TDMS Study 97013-92 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus WATER DISINFECTION MODEL (SODIUM BROMATE) DATE: 12/08/03
EXPERIMENT: 97013 TEST: 92 TIME: 14:32:25
TEST TYPE: 26-39 WEEKS CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-65406 ROUTE: SKIN APPLICATION NTP C#: 97013B
PATHOLOGIST: TOFT, JOHN CAS: 7789-38-0
------------------------------------------------------------------------------------------------------------------------------------
FINAL#1 MICE
REASONS FOR REMOVAL: 25019 Moribund Sacrifice
25020 Natural Death
25021 Terminal Sacrifice
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus WATER DISINFECTION MODEL (SODIUM BROMATE) DATE: 12/08/03
EXPERIMENT: 97013 TEST: 92 TIME: 14:32:25
TEST TYPE: 26-39 WEEKS CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-65406 ROUTE: SKIN APPLICATION NTP C#: 97013B
PATHOLOGIST: TOFT, JOHN CAS: 7789-38-0
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF WATER DISINFECTION MODEL (SODIUM BR
===============================================================
Male Mice
------------
Organ Morphology
----- ----------
Epididymis Degeneration
Kidney Nephropathy
Kidney: Renal Tubule Hypertrophy
Liver Necrosis
Liver: Hepatocyte Vacuolization Cytoplasmic
Lymph Node, Mandibular Hyperplasia Lymphoid
Testes: Germinal Epithelium Degeneration
Thymus Cyst
Thyroid Gland: Follicular Cell Hypertrophy
===============================================================
Female Mice
------------
Organ Morphology
----- ----------
Kidney Nephropathy
Kidney: Renal Tubule Hypertrophy
Ovary Cyst
Spleen Hematopoietic Cell Proliferation
Thymus Cyst
Thyroid Gland Infiltration Cellular Lymphocyte
Thyroid Gland: Follicle Depletion Secretory
Thyroid Gland: Follicular Cell Hypertrophy
===============================================================
Date: 12/08/03 EXPERIMENT: 97013 TEST: 92 Page 1
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (SO
DIUM BR
Terminal Sacrifice at 39 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 64 MG/KG 128 256 |0 MG/KG 64 MG/KG 128 256 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Accessory Adrenal Cortical Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 2/10 (20%) 1/10 (10%) |2/9 (22%) 2/10 (20%) 2/10 (20%) 4/10 (40%) |
|POLY-3 RATE (b) | 0/8.63 0/8.92 2/9.32 1/8.55 |2/8.79 2/7.32 2/9.54 4/9.52 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 21.5% 11.7% |22.8% 27.3% 21.0% 42.0% |
|TERMINAL (d) | 0/8 (0%) 0/8 (0%) 2/8 (25%) 1/8 (13%) |1/7 (14%) 2/7 (29%) 1/8 (13%) 3/8 (38%) |
|FIRST INCIDENCE | --- --- 272 (T) 272 (T) |217 272 (T) 127 257 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.240 (e) P=0.232 P=0.500 |P=0.277 P=0.679 P=0.661N P=0.403 |
|POLY 3 | P=0.227 (e) P=0.243 P=0.498 |P=0.253 P=0.635 P=0.673N P=0.356 |
|POLY 1.5 | P=0.224 (e) P=0.240 P=0.495 |P=0.252 P=0.661 P=0.669N P=0.362 |
|POLY 6 | P=0.230 (e) P=0.242 P=0.500 |P=0.251 P=0.628 P=0.677N P=0.351 |
|LOGISTIC REGRESSION| (e) (e) P=0.232 P=0.500 |P=0.219 P=0.699 P=0.547N P=0.354 |
|COCH-ARM / FISHERS | P=0.239 (e) P=0.237 P=0.500 |P=0.223 P=0.667N P=0.667N P=0.370 |
|ORDER RESTRICTED | P=0.169 (e) (e) (e) |P=0.291 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 64 MG/KG 128 256 |0 MG/KG 64 MG/KG 128 256 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/10 (60%) 5/10 (50%) 6/10 (60%) 6/10 (60%) |0/9 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 6/8.63 5/8.92 6/9.32 6/9.02 |0/8.29 0/7.32 0/8.64 0/9.36 |
|POLY-3 PERCENT (g) | 69.5% 56.0% 64.4% 66.6% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 6/8 (75%) 5/8 (63%) 6/8 (75%) 5/8 (63%) |0/7 (0%) 0/7 (0%) 0/8 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 272 (T) 272 (T) 272 (T) 221 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.529 P=0.500N P=0.712 P=0.669N |(e) (e) (e) (e) |
|POLY 3 | P=0.569 P=0.465N P=0.606N P=0.643N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.528 P=0.478N P=0.620N P=0.678N |(e) (e) (e) (e) |
|POLY 6 | P=0.578N P=0.454N P=0.616N P=0.599N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.518 P=0.500N P=0.712 P=0.688 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.522 P=0.500N P=0.675N P=0.675N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.594N (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 12/08/03 EXPERIMENT: 97013 TEST: 92 Page 2
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (SOD
IUM BR
Terminal Sacrifice at 39 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 64 MG/KG 128 256 |0 MG/KG 64 MG/KG 128 256 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Adrenal Cortex: Subcapsular |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |4/9 (44%) 7/10 (70%) 7/10 (70%) 3/10 (30%) |
|POLY-3 RATE (b) | 0/8.63 0/8.92 0/9.32 0/8.55 |4/9.00 7/8.16 7/9.10 3/9.36 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |44.4% 85.8% 76.9% 32.1% |
|TERMINAL (d) | 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) |2/7 (29%) 6/7 (86%) 6/8 (75%) 3/8 (38%) |
|FIRST INCIDENCE | --- --- --- --- |217 148 221 272 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.186N P=0.192 P=0.297 P=0.425N |
|POLY 3 | (e) (e) (e) (e) |P=0.216N P=0.092 P=0.174 P=0.475N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.196N P=0.117 P=0.193 P=0.456N |
|POLY 6 | (e) (e) (e) (e) |P=0.257N P=0.083 P=0.167 P=0.502N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.169N P=0.153 P=0.230 P=0.441N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.210N P=0.255 P=0.255 P=0.430N |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.063N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 64 MG/KG 128 256 |0 MG/KG 64 MG/KG 128 256 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Epididymis |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 2/10 (20%) 2/10 (20%) | |
|POLY-3 RATE (b) | 0/8.63 0/8.92 2/9.32 2/8.55 | |
|POLY-3 PERCENT (g) | 0.0% 0.0% 21.5% 23.4% | |
|TERMINAL (d) | 0/8 (0%) 0/8 (0%) 2/8 (25%) 2/8 (25%) | |
|FIRST INCIDENCE | --- --- 272 (T) 272 (T) | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.077 (e) P=0.232 P=0.232 | |
|POLY 3 | P=0.070 (e) P=0.243 P=0.221 | |
|POLY 1.5 | P=0.069 (e) P=0.240 P=0.219 | |
|POLY 6 | P=0.070 (e) P=0.242 P=0.223 | |
|LOGISTIC REGRESSION| (e) (e) P=0.232 P=0.232 | |
|COCH-ARM / FISHERS | P=0.077 (e) P=0.237 P=0.237 | |
|ORDER RESTRICTED | P=0.097 (e) (e) (e) | |
|=================================================================================================================================|
Date: 12/08/03 EXPERIMENT: 97013 TEST: 92 Page 3
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (SOD
IUM BR
Terminal Sacrifice at 39 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 64 MG/KG 128 256 |0 MG/KG 64 MG/KG 128 256 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Epididymis |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/10 (10%) 2/10 (20%) 3/10 (30%) 5/10 (50%) | |
|POLY-3 RATE (b) | 1/8.63 2/9.79 3/9.32 5/9.54 | |
|POLY-3 PERCENT (g) | 11.6% 20.4% 32.2% 52.4% | |
|TERMINAL (d) | 1/8 (13%) 1/8 (13%) 3/8 (38%) 4/8 (50%) | |
|FIRST INCIDENCE | 272 (T) 140 272 (T) 69 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.037 * P=0.512 P=0.288 P=0.082 | |
|POLY 3 | P=0.036 * P=0.545 P=0.319 P=0.078 | |
|POLY 1.5 | P=0.035 * P=0.531 P=0.313 P=0.073 | |
|POLY 6 | P=0.036 * P=0.554 P=0.316 P=0.081 | |
|LOGISTIC REGRESSION| P=0.034 * P=0.478 P=0.288 P=0.075 | |
|COCH-ARM / FISHERS | P=0.032 * P=0.500 P=0.291 P=0.070 | |
|ORDER RESTRICTED | P=0.040 * (e) (e) (e) | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 64 MG/KG 128 256 |0 MG/KG 64 MG/KG 128 256 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Epididymis |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 3/10 (30%) 2/10 (20%) | |
|POLY-3 RATE (b) | 0/8.63 0/8.92 3/9.32 2/8.55 | |
|POLY-3 PERCENT (g) | 0.0% 0.0% 32.2% 23.4% | |
|TERMINAL (d) | 0/8 (0%) 0/8 (0%) 3/8 (38%) 2/8 (25%) | |
|FIRST INCIDENCE | --- --- 272 (T) 272 (T) | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.084 (e) P=0.107 P=0.232 | |
|POLY 3 | P=0.070 (e) P=0.107 P=0.221 | |
|POLY 1.5 | P=0.069 (e) P=0.104 P=0.219 | |
|POLY 6 | P=0.071 (e) P=0.105 P=0.223 | |
|LOGISTIC REGRESSION| (e) (e) P=0.107 P=0.232 | |
|COCH-ARM / FISHERS | P=0.085 (e) P=0.105 P=0.237 | |
|ORDER RESTRICTED | P=0.066 (e) (e) (e) | |
|=================================================================================================================================|
Date: 12/08/03 EXPERIMENT: 97013 TEST: 92 Page 4
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (SOD
IUM BR
Terminal Sacrifice at 39 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 64 MG/KG 128 256 |0 MG/KG 64 MG/KG 128 256 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/10 (70%) 10/10 (100%) 9/10 (90%) 10/10 (100%)|5/9 (56%) 6/10 (60%) 8/10 (80%) 10/10 (100%) |
|POLY-3 RATE (b) | 7/8.63 10/10.00 9/9.79 10/10.00 |5/8.29 6/8.16 8/9.10 10/10.00 |
|POLY-3 PERCENT (g) | 81.1% 100.0% 92.0% 100.0% |60.3% 73.5% 87.9% 100.0% |
|TERMINAL (d) | 7/8 (88%) 8/8 (100%) 8/8 (100%) 8/8 (100%) |5/7 (71%) 5/7 (71%) 7/8 (88%) 8/8 (100%) |
|FIRST INCIDENCE | 272 (T) 140 221 69 |272 (T) 148 221 218 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.135 P=0.138 P=0.264 P=0.131 |P=0.038 * P=0.488 P=0.273 P=0.069 |
|POLY 3 | P=0.208 P=0.242 P=0.500 P=0.242 |P=0.016 * P=0.482 P=0.210 P=0.031 * |
|POLY 1.5 | P=0.141 P=0.163 P=0.420 P=0.163 |P=0.011 * P=0.487 P=0.208 P=0.025 * |
|POLY 6 | P=0.283 P=0.346 P=0.565 P=0.346 |P=0.026 * P=0.522 P=0.250 P=0.047 * |
|LOGISTIC REGRESSION| P=0.053 P=0.091 P=0.439 P=0.072 |P=0.017 * P=0.405 P=0.161 P=0.031 * |
|COCH-ARM / FISHERS | P=0.077 P=0.105 P=0.291 P=0.105 |P=0.013 * P=0.605 P=0.259 P=0.033 * |
|ORDER RESTRICTED | P=0.045 * (e) (e) (e) |P=0.012 * (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 64 MG/KG 128 256 |0 MG/KG 64 MG/KG 128 256 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Kidney: Cortex |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/10 (0%) 3/10 (30%) 1/10 (10%) 0/10 (0%) |1/9 (11%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/8.63 3/8.92 1/9.32 0/8.55 |1/8.29 0/7.32 0/8.64 0/9.36 |
|POLY-3 PERCENT (g) | 0.0% 33.6% 10.7% 0.0% |12.1% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/8 (0%) 3/8 (38%) 1/8 (13%) 0/8 (0%) |1/7 (14%) 0/7 (0%) 0/8 (0%) 0/8 (0%) |
|FIRST INCIDENCE | --- 272 (T) 272 (T) --- |272 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.361N P=0.107 P=0.500 (e) |P=0.287N P=0.500N P=0.473N P=0.473N |
|POLY 3 | P=0.350N P=0.097 P=0.515 (e) |P=0.274N P=0.525N P=0.492N P=0.476N |
|POLY 1.5 | P=0.358N P=0.096 P=0.512 (e) |P=0.277N P=0.517N P=0.490N P=0.477N |
|POLY 6 | P=0.346N P=0.098 P=0.515 (e) |P=0.275N P=0.522N P=0.489N P=0.474N |
|LOGISTIC REGRESSION| (e) P=0.107 P=0.500 (e) |P=0.287N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.361N P=0.105 P=0.500 (e) |P=0.292N P=0.474N P=0.474N P=0.474N |
|ORDER RESTRICTED | P=0.196N (e) (e) (e) |P=0.101N (e) (e) (e) |
|=================================================================================================================================|
Date: 12/08/03 EXPERIMENT: 97013 TEST: 92 Page 5
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (SOD
IUM BR
Terminal Sacrifice at 39 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 64 MG/KG 128 256 |0 MG/KG 64 MG/KG 128 256 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 2/10 (20%) |0/9 (0%) 0/10 (0%) 0/10 (0%) 4/10 (40%) |
|POLY-3 RATE (b) | 0/8.63 0/8.92 0/9.32 2/8.55 |0/8.29 0/7.32 0/8.64 4/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 23.4% |0.0% 0.0% 0.0% 40.0% |
|TERMINAL (d) | 0/8 (0%) 0/8 (0%) 0/8 (0%) 2/8 (25%) |0/7 (0%) 0/7 (0%) 0/8 (0%) 2/8 (25%) |
|FIRST INCIDENCE | --- --- --- 272 (T) |--- --- --- 218 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.044 * (e) (e) P=0.232 |P=0.006 ** (e) (e) P=0.089 |
|POLY 3 | P=0.036 * (e) (e) P=0.221 |P<0.001 ** (e) (e) P=0.055 |
|POLY 1.5 | P=0.036 * (e) (e) P=0.219 |P<0.001 ** (e) (e) P=0.050 |
|POLY 6 | P=0.036 * (e) (e) P=0.223 |P<0.001 ** (e) (e) P=0.063 |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.232 |P=0.003 ** (e) (e) P=0.044 * |
|COCH-ARM / FISHERS | P=0.043 * (e) (e) P=0.237 |P=0.003 ** (e) (e) P=0.054 |
|ORDER RESTRICTED | P=0.021 * (e) (e) (e) |P<0.001 ** (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 64 MG/KG 128 256 |0 MG/KG 64 MG/KG 128 256 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/10 (0%) 1/10 (10%) 1/10 (10%) 1/10 (10%) |2/9 (22%) 2/10 (20%) 2/10 (20%) 2/10 (20%) |
|POLY-3 RATE (b) | 0/8.63 1/8.92 1/9.32 1/9.02 |2/8.29 2/7.32 2/9.54 2/9.52 |
|POLY-3 PERCENT (g) | 0.0% 11.2% 10.7% 11.1% |24.1% 27.3% 21.0% 21.0% |
|TERMINAL (d) | 0/8 (0%) 1/8 (13%) 1/8 (13%) 0/8 (0%) |2/7 (29%) 2/7 (29%) 1/8 (13%) 1/8 (13%) |
|FIRST INCIDENCE | --- 272 (T) 272 (T) 221 |272 (T) 272 (T) 127 257 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.391 P=0.500 P=0.500 P=0.523 |P=0.529N P=0.716 P=0.654N P=0.640N |
|POLY 3 | P=0.400 P=0.507 P=0.515 P=0.509 |P=0.521N P=0.660 P=0.652N P=0.653N |
|POLY 1.5 | P=0.386 P=0.504 P=0.512 P=0.501 |P=0.532N P=0.675 P=0.657N P=0.658N |
|POLY 6 | P=0.416 P=0.508 P=0.515 P=0.517 |P=0.511N P=0.667 P=0.642N P=0.643N |
|LOGISTIC REGRESSION| P=0.380 P=0.500 P=0.500 P=0.521 |P=0.567N P=0.716 P=0.584N P=0.664N |
|COCH-ARM / FISHERS | P=0.380 P=0.500 P=0.500 P=0.500 |P=0.569N P=0.667N P=0.667N P=0.667N |
|ORDER RESTRICTED | P=0.334 (e) (e) (e) |P=0.639N (e) (e) (e) |
|=================================================================================================================================|
Date: 12/08/03 EXPERIMENT: 97013 TEST: 92 Page 6
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (SOD
IUM BR
Terminal Sacrifice at 39 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 64 MG/KG 128 256 |0 MG/KG 64 MG/KG 128 256 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 8/10 (80%) 8/10 (80%) 6/10 (60%) 6/10 (60%) |7/9 (78%) 9/10 (90%) 10/10 (100%) 9/10 (90%) |
|POLY-3 RATE (b) | 8/9.52 8/8.92 6/9.79 6/9.02 |7/8.79 9/9.15 10/10.00 9/10.00 |
|POLY-3 PERCENT (g) | 84.1% 89.7% 61.3% 66.6% |79.7% 98.4% 100.0% 90.0% |
|TERMINAL (d) | 7/8 (88%) 8/8 (100%) 5/8 (63%) 5/8 (63%) |6/7 (86%) 7/7 (100%) 8/8 (100%) 7/8 (88%) |
|FIRST INCIDENCE | 134 272 (T) 221 221 |217 62 127 218 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.173N P=0.760 P=0.313N P=0.329N |P=0.526 P=0.285 P=0.316 P=0.528 |
|POLY 3 | P=0.175N P=0.638 P=0.269N P=0.369N |P=0.466 P=0.290 P=0.226 P=0.509 |
|POLY 1.5 | P=0.198N P=0.655 P=0.288N P=0.385N |P=0.412 P=0.337 P=0.213 P=0.486 |
|POLY 6 | P=0.140N P=0.641 P=0.249N P=0.331N |P=0.539 P=0.287 P=0.255 P=0.550 |
|LOGISTIC REGRESSION| P=0.183N P=0.701N P=0.314N P=0.332N |P=0.361 P=0.355 P=0.209 P=0.459 |
|COCH-ARM / FISHERS | P=0.175N P=0.709N P=0.314N P=0.314N |P=0.336 P=0.458 P=0.211 P=0.458 |
|ORDER RESTRICTED | P=0.192N (e) (e) (e) |P=0.131 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 64 MG/KG 128 256 |0 MG/KG 64 MG/KG 128 256 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 2/10 (20%) |2/9 (22%) 1/10 (10%) 1/10 (10%) 2/10 (20%) |
|POLY-3 RATE (b) | 0/8.63 0/8.92 0/9.32 2/8.55 |2/8.29 1/7.32 1/8.64 2/9.84 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 23.4% |24.1% 13.7% 11.6% 20.3% |
|TERMINAL (d) | 0/8 (0%) 0/8 (0%) 0/8 (0%) 2/8 (25%) |2/7 (29%) 1/7 (14%) 1/8 (13%) 1/8 (13%) |
|FIRST INCIDENCE | --- --- --- 272 (T) |272 (T) 272 (T) 272 (T) 218 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.044 * (e) (e) P=0.232 |P=0.606N P=0.500N P=0.450N P=0.643N |
|POLY 3 | P=0.036 * (e) (e) P=0.221 |P=0.590N P=0.546N P=0.485N P=0.639N |
|POLY 1.5 | P=0.036 * (e) (e) P=0.219 |P=0.604N P=0.531N P=0.481N P=0.649N |
|POLY 6 | P=0.036 * (e) (e) P=0.223 |P=0.580N P=0.541N P=0.481N P=0.624N |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.232 |P=0.617 P=0.500N P=0.450N P=0.687N |
|COCH-ARM / FISHERS | P=0.043 * (e) (e) P=0.237 |P=0.592 P=0.458N P=0.458N P=0.667N |
|ORDER RESTRICTED | P=0.021 * (e) (e) (e) |P=0.502N (e) (e) (e) |
|=================================================================================================================================|
Date: 12/08/03 EXPERIMENT: 97013 TEST: 92 Page 7
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (SOD
IUM BR
Terminal Sacrifice at 39 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 64 MG/KG 128 256 |0 MG/KG 64 MG/KG 128 256 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/10 (50%) 8/10 (80%) 6/10 (60%) 2/10 (20%) |7/9 (78%) 4/10 (40%) 7/10 (70%) 8/10 (80%) |
|POLY-3 RATE (b) | 5/9.12 8/10.00 6/9.32 2/8.55 |7/8.29 4/8.16 7/9.10 8/9.84 |
|POLY-3 PERCENT (g) | 54.8% 80.0% 64.4% 23.4% |84.4% 49.0% 76.9% 81.3% |
|TERMINAL (d) | 4/8 (50%) 6/8 (75%) 6/8 (75%) 2/8 (25%) |7/7 (100%) 3/7 (43%) 6/8 (75%) 7/8 (88%) |
|FIRST INCIDENCE | 218 140 272 (T) 272 (T) |272 (T) 148 221 218 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.058N P=0.238 P=0.509 P=0.186N |P=0.388 P=0.168N P=0.518N P=0.751N |
|POLY 3 | P=0.058N P=0.249 P=0.522 P=0.193N |P=0.444 P=0.146N P=0.585N P=0.676N |
|POLY 1.5 | P=0.054N P=0.225 P=0.529 P=0.190N |P=0.398 P=0.154N P=0.599N P=0.708N |
|POLY 6 | P=0.066N P=0.261 P=0.487 P=0.202N |P=0.484 P=0.112N P=0.516N P=0.623N |
|LOGISTIC REGRESSION| P=0.050N P=0.176 P=0.583 P=0.175N |P=0.378 P=0.217N P=0.686N P=0.726 |
|COCH-ARM / FISHERS | P=0.049N* P=0.175 P=0.500 P=0.175N |P=0.295 P=0.115N P=0.556N P=0.667 |
|ORDER RESTRICTED | P=0.036N* (e) (e) (e) |P=0.378 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 64 MG/KG 128 256 |0 MG/KG 64 MG/KG 128 256 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Lung |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/10 (0%) 2/10 (20%) 1/10 (10%) 1/10 (10%) |0/9 (0%) 1/10 (10%) 1/10 (10%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/8.63 2/8.92 1/9.32 1/8.55 |0/8.29 1/7.32 1/8.64 0/9.36 |
|POLY-3 PERCENT (g) | 0.0% 22.4% 10.7% 11.7% |0.0% 13.7% 11.6% 0.0% |
|TERMINAL (d) | 0/8 (0%) 2/8 (25%) 1/8 (13%) 1/8 (13%) |0/7 (0%) 1/7 (14%) 1/8 (13%) 0/8 (0%) |
|FIRST INCIDENCE | --- 272 (T) 272 (T) 272 (T) |--- 272 (T) 272 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.500 P=0.232 P=0.500 P=0.500 |P=0.564N P=0.500 P=0.527 (e) |
|POLY 3 | P=0.497 P=0.232 P=0.515 P=0.498 |P=0.580N P=0.475 P=0.508 (e) |
|POLY 1.5 | P=0.491 P=0.230 P=0.512 P=0.495 |P=0.580N P=0.483 P=0.510 (e) |
|POLY 6 | P=0.502 P=0.234 P=0.515 P=0.500 |P=0.576N P=0.478 P=0.510 (e) |
|LOGISTIC REGRESSION| (e) P=0.232 P=0.500 P=0.500 |(e) P=0.500 P=0.527 (e) |
|COCH-ARM / FISHERS | P=0.500 P=0.237 P=0.500 P=0.500 |P=0.580N P=0.526 P=0.526 (e) |
|ORDER RESTRICTED | P=0.274 (e) (e) (e) |P=0.369N (e) (e) (e) |
|=================================================================================================================================|
Date: 12/08/03 EXPERIMENT: 97013 TEST: 92 Page 8
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (SOD
IUM BR
Terminal Sacrifice at 39 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 64 MG/KG 128 256 |0 MG/KG 64 MG/KG 128 256 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/10 (10%) 0/10 (0%) 0/10 (0%) 3/10 (30%) |1/9 (11%) 3/10 (30%) 2/10 (20%) 2/10 (20%) |
|POLY-3 RATE (b) | 1/8.63 0/8.92 0/9.32 3/9.02 |1/8.79 3/7.32 2/10.00 2/9.52 |
|POLY-3 PERCENT (g) | 11.6% 0.0% 0.0% 33.3% |11.4% 41.0% 20.0% 21.0% |
|TERMINAL (d) | 1/8 (13%) 0/8 (0%) 0/8 (0%) 2/8 (25%) |0/7 (0%) 3/7 (43%) 0/8 (0%) 1/8 (13%) |
|FIRST INCIDENCE | 272 (T) --- --- 221 |217 272 (T) 127 257 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.085 P=0.500N P=0.500N P=0.310 |P=0.573 P=0.274 P=0.526 P=0.556 |
|POLY 3 | P=0.069 P=0.493N P=0.485N P=0.305 |P=0.539 P=0.218 P=0.546 P=0.529 |
|POLY 1.5 | P=0.068 P=0.496N P=0.488N P=0.291 |P=0.542 P=0.241 P=0.542 P=0.532 |
|POLY 6 | P=0.071 P=0.492N P=0.485N P=0.321 |P=0.536 P=0.210 P=0.553 P=0.526 |
|LOGISTIC REGRESSION| P=0.075 (e) (e) P=0.282 |P=0.500 P=0.262 (e) P=0.511 |
|COCH-ARM / FISHERS | P=0.077 P=0.500N P=0.500N P=0.291 |P=0.539 P=0.333 P=0.542 P=0.542 |
|ORDER RESTRICTED | P=0.028 * (e) (e) (e) |P=0.363 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 64 MG/KG 128 256 |0 MG/KG 64 MG/KG 128 256 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Mesentery: Fat |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/1 (100%) 0/0 (0%) 2/2 (100%) 0/0 (0%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|POLY-3 RATE (b) | 1/1.00 0/0.00 2/2.00 0/0.00 |0/0.00 0/0.00 0/0.00 0/0.00 |
|POLY-3 PERCENT (g) | 100.0% 0.0% 100.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/1 (100%) 0/0 (0%) 2/2 (100%) 0/0 (0%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 272 (T) --- 272 (T) --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |(e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 12/08/03 EXPERIMENT: 97013 TEST: 92 Page 9
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (SOD
IUM BR
Terminal Sacrifice at 39 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 64 MG/KG 128 256 |0 MG/KG 64 MG/KG 128 256 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Mesentery: Fat |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/1 (100%) 0/0 (0%) 2/2 (100%) 0/0 (0%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|POLY-3 RATE (b) | 1/1.00 0/0.00 2/2.00 0/0.00 |0/0.00 0/0.00 0/0.00 0/0.00 |
|POLY-3 PERCENT (g) | 100.0% 0.0% 100.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/1 (100%) 0/0 (0%) 2/2 (100%) 0/0 (0%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 272 (T) --- 272 (T) --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |(e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 64 MG/KG 128 256 |0 MG/KG 64 MG/KG 128 256 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Ovary |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |1/9 (11%) 4/10 (40%) 2/10 (20%) 5/10 (50%) |
|POLY-3 RATE (b) | |1/8.29 4/7.32 2/8.64 5/9.52 |
|POLY-3 PERCENT (g) | |12.1% 54.6% 23.2% 52.6% |
|TERMINAL (d) | |1/7 (14%) 4/7 (57%) 2/8 (25%) 4/8 (50%) |
|FIRST INCIDENCE | |272 (T) 272 (T) 272 (T) 257 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.124 P=0.141 P=0.550 P=0.116 |
|POLY 3 | |P=0.102 P=0.095 P=0.515 P=0.086 |
|POLY 1.5 | |P=0.099 P=0.109 P=0.519 P=0.084 |
|POLY 6 | |P=0.108 P=0.096 P=0.519 P=0.091 |
|LOGISTIC REGRESSION| |P=0.124 P=0.141 P=0.550 P=0.095 |
|COCH-ARM / FISHERS | |P=0.099 P=0.184 P=0.542 P=0.091 |
|ORDER RESTRICTED | |P=0.043 * (e) (e) (e) |
|=================================================================================================================================|
Date: 12/08/03 EXPERIMENT: 97013 TEST: 92 Page 10
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (SOD
IUM BR
Terminal Sacrifice at 39 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 64 MG/KG 128 256 |0 MG/KG 64 MG/KG 128 256 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/9 (33%) 3/10 (30%) 1/10 (10%) 3/10 (30%) |0/9 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 3/7.63 3/8.92 1/9.79 3/9.02 |0/8.29 0/7.32 0/8.64 0/9.36 |
|POLY-3 PERCENT (g) | 39.3% 33.6% 10.2% 33.3% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 3/7 (43%) 3/8 (38%) 0/8 (0%) 2/8 (25%) |0/7 (0%) 0/7 (0%) 0/8 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 272 (T) 272 (T) 221 221 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.494N P=0.620N P=0.243N P=0.612N |(e) (e) (e) (e) |
|POLY 3 | P=0.481N P=0.603N P=0.196N P=0.597N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.495N P=0.612N P=0.212N P=0.619N |(e) (e) (e) (e) |
|POLY 6 | P=0.467N P=0.596N P=0.185N P=0.571N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.511N P=0.620N P=0.238N P=0.636N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.505N P=0.630N P=0.249N P=0.630N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.351N (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 64 MG/KG 128 256 |0 MG/KG 64 MG/KG 128 256 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Skin: Epidermis |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/10 (40%) 2/10 (20%) 1/10 (10%) 2/10 (20%) |2/9 (22%) 2/10 (20%) 6/10 (60%) 3/10 (30%) |
|POLY-3 RATE (b) | 4/9.12 2/9.14 1/9.32 2/8.55 |2/8.29 2/7.32 6/9.10 3/9.36 |
|POLY-3 PERCENT (g) | 43.9% 21.9% 10.7% 23.4% |24.1% 27.3% 65.9% 32.1% |
|TERMINAL (d) | 3/8 (38%) 1/8 (13%) 1/8 (13%) 2/8 (25%) |2/7 (29%) 2/7 (29%) 5/8 (63%) 3/8 (38%) |
|FIRST INCIDENCE | 218 251 272 (T) 272 (T) |272 (T) 272 (T) 221 272 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.250N P=0.321N P=0.158N P=0.322N |P=0.395 P=0.716 P=0.134 P=0.570 |
|POLY 3 | P=0.252N P=0.312N P=0.136N P=0.346N |P=0.423 P=0.660 P=0.092 P=0.561 |
|POLY 1.5 | P=0.250N P=0.313N P=0.135N P=0.341N |P=0.407 P=0.675 P=0.091 P=0.557 |
|POLY 6 | P=0.259N P=0.313N P=0.145N P=0.357N |P=0.429 P=0.667 P=0.106 P=0.566 |
|LOGISTIC REGRESSION| P=0.244N P=0.306N P=0.140N P=0.318N |P=0.410 P=0.716 P=0.090 P=0.570 |
|COCH-ARM / FISHERS | P=0.241N P=0.314N P=0.152N P=0.314N |P=0.350 P=0.667N P=0.115 P=0.556 |
|ORDER RESTRICTED | P=0.153N (e) (e) (e) |P=0.214 (e) (e) (e) |
|=================================================================================================================================|
Date: 12/08/03 EXPERIMENT: 97013 TEST: 92 Page 11
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (SOD
IUM BR
Terminal Sacrifice at 39 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 64 MG/KG 128 256 |0 MG/KG 64 MG/KG 128 256 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/10 (30%) 2/10 (20%) 2/10 (20%) 3/10 (30%) |3/9 (33%) 6/10 (60%) 8/10 (80%) 8/10 (80%) |
|POLY-3 RATE (b) | 3/9.52 2/8.92 2/9.32 3/9.02 |3/8.29 6/7.32 8/9.54 8/9.52 |
|POLY-3 PERCENT (g) | 31.5% 22.4% 21.5% 33.3% |36.2% 82.0% 83.9% 84.1% |
|TERMINAL (d) | 2/8 (25%) 2/8 (25%) 2/8 (25%) 2/8 (25%) |3/7 (43%) 6/7 (86%) 7/8 (88%) 7/8 (88%) |
|FIRST INCIDENCE | 134 272 (T) 272 (T) 221 |272 (T) 272 (T) 127 257 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.547 P=0.500N P=0.500N P=0.669N |P=0.041 * P=0.141 P=0.062 P=0.066 |
|POLY 3 | P=0.532 P=0.532N P=0.510N P=0.654 |P=0.028 * P=0.079 P=0.039 * P=0.038 * |
|POLY 1.5 | P=0.526 P=0.524N P=0.505N P=0.649 |P=0.028 * P=0.105 P=0.040 * P=0.040 * |
|POLY 6 | P=0.545 P=0.535N P=0.520N P=0.667 |P=0.030 * P=0.078 P=0.040 * P=0.039 * |
|LOGISTIC REGRESSION| P=0.553 P=0.512N P=0.592N P=0.677N |P=0.047 * P=0.141 P=0.050 P=0.048 * |
|COCH-ARM / FISHERS | P=0.549 P=0.500N P=0.500N P=0.686N |P=0.033 * P=0.242 P=0.055 P=0.055 |
|ORDER RESTRICTED | P=0.555 (e) (e) (e) |P=0.008 ** (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 64 MG/KG 128 256 |0 MG/KG 64 MG/KG 128 256 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Stomach, Forestomach: Epithelium |
| Hyperkeratosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/10 (0%) 2/10 (20%) 0/10 (0%) 1/10 (10%) |1/9 (11%) 1/10 (10%) 2/10 (20%) 1/10 (10%) |
|POLY-3 RATE (b) | 0/8.63 2/8.92 0/9.32 1/9.02 |1/8.29 1/7.32 2/9.54 1/9.36 |
|POLY-3 PERCENT (g) | 0.0% 22.4% 0.0% 11.1% |12.1% 13.7% 21.0% 10.7% |
|TERMINAL (d) | 0/8 (0%) 2/8 (25%) 0/8 (0%) 0/8 (0%) |1/7 (14%) 1/7 (14%) 1/8 (13%) 1/8 (13%) |
|FIRST INCIDENCE | --- 272 (T) --- 221 |272 (T) 272 (T) 127 272 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.548 P=0.232 (e) P=0.523 |P=0.605N P=0.769 P=0.544 P=0.738N |
|POLY 3 | P=0.560 P=0.232 (e) P=0.509 |P=0.593N P=0.734 P=0.550 P=0.735N |
|POLY 1.5 | P=0.547 P=0.230 (e) P=0.501 |P=0.600N P=0.743 P=0.545 P=0.736N |
|POLY 6 | P=0.574 P=0.234 (e) P=0.517 |P=0.591N P=0.738 P=0.560 P=0.733N |
|LOGISTIC REGRESSION| P=0.541 P=0.232 (e) P=0.521 |P=0.609 P=0.769 P=0.691 P=0.738N |
|COCH-ARM / FISHERS | P=0.540 P=0.237 (e) P=0.500 |P=0.624 P=0.737N P=0.542 P=0.737N |
|ORDER RESTRICTED | P=0.319 (e) (e) (e) |P=0.596N (e) (e) (e) |
|=================================================================================================================================|
Date: 12/08/03 EXPERIMENT: 97013 TEST: 92 Page 12
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (SOD
IUM BR
Terminal Sacrifice at 39 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 64 MG/KG 128 256 |0 MG/KG 64 MG/KG 128 256 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Stomach, Forestomach: Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/10 (0%) 2/10 (20%) 0/10 (0%) 1/10 (10%) |1/9 (11%) 1/10 (10%) 3/10 (30%) 2/10 (20%) |
|POLY-3 RATE (b) | 0/8.63 2/8.92 0/9.32 1/9.02 |1/8.29 1/7.32 3/9.54 2/9.36 |
|POLY-3 PERCENT (g) | 0.0% 22.4% 0.0% 11.1% |12.1% 13.7% 31.5% 21.4% |
|TERMINAL (d) | 0/8 (0%) 2/8 (25%) 0/8 (0%) 0/8 (0%) |1/7 (14%) 1/7 (14%) 2/8 (25%) 2/8 (25%) |
|FIRST INCIDENCE | --- 272 (T) --- 221 |272 (T) 272 (T) 127 272 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.548 P=0.232 (e) P=0.523 |P=0.372 P=0.769 P=0.346 P=0.550 |
|POLY 3 | P=0.560 P=0.232 (e) P=0.509 |P=0.394 P=0.734 P=0.345 P=0.544 |
|POLY 1.5 | P=0.547 P=0.230 (e) P=0.501 |P=0.384 P=0.743 P=0.339 P=0.541 |
|POLY 6 | P=0.574 P=0.234 (e) P=0.517 |P=0.398 P=0.738 P=0.354 P=0.548 |
|LOGISTIC REGRESSION| P=0.541 P=0.232 (e) P=0.521 |P=0.341 P=0.769 P=0.416 P=0.550 |
|COCH-ARM / FISHERS | P=0.540 P=0.237 (e) P=0.500 |P=0.342 P=0.737N P=0.333 P=0.542 |
|ORDER RESTRICTED | P=0.319 (e) (e) (e) |P=0.367 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 64 MG/KG 128 256 |0 MG/KG 64 MG/KG 128 256 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Testes |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/10 (0%) 1/10 (10%) 1/10 (10%) 2/10 (20%) | |
|POLY-3 RATE (b) | 0/8.63 1/9.79 1/9.32 2/9.54 | |
|POLY-3 PERCENT (g) | 0.0% 10.2% 10.7% 21.0% | |
|TERMINAL (d) | 0/8 (0%) 0/8 (0%) 1/8 (13%) 1/8 (13%) | |
|FIRST INCIDENCE | --- 140 272 (T) 69 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.151 P=0.521 P=0.500 P=0.240 | |
|POLY 3 | P=0.166 P=0.525 P=0.515 P=0.249 | |
|POLY 1.5 | P=0.161 P=0.517 P=0.512 P=0.243 | |
|POLY 6 | P=0.167 P=0.530 P=0.515 P=0.253 | |
|LOGISTIC REGRESSION| P=0.162 P=0.451 P=0.500 P=0.268 | |
|COCH-ARM / FISHERS | P=0.143 P=0.500 P=0.500 P=0.237 | |
|ORDER RESTRICTED | P=0.128 (e) (e) (e) | |
|=================================================================================================================================|
Date: 12/08/03 EXPERIMENT: 97013 TEST: 92 Page 13
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (SOD
IUM BR
Terminal Sacrifice at 39 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 64 MG/KG 128 256 |0 MG/KG 64 MG/KG 128 256 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Testes: Bilateral, Germinal Epithelium |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/10 (0%) 1/10 (10%) 1/10 (10%) 2/10 (20%) | |
|POLY-3 RATE (b) | 0/8.63 1/8.92 1/9.32 2/8.55 | |
|POLY-3 PERCENT (g) | 0.0% 11.2% 10.7% 23.4% | |
|TERMINAL (d) | 0/8 (0%) 1/8 (13%) 1/8 (13%) 2/8 (25%) | |
|FIRST INCIDENCE | --- 272 (T) 272 (T) 272 (T) | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.143 P=0.500 P=0.500 P=0.232 | |
|POLY 3 | P=0.143 P=0.507 P=0.515 P=0.221 | |
|POLY 1.5 | P=0.141 P=0.504 P=0.512 P=0.219 | |
|POLY 6 | P=0.145 P=0.508 P=0.515 P=0.223 | |
|LOGISTIC REGRESSION| (e) P=0.500 P=0.500 P=0.232 | |
|COCH-ARM / FISHERS | P=0.143 P=0.500 P=0.500 P=0.237 | |
|ORDER RESTRICTED | P=0.106 (e) (e) (e) | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 64 MG/KG 128 256 |0 MG/KG 64 MG/KG 128 256 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Testes: Germinal Epithelium |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/10 (10%) 3/10 (30%) 4/10 (40%) 8/10 (80%) | |
|POLY-3 RATE (b) | 1/8.63 3/9.79 4/9.32 8/9.54 | |
|POLY-3 PERCENT (g) | 11.6% 30.7% 42.9% 83.9% | |
|TERMINAL (d) | 1/8 (13%) 2/8 (25%) 4/8 (50%) 7/8 (88%) | |
|FIRST INCIDENCE | 272 (T) 140 272 (T) 69 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.309 P=0.148 P=0.004 ** | |
|POLY 3 | P<0.001 ** P=0.340 P=0.167 P<0.001 ** | |
|POLY 1.5 | P<0.001 ** P=0.325 P=0.163 P<0.001 ** | |
|POLY 6 | P<0.001 ** P=0.349 P=0.164 P<0.001 ** | |
|LOGISTIC REGRESSION| P<0.001 ** P=0.271 P=0.148 P=0.003 ** | |
|COCH-ARM / FISHERS | P<0.001 ** P=0.291 P=0.152 P=0.003 ** | |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) | |
|=================================================================================================================================|
Date: 12/08/03 EXPERIMENT: 97013 TEST: 92 Page 14
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (SOD
IUM BR
Terminal Sacrifice at 39 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 64 MG/KG 128 256 |0 MG/KG 64 MG/KG 128 256 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Thymus |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/10 (30%) 2/10 (20%) 4/10 (40%) 3/9 (33%) |1/8 (13%) 1/10 (10%) 2/10 (20%) 1/10 (10%) |
|POLY-3 RATE (b) | 3/8.63 2/9.79 4/9.54 3/9.00 |1/8.00 1/8.17 2/9.54 1/9.52 |
|POLY-3 PERCENT (g) | 34.7% 20.4% 41.9% 33.3% |12.5% 12.2% 21.0% 10.5% |
|TERMINAL (d) | 3/8 (38%) 1/8 (13%) 3/8 (38%) 1/7 (14%) |0/7 (0%) 0/7 (0%) 1/8 (13%) 0/8 (0%) |
|FIRST INCIDENCE | 272 (T) 140 251 69 |251 144 127 257 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.452 P=0.490N P=0.510 P=0.637 |P=0.593N P=0.746 P=0.527 P=0.719N |
|POLY 3 | P=0.504 P=0.437N P=0.564 P=0.662N |P=0.590N P=0.757N P=0.563 P=0.722N |
|POLY 1.5 | P=0.482 P=0.457N P=0.545 P=0.679 |P=0.586N P=0.749N P=0.570 P=0.717N |
|POLY 6 | P=0.526 P=0.425N P=0.574 P=0.640N |P=0.598N P=0.761N P=0.554 P=0.729N |
|LOGISTIC REGRESSION| P=0.473 P=0.511N P=0.551 P=0.669 |P=0.577 P=0.578N P=0.712N P=0.638N |
|COCH-ARM / FISHERS | P=0.434 P=0.500N P=0.500 P=0.630 |P=0.602N P=0.706N P=0.588 P=0.706N |
|ORDER RESTRICTED | P=0.514 (e) (e) (e) |P=0.603N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 64 MG/KG 128 256 |0 MG/KG 64 MG/KG 128 256 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Thymus |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/10 (70%) 1/10 (10%) 0/10 (0%) 3/9 (33%) |0/8 (0%) 1/10 (10%) 2/10 (20%) 5/10 (50%) |
|POLY-3 RATE (b) | 7/9.12 1/8.92 0/9.32 3/7.55 |0/7.79 1/7.32 2/8.64 5/9.52 |
|POLY-3 PERCENT (g) | 76.8% 11.2% 0.0% 39.7% |0.0% 13.7% 23.2% 52.6% |
|TERMINAL (d) | 6/8 (75%) 1/8 (13%) 0/8 (0%) 3/7 (43%) |0/7 (0%) 1/7 (14%) 2/8 (25%) 4/8 (50%) |
|FIRST INCIDENCE | 218 272 (T) --- 272 (T) |--- 272 (T) 272 (T) 257 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.134N P=0.014N* P=0.003N** P=0.138N |P=0.008 ** P=0.500 P=0.262 P=0.038 * |
|POLY 3 | P=0.074N P=0.002N** P<0.001N** P=0.144N |P=0.004 ** P=0.488 P=0.247 P=0.016 * |
|POLY 1.5 | P=0.077N P=0.002N** P<0.001N** P=0.139N |P=0.004 ** P=0.500 P=0.257 P=0.017 * |
|POLY 6 | P=0.075N P=0.002N** P<0.001N** P=0.157N |P=0.004 ** P=0.484 P=0.242 P=0.015 * |
|LOGISTIC REGRESSION| P=0.129N P=0.009N** P=0.002N** P=0.124N |P=0.007 ** P=0.500 P=0.262 P=0.029 * |
|COCH-ARM / FISHERS | P=0.129N P=0.010N* P=0.002N** P=0.128N |P=0.006 ** P=0.556 P=0.294 P=0.029 * |
|ORDER RESTRICTED | P<0.001N** (e) (e) (e) |P=0.004 ** (e) (e) (e) |
|=================================================================================================================================|
Date: 12/08/03 EXPERIMENT: 97013 TEST: 92 Page 15
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (SOD
IUM BR
Terminal Sacrifice at 39 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 64 MG/KG 128 256 |0 MG/KG 64 MG/KG 128 256 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Thyroid Gland |
| Infiltration Cellular Lymphocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 2/10 (20%) 1/10 (10%) |0/9 (0%) 2/10 (20%) 5/10 (50%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/8.63 0/8.92 2/9.32 1/8.55 |0/8.29 2/7.32 5/8.64 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 21.5% 11.7% |0.0% 27.3% 57.9% 100.0% |
|TERMINAL (d) | 0/8 (0%) 0/8 (0%) 2/8 (25%) 1/8 (13%) |0/7 (0%) 2/7 (29%) 5/8 (63%) 8/8 (100%) |
|FIRST INCIDENCE | --- --- 272 (T) 272 (T) |--- 272 (T) 272 (T) 218 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.240 (e) P=0.232 P=0.500 |P<0.001 ** P=0.231 P=0.026 * P<0.001 ** |
|POLY 3 | P=0.227 (e) P=0.243 P=0.498 |P<0.001 ** P=0.193 P=0.006 ** P<0.001 ** |
|POLY 1.5 | P=0.224 (e) P=0.240 P=0.495 |P<0.001 ** P=0.203 P=0.008 ** P<0.001 ** |
|POLY 6 | P=0.230 (e) P=0.242 P=0.500 |P<0.001 ** P=0.196 P=0.006 ** P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) P=0.232 P=0.500 |P<0.001 ** P=0.231 P=0.026 * P<0.001 ** |
|COCH-ARM / FISHERS | P=0.239 (e) P=0.237 P=0.500 |P<0.001 ** P=0.263 P=0.022 * P<0.001 ** |
|ORDER RESTRICTED | P=0.169 (e) (e) (e) |P<0.001 ** (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 64 MG/KG 128 256 |0 MG/KG 64 MG/KG 128 256 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicle |
| Depletion Secretory |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 8/10 (80%) 7/10 (70%) 9/10 (90%) 9/10 (90%) |5/9 (56%) 8/10 (80%) 10/10 (100%) 10/10 (100%) |
|POLY-3 RATE (b) | 8/9.12 7/9.14 9/9.79 9/10.00 |5/8.29 8/8.16 10/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 87.7% 76.6% 92.0% 90.0% |60.3% 98.0% 100.0% 100.0% |
|TERMINAL (d) | 7/8 (88%) 6/8 (75%) 8/8 (100%) 7/8 (88%) |5/7 (71%) 7/7 (100%) 8/8 (100%) 8/8 (100%) |
|FIRST INCIDENCE | 218 251 221 69 |272 (T) 148 127 218 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.308 P=0.489N P=0.538 P=0.511 |P=0.054 P=0.111 P=0.062 P=0.069 |
|POLY 3 | P=0.455 P=0.497N P=0.679 P=0.710 |P=0.005 ** P=0.073 P=0.031 * P=0.031 * |
|POLY 1.5 | P=0.394 P=0.496N P=0.636 P=0.655 |P=0.003 ** P=0.095 P=0.025 * P=0.025 * |
|POLY 6 | P=0.485 P=0.499N P=0.678 P=0.734 |P=0.013 * P=0.082 P=0.047 * P=0.047 * |
|LOGISTIC REGRESSION| P=0.222 P=0.447N P=0.712 P=0.473 |P=0.009 ** P=0.056 P=0.029 * P=0.031 * |
|COCH-ARM / FISHERS | P=0.263 P=0.500N P=0.500 P=0.500 |P=0.010 * P=0.259 P=0.033 * P=0.033 * |
|ORDER RESTRICTED | P=0.451 (e) (e) (e) |P<0.001 ** (e) (e) (e) |
|=================================================================================================================================|
Date: 12/08/03 EXPERIMENT: 97013 TEST: 92 Page 16
Statistical Analysis of Non-neoplastic Lesions in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (SOD
IUM BR
Terminal Sacrifice at 39 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 64 MG/KG 128 256 |0 MG/KG 64 MG/KG 128 256 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/10 (0%) 9/10 (90%) 8/10 (80%) 8/10 (80%) |1/9 (11%) 9/10 (90%) 9/10 (90%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/8.63 9/9.14 8/9.79 8/9.02 |1/8.29 9/9.15 9/9.10 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 98.5% 81.8% 88.7% |12.1% 98.4% 98.9% 100.0% |
|TERMINAL (d) | 0/8 (0%) 8/8 (100%) 7/8 (88%) 7/8 (88%) |1/7 (14%) 7/7 (100%) 8/8 (100%) 8/8 (100%) |
|FIRST INCIDENCE | --- 251 221 221 |272 (T) 62 221 218 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.005 ** P<0.001 ** P<0.001 ** P<0.001 ** |P=0.004 ** P=0.002 ** P=0.002 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P=0.003 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P<0.001 ** (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 64 MG/KG 128 256 |0 MG/KG 64 MG/KG 128 256 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Uterus: Endometrium |
| Hyperplasia Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |8/9 (89%) 7/10 (70%) 8/10 (80%) 10/10 (100%) |
|POLY-3 RATE (b) | |8/8.79 7/8.16 8/8.64 10/10.00 |
|POLY-3 PERCENT (g) | |91.1% 85.8% 92.6% 100.0% |
|TERMINAL (d) | |7/7 (100%) 6/7 (86%) 8/8 (100%) 8/8 (100%) |
|FIRST INCIDENCE | |217 148 272 (T) 218 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.347 P=0.542N P=0.500N P=0.567 |
|POLY 3 | |P=0.274 P=0.667N P=0.808 P=0.582 |
|POLY 1.5 | |P=0.246 P=0.597N P=0.759N P=0.528 |
|POLY 6 | |P=0.315 P=0.674N P=0.835 P=0.704 |
|LOGISTIC REGRESSION| |P=0.313 P=0.696N P=0.782N P=0.492 |
|COCH-ARM / FISHERS | |P=0.202 P=0.333N P=0.542N P=0.474 |
|ORDER RESTRICTED | |P=0.218 (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).