: 12/12/00 EXPERIMENT: 05161 TEST: 06 Page 13
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Casts Protein |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/49 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/42.05 0/41.46 |
|POLY-3 PERCENT (g) | 4.8% 0.0% |
|TERMINAL (d) | 1/34 (3%) 0/17 (0%) |
|FIRST INCIDENCE | 657 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.317N P=0.317N |
|POLY 3 | P=0.242N P=0.242N |
|POLY 1.5 | P=0.232N P=0.232N |
|POLY 6 | P=0.264N P=0.264N |
|LOGISTIC REGRESSION| P=0.235N P=0.235N |
|COCH-ARM / FISHERS | P=0.233N P=0.242N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Dilatation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/49 (4%) 2/50 (4%) |
|POLY-3 RATE (b) | 2/41.87 2/41.57 |
|POLY-3 PERCENT (g) | 4.8% 4.8% |
|TERMINAL (d) | 1/34 (3%) 0/17 (0%) |
|FIRST INCIDENCE | 709 709 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.517 P=0.517 |
|POLY 3 | P=0.692 P=0.693 |
|POLY 1.5 | P=0.686N P=0.686N |
|POLY 6 | P=0.678 P=0.678 |
|LOGISTIC REGRESSION| P=0.655 P=0.655 |
|COCH-ARM / FISHERS | P=0.688N P=0.684N |
|=================================================================================================================================|
Date: 12/12/00 EXPERIMENT: 05161 TEST: 06 Page 14
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/49 (4%) 27/50 (54%) |
|POLY-3 RATE (b) | 2/42.01 27/43.55 |
|POLY-3 PERCENT (g) | 4.8% 62.0% |
|TERMINAL (d) | 0/34 (0%) 9/17 (53%) |
|FIRST INCIDENCE | 675 656 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Liver |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/49 (4%) 2/50 (4%) |
|POLY-3 RATE (b) | 2/41.79 2/41.51 |
|POLY-3 PERCENT (g) | 4.8% 4.8% |
|TERMINAL (d) | 2/34 (6%) 1/17 (6%) |
|FIRST INCIDENCE | 729 (T) 716 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.452 P=0.452 |
|POLY 3 | P=0.693 P=0.693 |
|POLY 1.5 | P=0.685N P=0.685N |
|POLY 6 | P=0.678 P=0.679 |
|LOGISTIC REGRESSION| P=0.564 P=0.564 |
|COCH-ARM / FISHERS | P=0.688N P=0.684N |
|=================================================================================================================================|
Date: 12/12/00 EXPERIMENT: 05161 TEST: 06 Page 15
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Liver |
| Eosinophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/49 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/41.79 0/41.46 |
|POLY-3 PERCENT (g) | 4.8% 0.0% |
|TERMINAL (d) | 2/34 (6%) 0/17 (0%) |
|FIRST INCIDENCE | 729 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.400N P=0.400N |
|POLY 3 | P=0.239N P=0.239N |
|POLY 1.5 | P=0.231N P=0.231N |
|POLY 6 | P=0.259N P=0.259N |
|LOGISTIC REGRESSION| P=0.400N (e) |
|COCH-ARM / FISHERS | P=0.233N P=0.242N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Liver |
| Fibrosis Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/49 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/41.79 2/41.80 |
|POLY-3 PERCENT (g) | 0.0% 4.8% |
|TERMINAL (d) | 0/34 (0%) 1/17 (6%) |
|FIRST INCIDENCE | --- 637 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.171 P=0.171 |
|POLY 3 | P=0.237 P=0.237 |
|POLY 1.5 | P=0.240 P=0.240 |
|POLY 6 | P=0.231 P=0.231 |
|LOGISTIC REGRESSION| P=0.242 P=0.242 |
|COCH-ARM / FISHERS | P=0.242 P=0.253 |
|=================================================================================================================================|
Date: 12/12/00 EXPERIMENT: 05161 TEST: 06 Page 16
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Liver |
| Hemorrhage Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/49 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/41.79 2/42.13 |
|POLY-3 PERCENT (g) | 0.0% 4.8% |
|TERMINAL (d) | 0/34 (0%) 1/17 (6%) |
|FIRST INCIDENCE | --- 504 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.170 P=0.170 |
|POLY 3 | P=0.238 P=0.238 |
|POLY 1.5 | P=0.240 P=0.240 |
|POLY 6 | P=0.232 P=0.232 |
|LOGISTIC REGRESSION| P=0.215 P=0.215 |
|COCH-ARM / FISHERS | P=0.242 P=0.253 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Liver |
| Hyperplasia Focal Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/49 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/41.79 0/41.46 |
|POLY-3 PERCENT (g) | 4.8% 0.0% |
|TERMINAL (d) | 2/34 (6%) 0/17 (0%) |
|FIRST INCIDENCE | 729 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.400N P=0.400N |
|POLY 3 | P=0.239N P=0.239N |
|POLY 1.5 | P=0.231N P=0.231N |
|POLY 6 | P=0.259N P=0.259N |
|LOGISTIC REGRESSION| P=0.400N (e) |
|COCH-ARM / FISHERS | P=0.233N P=0.242N |
|=================================================================================================================================|
Date: 12/12/00 EXPERIMENT: 05161 TEST: 06 Page 17
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Liver |
| Infiltration Cellular Mixed Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 29/49 (59%) 41/50 (82%) |
|POLY-3 RATE (b) | 29/44.89 41/46.76 |
|POLY-3 PERCENT (g) | 64.6% 87.7% |
|TERMINAL (d) | 23/34 (68%) 16/17 (94%) |
|FIRST INCIDENCE | 27 434 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** |
|POLY 3 | P=0.005 ** P=0.005 ** |
|POLY 1.5 | P=0.007 ** P=0.007 ** |
|POLY 6 | P=0.003 ** P=0.003 ** |
|LOGISTIC REGRESSION| P=0.012 * P=0.012 * |
|COCH-ARM / FISHERS | P=0.012 * P=0.011 * |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Liver: Bile Duct |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/49 (0%) 28/50 (56%) |
|POLY-3 RATE (b) | 0/41.79 28/44.58 |
|POLY-3 PERCENT (g) | 0.0% 62.8% |
|TERMINAL (d) | 0/34 (0%) 12/17 (71%) |
|FIRST INCIDENCE | --- 596 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
Date: 12/12/00 EXPERIMENT: 05161 TEST: 06 Page 18
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Cytomegaly |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/49 (0%) 49/50 (98%) |
|POLY-3 RATE (b) | 0/41.79 49/50.00 |
|POLY-3 PERCENT (g) | 0.0% 98.0% |
|TERMINAL (d) | 0/34 (0%) 16/17 (94%) |
|FIRST INCIDENCE | --- 434 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Karyomegaly |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/49 (0%) 49/50 (98%) |
|POLY-3 RATE (b) | 0/41.79 49/50.00 |
|POLY-3 PERCENT (g) | 0.0% 98.0% |
|TERMINAL (d) | 0/34 (0%) 16/17 (94%) |
|FIRST INCIDENCE | --- 434 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
Date: 12/12/00 EXPERIMENT: 05161 TEST: 06 Page 19
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Necrosis Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 12/49 (24%) 19/50 (38%) |
|POLY-3 RATE (b) | 12/41.87 19/44.35 |
|POLY-3 PERCENT (g) | 28.7% 42.8% |
|TERMINAL (d) | 11/34 (32%) 7/17 (41%) |
|FIRST INCIDENCE | 709 489 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.003 ** P=0.003 ** |
|POLY 3 | P=0.120 P=0.120 |
|POLY 1.5 | P=0.123 P=0.123 |
|POLY 6 | P=0.107 P=0.107 |
|LOGISTIC REGRESSION| P=0.092 P=0.092 |
|COCH-ARM / FISHERS | P=0.109 P=0.109 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Vacuolization Cytoplasmic Diffuse |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 8/49 (16%) 1/50 (2%) |
|POLY-3 RATE (b) | 8/44.40 1/41.69 |
|POLY-3 PERCENT (g) | 18.0% 2.4% |
|TERMINAL (d) | 2/34 (6%) 0/17 (0%) |
|FIRST INCIDENCE | 545 669 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.044N* P=0.044N* |
|POLY 3 | P=0.020N* P=0.020N* |
|POLY 1.5 | P=0.016N* P=0.016N* |
|POLY 6 | P=0.029N* P=0.029N* |
|LOGISTIC REGRESSION| P=0.019N* P=0.019N* |
|COCH-ARM / FISHERS | P=0.017N* P=0.014N* |
|=================================================================================================================================|
Date: 12/12/00 EXPERIMENT: 05161 TEST: 06 Page 20
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Vacuolization Cytoplasmic Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/49 (6%) 0/50 (0%) |
|POLY-3 RATE (b) | 3/42.37 0/41.46 |
|POLY-3 PERCENT (g) | 7.1% 0.0% |
|TERMINAL (d) | 2/34 (6%) 0/17 (0%) |
|FIRST INCIDENCE | 545 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.210N P=0.210N |
|POLY 3 | P=0.123N P=0.123N |
|POLY 1.5 | P=0.116N P=0.116N |
|POLY 6 | P=0.140N P=0.140N |
|LOGISTIC REGRESSION| P=0.118N P=0.118N |
|COCH-ARM / FISHERS | P=0.117N P=0.117N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Liver: Hepatocyte, Midzonal |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/49 (2%) 6/50 (12%) |
|POLY-3 RATE (b) | 1/42.29 6/42.50 |
|POLY-3 PERCENT (g) | 2.4% 14.1% |
|TERMINAL (d) | 0/34 (0%) 0/17 (0%) |
|FIRST INCIDENCE | 577 618 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.045 * P=0.045 * |
|POLY 3 | P=0.056 P=0.056 |
|POLY 1.5 | P=0.059 P=0.059 |
|POLY 6 | P=0.049 * P=0.050 |
|LOGISTIC REGRESSION| P=0.060 P=0.060 |
|COCH-ARM / FISHERS | P=0.062 P=0.059 |
|=================================================================================================================================|
Date: 12/12/00 EXPERIMENT: 05161 TEST: 06 Page 21
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lung |
| Congestion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/50 (6%) 2/50 (4%) |
|POLY-3 RATE (b) | 3/42.06 2/41.94 |
|POLY-3 PERCENT (g) | 7.1% 4.8% |
|TERMINAL (d) | 3/34 (9%) 0/17 (0%) |
|FIRST INCIDENCE | 729 (T) 656 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.676 P=0.676 |
|POLY 3 | P=0.502N P=0.502N |
|POLY 1.5 | P=0.493N P=0.493N |
|POLY 6 | P=0.524N P=0.524N |
|LOGISTIC REGRESSION| P=0.513N P=0.513N |
|COCH-ARM / FISHERS | P=0.500N P=0.500N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lung |
| Foreign Body |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/50 (8%) 0/50 (0%) |
|POLY-3 RATE (b) | 4/44.39 0/41.46 |
|POLY-3 PERCENT (g) | 9.0% 0.0% |
|TERMINAL (d) | 0/34 (0%) 0/17 (0%) |
|FIRST INCIDENCE | 545 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.064N P=0.064N |
|POLY 3 | P=0.072N P=0.072N |
|POLY 1.5 | P=0.064N P=0.064N |
|POLY 6 | P=0.088N P=0.088N |
|LOGISTIC REGRESSION| P=0.089N P=0.089N |
|COCH-ARM / FISHERS | P=0.063N P=0.059N |
|=================================================================================================================================|
Date: 12/12/00 EXPERIMENT: 05161 TEST: 06 Page 22
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lung |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 4/50 (8%) |
|POLY-3 RATE (b) | 1/42.69 4/41.85 |
|POLY-3 PERCENT (g) | 2.3% 9.6% |
|TERMINAL (d) | 0/34 (0%) 2/17 (12%) |
|FIRST INCIDENCE | 524 637 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.093 P=0.093 |
|POLY 3 | P=0.173 P=0.173 |
|POLY 1.5 | P=0.179 P=0.179 |
|POLY 6 | P=0.161 P=0.161 |
|LOGISTIC REGRESSION| P=0.177 P=0.177 |
|COCH-ARM / FISHERS | P=0.179 P=0.181 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lung |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 9/50 (18%) |
|POLY-3 RATE (b) | 2/42.87 9/42.99 |
|POLY-3 PERCENT (g) | 4.7% 20.9% |
|TERMINAL (d) | 1/34 (3%) 3/17 (18%) |
|FIRST INCIDENCE | 419 530 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.007 ** P=0.007 ** |
|POLY 3 | P=0.024 * P=0.024 * |
|POLY 1.5 | P=0.026 * P=0.026 * |
|POLY 6 | P=0.021 * P=0.021 * |
|LOGISTIC REGRESSION| P=0.025 * P=0.025 * |
|COCH-ARM / FISHERS | P=0.028 * P=0.026 * |
|=================================================================================================================================|
Date: 12/12/00 EXPERIMENT: 05161 TEST: 06 Page 23
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lung |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/42.06 0/41.46 |
|POLY-3 PERCENT (g) | 4.8% 0.0% |
|TERMINAL (d) | 2/34 (6%) 0/17 (0%) |
|FIRST INCIDENCE | 729 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.400N P=0.400N |
|POLY 3 | P=0.242N P=0.242N |
|POLY 1.5 | P=0.235N P=0.235N |
|POLY 6 | P=0.260N P=0.260N |
|LOGISTIC REGRESSION| P=0.400N (e) |
|COCH-ARM / FISHERS | P=0.238N P=0.247N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lung |
| Infiltration Cellular Mixed Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 3/50 (6%) |
|POLY-3 RATE (b) | 0/42.06 3/42.78 |
|POLY-3 PERCENT (g) | 0.0% 7.0% |
|TERMINAL (d) | 0/34 (0%) 1/17 (6%) |
|FIRST INCIDENCE | --- 489 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.090 P=0.090 |
|POLY 3 | P=0.120 P=0.120 |
|POLY 1.5 | P=0.122 P=0.122 |
|POLY 6 | P=0.115 P=0.115 |
|LOGISTIC REGRESSION| P=0.080 P=0.080 |
|COCH-ARM / FISHERS | P=0.121 P=0.121 |
|=================================================================================================================================|
Date: 12/12/00 EXPERIMENT: 05161 TEST: 06 Page 24
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lung: Alveolar Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 6/50 (12%) |
|POLY-3 RATE (b) | 1/42.69 6/42.60 |
|POLY-3 PERCENT (g) | 2.3% 14.1% |
|TERMINAL (d) | 0/34 (0%) 2/17 (12%) |
|FIRST INCIDENCE | 524 434 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.027 * P=0.027 * |
|POLY 3 | P=0.055 P=0.055 |
|POLY 1.5 | P=0.058 P=0.058 |
|POLY 6 | P=0.048 * P=0.048 * |
|LOGISTIC REGRESSION| P=0.050 P=0.050 |
|COCH-ARM / FISHERS | P=0.058 P=0.056 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lung: Artery, Mediastinum |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/42.06 2/41.63 |
|POLY-3 PERCENT (g) | 0.0% 4.8% |
|TERMINAL (d) | 0/34 (0%) 0/17 (0%) |
|FIRST INCIDENCE | --- 696 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.171 P=0.171 |
|POLY 3 | P=0.236 P=0.236 |
|POLY 1.5 | P=0.238 P=0.238 |
|POLY 6 | P=0.230 P=0.230 |
|LOGISTIC REGRESSION| P=0.225 P=0.225 |
|COCH-ARM / FISHERS | P=0.238 P=0.247 |
|=================================================================================================================================|
Date: 12/12/00 EXPERIMENT: 05161 TEST: 06 Page 25
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/48 (4%) 1/47 (2%) |
|POLY-3 RATE (b) | 2/41.77 1/40.16 |
|POLY-3 PERCENT (g) | 4.8% 2.5% |
|TERMINAL (d) | 1/33 (3%) 1/17 (6%) |
|FIRST INCIDENCE | 27 729 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.650N P=0.650N |
|POLY 3 | P=0.518N P=0.518N |
|POLY 1.5 | P=0.512N P=0.512N |
|POLY 6 | P=0.539N P=0.539N |
|LOGISTIC REGRESSION| P=0.697N P=0.697N |
|COCH-ARM / FISHERS | P=0.507N P=0.508N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lymph Node, Mediastinal |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/42.06 2/42.83 |
|POLY-3 PERCENT (g) | 0.0% 4.7% |
|TERMINAL (d) | 0/34 (0%) 0/17 (0%) |
|FIRST INCIDENCE | --- 489 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.251 P=0.251 |
|POLY 3 | P=0.239 P=0.239 |
|POLY 1.5 | P=0.240 P=0.240 |
|POLY 6 | P=0.234 P=0.234 |
|LOGISTIC REGRESSION| P=0.124 P=0.124 |
|COCH-ARM / FISHERS | P=0.238 P=0.247 |
|=================================================================================================================================|
Date: 12/12/00 EXPERIMENT: 05161 TEST: 06 Page 26
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/48 (0%) 4/49 (8%) |
|POLY-3 RATE (b) | 0/41.37 4/40.74 |
|POLY-3 PERCENT (g) | 0.0% 9.8% |
|TERMINAL (d) | 0/34 (0%) 1/17 (6%) |
|FIRST INCIDENCE | --- 696 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.026 * P=0.026 * |
|POLY 3 | P=0.058 P=0.058 |
|POLY 1.5 | P=0.061 P=0.061 |
|POLY 6 | P=0.052 P=0.053 |
|LOGISTIC REGRESSION| P=0.047 * P=0.047 * |
|COCH-ARM / FISHERS | P=0.065 P=0.061 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/48 (0%) 4/49 (8%) |
|POLY-3 RATE (b) | 0/41.37 4/41.23 |
|POLY-3 PERCENT (g) | 0.0% 9.7% |
|TERMINAL (d) | 0/34 (0%) 0/17 (0%) |
|FIRST INCIDENCE | --- 656 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.053 P=0.053 |
|POLY 3 | P=0.059 P=0.059 |
|POLY 1.5 | P=0.062 P=0.062 |
|POLY 6 | P=0.054 P=0.055 |
|LOGISTIC REGRESSION| P=0.065 P=0.065 |
|COCH-ARM / FISHERS | P=0.065 P=0.061 |
|=================================================================================================================================|
Date: 12/12/00 EXPERIMENT: 05161 TEST: 06 Page 27
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/48 (6%) 3/49 (6%) |
|POLY-3 RATE (b) | 3/41.95 3/41.77 |
|POLY-3 PERCENT (g) | 7.2% 7.2% |
|TERMINAL (d) | 2/34 (6%) 0/17 (0%) |
|FIRST INCIDENCE | 545 489 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.559 P=0.559 |
|POLY 3 | P=0.661 P=0.661 |
|POLY 1.5 | P=0.651N P=0.651N |
|POLY 6 | P=0.642 P=0.642 |
|LOGISTIC REGRESSION| P=0.651 P=0.651 |
|COCH-ARM / FISHERS | P=0.654N P=0.651N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/48 (4%) 2/49 (4%) |
|POLY-3 RATE (b) | 2/41.37 2/40.49 |
|POLY-3 PERCENT (g) | 4.8% 4.9% |
|TERMINAL (d) | 2/34 (6%) 2/17 (12%) |
|FIRST INCIDENCE | 729 (T) 729 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.428 P=0.428 |
|POLY 3 | P=0.689 P=0.689 |
|POLY 1.5 | P=0.689N P=0.689N |
|POLY 6 | P=0.672 P=0.672 |
|LOGISTIC REGRESSION| P=0.428 P=0.428 |
|COCH-ARM / FISHERS | P=0.688N P=0.684N |
|=================================================================================================================================|
Date: 12/12/00 EXPERIMENT: 05161 TEST: 06 Page 28
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Lymph Node: Renal |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/7 (0%) 2/15 (13%) |
|POLY-3 RATE (b) | 0/4.74 2/11.32 |
|POLY-3 PERCENT (g) | 0.0% 17.7% |
|TERMINAL (d) | 0/2 (0%) 0/3 (0%) |
|FIRST INCIDENCE | --- 596 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.248 P=0.248 |
|POLY 3 | P=0.406 P=0.326 |
|POLY 1.5 | P=0.411 P=0.332 |
|POLY 6 | P=0.399 P=0.319 |
|LOGISTIC REGRESSION| P=0.418 P=0.418 |
|COCH-ARM / FISHERS | P=0.414 P=0.455 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Mammary Gland |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/49 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/41.79 2/41.46 |
|POLY-3 PERCENT (g) | 0.0% 4.8% |
|TERMINAL (d) | 0/34 (0%) 2/17 (12%) |
|FIRST INCIDENCE | --- 729 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.103 P=0.103 |
|POLY 3 | P=0.236 P=0.236 |
|POLY 1.5 | P=0.239 P=0.239 |
|POLY 6 | P=0.230 P=0.230 |
|LOGISTIC REGRESSION| (e) P=0.103 |
|COCH-ARM / FISHERS | P=0.242 P=0.253 |
|=================================================================================================================================|
Date: 12/12/00 EXPERIMENT: 05161 TEST: 06 Page 29
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Mesentery |
| Fibrosis Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/23 (0%) 2/29 (7%) |
|POLY-3 RATE (b) | 0/19.50 2/23.39 |
|POLY-3 PERCENT (g) | 0.0% 8.6% |
|TERMINAL (d) | 0/15 (0%) 1/5 (20%) |
|FIRST INCIDENCE | --- 637 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.130 P=0.130 |
|POLY 3 | P=0.260 P=0.253 |
|POLY 1.5 | P=0.265 P=0.257 |
|POLY 6 | P=0.247 P=0.243 |
|LOGISTIC REGRESSION| P=0.282 P=0.282 |
|COCH-ARM / FISHERS | P=0.288 P=0.306 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Mesentery |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/23 (0%) 2/29 (7%) |
|POLY-3 RATE (b) | 0/19.50 2/23.80 |
|POLY-3 PERCENT (g) | 0.0% 8.4% |
|TERMINAL (d) | 0/15 (0%) 0/5 (0%) |
|FIRST INCIDENCE | --- 587 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.256 P=0.256 |
|POLY 3 | P=0.263 P=0.255 |
|POLY 1.5 | P=0.267 P=0.259 |
|POLY 6 | P=0.252 P=0.247 |
|LOGISTIC REGRESSION| P=0.287 P=0.287 |
|COCH-ARM / FISHERS | P=0.288 P=0.306 |
|=================================================================================================================================|
Date: 12/12/00 EXPERIMENT: 05161 TEST: 06 Page 30
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Mesentery: Artery |
| Inflammation Chronic Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/23 (4%) 19/29 (66%) |
|POLY-3 RATE (b) | 1/19.50 19/26.08 |
|POLY-3 PERCENT (g) | 5.1% 72.9% |
|TERMINAL (d) | 1/15 (7%) 2/5 (40%) |
|FIRST INCIDENCE | 729 (T) 434 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Mesentery: Fat |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 19/23 (83%) 2/29 (7%) |
|POLY-3 RATE (b) | 19/22.27 2/23.31 |
|POLY-3 PERCENT (g) | 85.3% 8.6% |
|TERMINAL (d) | 14/15 (93%) 0/5 (0%) |
|FIRST INCIDENCE | 419 669 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.004N** P=0.004N** |
|POLY 3 | P<0.001N** P<0.001N** |
|POLY 1.5 | P<0.001N** P<0.001N** |
|POLY 6 | P<0.001N** P<0.001N** |
|LOGISTIC REGRESSION| P<0.001N** P<0.001N** |
|COCH-ARM / FISHERS | P<0.001N** P<0.001N** |
|=================================================================================================================================|
Date: 12/12/00 EXPERIMENT: 05161 TEST: 06 Page 31
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Nose: Nasolacrimal Duct |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/42.64 1/41.80 |
|POLY-3 PERCENT (g) | 4.7% 2.4% |
|TERMINAL (d) | 1/34 (3%) 0/17 (0%) |
|FIRST INCIDENCE | 545 637 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.572N P=0.572N |
|POLY 3 | P=0.509N P=0.509N |
|POLY 1.5 | P=0.499N P=0.499N |
|POLY 6 | P=0.534N P=0.534N |
|LOGISTIC REGRESSION| P=0.521N P=0.521N |
|COCH-ARM / FISHERS | P=0.500N P=0.500N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Ovary |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/49 (6%) 1/48 (2%) |
|POLY-3 RATE (b) | 3/41.80 1/40.23 |
|POLY-3 PERCENT (g) | 7.2% 2.5% |
|TERMINAL (d) | 2/34 (6%) 0/17 (0%) |
|FIRST INCIDENCE | 725 720 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.555N P=0.555N |
|POLY 3 | P=0.322N P=0.322N |
|POLY 1.5 | P=0.312N P=0.312N |
|POLY 6 | P=0.347N P=0.347N |
|LOGISTIC REGRESSION| P=0.442N P=0.442N |
|COCH-ARM / FISHERS | P=0.312N P=0.316N |
|=================================================================================================================================|
Date: 12/12/00 EXPERIMENT: 05161 TEST: 06 Page 32
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Ovary |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 16/49 (33%) 19/48 (40%) |
|POLY-3 RATE (b) | 16/43.56 19/42.56 |
|POLY-3 PERCENT (g) | 36.7% 44.6% |
|TERMINAL (d) | 12/34 (35%) 11/17 (65%) |
|FIRST INCIDENCE | 545 434 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.016 * P=0.016 * |
|POLY 3 | P=0.297 P=0.297 |
|POLY 1.5 | P=0.322 P=0.322 |
|POLY 6 | P=0.243 P=0.243 |
|LOGISTIC REGRESSION| P=0.311 P=0.311 |
|COCH-ARM / FISHERS | P=0.309 P=0.309 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Ovary: Artery |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/49 (0%) 26/48 (54%) |
|POLY-3 RATE (b) | 0/41.79 26/43.35 |
|POLY-3 PERCENT (g) | 0.0% 60.0% |
|TERMINAL (d) | 0/34 (0%) 8/17 (47%) |
|FIRST INCIDENCE | --- 434 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
Date: 12/12/00 EXPERIMENT: 05161 TEST: 06 Page 33
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Pancreas: Artery |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/49 (0%) 3/50 (6%) |
|POLY-3 RATE (b) | 0/41.79 3/41.83 |
|POLY-3 PERCENT (g) | 0.0% 7.2% |
|TERMINAL (d) | 0/34 (0%) 1/17 (6%) |
|FIRST INCIDENCE | --- 637 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.064 P=0.064 |
|POLY 3 | P=0.118 P=0.118 |
|POLY 1.5 | P=0.121 P=0.121 |
|POLY 6 | P=0.112 P=0.112 |
|LOGISTIC REGRESSION| P=0.121 P=0.121 |
|COCH-ARM / FISHERS | P=0.124 P=0.125 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Pituitary Gland |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/48 (8%) 1/49 (2%) |
|POLY-3 RATE (b) | 4/40.61 1/40.54 |
|POLY-3 PERCENT (g) | 9.9% 2.5% |
|TERMINAL (d) | 3/33 (9%) 1/17 (6%) |
|FIRST INCIDENCE | 725 729 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.428N P=0.428N |
|POLY 3 | P=0.178N P=0.178N |
|POLY 1.5 | P=0.170N P=0.170N |
|POLY 6 | P=0.199N P=0.199N |
|LOGISTIC REGRESSION| P=0.364N P=0.364N |
|COCH-ARM / FISHERS | P=0.173N P=0.175N |
|=================================================================================================================================|
Date: 12/12/00 EXPERIMENT: 05161 TEST: 06 Page 34
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Cytoplasmic Alteration Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/48 (6%) 3/49 (6%) |
|POLY-3 RATE (b) | 3/40.59 3/40.62 |
|POLY-3 PERCENT (g) | 7.4% 7.4% |
|TERMINAL (d) | 3/33 (9%) 2/17 (12%) |
|FIRST INCIDENCE | 729 (T) 709 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.368 P=0.368 |
|POLY 3 | P=0.663N P=0.663N |
|POLY 1.5 | P=0.649N P=0.649N |
|POLY 6 | P=0.643 P=0.643 |
|LOGISTIC REGRESSION| P=0.501 P=0.501 |
|COCH-ARM / FISHERS | P=0.654N P=0.651N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Salivary Glands: Artery |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 1/42.06 2/41.75 |
|POLY-3 PERCENT (g) | 2.4% 4.8% |
|TERMINAL (d) | 1/34 (3%) 0/17 (0%) |
|FIRST INCIDENCE | 729 (T) 675 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.383 P=0.383 |
|POLY 3 | P=0.498 P=0.498 |
|POLY 1.5 | P=0.502 P=0.502 |
|POLY 6 | P=0.488 P=0.488 |
|LOGISTIC REGRESSION| P=0.489 P=0.489 |
|COCH-ARM / FISHERS | P=0.500 P=0.500 |
|=================================================================================================================================|
Date: 12/12/00 EXPERIMENT: 05161 TEST: 06 Page 35
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 32/49 (65%) 43/50 (86%) |
|POLY-3 RATE (b) | 32/45.69 43/48.52 |
|POLY-3 PERCENT (g) | 70.0% 88.6% |
|TERMINAL (d) | 22/34 (65%) 14/17 (82%) |
|FIRST INCIDENCE | 27 434 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** |
|POLY 3 | P=0.018 * P=0.018 * |
|POLY 1.5 | P=0.016 * P=0.016 * |
|POLY 6 | P=0.018 * P=0.018 * |
|LOGISTIC REGRESSION| P=0.016 * P=0.016 * |
|COCH-ARM / FISHERS | P=0.015 * P=0.015 * |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Spleen |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 9/49 (18%) 4/50 (8%) |
|POLY-3 RATE (b) | 9/41.79 4/41.46 |
|POLY-3 PERCENT (g) | 21.5% 9.7% |
|TERMINAL (d) | 9/34 (27%) 4/17 (24%) |
|FIRST INCIDENCE | 729 (T) 729 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.545N P=0.545N |
|POLY 3 | P=0.115N P=0.115N |
|POLY 1.5 | P=0.106N P=0.106N |
|POLY 6 | P=0.138N P=0.138N |
|LOGISTIC REGRESSION| P=0.545N P=0.545N |
|COCH-ARM / FISHERS | P=0.109N P=0.109N |
|=================================================================================================================================|
Date: 12/12/00 EXPERIMENT: 05161 TEST: 06 Page 36
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Spleen: Artery |
| Inflammation Chronic Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/49 (0%) 6/50 (12%) |
|POLY-3 RATE (b) | 0/41.79 6/42.17 |
|POLY-3 PERCENT (g) | 0.0% 14.2% |
|TERMINAL (d) | 0/34 (0%) 2/17 (12%) |
|FIRST INCIDENCE | --- 637 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.006 ** P=0.006 ** |
|POLY 3 | P=0.015 * P=0.015 * |
|POLY 1.5 | P=0.016 * P=0.016 * |
|POLY 6 | P=0.013 * P=0.013 * |
|LOGISTIC REGRESSION| P=0.017 * P=0.017 * |
|COCH-ARM / FISHERS | P=0.019 * P=0.014 * |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Inflammation Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/49 (4%) 0/49 (0%) |
|POLY-3 RATE (b) | 2/42.41 0/40.53 |
|POLY-3 PERCENT (g) | 4.7% 0.0% |
|TERMINAL (d) | 1/34 (3%) 0/17 (0%) |
|FIRST INCIDENCE | 524 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.311N P=0.311N |
|POLY 3 | P=0.253N P=0.253N |
|POLY 1.5 | P=0.241N P=0.241N |
|POLY 6 | P=0.277N P=0.277N |
|LOGISTIC REGRESSION| P=0.250N P=0.250N |
|COCH-ARM / FISHERS | P=0.237N P=0.247N |
|=================================================================================================================================|
Date: 12/12/00 EXPERIMENT: 05161 TEST: 06 Page 37
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/49 (0%) 2/48 (4%) |
|POLY-3 RATE (b) | 0/41.79 2/40.33 |
|POLY-3 PERCENT (g) | 0.0% 5.0% |
|TERMINAL (d) | 0/34 (0%) 1/17 (6%) |
|FIRST INCIDENCE | --- 637 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.171 P=0.171 |
|POLY 3 | P=0.233 P=0.233 |
|POLY 1.5 | P=0.235 P=0.235 |
|POLY 6 | P=0.228 P=0.228 |
|LOGISTIC REGRESSION| P=0.233 P=0.233 |
|COCH-ARM / FISHERS | P=0.233 P=0.242 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Thymus |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/49 (0%) 2/39 (5%) |
|POLY-3 RATE (b) | 0/41.77 2/32.86 |
|POLY-3 PERCENT (g) | 0.0% 6.1% |
|TERMINAL (d) | 0/34 (0%) 0/14 (0%) |
|FIRST INCIDENCE | --- 696 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.182 P=0.182 |
|POLY 3 | P=0.219 P=0.209 |
|POLY 1.5 | P=0.220 P=0.211 |
|POLY 6 | P=0.217 P=0.206 |
|LOGISTIC REGRESSION| P=0.183 P=0.183 |
|COCH-ARM / FISHERS | P=0.188 P=0.194 |
|=================================================================================================================================|
Date: 12/12/00 EXPERIMENT: 05161 TEST: 06 Page 38
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Thymus |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/49 (6%) 0/39 (0%) |
|POLY-3 RATE (b) | 3/41.77 0/32.65 |
|POLY-3 PERCENT (g) | 7.2% 0.0% |
|TERMINAL (d) | 3/34 (9%) 0/14 (0%) |
|FIRST INCIDENCE | 729 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.313N P=0.313N |
|POLY 3 | P=0.193N P=0.185N |
|POLY 1.5 | P=0.185N P=0.178N |
|POLY 6 | P=0.213N P=0.202N |
|LOGISTIC REGRESSION| P=0.313N (e) |
|COCH-ARM / FISHERS | P=0.163N P=0.168N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Thyroid Gland |
| Degeneration Cystic Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 13/49 (27%) 21/50 (42%) |
|POLY-3 RATE (b) | 13/42.56 21/44.09 |
|POLY-3 PERCENT (g) | 30.5% 47.6% |
|TERMINAL (d) | 10/34 (29%) 9/17 (53%) |
|FIRST INCIDENCE | 577 434 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.002 ** P=0.002 ** |
|POLY 3 | P=0.074 P=0.074 |
|POLY 1.5 | P=0.083 P=0.083 |
|POLY 6 | P=0.056 P=0.056 |
|LOGISTIC REGRESSION| P=0.068 P=0.068 |
|COCH-ARM / FISHERS | P=0.079 P=0.079 |
|=================================================================================================================================|
Date: 12/12/00 EXPERIMENT: 05161 TEST: 06 Page 39
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Thyroid Gland |
| Inflammation Chronic Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/49 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 1/41.77 2/41.50 |
|POLY-3 PERCENT (g) | 2.4% 4.8% |
|TERMINAL (d) | 1/34 (3%) 1/17 (6%) |
|FIRST INCIDENCE | 729 (T) 720 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.288 P=0.288 |
|POLY 3 | P=0.498 P=0.498 |
|POLY 1.5 | P=0.505 P=0.504 |
|POLY 6 | P=0.486 P=0.486 |
|LOGISTIC REGRESSION| P=0.365 P=0.365 |
|COCH-ARM / FISHERS | P=0.507 P=0.508 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Tooth: Peridontal Tissue |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 6/7 (86%) 0/0 (0%) |
|POLY-3 RATE (b) | 6/6.98 0/0.00 |
|POLY-3 PERCENT (g) | 85.9% 0.0% |
|TERMINAL (d) | 4/4 (100%) 0/0 (0%) |
|FIRST INCIDENCE | 475 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.342N P=0.342N |
|POLY 3 | P=1.000N (e) |
|POLY 1.5 | P=1.000N (e) |
|POLY 6 | P=1.000N (e) |
|LOGISTIC REGRESSION| (e) (e) |
|COCH-ARM / FISHERS | P=1.000N P=1.000 |
|=================================================================================================================================|
Date: 12/12/00 EXPERIMENT: 05161 TEST: 06 Page 40
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Uterus |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/49 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 1/41.79 2/42.16 |
|POLY-3 PERCENT (g) | 2.4% 4.7% |
|TERMINAL (d) | 1/34 (3%) 0/17 (0%) |
|FIRST INCIDENCE | 729 (T) 530 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.394 P=0.394 |
|POLY 3 | P=0.502 P=0.502 |
|POLY 1.5 | P=0.507 P=0.506 |
|POLY 6 | P=0.491 P=0.492 |
|LOGISTIC REGRESSION| P=0.500 P=0.500 |
|COCH-ARM / FISHERS | P=0.507 P=0.508 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Uterus |
| Hydrometra |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 27/49 (55%) 19/50 (38%) |
|POLY-3 RATE (b) | 27/45.17 19/43.46 |
|POLY-3 PERCENT (g) | 59.8% 43.7% |
|TERMINAL (d) | 20/34 (59%) 10/17 (59%) |
|FIRST INCIDENCE | 482 530 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.379 P=0.379 |
|POLY 3 | P=0.091N P=0.091N |
|POLY 1.5 | P=0.069N P=0.069N |
|POLY 6 | P=0.143N P=0.143N |
|LOGISTIC REGRESSION| P=0.065N P=0.065N |
|COCH-ARM / FISHERS | P=0.066N P=0.066N |
|=================================================================================================================================|
Date: 12/12/00 EXPERIMENT: 05161 TEST: 06 Page 41
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Uterus |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/49 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/42.05 0/41.46 |
|POLY-3 PERCENT (g) | 4.8% 0.0% |
|TERMINAL (d) | 1/34 (3%) 0/17 (0%) |
|FIRST INCIDENCE | 657 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.317N P=0.317N |
|POLY 3 | P=0.242N P=0.242N |
|POLY 1.5 | P=0.232N P=0.232N |
|POLY 6 | P=0.264N P=0.264N |
|LOGISTIC REGRESSION| P=0.235N P=0.235N |
|COCH-ARM / FISHERS | P=0.233N P=0.242N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Uterus: Artery |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/49 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/41.79 2/41.75 |
|POLY-3 PERCENT (g) | 0.0% 4.8% |
|TERMINAL (d) | 0/34 (0%) 0/17 (0%) |
|FIRST INCIDENCE | --- 675 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.203 P=0.203 |
|POLY 3 | P=0.237 P=0.237 |
|POLY 1.5 | P=0.240 P=0.240 |
|POLY 6 | P=0.231 P=0.231 |
|LOGISTIC REGRESSION| P=0.240 P=0.240 |
|COCH-ARM / FISHERS | P=0.242 P=0.253 |
|=================================================================================================================================|
Date: 12/12/00 EXPERIMENT: 05161 TEST: 06 Page 42
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - RIDDELLIINE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Uterus: Artery |
| Inflammation Chronic Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/49 (0%) 21/50 (42%) |
|POLY-3 RATE (b) | 0/41.79 21/44.32 |
|POLY-3 PERCENT (g) | 0.0% 47.4% |
|TERMINAL (d) | 0/34 (0%) 5/17 (29%) |
|FIRST INCIDENCE | --- 434 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 3.0 |
| | MG/KG/DY MG/KG/DY |
|=================================================================================================================================|
| |
|Uterus: Endometrium |
| Hyperplasia Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 43/49 (88%) 41/50 (82%) |
|POLY-3 RATE (b) | 43/45.35 41/47.58 |
|POLY-3 PERCENT (g) | 94.8% 86.2% |
|TERMINAL (d) | 33/34 (97%) 14/17 (82%) |
|FIRST INCIDENCE | 545 434 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.007 ** P=0.007 ** |
|POLY 3 | P=0.115N P=0.115N |
|POLY 1.5 | P=0.144N P=0.144N |
|POLY 6 | P=0.109N P=0.109N |
|LOGISTIC REGRESSION| P=0.219N P=0.219N |
|COCH-ARM / FISHERS | P=0.302N P=0.303N |
|=================================================================================================================================|
(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).