TDMS Study 99036-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus TRANSGENIC MODEL EVALUATION II (PHENOLPHTHALEIN) DATE: 04/21/04
EXPERIMENT: 99036 TEST: 01 TIME: 08:36:55
TEST TYPE: SUBCHRON 26-WEEK CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-65406 ROUTE: DOSED FEED NTP C#: C99036
PATHOLOGIST: MISSING CAS: 77-09-08
------------------------------------------------------------------------------------------------------------------------------------
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 (PHENOLPHTHALEIN) DATE: 04/21/04
EXPERIMENT: 99036 TEST: 01 TIME: 08:36:55
TEST TYPE: SUBCHRON 26-WEEK CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-65406 ROUTE: DOSED FEED NTP C#: C99036
PATHOLOGIST: MISSING CAS: 77-09-08
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF TRANSGENIC MODEL EVALUATION II (PHENOLP
===============================================================
Male Mice
------------
Organ Morphology
----- ----------
Adrenal Cortex Hyperplasia Focal
Hypertrophy Focal
Epididymis Hypospermia
Kidney Nephropathy
Kidney: Renal Tubule Hypertrophy
Liver Inflammation Chronic
Spleen Hematopoietic Cell Proliferation
Testes: Germinal Epithelium Atrophy
Testes: Interstitial Cell Hyperplasia
===============================================================
Female Mice
------------
Organ Morphology
----- ----------
Lymph Node, Mandibular Hyperplasia Lymphoid
Spleen Hematopoietic Cell Proliferation
Thymus Hyperplasia Atypical
===============================================================
Date: 04/21/04 EXPERIMENT: 99036 TEST: 01 Page 1
Statistical Analysis of Non-neoplastic Lesions in Mice(P16(INK4A)/(+/-) (C57BL/6)) - TRANSGENIC MODEL EVALUATION II (PHE
NOLP
Terminal Sacrifice at 27 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 200 PPM 375 PPM 750 PPM 3000 PPM 12,000 |
| | PPM |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/14 (0%) 0/15 (0%) 0/15 (0%) 4/14 (29%) 1/15 (7%) 0/14 (0%) |
|POLY-3 RATE (b) | 0/13.07 0/15.00 0/15.00 4/13.01 1/15.00 0/14.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 30.7% 6.7% 0.0% |
|TERMINAL (d) | 0/13 (0%) 0/15 (0%) 0/15 (0%) 4/13 (31%) 1/15 (7%) 0/14 (0%) |
|FIRST INCIDENCE | --- --- --- 183 (T) 183 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.369N (e) (e) P=0.055 P=0.529 (e) |
|POLY 3 | P=0.371N (e) (e) P=0.042 * P=0.527 (e) |
|POLY 1.5 | P=0.372N (e) (e) P=0.041 * P=0.524 (e) |
|POLY 6 | P=0.370N (e) (e) P=0.042 * P=0.528 (e) |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.055 P=0.529 (e) |
|COCH-ARM / FISHERS | P=0.378N (e) (e) P=0.049 * P=0.517 (e) |
|ORDER RESTRICTED | P=0.141 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 200 PPM 375 PPM 750 PPM 3000 PPM 12,000 |
| | PPM |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/15 (0%) 0/14 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) |
|POLY-3 RATE (b) | 0/15.00 0/13.00 0/14.00 0/15.00 0/14.00 0/15.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/15 (0%) 0/13 (0%) 0/14 (0%) 0/15 (0%) 0/14 (0%) 0/15 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 04/21/04 EXPERIMENT: 99036 TEST: 01 Page 2
Statistical Analysis of Non-neoplastic Lesions in Mice(P16(INK4A)/(+/-) (C57BL/6)) - TRANSGENIC MODEL EVALUATION II (PHEN
OLP
Terminal Sacrifice at 27 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 200 PPM 375 PPM 750 PPM 3000 PPM 12,000 |
| | PPM |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hypertrophy Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/14 (29%) 3/15 (20%) 1/15 (7%) 1/14 (7%) 2/15 (13%) 0/14 (0%) |
|POLY-3 RATE (b) | 4/13.07 3/15.00 1/15.00 1/13.01 2/15.00 0/14.00 |
|POLY-3 PERCENT (g) | 30.6% 20.0% 6.7% 7.7% 13.3% 0.0% |
|TERMINAL (d) | 4/13 (31%) 3/15 (20%) 1/15 (7%) 1/13 (8%) 2/15 (13%) 0/14 (0%) |
|FIRST INCIDENCE | 183 (T) 183 (T) 183 (T) 183 (T) 183 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.090N P=0.415N P=0.126N P=0.165N P=0.259N P=0.047N* |
|POLY 3 | P=0.088N P=0.419N P=0.121N P=0.160N P=0.261N P=0.035N* |
|POLY 1.5 | P=0.089N P=0.428N P=0.125N P=0.163N P=0.267N P=0.037N* |
|POLY 6 | P=0.088N P=0.416N P=0.119N P=0.159N P=0.258N P=0.035N* |
|LOGISTIC REGRESSION| P=0.090N P=0.415N P=0.126N P=0.160N P=0.259N (e) |
|COCH-ARM / FISHERS | P=0.095N P=0.458N P=0.143N P=0.163N P=0.291N P=0.049N* |
|ORDER RESTRICTED | P=0.013N* (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 200 PPM 375 PPM 750 PPM 3000 PPM 12,000 |
| | PPM |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hypertrophy Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/15 (0%) 0/14 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) |
|POLY-3 RATE (b) | 0/15.00 0/13.00 0/14.00 0/15.00 0/14.00 0/15.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/15 (0%) 0/13 (0%) 0/14 (0%) 0/15 (0%) 0/14 (0%) 0/15 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 04/21/04 EXPERIMENT: 99036 TEST: 01 Page 3
Statistical Analysis of Non-neoplastic Lesions in Mice(P16(INK4A)/(+/-) (C57BL/6)) - TRANSGENIC MODEL EVALUATION II (PHEN
OLP
Terminal Sacrifice at 27 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 200 PPM 375 PPM 750 PPM 3000 PPM 12,000 |
| | PPM |
|=================================================================================================================================|
| |
|Epididymis |
| Hypospermia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/15 (0%) 0/15 (0%) 1/15 (7%) 0/15 (0%) 15/15 (100%) 14/15 (93%) |
|POLY-3 RATE (b) | 0/13.07 0/15.00 1/15.00 0/13.01 15/15.00 14/14.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 6.7% 0.0% 100.0% 100.0% |
|TERMINAL (d) | 0/13 (0%) 0/15 (0%) 1/15 (7%) 0/13 (0%) 15/15 (100%) 14/14 (100%) |
|FIRST INCIDENCE | --- --- 183 (T) --- 183 (T) 183 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) P=0.529 (e) P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** (e) P=0.527 (e) P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) P=0.524 (e) P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** (e) P=0.528 (e) P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) P=0.529 (e) P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** (e) P=0.500 (e) P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 200 PPM 375 PPM 750 PPM 3000 PPM 12,000 |
| | PPM |
|=================================================================================================================================|
| |
|Epididymis |
| Hypospermia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | |
|POLY-3 RATE (b) | |
|POLY-3 PERCENT (g) | |
|TERMINAL (d) | |
|FIRST INCIDENCE | |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | |
|POLY 3 | |
|POLY 1.5 | |
|POLY 6 | |
|LOGISTIC REGRESSION| |
|COCH-ARM / FISHERS | |
|ORDER RESTRICTED | |
|=================================================================================================================================|
Date: 04/21/04 EXPERIMENT: 99036 TEST: 01 Page 4
Statistical Analysis of Non-neoplastic Lesions in Mice(P16(INK4A)/(+/-) (C57BL/6)) - TRANSGENIC MODEL EVALUATION II (PHEN
OLP
Terminal Sacrifice at 27 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 200 PPM 375 PPM 750 PPM 3000 PPM 12,000 |
| | PPM |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 6/14 (43%) 7/15 (47%) 8/15 (53%) 6/14 (43%) 15/15 (100%) 14/15 (93%) |
|POLY-3 RATE (b) | 6/13.07 7/15.00 8/15.00 6/13.01 15/15.00 14/14.00 |
|POLY-3 PERCENT (g) | 45.9% 46.7% 53.3% 46.1% 100.0% 100.0% |
|TERMINAL (d) | 6/13 (46%) 7/15 (47%) 8/15 (53%) 6/13 (46%) 15/15 (100%) 14/14 (100%) |
|FIRST INCIDENCE | 183 (T) 183 (T) 183 (T) 183 (T) 183 (T) 183 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.635 P=0.500 P=0.650 P=0.003 ** P=0.003 ** |
|POLY 3 | P<0.001 ** P=0.628 P=0.494 P=0.644 P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.615 P=0.479 P=0.638 P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.633 P=0.500 P=0.647 P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.635 P=0.500 P=0.650 P=0.003 ** P=0.003 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.566 P=0.424 P=0.648N P<0.001 ** P=0.005 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 200 PPM 375 PPM 750 PPM 3000 PPM 12,000 |
| | PPM |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 10/15 (67%) 6/15 (40%) 8/15 (53%) 8/15 (53%) 7/15 (47%) 11/15 (73%) |
|POLY-3 RATE (b) | 10/15.00 6/13.00 8/14.00 8/15.00 7/14.00 11/15.00 |
|POLY-3 PERCENT (g) | 66.7% 46.2% 57.1% 53.3% 50.0% 73.3% |
|TERMINAL (d) | 10/15 (67%) 6/13 (46%) 8/14 (57%) 8/15 (53%) 7/14 (50%) 11/15 (73%) |
|FIRST INCIDENCE | 184 (T) 184 (T) 184 (T) 184 (T) 184 (T) 184 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.177 P=0.243N P=0.443N P=0.357N P=0.300N P=0.500 |
|POLY 3 | P=0.180 P=0.243N P=0.444N P=0.358N P=0.301N P=0.500 |
|POLY 1.5 | P=0.179 P=0.239N P=0.442N P=0.358N P=0.297N P=0.500 |
|POLY 6 | P=0.180 P=0.243N P=0.444N P=0.358N P=0.301N P=0.500 |
|LOGISTIC REGRESSION| P=0.177 P=0.243N P=0.443N P=0.357N P=0.300N P=0.500 |
|COCH-ARM / FISHERS | P=0.130 P=0.136N P=0.355N P=0.355N P=0.231N P=0.500 |
|ORDER RESTRICTED | P=0.270 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 04/21/04 EXPERIMENT: 99036 TEST: 01 Page 5
Statistical Analysis of Non-neoplastic Lesions in Mice(P16(INK4A)/(+/-) (C57BL/6)) - TRANSGENIC MODEL EVALUATION II (PHEN
OLP
Terminal Sacrifice at 27 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 200 PPM 375 PPM 750 PPM 3000 PPM 12,000 |
| | PPM |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/14 (0%) 0/15 (0%) 0/15 (0%) 10/14 (71%) 15/15 (100%) 14/15 (93%) |
|POLY-3 RATE (b) | 0/13.07 0/15.00 0/15.00 10/13.01 15/15.00 14/14.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 76.9% 100.0% 100.0% |
|TERMINAL (d) | 0/13 (0%) 0/15 (0%) 0/15 (0%) 10/13 (77%) 15/15 (100%) 14/14 (100%) |
|FIRST INCIDENCE | --- --- --- 183 (T) 183 (T) 183 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** (e) (e) P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** (e) (e) P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) (e) P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) P<0.001 ** P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 200 PPM 375 PPM 750 PPM 3000 PPM 12,000 |
| | PPM |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) |
|POLY-3 RATE (b) | 0/15.00 0/13.00 0/14.00 0/15.00 0/14.00 0/15.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/15 (0%) 0/13 (0%) 0/14 (0%) 0/15 (0%) 0/14 (0%) 0/15 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 04/21/04 EXPERIMENT: 99036 TEST: 01 Page 6
Statistical Analysis of Non-neoplastic Lesions in Mice(P16(INK4A)/(+/-) (C57BL/6)) - TRANSGENIC MODEL EVALUATION II (PHEN
OLP
Terminal Sacrifice at 27 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 200 PPM 375 PPM 750 PPM 3000 PPM 12,000 |
| | PPM |
|=================================================================================================================================|
| |
|Liver |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 11/15 (73%) 8/15 (53%) 7/15 (47%) 9/14 (64%) 10/15 (67%) 5/14 (36%) |
|POLY-3 RATE (b) | 11/13.07 8/15.00 7/15.00 9/13.01 10/15.00 5/14.00 |
|POLY-3 PERCENT (g) | 84.2% 53.3% 46.7% 69.2% 66.7% 35.7% |
|TERMINAL (d) | 11/13 (85%) 8/15 (53%) 7/15 (47%) 9/13 (69%) 10/15 (67%) 5/14 (36%) |
|FIRST INCIDENCE | 183 (T) 183 (T) 183 (T) 183 (T) 183 (T) 183 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.057N P=0.091N P=0.048N* P=0.324N P=0.260N P=0.016N* |
|POLY 3 | P=0.058N P=0.087N P=0.041N* P=0.332N P=0.268N P=0.009N** |
|POLY 1.5 | P=0.061N P=0.100N P=0.048N* P=0.349N P=0.295N P=0.011N* |
|POLY 6 | P=0.058N P=0.084N P=0.039N* P=0.325N P=0.260N P=0.008N** |
|LOGISTIC REGRESSION| P=0.057N P=0.091N P=0.048N* P=0.324N P=0.260N P=0.016N* |
|COCH-ARM / FISHERS | P=0.088N P=0.225N P=0.132N P=0.450N P=0.500N P=0.048N* |
|ORDER RESTRICTED | P=0.008N** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 200 PPM 375 PPM 750 PPM 3000 PPM 12,000 |
| | PPM |
|=================================================================================================================================|
| |
|Liver |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 10/15 (67%) 8/15 (53%) 12/15 (80%) 10/15 (67%) 7/15 (47%) 8/15 (53%) |
|POLY-3 RATE (b) | 10/15.00 8/13.00 12/14.00 10/15.00 7/14.00 8/15.00 |
|POLY-3 PERCENT (g) | 66.7% 61.5% 85.7% 66.7% 50.0% 53.3% |
|TERMINAL (d) | 10/15 (67%) 8/13 (62%) 12/14 (86%) 10/15 (67%) 7/14 (50%) 8/15 (53%) |
|FIRST INCIDENCE | 184 (T) 184 (T) 184 (T) 184 (T) 184 (T) 184 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.163N P=0.544N P=0.227 P=0.648 P=0.300N P=0.357N |
|POLY 3 | P=0.162N P=0.543N P=0.225 P=0.646 P=0.301N P=0.358N |
|POLY 1.5 | P=0.163N P=0.537N P=0.228 P=0.646 P=0.297N P=0.358N |
|POLY 6 | P=0.162N P=0.543N P=0.225 P=0.646 P=0.301N P=0.358N |
|LOGISTIC REGRESSION| P=0.163N P=0.544N P=0.223 P=0.648 P=0.300N P=0.357N |
|COCH-ARM / FISHERS | P=0.231N P=0.355N P=0.341 P=0.650N P=0.231N P=0.355N |
|ORDER RESTRICTED | P=0.220N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 04/21/04 EXPERIMENT: 99036 TEST: 01 Page 7
Statistical Analysis of Non-neoplastic Lesions in Mice(P16(INK4A)/(+/-) (C57BL/6)) - TRANSGENIC MODEL EVALUATION II (PHEN
OLP
Terminal Sacrifice at 27 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 200 PPM 375 PPM 750 PPM 3000 PPM 12,000 |
| | PPM |
|=================================================================================================================================|
| |
|Lung |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/15 (0%) 2/15 (13%) 0/15 (0%) 2/14 (14%) 1/15 (7%) 0/15 (0%) |
|POLY-3 RATE (b) | 0/13.07 2/15.00 0/15.00 2/12.01 1/15.00 0/14.00 |
|POLY-3 PERCENT (g) | 0.0% 13.3% 0.0% 16.7% 6.7% 0.0% |
|TERMINAL (d) | 0/13 (0%) 2/15 (13%) 0/15 (0%) 2/12 (17%) 1/15 (7%) 0/14 (0%) |
|FIRST INCIDENCE | --- 183 (T) --- 183 (T) 183 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.321N P=0.268 (e) P=0.217 P=0.529 (e) |
|POLY 3 | P=0.321N P=0.264 (e) P=0.210 P=0.527 (e) |
|POLY 1.5 | P=0.322N P=0.260 (e) P=0.209 P=0.524 (e) |
|POLY 6 | P=0.321N P=0.266 (e) P=0.211 P=0.528 (e) |
|LOGISTIC REGRESSION| (e) P=0.268 (e) P=0.217 P=0.529 (e) |
|COCH-ARM / FISHERS | P=0.322N P=0.241 (e) P=0.224 P=0.500 (e) |
|ORDER RESTRICTED | P=0.391 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 200 PPM 375 PPM 750 PPM 3000 PPM 12,000 |
| | PPM |
|=================================================================================================================================|
| |
|Lung |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/15 (13%) 1/15 (7%) 1/15 (7%) 3/15 (20%) 1/15 (7%) 0/15 (0%) |
|POLY-3 RATE (b) | 2/15.00 1/13.00 1/14.00 3/15.00 1/14.00 0/15.00 |
|POLY-3 PERCENT (g) | 13.3% 7.7% 7.1% 20.0% 7.1% 0.0% |
|TERMINAL (d) | 2/15 (13%) 1/13 (8%) 1/14 (7%) 3/15 (20%) 1/14 (7%) 0/15 (0%) |
|FIRST INCIDENCE | 184 (T) 184 (T) 184 (T) 184 (T) 184 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.152N P=0.551N P=0.525N P=0.500 P=0.525N P=0.236N |
|POLY 3 | P=0.144N P=0.550N P=0.524N P=0.500 P=0.524N P=0.232N |
|POLY 1.5 | P=0.144N P=0.549N P=0.524N P=0.500 P=0.523N P=0.232N |
|POLY 6 | P=0.144N P=0.550N P=0.524N P=0.500 P=0.524N P=0.232N |
|LOGISTIC REGRESSION| P=0.152N P=0.551N P=0.525N P=0.500 P=0.525N (e) |
|COCH-ARM / FISHERS | P=0.160N P=0.500N P=0.500N P=0.500 P=0.500N P=0.241N |
|ORDER RESTRICTED | P=0.174N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 04/21/04 EXPERIMENT: 99036 TEST: 01 Page 8
Statistical Analysis of Non-neoplastic Lesions in Mice(P16(INK4A)/(+/-) (C57BL/6)) - TRANSGENIC MODEL EVALUATION II (PHEN
OLP
Terminal Sacrifice at 27 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 200 PPM 375 PPM 750 PPM 3000 PPM 12,000 |
| | PPM |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/14 (0%) 0/15 (0%) 0/15 (0%) 0/14 (0%) 0/15 (0%) 0/13 (0%) |
|POLY-3 RATE (b) | 0/13.07 0/15.00 0/15.00 0/13.01 0/15.00 0/13.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/13 (0%) 0/15 (0%) 0/15 (0%) 0/13 (0%) 0/15 (0%) 0/13 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 200 PPM 375 PPM 750 PPM 3000 PPM 12,000 |
| | PPM |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/15 (0%) 2/15 (13%) 0/15 (0%) 0/15 (0%) 2/15 (13%) 0/15 (0%) |
|POLY-3 RATE (b) | 0/15.00 2/15.00 0/14.00 0/15.00 2/15.00 0/15.00 |
|POLY-3 PERCENT (g) | 0.0% 13.3% 0.0% 0.0% 13.3% 0.0% |
|TERMINAL (d) | 0/15 (0%) 0/13 (0%) 0/14 (0%) 0/15 (0%) 1/14 (7%) 0/15 (0%) |
|FIRST INCIDENCE | --- 13 --- --- 26 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.490N P=0.232 (e) (e) P=0.232 (e) |
|POLY 3 | P=0.491N P=0.232 (e) (e) P=0.232 (e) |
|POLY 1.5 | P=0.491N P=0.232 (e) (e) P=0.232 (e) |
|POLY 6 | P=0.491N P=0.232 (e) (e) P=0.232 (e) |
|LOGISTIC REGRESSION| P=0.792 (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.501N P=0.241 (e) (e) P=0.241 (e) |
|ORDER RESTRICTED | P=0.332 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 04/21/04 EXPERIMENT: 99036 TEST: 01 Page 9
Statistical Analysis of Non-neoplastic Lesions in Mice(P16(INK4A)/(+/-) (C57BL/6)) - TRANSGENIC MODEL EVALUATION II (PHEN
OLP
Terminal Sacrifice at 27 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 200 PPM 375 PPM 750 PPM 3000 PPM 12,000 |
| | PPM |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/14 (14%) 1/15 (7%) 2/15 (13%) 0/14 (0%) 3/15 (20%) 1/13 (8%) |
|POLY-3 RATE (b) | 2/13.07 1/15.00 2/15.00 0/13.01 3/15.00 1/13.00 |
|POLY-3 PERCENT (g) | 15.3% 6.7% 13.3% 0.0% 20.0% 7.7% |
|TERMINAL (d) | 2/13 (15%) 1/15 (7%) 2/15 (13%) 0/13 (0%) 3/15 (20%) 1/13 (8%) |
|FIRST INCIDENCE | 183 (T) 183 (T) 183 (T) --- 183 (T) 183 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.598N P=0.449N P=0.648N P=0.235N P=0.569 P=0.500N |
|POLY 3 | P=0.597N P=0.451N P=0.647N P=0.231N P=0.565 P=0.502N |
|POLY 1.5 | P=0.599N P=0.456N P=0.653N P=0.233N P=0.558 P=0.507N |
|POLY 6 | P=0.597N P=0.449N P=0.645N P=0.230N P=0.567 P=0.500N |
|LOGISTIC REGRESSION| P=0.598N P=0.449N P=0.648N (e) P=0.569 P=0.500N |
|COCH-ARM / FISHERS | P=0.615N P=0.473N P=0.674N P=0.241N P=0.535 P=0.529N |
|ORDER RESTRICTED | P=0.501N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 200 PPM 375 PPM 750 PPM 3000 PPM 12,000 |
| | PPM |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/15 (27%) 2/15 (13%) 2/15 (13%) 0/15 (0%) 1/15 (7%) 6/15 (40%) |
|POLY-3 RATE (b) | 4/15.00 2/13.00 2/14.00 0/15.00 1/14.00 6/15.00 |
|POLY-3 PERCENT (g) | 26.7% 15.4% 14.3% 0.0% 7.1% 40.0% |
|TERMINAL (d) | 4/15 (27%) 2/13 (15%) 2/14 (14%) 0/15 (0%) 1/14 (7%) 6/15 (40%) |
|FIRST INCIDENCE | 184 (T) 184 (T) 184 (T) --- 184 (T) 184 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.027 * P=0.398N P=0.360N P=0.057N P=0.189N P=0.352 |
|POLY 3 | P=0.021 * P=0.399N P=0.361N P=0.045N* P=0.185N P=0.353 |
|POLY 1.5 | P=0.020 * P=0.397N P=0.360N P=0.045N* P=0.184N P=0.353 |
|POLY 6 | P=0.021 * P=0.399N P=0.361N P=0.045N* P=0.185N P=0.353 |
|LOGISTIC REGRESSION| P=0.027 * P=0.398N P=0.360N (e) P=0.184N P=0.352 |
|COCH-ARM / FISHERS | P=0.021 * P=0.326N P=0.326N P=0.050N P=0.165N P=0.350 |
|ORDER RESTRICTED | P=0.026 * (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 04/21/04 EXPERIMENT: 99036 TEST: 01 Page 10
Statistical Analysis of Non-neoplastic Lesions in Mice(P16(INK4A)/(+/-) (C57BL/6)) - TRANSGENIC MODEL EVALUATION II (PHEN
OLP
Terminal Sacrifice at 27 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 200 PPM 375 PPM 750 PPM 3000 PPM 12,000 |
| | PPM |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/14 (0%) 1/15 (7%) 1/15 (7%) 1/14 (7%) 0/15 (0%) 0/14 (0%) |
|POLY-3 RATE (b) | 0/13.07 1/15.00 1/15.00 1/14.00 0/15.00 0/14.00 |
|POLY-3 PERCENT (g) | 0.0% 6.7% 6.7% 7.1% 0.0% 0.0% |
|TERMINAL (d) | 0/13 (0%) 1/15 (7%) 1/15 (7%) 0/13 (0%) 0/15 (0%) 0/14 (0%) |
|FIRST INCIDENCE | --- 183 (T) 183 (T) 43 --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.377N P=0.529 P=0.529 P=0.500 (e) (e) |
|POLY 3 | P=0.373N P=0.527 P=0.527 P=0.514 (e) (e) |
|POLY 1.5 | P=0.375N P=0.524 P=0.524 P=0.511 (e) (e) |
|POLY 6 | P=0.373N P=0.528 P=0.528 P=0.515 (e) (e) |
|LOGISTIC REGRESSION| P=0.510N P=0.529 P=0.529 (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.381N P=0.517 P=0.517 P=0.500 (e) (e) |
|ORDER RESTRICTED | P=0.436N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 200 PPM 375 PPM 750 PPM 3000 PPM 12,000 |
| | PPM |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/15 (7%) 1/14 (7%) 1/15 (7%) 0/15 (0%) 2/15 (13%) 2/15 (13%) |
|POLY-3 RATE (b) | 1/15.00 1/14.00 1/15.00 0/15.00 2/15.00 2/15.00 |
|POLY-3 PERCENT (g) | 6.7% 7.1% 6.7% 0.0% 13.3% 13.3% |
|TERMINAL (d) | 1/15 (7%) 0/13 (0%) 0/14 (0%) 0/15 (0%) 1/14 (7%) 2/15 (13%) |
|FIRST INCIDENCE | 184 (T) 21 15 --- 26 184 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.282 P=0.737 P=0.753 P=0.500N P=0.484 P=0.500 |
|POLY 3 | P=0.269 P=0.745 P=0.760 P=0.500N P=0.500 P=0.500 |
|POLY 1.5 | P=0.269 P=0.745 P=0.760 P=0.500N P=0.500 P=0.500 |
|POLY 6 | P=0.269 P=0.745 P=0.760 P=0.500N P=0.500 P=0.500 |
|LOGISTIC REGRESSION| P=0.282 (e) (e) (e) (e) P=0.500 |
|COCH-ARM / FISHERS | P=0.265 P=0.741 P=0.759N P=0.500N P=0.500 P=0.500 |
|ORDER RESTRICTED | P=0.370 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 04/21/04 EXPERIMENT: 99036 TEST: 01 Page 11
Statistical Analysis of Non-neoplastic Lesions in Mice(P16(INK4A)/(+/-) (C57BL/6)) - TRANSGENIC MODEL EVALUATION II (PHEN
OLP
Terminal Sacrifice at 27 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 200 PPM 375 PPM 750 PPM 3000 PPM 12,000 |
| | PPM |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/14 (0%) 0/15 (0%) 1/15 (7%) 0/14 (0%) 2/15 (13%) 1/14 (7%) |
|POLY-3 RATE (b) | 0/13.07 0/15.00 1/15.00 0/13.01 2/15.00 1/14.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 6.7% 0.0% 13.3% 7.1% |
|TERMINAL (d) | 0/13 (0%) 0/15 (0%) 1/15 (7%) 0/13 (0%) 2/15 (13%) 1/14 (7%) |
|FIRST INCIDENCE | --- --- 183 (T) --- 183 (T) 183 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.360 (e) P=0.529 (e) P=0.268 P=0.515 |
|POLY 3 | P=0.367 (e) P=0.527 (e) P=0.264 P=0.514 |
|POLY 1.5 | P=0.364 (e) P=0.524 (e) P=0.260 P=0.511 |
|POLY 6 | P=0.368 (e) P=0.528 (e) P=0.265 P=0.515 |
|LOGISTIC REGRESSION| (e) (e) P=0.529 (e) P=0.268 P=0.515 |
|COCH-ARM / FISHERS | P=0.348 (e) P=0.517 (e) P=0.259 P=0.500 |
|ORDER RESTRICTED | P=0.188 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 200 PPM 375 PPM 750 PPM 3000 PPM 12,000 |
| | PPM |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/15 (0%) 0/14 (0%) 1/15 (7%) 0/15 (0%) 0/15 (0%) 0/15 (0%) |
|POLY-3 RATE (b) | 0/15.00 0/13.00 1/14.00 0/15.00 0/14.00 0/15.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 7.1% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/15 (0%) 0/13 (0%) 1/14 (7%) 0/15 (0%) 0/14 (0%) 0/15 (0%) |
|FIRST INCIDENCE | --- --- 184 (T) --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.683N (e) P=0.486 (e) (e) (e) |
|POLY 3 | P=0.697N (e) P=0.486 (e) (e) (e) |
|POLY 1.5 | P=0.696N (e) P=0.487 (e) (e) (e) |
|POLY 6 | P=0.697N (e) P=0.486 (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) P=0.486 (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.691N (e) P=0.500 (e) (e) (e) |
|ORDER RESTRICTED | P=0.490N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 04/21/04 EXPERIMENT: 99036 TEST: 01 Page 12
Statistical Analysis of Non-neoplastic Lesions in Mice(P16(INK4A)/(+/-) (C57BL/6)) - TRANSGENIC MODEL EVALUATION II (PHEN
OLP
Terminal Sacrifice at 27 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 200 PPM 375 PPM 750 PPM 3000 PPM 12,000 |
| | PPM |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/14 (14%) 5/15 (33%) 3/15 (20%) 1/14 (7%) 2/15 (13%) 14/14 (100%) |
|POLY-3 RATE (b) | 2/13.07 5/15.00 3/15.00 1/13.01 2/15.00 14/14.00 |
|POLY-3 PERCENT (g) | 15.3% 33.3% 20.0% 7.7% 13.3% 100.0% |
|TERMINAL (d) | 2/13 (15%) 5/15 (33%) 3/15 (20%) 1/13 (8%) 2/15 (13%) 14/14 (100%) |
|FIRST INCIDENCE | 183 (T) 183 (T) 183 (T) 183 (T) 183 (T) 183 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.260 P=0.569 P=0.500N P=0.648N P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.257 P=0.565 P=0.502N P=0.647N P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.249 P=0.558 P=0.504N P=0.653N P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.259 P=0.567 P=0.500N P=0.645N P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.260 P=0.569 P=0.500N P=0.648N P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.224 P=0.535 P=0.500N P=0.674N P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 200 PPM 375 PPM 750 PPM 3000 PPM 12,000 |
| | PPM |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/15 (13%) 5/14 (36%) 9/14 (64%) 8/15 (53%) 7/15 (47%) 13/15 (87%) |
|POLY-3 RATE (b) | 2/15.00 5/13.00 9/14.00 8/15.00 7/14.00 13/15.00 |
|POLY-3 PERCENT (g) | 13.3% 38.5% 64.3% 53.3% 50.0% 86.7% |
|TERMINAL (d) | 2/15 (13%) 5/13 (39%) 9/14 (64%) 8/15 (53%) 7/14 (50%) 13/15 (87%) |
|FIRST INCIDENCE | 184 (T) 184 (T) 184 (T) 184 (T) 184 (T) 184 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.002 ** P=0.141 P=0.008 ** P=0.028 * P=0.044 * P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.136 P=0.003 ** P=0.019 * P=0.035 * P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.137 P=0.003 ** P=0.019 * P=0.036 * P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.136 P=0.003 ** P=0.019 * P=0.035 * P<0.001 ** |
|LOGISTIC REGRESSION| P=0.002 ** P=0.141 P=0.008 ** P=0.028 * P=0.044 * P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.166 P=0.007 ** P=0.025 * P=0.054 P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 04/21/04 EXPERIMENT: 99036 TEST: 01 Page 13
Statistical Analysis of Non-neoplastic Lesions in Mice(P16(INK4A)/(+/-) (C57BL/6)) - TRANSGENIC MODEL EVALUATION II (PHEN
OLP
Terminal Sacrifice at 27 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 200 PPM 375 PPM 750 PPM 3000 PPM 12,000 |
| | PPM |
|=================================================================================================================================|
| |
|Spleen: Lymphoid Follicle |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/14 (0%) 0/15 (0%) 0/15 (0%) 1/14 (7%) 0/15 (0%) 0/14 (0%) |
|POLY-3 RATE (b) | 0/13.07 0/15.00 0/15.00 1/14.00 0/15.00 0/14.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 7.1% 0.0% 0.0% |
|TERMINAL (d) | 0/13 (0%) 0/15 (0%) 0/15 (0%) 0/13 (0%) 0/15 (0%) 0/14 (0%) |
|FIRST INCIDENCE | --- --- --- 43 --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.730N (e) (e) P=0.500 (e) (e) |
|POLY 3 | P=0.727N (e) (e) P=0.514 (e) (e) |
|POLY 1.5 | P=0.728N (e) (e) P=0.511 (e) (e) |
|POLY 6 | P=0.727N (e) (e) P=0.515 (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.731N (e) (e) P=0.500 (e) (e) |
|ORDER RESTRICTED | P=0.533 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 200 PPM 375 PPM 750 PPM 3000 PPM 12,000 |
| | PPM |
|=================================================================================================================================|
| |
|Spleen: Lymphoid Follicle |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/15 (0%) 1/14 (7%) 0/14 (0%) 0/15 (0%) 2/15 (13%) 0/15 (0%) |
|POLY-3 RATE (b) | 0/15.00 1/14.00 0/14.00 0/15.00 2/15.00 0/15.00 |
|POLY-3 PERCENT (g) | 0.0% 7.1% 0.0% 0.0% 13.3% 0.0% |
|TERMINAL (d) | 0/15 (0%) 0/13 (0%) 0/14 (0%) 0/15 (0%) 1/14 (7%) 0/15 (0%) |
|FIRST INCIDENCE | --- 21 --- --- 26 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.621N P=0.486 (e) (e) P=0.232 (e) |
|POLY 3 | P=0.628N P=0.486 (e) (e) P=0.232 (e) |
|POLY 1.5 | P=0.628N P=0.486 (e) (e) P=0.232 (e) |
|POLY 6 | P=0.628N P=0.486 (e) (e) P=0.232 (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.627N P=0.483 (e) (e) P=0.241 (e) |
|ORDER RESTRICTED | P=0.271 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 04/21/04 EXPERIMENT: 99036 TEST: 01 Page 14
Statistical Analysis of Non-neoplastic Lesions in Mice(P16(INK4A)/(+/-) (C57BL/6)) - TRANSGENIC MODEL EVALUATION II (PHEN
OLP
Terminal Sacrifice at 27 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 200 PPM 375 PPM 750 PPM 3000 PPM 12,000 |
| | PPM |
|=================================================================================================================================|
| |
|Testes: Germinal Epithelium |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/15 (0%) 1/15 (7%) 1/15 (7%) 0/15 (0%) 15/15 (100%) 14/15 (93%) |
|POLY-3 RATE (b) | 0/13.07 1/15.00 1/15.00 0/13.01 15/15.00 14/14.00 |
|POLY-3 PERCENT (g) | 0.0% 6.7% 6.7% 0.0% 100.0% 100.0% |
|TERMINAL (d) | 0/13 (0%) 1/15 (7%) 1/15 (7%) 0/13 (0%) 15/15 (100%) 14/14 (100%) |
|FIRST INCIDENCE | --- 183 (T) 183 (T) --- 183 (T) 183 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.529 P=0.529 (e) P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.527 P=0.527 (e) P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.524 P=0.524 (e) P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.528 P=0.528 (e) P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| (e) P=0.529 P=0.529 (e) P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.500 P=0.500 (e) P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 200 PPM 375 PPM 750 PPM 3000 PPM 12,000 |
| | PPM |
|=================================================================================================================================|
| |
|Testes: Germinal Epithelium |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | |
|POLY-3 RATE (b) | |
|POLY-3 PERCENT (g) | |
|TERMINAL (d) | |
|FIRST INCIDENCE | |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | |
|POLY 3 | |
|POLY 1.5 | |
|POLY 6 | |
|LOGISTIC REGRESSION| |
|COCH-ARM / FISHERS | |
|ORDER RESTRICTED | |
|=================================================================================================================================|
Date: 04/21/04 EXPERIMENT: 99036 TEST: 01 Page 15
Statistical Analysis of Non-neoplastic Lesions in Mice(P16(INK4A)/(+/-) (C57BL/6)) - TRANSGENIC MODEL EVALUATION II (PHEN
OLP
Terminal Sacrifice at 27 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 200 PPM 375 PPM 750 PPM 3000 PPM 12,000 |
| | PPM |
|=================================================================================================================================|
| |
|Testes: Interstitial Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/15 (0%) 1/15 (7%) 1/15 (7%) 0/15 (0%) 15/15 (100%) 14/15 (93%) |
|POLY-3 RATE (b) | 0/13.07 1/15.00 1/15.00 0/13.01 15/15.00 14/14.00 |
|POLY-3 PERCENT (g) | 0.0% 6.7% 6.7% 0.0% 100.0% 100.0% |
|TERMINAL (d) | 0/13 (0%) 1/15 (7%) 1/15 (7%) 0/13 (0%) 15/15 (100%) 14/14 (100%) |
|FIRST INCIDENCE | --- 183 (T) 183 (T) --- 183 (T) 183 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.529 P=0.529 (e) P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.527 P=0.527 (e) P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.524 P=0.524 (e) P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.528 P=0.528 (e) P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| (e) P=0.529 P=0.529 (e) P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.500 P=0.500 (e) P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 200 PPM 375 PPM 750 PPM 3000 PPM 12,000 |
| | PPM |
|=================================================================================================================================|
| |
|Testes: Interstitial Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | |
|POLY-3 RATE (b) | |
|POLY-3 PERCENT (g) | |
|TERMINAL (d) | |
|FIRST INCIDENCE | |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | |
|POLY 3 | |
|POLY 1.5 | |
|POLY 6 | |
|LOGISTIC REGRESSION| |
|COCH-ARM / FISHERS | |
|ORDER RESTRICTED | |
|=================================================================================================================================|
Date: 04/21/04 EXPERIMENT: 99036 TEST: 01 Page 16
Statistical Analysis of Non-neoplastic Lesions in Mice(P16(INK4A)/(+/-) (C57BL/6)) - TRANSGENIC MODEL EVALUATION II (PHEN
OLP
Terminal Sacrifice at 27 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 200 PPM 375 PPM 750 PPM 3000 PPM 12,000 |
| | PPM |
|=================================================================================================================================|
| |
|Thymus |
| Hyperplasia Atypical |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/14 (0%) 0/15 (0%) 1/15 (7%) 0/14 (0%) 1/15 (7%) 0/14 (0%) |
|POLY-3 RATE (b) | 0/13.07 0/15.00 1/15.00 0/13.01 1/15.00 0/14.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 6.7% 0.0% 6.7% 0.0% |
|TERMINAL (d) | 0/13 (0%) 0/15 (0%) 1/15 (7%) 0/13 (0%) 1/15 (7%) 0/14 (0%) |
|FIRST INCIDENCE | --- --- 183 (T) --- 183 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.658N (e) P=0.529 (e) P=0.529 (e) |
|POLY 3 | P=0.653N (e) P=0.527 (e) P=0.527 (e) |
|POLY 1.5 | P=0.655N (e) P=0.524 (e) P=0.524 (e) |
|POLY 6 | P=0.653N (e) P=0.528 (e) P=0.528 (e) |
|LOGISTIC REGRESSION| (e) (e) P=0.529 (e) P=0.529 (e) |
|COCH-ARM / FISHERS | P=0.667N (e) P=0.517 (e) P=0.517 (e) |
|ORDER RESTRICTED | P=0.512 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 200 PPM 375 PPM 750 PPM 3000 PPM 12,000 |
| | PPM |
|=================================================================================================================================|
| |
|Thymus |
| Hyperplasia Atypical |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/15 (0%) 0/15 (0%) 1/15 (7%) 0/15 (0%) 3/14 (21%) 5/15 (33%) |
|POLY-3 RATE (b) | 0/15.00 0/13.00 1/14.00 0/15.00 3/13.00 5/15.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 7.1% 0.0% 23.1% 33.3% |
|TERMINAL (d) | 0/15 (0%) 0/13 (0%) 1/14 (7%) 0/15 (0%) 3/13 (23%) 5/15 (33%) |
|FIRST INCIDENCE | --- --- 184 (T) --- 184 (T) 184 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) P=0.486 (e) P=0.091 P=0.027 * |
|POLY 3 | P<0.001 ** (e) P=0.486 (e) P=0.080 P=0.017 * |
|POLY 1.5 | P<0.001 ** (e) P=0.487 (e) P=0.081 P=0.017 * |
|POLY 6 | P<0.001 ** (e) P=0.486 (e) P=0.080 P=0.017 * |
|LOGISTIC REGRESSION| (e) (e) P=0.486 (e) P=0.091 P=0.027 * |
|COCH-ARM / FISHERS | P<0.001 ** (e) P=0.500 (e) P=0.100 P=0.021 * |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 04/21/04 EXPERIMENT: 99036 TEST: 01 Page 17
Statistical Analysis of Non-neoplastic Lesions in Mice(P16(INK4A)/(+/-) (C57BL/6)) - TRANSGENIC MODEL EVALUATION II (PHEN
OLP
Terminal Sacrifice at 27 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 PPM 200 PPM 375 PPM 750 PPM 3000 PPM 12,000 |
| | PPM |
|=================================================================================================================================|
| |
|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 PPM 200 PPM 375 PPM 750 PPM 3000 PPM 12,000 |
| | PPM |
|=================================================================================================================================|
| |
|Uterus: Endometrium |
| Hyperplasia Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 15/15 (100%) 12/15 (80%) 14/15 (93%) 15/15 (100%) 13/15 (87%) 14/15 (93%) |
|POLY-3 RATE (b) | 15/15.00 12/13.00 14/14.00 15/15.00 13/14.00 14/15.00 |
|POLY-3 PERCENT (g) | 100.0% 92.3% 100.0% 100.0% 92.8% 93.3% |
|TERMINAL (d) | 15/15 (100%) 12/13 (92%) 14/14 (100%) 15/15 (100%) 13/14 (93%) 14/15 (93%) |
|FIRST INCIDENCE | 184 (T) 184 (T) 184 (T) 184 (T) 184 (T) 184 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.379N P=0.471N P=1.000N (e) P=0.486N P=0.500N |
|POLY 3 | P=0.372N P=0.471N P=1.000N (e) P=0.485N P=0.500N |
|POLY 1.5 | P=0.381N P=0.448N P=1.000N (e) P=0.465N P=0.500N |
|POLY 6 | P=0.371N P=0.471N P=1.000N (e) P=0.486N P=0.500N |
|LOGISTIC REGRESSION| P=0.378N P=0.471N P=1.000N (e) P=0.486N P=0.500N |
|COCH-ARM / FISHERS | P=0.659 P=0.112N P=0.500N (e) P=0.241N P=0.500N |
|ORDER RESTRICTED | P=0.265N (e) (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).