TDMS Study 05007-06 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst POLYSORBATE 80 DATE: 09/03/94
EXPERIMENT: 05007 TEST: 06 TIME: 13:00:00
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01CP9565102 ROUTE: DOSED FEED NTP C#: 60286
PATHOLOGIST: J. SAGARTZ S. EUSTIS CAS: 9005-65-6
------------------------------------------------------------------------------------------------------------------------------------
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst POLYSORBATE 80 DATE: 09/03/94
EXPERIMENT: 05007 TEST: 06 TIME: 13:00:00
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01CP9565102 ROUTE: DOSED FEED NTP C#: 60286
PATHOLOGIST: J. SAGARTZ S. EUSTIS CAS: 9005-65-6
RATS(FISCHER344)
----------------------------
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 NUMBER OF ANIMALS NECROPSIED.
----------------
Adrenal Gland
Bone Marrow
Brain
Clitoral Gland
Epididymis
Heart
Islets, Pancreatic
Kidney
Liver
Lung
Nose
Ovary
Pancreas
Parathyroid Gland
Pituitary Gland
Preputial Gland
Prostate
Salivary Glands
Spleen
Testes
Thymus
Thyroid Gland
Urinary Bladder
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst POLYSORBATE 80 DATE: 09/03/94
EXPERIMENT: 05007 TEST: 06 TIME: 13:00:00
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01CP9565102 ROUTE: DOSED FEED NTP C#: 60286
PATHOLOGIST: J. SAGARTZ S. EUSTIS CAS: 9005-65-6
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF THE STUDY OF POLYSORBATE 80
====================================================================================================
MALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Adrenal Medulla Pheochromocytoma Benign
Pheochromocytoma: Benign, Complex, Malignant, NOS
Testes Adenoma
All Organs Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
====================================================================================================
FEMALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Pituitary Gland: Pars Intermedia
Carcinoma or Adenoma
All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear,
or Undifferentiated
Malignant Tumors
====================================================================================================
DATE: 09/03/94 EXPERIMENT: 05007 TEST: 06 PAGE 1
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- POLYSORBATE 80
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 2.5% 5.0% | UNTREATD 2.5% 5.0% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 0/50 (0%) 0/50 (0%) | 1/50 (2%) 2/50 (4%) 0/50 (0%) |
|ADJUSTED (b) | 3.6% 0.0% 0.0% | 4.3% 8.0% 0.0% |
|TERMINAL (d) | 1/28 (4%) 0/18 (0%) 0/18 (0%) | 1/23 (4%) 2/25 (8%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) --- --- | 729 (T) 729 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.340N P=0.588N P=0.588N | P=0.337N P=0.529 P=0.483N |
|INCIDENTAL TUMOR | P=0.340N P=0.588N P=0.588N | P=0.337N P=0.529 P=0.483N |
|LOGISTIC REGRESSION | P=0.340N P=0.588N P=0.588N | P=0.337N P=0.529 P=0.483N |
|COCHRAN-ARMITAGE | P=0.266N | P=0.360N |
|FISHER EXACT | P=0.495N P=0.495N | P=0.500 P=0.500N |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 21/50 (42%) 16/50 (32%) 28/50 (56%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 57.0% 52.5% 86.8% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 14/29 (48%) 6/18 (33%) 14/18 (78%) | 0/23 (0%) 0/25 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | 561 613 570 | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.006 ** P=0.496 P=0.005 ** | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.042 * P=0.224N P=0.048 * | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.030 * P=0.256N P=0.032 * | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.095 | (e) |
|FISHER EXACT | P=0.204N P=0.115 | (e) (e) |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05007 TEST: 06 PAGE 2
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- POLYSORBATE 80
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 2.5% 5.0% | UNTREATD 2.5% 5.0% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Malignant |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 4/50 (8%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 3.4% 16.5% 7.5% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/29 (3%) 2/18 (11%) 1/18 (6%) | 0/23 (0%) 0/25 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 644 400 | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.283 P=0.094 P=0.388 | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.345 P=0.150 P=0.436 | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.412 P=0.154 P=0.557 | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.406 | (e) |
|FISHER EXACT | P=0.181 P=0.500 | (e) (e) |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | 6/50 (12%) 6/50 (12%) 7/50 (14%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% | 22.3% 20.4% 24.7% |
|TERMINAL (d) | 0/29 (0%) 0/18 (0%) 0/18 (0%) | 4/23 (17%) 4/25 (16%) 4/25 (16%) |
|FIRST INCIDENCE (DAYS) | --- --- --- | 645 610 700 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) | P=0.491 P=0.566N P=0.551 |
|INCIDENTAL TUMOR | (e) (e) (e) | P=0.413 P=0.612 P=0.454 |
|LOGISTIC REGRESSION | (e) (e) (e) | P=0.471 P=0.604N P=0.538 |
|COCHRAN-ARMITAGE | (e) | P=0.440 |
|FISHER EXACT | (e) (e) | P=0.620N P=0.500 |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05007 TEST: 06 PAGE 3
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- POLYSORBATE 80
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 2.5% 5.0% | UNTREATD 2.5% 5.0% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 21/50 (42%) 19/50 (38%) 29/50 (58%) | 6/50 (12%) 6/50 (12%) 7/50 (14%) |
|ADJUSTED (b) | 57.0% 61.6% 87.0% | 22.3% 20.4% 24.7% |
|TERMINAL (d) | 14/29 (48%) 8/18 (44%) 14/18 (78%) | 4/23 (17%) 4/25 (16%) 4/25 (16%) |
|FIRST INCIDENCE (DAYS) | 561 613 400 | 645 610 700 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.003 ** P=0.254 P=0.003 ** | P=0.491 P=0.566N P=0.551 |
|INCIDENTAL TUMOR | P=0.025 * P=0.479N P=0.036 * | P=0.413 P=0.612 P=0.454 |
|LOGISTIC REGRESSION | P=0.023 * P=0.499N P=0.027 * | P=0.471 P=0.604N P=0.538 |
|COCHRAN-ARMITAGE | P=0.066 | P=0.440 |
|FISHER EXACT | P=0.419N P=0.081 | P=0.620N P=0.500 |
|=================================================================================================================================|
| |
|Brain |
| Oligodendroglioma Malignant |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% | 0.0% 4.1% 0.0% |
|TERMINAL (d) | 0/29 (0%) 0/18 (0%) 0/18 (0%) | 0/23 (0%) 0/25 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- | --- 323 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) | P=0.667 P=0.240 (e) |
|INCIDENTAL TUMOR | (e) (e) (e) | P=0.691 P=0.401 (e) |
|LOGISTIC REGRESSION | (e) (e) (e) | P=0.556 P=0.197 (e) |
|COCHRAN-ARMITAGE | (e) | P=0.669 |
|FISHER EXACT | (e) (e) | P=0.247 (e) |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05007 TEST: 06 PAGE 4
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- POLYSORBATE 80
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 2.5% 5.0% | UNTREATD 2.5% 5.0% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/48 (10%) 1/50 (2%) 2/49 (4%) | 3/48 (6%) 3/49 (6%) 3/50 (6%) |
|ADJUSTED (b) | 15.0% 3.7% 8.6% | 11.1% 12.0% 9.1% |
|TERMINAL (d) | 3/28 (11%) 0/18 (0%) 1/18 (6%) | 2/22 (9%) 3/25 (12%) 1/25 (4%) |
|FIRST INCIDENCE (DAYS) | 561 692 682 | 561 729 (T) 623 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.237N P=0.186N P=0.355N | P=0.544N P=0.617N P=0.633N |
|INCIDENTAL TUMOR | P=0.125N P=0.083N P=0.240N | P=0.527N P=0.637N P=0.614N |
|LOGISTIC REGRESSION | P=0.143N P=0.098N P=0.231N | P=0.552N P=0.642N P=0.645N |
|COCHRAN-ARMITAGE | P=0.126N | P=0.563N |
|FISHER EXACT | P=0.093N P=0.209N | P=0.651N P=0.641N |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/48 (10%) 6/50 (12%) 5/49 (10%) | 7/48 (15%) 5/49 (10%) 4/50 (8%) |
|ADJUSTED (b) | 15.8% 21.4% 18.9% | 23.4% 15.7% 11.8% |
|TERMINAL (d) | 3/28 (11%) 2/18 (11%) 1/18 (6%) | 3/22 (14%) 2/25 (8%) 1/25 (4%) |
|FIRST INCIDENCE (DAYS) | 640 477 682 | 617 630 610 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.358 P=0.307 P=0.419 | P=0.190N P=0.325N P=0.240N |
|INCIDENTAL TUMOR | P=0.511N P=0.505 P=0.513N | P=0.207N P=0.440N P=0.250N |
|LOGISTIC REGRESSION | P=0.542 P=0.521 P=0.570 | P=0.179N P=0.352N P=0.229N |
|COCHRAN-ARMITAGE | P=0.551N | P=0.189N |
|FISHER EXACT | P=0.529 P=0.617N | P=0.365N P=0.239N |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05007 TEST: 06 PAGE 5
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- POLYSORBATE 80
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 2.5% 5.0% | UNTREATD 2.5% 5.0% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 10/48 (21%) 7/50 (14%) 7/49 (14%) | 10/48 (21%) 8/49 (16%) 7/50 (14%) |
|ADJUSTED (b) | 29.4% 24.3% 26.2% | 33.0% 26.7% 20.0% |
|TERMINAL (d) | 6/28 (21%) 2/18 (11%) 2/18 (11%) | 5/22 (23%) 5/25 (20%) 2/25 (8%) |
|FIRST INCIDENCE (DAYS) | 561 477 682 | 561 630 610 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.503N P=0.549N P=0.569N | P=0.217N P=0.323N P=0.267N |
|INCIDENTAL TUMOR | P=0.205N P=0.272N P=0.228N | P=0.221N P=0.431N P=0.258N |
|LOGISTIC REGRESSION | P=0.271N P=0.275N P=0.352N | P=0.207N P=0.361N P=0.258N |
|COCHRAN-ARMITAGE | P=0.232N | P=0.223N |
|FISHER EXACT | P=0.266N P=0.281N | P=0.379N P=0.266N |
|=================================================================================================================================|
| |
|Ear |
| Squamous Cell Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 4.9% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/29 (0%) 0/18 (0%) 0/18 (0%) | 0/23 (0%) 0/25 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 575 | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.089 (e) P=0.229 | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.064 (e) P=0.202 | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.108 (e) P=0.292 | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.095 | (e) |
|FISHER EXACT | (e) P=0.247 | (e) (e) |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05007 TEST: 06 PAGE 6
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- POLYSORBATE 80
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 2.5% 5.0% | UNTREATD 2.5% 5.0% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 5/48 (10%) 3/48 (6%) | 0/50 (0%) 2/47 (4%) 0/50 (0%) |
|ADJUSTED (b) | 13.8% 15.8% 16.7% | 0.0% 8.3% 0.0% |
|TERMINAL (d) | 4/29 (14%) 0/18 (0%) 3/18 (17%) | 0/23 (0%) 2/24 (8%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 616 729 (T) | --- 729 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.499 P=0.323 P=0.560 | P=0.651N P=0.247 (e) |
|INCIDENTAL TUMOR | P=0.518N P=0.518 P=0.560 | P=0.651N P=0.247 (e) |
|LOGISTIC REGRESSION | P=0.506N P=0.446 P=0.560 | P=0.652N P=0.247 (e) |
|COCHRAN-ARMITAGE | P=0.451N | P=0.667 |
|FISHER EXACT | P=0.474 P=0.523N | P=0.232 (e) |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 6/48 (13%) 3/48 (6%) | 0/50 (0%) 2/47 (4%) 0/50 (0%) |
|ADJUSTED (b) | 13.8% 18.3% 16.7% | 0.0% 8.3% 0.0% |
|TERMINAL (d) | 4/29 (14%) 0/18 (0%) 3/18 (17%) | 0/23 (0%) 2/24 (8%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 616 729 (T) | --- 729 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.497 P=0.219 P=0.560 | P=0.651N P=0.247 (e) |
|INCIDENTAL TUMOR | P=0.486N P=0.416 P=0.560 | P=0.651N P=0.247 (e) |
|LOGISTIC REGRESSION | P=0.501N P=0.323 P=0.560 | P=0.652N P=0.247 (e) |
|COCHRAN-ARMITAGE | P=0.455N | P=0.667 |
|FISHER EXACT | P=0.344 P=0.523N | P=0.232 (e) |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05007 TEST: 06 PAGE 7
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- POLYSORBATE 80
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 2.5% 5.0% | UNTREATD 2.5% 5.0% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 2/50 (4%) | 0/50 (0%) 1/50 (2%) 3/50 (6%) |
|ADJUSTED (b) | 5.7% 0.0% 6.5% | 0.0% 4.0% 11.3% |
|TERMINAL (d) | 0/29 (0%) 0/18 (0%) 0/18 (0%) | 0/23 (0%) 1/25 (4%) 2/25 (8%) |
|FIRST INCIDENCE (DAYS) | 698 --- 400 | --- 729 (T) 708 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.531 P=0.313N P=0.594 | P=0.066 P=0.517 P=0.132 |
|INCIDENTAL TUMOR | P=0.428N P=0.120N P=0.457N | P=0.059 P=0.517 P=0.115 |
|LOGISTIC REGRESSION | P=0.589N P=0.251N P=0.648N | P=0.064 P=0.517 P=0.130 |
|COCHRAN-ARMITAGE | P=0.622N | P=0.060 |
|FISHER EXACT | P=0.247N P=0.691N | P=0.500 P=0.121 |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) | 1/50 (2%) 2/50 (4%) 0/50 (0%) |
|ADJUSTED (b) | 2.2% 0.0% 5.6% | 2.7% 6.7% 0.0% |
|TERMINAL (d) | 0/29 (0%) 0/18 (0%) 1/18 (6%) | 0/23 (0%) 1/25 (4%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | 561 --- 729 (T) | 640 646 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.605 P=0.500N P=0.700 | P=0.354N P=0.516 P=0.505N |
|INCIDENTAL TUMOR | P=0.604 P=0.419N P=0.692 | P=0.374N P=0.456 P=0.484N |
|LOGISTIC REGRESSION | P=0.657N P=0.443N P=0.750N | P=0.360N P=0.500 P=0.508N |
|COCHRAN-ARMITAGE | P=0.669N | P=0.360N |
|FISHER EXACT | P=0.500N P=0.753N | P=0.500 P=0.500N |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05007 TEST: 06 PAGE 8
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- POLYSORBATE 80
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 2.5% 5.0% | UNTREATD 2.5% 5.0% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 2/50 (4%) 1/50 (2%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% | 0.0% 6.1% 2.4% |
|TERMINAL (d) | 0/29 (0%) 0/18 (0%) 0/18 (0%) | 0/23 (0%) 0/25 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- | --- 619 612 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) | P=0.368 P=0.259 P=0.500 |
|INCIDENTAL TUMOR | (e) (e) (e) | P=0.355 P=0.190 P=0.516 |
|LOGISTIC REGRESSION | (e) (e) (e) | P=0.355 P=0.238 P=0.483 |
|COCHRAN-ARMITAGE | (e) | P=0.360 |
|FISHER EXACT | (e) (e) | P=0.247 P=0.500 |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | 1/50 (2%) 2/50 (4%) 1/50 (2%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% | 2.4% 6.1% 2.4% |
|TERMINAL (d) | 0/29 (0%) 0/18 (0%) 0/18 (0%) | 0/23 (0%) 0/25 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- | 617 619 612 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) | P=0.618N P=0.520 P=0.755 |
|INCIDENTAL TUMOR | (e) (e) (e) | P=0.617 P=0.412 P=0.747N |
|LOGISTIC REGRESSION | (e) (e) (e) | P=0.613 P=0.500 P=0.748 |
|COCHRAN-ARMITAGE | (e) | P=0.622N |
|FISHER EXACT | (e) (e) | P=0.500 P=0.753N |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05007 TEST: 06 PAGE 9
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- POLYSORBATE 80
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 2.5% 5.0% | UNTREATD 2.5% 5.0% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 0/50 (0%) | 28/50 (56%) 27/50 (54%) 26/50 (52%) |
|ADJUSTED (b) | 3.0% 7.3% 0.0% | 74.8% 68.4% 69.4% |
|TERMINAL (d) | 0/29 (0%) 0/18 (0%) 0/18 (0%) | 14/23 (61%) 13/25 (52%) 14/25 (56%) |
|FIRST INCIDENCE (DAYS) | 701 675 --- | 367 532 610 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.452N P=0.406 P=0.581N | P=0.311N P=0.374N P=0.340N |
|INCIDENTAL TUMOR | P=0.191N P=0.701 P=0.362N | P=0.421N P=0.575 P=0.451N |
|LOGISTIC REGRESSION | P=0.383N P=0.485 P=0.523N | P=0.336N P=0.497N P=0.374N |
|COCHRAN-ARMITAGE | P=0.360N | P=0.382N |
|FISHER EXACT | P=0.500 P=0.500N | P=0.500N P=0.421N |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 0/50 (0%) | 29/50 (58%) 27/50 (54%) 26/50 (52%) |
|ADJUSTED (b) | 3.0% 7.3% 0.0% | 75.4% 68.4% 69.4% |
|TERMINAL (d) | 0/29 (0%) 0/18 (0%) 0/18 (0%) | 14/23 (61%) 13/25 (52%) 14/25 (56%) |
|FIRST INCIDENCE (DAYS) | 701 675 --- | 367 532 610 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.452N P=0.406 P=0.581N | P=0.259N P=0.318N P=0.286N |
|INCIDENTAL TUMOR | P=0.191N P=0.701 P=0.362N | P=0.341N P=0.519N P=0.369N |
|LOGISTIC REGRESSION | P=0.383N P=0.485 P=0.523N | P=0.265N P=0.416N P=0.300N |
|COCHRAN-ARMITAGE | P=0.360N | P=0.308N |
|FISHER EXACT | P=0.500 P=0.500N | P=0.420N P=0.344N |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05007 TEST: 06 PAGE 10
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- POLYSORBATE 80
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 2.5% 5.0% | UNTREATD 2.5% 5.0% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 0/50 (0%) | 29/50 (58%) 28/50 (56%) 27/50 (54%) |
|ADJUSTED (b) | 3.0% 7.3% 0.0% | 75.4% 69.1% 70.2% |
|TERMINAL (d) | 0/29 (0%) 0/18 (0%) 0/18 (0%) | 14/23 (61%) 13/25 (52%) 14/25 (56%) |
|FIRST INCIDENCE (DAYS) | 701 675 --- | 367 532 610 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.452N P=0.406 P=0.581N | P=0.317N P=0.376N P=0.345N |
|INCIDENTAL TUMOR | P=0.191N P=0.701 P=0.362N | P=0.414N P=0.551 P=0.444N |
|LOGISTIC REGRESSION | P=0.383N P=0.485 P=0.523N | P=0.339N P=0.499N P=0.377N |
|COCHRAN-ARMITAGE | P=0.360N | P=0.381N |
|FISHER EXACT | P=0.500 P=0.500N | P=0.500N P=0.420N |
|=================================================================================================================================|
| |
|Pancreas |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 1/48 (2%) | 0/50 (0%) 0/47 (0%) 0/50 (0%) |
|ADJUSTED (b) | 3.4% 11.1% 5.6% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/29 (3%) 2/18 (11%) 1/18 (6%) | 0/23 (0%) 0/24 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 729 (T) | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.457 P=0.335 P=0.652 | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.457 P=0.335 P=0.652 | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.457 P=0.335 P=0.652 | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.609 | (e) |
|FISHER EXACT | P=0.500 P=0.742 | (e) (e) |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05007 TEST: 06 PAGE 11
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- POLYSORBATE 80
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 2.5% 5.0% | UNTREATD 2.5% 5.0% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 30/50 (60%) 23/49 (47%) 26/50 (52%) | 37/50 (74%) 30/50 (60%) 36/50 (72%) |
|ADJUSTED (b) | 74.1% 60.5% 78.5% | 87.7% 78.1% 89.5% |
|TERMINAL (d) | 19/29 (66%) 6/18 (33%) 12/18 (67%) | 18/23 (78%) 17/25 (68%) 21/25 (84%) |
|FIRST INCIDENCE (DAYS) | 455 477 454 | 548 466 535 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.257 P=0.521 P=0.232 | P=0.355N P=0.102N P=0.387N |
|INCIDENTAL TUMOR | P=0.334N P=0.150N P=0.505N | P=0.425N P=0.175N P=0.481N |
|LOGISTIC REGRESSION | P=0.286N P=0.144N P=0.348N | P=0.403N P=0.092N P=0.443N |
|COCHRAN-ARMITAGE | P=0.242N | P=0.457N |
|FISHER EXACT | P=0.135N P=0.273N | P=0.101N P=0.500N |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 30/50 (60%) 23/49 (47%) 26/50 (52%) | 38/50 (76%) 30/50 (60%) 36/50 (72%) |
|ADJUSTED (b) | 74.1% 60.5% 78.5% | 88.1% 78.1% 89.5% |
|TERMINAL (d) | 19/29 (66%) 6/18 (33%) 12/18 (67%) | 18/23 (78%) 17/25 (68%) 21/25 (84%) |
|FIRST INCIDENCE (DAYS) | 455 477 454 | 548 466 535 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.257 P=0.521 P=0.232 | P=0.298N P=0.078N P=0.329N |
|INCIDENTAL TUMOR | P=0.334N P=0.150N P=0.505N | P=0.346N P=0.125N P=0.400N |
|LOGISTIC REGRESSION | P=0.286N P=0.144N P=0.348N | P=0.316N P=0.058N P=0.348N |
|COCHRAN-ARMITAGE | P=0.242N | P=0.372N |
|FISHER EXACT | P=0.135N P=0.273N | P=0.066N P=0.410N |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05007 TEST: 06 PAGE 12
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- POLYSORBATE 80
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 2.5% 5.0% | UNTREATD 2.5% 5.0% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Intermedia |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/49 (2%) 0/50 (0%) | 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 3.4% 5.3% 0.0% | 8.7% 0.0% 0.0% |
|TERMINAL (d) | 1/29 (3%) 0/18 (0%) 0/18 (0%) | 2/23 (9%) 0/25 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 724 --- | 729 (T) --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.439N P=0.657 P=0.595N | P=0.086N P=0.219N P=0.219N |
|INCIDENTAL TUMOR | P=0.316N P=0.763N P=0.595N | P=0.086N P=0.219N P=0.219N |
|LOGISTIC REGRESSION | P=0.426N P=0.671 P=0.595N | P=0.086N P=0.219N P=0.219N |
|COCHRAN-ARMITAGE | P=0.332N | P=0.095N |
|FISHER EXACT | P=0.747 P=0.500N | P=0.247N P=0.247N |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Intermedia |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/49 (2%) 0/50 (0%) | 3/50 (6%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 3.4% 5.3% 0.0% | 10.9% 0.0% 0.0% |
|TERMINAL (d) | 1/29 (3%) 0/18 (0%) 0/18 (0%) | 2/23 (9%) 0/25 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 724 --- | 617 --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.439N P=0.657 P=0.595N | P=0.035N* P=0.113N P=0.115N |
|INCIDENTAL TUMOR | P=0.316N P=0.763N P=0.595N | P=0.035N* P=0.129N P=0.108N |
|LOGISTIC REGRESSION | P=0.426N P=0.671 P=0.595N | P=0.036N* P=0.119N P=0.117N |
|COCHRAN-ARMITAGE | P=0.332N | P=0.037N* |
|FISHER EXACT | P=0.747 P=0.500N | P=0.121N P=0.121N |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05007 TEST: 06 PAGE 13
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- POLYSORBATE 80
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 2.5% 5.0% | UNTREATD 2.5% 5.0% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Basal Cell Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 8.3% 3.7% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/29 (0%) 1/18 (6%) 0/18 (0%) | 0/23 (0%) 0/25 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | --- 644 699 | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.299 P=0.180 P=0.454 | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.357 P=0.227 P=0.638 | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.339 P=0.230 P=0.479 | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.360 | (e) |
|FISHER EXACT | P=0.247 P=0.500 | (e) (e) |
|=================================================================================================================================|
| |
|Skin |
| Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 5/50 (10%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 6.9% 8.2% 21.0% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/29 (7%) 0/18 (0%) 3/18 (17%) | 0/23 (0%) 0/25 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 667 597 | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.072 P=0.551 P=0.100 | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.120 P=0.684N P=0.122 | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.116 P=0.641 P=0.175 | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.146 | (e) |
|FISHER EXACT | P=0.691N P=0.218 | (e) (e) |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05007 TEST: 06 PAGE 14
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- POLYSORBATE 80
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 2.5% 5.0% | UNTREATD 2.5% 5.0% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) | 1/50 (2%) 1/50 (2%) 0/50 (0%) |
|ADJUSTED (b) | 6.9% 0.0% 5.6% | 3.7% 3.8% 0.0% |
|TERMINAL (d) | 2/29 (7%) 0/18 (0%) 1/18 (6%) | 0/23 (0%) 0/25 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) --- 729 (T) | 710 724 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.502N P=0.348N P=0.665N | P=0.322N P=0.739N P=0.500N |
|INCIDENTAL TUMOR | P=0.502N P=0.348N P=0.665N | P=0.394N P=0.724 P=0.557N |
|LOGISTIC REGRESSION | P=0.502N P=0.348N P=0.665N | P=0.319N P=0.750N P=0.492N |
|COCHRAN-ARMITAGE | P=0.360N | P=0.331N |
|FISHER EXACT | P=0.247N P=0.500N | P=0.753N P=0.500N |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) | 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|ADJUSTED (b) | 6.9% 0.0% 5.6% | 0.0% 3.8% 0.0% |
|TERMINAL (d) | 2/29 (7%) 0/18 (0%) 1/18 (6%) | 0/23 (0%) 0/25 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) --- 729 (T) | --- 724 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.502N P=0.348N P=0.665N | P=0.722N P=0.524 (e) |
|INCIDENTAL TUMOR | P=0.502N P=0.348N P=0.665N | P=0.689 P=0.464 (e) |
|LOGISTIC REGRESSION | P=0.502N P=0.348N P=0.665N | P=0.724N P=0.519 (e) |
|COCHRAN-ARMITAGE | P=0.360N | P=0.731 |
|FISHER EXACT | P=0.247N P=0.500N | P=0.500 (e) |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05007 TEST: 06 PAGE 15
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- POLYSORBATE 80
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 2.5% 5.0% | UNTREATD 2.5% 5.0% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma, |
| Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 4/50 (8%) 7/50 (14%) | 1/50 (2%) 1/50 (2%) 0/50 (0%) |
|ADJUSTED (b) | 13.8% 15.8% 29.0% | 3.7% 3.8% 0.0% |
|TERMINAL (d) | 4/29 (14%) 1/18 (6%) 4/18 (22%) | 0/23 (0%) 0/25 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 644 597 | 710 724 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.080 P=0.428 P=0.094 | P=0.322N P=0.739N P=0.500N |
|INCIDENTAL TUMOR | P=0.135 P=0.588 P=0.139 | P=0.394N P=0.724 P=0.557N |
|LOGISTIC REGRESSION | P=0.144 P=0.570 P=0.184 | P=0.319N P=0.750N P=0.492N |
|COCHRAN-ARMITAGE | P=0.202 | P=0.331N |
|FISHER EXACT | P=0.643N P=0.262 | P=0.753N P=0.500N |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Fibroma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) 4/50 (8%) | 2/50 (4%) 2/50 (4%) 0/50 (0%) |
|ADJUSTED (b) | 2.7% 11.0% 14.6% | 7.1% 6.9% 0.0% |
|TERMINAL (d) | 0/29 (0%) 1/18 (6%) 1/18 (6%) | 1/23 (4%) 1/25 (4%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | 681 616 647 | 645 700 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.088 P=0.231 P=0.123 | P=0.167N P=0.666N P=0.234N |
|INCIDENTAL TUMOR | P=0.196 P=0.402 P=0.328 | P=0.199N P=0.677 P=0.261N |
|LOGISTIC REGRESSION | P=0.119 P=0.301 P=0.159 | P=0.169N P=0.689N P=0.234N |
|COCHRAN-ARMITAGE | P=0.133 | P=0.176N |
|FISHER EXACT | P=0.309 P=0.181 | P=0.691N P=0.247N |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05007 TEST: 06 PAGE 16
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- POLYSORBATE 80
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 2.5% 5.0% | UNTREATD 2.5% 5.0% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Fibrosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% | 0.0% 6.7% 0.0% |
|TERMINAL (d) | 0/29 (0%) 0/18 (0%) 0/18 (0%) | 0/23 (0%) 0/25 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- | --- 687 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) | P=0.648N P=0.267 (e) |
|INCIDENTAL TUMOR | (e) (e) (e) | P=0.606 P=0.195 (e) |
|LOGISTIC REGRESSION | (e) (e) (e) | P=0.662N P=0.243 (e) |
|COCHRAN-ARMITAGE | (e) | P=0.669 |
|FISHER EXACT | (e) (e) | P=0.247 (e) |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Lipoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 2/50 (4%) | 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 4.2% 5.9% | 0.0% 4.0% 0.0% |
|TERMINAL (d) | 0/29 (0%) 0/18 (0%) 0/18 (0%) | 0/23 (0%) 1/25 (4%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | --- 701 570 | --- 729 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.114 P=0.436 P=0.215 | P=0.720N P=0.517 (e) |
|INCIDENTAL TUMOR | P=0.195 P=0.615 P=0.297 | P=0.720N P=0.517 (e) |
|LOGISTIC REGRESSION | P=0.145 P=0.484 P=0.257 | P=0.720N P=0.517 (e) |
|COCHRAN-ARMITAGE | P=0.142 | P=0.731 |
|FISHER EXACT | P=0.500 P=0.247 | P=0.500 (e) |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05007 TEST: 06 PAGE 17
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- POLYSORBATE 80
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 2.5% 5.0% | UNTREATD 2.5% 5.0% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Neurofibroma or Fibroma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) 4/50 (8%) | 2/50 (4%) 2/50 (4%) 0/50 (0%) |
|ADJUSTED (b) | 2.7% 11.0% 14.6% | 7.1% 6.9% 0.0% |
|TERMINAL (d) | 0/29 (0%) 1/18 (6%) 1/18 (6%) | 1/23 (4%) 1/25 (4%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | 681 616 647 | 645 700 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.088 P=0.231 P=0.123 | P=0.167N P=0.666N P=0.234N |
|INCIDENTAL TUMOR | P=0.196 P=0.402 P=0.328 | P=0.199N P=0.677 P=0.261N |
|LOGISTIC REGRESSION | P=0.119 P=0.301 P=0.159 | P=0.169N P=0.689N P=0.234N |
|COCHRAN-ARMITAGE | P=0.133 | P=0.176N |
|FISHER EXACT | P=0.309 P=0.181 | P=0.691N P=0.247N |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Neurofibrosarcoma, Fibrosarcoma, Sarcoma, |
| Neurofibroma, or Fibroma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) 6/50 (12%) | 2/50 (4%) 4/50 (8%) 0/50 (0%) |
|ADJUSTED (b) | 6.1% 11.0% 20.2% | 7.1% 13.1% 0.0% |
|TERMINAL (d) | 1/29 (3%) 1/18 (6%) 1/18 (6%) | 1/23 (4%) 1/25 (4%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | 681 616 458 | 645 687 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.050 P=0.377 P=0.075 | P=0.205N P=0.383 P=0.234N |
|INCIDENTAL TUMOR | P=0.149 P=0.554 P=0.266 | P=0.272N P=0.290 P=0.261N |
|LOGISTIC REGRESSION | P=0.087 P=0.485 P=0.134 | P=0.212N P=0.346 P=0.234N |
|COCHRAN-ARMITAGE | P=0.090 | P=0.222N |
|FISHER EXACT | P=0.500 P=0.134 | P=0.339 P=0.247N |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05007 TEST: 06 PAGE 18
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- POLYSORBATE 80
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 2.5% 5.0% | UNTREATD 2.5% 5.0% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Neurofibrosarcoma, Fibrosarcoma, or Sarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 2/50 (4%) | 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|ADJUSTED (b) | 3.4% 0.0% 6.6% | 0.0% 6.7% 0.0% |
|TERMINAL (d) | 1/29 (3%) 0/18 (0%) 0/18 (0%) | 0/23 (0%) 0/25 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) --- 458 | --- 687 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.282 P=0.595N P=0.395 | P=0.648N P=0.267 (e) |
|INCIDENTAL TUMOR | P=0.415 P=0.595N P=0.571 | P=0.606 P=0.195 (e) |
|LOGISTIC REGRESSION | P=0.385 P=0.595N P=0.545 | P=0.662N P=0.243 (e) |
|COCHRAN-ARMITAGE | P=0.360 | P=0.669 |
|FISHER EXACT | P=0.500N P=0.500 | P=0.247 (e) |
|=================================================================================================================================|
| |
|Spleen |
| Sarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 7.7% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/29 (0%) 0/18 (0%) 1/18 (6%) | 0/23 (0%) 0/25 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 494 | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.074 (e) P=0.186 | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.103 (e) P=0.227 | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.105 (e) P=0.273 | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.095 | (e) |
|FISHER EXACT | (e) P=0.247 | (e) (e) |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05007 TEST: 06 PAGE 19
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- POLYSORBATE 80
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 2.5% 5.0% | UNTREATD 2.5% 5.0% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 39/49 (80%) 35/50 (70%) 41/50 (82%) | |
|ADJUSTED (b) | 97.5% 94.2% 97.6% | |
|TERMINAL (d) | 28/29 (97%) 16/18 (89%) 17/18 (94%) | |
|FIRST INCIDENCE (DAYS) | 470 503 494 | |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.006 ** P=0.072 P=0.005 ** | |
|INCIDENTAL TUMOR | P=0.176 P=0.439N P=0.280 | |
|LOGISTIC REGRESSION | P=0.132 P=0.224N P=0.136 | |
|COCHRAN-ARMITAGE | P=0.431 | |
|FISHER EXACT | P=0.193N P=0.480 | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 2/50 (4%) 2/50 (4%) | 5/50 (10%) 6/50 (12%) 10/50 (20%) |
|ADJUSTED (b) | 19.9% 11.1% 11.1% | 14.3% 22.9% 34.3% |
|TERMINAL (d) | 5/29 (17%) 2/18 (11%) 2/18 (11%) | 1/23 (4%) 5/25 (20%) 7/25 (28%) |
|FIRST INCIDENCE (DAYS) | 717 729 (T) 729 (T) | 617 717 612 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.233N P=0.329N P=0.332N | P=0.121 P=0.551 P=0.162 |
|INCIDENTAL TUMOR | P=0.187N P=0.263N P=0.255N | P=0.110 P=0.454 P=0.147 |
|LOGISTIC REGRESSION | P=0.211N P=0.291N P=0.300N | P=0.105 P=0.509 P=0.139 |
|COCHRAN-ARMITAGE | P=0.080N | P=0.097 |
|FISHER EXACT | P=0.134N P=0.134N | P=0.500 P=0.131 |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05007 TEST: 06 PAGE 20
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- POLYSORBATE 80
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 2.5% 5.0% | UNTREATD 2.5% 5.0% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 2/50 (4%) 2/50 (4%) | 6/50 (12%) 6/50 (12%) 10/50 (20%) |
|ADJUSTED (b) | 19.9% 11.1% 11.1% | 18.1% 22.9% 34.3% |
|TERMINAL (d) | 5/29 (17%) 2/18 (11%) 2/18 (11%) | 2/23 (9%) 5/25 (20%) 7/25 (28%) |
|FIRST INCIDENCE (DAYS) | 717 729 (T) 729 (T) | 617 717 612 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.233N P=0.329N P=0.332N | P=0.194 P=0.566N P=0.245 |
|INCIDENTAL TUMOR | P=0.187N P=0.263N P=0.255N | P=0.180 P=0.583 P=0.230 |
|LOGISTIC REGRESSION | P=0.211N P=0.291N P=0.300N | P=0.174 P=0.610N P=0.219 |
|COCHRAN-ARMITAGE | P=0.080N | P=0.161 |
|FISHER EXACT | P=0.134N P=0.134N | P=0.620N P=0.207 |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 2/50 (4%) | 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 2.3% 9.7% | 6.6% 0.0% 0.0% |
|TERMINAL (d) | 0/29 (0%) 0/18 (0%) 1/18 (6%) | 1/23 (4%) 0/25 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | --- 616 700 | 617 --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.100 P=0.510 P=0.151 | P=0.094N P=0.231N P=0.236N |
|INCIDENTAL TUMOR | P=0.134 P=0.581 P=0.253 | P=0.093N P=0.261N P=0.222N |
|LOGISTIC REGRESSION | P=0.134 P=0.526 P=0.193 | P=0.095N P=0.237N P=0.237N |
|COCHRAN-ARMITAGE | P=0.142 | P=0.095N |
|FISHER EXACT | P=0.500 P=0.247 | P=0.247N P=0.247N |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05007 TEST: 06 PAGE 21
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- POLYSORBATE 80
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 2.5% 5.0% | UNTREATD 2.5% 5.0% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # |
|----------- | | |
|OVERALL (a) | | 9/50 (18%) 11/50 (22%) 12/50 (24%) |
|ADJUSTED (b) | | 26.1% 37.3% 34.3% |
|TERMINAL (d) | | 2/23 (9%) 8/25 (32%) 5/25 (20%) |
|FIRST INCIDENCE (DAYS) | | 367 467 567 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.330 P=0.466 P=0.365 |
|INCIDENTAL TUMOR | | P=0.249 P=0.426 P=0.256 |
|LOGISTIC REGRESSION | | P=0.276 P=0.402 P=0.308 |
|COCHRAN-ARMITAGE | | P=0.271 |
|FISHER EXACT | | P=0.402 P=0.312 |
|=================================================================================================================================|
| |
|Uterus |
| Sarcoma Stromal or Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # |
|----------- | | |
|OVERALL (a) | | 9/50 (18%) 11/50 (22%) 13/50 (26%) |
|ADJUSTED (b) | | 26.1% 37.3% 35.9% |
|TERMINAL (d) | | 2/23 (9%) 8/25 (32%) 5/25 (20%) |
|FIRST INCIDENCE (DAYS) | | 367 467 567 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.255 P=0.466 P=0.289 |
|INCIDENTAL TUMOR | | P=0.184 P=0.426 P=0.190 |
|LOGISTIC REGRESSION | | P=0.203 P=0.402 P=0.229 |
|COCHRAN-ARMITAGE | | P=0.199 |
|FISHER EXACT | | P=0.402 P=0.235 |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05007 TEST: 06 PAGE 22
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- POLYSORBATE 80
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 2.5% 5.0% | UNTREATD 2.5% 5.0% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, |
| or Undifferentiated |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 23/50 (46%) 21/50 (42%) 26/50 (52%) | 26/50 (52%) 10/50 (20%) 13/50 (26%) |
|ADJUSTED (b) | 55.8% 56.3% 70.4% | 65.1% 27.3% 40.2% |
|TERMINAL (d) | 12/29 (41%) 4/18 (22%) 8/18 (44%) | 10/23 (43%) 3/25 (12%) 7/25 (28%) |
|FIRST INCIDENCE (DAYS) | 464 503 458 | 514 561 568 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.069 P=0.315 P=0.069 | P=0.007N** P=0.003N** P=0.012N* |
|INCIDENTAL TUMOR | P=0.481 P=0.257N P=0.461 | P=0.005N** P=0.002N** P=0.010N** |
|LOGISTIC REGRESSION | P=0.279 P=0.423N P=0.315 | P=0.003N** P<0.001N** P=0.006N** |
|COCHRAN-ARMITAGE | P=0.308 | P=0.004N** |
|FISHER EXACT | P=0.420N P=0.345 | P<0.001N** P=0.007N** |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma Benign, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 5.5% 10.1% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/29 (0%) 0/18 (0%) 1/18 (6%) | 0/23 (0%) 0/25 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | --- 637 709 | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.132 P=0.222 P=0.148 | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.202 P=0.352 P=0.253 | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.166 P=0.250 P=0.182 | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.176 | (e) |
|FISHER EXACT | P=0.247 P=0.247 | (e) (e) |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05007 TEST: 06 PAGE 23
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- POLYSORBATE 80
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 2.5% 5.0% | UNTREATD 2.5% 5.0% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 48/50 (96%) 47/50 (94%) 47/50 (94%) | 47/50 (94%) 44/50 (88%) 46/50 (92%) |
|ADJUSTED (b) | 100.0% 100.0% 100.0% | 97.9% 97.8% 100.0% |
|TERMINAL (d) | 29/29 (100%) 18/18 (100%) 18/18 (100%) | 22/23 (96%) 24/25 (96%) 25/25 (100%) |
|FIRST INCIDENCE (DAYS) | 455 477 400 | 367 466 535 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.026 * P=0.037 * P=0.029 * | P=0.331N P=0.233N P=0.366N |
|INCIDENTAL TUMOR | P=0.377 P=0.564 P=0.515 | P=0.420N P=0.407N P=0.488N |
|LOGISTIC REGRESSION | P=0.518 P=0.629N P=0.580 | P=0.319N P=0.259N P=0.396N |
|COCHRAN-ARMITAGE | P=0.412N | P=0.429N |
|FISHER EXACT | P=0.500N P=0.500N | P=0.243N P=0.500N |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 31/50 (62%) 31/50 (62%) 34/50 (68%) | 35/50 (70%) 21/50 (42%) 20/50 (40%) |
|ADJUSTED (b) | 71.0% 74.1% 80.2% | 78.7% 49.8% 51.5% |
|TERMINAL (d) | 17/29 (59%) 8/18 (44%) 10/18 (56%) | 14/23 (61%) 6/25 (24%) 8/25 (32%) |
|FIRST INCIDENCE (DAYS) | 455 477 400 | 195 323 432 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.048 * P=0.137 P=0.050 * | P=0.009N** P=0.018N* P=0.012N* |
|INCIDENTAL TUMOR | P=0.449 P=0.470N P=0.449 | P=0.002N** P=0.005N** P=0.004N** |
|LOGISTIC REGRESSION | P=0.288 P=0.578N P=0.338 | P=0.002N** P=0.004N** P=0.003N** |
|COCHRAN-ARMITAGE | P=0.301 | P=0.002N** |
|FISHER EXACT | P=0.582N P=0.338 | P=0.004N** P=0.002N** |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05007 TEST: 06 PAGE 24
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- POLYSORBATE 80
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 2.5% 5.0% | UNTREATD 2.5% 5.0% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 50/50 (100%) 49/50 (98%) 48/50 (96%) | 49/50 (98%) 48/50 (96%) 48/50 (96%) |
|ADJUSTED (b) | 100.0% 100.0% 100.0% | 98.0% 98.0% 100.0% |
|TERMINAL (d) | 29/29 (100%) 18/18 (100%) 18/18 (100%) | 22/23 (96%) 24/25 (96%) 25/25 (100%) |
|FIRST INCIDENCE (DAYS) | 455 477 400 | 195 323 432 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.036 * P=0.038 * P=0.042 * | P=0.339N P=0.344N P=0.370N |
|INCIDENTAL TUMOR | P=0.344N (e) P=0.581N | P=0.369N P=0.598N P=0.477N |
|LOGISTIC REGRESSION | P=0.422N (e) P=0.657N | P=0.324N P=0.500N P=0.454N |
|COCHRAN-ARMITAGE | P=0.142N | P=0.390N |
|FISHER EXACT | P=0.500N P=0.247N | P=0.500N P=0.500N |
|=================================================================================================================================|
(a) Number of tumor-bearing animals / number of animals examined at site.
(b) Kaplan-Meier estimated lifetime tumor incidence after adjustment for
intercurrent mortality.
(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. The incidental tumor
test regards these lesions as non-fatal. Logistic regression is an alternative
method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage
and Fisher's 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.
(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).