TDMS Study 99034-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus TRANSGENIC MODEL EVALUATION II (BENZENE) DATE: 11/05/03
EXPERIMENT: 99034 TEST: 01 TIME: 14:55:50
TEST TYPE: SUBCHRON 26-WEEK CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-65406 ROUTE: GAVAGE NTP C#: C99034
PATHOLOGIST: MISSING CAS: 71-43-2
------------------------------------------------------------------------------------------------------------------------------------
FINAL #1 MICE
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus TRANSGENIC MODEL EVALUATION II (BENZENE) DATE: 11/05/03
EXPERIMENT: 99034 TEST: 01 TIME: 14:55:50
TEST TYPE: SUBCHRON 26-WEEK CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-65406 ROUTE: GAVAGE NTP C#: C99034
PATHOLOGIST: MISSING CAS: 71-43-2
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF TRANSGENIC MODEL EVALUATION II (BEN
===============================================================
Male Mice
------------
Organ Morphology
----- ----------
Bone Marrow Atrophy
Pigmentation Hemosiderin
Kidney Nephropathy
Lung Inflammation Chronic
Lymph Node, Mandibular Atrophy
Lymph Node, Mesenteric Atrophy
Lymph Node: Mediastinal Atrophy
Skin Pigmentation
Spleen Hematopoietic Cell Proliferation
Spleen: Lymphoid Follicle Atrophy
Stomach, Forestomach Hyperplasia
Thymus Atrophy
===============================================================
Female Mice
------------
Organ Morphology
----- ----------
Liver Inflammation Chronic
Lung: Alveolar Epithelium Hyperplasia Focal
Lymph Node, Mesenteric Atrophy
Lymph Node: Mediastinal Atrophy
Mammary Gland Hyperplasia
Skin Pigmentation
Uterus: Endometrium Hyperplasia Cystic
===============================================================
Date: 11/05/03 EXPERIMENT: 99034 TEST: 01 Page 1
Statistical Analysis of Non-neoplastic Lesions in Mice(P16(INK4A)/(+/-) (C57BL/6)) - TRANSGENIC MODEL EVALUATION II
(BEN
Terminal Sacrifice at 27 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Bone Marrow |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 10/15 (67%) 12/15 (80%) |
|POLY-3 RATE (b) | 0/15.00 0/15.00 0/15.00 10/15.00 12/14.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 66.7% 85.7% |
|TERMINAL (d) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 10/15 (67%) 12/14 (86%) |
|FIRST INCIDENCE | --- --- --- 188 (T) 188 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** (e) (e) P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** (e) (e) P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** (e) (e) P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Bone Marrow |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) |
|POLY-3 RATE (b) | 0/15.00 0/15.00 0/15.00 0/15.00 0/15.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 11/05/03 EXPERIMENT: 99034 TEST: 01 Page 2
Statistical Analysis of Non-neoplastic Lesions in Mice(P16(INK4A)/(+/-) (C57BL/6)) - TRANSGENIC MODEL EVALUATION II (
BEN
Terminal Sacrifice at 27 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Bone Marrow |
| Pigmentation Hemosiderin |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/15 (7%) 13/15 (87%) 13/15 (87%) 15/15 (100%) 14/15 (93%) |
|POLY-3 RATE (b) | 1/15.00 13/15.00 13/15.00 15/15.00 14/14.00 |
|POLY-3 PERCENT (g) | 6.7% 86.7% 86.7% 100.0% 100.0% |
|TERMINAL (d) | 1/15 (7%) 13/15 (87%) 13/15 (87%) 15/15 (100%) 14/14 (100%) |
|FIRST INCIDENCE | 188 (T) 188 (T) 188 (T) 188 (T) 188 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Bone Marrow |
| Pigmentation Hemosiderin |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) |
|POLY-3 RATE (b) | 0/15.00 0/15.00 0/15.00 0/15.00 0/15.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 11/05/03 EXPERIMENT: 99034 TEST: 01 Page 3
Statistical Analysis of Non-neoplastic Lesions in Mice(P16(INK4A)/(+/-) (C57BL/6)) - TRANSGENIC MODEL EVALUATION II (
BEN
Terminal Sacrifice at 27 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Intestine Small, Duodenum |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) |
|POLY-3 RATE (b) | 0/15.00 0/15.00 0/15.00 0/15.00 0/14.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/14 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Intestine Small, Duodenum |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 2/15 (13%) 0/15 (0%) |
|POLY-3 RATE (b) | 0/15.00 0/15.00 0/15.00 2/15.00 0/15.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 13.3% 0.0% |
|TERMINAL (d) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 2/15 (13%) 0/15 (0%) |
|FIRST INCIDENCE | --- --- --- 189 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.500 (e) (e) P=0.236 (e) |
|POLY 3 | P=0.500 (e) (e) P=0.232 (e) |
|POLY 1.5 | P=0.500 (e) (e) P=0.232 (e) |
|POLY 6 | P=0.500 (e) (e) P=0.232 (e) |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.236 (e) |
|COCH-ARM / FISHERS | P=0.500 (e) (e) P=0.241 (e) |
|ORDER RESTRICTED | P=0.205 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 11/05/03 EXPERIMENT: 99034 TEST: 01 Page 4
Statistical Analysis of Non-neoplastic Lesions in Mice(P16(INK4A)/(+/-) (C57BL/6)) - TRANSGENIC MODEL EVALUATION II (
BEN
Terminal Sacrifice at 27 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Kidney |
| Casts Protein |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/15 (7%) 0/15 (0%) 2/15 (13%) 1/15 (7%) 2/15 (13%) |
|POLY-3 RATE (b) | 1/15.00 0/15.00 2/15.00 1/15.00 2/14.00 |
|POLY-3 PERCENT (g) | 6.7% 0.0% 13.3% 6.7% 14.3% |
|TERMINAL (d) | 1/15 (7%) 0/15 (0%) 2/15 (13%) 1/15 (7%) 2/14 (14%) |
|FIRST INCIDENCE | 188 (T) --- 188 (T) 188 (T) 188 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.252 P=0.500N P=0.500 P=0.764 P=0.475 |
|POLY 3 | P=0.254 P=0.500N P=0.500 P=0.760 P=0.476 |
|POLY 1.5 | P=0.254 P=0.500N P=0.500 P=0.760 P=0.476 |
|POLY 6 | P=0.254 P=0.500N P=0.500 P=0.760 P=0.476 |
|LOGISTIC REGRESSION| P=0.252 (e) P=0.500 P=0.764 P=0.475 |
|COCH-ARM / FISHERS | P=0.274 P=0.500N P=0.500 P=0.759N P=0.500 |
|ORDER RESTRICTED | P=0.250 (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Kidney |
| Casts Protein |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/15 (33%) 4/15 (27%) 5/15 (33%) 8/15 (53%) 7/15 (47%) |
|POLY-3 RATE (b) | 5/15.00 4/15.00 5/15.00 8/15.00 7/15.00 |
|POLY-3 PERCENT (g) | 33.3% 26.7% 33.3% 53.3% 46.7% |
|TERMINAL (d) | 5/15 (33%) 4/15 (27%) 5/15 (33%) 8/15 (53%) 7/15 (47%) |
|FIRST INCIDENCE | 189 (T) 189 (T) 189 (T) 189 (T) 189 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.140 P=0.500N P=0.648 P=0.234 P=0.357 |
|POLY 3 | P=0.141 P=0.500N P=0.646 P=0.234 P=0.358 |
|POLY 1.5 | P=0.141 P=0.500N P=0.646 P=0.234 P=0.358 |
|POLY 6 | P=0.141 P=0.500N P=0.646 P=0.234 P=0.358 |
|LOGISTIC REGRESSION| P=0.140 P=0.500N P=0.648 P=0.234 P=0.357 |
|COCH-ARM / FISHERS | P=0.138 P=0.500N P=0.650N P=0.231 P=0.355 |
|ORDER RESTRICTED | P=0.225 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 11/05/03 EXPERIMENT: 99034 TEST: 01 Page 5
Statistical Analysis of Non-neoplastic Lesions in Mice(P16(INK4A)/(+/-) (C57BL/6)) - TRANSGENIC MODEL EVALUATION II (
BEN
Terminal Sacrifice at 27 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/15 (7%) 1/15 (7%) 0/15 (0%) 2/15 (13%) 4/15 (27%) |
|POLY-3 RATE (b) | 1/15.00 1/15.00 0/15.00 2/15.00 4/14.00 |
|POLY-3 PERCENT (g) | 6.7% 6.7% 0.0% 13.3% 28.6% |
|TERMINAL (d) | 1/15 (7%) 1/15 (7%) 0/15 (0%) 2/15 (13%) 4/14 (29%) |
|FIRST INCIDENCE | 188 (T) 188 (T) --- 188 (T) 188 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.019 * P=0.764 P=0.500N P=0.500 P=0.147 |
|POLY 3 | P=0.019 * P=0.760 P=0.500N P=0.500 P=0.141 |
|POLY 1.5 | P=0.019 * P=0.760 P=0.500N P=0.500 P=0.141 |
|POLY 6 | P=0.019 * P=0.760 P=0.500N P=0.500 P=0.141 |
|LOGISTIC REGRESSION| P=0.019 * P=0.764 (e) P=0.500 P=0.143 |
|COCH-ARM / FISHERS | P=0.024 * P=0.759N P=0.500N P=0.500 P=0.165 |
|ORDER RESTRICTED | P=0.024 * (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/15 (20%) 0/15 (0%) 1/15 (7%) 2/15 (13%) 1/15 (7%) |
|POLY-3 RATE (b) | 3/15.00 0/15.00 1/15.00 2/15.00 1/15.00 |
|POLY-3 PERCENT (g) | 20.0% 0.0% 6.7% 13.3% 6.7% |
|TERMINAL (d) | 3/15 (20%) 0/15 (0%) 1/15 (7%) 2/15 (13%) 1/15 (7%) |
|FIRST INCIDENCE | 189 (T) --- 189 (T) 189 (T) 189 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.445N P=0.116N P=0.299N P=0.500N P=0.299N |
|POLY 3 | P=0.445N P=0.106N P=0.298N P=0.500N P=0.298N |
|POLY 1.5 | P=0.445N P=0.106N P=0.298N P=0.500N P=0.298N |
|POLY 6 | P=0.445N P=0.106N P=0.298N P=0.500N P=0.298N |
|LOGISTIC REGRESSION| P=0.445N (e) P=0.299N P=0.500N P=0.299N |
|COCH-ARM / FISHERS | P=0.444N P=0.112N P=0.299N P=0.500N P=0.299N |
|ORDER RESTRICTED | P=0.175N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 11/05/03 EXPERIMENT: 99034 TEST: 01 Page 6
Statistical Analysis of Non-neoplastic Lesions in Mice(P16(INK4A)/(+/-) (C57BL/6)) - TRANSGENIC MODEL EVALUATION II (
BEN
Terminal Sacrifice at 27 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/15 (20%) 6/15 (40%) 1/15 (7%) 3/15 (20%) 1/15 (7%) |
|POLY-3 RATE (b) | 3/15.00 6/15.00 1/15.00 3/15.00 1/14.00 |
|POLY-3 PERCENT (g) | 20.0% 40.0% 6.7% 20.0% 7.1% |
|TERMINAL (d) | 3/15 (20%) 6/15 (40%) 1/15 (7%) 3/15 (20%) 1/14 (7%) |
|FIRST INCIDENCE | 188 (T) 188 (T) 188 (T) 188 (T) 188 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.121N P=0.217 P=0.299N P=0.673 P=0.324N |
|POLY 3 | P=0.118N P=0.215 P=0.298N P=0.670 P=0.324N |
|POLY 1.5 | P=0.118N P=0.215 P=0.298N P=0.670 P=0.324N |
|POLY 6 | P=0.118N P=0.215 P=0.298N P=0.670 P=0.324N |
|LOGISTIC REGRESSION| P=0.121N P=0.217 P=0.299N P=0.673 P=0.324N |
|COCH-ARM / FISHERS | P=0.104N P=0.213 P=0.299N P=0.674N P=0.299N |
|ORDER RESTRICTED | P=0.088N (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 10/15 (67%) 6/15 (40%) 6/15 (40%) 4/15 (27%) 11/15 (73%) |
|POLY-3 RATE (b) | 10/15.00 6/15.00 6/15.00 4/15.00 11/15.00 |
|POLY-3 PERCENT (g) | 66.7% 40.0% 40.0% 26.7% 73.3% |
|TERMINAL (d) | 10/15 (67%) 6/15 (40%) 6/15 (40%) 4/15 (27%) 11/15 (73%) |
|FIRST INCIDENCE | 189 (T) 189 (T) 189 (T) 189 (T) 189 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.233 P=0.140N P=0.140N P=0.036N* P=0.500 |
|POLY 3 | P=0.224 P=0.136N P=0.136N P=0.027N* P=0.500 |
|POLY 1.5 | P=0.224 P=0.136N P=0.136N P=0.027N* P=0.500 |
|POLY 6 | P=0.224 P=0.136N P=0.136N P=0.027N* P=0.500 |
|LOGISTIC REGRESSION| P=0.233 P=0.140N P=0.140N P=0.036N* P=0.500 |
|COCH-ARM / FISHERS | P=0.231 P=0.136N P=0.136N P=0.033N* P=0.500 |
|ORDER RESTRICTED | P=0.066 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 11/05/03 EXPERIMENT: 99034 TEST: 01 Page 7
Statistical Analysis of Non-neoplastic Lesions in Mice(P16(INK4A)/(+/-) (C57BL/6)) - TRANSGENIC MODEL EVALUATION II (
BEN
Terminal Sacrifice at 27 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Lung |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/15 (13%) 0/15 (0%) 1/15 (7%) 3/15 (20%) 5/15 (33%) |
|POLY-3 RATE (b) | 2/15.00 0/15.00 1/15.00 3/15.00 5/14.00 |
|POLY-3 PERCENT (g) | 13.3% 0.0% 6.7% 20.0% 35.7% |
|TERMINAL (d) | 2/15 (13%) 0/15 (0%) 1/15 (7%) 3/15 (20%) 5/14 (36%) |
|FIRST INCIDENCE | 188 (T) --- 188 (T) 188 (T) 188 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.011 * P=0.236N P=0.500N P=0.500 P=0.169 |
|POLY 3 | P=0.010 * P=0.232N P=0.500N P=0.500 P=0.166 |
|POLY 1.5 | P=0.010 * P=0.232N P=0.500N P=0.500 P=0.166 |
|POLY 6 | P=0.010 * P=0.232N P=0.500N P=0.500 P=0.166 |
|LOGISTIC REGRESSION| P=0.011 * (e) P=0.500N P=0.500 P=0.169 |
|COCH-ARM / FISHERS | P=0.014 * P=0.241N P=0.500N P=0.500 P=0.195 |
|ORDER RESTRICTED | P=0.018 * (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Lung |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/15 (13%) 2/15 (13%) 0/15 (0%) 0/15 (0%) 2/15 (13%) |
|POLY-3 RATE (b) | 2/15.00 2/15.00 0/15.00 0/15.00 2/15.00 |
|POLY-3 PERCENT (g) | 13.3% 13.3% 0.0% 0.0% 13.3% |
|TERMINAL (d) | 2/15 (13%) 2/15 (13%) 0/15 (0%) 0/15 (0%) 2/15 (13%) |
|FIRST INCIDENCE | 189 (T) 189 (T) --- --- 189 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.618 P=0.701 P=0.236N P=0.236N P=0.701 |
|POLY 3 | P=0.618 P=0.698 P=0.232N P=0.232N P=0.698 |
|POLY 1.5 | P=0.618 P=0.698 P=0.232N P=0.232N P=0.698 |
|POLY 6 | P=0.618 P=0.698 P=0.232N P=0.232N P=0.698 |
|LOGISTIC REGRESSION| P=0.618 P=0.701 (e) (e) P=0.701 |
|COCH-ARM / FISHERS | P=0.618 P=0.701N P=0.241N P=0.241N P=0.701N |
|ORDER RESTRICTED | P=0.322N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 11/05/03 EXPERIMENT: 99034 TEST: 01 Page 8
Statistical Analysis of Non-neoplastic Lesions in Mice(P16(INK4A)/(+/-) (C57BL/6)) - TRANSGENIC MODEL EVALUATION II (
BEN
Terminal Sacrifice at 27 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Lung: Alveolar Epithelium |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/15 (0%) 0/15 (0%) 1/15 (7%) 0/15 (0%) 0/15 (0%) |
|POLY-3 RATE (b) | 0/15.00 0/15.00 1/15.00 0/15.00 0/14.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 6.7% 0.0% 0.0% |
|TERMINAL (d) | 0/15 (0%) 0/15 (0%) 1/15 (7%) 0/15 (0%) 0/14 (0%) |
|FIRST INCIDENCE | --- --- 188 (T) --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.649N (e) P=0.500 (e) (e) |
|POLY 3 | P=0.639N (e) P=0.500 (e) (e) |
|POLY 1.5 | P=0.639N (e) P=0.500 (e) (e) |
|POLY 6 | P=0.639N (e) P=0.500 (e) (e) |
|LOGISTIC REGRESSION| (e) (e) P=0.500 (e) (e) |
|COCH-ARM / FISHERS | P=0.639N (e) P=0.500 (e) (e) |
|ORDER RESTRICTED | P=0.522 (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Lung: Alveolar Epithelium |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/15 (7%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 3/15 (20%) |
|POLY-3 RATE (b) | 1/15.00 0/15.00 0/15.00 0/15.00 3/15.00 |
|POLY-3 PERCENT (g) | 6.7% 0.0% 0.0% 0.0% 20.0% |
|TERMINAL (d) | 1/15 (7%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 3/15 (20%) |
|FIRST INCIDENCE | 189 (T) --- --- --- 189 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.036 * P=0.500N P=0.500N P=0.500N P=0.299 |
|POLY 3 | P=0.031 * P=0.500N P=0.500N P=0.500N P=0.298 |
|POLY 1.5 | P=0.031 * P=0.500N P=0.500N P=0.500N P=0.298 |
|POLY 6 | P=0.031 * P=0.500N P=0.500N P=0.500N P=0.298 |
|LOGISTIC REGRESSION| P=0.036 * (e) (e) (e) P=0.299 |
|COCH-ARM / FISHERS | P=0.035 * P=0.500N P=0.500N P=0.500N P=0.299 |
|ORDER RESTRICTED | P=0.014 * (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 11/05/03 EXPERIMENT: 99034 TEST: 01 Page 9
Statistical Analysis of Non-neoplastic Lesions in Mice(P16(INK4A)/(+/-) (C57BL/6)) - TRANSGENIC MODEL EVALUATION II (
BEN
Terminal Sacrifice at 27 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 6/14 (43%) 11/14 (79%) |
|POLY-3 RATE (b) | 0/15.00 0/15.00 0/15.00 6/14.00 11/13.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 42.9% 84.6% |
|TERMINAL (d) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 6/14 (43%) 11/13 (85%) |
|FIRST INCIDENCE | --- --- --- 188 (T) 188 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) P=0.009 ** P<0.001 ** |
|POLY 3 | P<0.001 ** (e) (e) P=0.003 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) P=0.003 ** P<0.001 ** |
|POLY 6 | P<0.001 ** (e) (e) P=0.003 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** (e) (e) P=0.009 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) P=0.006 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/14 (0%) 1/15 (7%) 2/15 (13%) 4/15 (27%) 0/15 (0%) |
|POLY-3 RATE (b) | 0/14.00 1/15.00 2/15.00 4/15.00 0/15.00 |
|POLY-3 PERCENT (g) | 0.0% 6.7% 13.3% 26.7% 0.0% |
|TERMINAL (d) | 0/14 (0%) 1/15 (7%) 2/15 (13%) 4/15 (27%) 0/15 (0%) |
|FIRST INCIDENCE | --- 189 (T) 189 (T) 189 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.595N P=0.514 P=0.251 P=0.065 (e) |
|POLY 3 | P=0.598N P=0.514 P=0.247 P=0.053 (e) |
|POLY 1.5 | P=0.598N P=0.514 P=0.247 P=0.053 (e) |
|POLY 6 | P=0.598N P=0.514 P=0.247 P=0.053 (e) |
|LOGISTIC REGRESSION| (e) P=0.514 P=0.251 P=0.065 (e) |
|COCH-ARM / FISHERS | P=0.595N P=0.517 P=0.259 P=0.057 (e) |
|ORDER RESTRICTED | P=0.176 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 11/05/03 EXPERIMENT: 99034 TEST: 01 Page 10
Statistical Analysis of Non-neoplastic Lesions in Mice(P16(INK4A)/(+/-) (C57BL/6)) - TRANSGENIC MODEL EVALUATION II (
BEN
Terminal Sacrifice at 27 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/15 (13%) 1/15 (7%) 1/15 (7%) 0/14 (0%) 0/14 (0%) |
|POLY-3 RATE (b) | 2/15.00 1/15.00 1/15.00 0/14.00 0/13.00 |
|POLY-3 PERCENT (g) | 13.3% 6.7% 6.7% 0.0% 0.0% |
|TERMINAL (d) | 2/15 (13%) 1/15 (7%) 1/15 (7%) 0/14 (0%) 0/13 (0%) |
|FIRST INCIDENCE | 188 (T) 188 (T) 188 (T) --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.118N P=0.500N P=0.500N P=0.251N P=0.268N |
|POLY 3 | P=0.115N P=0.500N P=0.500N P=0.247N P=0.265N |
|POLY 1.5 | P=0.115N P=0.500N P=0.500N P=0.247N P=0.265N |
|POLY 6 | P=0.115N P=0.500N P=0.500N P=0.247N P=0.265N |
|LOGISTIC REGRESSION| P=0.118N P=0.500N P=0.500N (e) (e) |
|COCH-ARM / FISHERS | P=0.110N P=0.500N P=0.500N P=0.259N P=0.259N |
|ORDER RESTRICTED | P=0.107N (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/14 (7%) 4/15 (27%) 2/15 (13%) 5/15 (33%) 3/15 (20%) |
|POLY-3 RATE (b) | 1/14.00 4/15.00 2/15.00 5/15.00 3/15.00 |
|POLY-3 PERCENT (g) | 7.1% 26.7% 13.3% 33.3% 20.0% |
|TERMINAL (d) | 1/14 (7%) 4/15 (27%) 2/15 (13%) 5/15 (33%) 3/15 (20%) |
|FIRST INCIDENCE | 189 (T) 189 (T) 189 (T) 189 (T) 189 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.328 P=0.189 P=0.525 P=0.104 P=0.324 |
|POLY 3 | P=0.328 P=0.185 P=0.524 P=0.096 P=0.324 |
|POLY 1.5 | P=0.328 P=0.185 P=0.524 P=0.096 P=0.324 |
|POLY 6 | P=0.328 P=0.185 P=0.524 P=0.096 P=0.324 |
|LOGISTIC REGRESSION| P=0.328 P=0.189 P=0.525 P=0.104 P=0.324 |
|COCH-ARM / FISHERS | P=0.327 P=0.186 P=0.527 P=0.099 P=0.326 |
|ORDER RESTRICTED | P=0.163 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 11/05/03 EXPERIMENT: 99034 TEST: 01 Page 11
Statistical Analysis of Non-neoplastic Lesions in Mice(P16(INK4A)/(+/-) (C57BL/6)) - TRANSGENIC MODEL EVALUATION II (
BEN
Terminal Sacrifice at 27 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Infiltration Cellular Polymorphonuclear |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 1/14 (7%) 1/14 (7%) |
|POLY-3 RATE (b) | 0/15.00 0/15.00 0/15.00 1/14.00 1/13.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 7.1% 7.7% |
|TERMINAL (d) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 1/14 (7%) 1/13 (8%) |
|FIRST INCIDENCE | --- --- --- 188 (T) 188 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.133 (e) (e) P=0.486 P=0.471 |
|POLY 3 | P=0.130 (e) (e) P=0.486 P=0.471 |
|POLY 1.5 | P=0.130 (e) (e) P=0.486 P=0.472 |
|POLY 6 | P=0.130 (e) (e) P=0.486 P=0.471 |
|LOGISTIC REGRESSION| P=0.131 (e) (e) P=0.486 P=0.471 |
|COCH-ARM / FISHERS | P=0.143 (e) (e) P=0.483 P=0.483 |
|ORDER RESTRICTED | P=0.192 (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Infiltration Cellular Polymorphonuclear |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/14 (7%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 2/15 (13%) |
|POLY-3 RATE (b) | 1/14.00 0/15.00 0/15.00 0/15.00 2/15.00 |
|POLY-3 PERCENT (g) | 7.1% 0.0% 0.0% 0.0% 13.3% |
|TERMINAL (d) | 1/14 (7%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 2/15 (13%) |
|FIRST INCIDENCE | 189 (T) --- --- --- 189 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.156 P=0.486N P=0.486N P=0.486N P=0.525 |
|POLY 3 | P=0.153 P=0.486N P=0.486N P=0.486N P=0.524 |
|POLY 1.5 | P=0.153 P=0.486N P=0.486N P=0.486N P=0.524 |
|POLY 6 | P=0.153 P=0.486N P=0.486N P=0.486N P=0.524 |
|LOGISTIC REGRESSION| P=0.156 (e) (e) (e) P=0.525 |
|COCH-ARM / FISHERS | P=0.154 P=0.483N P=0.483N P=0.483N P=0.527 |
|ORDER RESTRICTED | P=0.088 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 11/05/03 EXPERIMENT: 99034 TEST: 01 Page 12
Statistical Analysis of Non-neoplastic Lesions in Mice(P16(INK4A)/(+/-) (C57BL/6)) - TRANSGENIC MODEL EVALUATION II (
BEN
Terminal Sacrifice at 27 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/15 (7%) 2/15 (13%) 2/14 (14%) 13/15 (87%) 13/15 (87%) |
|POLY-3 RATE (b) | 1/15.00 2/15.00 2/14.00 13/15.00 13/14.00 |
|POLY-3 PERCENT (g) | 6.7% 13.3% 14.3% 86.7% 92.9% |
|TERMINAL (d) | 1/15 (7%) 2/15 (13%) 2/14 (14%) 13/15 (87%) 13/14 (93%) |
|FIRST INCIDENCE | 188 (T) 188 (T) 188 (T) 188 (T) 188 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.500 P=0.475 P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.500 P=0.476 P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.500 P=0.476 P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.500 P=0.476 P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.500 P=0.475 P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.500 P=0.473 P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/15 (0%) 2/15 (13%) 3/15 (20%) 8/15 (53%) 6/15 (40%) |
|POLY-3 RATE (b) | 0/15.00 2/15.00 3/15.00 8/15.00 6/15.00 |
|POLY-3 PERCENT (g) | 0.0% 13.3% 20.0% 53.3% 40.0% |
|TERMINAL (d) | 0/15 (0%) 2/15 (13%) 3/15 (20%) 8/15 (53%) 6/15 (40%) |
|FIRST INCIDENCE | --- 189 (T) 189 (T) 189 (T) 189 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.003 ** P=0.236 P=0.116 P=0.002 ** P=0.012 * |
|POLY 3 | P=0.002 ** P=0.232 P=0.106 P<0.001 ** P=0.005 ** |
|POLY 1.5 | P=0.002 ** P=0.232 P=0.106 P<0.001 ** P=0.005 ** |
|POLY 6 | P=0.002 ** P=0.232 P=0.106 P<0.001 ** P=0.005 ** |
|LOGISTIC REGRESSION| (e) P=0.236 P=0.116 P=0.002 ** P=0.012 * |
|COCH-ARM / FISHERS | P=0.003 ** P=0.241 P=0.112 P<0.001 ** P=0.008 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 11/05/03 EXPERIMENT: 99034 TEST: 01 Page 13
Statistical Analysis of Non-neoplastic Lesions in Mice(P16(INK4A)/(+/-) (C57BL/6)) - TRANSGENIC MODEL EVALUATION II (
BEN
Terminal Sacrifice at 27 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Lymph Node: Mediastinal |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/11 (0%) 0/11 (0%) 2/12 (17%) 6/9 (67%) 6/7 (86%) |
|POLY-3 RATE (b) | 0/11.00 0/11.00 2/12.00 6/9.00 6/7.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 16.7% 66.7% 85.7% |
|TERMINAL (d) | 0/11 (0%) 0/11 (0%) 2/12 (17%) 6/9 (67%) 6/7 (86%) |
|FIRST INCIDENCE | --- --- 188 (T) 188 (T) 188 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) P=0.254 P=0.004 ** P<0.001 ** |
|POLY 3 | P<0.001 ** (e) P=0.249 P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) P=0.249 P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** (e) P=0.249 P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) P=0.254 P=0.004 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** (e) P=0.261 P=0.002 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Lymph Node: Mediastinal |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/13 (0%) 0/11 (0%) 2/11 (18%) 4/12 (33%) 2/13 (15%) |
|POLY-3 RATE (b) | 0/13.00 0/11.00 2/11.00 4/12.00 2/13.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 18.2% 33.3% 15.4% |
|TERMINAL (d) | 0/13 (0%) 0/11 (0%) 2/11 (18%) 4/12 (33%) 2/13 (15%) |
|FIRST INCIDENCE | --- --- 189 (T) 189 (T) 189 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.114 (e) P=0.199 P=0.045 * P=0.235 |
|POLY 3 | P=0.105 (e) P=0.190 P=0.032 * P=0.230 |
|POLY 1.5 | P=0.105 (e) P=0.190 P=0.032 * P=0.230 |
|POLY 6 | P=0.105 (e) P=0.190 P=0.032 * P=0.230 |
|LOGISTIC REGRESSION| (e) (e) P=0.199 P=0.045 * P=0.235 |
|COCH-ARM / FISHERS | P=0.112 (e) P=0.199 P=0.039 * P=0.240 |
|ORDER RESTRICTED | P=0.039 * (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 11/05/03 EXPERIMENT: 99034 TEST: 01 Page 14
Statistical Analysis of Non-neoplastic Lesions in Mice(P16(INK4A)/(+/-) (C57BL/6)) - TRANSGENIC MODEL EVALUATION II (
BEN
Terminal Sacrifice at 27 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/0 (0%) 0/1 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|POLY-3 RATE (b) | 0/0.00 0/1.00 0/0.00 0/0.00 0/0.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/0 (0%) 0/1 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 2/15 (13%) |
|POLY-3 RATE (b) | 0/15.00 0/15.00 0/15.00 0/15.00 2/15.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 13.3% |
|TERMINAL (d) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 2/15 (13%) |
|FIRST INCIDENCE | --- --- --- --- 189 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.022 * (e) (e) (e) P=0.236 |
|POLY 3 | P=0.019 * (e) (e) (e) P=0.232 |
|POLY 1.5 | P=0.019 * (e) (e) (e) P=0.232 |
|POLY 6 | P=0.019 * (e) (e) (e) P=0.232 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) P=0.236 |
|COCH-ARM / FISHERS | P=0.021 * (e) (e) (e) P=0.241 |
|ORDER RESTRICTED | P=0.014 * (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 11/05/03 EXPERIMENT: 99034 TEST: 01 Page 15
Statistical Analysis of Non-neoplastic Lesions in Mice(P16(INK4A)/(+/-) (C57BL/6)) - TRANSGENIC MODEL EVALUATION II (
BEN
Terminal Sacrifice at 27 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Ovary |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | |
|POLY-3 RATE (b) | |
|POLY-3 PERCENT (g) | |
|TERMINAL (d) | |
|FIRST INCIDENCE | |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | |
|POLY 3 | |
|POLY 1.5 | |
|POLY 6 | |
|LOGISTIC REGRESSION| |
|COCH-ARM / FISHERS | |
|ORDER RESTRICTED | |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Ovary |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/14 (7%) 0/15 (0%) 0/15 (0%) 2/15 (13%) 2/15 (13%) |
|POLY-3 RATE (b) | 1/14.00 0/15.00 0/15.00 2/15.00 2/15.00 |
|POLY-3 PERCENT (g) | 7.1% 0.0% 0.0% 13.3% 13.3% |
|TERMINAL (d) | 1/14 (7%) 0/15 (0%) 0/15 (0%) 2/15 (13%) 2/15 (13%) |
|FIRST INCIDENCE | 189 (T) --- --- 189 (T) 189 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.134 P=0.486N P=0.486N P=0.525 P=0.525 |
|POLY 3 | P=0.134 P=0.486N P=0.486N P=0.524 P=0.524 |
|POLY 1.5 | P=0.134 P=0.486N P=0.486N P=0.524 P=0.524 |
|POLY 6 | P=0.134 P=0.486N P=0.486N P=0.524 P=0.524 |
|LOGISTIC REGRESSION| P=0.134 (e) (e) P=0.525 P=0.525 |
|COCH-ARM / FISHERS | P=0.133 P=0.483N P=0.483N P=0.527 P=0.527 |
|ORDER RESTRICTED | P=0.204 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 11/05/03 EXPERIMENT: 99034 TEST: 01 Page 16
Statistical Analysis of Non-neoplastic Lesions in Mice(P16(INK4A)/(+/-) (C57BL/6)) - TRANSGENIC MODEL EVALUATION II (
BEN
Terminal Sacrifice at 27 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/15 (0%) 15/15 (100%) 15/15 (100%) 15/15 (100%) 14/15 (93%) |
|POLY-3 RATE (b) | 0/15.00 15/15.00 15/15.00 15/15.00 14/14.00 |
|POLY-3 PERCENT (g) | 0.0% 100.0% 100.0% 100.0% 100.0% |
|TERMINAL (d) | 0/15 (0%) 15/15 (100%) 15/15 (100%) 15/15 (100%) 14/14 (100%) |
|FIRST INCIDENCE | --- 188 (T) 188 (T) 188 (T) 188 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| (e) P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/15 (0%) 1/15 (7%) 8/15 (53%) 15/15 (100%) 15/15 (100%) |
|POLY-3 RATE (b) | 0/15.00 1/15.00 8/15.00 15/15.00 15/15.00 |
|POLY-3 PERCENT (g) | 0.0% 6.7% 53.3% 100.0% 100.0% |
|TERMINAL (d) | 0/15 (0%) 1/15 (7%) 8/15 (53%) 15/15 (100%) 15/15 (100%) |
|FIRST INCIDENCE | --- 189 (T) 189 (T) 189 (T) 189 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.500 P=0.002 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.500 P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.500 P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.500 P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.500 P=0.002 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.500 P<0.001 ** P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 11/05/03 EXPERIMENT: 99034 TEST: 01 Page 17
Statistical Analysis of Non-neoplastic Lesions in Mice(P16(INK4A)/(+/-) (C57BL/6)) - TRANSGENIC MODEL EVALUATION II (
BEN
Terminal Sacrifice at 27 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/15 (0%) 1/15 (7%) 0/15 (0%) 2/15 (13%) 8/15 (53%) |
|POLY-3 RATE (b) | 0/15.00 1/15.00 0/15.00 2/15.00 8/14.00 |
|POLY-3 PERCENT (g) | 0.0% 6.7% 0.0% 13.3% 57.1% |
|TERMINAL (d) | 0/15 (0%) 1/15 (7%) 0/15 (0%) 2/15 (13%) 8/14 (57%) |
|FIRST INCIDENCE | --- 188 (T) --- 188 (T) 188 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.500 (e) P=0.236 P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.500 (e) P=0.232 P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.500 (e) P=0.232 P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.500 (e) P=0.232 P<0.001 ** |
|LOGISTIC REGRESSION| (e) P=0.500 (e) P=0.236 P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.500 (e) P=0.241 P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/15 (33%) 5/15 (33%) 2/15 (13%) 3/15 (20%) 7/15 (47%) |
|POLY-3 RATE (b) | 5/15.00 5/15.00 2/15.00 3/15.00 7/15.00 |
|POLY-3 PERCENT (g) | 33.3% 33.3% 13.3% 20.0% 46.7% |
|TERMINAL (d) | 5/15 (33%) 5/15 (33%) 2/15 (13%) 3/15 (20%) 7/15 (47%) |
|FIRST INCIDENCE | 189 (T) 189 (T) 189 (T) 189 (T) 189 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.211 P=0.648 P=0.198N P=0.342N P=0.357 |
|POLY 3 | P=0.210 P=0.646 P=0.195N P=0.343N P=0.358 |
|POLY 1.5 | P=0.210 P=0.646 P=0.195N P=0.343N P=0.358 |
|POLY 6 | P=0.210 P=0.646 P=0.195N P=0.343N P=0.358 |
|LOGISTIC REGRESSION| P=0.211 P=0.648 P=0.198N P=0.342N P=0.357 |
|COCH-ARM / FISHERS | P=0.210 P=0.650N P=0.195N P=0.341N P=0.355 |
|ORDER RESTRICTED | P=0.156 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 11/05/03 EXPERIMENT: 99034 TEST: 01 Page 18
Statistical Analysis of Non-neoplastic Lesions in Mice(P16(INK4A)/(+/-) (C57BL/6)) - TRANSGENIC MODEL EVALUATION II (
BEN
Terminal Sacrifice at 27 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Spleen: Lymphoid Follicle |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 15/15 (100%) 14/15 (93%) |
|POLY-3 RATE (b) | 0/15.00 0/15.00 0/15.00 15/15.00 14/14.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 100.0% 100.0% |
|TERMINAL (d) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 15/15 (100%) 14/14 (100%) |
|FIRST INCIDENCE | --- --- --- 188 (T) 188 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** (e) (e) P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** (e) (e) P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) (e) P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Spleen: Lymphoid Follicle |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/15 (0%) 1/15 (7%) 1/15 (7%) 0/15 (0%) 1/15 (7%) |
|POLY-3 RATE (b) | 0/15.00 1/15.00 1/15.00 0/15.00 1/15.00 |
|POLY-3 PERCENT (g) | 0.0% 6.7% 6.7% 0.0% 6.7% |
|TERMINAL (d) | 0/15 (0%) 1/15 (7%) 1/15 (7%) 0/15 (0%) 1/15 (7%) |
|FIRST INCIDENCE | --- 189 (T) 189 (T) --- 189 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.500 P=0.500 P=0.500 (e) P=0.500 |
|POLY 3 | P=0.500 P=0.500 P=0.500 (e) P=0.500 |
|POLY 1.5 | P=0.500 P=0.500 P=0.500 (e) P=0.500 |
|POLY 6 | P=0.500 P=0.500 P=0.500 (e) P=0.500 |
|LOGISTIC REGRESSION| (e) P=0.500 P=0.500 (e) P=0.500 |
|COCH-ARM / FISHERS | P=0.500 P=0.500 P=0.500 (e) P=0.500 |
|ORDER RESTRICTED | P=0.312 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 11/05/03 EXPERIMENT: 99034 TEST: 01 Page 19
Statistical Analysis of Non-neoplastic Lesions in Mice(P16(INK4A)/(+/-) (C57BL/6)) - TRANSGENIC MODEL EVALUATION II (
BEN
Terminal Sacrifice at 27 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/15 (7%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 3/15 (20%) |
|POLY-3 RATE (b) | 1/15.00 0/15.00 0/15.00 0/15.00 3/15.00 |
|POLY-3 PERCENT (g) | 6.7% 0.0% 0.0% 0.0% 20.0% |
|TERMINAL (d) | 1/15 (7%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 2/14 (14%) |
|FIRST INCIDENCE | 188 (T) --- --- --- 11 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.033 * P=0.500N P=0.500N P=0.500N P=0.285 |
|POLY 3 | P=0.031 * P=0.500N P=0.500N P=0.500N P=0.298 |
|POLY 1.5 | P=0.031 * P=0.500N P=0.500N P=0.500N P=0.298 |
|POLY 6 | P=0.031 * P=0.500N P=0.500N P=0.500N P=0.298 |
|LOGISTIC REGRESSION| P=0.033 * (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.035 * P=0.500N P=0.500N P=0.500N P=0.299 |
|ORDER RESTRICTED | P=0.014 * (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/15 (7%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) |
|POLY-3 RATE (b) | 1/15.00 0/15.00 0/15.00 0/15.00 0/15.00 |
|POLY-3 PERCENT (g) | 6.7% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/15 (7%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) |
|FIRST INCIDENCE | 189 (T) --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.362N P=0.500N P=0.500N P=0.500N P=0.500N |
|POLY 3 | P=0.362N P=0.500N P=0.500N P=0.500N P=0.500N |
|POLY 1.5 | P=0.362N P=0.500N P=0.500N P=0.500N P=0.500N |
|POLY 6 | P=0.362N P=0.500N P=0.500N P=0.500N P=0.500N |
|LOGISTIC REGRESSION| P=0.362N (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.361N P=0.500N P=0.500N P=0.500N P=0.500N |
|ORDER RESTRICTED | P=0.087N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 11/05/03 EXPERIMENT: 99034 TEST: 01 Page 20
Statistical Analysis of Non-neoplastic Lesions in Mice(P16(INK4A)/(+/-) (C57BL/6)) - TRANSGENIC MODEL EVALUATION II (
BEN
Terminal Sacrifice at 27 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) |
|POLY-3 RATE (b) | 0/15.00 0/15.00 0/15.00 0/15.00 0/14.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/14 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/15 (0%) 0/15 (0%) 3/15 (20%) 0/15 (0%) 0/15 (0%) |
|POLY-3 RATE (b) | 0/15.00 0/15.00 3/15.00 0/15.00 0/15.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 20.0% 0.0% 0.0% |
|TERMINAL (d) | 0/15 (0%) 0/15 (0%) 3/15 (20%) 0/15 (0%) 0/15 (0%) |
|FIRST INCIDENCE | --- --- 189 (T) --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.418N (e) P=0.116 (e) (e) |
|POLY 3 | P=0.413N (e) P=0.106 (e) (e) |
|POLY 1.5 | P=0.413N (e) P=0.106 (e) (e) |
|POLY 6 | P=0.413N (e) P=0.106 (e) (e) |
|LOGISTIC REGRESSION| (e) (e) P=0.116 (e) (e) |
|COCH-ARM / FISHERS | P=0.417N (e) P=0.112 (e) (e) |
|ORDER RESTRICTED | P=0.278 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 11/05/03 EXPERIMENT: 99034 TEST: 01 Page 21
Statistical Analysis of Non-neoplastic Lesions in Mice(P16(INK4A)/(+/-) (C57BL/6)) - TRANSGENIC MODEL EVALUATION II (
BEN
Terminal Sacrifice at 27 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Thymus |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 7/15 (47%) 13/15 (87%) |
|POLY-3 RATE (b) | 0/15.00 0/15.00 0/15.00 7/15.00 13/14.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 46.7% 92.9% |
|TERMINAL (d) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 7/15 (47%) 13/14 (93%) |
|FIRST INCIDENCE | --- --- --- 188 (T) 188 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) P=0.005 ** P<0.001 ** |
|POLY 3 | P<0.001 ** (e) (e) P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** (e) (e) P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.005 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) P=0.003 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Thymus |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) |
|POLY-3 RATE (b) | 0/15.00 0/15.00 0/15.00 0/15.00 0/15.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 11/05/03 EXPERIMENT: 99034 TEST: 01 Page 22
Statistical Analysis of Non-neoplastic Lesions in Mice(P16(INK4A)/(+/-) (C57BL/6)) - TRANSGENIC MODEL EVALUATION II (
BEN
Terminal Sacrifice at 27 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Uterus: Endometrium |
| Hyperplasia Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | |
|POLY-3 RATE (b) | |
|POLY-3 PERCENT (g) | |
|TERMINAL (d) | |
|FIRST INCIDENCE | |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | |
|POLY 3 | |
|POLY 1.5 | |
|POLY 6 | |
|LOGISTIC REGRESSION| |
|COCH-ARM / FISHERS | |
|ORDER RESTRICTED | |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Uterus: Endometrium |
| Hyperplasia Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 12/15 (80%) 15/15 (100%) 15/15 (100%) 15/15 (100%) 14/15 (93%) |
|POLY-3 RATE (b) | 12/15.00 15/15.00 15/15.00 15/15.00 14/15.00 |
|POLY-3 PERCENT (g) | 80.0% 100.0% 100.0% 100.0% 93.3% |
|TERMINAL (d) | 12/15 (80%) 15/15 (100%) 15/15 (100%) 15/15 (100%) 14/15 (93%) |
|FIRST INCIDENCE | 189 (T) 189 (T) 189 (T) 189 (T) 189 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.359 P=0.116 P=0.116 P=0.116 P=0.299 |
|POLY 3 | P=0.354 P=0.106 P=0.106 P=0.106 P=0.298 |
|POLY 1.5 | P=0.354 P=0.106 P=0.106 P=0.106 P=0.298 |
|POLY 6 | P=0.354 P=0.106 P=0.106 P=0.106 P=0.298 |
|LOGISTIC REGRESSION| P=0.359 P=0.116 P=0.116 P=0.116 P=0.299 |
|COCH-ARM / FISHERS | P=0.358 P=0.112 P=0.112 P=0.112 P=0.299 |
|ORDER RESTRICTED | P=0.014 * (e) (e) (e) (e) |
|=================================================================================================================================|
(a) Number of tumor-bearing animals / number of animals examined at site.
(b) Number of tumor-bearing animals / Poly-3 number
(d) Observed incidence at terminal kill.
(f) Beneath the control incidence are the P-values associated with the trend
test. Beneath the dosed group incidence are the P-values corresponding to
pairwise comparisons between the controls and that dosed group. The life
table analysis regards tumors in animals dying prior to terminal kill as
being (directly or indirectly) the cause of death.
Logistic regression is an alternative
method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage
and Fishers exact tests compare directly the overall incidence rates
For all tests a negative trend is indicated by N
(e) Value of Statistic cannot be computed.
(g) Poly-3 adjusted lifetime tumor incidence.
(I) Interim sacrifice
(T) Terminal sacrifice
# Tumor rates based on number of animals necropsied.
* To the right of any statistical result, indicates significance at (P<=0.05).
** To the right of any statistical result, indicates significance at (P<=0.01).