TDMS Study 99035-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus TRANSGENIC MODEL EVALUATION II (GLYCIDOL) DATE: 04/14/04
EXPERIMENT: 99035 TEST: 01 TIME: 10:53:58
TEST TYPE: 26-39 WEEKS CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-65406 ROUTE: GAVAGE NTP C#: C99035
PATHOLOGIST: MISSING CAS: 556-52-5
------------------------------------------------------------------------------------------------------------------------------------
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 (GLYCIDOL) DATE: 04/14/04
EXPERIMENT: 99035 TEST: 01 TIME: 10:53:58
TEST TYPE: 26-39 WEEKS CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-65406 ROUTE: GAVAGE NTP C#: C99035
PATHOLOGIST: MISSING CAS: 556-52-5
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF TRANSGENIC MODEL EVALUATION II (GLY
===============================================================
Male Mice
------------
Organ Morphology
----- ----------
Brain: Cerebellum Gliosis
Neuronopathy
Brain: Cerebrum Necrosis Focal
Brain: Medulla Gliosis
Neuronopathy
Brain: Thalamus Gliosis
Neuronopathy
Heart: Myocardium Degeneration
Mineralization
Necrosis
Liver Inflammation Chronic
Necrosis Focal
Spleen Atrophy
Stomach, Forestomach Ulcer
Stomach, Forestomach: Epithelium Hyperplasia
Stomach, Glandular Mineralization
Thymus Atrophy
===============================================================
Female Mice
------------
Organ Morphology
----- ----------
Adrenal Cortex: Subcapsular Hyperplasia
Brain: Cerebellum Neuronopathy
Brain: Medulla Gliosis
Neuronopathy
Brain: Thalamus Neuronopathy
Kidney: Renal Tubule Accumulation, Hyaline Droplet
Liver Angiectasis Focal
Necrosis Focal
Lung Inflammation
Lymph Node: Mediastinal Hyperplasia Lymphoid
Ovary Cyst
Spleen Hematopoietic Cell Proliferation
Stomach, Forestomach: Epithelium Hyperplasia
Stomach, Glandular Mineralization
Stomach, Glandular: Muscularis Mineralization
Thymus Atrophy
===============================================================
Date: 04/14/04 EXPERIMENT: 99035 TEST: 01 Page 1
Statistical Analysis of Non-neoplastic Lesions in Mice(P16(INK4A)/(+/-) (C57BL/6)) - TRANSGENIC MODEL EVALUATION II
(GLY
Terminal Sacrifice at 40 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/15 (7%) 0/15 (0%) 0/15 (0%) 1/14 (7%) 0/15 (0%) |
|POLY-3 RATE (b) | 1/13.95 0/14.74 0/13.80 1/14.00 0/11.42 |
|POLY-3 PERCENT (g) | 7.2% 0.0% 0.0% 7.1% 0.0% |
|TERMINAL (d) | 1/13 (8%) 0/14 (0%) 0/13 (0%) 1/14 (7%) 0/7 (0%) |
|FIRST INCIDENCE | 280 (T) --- --- 280 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.617N P=0.485N P=0.500N P=0.748N P=0.623N |
|POLY 3 | P=0.533N P=0.489N P=0.502N P=0.760N P=0.540N |
|POLY 1.5 | P=0.522N P=0.493N P=0.502N P=0.755 P=0.522N |
|POLY 6 | P=0.545N P=0.485N P=0.500N P=0.752N P=0.562N |
|LOGISTIC REGRESSION| P=0.617N (e) (e) P=0.748N (e) |
|COCH-ARM / FISHERS | P=0.503N P=0.500N P=0.500N P=0.741 P=0.500N |
|ORDER RESTRICTED | P=0.271N (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/15 (0%) 2/15 (13%) 0/15 (0%) 0/15 (0%) 1/15 (7%) |
|POLY-3 RATE (b) | 0/13.88 2/14.62 0/14.15 0/14.62 1/12.41 |
|POLY-3 PERCENT (g) | 0.0% 13.7% 0.0% 0.0% 8.1% |
|TERMINAL (d) | 0/13 (0%) 2/14 (14%) 0/12 (0%) 0/14 (0%) 1/9 (11%) |
|FIRST INCIDENCE | --- 281 (T) --- --- 281 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.503 P=0.252 (e) (e) P=0.427 |
|POLY 3 | P=0.566 P=0.243 (e) (e) P=0.478 |
|POLY 1.5 | P=0.576 P=0.243 (e) (e) P=0.488 |
|POLY 6 | P=0.556 P=0.242 (e) (e) P=0.466 |
|LOGISTIC REGRESSION| (e) P=0.252 (e) (e) P=0.427 |
|COCH-ARM / FISHERS | P=0.583 P=0.241 (e) (e) P=0.500 |
|ORDER RESTRICTED | P=0.277 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 99035 TEST: 01 Page 2
Statistical Analysis of Non-neoplastic Lesions in Mice(P16(INK4A)/(+/-) (C57BL/6)) - TRANSGENIC MODEL EVALUATION II (
GLY
Terminal Sacrifice at 40 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Adrenal Cortex: Subcapsular |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/15 (7%) 2/15 (13%) 2/15 (13%) 3/14 (21%) 1/15 (7%) |
|POLY-3 RATE (b) | 1/13.95 2/14.74 2/13.80 3/14.00 1/11.42 |
|POLY-3 PERCENT (g) | 7.2% 13.6% 14.5% 21.4% 8.8% |
|TERMINAL (d) | 1/13 (8%) 2/14 (14%) 2/13 (15%) 3/14 (21%) 1/7 (14%) |
|FIRST INCIDENCE | 280 (T) 280 (T) 280 (T) 280 (T) 280 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.408 P=0.527 P=0.500 P=0.325 P=0.620 |
|POLY 3 | P=0.499 P=0.519 P=0.496 P=0.298 P=0.715 |
|POLY 1.5 | P=0.560 P=0.512 P=0.496 P=0.288 P=0.736 |
|POLY 6 | P=0.423 P=0.527 P=0.499 P=0.311 P=0.686 |
|LOGISTIC REGRESSION| P=0.408 P=0.527 P=0.500 P=0.325 P=0.620 |
|COCH-ARM / FISHERS | P=0.556N P=0.500 P=0.500 P=0.272 P=0.759N |
|ORDER RESTRICTED | P=0.480 (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Adrenal Cortex: Subcapsular |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 15/15 (100%) 15/15 (100%) 10/15 (67%) 14/15 (93%) 15/15 (100%) |
|POLY-3 RATE (b) | 15/15.00 15/15.00 10/14.59 14/15.00 15/15.00 |
|POLY-3 PERCENT (g) | 100.0% 100.0% 68.6% 93.3% 100.0% |
|TERMINAL (d) | 13/13 (100%) 14/14 (100%) 9/12 (75%) 13/14 (93%) 9/9 (100%) |
|FIRST INCIDENCE | 83 239 232 239 133 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.017 * (e) P=0.097N P=0.309N (e) |
|POLY 3 | P=0.396 (e) P=0.020N* P=0.500N (e) |
|POLY 1.5 | P=0.384 (e) P=0.018N* P=0.500N (e) |
|POLY 6 | P=0.414 (e) P=0.025N* P=0.500N (e) |
|LOGISTIC REGRESSION| P=0.392 (e) P=0.025N* (e) (e) |
|COCH-ARM / FISHERS | P=0.382 (e) P=0.021N* P=0.500N (e) |
|ORDER RESTRICTED | P=0.115N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 99035 TEST: 01 Page 3
Statistical Analysis of Non-neoplastic Lesions in Mice(P16(INK4A)/(+/-) (C57BL/6)) - TRANSGENIC MODEL EVALUATION II (
GLY
Terminal Sacrifice at 40 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Brain: Cerebellum |
| Gliosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 2/15 (13%) |
|POLY-3 RATE (b) | 0/13.95 0/14.74 0/13.80 0/14.37 2/12.20 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 16.4% |
|TERMINAL (d) | 0/13 (0%) 0/14 (0%) 0/13 (0%) 0/14 (0%) 0/7 (0%) |
|FIRST INCIDENCE | --- --- --- --- 210 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.013 * (e) (e) (e) P=0.192 |
|POLY 3 | P=0.016 * (e) (e) (e) P=0.200 |
|POLY 1.5 | P=0.017 * (e) (e) (e) P=0.213 |
|POLY 6 | P=0.016 * (e) (e) (e) P=0.185 |
|LOGISTIC REGRESSION| P=0.053 (e) (e) (e) P=0.345 |
|COCH-ARM / FISHERS | P=0.021 * (e) (e) (e) P=0.241 |
|ORDER RESTRICTED | P=0.009 ** (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Brain: Cerebellum |
| Gliosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 1/15 (7%) |
|POLY-3 RATE (b) | 0/13.88 0/14.62 0/14.15 0/14.62 1/13.01 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 7.7% |
|TERMINAL (d) | 0/13 (0%) 0/14 (0%) 0/12 (0%) 0/14 (0%) 0/9 (0%) |
|FIRST INCIDENCE | --- --- --- --- 208 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.129 (e) (e) (e) P=0.485 |
|POLY 3 | P=0.135 (e) (e) (e) P=0.487 |
|POLY 1.5 | P=0.138 (e) (e) (e) P=0.494 |
|POLY 6 | P=0.132 (e) (e) (e) P=0.480 |
|LOGISTIC REGRESSION| P=0.177 (e) (e) (e) P=0.498 |
|COCH-ARM / FISHERS | P=0.143 (e) (e) (e) P=0.500 |
|ORDER RESTRICTED | P=0.077 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 99035 TEST: 01 Page 4
Statistical Analysis of Non-neoplastic Lesions in Mice(P16(INK4A)/(+/-) (C57BL/6)) - TRANSGENIC MODEL EVALUATION II (
GLY
Terminal Sacrifice at 40 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Brain: Cerebellum |
| Neuronopathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 3/15 (20%) |
|POLY-3 RATE (b) | 0/13.95 0/14.74 0/13.80 0/14.37 3/12.93 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 23.2% |
|TERMINAL (d) | 0/13 (0%) 0/14 (0%) 0/13 (0%) 0/14 (0%) 0/7 (0%) |
|FIRST INCIDENCE | --- --- --- --- 181 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.002 ** (e) (e) (e) P=0.099 |
|POLY 3 | P=0.002 ** (e) (e) (e) P=0.090 |
|POLY 1.5 | P=0.002 ** (e) (e) (e) P=0.097 |
|POLY 6 | P=0.002 ** (e) (e) (e) P=0.082 |
|LOGISTIC REGRESSION| P=0.019 * (e) (e) (e) P=0.277 |
|COCH-ARM / FISHERS | P=0.003 ** (e) (e) (e) P=0.112 |
|ORDER RESTRICTED | P=0.002 ** (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Brain: Cerebellum |
| Neuronopathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 1/15 (7%) 3/15 (20%) |
|POLY-3 RATE (b) | 0/13.88 0/14.62 0/14.15 1/14.62 3/13.90 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 6.8% 21.6% |
|TERMINAL (d) | 0/13 (0%) 0/14 (0%) 0/12 (0%) 1/14 (7%) 1/9 (11%) |
|FIRST INCIDENCE | --- --- --- 281 (T) 133 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.003 ** (e) (e) P=0.515 P=0.102 |
|POLY 3 | P=0.004 ** (e) (e) P=0.510 P=0.105 |
|POLY 1.5 | P=0.004 ** (e) (e) P=0.510 P=0.108 |
|POLY 6 | P=0.004 ** (e) (e) P=0.509 P=0.100 |
|LOGISTIC REGRESSION| P=0.012 * (e) (e) P=0.515 P=0.104 |
|COCH-ARM / FISHERS | P=0.005 ** (e) (e) P=0.500 P=0.112 |
|ORDER RESTRICTED | P=0.008 ** (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 99035 TEST: 01 Page 5
Statistical Analysis of Non-neoplastic Lesions in Mice(P16(INK4A)/(+/-) (C57BL/6)) - TRANSGENIC MODEL EVALUATION II (
GLY
Terminal Sacrifice at 40 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Brain: Cerebrum |
| Necrosis Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 2/15 (13%) |
|POLY-3 RATE (b) | 0/13.95 0/14.74 0/13.80 0/14.37 2/12.04 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 16.6% |
|TERMINAL (d) | 0/13 (0%) 0/14 (0%) 0/13 (0%) 0/14 (0%) 0/7 (0%) |
|FIRST INCIDENCE | --- --- --- --- 210 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.011 * (e) (e) (e) P=0.180 |
|POLY 3 | P=0.016 * (e) (e) (e) P=0.197 |
|POLY 1.5 | P=0.017 * (e) (e) (e) P=0.211 |
|POLY 6 | P=0.016 * (e) (e) (e) P=0.180 |
|LOGISTIC REGRESSION| P=0.046 * (e) (e) (e) P=0.306 |
|COCH-ARM / FISHERS | P=0.021 * (e) (e) (e) P=0.241 |
|ORDER RESTRICTED | P=0.009 ** (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Brain: Cerebrum |
| Necrosis Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) |
|POLY-3 RATE (b) | 0/13.88 0/14.62 0/14.15 0/14.62 0/12.41 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/13 (0%) 0/14 (0%) 0/12 (0%) 0/14 (0%) 0/9 (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: 04/14/04 EXPERIMENT: 99035 TEST: 01 Page 6
Statistical Analysis of Non-neoplastic Lesions in Mice(P16(INK4A)/(+/-) (C57BL/6)) - TRANSGENIC MODEL EVALUATION II (
GLY
Terminal Sacrifice at 40 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Brain: Medulla |
| Gliosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 2/15 (13%) |
|POLY-3 RATE (b) | 0/13.95 0/14.74 0/13.80 0/14.37 2/12.73 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 15.7% |
|TERMINAL (d) | 0/13 (0%) 0/14 (0%) 0/13 (0%) 0/14 (0%) 0/7 (0%) |
|FIRST INCIDENCE | --- --- --- --- 181 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.021 * (e) (e) (e) P=0.232 |
|POLY 3 | P=0.017 * (e) (e) (e) P=0.209 |
|POLY 1.5 | P=0.018 * (e) (e) (e) P=0.219 |
|POLY 6 | P=0.016 * (e) (e) (e) P=0.195 |
|LOGISTIC REGRESSION| P=0.062 (e) (e) (e) P=0.476 |
|COCH-ARM / FISHERS | P=0.021 * (e) (e) (e) P=0.241 |
|ORDER RESTRICTED | P=0.010 * (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Brain: Medulla |
| Gliosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 2/15 (13%) |
|POLY-3 RATE (b) | 0/13.88 0/14.62 0/14.15 0/14.62 2/13.31 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 15.0% |
|TERMINAL (d) | 0/13 (0%) 0/14 (0%) 0/12 (0%) 0/14 (0%) 1/9 (11%) |
|FIRST INCIDENCE | --- --- --- --- 133 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.015 * (e) (e) (e) P=0.207 |
|POLY 3 | P=0.018 * (e) (e) (e) P=0.221 |
|POLY 1.5 | P=0.018 * (e) (e) (e) P=0.229 |
|POLY 6 | P=0.017 * (e) (e) (e) P=0.210 |
|LOGISTIC REGRESSION| P=0.037 * (e) (e) (e) P=0.225 |
|COCH-ARM / FISHERS | P=0.021 * (e) (e) (e) P=0.241 |
|ORDER RESTRICTED | P=0.012 * (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 99035 TEST: 01 Page 7
Statistical Analysis of Non-neoplastic Lesions in Mice(P16(INK4A)/(+/-) (C57BL/6)) - TRANSGENIC MODEL EVALUATION II (
GLY
Terminal Sacrifice at 40 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Brain: Medulla |
| Neuronopathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 3/15 (20%) |
|POLY-3 RATE (b) | 0/13.95 0/14.74 0/13.80 0/14.37 3/12.93 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 23.2% |
|TERMINAL (d) | 0/13 (0%) 0/14 (0%) 0/13 (0%) 0/14 (0%) 0/7 (0%) |
|FIRST INCIDENCE | --- --- --- --- 181 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.002 ** (e) (e) (e) P=0.099 |
|POLY 3 | P=0.002 ** (e) (e) (e) P=0.090 |
|POLY 1.5 | P=0.002 ** (e) (e) (e) P=0.097 |
|POLY 6 | P=0.002 ** (e) (e) (e) P=0.082 |
|LOGISTIC REGRESSION| P=0.019 * (e) (e) (e) P=0.277 |
|COCH-ARM / FISHERS | P=0.003 ** (e) (e) (e) P=0.112 |
|ORDER RESTRICTED | P=0.002 ** (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Brain: Medulla |
| Neuronopathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 3/15 (20%) |
|POLY-3 RATE (b) | 0/13.88 0/14.62 0/14.15 0/14.62 3/14.02 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 21.4% |
|TERMINAL (d) | 0/13 (0%) 0/14 (0%) 0/12 (0%) 0/14 (0%) 1/9 (11%) |
|FIRST INCIDENCE | --- --- --- --- 133 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.002 ** (e) (e) (e) P=0.106 |
|POLY 3 | P=0.002 ** (e) (e) (e) P=0.106 |
|POLY 1.5 | P=0.002 ** (e) (e) (e) P=0.110 |
|POLY 6 | P=0.002 ** (e) (e) (e) P=0.101 |
|LOGISTIC REGRESSION| P=0.007 ** (e) (e) (e) P=0.099 |
|COCH-ARM / FISHERS | P=0.003 ** (e) (e) (e) P=0.112 |
|ORDER RESTRICTED | P=0.003 ** (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 99035 TEST: 01 Page 8
Statistical Analysis of Non-neoplastic Lesions in Mice(P16(INK4A)/(+/-) (C57BL/6)) - TRANSGENIC MODEL EVALUATION II (
GLY
Terminal Sacrifice at 40 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Brain: Thalamus |
| Gliosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 2/15 (13%) |
|POLY-3 RATE (b) | 0/13.95 0/14.74 0/13.80 0/14.37 2/12.59 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 15.9% |
|TERMINAL (d) | 0/13 (0%) 0/14 (0%) 0/13 (0%) 0/14 (0%) 0/7 (0%) |
|FIRST INCIDENCE | --- --- --- --- 208 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.020 * (e) (e) (e) P=0.232 |
|POLY 3 | P=0.017 * (e) (e) (e) P=0.207 |
|POLY 1.5 | P=0.018 * (e) (e) (e) P=0.217 |
|POLY 6 | P=0.016 * (e) (e) (e) P=0.194 |
|LOGISTIC REGRESSION| P=0.065 (e) (e) (e) P=0.475 |
|COCH-ARM / FISHERS | P=0.021 * (e) (e) (e) P=0.241 |
|ORDER RESTRICTED | P=0.010 * (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Brain: Thalamus |
| Gliosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 1/15 (7%) |
|POLY-3 RATE (b) | 0/13.88 0/14.62 0/14.15 0/14.62 1/13.12 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 7.6% |
|TERMINAL (d) | 0/13 (0%) 0/14 (0%) 0/12 (0%) 0/14 (0%) 0/9 (0%) |
|FIRST INCIDENCE | --- --- --- --- 186 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.138 (e) (e) (e) P=0.500 |
|POLY 3 | P=0.136 (e) (e) (e) P=0.489 |
|POLY 1.5 | P=0.139 (e) (e) (e) P=0.495 |
|POLY 6 | P=0.133 (e) (e) (e) P=0.481 |
|LOGISTIC REGRESSION| P=0.170 (e) (e) (e) P=0.481 |
|COCH-ARM / FISHERS | P=0.143 (e) (e) (e) P=0.500 |
|ORDER RESTRICTED | P=0.079 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 99035 TEST: 01 Page 9
Statistical Analysis of Non-neoplastic Lesions in Mice(P16(INK4A)/(+/-) (C57BL/6)) - TRANSGENIC MODEL EVALUATION II (
GLY
Terminal Sacrifice at 40 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Brain: Thalamus |
| Neuronopathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 5/15 (33%) |
|POLY-3 RATE (b) | 0/13.95 0/14.74 0/13.80 0/14.37 5/13.56 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 36.9% |
|TERMINAL (d) | 0/13 (0%) 0/14 (0%) 0/13 (0%) 0/14 (0%) 0/7 (0%) |
|FIRST INCIDENCE | --- --- --- --- 181 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) P=0.022 * |
|POLY 3 | P<0.001 ** (e) (e) (e) P=0.014 * |
|POLY 1.5 | P<0.001 ** (e) (e) (e) P=0.015 * |
|POLY 6 | P<0.001 ** (e) (e) (e) P=0.012 * |
|LOGISTIC REGRESSION| P<0.001 ** (e) (e) (e) P=0.077 |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) P=0.021 * |
|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 |
|=================================================================================================================================|
| |
|Brain: Thalamus |
| Neuronopathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 3/15 (20%) |
|POLY-3 RATE (b) | 0/13.88 0/14.62 0/14.15 0/14.62 3/14.61 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 20.5% |
|TERMINAL (d) | 0/13 (0%) 0/14 (0%) 0/12 (0%) 0/14 (0%) 0/9 (0%) |
|FIRST INCIDENCE | --- --- --- --- 133 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.003 ** (e) (e) (e) P=0.124 |
|POLY 3 | P=0.002 ** (e) (e) (e) P=0.115 |
|POLY 1.5 | P=0.002 ** (e) (e) (e) P=0.115 |
|POLY 6 | P=0.002 ** (e) (e) (e) P=0.113 |
|LOGISTIC REGRESSION| P=0.003 ** (e) (e) (e) P=0.074 |
|COCH-ARM / FISHERS | P=0.003 ** (e) (e) (e) P=0.112 |
|ORDER RESTRICTED | P=0.003 ** (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 99035 TEST: 01 Page 10
Statistical Analysis of Non-neoplastic Lesions in Mice(P16(INK4A)/(+/-) (C57BL/6)) - TRANSGENIC MODEL EVALUATION II (
GLY
Terminal Sacrifice at 40 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Heart: Myocardium |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/15 (13%) 0/15 (0%) 0/15 (0%) 2/15 (13%) 0/15 (0%) |
|POLY-3 RATE (b) | 2/15.00 0/14.74 0/13.80 2/14.37 0/11.42 |
|POLY-3 PERCENT (g) | 13.3% 0.0% 0.0% 13.9% 0.0% |
|TERMINAL (d) | 0/13 (0%) 0/14 (0%) 0/13 (0%) 2/14 (14%) 0/7 (0%) |
|FIRST INCIDENCE | 196 --- --- 280 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.453N P=0.232N P=0.247N P=0.680N P=0.285N |
|POLY 3 | P=0.420N P=0.236N P=0.251N P=0.683 P=0.298N |
|POLY 1.5 | P=0.393N P=0.234N P=0.244N P=0.689 P=0.268N |
|POLY 6 | P=0.452N P=0.239N P=0.257N P=0.677 P=0.339N |
|LOGISTIC REGRESSION| P=0.243N (e) P=0.121N P=0.667 P=0.049N* |
|COCH-ARM / FISHERS | P=0.358N P=0.241N P=0.241N P=0.701N P=0.241N |
|ORDER RESTRICTED | P=0.129N (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Heart: Myocardium |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) |
|POLY-3 RATE (b) | 0/13.88 0/14.62 0/14.15 0/14.62 0/12.41 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/13 (0%) 0/14 (0%) 0/12 (0%) 0/14 (0%) 0/9 (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: 04/14/04 EXPERIMENT: 99035 TEST: 01 Page 11
Statistical Analysis of Non-neoplastic Lesions in Mice(P16(INK4A)/(+/-) (C57BL/6)) - TRANSGENIC MODEL EVALUATION II (
GLY
Terminal Sacrifice at 40 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Heart: Myocardium |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/15 (0%) 0/15 (0%) 2/15 (13%) 1/15 (7%) 5/15 (33%) |
|POLY-3 RATE (b) | 0/13.95 0/14.74 2/14.66 1/14.37 5/13.21 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 13.6% 7.0% 37.9% |
|TERMINAL (d) | 0/13 (0%) 0/14 (0%) 1/13 (8%) 1/14 (7%) 0/7 (0%) |
|FIRST INCIDENCE | --- --- 146 280 (T) 208 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) P=0.240 P=0.515 P=0.019 * |
|POLY 3 | P<0.001 ** (e) P=0.243 P=0.506 P=0.012 * |
|POLY 1.5 | P<0.001 ** (e) P=0.238 P=0.503 P=0.014 * |
|POLY 6 | P<0.001 ** (e) P=0.247 P=0.509 P=0.011 * |
|LOGISTIC REGRESSION| P=0.015 * (e) P=0.292 P=0.515 P=0.054 |
|COCH-ARM / FISHERS | P=0.002 ** (e) P=0.241 P=0.500 P=0.021 * |
|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 |
|=================================================================================================================================|
| |
|Heart: Myocardium |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/15 (7%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) |
|POLY-3 RATE (b) | 1/13.88 0/14.62 0/14.15 0/14.62 0/12.41 |
|POLY-3 PERCENT (g) | 7.2% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/13 (8%) 0/14 (0%) 0/12 (0%) 0/14 (0%) 0/9 (0%) |
|FIRST INCIDENCE | 281 (T) --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.397N P=0.485N P=0.516N P=0.485N P=0.573N |
|POLY 3 | P=0.342N P=0.490N P=0.496N P=0.490N P=0.522N |
|POLY 1.5 | P=0.353N P=0.490N P=0.494N P=0.490N P=0.512N |
|POLY 6 | P=0.329N P=0.491N P=0.501N P=0.491N P=0.534N |
|LOGISTIC REGRESSION| P=0.397N (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=0.107N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 99035 TEST: 01 Page 12
Statistical Analysis of Non-neoplastic Lesions in Mice(P16(INK4A)/(+/-) (C57BL/6)) - TRANSGENIC MODEL EVALUATION II (
GLY
Terminal Sacrifice at 40 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Heart: Myocardium |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 2/15 (13%) |
|POLY-3 RATE (b) | 0/13.95 0/14.74 0/13.80 0/14.37 2/11.66 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 17.2% |
|TERMINAL (d) | 0/13 (0%) 0/14 (0%) 0/13 (0%) 0/14 (0%) 0/7 (0%) |
|FIRST INCIDENCE | --- --- --- --- 260 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.007 ** (e) (e) (e) P=0.152 |
|POLY 3 | P=0.016 * (e) (e) (e) P=0.190 |
|POLY 1.5 | P=0.017 * (e) (e) (e) P=0.207 |
|POLY 6 | P=0.015 * (e) (e) (e) P=0.171 |
|LOGISTIC REGRESSION| P=0.018 * (e) (e) (e) P=0.189 |
|COCH-ARM / FISHERS | P=0.021 * (e) (e) (e) P=0.241 |
|ORDER RESTRICTED | P=0.008 ** (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Heart: Myocardium |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) |
|POLY-3 RATE (b) | 0/13.88 0/14.62 0/14.15 0/14.62 0/12.41 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/13 (0%) 0/14 (0%) 0/12 (0%) 0/14 (0%) 0/9 (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: 04/14/04 EXPERIMENT: 99035 TEST: 01 Page 13
Statistical Analysis of Non-neoplastic Lesions in Mice(P16(INK4A)/(+/-) (C57BL/6)) - TRANSGENIC MODEL EVALUATION II (
GLY
Terminal Sacrifice at 40 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/15 (27%) 5/15 (33%) 5/15 (33%) 4/15 (27%) 4/15 (27%) |
|POLY-3 RATE (b) | 4/13.95 5/15.00 5/13.80 4/14.37 4/11.42 |
|POLY-3 PERCENT (g) | 28.7% 33.3% 36.2% 27.8% 35.0% |
|TERMINAL (d) | 4/13 (31%) 4/14 (29%) 5/13 (39%) 4/14 (29%) 4/7 (57%) |
|FIRST INCIDENCE | 280 (T) 253 280 (T) 280 (T) 280 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.261 P=0.556 P=0.500 P=0.615N P=0.257 |
|POLY 3 | P=0.512 P=0.551 P=0.493 P=0.639N P=0.534 |
|POLY 1.5 | P=0.549N P=0.530 P=0.491 P=0.647N P=0.590 |
|POLY 6 | P=0.432 P=0.574 P=0.499 P=0.629N P=0.455 |
|LOGISTIC REGRESSION| P=0.380 P=0.534 P=0.500 P=0.615N P=0.257 |
|COCH-ARM / FISHERS | P=0.464N P=0.500 P=0.500 P=0.659N P=0.659N |
|ORDER RESTRICTED | P=0.638 (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) | 12/15 (80%) 12/15 (80%) 10/15 (67%) 14/15 (93%) 9/15 (60%) |
|POLY-3 RATE (b) | 12/14.86 12/15.00 10/14.15 14/15.00 9/13.49 |
|POLY-3 PERCENT (g) | 80.8% 80.0% 70.7% 93.3% 66.7% |
|TERMINAL (d) | 11/13 (85%) 11/14 (79%) 10/12 (83%) 13/14 (93%) 6/9 (67%) |
|FIRST INCIDENCE | 83 239 281 (T) 239 186 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.347 P=0.524N P=0.470N P=0.486 P=0.605 |
|POLY 3 | P=0.348N P=0.655N P=0.420N P=0.317 P=0.336N |
|POLY 1.5 | P=0.298N P=0.662N P=0.384N P=0.308 P=0.294N |
|POLY 6 | P=0.378N P=0.640N P=0.472N P=0.334 P=0.364N |
|LOGISTIC REGRESSION| P=0.245N P=0.654 P=0.326N P=0.280 P=0.226N |
|COCH-ARM / FISHERS | P=0.195N P=0.674N P=0.341N P=0.299 P=0.213N |
|ORDER RESTRICTED | P=0.292N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 99035 TEST: 01 Page 14
Statistical Analysis of Non-neoplastic Lesions in Mice(P16(INK4A)/(+/-) (C57BL/6)) - TRANSGENIC MODEL EVALUATION II (
GLY
Terminal Sacrifice at 40 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Accumulation, Hyaline Droplet |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/15 (0%) 0/15 (0%) 1/15 (7%) 0/15 (0%) 1/15 (7%) |
|POLY-3 RATE (b) | 0/13.95 0/14.74 1/14.14 0/14.37 1/11.62 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 7.1% 0.0% 8.6% |
|TERMINAL (d) | 0/13 (0%) 0/14 (0%) 0/13 (0%) 0/14 (0%) 0/7 (0%) |
|FIRST INCIDENCE | --- --- 244 --- 260 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.228 (e) P=0.515 (e) P=0.427 |
|POLY 3 | P=0.263 (e) P=0.503 (e) P=0.464 |
|POLY 1.5 | P=0.281 (e) P=0.500 (e) P=0.479 |
|POLY 6 | P=0.244 (e) P=0.508 (e) P=0.444 |
|LOGISTIC REGRESSION| P=0.382 (e) P=0.538 (e) P=0.506 |
|COCH-ARM / FISHERS | P=0.306 (e) P=0.500 (e) P=0.500 |
|ORDER RESTRICTED | P=0.185 (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Accumulation, Hyaline Droplet |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/15 (0%) 0/15 (0%) 2/15 (13%) 1/15 (7%) 3/15 (20%) |
|POLY-3 RATE (b) | 0/13.88 0/14.62 2/14.59 1/14.62 3/13.48 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 13.7% 6.8% 22.3% |
|TERMINAL (d) | 0/13 (0%) 0/14 (0%) 1/12 (8%) 1/14 (7%) 0/9 (0%) |
|FIRST INCIDENCE | --- --- 232 281 (T) 186 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.022 * (e) P=0.238 P=0.515 P=0.100 |
|POLY 3 | P=0.030 * (e) P=0.243 P=0.510 P=0.099 |
|POLY 1.5 | P=0.032 * (e) P=0.242 P=0.510 P=0.103 |
|POLY 6 | P=0.029 * (e) P=0.241 P=0.509 P=0.096 |
|LOGISTIC REGRESSION| P=0.054 (e) P=0.201 P=0.515 P=0.117 |
|COCH-ARM / FISHERS | P=0.035 * (e) P=0.241 P=0.500 P=0.112 |
|ORDER RESTRICTED | P=0.026 * (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 99035 TEST: 01 Page 15
Statistical Analysis of Non-neoplastic Lesions in Mice(P16(INK4A)/(+/-) (C57BL/6)) - TRANSGENIC MODEL EVALUATION II (
GLY
Terminal Sacrifice at 40 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Angiectasis Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 1/15 (7%) |
|POLY-3 RATE (b) | 0/13.95 0/14.74 0/13.80 0/14.37 1/11.42 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 8.8% |
|TERMINAL (d) | 0/13 (0%) 0/14 (0%) 0/13 (0%) 0/14 (0%) 1/7 (14%) |
|FIRST INCIDENCE | --- --- --- --- 280 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.074 (e) (e) (e) P=0.377 |
|POLY 3 | P=0.123 (e) (e) (e) P=0.460 |
|POLY 1.5 | P=0.132 (e) (e) (e) P=0.478 |
|POLY 6 | P=0.114 (e) (e) (e) P=0.437 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) P=0.377 |
|COCH-ARM / FISHERS | P=0.143 (e) (e) (e) P=0.500 |
|ORDER RESTRICTED | P=0.061 (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Angiectasis Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 1/15 (7%) 2/15 (13%) |
|POLY-3 RATE (b) | 0/13.88 0/14.62 0/14.15 1/14.62 2/12.44 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 6.8% 16.1% |
|TERMINAL (d) | 0/13 (0%) 0/14 (0%) 0/12 (0%) 1/14 (7%) 1/9 (11%) |
|FIRST INCIDENCE | --- --- --- 281 (T) 278 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.015 * (e) (e) P=0.515 P=0.183 |
|POLY 3 | P=0.023 * (e) (e) P=0.510 P=0.205 |
|POLY 1.5 | P=0.025 * (e) (e) P=0.510 P=0.217 |
|POLY 6 | P=0.021 * (e) (e) P=0.509 P=0.194 |
|LOGISTIC REGRESSION| P=0.018 * (e) (e) P=0.515 P=0.188 |
|COCH-ARM / FISHERS | P=0.030 * (e) (e) P=0.500 P=0.241 |
|ORDER RESTRICTED | P=0.033 * (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 99035 TEST: 01 Page 16
Statistical Analysis of Non-neoplastic Lesions in Mice(P16(INK4A)/(+/-) (C57BL/6)) - TRANSGENIC MODEL EVALUATION II (
GLY
Terminal Sacrifice at 40 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/15 (0%) 1/15 (7%) 0/15 (0%) 2/15 (13%) 1/15 (7%) |
|POLY-3 RATE (b) | 0/13.95 1/14.74 0/13.80 2/14.37 1/11.95 |
|POLY-3 PERCENT (g) | 0.0% 6.8% 0.0% 13.9% 8.4% |
|TERMINAL (d) | 0/13 (0%) 1/14 (7%) 0/13 (0%) 2/14 (14%) 0/7 (0%) |
|FIRST INCIDENCE | --- 280 (T) --- 280 (T) 217 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.171 P=0.515 (e) P=0.252 P=0.469 |
|POLY 3 | P=0.224 P=0.511 (e) P=0.238 P=0.469 |
|POLY 1.5 | P=0.254 P=0.507 (e) P=0.235 P=0.482 |
|POLY 6 | P=0.190 P=0.515 (e) P=0.242 P=0.452 |
|LOGISTIC REGRESSION| P=0.322 P=0.515 (e) P=0.252 P=0.688 |
|COCH-ARM / FISHERS | P=0.293 P=0.500 (e) P=0.241 P=0.500 |
|ORDER RESTRICTED | P=0.198 (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/15 (13%) 3/15 (20%) 1/15 (7%) 1/15 (7%) 2/15 (13%) |
|POLY-3 RATE (b) | 2/13.88 3/14.62 1/14.15 1/14.62 2/12.44 |
|POLY-3 PERCENT (g) | 14.4% 20.5% 7.1% 6.8% 16.1% |
|TERMINAL (d) | 2/13 (15%) 3/14 (21%) 1/12 (8%) 1/14 (7%) 1/9 (11%) |
|FIRST INCIDENCE | 281 (T) 281 (T) 281 (T) 281 (T) 278 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.567 P=0.536 P=0.529N P=0.473N P=0.577 |
|POLY 3 | P=0.521N P=0.524 P=0.493N P=0.482N P=0.659 |
|POLY 1.5 | P=0.512N P=0.523 P=0.489N P=0.483N P=0.679 |
|POLY 6 | P=0.528N P=0.522 P=0.502N P=0.484N P=0.638 |
|LOGISTIC REGRESSION| P=0.596N P=0.536 P=0.529N P=0.473N P=0.626 |
|COCH-ARM / FISHERS | P=0.500N P=0.500 P=0.500N P=0.500N P=0.701N |
|ORDER RESTRICTED | P=0.494N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 99035 TEST: 01 Page 17
Statistical Analysis of Non-neoplastic Lesions in Mice(P16(INK4A)/(+/-) (C57BL/6)) - TRANSGENIC MODEL EVALUATION II (
GLY
Terminal Sacrifice at 40 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Infiltration Cellular Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/15 (7%) 2/15 (13%) 0/15 (0%) 2/15 (13%) 1/15 (7%) |
|POLY-3 RATE (b) | 1/14.34 2/14.74 0/13.80 2/14.37 1/11.42 |
|POLY-3 PERCENT (g) | 7.0% 13.6% 0.0% 13.9% 8.8% |
|TERMINAL (d) | 0/13 (0%) 2/14 (14%) 0/13 (0%) 2/14 (14%) 1/7 (14%) |
|FIRST INCIDENCE | 237 280 (T) --- 280 (T) 280 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.441 P=0.525 P=0.500N P=0.517 P=0.651 |
|POLY 3 | P=0.514 P=0.510 P=0.508N P=0.501 P=0.708 |
|POLY 1.5 | P=0.560 P=0.507 P=0.505N P=0.501 P=0.732 |
|POLY 6 | P=0.456 P=0.511 P=0.510N P=0.500 P=0.674 |
|LOGISTIC REGRESSION| P=0.580 P=0.414 P=0.448N P=0.483 P=0.768N |
|COCH-ARM / FISHERS | P=0.618 P=0.500 P=0.500N P=0.500 P=0.759N |
|ORDER RESTRICTED | P=0.596 (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Infiltration Cellular Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/15 (0%) 3/15 (20%) 1/15 (7%) 1/15 (7%) 1/15 (7%) |
|POLY-3 RATE (b) | 0/13.88 3/14.62 1/14.15 1/14.62 1/12.41 |
|POLY-3 PERCENT (g) | 0.0% 20.5% 7.1% 6.8% 8.1% |
|TERMINAL (d) | 0/13 (0%) 3/14 (21%) 1/12 (8%) 1/14 (7%) 1/9 (11%) |
|FIRST INCIDENCE | --- 281 (T) 281 (T) 281 (T) 281 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.569 P=0.128 P=0.484 P=0.515 P=0.427 |
|POLY 3 | P=0.581N P=0.115 P=0.504 P=0.510 P=0.478 |
|POLY 1.5 | P=0.569N P=0.115 P=0.506 P=0.510 P=0.488 |
|POLY 6 | P=0.593N P=0.114 P=0.499 P=0.509 P=0.466 |
|LOGISTIC REGRESSION| (e) P=0.128 P=0.484 P=0.515 P=0.427 |
|COCH-ARM / FISHERS | P=0.560N P=0.112 P=0.500 P=0.500 P=0.500 |
|ORDER RESTRICTED | P=0.295 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 99035 TEST: 01 Page 18
Statistical Analysis of Non-neoplastic Lesions in Mice(P16(INK4A)/(+/-) (C57BL/6)) - TRANSGENIC MODEL EVALUATION II (
GLY
Terminal Sacrifice at 40 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) | 6/15 (40%) 9/15 (60%) 8/15 (53%) 9/15 (60%) 2/15 (13%) |
|POLY-3 RATE (b) | 6/13.95 9/14.74 8/13.80 9/15.00 2/11.95 |
|POLY-3 PERCENT (g) | 43.0% 61.1% 58.0% 60.0% 16.7% |
|TERMINAL (d) | 6/13 (46%) 9/14 (64%) 8/13 (62%) 8/14 (57%) 1/7 (14%) |
|FIRST INCIDENCE | 280 (T) 280 (T) 280 (T) 201 217 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.263N P=0.291 P=0.350 P=0.304 P=0.361N |
|POLY 3 | P=0.070N P=0.278 P=0.343 P=0.296 P=0.152N |
|POLY 1.5 | P=0.046N* P=0.261 P=0.344 P=0.270 P=0.129N |
|POLY 6 | P=0.111N P=0.295 P=0.350 P=0.329 P=0.188N |
|LOGISTIC REGRESSION| P=0.084N P=0.291 P=0.350 P=0.241 P=0.185N |
|COCH-ARM / FISHERS | P=0.030N* P=0.233 P=0.358 P=0.233 P=0.107N |
|ORDER RESTRICTED | P=0.036N* (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) | 11/15 (73%) 10/15 (67%) 8/15 (53%) 8/15 (53%) 7/15 (47%) |
|POLY-3 RATE (b) | 11/13.88 10/15.00 8/14.15 8/14.62 7/12.44 |
|POLY-3 PERCENT (g) | 79.2% 66.7% 56.5% 54.7% 56.3% |
|TERMINAL (d) | 11/13 (85%) 9/14 (64%) 8/12 (67%) 8/14 (57%) 6/9 (67%) |
|FIRST INCIDENCE | 281 (T) 239 281 (T) 281 (T) 278 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.418N P=0.379N P=0.285N P=0.132N P=0.531N |
|POLY 3 | P=0.167N P=0.370N P=0.184N P=0.158N P=0.191N |
|POLY 1.5 | P=0.132N P=0.394N P=0.179N P=0.165N P=0.149N |
|POLY 6 | P=0.207N P=0.351N P=0.206N P=0.160N P=0.248N |
|LOGISTIC REGRESSION| P=0.232N P=0.410N P=0.285N P=0.132N P=0.307N |
|COCH-ARM / FISHERS | P=0.092N P=0.500N P=0.225N P=0.225N P=0.132N |
|ORDER RESTRICTED | P=0.184N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 99035 TEST: 01 Page 19
Statistical Analysis of Non-neoplastic Lesions in Mice(P16(INK4A)/(+/-) (C57BL/6)) - TRANSGENIC MODEL EVALUATION II (
GLY
Terminal Sacrifice at 40 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Necrosis Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/15 (7%) 2/15 (13%) 2/15 (13%) 0/15 (0%) 5/15 (33%) |
|POLY-3 RATE (b) | 1/14.61 2/15.00 2/15.00 0/14.37 5/13.56 |
|POLY-3 PERCENT (g) | 6.9% 13.3% 13.3% 0.0% 36.9% |
|TERMINAL (d) | 0/13 (0%) 1/14 (7%) 0/13 (0%) 0/14 (0%) 0/7 (0%) |
|FIRST INCIDENCE | 196 253 146 --- 181 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.028 * P=0.525 P=0.501 P=0.500N P=0.075 |
|POLY 3 | P=0.035 * P=0.509 P=0.509 P=0.503N P=0.062 |
|POLY 1.5 | P=0.038 * P=0.505 P=0.505 P=0.502N P=0.069 |
|POLY 6 | P=0.033 * P=0.515 P=0.515 P=0.503N P=0.054 |
|LOGISTIC REGRESSION| P=0.452 P=0.170 P=0.381 (e) P=0.349 |
|COCH-ARM / FISHERS | P=0.046 * P=0.500 P=0.500 P=0.500N P=0.084 |
|ORDER RESTRICTED | P=0.013 * (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Necrosis Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/15 (0%) 0/15 (0%) 5/15 (33%) 2/15 (13%) 2/15 (13%) |
|POLY-3 RATE (b) | 0/13.88 0/14.62 5/14.98 2/14.62 2/13.46 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 33.4% 13.7% 14.9% |
|TERMINAL (d) | 0/13 (0%) 0/14 (0%) 3/12 (25%) 2/14 (14%) 0/9 (0%) |
|FIRST INCIDENCE | --- --- 232 281 (T) 186 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.182 (e) P=0.030 * P=0.252 P=0.223 |
|POLY 3 | P=0.231 (e) P=0.022 * P=0.243 P=0.223 |
|POLY 1.5 | P=0.243 (e) P=0.021 * P=0.243 P=0.228 |
|POLY 6 | P=0.223 (e) P=0.023 * P=0.242 P=0.219 |
|LOGISTIC REGRESSION| P=0.324 (e) P=0.019 * P=0.252 P=0.231 |
|COCH-ARM / FISHERS | P=0.265 (e) P=0.021 * P=0.241 P=0.241 |
|ORDER RESTRICTED | P=0.070 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 99035 TEST: 01 Page 20
Statistical Analysis of Non-neoplastic Lesions in Mice(P16(INK4A)/(+/-) (C57BL/6)) - TRANSGENIC MODEL EVALUATION II (
GLY
Terminal Sacrifice at 40 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Lung |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/15 (20%) 7/15 (47%) 5/15 (33%) 4/15 (27%) 2/15 (13%) |
|POLY-3 RATE (b) | 3/13.95 7/14.74 5/13.80 4/14.37 2/11.42 |
|POLY-3 PERCENT (g) | 21.5% 47.5% 36.2% 27.8% 17.5% |
|TERMINAL (d) | 3/13 (23%) 7/14 (50%) 5/13 (39%) 4/14 (29%) 2/7 (29%) |
|FIRST INCIDENCE | 280 (T) 280 (T) 280 (T) 280 (T) 280 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.442N P=0.152 P=0.338 P=0.545 P=0.604 |
|POLY 3 | P=0.230N P=0.141 P=0.334 P=0.518 P=0.596N |
|POLY 1.5 | P=0.187N P=0.133 P=0.334 P=0.510 P=0.554N |
|POLY 6 | P=0.287N P=0.149 P=0.338 P=0.528 P=0.650N |
|LOGISTIC REGRESSION| P=0.442N P=0.152 P=0.338 P=0.545 P=0.604 |
|COCH-ARM / FISHERS | P=0.138N P=0.123 P=0.341 P=0.500 P=0.500N |
|ORDER RESTRICTED | P=0.307N (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Lung |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 8/15 (53%) 8/15 (53%) 7/15 (47%) 5/15 (33%) 3/15 (20%) |
|POLY-3 RATE (b) | 8/13.88 8/15.00 7/14.15 5/14.62 3/12.44 |
|POLY-3 PERCENT (g) | 57.6% 53.3% 49.5% 34.2% 24.1% |
|TERMINAL (d) | 8/13 (62%) 7/14 (50%) 7/12 (58%) 5/14 (36%) 2/9 (22%) |
|FIRST INCIDENCE | 281 (T) 239 281 (T) 281 (T) 278 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.081N P=0.558N P=0.595N P=0.174N P=0.206N |
|POLY 3 | P=0.033N* P=0.555N P=0.479N P=0.191N P=0.083N |
|POLY 1.5 | P=0.026N* P=0.571N P=0.467N P=0.194N P=0.068N |
|POLY 6 | P=0.042N* P=0.543N P=0.508N P=0.193N P=0.102N |
|LOGISTIC REGRESSION| P=0.040N* P=0.592N P=0.595N P=0.174N P=0.125N |
|COCH-ARM / FISHERS | P=0.019N* P=0.642N P=0.500N P=0.231N P=0.064N |
|ORDER RESTRICTED | P=0.070N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 99035 TEST: 01 Page 21
Statistical Analysis of Non-neoplastic Lesions in Mice(P16(INK4A)/(+/-) (C57BL/6)) - TRANSGENIC MODEL EVALUATION II (
GLY
Terminal Sacrifice at 40 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%) 2/15 (13%) 0/15 (0%) 2/15 (13%) 2/15 (13%) |
|POLY-3 RATE (b) | 0/13.95 2/14.74 0/13.80 2/14.37 2/11.42 |
|POLY-3 PERCENT (g) | 0.0% 13.6% 0.0% 13.9% 17.5% |
|TERMINAL (d) | 0/13 (0%) 2/14 (14%) 0/13 (0%) 2/14 (14%) 2/7 (29%) |
|FIRST INCIDENCE | --- 280 (T) --- 280 (T) 280 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.056 P=0.252 (e) P=0.252 P=0.112 |
|POLY 3 | P=0.128 P=0.244 (e) P=0.238 P=0.186 |
|POLY 1.5 | P=0.150 P=0.239 (e) P=0.235 P=0.205 |
|POLY 6 | P=0.103 P=0.249 (e) P=0.242 P=0.163 |
|LOGISTIC REGRESSION| (e) P=0.252 (e) P=0.252 P=0.112 |
|COCH-ARM / FISHERS | P=0.183 P=0.241 (e) P=0.241 P=0.241 |
|ORDER RESTRICTED | P=0.110 (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%) 2/15 (13%) 1/15 (7%) 0/15 (0%) 1/15 (7%) |
|POLY-3 RATE (b) | 1/13.88 2/14.62 1/14.15 0/14.62 1/12.41 |
|POLY-3 PERCENT (g) | 7.2% 13.7% 7.1% 0.0% 8.1% |
|TERMINAL (d) | 1/13 (8%) 2/14 (14%) 1/12 (8%) 0/14 (0%) 1/9 (11%) |
|FIRST INCIDENCE | 281 (T) 281 (T) 281 (T) --- 281 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.544N P=0.527 P=0.747 P=0.485N P=0.680 |
|POLY 3 | P=0.437N P=0.518 P=0.757N P=0.490N P=0.736 |
|POLY 1.5 | P=0.435N P=0.517 P=0.754N P=0.490N P=0.748 |
|POLY 6 | P=0.438N P=0.516 P=0.760 P=0.491N P=0.722 |
|LOGISTIC REGRESSION| P=0.544N P=0.527 P=0.747 (e) P=0.680 |
|COCH-ARM / FISHERS | P=0.435N P=0.500 P=0.759N P=0.500N P=0.759N |
|ORDER RESTRICTED | P=0.452N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 99035 TEST: 01 Page 22
Statistical Analysis of Non-neoplastic Lesions in Mice(P16(INK4A)/(+/-) (C57BL/6)) - TRANSGENIC MODEL EVALUATION II (
GLY
Terminal Sacrifice at 40 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) | 0/15 (0%) 2/15 (13%) 0/15 (0%) 1/15 (7%) 0/15 (0%) |
|POLY-3 RATE (b) | 0/13.95 2/14.74 0/13.80 1/14.37 0/11.42 |
|POLY-3 PERCENT (g) | 0.0% 13.6% 0.0% 7.0% 0.0% |
|TERMINAL (d) | 0/13 (0%) 2/14 (14%) 0/13 (0%) 1/14 (7%) 0/7 (0%) |
|FIRST INCIDENCE | --- 280 (T) --- 280 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.551N P=0.252 (e) P=0.515 (e) |
|POLY 3 | P=0.450N P=0.244 (e) P=0.506 (e) |
|POLY 1.5 | P=0.436N P=0.239 (e) P=0.503 (e) |
|POLY 6 | P=0.467N P=0.249 (e) P=0.509 (e) |
|LOGISTIC REGRESSION| (e) P=0.252 (e) P=0.515 (e) |
|COCH-ARM / FISHERS | P=0.417N P=0.241 (e) P=0.500 (e) |
|ORDER RESTRICTED | P=0.360N (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) | 1/15 (7%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 1/15 (7%) |
|POLY-3 RATE (b) | 1/13.88 0/14.62 0/14.15 0/14.62 1/12.41 |
|POLY-3 PERCENT (g) | 7.2% 0.0% 0.0% 0.0% 8.1% |
|TERMINAL (d) | 1/13 (8%) 0/14 (0%) 0/12 (0%) 0/14 (0%) 1/9 (11%) |
|FIRST INCIDENCE | 281 (T) --- --- --- 281 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.430 P=0.485N P=0.516N P=0.485N P=0.680 |
|POLY 3 | P=0.478 P=0.490N P=0.496N P=0.490N P=0.736 |
|POLY 1.5 | P=0.484 P=0.490N P=0.494N P=0.490N P=0.748 |
|POLY 6 | P=0.474 P=0.491N P=0.501N P=0.491N P=0.722 |
|LOGISTIC REGRESSION| P=0.430 (e) (e) (e) P=0.680 |
|COCH-ARM / FISHERS | P=0.500 P=0.500N P=0.500N P=0.500N P=0.759N |
|ORDER RESTRICTED | P=0.305 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 99035 TEST: 01 Page 23
Statistical Analysis of Non-neoplastic Lesions in Mice(P16(INK4A)/(+/-) (C57BL/6)) - TRANSGENIC MODEL EVALUATION II (
GLY
Terminal Sacrifice at 40 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/15 (0%) 2/15 (13%) 0/15 (0%) 1/14 (7%) 1/15 (7%) |
|POLY-3 RATE (b) | 0/13.95 2/14.74 0/13.80 1/14.00 1/11.42 |
|POLY-3 PERCENT (g) | 0.0% 13.6% 0.0% 7.1% 8.8% |
|TERMINAL (d) | 0/13 (0%) 2/14 (14%) 0/13 (0%) 1/14 (7%) 1/7 (14%) |
|FIRST INCIDENCE | --- 280 (T) --- 280 (T) 280 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.334 P=0.252 (e) P=0.515 P=0.377 |
|POLY 3 | P=0.424 P=0.244 (e) P=0.501 P=0.460 |
|POLY 1.5 | P=0.455 P=0.239 (e) P=0.495 P=0.478 |
|POLY 6 | P=0.385 P=0.249 (e) P=0.507 P=0.437 |
|LOGISTIC REGRESSION| (e) P=0.252 (e) P=0.515 P=0.377 |
|COCH-ARM / FISHERS | P=0.496 P=0.241 (e) P=0.483 P=0.500 |
|ORDER RESTRICTED | P=0.326 (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 1/15 (7%) 0/15 (0%) |
|POLY-3 RATE (b) | 0/13.88 0/14.62 0/14.15 1/14.62 0/12.41 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 6.8% 0.0% |
|TERMINAL (d) | 0/13 (0%) 0/14 (0%) 0/12 (0%) 1/14 (7%) 0/9 (0%) |
|FIRST INCIDENCE | --- --- --- 281 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.603 (e) (e) P=0.515 (e) |
|POLY 3 | P=0.560 (e) (e) P=0.510 (e) |
|POLY 1.5 | P=0.591 (e) (e) P=0.510 (e) |
|POLY 6 | P=0.529 (e) (e) P=0.509 (e) |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.515 (e) |
|COCH-ARM / FISHERS | P=0.639 (e) (e) P=0.500 (e) |
|ORDER RESTRICTED | P=0.388 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 99035 TEST: 01 Page 24
Statistical Analysis of Non-neoplastic Lesions in Mice(P16(INK4A)/(+/-) (C57BL/6)) - TRANSGENIC MODEL EVALUATION II (
GLY
Terminal Sacrifice at 40 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Lymph Node: Mediastinal |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/14 (0%) 1/14 (7%) 0/15 (0%) 0/13 (0%) 0/13 (0%) |
|POLY-3 RATE (b) | 0/12.95 1/13.74 0/13.80 0/12.37 0/9.42 |
|POLY-3 PERCENT (g) | 0.0% 7.3% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/12 (0%) 1/13 (8%) 0/13 (0%) 0/12 (0%) 0/5 (0%) |
|FIRST INCIDENCE | --- 280 (T) --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.620N P=0.516 (e) (e) (e) |
|POLY 3 | P=0.469N P=0.512 (e) (e) (e) |
|POLY 1.5 | P=0.491N P=0.507 (e) (e) (e) |
|POLY 6 | P=0.435N P=0.516 (e) (e) (e) |
|LOGISTIC REGRESSION| (e) P=0.516 (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.515N P=0.500 (e) (e) (e) |
|ORDER RESTRICTED | P=0.455N (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Lymph Node: Mediastinal |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/13 (15%) 1/15 (7%) 0/15 (0%) 0/13 (0%) 0/14 (0%) |
|POLY-3 RATE (b) | 2/11.88 1/14.62 0/14.15 0/12.62 0/11.41 |
|POLY-3 PERCENT (g) | 16.8% 6.8% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/11 (18%) 1/14 (7%) 0/12 (0%) 0/12 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 281 (T) 281 (T) --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.130N P=0.413N P=0.216N P=0.216N P=0.307N |
|POLY 3 | P=0.101N P=0.426N P=0.190N P=0.216N P=0.238N |
|POLY 1.5 | P=0.104N P=0.428N P=0.189N P=0.217N P=0.225N |
|POLY 6 | P=0.098N P=0.428N P=0.195N P=0.217N P=0.253N |
|LOGISTIC REGRESSION| P=0.130N P=0.413N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.106N P=0.444N P=0.206N P=0.240N P=0.222N |
|ORDER RESTRICTED | P=0.047N* (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 99035 TEST: 01 Page 25
Statistical Analysis of Non-neoplastic Lesions in Mice(P16(INK4A)/(+/-) (C57BL/6)) - TRANSGENIC MODEL EVALUATION II (
GLY
Terminal Sacrifice at 40 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) | 4/15 (27%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 2/15 (13%) |
|POLY-3 RATE (b) | 4/13.88 0/14.62 0/14.15 0/14.62 2/13.12 |
|POLY-3 PERCENT (g) | 28.8% 0.0% 0.0% 0.0% 15.2% |
|TERMINAL (d) | 4/13 (31%) 0/14 (0%) 0/12 (0%) 0/14 (0%) 1/9 (11%) |
|FIRST INCIDENCE | 281 (T) --- --- --- 186 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.603N P=0.047N* P=0.064N P=0.047N* P=0.484N |
|POLY 3 | P=0.504N P=0.038N* P=0.042N* P=0.038N* P=0.353N |
|POLY 1.5 | P=0.508N P=0.039N* P=0.041N* P=0.039N* P=0.337N |
|POLY 6 | P=0.496N P=0.039N* P=0.044N* P=0.039N* P=0.372N |
|LOGISTIC REGRESSION| P=0.477N (e) (e) (e) P=0.330N |
|COCH-ARM / FISHERS | P=0.500N P=0.050N P=0.050N P=0.050N P=0.326N |
|ORDER RESTRICTED | P=0.011N* (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 99035 TEST: 01 Page 26
Statistical Analysis of Non-neoplastic Lesions in Mice(P16(INK4A)/(+/-) (C57BL/6)) - TRANSGENIC MODEL EVALUATION II (
GLY
Terminal Sacrifice at 40 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/14 (0%) 0/15 (0%) 0/15 (0%) |
|POLY-3 RATE (b) | 0/13.95 0/14.74 0/12.80 0/14.37 0/11.42 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/13 (0%) 0/14 (0%) 0/12 (0%) 0/14 (0%) 0/7 (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 |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/15 (7%) 1/15 (7%) 2/15 (13%) 1/15 (7%) 0/15 (0%) |
|POLY-3 RATE (b) | 1/13.88 1/14.62 2/14.15 1/14.62 0/12.41 |
|POLY-3 PERCENT (g) | 7.2% 6.8% 14.1% 6.8% 0.0% |
|TERMINAL (d) | 1/13 (8%) 1/14 (7%) 2/12 (17%) 1/14 (7%) 0/9 (0%) |
|FIRST INCIDENCE | 281 (T) 281 (T) 281 (T) 281 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.335N P=0.748N P=0.471 P=0.748N P=0.573N |
|POLY 3 | P=0.290N P=0.749N P=0.507 P=0.749N P=0.522N |
|POLY 1.5 | P=0.277N P=0.750N P=0.511 P=0.750N P=0.512N |
|POLY 6 | P=0.303N P=0.751N P=0.498 P=0.751N P=0.534N |
|LOGISTIC REGRESSION| P=0.335N P=0.748N P=0.471 P=0.748N (e) |
|COCH-ARM / FISHERS | P=0.256N P=0.759N P=0.500 P=0.759N P=0.500N |
|ORDER RESTRICTED | P=0.328N (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 99035 TEST: 01 Page 27
Statistical Analysis of Non-neoplastic Lesions in Mice(P16(INK4A)/(+/-) (C57BL/6)) - TRANSGENIC MODEL EVALUATION II (
GLY
Terminal Sacrifice at 40 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Spleen |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 1/15 (7%) 2/15 (13%) |
|POLY-3 RATE (b) | 0/13.95 0/14.74 0/13.80 1/15.00 2/12.48 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 6.7% 16.0% |
|TERMINAL (d) | 0/13 (0%) 0/14 (0%) 0/13 (0%) 0/14 (0%) 0/7 (0%) |
|FIRST INCIDENCE | --- --- --- 201 217 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.023 * (e) (e) P=0.514 P=0.197 |
|POLY 3 | P=0.023 * (e) (e) P=0.514 P=0.205 |
|POLY 1.5 | P=0.026 * (e) (e) P=0.509 P=0.216 |
|POLY 6 | P=0.020 * (e) (e) P=0.521 P=0.192 |
|LOGISTIC REGRESSION| P=0.109 (e) (e) P=0.425 P=0.434 |
|COCH-ARM / FISHERS | P=0.030 * (e) (e) P=0.500 P=0.241 |
|ORDER RESTRICTED | P=0.033 * (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Spleen |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) |
|POLY-3 RATE (b) | 0/13.88 0/14.62 0/14.15 0/14.62 0/12.41 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/13 (0%) 0/14 (0%) 0/12 (0%) 0/14 (0%) 0/9 (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: 04/14/04 EXPERIMENT: 99035 TEST: 01 Page 28
Statistical Analysis of Non-neoplastic Lesions in Mice(P16(INK4A)/(+/-) (C57BL/6)) - TRANSGENIC MODEL EVALUATION II (
GLY
Terminal Sacrifice at 40 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) | 4/15 (27%) 7/15 (47%) 7/15 (47%) 5/15 (33%) 5/15 (33%) |
|POLY-3 RATE (b) | 4/15.00 7/15.00 7/15.00 5/14.37 5/12.79 |
|POLY-3 PERCENT (g) | 26.7% 46.7% 46.7% 34.8% 39.1% |
|TERMINAL (d) | 2/13 (15%) 6/14 (43%) 5/13 (39%) 5/14 (36%) 2/7 (29%) |
|FIRST INCIDENCE | 196 253 146 280 (T) 208 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.283 P=0.295 P=0.256 P=0.538 P=0.283 |
|POLY 3 | P=0.504 P=0.227 P=0.227 P=0.470 P=0.388 |
|POLY 1.5 | P=0.557N P=0.227 P=0.227 P=0.482 P=0.434 |
|POLY 6 | P=0.429 P=0.227 P=0.227 P=0.459 P=0.335 |
|LOGISTIC REGRESSION| P=0.291N (e) (e) P=0.464 P=0.625N |
|COCH-ARM / FISHERS | P=0.466N P=0.225 P=0.225 P=0.500 P=0.500 |
|ORDER RESTRICTED | P=0.372 (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) | 9/15 (60%) 5/15 (33%) 10/15 (67%) 10/15 (67%) 10/15 (67%) |
|POLY-3 RATE (b) | 9/15.00 5/15.00 10/15.00 10/14.62 10/14.41 |
|POLY-3 PERCENT (g) | 60.0% 33.3% 66.7% 68.4% 69.4% |
|TERMINAL (d) | 7/13 (54%) 4/14 (29%) 7/12 (58%) 10/14 (71%) 5/9 (56%) |
|FIRST INCIDENCE | 83 239 232 281 (T) 133 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.046 * P=0.135N P=0.434 P=0.585 P=0.235 |
|POLY 3 | P=0.134 P=0.136N P=0.500 P=0.463 P=0.442 |
|POLY 1.5 | P=0.152 P=0.136N P=0.500 P=0.480 P=0.465 |
|POLY 6 | P=0.117 P=0.136N P=0.500 P=0.440 P=0.418 |
|LOGISTIC REGRESSION| P=0.254 (e) (e) P=0.468 P=0.574 |
|COCH-ARM / FISHERS | P=0.181 P=0.136N P=0.500 P=0.500 P=0.500 |
|ORDER RESTRICTED | P=0.169 (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 99035 TEST: 01 Page 29
Statistical Analysis of Non-neoplastic Lesions in Mice(P16(INK4A)/(+/-) (C57BL/6)) - TRANSGENIC MODEL EVALUATION II (
GLY
Terminal Sacrifice at 40 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/15 (0%) 1/15 (7%) 0/15 (0%) 0/15 (0%) 3/15 (20%) |
|POLY-3 RATE (b) | 0/13.95 1/15.00 0/13.80 0/14.37 3/12.19 |
|POLY-3 PERCENT (g) | 0.0% 6.7% 0.0% 0.0% 24.6% |
|TERMINAL (d) | 0/13 (0%) 0/14 (0%) 0/13 (0%) 0/14 (0%) 1/7 (14%) |
|FIRST INCIDENCE | --- 253 --- --- 181 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.009 ** P=0.529 (e) (e) P=0.066 |
|POLY 3 | P=0.017 * P=0.514 (e) (e) P=0.080 |
|POLY 1.5 | P=0.018 * P=0.509 (e) (e) P=0.091 |
|POLY 6 | P=0.017 * P=0.521 (e) (e) P=0.067 |
|LOGISTIC REGRESSION| P=0.054 P=0.372 (e) (e) P=0.155 |
|COCH-ARM / FISHERS | P=0.023 * P=0.500 (e) (e) P=0.112 |
|ORDER RESTRICTED | P=0.005 ** (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) |
|POLY-3 RATE (b) | 0/13.88 0/14.62 0/14.15 0/14.62 0/12.41 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/13 (0%) 0/14 (0%) 0/12 (0%) 0/14 (0%) 0/9 (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: 04/14/04 EXPERIMENT: 99035 TEST: 01 Page 30
Statistical Analysis of Non-neoplastic Lesions in Mice(P16(INK4A)/(+/-) (C57BL/6)) - TRANSGENIC MODEL EVALUATION II (
GLY
Terminal Sacrifice at 40 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Stomach, Forestomach: Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/15 (0%) 1/15 (7%) 1/15 (7%) 0/15 (0%) 6/15 (40%) |
|POLY-3 RATE (b) | 0/13.95 1/15.00 1/14.14 0/14.37 6/13.56 |
|POLY-3 PERCENT (g) | 0.0% 6.7% 7.1% 0.0% 44.3% |
|TERMINAL (d) | 0/13 (0%) 0/14 (0%) 0/13 (0%) 0/14 (0%) 1/7 (14%) |
|FIRST INCIDENCE | --- 253 244 --- 181 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.529 P=0.515 (e) P=0.009 ** |
|POLY 3 | P<0.001 ** P=0.514 P=0.503 (e) P=0.004 ** |
|POLY 1.5 | P<0.001 ** P=0.509 P=0.500 (e) P=0.004 ** |
|POLY 6 | P<0.001 ** P=0.521 P=0.508 (e) P=0.003 ** |
|LOGISTIC REGRESSION| P=0.005 ** P=0.372 P=0.538 (e) P=0.031 * |
|COCH-ARM / FISHERS | P<0.001 ** P=0.500 P=0.500 (e) P=0.008 ** |
|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 |
|=================================================================================================================================|
| |
|Stomach, Forestomach: Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 1/15 (7%) 4/15 (27%) |
|POLY-3 RATE (b) | 0/13.88 0/14.62 0/14.15 1/14.62 4/13.12 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 6.8% 30.5% |
|TERMINAL (d) | 0/13 (0%) 0/14 (0%) 0/12 (0%) 1/14 (7%) 3/9 (33%) |
|FIRST INCIDENCE | --- --- --- 281 (T) 186 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) P=0.515 P=0.031 * |
|POLY 3 | P<0.001 ** (e) (e) P=0.510 P=0.037 * |
|POLY 1.5 | P<0.001 ** (e) (e) P=0.510 P=0.041 * |
|POLY 6 | P<0.001 ** (e) (e) P=0.509 P=0.033 * |
|LOGISTIC REGRESSION| P<0.001 ** (e) (e) P=0.515 P=0.055 |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) P=0.500 P=0.050 |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 99035 TEST: 01 Page 31
Statistical Analysis of Non-neoplastic Lesions in Mice(P16(INK4A)/(+/-) (C57BL/6)) - TRANSGENIC MODEL EVALUATION II (
GLY
Terminal Sacrifice at 40 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 10/15 (67%) 0/15 (0%) 0/15 (0%) 5/15 (33%) 1/15 (7%) |
|POLY-3 RATE (b) | 10/13.95 0/14.74 0/13.80 5/14.37 1/11.42 |
|POLY-3 PERCENT (g) | 71.7% 0.0% 0.0% 34.8% 8.8% |
|TERMINAL (d) | 10/13 (77%) 0/14 (0%) 0/13 (0%) 5/14 (36%) 1/7 (14%) |
|FIRST INCIDENCE | 280 (T) --- --- 280 (T) 280 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.120N P<0.001N** P<0.001N** P=0.042N* P=0.015N* |
|POLY 3 | P=0.028N* P<0.001N** P<0.001N** P=0.047N* P<0.001N** |
|POLY 1.5 | P=0.020N* P<0.001N** P<0.001N** P=0.054N P<0.001N** |
|POLY 6 | P=0.040N* P<0.001N** P<0.001N** P=0.040N* P<0.001N** |
|LOGISTIC REGRESSION| P=0.120N (e) (e) P=0.042N* P=0.015N* |
|COCH-ARM / FISHERS | P=0.036N* P<0.001N** P<0.001N** P=0.072N P<0.001N** |
|ORDER RESTRICTED | P<0.001N** (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/15 (27%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 2/15 (13%) |
|POLY-3 RATE (b) | 4/13.88 0/14.62 0/14.15 0/14.62 2/12.41 |
|POLY-3 PERCENT (g) | 28.8% 0.0% 0.0% 0.0% 16.1% |
|TERMINAL (d) | 4/13 (31%) 0/14 (0%) 0/12 (0%) 0/14 (0%) 2/9 (22%) |
|FIRST INCIDENCE | 281 (T) --- --- --- 281 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.625N P=0.047N* P=0.064N P=0.047N* P=0.517N |
|POLY 3 | P=0.496N P=0.038N* P=0.042N* P=0.038N* P=0.381N |
|POLY 1.5 | P=0.505N P=0.039N* P=0.041N* P=0.039N* P=0.354N |
|POLY 6 | P=0.483N P=0.039N* P=0.044N* P=0.039N* P=0.411N |
|LOGISTIC REGRESSION| P=0.625N (e) (e) (e) P=0.517N |
|COCH-ARM / FISHERS | P=0.500N P=0.050N P=0.050N P=0.050N P=0.326N |
|ORDER RESTRICTED | P=0.013N* (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 99035 TEST: 01 Page 32
Statistical Analysis of Non-neoplastic Lesions in Mice(P16(INK4A)/(+/-) (C57BL/6)) - TRANSGENIC MODEL EVALUATION II (
GLY
Terminal Sacrifice at 40 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Stomach, Glandular: Muscularis |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 1/15 (7%) 0/15 (0%) |
|POLY-3 RATE (b) | 0/13.95 0/14.74 0/13.80 1/14.37 0/11.42 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 7.0% 0.0% |
|TERMINAL (d) | 0/13 (0%) 0/14 (0%) 0/13 (0%) 1/14 (7%) 0/7 (0%) |
|FIRST INCIDENCE | --- --- --- 280 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.580 (e) (e) P=0.515 (e) |
|POLY 3 | P=0.512 (e) (e) P=0.506 (e) |
|POLY 1.5 | P=0.570 (e) (e) P=0.503 (e) |
|POLY 6 | P=0.431 (e) (e) P=0.509 (e) |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.515 (e) |
|COCH-ARM / FISHERS | P=0.639 (e) (e) P=0.500 (e) |
|ORDER RESTRICTED | P=0.387 (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Stomach, Glandular: Muscularis |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 2/15 (13%) |
|POLY-3 RATE (b) | 0/13.88 0/14.62 0/14.15 0/14.62 2/12.41 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 16.1% |
|TERMINAL (d) | 0/13 (0%) 0/14 (0%) 0/12 (0%) 0/14 (0%) 2/9 (22%) |
|FIRST INCIDENCE | --- --- --- --- 281 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.009 ** (e) (e) (e) P=0.157 |
|POLY 3 | P=0.017 * (e) (e) (e) P=0.205 |
|POLY 1.5 | P=0.017 * (e) (e) (e) P=0.217 |
|POLY 6 | P=0.016 * (e) (e) (e) P=0.193 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) P=0.157 |
|COCH-ARM / FISHERS | P=0.021 * (e) (e) (e) P=0.241 |
|ORDER RESTRICTED | P=0.010 * (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 99035 TEST: 01 Page 33
Statistical Analysis of Non-neoplastic Lesions in Mice(P16(INK4A)/(+/-) (C57BL/6)) - TRANSGENIC MODEL EVALUATION II (
GLY
Terminal Sacrifice at 40 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 200 |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Thymus |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/15 (13%) 0/15 (0%) 1/15 (7%) 0/15 (0%) 4/15 (27%) |
|POLY-3 RATE (b) | 2/15.00 0/14.74 1/14.66 0/14.37 4/12.77 |
|POLY-3 PERCENT (g) | 13.3% 0.0% 6.8% 0.0% 31.3% |
|TERMINAL (d) | 0/13 (0%) 0/14 (0%) 0/13 (0%) 0/14 (0%) 0/7 (0%) |
|FIRST INCIDENCE | 196 --- 146 --- 210 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.039 * P=0.232N P=0.508N P=0.240N P=0.231 |
|POLY 3 | P=0.048 * P=0.236N P=0.508N P=0.241N P=0.249 |
|POLY 1.5 | P=0.051 P=0.234N P=0.504N P=0.238N P=0.280 |
|POLY 6 | P=0.046 * P=0.239N P=0.514N P=0.245N P=0.217 |
|LOGISTIC REGRESSION| P=0.367 (e) (e) P=0.207N P=0.662 |
|COCH-ARM / FISHERS | P=0.061 P=0.241N P=0.500N P=0.241N P=0.326 |
|ORDER RESTRICTED | P=0.013 * (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%) 2/15 (13%) 0/15 (0%) 1/15 (7%) 3/15 (20%) |
|POLY-3 RATE (b) | 0/13.88 2/15.00 0/14.15 1/14.62 3/14.05 |
|POLY-3 PERCENT (g) | 0.0% 13.3% 0.0% 6.8% 21.4% |
|TERMINAL (d) | 0/13 (0%) 1/14 (7%) 0/12 (0%) 1/14 (7%) 0/9 (0%) |
|FIRST INCIDENCE | --- 239 --- 281 (T) 186 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.047 * P=0.256 (e) P=0.515 P=0.111 |
|POLY 3 | P=0.066 P=0.250 (e) P=0.510 P=0.107 |
|POLY 1.5 | P=0.066 P=0.246 (e) P=0.510 P=0.108 |
|POLY 6 | P=0.067 P=0.252 (e) P=0.509 P=0.107 |
|LOGISTIC REGRESSION| P=0.105 P=0.197 (e) P=0.515 P=0.108 |
|COCH-ARM / FISHERS | P=0.066 P=0.241 (e) P=0.500 P=0.112 |
|ORDER RESTRICTED | P=0.028 * (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 04/14/04 EXPERIMENT: 99035 TEST: 01 Page 34
Statistical Analysis of Non-neoplastic Lesions in Mice(P16(INK4A)/(+/-) (C57BL/6)) - TRANSGENIC MODEL EVALUATION II (
GLY
Terminal Sacrifice at 40 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) | 13/15 (87%) 14/15 (93%) 10/15 (67%) 14/15 (93%) 9/15 (60%) |
|POLY-3 RATE (b) | 13/13.88 14/14.62 10/14.15 14/15.00 9/12.44 |
|POLY-3 PERCENT (g) | 93.6% 95.8% 70.7% 93.3% 72.3% |
|TERMINAL (d) | 13/13 (100%) 14/14 (100%) 10/12 (83%) 13/14 (93%) 8/9 (89%) |
|FIRST INCIDENCE | 281 (T) 281 (T) 281 (T) 239 278 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.561 P=1.000 P=0.217N P=0.760 P=0.740N |
|POLY 3 | P=0.109N P=0.741 P=0.121N P=0.765N P=0.146N |
|POLY 1.5 | P=0.072N P=0.702 P=0.121N P=0.731 P=0.102N |
|POLY 6 | P=0.155N P=0.767 P=0.138N P=0.742N P=0.221N |
|LOGISTIC REGRESSION| P=0.259N P=1.000 P=0.217N P=0.716 (e) |
|COCH-ARM / FISHERS | P=0.051N P=0.500 P=0.195N P=0.500 P=0.107N |
|ORDER RESTRICTED | P=0.060N (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).