TDMS Study 97013-92 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus WATER DISINFECTION MODEL (SODIUM BROMATE) DATE: 12/08/03
EXPERIMENT: 97013 TEST: 92 TIME: 14:31:08
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 PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus WATER DISINFECTION MODEL (SODIUM BROMATE) DATE: 12/08/03
EXPERIMENT: 97013 TEST: 92 TIME: 14:31:08
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
Mice(TG.AC HETEROZYGOUS TRANSGENIC)
-----------------------------
FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE
BASED ON NUMBER OF TISSUES EXAMINED. IN OTHER TISSUES/ORGANS RATES
ARE BASED ON THE NUMBER OF ANIMALS NECROPSIED.
---------------
Lung
Ovary
Salivary Glands
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus WATER DISINFECTION MODEL (SODIUM BROMATE) DATE: 12/08/03
EXPERIMENT: 97013 TEST: 92 TIME: 14:31:08
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
===============================================================
Female Mice
------------
Organ Morphology
----- ----------
Stomach, Forestomach Squamous Cell Papilloma
===============================================================
Date: 12/08/03 EXPERIMENT: 97013 TEST: 92 Page 1
Statistical Analysis of Primary Tumors in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (SODIUM 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 |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/10 (10%) 2/10 (20%) 1/10 (10%) 1/10 (10%) |0/9 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) |
|POLY-3 RATE (b) | 1/8.63 2/8.92 1/9.32 1/8.55 |0/8.29 0/7.32 0/8.64 1/9.36 |
|POLY-3 PERCENT (g) | 11.6% 22.4% 10.7% 11.7% |0.0% 0.0% 0.0% 10.7% |
|TERMINAL (d) | 1/8 (13%) 2/8 (25%) 1/8 (13%) 1/8 (13%) |0/7 (0%) 0/7 (0%) 0/8 (0%) 1/8 (13%) |
|FIRST INCIDENCE | 272 (T) 272 (T) 272 (T) 272 (T) |--- --- --- 272 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.532N P=0.500 P=0.768 P=0.768 |P=0.216 (e) (e) P=0.527 |
|POLY 3 | P=0.530N P=0.512 P=0.745N P=0.761 |P=0.222 (e) (e) P=0.524 |
|POLY 1.5 | P=0.534N P=0.508 P=0.748N P=0.757 |P=0.219 (e) (e) P=0.523 |
|POLY 6 | P=0.528N P=0.515 P=0.746N P=0.763N |P=0.222 (e) (e) P=0.526 |
|LOGISTIC REGRESSION| P=0.532N P=0.500 P=0.768 P=0.768 |(e) (e) (e) P=0.527 |
|COCH-ARM / FISHERS | P=0.532N P=0.500 P=0.763N P=0.763N |P=0.203 (e) (e) P=0.526 |
|ORDER RESTRICTED | P=0.579N (e) (e) (e) |P=0.143 (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 |
|=================================================================================================================================|
| |
|Salivary Glands |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/2 (100%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |0/1 (0%) 1/1 (100%) 1/1 (100%) 0/0 (0%) |
|POLY-3 RATE (b) | 2/2.00 0/0.00 0/0.00 0/0.00 |0/1.00 1/1.00 1/1.00 0/0.00 |
|POLY-3 PERCENT (g) | 100.0% 0.0% 0.0% 0.0% |0.0% 100.0% 100.0% 0.0% |
|TERMINAL (d) | 1/1 (100%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |0/1 (0%) 0/0 (0%) 1/1 (100%) 0/0 (0%) |
|FIRST INCIDENCE | 134 --- --- --- |--- 144 272 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.675 P=0.527 P=0.500 (e) |
|POLY 3 | (e) (e) (e) (e) |(e) P=1.000N P=1.000N (e) |
|POLY 1.5 | (e) (e) (e) (e) |(e) P=1.000N P=1.000N (e) |
|POLY 6 | (e) (e) (e) (e) |(e) P=1.000N P=1.000N (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) P=0.250 (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.500 P=0.500 P=0.500 (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 12/08/03 EXPERIMENT: 97013 TEST: 92 Page 2
Statistical Analysis of Primary Tumors in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (SODIUM 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 |
|=================================================================================================================================|
| |
|Skin |
| Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor |
| (M or B), Basal Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepitheliom |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 7/10 (70%) 9/10 (90%) 6/10 (60%) 6/10 (60%) |6/9 (67%) 5/10 (50%) 5/10 (50%) 5/10 (50%) |
|POLY-3 RATE (b) | 7/8.63 9/9.14 6/9.79 6/9.02 |6/8.51 5/7.32 5/8.64 5/9.52 |
|POLY-3 PERCENT (g) | 81.1% 98.5% 61.3% 66.6% |70.5% 68.3% 57.9% 52.6% |
|TERMINAL (d) | 7/8 (88%) 8/8 (100%) 5/8 (63%) 5/8 (63%) |5/7 (71%) 5/7 (71%) 5/8 (63%) 4/8 (50%) |
|FIRST INCIDENCE | 272 (T) 251 221 221 |251 272 (T) 272 (T) 257 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.236N P=0.253 P=0.478N P=0.489N |P=0.284N P=0.513N P=0.377N P=0.373N |
|POLY 3 | P=0.157N P=0.309 P=0.338N P=0.440N |P=0.265N P=0.670N P=0.483N P=0.385N |
|POLY 1.5 | P=0.202N P=0.282 P=0.391N P=0.491N |P=0.285N P=0.610N P=0.460N P=0.390N |
|POLY 6 | P=0.120N P=0.377 P=0.302N P=0.383N |P=0.256N P=0.682N P=0.495N P=0.379N |
|LOGISTIC REGRESSION| P=0.222N P=0.354 P=0.385N P=0.505N |P=0.248N P=0.648N P=0.439N P=0.364N |
|COCH-ARM / FISHERS | P=0.242N P=0.291 P=0.500N P=0.500N |P=0.356N P=0.395N P=0.395N P=0.395N |
|ORDER RESTRICTED | P=0.143N (e) (e) (e) |P=0.339N (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 |
| Squamous Cell Papilloma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 7/10 (70%) 9/10 (90%) 6/10 (60%) 6/10 (60%) |6/9 (67%) 5/10 (50%) 5/10 (50%) 5/10 (50%) |
|POLY-3 RATE (b) | 7/8.63 9/9.14 6/9.79 6/9.02 |6/8.51 5/7.32 5/8.64 5/9.52 |
|POLY-3 PERCENT (g) | 81.1% 98.5% 61.3% 66.6% |70.5% 68.3% 57.9% 52.6% |
|TERMINAL (d) | 7/8 (88%) 8/8 (100%) 5/8 (63%) 5/8 (63%) |5/7 (71%) 5/7 (71%) 5/8 (63%) 4/8 (50%) |
|FIRST INCIDENCE | 272 (T) 251 221 221 |251 272 (T) 272 (T) 257 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.236N P=0.253 P=0.478N P=0.489N |P=0.284N P=0.513N P=0.377N P=0.373N |
|POLY 3 | P=0.157N P=0.309 P=0.338N P=0.440N |P=0.265N P=0.670N P=0.483N P=0.385N |
|POLY 1.5 | P=0.202N P=0.282 P=0.391N P=0.491N |P=0.285N P=0.610N P=0.460N P=0.390N |
|POLY 6 | P=0.120N P=0.377 P=0.302N P=0.383N |P=0.256N P=0.682N P=0.495N P=0.379N |
|LOGISTIC REGRESSION| P=0.222N P=0.354 P=0.385N P=0.505N |P=0.248N P=0.648N P=0.439N P=0.364N |
|COCH-ARM / FISHERS | P=0.242N P=0.291 P=0.500N P=0.500N |P=0.356N P=0.395N P=0.395N P=0.395N |
|ORDER RESTRICTED | P=0.143N (e) (e) (e) |P=0.339N (e) (e) (e) |
|=================================================================================================================================|
Date: 12/08/03 EXPERIMENT: 97013 TEST: 92 Page 3
Statistical Analysis of Primary Tumors in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (SODIUM 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 |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, Squamous Cell |
| Carcinoma or Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 7/10 (70%) 9/10 (90%) 6/10 (60%) 6/10 (60%) |6/9 (67%) 5/10 (50%) 5/10 (50%) 5/10 (50%) |
|POLY-3 RATE (b) | 7/8.63 9/9.14 6/9.79 6/9.02 |6/8.51 5/7.32 5/8.64 5/9.52 |
|POLY-3 PERCENT (g) | 81.1% 98.5% 61.3% 66.6% |70.5% 68.3% 57.9% 52.6% |
|TERMINAL (d) | 7/8 (88%) 8/8 (100%) 5/8 (63%) 5/8 (63%) |5/7 (71%) 5/7 (71%) 5/8 (63%) 4/8 (50%) |
|FIRST INCIDENCE | 272 (T) 251 221 221 |251 272 (T) 272 (T) 257 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.236N P=0.253 P=0.478N P=0.489N |P=0.284N P=0.513N P=0.377N P=0.373N |
|POLY 3 | P=0.157N P=0.309 P=0.338N P=0.440N |P=0.265N P=0.670N P=0.483N P=0.385N |
|POLY 1.5 | P=0.202N P=0.282 P=0.391N P=0.491N |P=0.285N P=0.610N P=0.460N P=0.390N |
|POLY 6 | P=0.120N P=0.377 P=0.302N P=0.383N |P=0.256N P=0.682N P=0.495N P=0.379N |
|LOGISTIC REGRESSION| P=0.222N P=0.354 P=0.385N P=0.505N |P=0.248N P=0.648N P=0.439N P=0.364N |
|COCH-ARM / FISHERS | P=0.242N P=0.291 P=0.500N P=0.500N |P=0.356N P=0.395N P=0.395N P=0.395N |
|ORDER RESTRICTED | P=0.143N (e) (e) (e) |P=0.339N (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 |
| Squamous Cell Papilloma, Papilloma, or Keratoacanthoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 7/10 (70%) 9/10 (90%) 6/10 (60%) 6/10 (60%) |6/9 (67%) 5/10 (50%) 5/10 (50%) 5/10 (50%) |
|POLY-3 RATE (b) | 7/8.63 9/9.14 6/9.79 6/9.02 |6/8.51 5/7.32 5/8.64 5/9.52 |
|POLY-3 PERCENT (g) | 81.1% 98.5% 61.3% 66.6% |70.5% 68.3% 57.9% 52.6% |
|TERMINAL (d) | 7/8 (88%) 8/8 (100%) 5/8 (63%) 5/8 (63%) |5/7 (71%) 5/7 (71%) 5/8 (63%) 4/8 (50%) |
|FIRST INCIDENCE | 272 (T) 251 221 221 |251 272 (T) 272 (T) 257 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.236N P=0.253 P=0.478N P=0.489N |P=0.284N P=0.513N P=0.377N P=0.373N |
|POLY 3 | P=0.157N P=0.309 P=0.338N P=0.440N |P=0.265N P=0.670N P=0.483N P=0.385N |
|POLY 1.5 | P=0.202N P=0.282 P=0.391N P=0.491N |P=0.285N P=0.610N P=0.460N P=0.390N |
|POLY 6 | P=0.120N P=0.377 P=0.302N P=0.383N |P=0.256N P=0.682N P=0.495N P=0.379N |
|LOGISTIC REGRESSION| P=0.222N P=0.354 P=0.385N P=0.505N |P=0.248N P=0.648N P=0.439N P=0.364N |
|COCH-ARM / FISHERS | P=0.242N P=0.291 P=0.500N P=0.500N |P=0.356N P=0.395N P=0.395N P=0.395N |
|ORDER RESTRICTED | P=0.143N (e) (e) (e) |P=0.339N (e) (e) (e) |
|=================================================================================================================================|
Date: 12/08/03 EXPERIMENT: 97013 TEST: 92 Page 4
Statistical Analysis of Primary Tumors in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (SODIUM 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 |
| Squamous Cell Papilloma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 3/10 (30%) 3/10 (30%) 2/10 (20%) 4/10 (40%) |2/9 (22%) 2/10 (20%) 7/10 (70%) 4/10 (40%) |
|POLY-3 RATE (b) | 3/8.63 3/8.92 2/9.32 4/9.02 |2/8.29 2/7.32 7/9.10 4/9.52 |
|POLY-3 PERCENT (g) | 34.7% 33.6% 21.5% 44.4% |24.1% 27.3% 76.9% 42.0% |
|TERMINAL (d) | 3/8 (38%) 3/8 (38%) 2/8 (25%) 3/8 (38%) |2/7 (29%) 2/7 (29%) 6/8 (75%) 3/8 (38%) |
|FIRST INCIDENCE | 272 (T) 272 (T) 272 (T) 221 |272 (T) 272 (T) 221 257 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.413 P=0.691 P=0.500N P=0.510 |P=0.230 P=0.716 P=0.063 P=0.400 |
|POLY 3 | P=0.432 P=0.668N P=0.461N P=0.528 |P=0.242 P=0.660 P=0.027 * P=0.387 |
|POLY 1.5 | P=0.414 P=0.673N P=0.470N P=0.505 |P=0.221 P=0.675 P=0.027 * P=0.380 |
|POLY 6 | P=0.452 P=0.664N P=0.463N P=0.554 |P=0.261 P=0.667 P=0.033 * P=0.400 |
|LOGISTIC REGRESSION| P=0.399 P=0.691 P=0.500N P=0.491 |P=0.228 P=0.716 P=0.035 * P=0.381 |
|COCH-ARM / FISHERS | P=0.408 P=0.686N P=0.500N P=0.500 |P=0.181 P=0.667N P=0.051 P=0.370 |
|ORDER RESTRICTED | P=0.421 (e) (e) (e) |P=0.087 (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 |
|=================================================================================================================================|
| |
|Tooth |
| Odontogenic Tumor |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/10 (20%) 3/10 (30%) 3/10 (30%) 2/10 (20%) |2/9 (22%) 3/10 (30%) 3/10 (30%) 3/10 (30%) |
|POLY-3 RATE (b) | 2/8.63 3/8.92 3/9.32 2/9.02 |2/9.00 3/7.32 3/9.54 3/9.52 |
|POLY-3 PERCENT (g) | 23.2% 33.6% 32.2% 22.2% |22.2% 41.0% 31.5% 31.5% |
|TERMINAL (d) | 2/8 (25%) 3/8 (38%) 3/8 (38%) 1/8 (13%) |0/7 (0%) 3/7 (43%) 2/8 (25%) 2/8 (25%) |
|FIRST INCIDENCE | 272 (T) 272 (T) 272 (T) 221 |217 272 (T) 127 257 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.543N P=0.500 P=0.500 P=0.690N |P=0.522 P=0.464 P=0.534 P=0.567 |
|POLY 3 | P=0.524N P=0.517 P=0.539 P=0.689N |P=0.484 P=0.396 P=0.529 P=0.528 |
|POLY 1.5 | P=0.543N P=0.511 P=0.530 P=0.703N |P=0.491 P=0.434 P=0.539 P=0.538 |
|POLY 6 | P=0.503N P=0.521 P=0.537 P=0.674N |P=0.468 P=0.377 P=0.516 P=0.514 |
|LOGISTIC REGRESSION| P=0.557N P=0.500 P=0.500 P=0.707 |P=0.472 P=0.480 P=0.686 P=0.528 |
|COCH-ARM / FISHERS | P=0.549N P=0.500 P=0.500 P=0.709N |P=0.475 P=0.556 P=0.556 P=0.556 |
|ORDER RESTRICTED | P=0.576N (e) (e) (e) |P=0.463 (e) (e) (e) |
|=================================================================================================================================|
Date: 12/08/03 EXPERIMENT: 97013 TEST: 92 Page 5
Statistical Analysis of Primary Tumors in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (SODIUM 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 |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 7/10 (70%) 9/10 (90%) 6/10 (60%) 6/10 (60%) |6/9 (67%) 5/10 (50%) 8/10 (80%) 8/10 (80%) |
|POLY-3 RATE (b) | 7/8.63 9/9.14 6/9.79 6/9.02 |6/8.51 5/7.32 8/9.10 8/9.52 |
|POLY-3 PERCENT (g) | 81.1% 98.5% 61.3% 66.6% |70.5% 68.3% 87.9% 84.1% |
|TERMINAL (d) | 7/8 (88%) 8/8 (100%) 5/8 (63%) 5/8 (63%) |5/7 (71%) 5/7 (71%) 7/8 (88%) 7/8 (88%) |
|FIRST INCIDENCE | 272 (T) 251 221 221 |251 272 (T) 221 257 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.236N P=0.253 P=0.478N P=0.489N |P=0.284 P=0.513N P=0.474 P=0.497 |
|POLY 3 | P=0.157N P=0.309 P=0.338N P=0.440N |P=0.281 P=0.670N P=0.377 P=0.450 |
|POLY 1.5 | P=0.202N P=0.282 P=0.391N P=0.491N |P=0.264 P=0.610N P=0.381 P=0.449 |
|POLY 6 | P=0.120N P=0.377 P=0.302N P=0.383N |P=0.286 P=0.682N P=0.406 P=0.453 |
|LOGISTIC REGRESSION| P=0.222N P=0.354 P=0.385N P=0.505N |P=0.290 P=0.648N P=0.320 P=0.484 |
|COCH-ARM / FISHERS | P=0.242N P=0.291 P=0.500N P=0.500N |P=0.202 P=0.395N P=0.444 P=0.444 |
|ORDER RESTRICTED | P=0.143N (e) (e) (e) |P=0.301 (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 |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 3/10 (30%) 2/10 (20%) 1/10 (10%) 1/10 (10%) |2/9 (22%) 1/10 (10%) 1/10 (10%) 1/10 (10%) |
|POLY-3 RATE (b) | 3/9.52 2/10.00 1/9.54 1/9.54 |2/8.51 1/8.17 1/8.64 1/9.36 |
|POLY-3 PERCENT (g) | 31.5% 20.0% 10.5% 10.5% |23.5% 12.2% 11.6% 10.7% |
|TERMINAL (d) | 2/8 (25%) 0/8 (0%) 0/8 (0%) 0/8 (0%) |1/7 (14%) 0/7 (0%) 1/8 (13%) 1/8 (13%) |
|FIRST INCIDENCE | 134 140 251 69 |251 144 272 (T) 272 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.205N P=0.480N P=0.295N P=0.315N |P=0.362N P=0.515N P=0.469N P=0.455N |
|POLY 3 | P=0.190N P=0.475N P=0.289N P=0.289N |P=0.365N P=0.515N P=0.494N P=0.465N |
|POLY 1.5 | P=0.189N P=0.486N P=0.290N P=0.290N |P=0.365N P=0.509N P=0.486N P=0.463N |
|POLY 6 | P=0.193N P=0.462N P=0.288N P=0.288N |P=0.369N P=0.510N P=0.498N P=0.469N |
|LOGISTIC REGRESSION| P=0.115N P=0.570N P=0.411N P=0.213N |P=0.393N P=0.355N P=0.480N P=0.459N |
|COCH-ARM / FISHERS | P=0.180N P=0.500N P=0.291N P=0.291N |P=0.376N P=0.458N P=0.458N P=0.458N |
|ORDER RESTRICTED | P=0.193N (e) (e) (e) |P=0.360N (e) (e) (e) |
|=================================================================================================================================|
Date: 12/08/03 EXPERIMENT: 97013 TEST: 92 Page 6
Statistical Analysis of Primary Tumors in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (SODIUM 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 |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 9/10 (90%) 10/10 (100%) 7/10 (70%) 7/10 (70%) |7/9 (78%) 7/10 (70%) 10/10 (100%) 9/10 (90%) |
|POLY-3 RATE (b) | 9/9.52 10/10.00 7/10.00 7/10.00 |7/9.00 7/8.17 10/10.00 9/9.52 |
|POLY-3 PERCENT (g) | 94.6% 100.0% 70.0% 70.0% |77.8% 85.7% 100.0% 94.6% |
|TERMINAL (d) | 8/8 (100%) 8/8 (100%) 5/8 (63%) 5/8 (63%) |5/7 (71%) 6/7 (86%) 8/8 (100%) 8/8 (100%) |
|FIRST INCIDENCE | 134 140 221 69 |217 144 127 257 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.173N P=0.526 P=0.310N P=0.335N |P=0.375 P=0.635 P=0.336 P=0.519 |
|POLY 3 | P=0.050N P=0.815 P=0.197N P=0.197N |P=0.167 P=0.578 P=0.201 P=0.350 |
|POLY 1.5 | P=0.064N P=0.646 P=0.236N P=0.236N |P=0.201 P=0.640 P=0.201 P=0.400 |
|POLY 6 | P=0.036N* P=0.996 P=0.154N P=0.154N |P=0.119 P=0.548 P=0.201 P=0.287 |
|LOGISTIC REGRESSION| P=0.085N P=0.515 P=0.283N P=0.282N |P=0.264 P=0.647 (e) P=0.479 |
|COCH-ARM / FISHERS | P=0.091N P=0.500 P=0.291N P=0.291N |P=0.202 P=0.556N P=0.211 P=0.458 |
|ORDER RESTRICTED | P=0.068N (e) (e) (e) |P=0.108 (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).