TDMS Study 05103-05 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL DATE: 05/19/95
EXPERIMENT: 05103 TEST: 05 TIME: 20:08:39
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-85234 ROUTE: DOSED FEED NTP C#: 55516C
PATHOLOGIST: DR. D. FARNELL CAS: 3296-90-0
------------------------------------------------------------------------------------------------------------------------------------
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL DATE: 05/19/95
EXPERIMENT: 05103 TEST: 05 TIME: 20:08:39
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-85234 ROUTE: DOSED FEED NTP C#: 55516C
PATHOLOGIST: DR. D. FARNELL CAS: 3296-90-0
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 Cortex
Adrenal Medulla
Bone Marrow
Brain
Clitoral Gland
Clitoral/Preputial 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 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL DATE: 05/19/95
EXPERIMENT: 05103 TEST: 05 TIME: 20:08:39
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-85234 ROUTE: DOSED FEED NTP C#: 55516C
PATHOLOGIST: DR. D. FARNELL CAS: 3296-90-0
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF THE STUDY OF 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
====================================================================================================
MALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Adrenal Medulla Pheochromocytoma Benign
Pheochromocytoma Malignant
Pheochromocytoma: Benign, Complex, Malignant, NOS
Clitoral/Preputial Gland Adenoma
Carcinoma or Adenoma
Esophagus Squamous Cell Papilloma
Intestine Large: Colon/Rectum Carcinoma
Polyp Adenomatous
Intestine Small: Ileum Carcinoma
Intestine Small: Jejunum Carcinoma
Intestine Small: Site Unspecified
Carcinoma
Islets, Pancreatic Adenoma
Carcinoma or Adenoma
Kidney: Renal Tubule Adenoma
Liver Hepatocellular Carcinoma or Hepatocellular Adenoma
Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
Lung Alveolar/Bronchiolar Adenoma
Alveolar/Bronchiolar Carcinoma
Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
Squamous Cell Carcinoma
Mammary Gland Fibroadenoma
Fibroma, Fibroadenoma or Adenoma
Fibroma, Fibroadenoma, Carcinoma, or Adenoma
Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva)
Papilloma Squamous or Papilloma
Squamous Cell Carcinoma
Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma
Pancreas Adenoma
Pharynx Squamous Cell Carcinoma
Squamous Cell Papilloma
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
Carcinoma or Adenoma
Skin Basal Cell Adenoma
Basal Cell Adenoma, Basosquamous Tumor Benign, or Trichoepithelioma
Basal Cell Carcinoma
Basal Cell Carcinoma, Basal Cell Adenoma, Basosquamous Tumor (benign,
malignant or NOS), or Trichoepithelioma
Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor (M or B), Basal
Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepithelioma
Fibroma
Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma
Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma
Keratoacanthoma
Sarcoma
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL DATE: 05/19/95
EXPERIMENT: 05103 TEST: 05 TIME: 20:08:39
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-85234 ROUTE: DOSED FEED NTP C#: 55516C
PATHOLOGIST: DR. D. FARNELL CAS: 3296-90-0
Squamous Cell Carcinoma, Basal Cell Carcinoma, Basosquamous Tumor
(malignant or NOS), or Carcinoma
Squamous Cell Papilloma
Squamous Cell Papilloma, Papilloma, Squamous Cell Carcinoma or Keratoacanthoma
Squamous Cell Papilloma, Papilloma, or Keratoacanthoma
Skin: Sebaceous Gland Adenoma
Stomach, Forestomach Squamous Cell Papilloma
Testes Adenoma
Thyroid Gland: C-Cell Adenoma
Carcinoma
Carcinoma or Adenoma
Thyroid Gland: Follicular Cell
Adenoma
Carcinoma
Carcinoma or Adenoma
Tongue Squamous Cell Carcinoma or Papilloma Squamous
Squamous Cell Papilloma
Urinary Bladder Papilloma
Zymbal's Gland Adenoma
Carcinoma
Carcinoma or Adenoma
All Organs Hemangiosarcoma or Hemangioma
Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated
Mesothelioma: Benign, Malignant, NOS
Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
====================================================================================================
FEMALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Clitoral/Preputial Gland Carcinoma or Adenoma
Esophagus Squamous Cell Papilloma
Lung Alveolar/Bronchiolar Carcinoma
Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
Mammary Gland Fibroadenoma
Fibroma, Fibroadenoma or Adenoma
Fibroma, Fibroadenoma, Carcinoma, or Adenoma
Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva)
Papilloma Squamous or Papilloma
Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
Carcinoma or Adenoma
Skin Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma
Fibrosarcoma
Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma
Stomach, Forestomach Squamous Cell Papilloma
Thyroid Gland: Follicular Cell
Adenoma
Carcinoma
Carcinoma or Adenoma
Tongue Squamous Cell Carcinoma or Papilloma Squamous
Squamous Cell Papilloma
Uterus Polyp Stromal
Sarcoma Stromal or Polyp Stromal
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL DATE: 05/19/95
EXPERIMENT: 05103 TEST: 05 TIME: 20:08:39
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-85234 ROUTE: DOSED FEED NTP C#: 55516C
PATHOLOGIST: DR. D. FARNELL CAS: 3296-90-0
All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated
Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
====================================================================================================
DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 PAGE 1
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE | UNTREATD 0.25% 0.50% 1.00% 2.00% |
| | CONTROL |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 7/70 (10%) 12/60 (20%) 4/60 (7%) 4/59 (7%) 0/70 (0%) |
|ADJUSTED (b) | 21.0% 42.2% 18.5% 18.3% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 1/9 (11%) 0/7 (0%) 0/9 (0%) 0/5 (0%) 0/0 |
|TERMINAL (d) | 3/26 (12%) 6/20 (30%) 1/13 (8%) 0/1 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | 456 (I) 543 656 576 --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.543N P=0.069 P=0.567N P=0.170 P=0.673N |
|INCIDENTAL TUMOR | P=0.016N* P=0.129 P=0.268N P=0.299N P=0.084N |
|LOGISTIC REGRESSION | P=0.022N* P=0.100 P=0.328N P=0.489N P=0.048N* |
|COCHRAN-ARMITAGE | P=0.001N** |
|FISHER EXACT | P=0.087 P=0.361N P=0.372N P=0.007N** |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Malignant |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 3/70 (4%) 3/60 (5%) 1/60 (2%) 1/59 (2%) 0/70 (0%) |
|ADJUSTED (b) | 11.0% 14.1% 2.7% 3.3% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/7 (0%) 0/9 (0%) 0/5 (0%) 0/0 |
|TERMINAL (d) | 2/26 (8%) 2/20 (10%) 0/13 (0%) 0/1 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | 725 725 641 577 --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.622N P=0.540 P=0.504N P=0.520 P=0.995N |
|INCIDENTAL TUMOR | P=0.158N P=0.591 P=0.316N P=0.572N P=0.545N |
|LOGISTIC REGRESSION | P=0.245N P=0.549 P=0.393N P=0.624N P=0.877N |
|COCHRAN-ARMITAGE | P=0.050N* |
|FISHER EXACT | P=0.584 P=0.370N P=0.377N P=0.122N |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 PAGE 2
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE | UNTREATD 0.25% 0.50% 1.00% 2.00% |
| | CONTROL |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 10/70 (14%) 14/60 (23%) 5/60 (8%) 5/59 (8%) 0/70 (0%) |
|ADJUSTED (b) | 30.4% 48.8% 20.7% 21.2% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 1/9 (11%) 0/7 (0%) 0/9 (0%) 0/5 (0%) 0/0 |
|TERMINAL (d) | 5/26 (19%) 7/20 (35%) 1/13 (8%) 0/1 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | 456 (I) 543 641 576 --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.506N P=0.102 P=0.451N P=0.112 P=0.637N |
|INCIDENTAL TUMOR | P=0.004N** P=0.187 P=0.139N P=0.229N P=0.047N* |
|LOGISTIC REGRESSION | P=0.010N** P=0.144 P=0.195N P=0.400N P=0.028N* |
|COCHRAN-ARMITAGE | P<0.001N** |
|FISHER EXACT | P=0.136 P=0.218N P=0.228N P<0.001N** |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 3/70 (4%) 3/59 (5%) 4/60 (7%) 4/60 (7%) 4/70 (6%) |
|ADJUSTED (b) | 11.5% 11.6% 19.5% 31.7% 100.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/7 (0%) 0/9 (0%) 0/5 (0%) 0/0 |
|TERMINAL (d) | 3/26 (12%) 1/20 (5%) 2/13 (15%) 0/1 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | 736 (T) 648 620 542 659 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P<0.001 ** P=0.546 P=0.237 P=0.017 * P<0.001 ** |
|INCIDENTAL TUMOR | P=0.096 P=0.580 P=0.357 P=0.305 P=0.033 * |
|LOGISTIC REGRESSION | P=0.027 * P=0.562 P=0.389 P=0.277 P<0.001 ** |
|COCHRAN-ARMITAGE | P=0.442 |
|FISHER EXACT | P=0.576 P=0.414 P=0.414 P=0.500 |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 PAGE 3
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE | UNTREATD 0.25% 0.50% 1.00% 2.00% |
| | CONTROL |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/70 (3%) 1/59 (2%) 1/60 (2%) 1/60 (2%) 0/70 (0%) |
|ADJUSTED (b) | 5.2% 5.0% 4.5% 5.9% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/7 (0%) 0/9 (0%) 0/5 (0%) 0/0 |
|TERMINAL (d) | 0/26 (0%) 1/20 (5%) 0/13 (0%) 0/1 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | 628 736 (T) 695 647 --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.650N P=0.585N P=0.629N P=0.626 P=0.635N |
|INCIDENTAL TUMOR | P=0.225N P=0.497N P=0.329N P=0.339N P=0.151N |
|LOGISTIC REGRESSION | P=0.343N P=0.547N P=0.533N P=0.634N P=0.373N |
|COCHRAN-ARMITAGE | P=0.164N |
|FISHER EXACT | P=0.564N P=0.558N P=0.558N P=0.248N |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 5/70 (7%) 4/59 (7%) 5/60 (8%) 5/60 (8%) 4/70 (6%) |
|ADJUSTED (b) | 16.2% 16.2% 23.2% 35.7% 100.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/7 (0%) 0/9 (0%) 0/5 (0%) 0/0 |
|TERMINAL (d) | 3/26 (12%) 2/20 (10%) 2/13 (15%) 0/1 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | 628 648 620 542 659 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P<0.001 ** P=0.622 P=0.330 P=0.029 * P<0.001 ** |
|INCIDENTAL TUMOR | P=0.282 P=0.570N P=0.619 P=0.624 P=0.314 |
|LOGISTIC REGRESSION | P=0.094 P=0.612N P=0.535 P=0.372 P=0.050 |
|COCHRAN-ARMITAGE | P=0.424N |
|FISHER EXACT | P=0.607N P=0.527 P=0.527 P=0.500N |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 PAGE 4
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE | UNTREATD 0.25% 0.50% 1.00% 2.00% |
| | CONTROL |
|=================================================================================================================================|
| |
|Esophagus |
| Squamous Cell Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 0/70 (0%) 0/60 (0%) 1/60 (2%) 5/60 (8%) 0/70 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 3.2% 62.6% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/7 (0%) 0/9 (0%) 0/5 (0%) 0/0 |
|TERMINAL (d) | 0/26 (0%) 0/20 (0%) 0/13 (0%) 0/1 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- --- 662 549 --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.037 * (e) P=0.454 P<0.001 ** (e) |
|INCIDENTAL TUMOR | P=0.489 (e) P=0.567 P=0.134 (e) |
|LOGISTIC REGRESSION | P=0.240 (e) P=0.483 P=0.013 * (e) |
|COCHRAN-ARMITAGE | P=0.409 |
|FISHER EXACT | (e) P=0.462 P=0.019 * (e) |
|=================================================================================================================================|
| |
|Intestine Large: Colon/Rectum |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 0/70 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) 2/70 (3%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% 12.8% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/7 (0%) 0/9 (0%) 0/5 (0%) 0/0 |
|TERMINAL (d) | 0/26 (0%) 0/20 (0%) 0/13 (0%) 0/1 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- --- --- --- 410 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.004 ** (e) (e) (e) P=0.091 |
|INCIDENTAL TUMOR | P=0.065 (e) (e) (e) P=0.398 |
|LOGISTIC REGRESSION | P=0.035 * (e) (e) (e) P=0.228 |
|COCHRAN-ARMITAGE | P=0.028 * |
|FISHER EXACT | (e) (e) (e) P=0.248 |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 PAGE 5
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE | UNTREATD 0.25% 0.50% 1.00% 2.00% |
| | CONTROL |
|=================================================================================================================================|
| |
|Intestine Large: Colon/Rectum |
| Polyp Adenomatous |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 0/70 (0%) 0/60 (0%) 3/60 (5%) 4/60 (7%) 10/70 (14%) |
|ADJUSTED (b) | 0.0% 0.0% 15.3% 46.0% 35.8% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/7 (0%) 0/9 (0%) 0/5 (0%) 0/0 |
|TERMINAL (d) | 0/26 (0%) 0/20 (0%) 1/13 (8%) 0/1 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- --- 684 495 365 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P<0.001 ** (e) P=0.055 P=0.003 ** P<0.001 ** |
|INCIDENTAL TUMOR | P<0.001 ** (e) P=0.115 P=0.169 P=0.053 |
|LOGISTIC REGRESSION | P<0.001 ** (e) P=0.082 P=0.038 * P=0.001 ** |
|COCHRAN-ARMITAGE | P<0.001 ** |
|FISHER EXACT | (e) P=0.096 P=0.043 * P<0.001 ** |
|=================================================================================================================================|
| |
|Intestine Small: Ileum |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 0/70 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) 2/70 (3%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% 7.7% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/7 (0%) 0/9 (0%) 0/5 (0%) 0/0 |
|TERMINAL (d) | 0/26 (0%) 0/20 (0%) 0/13 (0%) 0/1 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- --- --- --- 576 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.005 ** (e) (e) (e) P=0.119 |
|INCIDENTAL TUMOR | P=0.049 * (e) (e) (e) P=0.486 |
|LOGISTIC REGRESSION | P=0.022 * (e) (e) (e) P=0.194 |
|COCHRAN-ARMITAGE | P=0.028 * |
|FISHER EXACT | (e) (e) (e) P=0.248 |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 PAGE 6
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE | UNTREATD 0.25% 0.50% 1.00% 2.00% |
| | CONTROL |
|=================================================================================================================================|
| |
|Intestine Small: Jejunum |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 0/70 (0%) 0/60 (0%) 0/60 (0%) 2/60 (3%) 2/70 (3%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 12.3% 7.2% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/7 (0%) 0/9 (0%) 0/5 (0%) 0/0 |
|TERMINAL (d) | 0/26 (0%) 0/20 (0%) 0/13 (0%) 0/1 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- --- --- 619 366 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.003 ** (e) (e) P=0.073 P=0.141 |
|INCIDENTAL TUMOR | P=0.128 (e) (e) P=0.387 P=0.609 |
|LOGISTIC REGRESSION | P=0.044 * (e) (e) P=0.167 P=0.249 |
|COCHRAN-ARMITAGE | P=0.047 * |
|FISHER EXACT | (e) (e) P=0.211 P=0.248 |
|=================================================================================================================================|
| |
|Intestine Small: Site Unspecified |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 0/70 (0%) 0/60 (0%) 0/60 (0%) 2/60 (3%) 4/70 (6%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 12.3% 14.3% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/7 (0%) 0/9 (0%) 0/5 (0%) 0/0 |
|TERMINAL (d) | 0/26 (0%) 0/20 (0%) 0/13 (0%) 0/1 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- --- --- 619 366 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) P=0.073 P=0.017 * |
|INCIDENTAL TUMOR | P=0.014 * (e) (e) P=0.387 P=0.315 |
|LOGISTIC REGRESSION | P=0.002 ** (e) (e) P=0.167 P=0.056 |
|COCHRAN-ARMITAGE | P=0.003 ** |
|FISHER EXACT | (e) (e) P=0.211 P=0.060 |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 PAGE 7
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE | UNTREATD 0.25% 0.50% 1.00% 2.00% |
| | CONTROL |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/70 (1%) 6/60 (10%) 1/60 (2%) 0/60 (0%) 0/69 (0%) |
|ADJUSTED (b) | 3.8% 25.8% 1.7% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/7 (0%) 1/9 (11%) 0/5 (0%) 0/0 |
|TERMINAL (d) | 1/26 (4%) 4/20 (20%) 0/13 (0%) 0/1 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | 736 (T) 648 456 (I) --- --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.665N P=0.028 * P=0.686 P=0.993N (e) |
|INCIDENTAL TUMOR | P=0.398N P=0.035 * P=0.686 P=0.993N (e) |
|LOGISTIC REGRESSION | P=0.133N P=0.030 * P=0.728 P=0.993N (e) |
|COCHRAN-ARMITAGE | P=0.039N* |
|FISHER EXACT | P=0.037 * P=0.712 P=0.538N P=0.504N |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/70 (0%) 2/60 (3%) 1/60 (2%) 0/60 (0%) 0/69 (0%) |
|ADJUSTED (b) | 0.0% 6.5% 2.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/7 (0%) 0/9 (0%) 0/5 (0%) 0/0 |
|TERMINAL (d) | 0/26 (0%) 0/20 (0%) 0/13 (0%) 0/1 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- 543 536 --- --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.480N P=0.214 P=0.512 (e) (e) |
|INCIDENTAL TUMOR | P=0.069N P=0.351 P=0.500 (e) (e) |
|LOGISTIC REGRESSION | P=0.278N P=0.214 P=0.432 (e) (e) |
|COCHRAN-ARMITAGE | P=0.266N |
|FISHER EXACT | P=0.211 P=0.462 (e) (e) |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 PAGE 8
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE | UNTREATD 0.25% 0.50% 1.00% 2.00% |
| | CONTROL |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/70 (1%) 8/60 (13%) 2/60 (3%) 0/60 (0%) 0/69 (0%) |
|ADJUSTED (b) | 3.8% 30.6% 3.7% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/7 (0%) 1/9 (11%) 0/5 (0%) 0/0 |
|TERMINAL (d) | 1/26 (4%) 4/20 (20%) 0/13 (0%) 0/1 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | 736 (T) 543 456 (I) --- --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.444N P=0.008 ** P=0.429 P=0.993N (e) |
|INCIDENTAL TUMOR | P=0.055N P=0.016 * P=0.422 P=0.993N (e) |
|LOGISTIC REGRESSION | P=0.053N P=0.010 ** P=0.424 P=0.993N (e) |
|COCHRAN-ARMITAGE | P=0.020N* |
|FISHER EXACT | P=0.009 ** P=0.442 P=0.538N P=0.504N |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/70 (0%) 0/60 (0%) 1/60 (2%) 3/60 (5%) 1/69 (1%) |
|ADJUSTED (b) | 0.0% 0.0% 4.5% 41.7% 6.7% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/7 (0%) 0/9 (0%) 0/5 (0%) 0/0 |
|TERMINAL (d) | 0/26 (0%) 0/20 (0%) 0/13 (0%) 0/1 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- --- 695 690 620 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P<0.001 ** (e) P=0.413 P<0.001 ** P=0.286 |
|INCIDENTAL TUMOR | P=0.181 (e) P=0.567 P=0.128 P=0.707 |
|LOGISTIC REGRESSION | P=0.029 * (e) P=0.469 P=0.009 ** P=0.428 |
|COCHRAN-ARMITAGE | P=0.231 |
|FISHER EXACT | (e) P=0.462 P=0.096 P=0.496 |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 PAGE 9
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE | UNTREATD 0.25% 0.50% 1.00% 2.00% |
| | CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/70 (0%) 2/60 (3%) 0/60 (0%) 0/60 (0%) 0/70 (0%) |
|ADJUSTED (b) | 0.0% 10.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/7 (0%) 0/9 (0%) 0/5 (0%) 0/0 |
|TERMINAL (d) | 0/26 (0%) 2/20 (10%) 0/13 (0%) 0/1 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- 736 (T) --- --- --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.912 P=0.182 (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.912 P=0.182 (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.912 P=0.182 (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.303N |
|FISHER EXACT | P=0.211 (e) (e) (e) |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/70 (0%) 2/60 (3%) 0/60 (0%) 0/60 (0%) 1/70 (1%) |
|ADJUSTED (b) | 0.0% 10.0% 0.0% 0.0% 9.1% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/7 (0%) 0/9 (0%) 0/5 (0%) 0/0 |
|TERMINAL (d) | 0/26 (0%) 2/20 (10%) 0/13 (0%) 0/1 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- 736 (T) --- --- 653 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.038 * P=0.182 (e) (e) P=0.240 |
|INCIDENTAL TUMOR | P=0.103 P=0.182 (e) (e) P=0.455 |
|LOGISTIC REGRESSION | P=0.189 P=0.182 (e) (e) P=0.374 |
|COCHRAN-ARMITAGE | P=0.593 |
|FISHER EXACT | P=0.211 (e) (e) P=0.500 |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 PAGE 10
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE | UNTREATD 0.25% 0.50% 1.00% 2.00% |
| | CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/70 (0%) 2/60 (3%) 0/60 (0%) 0/60 (0%) 1/70 (1%) |
|ADJUSTED (b) | 0.0% 10.0% 0.0% 0.0% 9.1% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/7 (0%) 0/9 (0%) 0/5 (0%) 0/0 |
|TERMINAL (d) | 0/26 (0%) 2/20 (10%) 0/13 (0%) 0/1 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- 736 (T) --- --- 653 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.038 * P=0.182 (e) (e) P=0.240 |
|INCIDENTAL TUMOR | P=0.103 P=0.182 (e) (e) P=0.455 |
|LOGISTIC REGRESSION | P=0.189 P=0.182 (e) (e) P=0.374 |
|COCHRAN-ARMITAGE | P=0.593 |
|FISHER EXACT | P=0.211 (e) (e) P=0.500 |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/70 (1%) 0/60 (0%) 3/60 (5%) 1/60 (2%) 4/70 (6%) |
|ADJUSTED (b) | 2.9% 0.0% 18.6% 10.0% 100.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/7 (0%) 0/9 (0%) 0/5 (0%) 0/0 |
|TERMINAL (d) | 0/26 (0%) 0/20 (0%) 2/13 (15%) 0/1 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | 696 --- 684 682 513 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P<0.001 ** P=0.553N P=0.143 P=0.408 P=0.003 ** |
|INCIDENTAL TUMOR | P=0.013 * P=0.487N P=0.242 P=0.750N P=0.297 |
|LOGISTIC REGRESSION | P=0.003 ** P=0.525N P=0.206 P=0.613 P=0.059 |
|COCHRAN-ARMITAGE | P=0.075 |
|FISHER EXACT | P=0.538N P=0.254 P=0.712 P=0.183 |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 PAGE 11
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE | UNTREATD 0.25% 0.50% 1.00% 2.00% |
| | CONTROL |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/70 (0%) 1/60 (2%) 0/60 (0%) 3/60 (5%) 3/70 (4%) |
|ADJUSTED (b) | 0.0% 5.0% 0.0% 59.3% 21.4% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/7 (0%) 0/9 (0%) 0/5 (0%) 0/0 |
|TERMINAL (d) | 0/26 (0%) 1/20 (5%) 0/13 (0%) 0/1 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- 736 (T) --- 620 522 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P<0.001 ** P=0.448 (e) P=0.001 ** P=0.015 * |
|INCIDENTAL TUMOR | P=0.025 * P=0.448 (e) P=0.202 P=0.286 |
|LOGISTIC REGRESSION | P=0.003 ** P=0.448 (e) P=0.024 * P=0.072 |
|COCHRAN-ARMITAGE | P=0.038 * |
|FISHER EXACT | P=0.462 (e) P=0.096 P=0.122 |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/70 (1%) 1/60 (2%) 3/60 (5%) 4/60 (7%) 7/70 (10%) |
|ADJUSTED (b) | 2.9% 5.0% 18.6% 63.4% 100.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/7 (0%) 0/9 (0%) 0/5 (0%) 0/0 |
|TERMINAL (d) | 0/26 (0%) 1/20 (5%) 2/13 (15%) 0/1 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | 696 736 (T) 684 620 513 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P<0.001 ** P=0.700 P=0.143 P=0.001 ** P<0.001 ** |
|INCIDENTAL TUMOR | P<0.001 ** P=0.739 P=0.242 P=0.268 P=0.114 |
|LOGISTIC REGRESSION | P<0.001 ** P=0.723 P=0.206 P=0.027 * P=0.005 ** |
|COCHRAN-ARMITAGE | P=0.007 ** |
|FISHER EXACT | P=0.712 P=0.254 P=0.138 P=0.031 * |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 PAGE 12
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE | UNTREATD 0.25% 0.50% 1.00% 2.00% |
| | CONTROL |
|=================================================================================================================================|
| |
|Lung |
| Squamous Cell Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/70 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) 3/70 (4%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% 13.2% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/7 (0%) 0/9 (0%) 0/5 (0%) 0/0 |
|TERMINAL (d) | 0/26 (0%) 0/20 (0%) 0/13 (0%) 0/1 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- --- --- --- 365 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) P=0.047 * |
|INCIDENTAL TUMOR | P=0.030 * (e) (e) (e) P=0.258 |
|LOGISTIC REGRESSION | P=0.010 ** (e) (e) (e) P=0.121 |
|COCHRAN-ARMITAGE | P=0.006 ** |
|FISHER EXACT | (e) (e) (e) P=0.122 |
|=================================================================================================================================|
| |
|Mammary Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 0/70 (0%) 0/60 (0%) 1/60 (2%) 1/60 (2%) 0/70 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 3.8% 3.4% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/7 (0%) 0/9 (0%) 0/5 (0%) 0/0 |
|TERMINAL (d) | 0/26 (0%) 0/20 (0%) 0/13 (0%) 0/1 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- --- 684 585 --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.483 (e) P=0.447 P=0.404 (e) |
|INCIDENTAL TUMOR | P=0.646N (e) P=0.567 P=0.773 (e) |
|LOGISTIC REGRESSION | P=0.650 (e) P=0.477 P=0.469 (e) |
|COCHRAN-ARMITAGE | P=0.675N |
|FISHER EXACT | (e) P=0.462 P=0.462 (e) |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 PAGE 13
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE | UNTREATD 0.25% 0.50% 1.00% 2.00% |
| | CONTROL |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 0/70 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/70 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/7 (0%) 0/9 (0%) 0/5 (0%) 0/0 |
|TERMINAL (d) | 0/26 (0%) 0/20 (0%) 0/13 (0%) 0/1 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- --- --- --- --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) |
|INCIDENTAL TUMOR | (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION | (e) (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | (e) |
|FISHER EXACT | (e) (e) (e) (e) |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 0/70 (0%) 0/60 (0%) 1/60 (2%) 1/60 (2%) 0/70 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 3.8% 3.4% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/7 (0%) 0/9 (0%) 0/5 (0%) 0/0 |
|TERMINAL (d) | 0/26 (0%) 0/20 (0%) 0/13 (0%) 0/1 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- --- 684 585 --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.483 (e) P=0.447 P=0.404 (e) |
|INCIDENTAL TUMOR | P=0.646N (e) P=0.567 P=0.773 (e) |
|LOGISTIC REGRESSION | P=0.650 (e) P=0.477 P=0.469 (e) |
|COCHRAN-ARMITAGE | P=0.675N |
|FISHER EXACT | (e) P=0.462 P=0.462 (e) |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 PAGE 14
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE | UNTREATD 0.25% 0.50% 1.00% 2.00% |
| | CONTROL |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 0/70 (0%) 4/60 (7%) 6/60 (10%) 6/60 (10%) 5/70 (7%) |
|ADJUSTED (b) | 0.0% 18.9% 42.6% 51.6% 57.6% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/7 (0%) 0/9 (0%) 0/5 (0%) 0/0 |
|TERMINAL (d) | 0/26 (0%) 3/20 (15%) 5/13 (38%) 0/1 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- 725 726 576 592 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P<0.001 ** P=0.036 * P<0.001 ** P<0.001 ** P<0.001 ** |
|INCIDENTAL TUMOR | P<0.001 ** P=0.043 * P=0.002 ** P=0.029 * P=0.027 * |
|LOGISTIC REGRESSION | P<0.001 ** P=0.034 * P<0.001 ** P=0.002 ** P=0.001 ** |
|COCHRAN-ARMITAGE | P=0.145 |
|FISHER EXACT | P=0.043 * P=0.008 ** P=0.008 ** P=0.029 * |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 0/70 (0%) 4/60 (7%) 7/60 (12%) 7/60 (12%) 5/70 (7%) |
|ADJUSTED (b) | 0.0% 18.9% 44.8% 53.2% 57.6% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/7 (0%) 0/9 (0%) 0/5 (0%) 0/0 |
|TERMINAL (d) | 0/26 (0%) 3/20 (15%) 5/13 (38%) 0/1 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- 725 684 576 592 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P<0.001 ** P=0.036 * P<0.001 ** P<0.001 ** P<0.001 ** |
|INCIDENTAL TUMOR | P<0.001 ** P=0.043 * P=0.001 ** P=0.025 * P=0.027 * |
|LOGISTIC REGRESSION | P<0.001 ** P=0.034 * P<0.001 ** P=0.002 ** P=0.001 ** |
|COCHRAN-ARMITAGE | P=0.158 |
|FISHER EXACT | P=0.043 * P=0.004 ** P=0.004 ** P=0.029 * |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 PAGE 15
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE | UNTREATD 0.25% 0.50% 1.00% 2.00% |
| | CONTROL |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 0/70 (0%) 4/60 (7%) 7/60 (12%) 7/60 (12%) 5/70 (7%) |
|ADJUSTED (b) | 0.0% 18.9% 44.8% 53.2% 57.6% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/7 (0%) 0/9 (0%) 0/5 (0%) 0/0 |
|TERMINAL (d) | 0/26 (0%) 3/20 (15%) 5/13 (38%) 0/1 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- 725 684 576 592 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P<0.001 ** P=0.036 * P<0.001 ** P<0.001 ** P<0.001 ** |
|INCIDENTAL TUMOR | P<0.001 ** P=0.043 * P=0.001 ** P=0.025 * P=0.027 * |
|LOGISTIC REGRESSION | P<0.001 ** P=0.034 * P<0.001 ** P=0.002 ** P=0.001 ** |
|COCHRAN-ARMITAGE | P=0.158 |
|FISHER EXACT | P=0.043 * P=0.004 ** P=0.004 ** P=0.029 * |
|=================================================================================================================================|
| |
|Mesentery |
| Sarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 0/70 (0%) 0/60 (0%) 0/60 (0%) 2/60 (3%) 0/70 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 4.4% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/7 (0%) 0/9 (0%) 0/5 (0%) 0/0 |
|TERMINAL (d) | 0/26 (0%) 0/20 (0%) 0/13 (0%) 0/1 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- --- --- 471 --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.451 (e) (e) P=0.224 (e) |
|INCIDENTAL TUMOR | P=0.579N (e) (e) P=0.580 (e) |
|LOGISTIC REGRESSION | P=0.558 (e) (e) P=0.188 (e) |
|COCHRAN-ARMITAGE | P=0.512 |
|FISHER EXACT | (e) (e) P=0.211 (e) |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 PAGE 16
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE | UNTREATD 0.25% 0.50% 1.00% 2.00% |
| | CONTROL |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) |
| Papilloma Squamous or Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 0/70 (0%) 4/60 (7%) 8/60 (13%) 10/60 (17%) 12/70 (17%) |
|ADJUSTED (b) | 0.0% 20.0% 35.7% 44.1% 100.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/7 (0%) 0/9 (0%) 0/5 (0%) 0/0 |
|TERMINAL (d) | 0/26 (0%) 4/20 (20%) 3/13 (23%) 0/1 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- 736 (T) 536 381 511 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P<0.001 ** P=0.033 * P<0.001 ** P<0.001 ** P<0.001 ** |
|INCIDENTAL TUMOR | P=0.002 ** P=0.033 * P=0.004 ** P=0.051 P=0.025 * |
|LOGISTIC REGRESSION | P<0.001 ** P=0.033 * P=0.003 ** P<0.001 ** P<0.001 ** |
|COCHRAN-ARMITAGE | P<0.001 ** |
|FISHER EXACT | P=0.043 * P=0.002 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) |
| Squamous Cell Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 0/70 (0%) 0/60 (0%) 1/60 (2%) 0/60 (0%) 2/70 (3%) |
|ADJUSTED (b) | 0.0% 0.0% 5.3% 0.0% 9.1% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/7 (0%) 0/9 (0%) 0/5 (0%) 0/0 |
|TERMINAL (d) | 0/26 (0%) 0/20 (0%) 0/13 (0%) 0/1 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- --- 697 --- 516 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.007 ** (e) P=0.390 (e) P=0.114 |
|INCIDENTAL TUMOR | P=0.196 (e) P=0.567 (e) P=0.609 |
|LOGISTIC REGRESSION | P=0.054 (e) P=0.467 (e) P=0.205 |
|COCHRAN-ARMITAGE | P=0.088 |
|FISHER EXACT | (e) P=0.462 (e) P=0.248 |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 PAGE 17
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE | UNTREATD 0.25% 0.50% 1.00% 2.00% |
| | CONTROL |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) |
| Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 0/70 (0%) 4/60 (7%) 9/60 (15%) 10/60 (17%) 13/70 (19%) |
|ADJUSTED (b) | 0.0% 20.0% 39.0% 44.1% 100.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/7 (0%) 0/9 (0%) 0/5 (0%) 0/0 |
|TERMINAL (d) | 0/26 (0%) 4/20 (20%) 3/13 (23%) 0/1 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- 736 (T) 536 381 511 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P<0.001 ** P=0.033 * P<0.001 ** P<0.001 ** P<0.001 ** |
|INCIDENTAL TUMOR | P=0.001 ** P=0.033 * P=0.002 ** P=0.051 P=0.019 * |
|LOGISTIC REGRESSION | P<0.001 ** P=0.033 * P=0.001 ** P<0.001 ** P<0.001 ** |
|COCHRAN-ARMITAGE | P<0.001 ** |
|FISHER EXACT | P=0.043 * P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| |
|Pancreas |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/70 (1%) 2/60 (3%) 4/60 (7%) 3/58 (5%) 3/69 (4%) |
|ADJUSTED (b) | 3.8% 10.0% 30.8% 34.1% 8.5% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/7 (0%) 0/9 (0%) 0/5 (0%) 0/0 |
|TERMINAL (d) | 1/26 (4%) 2/20 (10%) 4/13 (31%) 0/1 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | 736 (T) 736 (T) 736 (T) 604 507 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P<0.001 ** P=0.408 P=0.033 * P=0.007 ** P=0.077 |
|INCIDENTAL TUMOR | P=0.021 * P=0.408 P=0.033 * P=0.210 P=0.530 |
|LOGISTIC REGRESSION | P=0.035 * P=0.408 P=0.033 * P=0.082 P=0.234 |
|COCHRAN-ARMITAGE | P=0.333 |
|FISHER EXACT | P=0.442 P=0.138 P=0.242 P=0.304 |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 PAGE 18
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE | UNTREATD 0.25% 0.50% 1.00% 2.00% |
| | CONTROL |
|=================================================================================================================================|
| |
|Pharynx |
| Squamous Cell Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 0/70 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) 2/70 (3%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% 9.1% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/7 (0%) 0/9 (0%) 0/5 (0%) 0/0 |
|TERMINAL (d) | 0/26 (0%) 0/20 (0%) 0/13 (0%) 0/1 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- --- --- --- 516 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.005 ** (e) (e) (e) P=0.114 |
|INCIDENTAL TUMOR | P=0.116 (e) (e) (e) P=0.609 |
|LOGISTIC REGRESSION | P=0.026 * (e) (e) (e) P=0.205 |
|COCHRAN-ARMITAGE | P=0.028 * |
|FISHER EXACT | (e) (e) (e) P=0.248 |
|=================================================================================================================================|
| |
|Pharynx |
| Squamous Cell Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 0/70 (0%) 2/60 (3%) 3/60 (5%) 2/60 (3%) 7/70 (10%) |
|ADJUSTED (b) | 0.0% 10.0% 13.5% 18.4% 46.5% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/7 (0%) 0/9 (0%) 0/5 (0%) 0/0 |
|TERMINAL (d) | 0/26 (0%) 2/20 (10%) 1/13 (8%) 0/1 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- 736 (T) 641 509 516 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P<0.001 ** P=0.182 P=0.069 P=0.085 P<0.001 ** |
|INCIDENTAL TUMOR | P=0.005 ** P=0.182 P=0.141 P=0.393 P=0.087 |
|LOGISTIC REGRESSION | P<0.001 ** P=0.182 P=0.099 P=0.201 P=0.003 ** |
|COCHRAN-ARMITAGE | P=0.006 ** |
|FISHER EXACT | P=0.211 P=0.096 P=0.211 P=0.007 ** |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 PAGE 19
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE | UNTREATD 0.25% 0.50% 1.00% 2.00% |
| | CONTROL |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 9/69 (13%) 10/58 (17%) 6/59 (10%) 6/58 (10%) 5/67 (7%) |
|ADJUSTED (b) | 25.0% 35.3% 31.1% 70.2% 43.2% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 2/9 (22%) 1/7 (14%) 0/9 (0%) 0/5 (0%) 0/0 |
|TERMINAL (d) | 3/25 (12%) 5/20 (25%) 3/13 (23%) 0/1 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | 456 (I) 456 (I) 576 604 507 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P<0.001 ** P=0.309 P=0.588 P=0.027 * P=0.010 * |
|INCIDENTAL TUMOR | P=0.531N P=0.395 P=0.338N P=0.554N P=0.507N |
|LOGISTIC REGRESSION | P=0.493N P=0.399 P=0.350N P=0.603 P=0.473N |
|COCHRAN-ARMITAGE | P=0.098N |
|FISHER EXACT | P=0.339 P=0.412N P=0.426N P=0.216N |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 9/69 (13%) 11/58 (19%) 6/59 (10%) 6/58 (10%) 5/67 (7%) |
|ADJUSTED (b) | 25.0% 39.6% 31.1% 70.2% 43.2% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 2/9 (22%) 1/7 (14%) 0/9 (0%) 0/5 (0%) 0/0 |
|TERMINAL (d) | 3/25 (12%) 6/20 (30%) 3/13 (23%) 0/1 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | 456 (I) 456 (I) 576 604 507 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P<0.001 ** P=0.225 P=0.588 P=0.027 * P=0.010 * |
|INCIDENTAL TUMOR | P=0.535N P=0.295 P=0.338N P=0.554N P=0.507N |
|LOGISTIC REGRESSION | P=0.474N P=0.304 P=0.350N P=0.603 P=0.473N |
|COCHRAN-ARMITAGE | P=0.081N |
|FISHER EXACT | P=0.252 P=0.412N P=0.426N P=0.216N |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 PAGE 20
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE | UNTREATD 0.25% 0.50% 1.00% 2.00% |
| | CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Basal Cell Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 0/70 (0%) 1/60 (2%) 0/60 (0%) 3/60 (5%) 6/70 (9%) |
|ADJUSTED (b) | 0.0% 2.9% 0.0% 62.5% 56.1% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/7 (0%) 0/9 (0%) 0/5 (0%) 0/0 |
|TERMINAL (d) | 0/26 (0%) 0/20 (0%) 0/13 (0%) 0/1 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- 659 --- 690 519 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P<0.001 ** P=0.463 (e) P<0.001 ** P<0.001 ** |
|INCIDENTAL TUMOR | P<0.001 ** P=0.513 (e) P=0.128 P=0.047 * |
|LOGISTIC REGRESSION | P<0.001 ** P=0.481 (e) P=0.005 ** P=0.003 ** |
|COCHRAN-ARMITAGE | P<0.001 ** |
|FISHER EXACT | P=0.462 (e) P=0.096 P=0.014 * |
|=================================================================================================================================|
| |
|Skin |
| Basal Cell Adenoma, Basosquamous Tumor Benign, or Trichoepithelioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 0/70 (0%) 1/60 (2%) 0/60 (0%) 4/60 (7%) 7/70 (10%) |
|ADJUSTED (b) | 0.0% 2.9% 0.0% 63.3% 64.9% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/7 (0%) 0/9 (0%) 0/5 (0%) 0/0 |
|TERMINAL (d) | 0/26 (0%) 0/20 (0%) 0/13 (0%) 0/1 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- 659 --- 516 519 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P<0.001 ** P=0.463 (e) P<0.001 ** P<0.001 ** |
|INCIDENTAL TUMOR | P<0.001 ** P=0.513 (e) P=0.109 P=0.021 * |
|LOGISTIC REGRESSION | P<0.001 ** P=0.481 (e) P=0.019 * P<0.001 ** |
|COCHRAN-ARMITAGE | P<0.001 ** |
|FISHER EXACT | P=0.462 (e) P=0.043 * P=0.007 ** |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 PAGE 21
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE | UNTREATD 0.25% 0.50% 1.00% 2.00% |
| | CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Basal Cell Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 0/70 (0%) 0/60 (0%) 2/60 (3%) 2/60 (3%) 0/70 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 8.7% 40.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/7 (0%) 0/9 (0%) 0/5 (0%) 0/0 |
|TERMINAL (d) | 0/26 (0%) 0/20 (0%) 0/13 (0%) 0/1 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- --- 694 709 --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.054 (e) P=0.155 P=0.004 ** (e) |
|INCIDENTAL TUMOR | P=0.571 (e) P=0.314 P=0.250 (e) |
|LOGISTIC REGRESSION | P=0.248 (e) P=0.202 P=0.029 * (e) |
|COCHRAN-ARMITAGE | P=0.618N |
|FISHER EXACT | (e) P=0.211 P=0.211 (e) |
|=================================================================================================================================|
| |
|Skin |
| Basal Cell Carcinoma, Basal Cell Adenoma, Basosquamous Tumor (benign, |
| malignant or NOS), or Trichoepithelioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 0/70 (0%) 1/60 (2%) 2/60 (3%) 6/60 (10%) 7/70 (10%) |
|ADJUSTED (b) | 0.0% 2.9% 8.7% 78.0% 64.9% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/7 (0%) 0/9 (0%) 0/5 (0%) 0/0 |
|TERMINAL (d) | 0/26 (0%) 0/20 (0%) 0/13 (0%) 0/1 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- 659 694 516 519 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P<0.001 ** P=0.463 P=0.155 P<0.001 ** P<0.001 ** |
|INCIDENTAL TUMOR | P<0.001 ** P=0.513 P=0.314 P=0.029 * P=0.021 * |
|LOGISTIC REGRESSION | P<0.001 ** P=0.481 P=0.202 P<0.001 ** P<0.001 ** |
|COCHRAN-ARMITAGE | P=0.001 ** |
|FISHER EXACT | P=0.462 P=0.211 P=0.008 ** P=0.007 ** |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 PAGE 22
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE | UNTREATD 0.25% 0.50% 1.00% 2.00% |
| | CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor (M or B), Basal |
| Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepithelioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 4/70 (6%) 7/60 (12%) 14/60 (23%) 25/60 (42%) 21/70 (30%) |
|ADJUSTED (b) | 13.5% 27.2% 50.4% 100.0% 100.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 1/7 (14%) 0/9 (0%) 1/5 (20%) 0/0 |
|TERMINAL (d) | 3/26 (12%) 4/20 (20%) 3/13 (23%) 1/1 (100%) 0/0 |
|FIRST INCIDENCE (DAYS) | 619 456 (I) 633 393 425 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P<0.001 ** P=0.143 P<0.001 ** P<0.001 ** P<0.001 ** |
|INCIDENTAL TUMOR | P<0.001 ** P=0.184 P=0.012 * P<0.001 ** P=0.001 ** |
|LOGISTIC REGRESSION | P<0.001 ** P=0.199 P=0.004 ** P<0.001 ** P<0.001 ** |
|COCHRAN-ARMITAGE | P<0.001 ** |
|FISHER EXACT | P=0.184 P=0.004 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| |
|Skin |
| Fibroma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 2/70 (3%) 8/60 (13%) 11/60 (18%) 15/60 (25%) 7/70 (10%) |
|ADJUSTED (b) | 6.3% 26.5% 35.2% 100.0% 30.2% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/7 (0%) 0/9 (0%) 0/5 (0%) 0/0 |
|TERMINAL (d) | 1/26 (4%) 3/20 (15%) 1/13 (8%) 1/1 (100%) 0/0 |
|FIRST INCIDENCE (DAYS) | 660 576 536 381 388 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P<0.001 ** P=0.026 * P=0.003 ** P<0.001 ** P=0.002 ** |
|INCIDENTAL TUMOR | P=0.409 P=0.045 * P=0.031 * P=0.003 ** P=0.230 |
|LOGISTIC REGRESSION | P=0.057 P=0.034 * P=0.006 ** P<0.001 ** P=0.046 * |
|COCHRAN-ARMITAGE | P=0.245 |
|FISHER EXACT | P=0.027 * P=0.004 ** P<0.001 ** P=0.083 |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 PAGE 23
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE | UNTREATD 0.25% 0.50% 1.00% 2.00% |
| | CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 2/70 (3%) 9/60 (15%) 13/60 (22%) 16/60 (27%) 10/70 (14%) |
|ADJUSTED (b) | 6.3% 30.8% 39.3% 100.0% 37.1% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/7 (0%) 0/9 (0%) 0/5 (0%) 0/0 |
|TERMINAL (d) | 1/26 (4%) 4/20 (20%) 1/13 (8%) 1/1 (100%) 0/0 |
|FIRST INCIDENCE (DAYS) | 660 576 536 381 388 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P<0.001 ** P=0.013 * P<0.001 ** P<0.001 ** P<0.001 ** |
|INCIDENTAL TUMOR | P=0.204 P=0.024 * P=0.014 * P=0.002 ** P=0.130 |
|LOGISTIC REGRESSION | P=0.011 * P=0.018 * P=0.015 * P<0.001 ** P=0.008 ** |
|COCHRAN-ARMITAGE | P=0.104 |
|FISHER EXACT | P=0.014 * P<0.001 ** P<0.001 ** P=0.015 * |
|=================================================================================================================================|
| |
|Skin |
| Fibrosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 0/70 (0%) 1/60 (2%) 0/60 (0%) 0/60 (0%) 1/70 (1%) |
|ADJUSTED (b) | 0.0% 5.0% 0.0% 0.0% 3.6% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/7 (0%) 0/9 (0%) 0/5 (0%) 0/0 |
|TERMINAL (d) | 0/26 (0%) 1/20 (5%) 0/13 (0%) 0/1 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- 736 (T) --- --- 575 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.091 P=0.448 (e) (e) P=0.397 |
|INCIDENTAL TUMOR | P=0.209 P=0.448 (e) (e) P=0.707 |
|LOGISTIC REGRESSION | P=0.278 P=0.448 (e) (e) P=0.473 |
|COCHRAN-ARMITAGE | P=0.416 |
|FISHER EXACT | P=0.462 (e) (e) P=0.500 |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 PAGE 24
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE | UNTREATD 0.25% 0.50% 1.00% 2.00% |
| | CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 0/70 (0%) 1/60 (2%) 2/60 (3%) 3/60 (5%) 3/70 (4%) |
|ADJUSTED (b) | 0.0% 5.0% 6.2% 56.5% 9.8% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/7 (0%) 0/9 (0%) 0/5 (0%) 0/0 |
|TERMINAL (d) | 0/26 (0%) 1/20 (5%) 0/13 (0%) 0/1 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- 736 (T) 621 577 439 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P<0.001 ** P=0.448 P=0.203 P=0.004 ** P=0.053 |
|INCIDENTAL TUMOR | P=0.112 P=0.448 P=0.374 P=0.202 P=0.432 |
|LOGISTIC REGRESSION | P=0.032 * P=0.448 P=0.219 P=0.046 * P=0.111 |
|COCHRAN-ARMITAGE | P=0.093 |
|FISHER EXACT | P=0.462 P=0.211 P=0.096 P=0.122 |
|=================================================================================================================================|
| |
|Skin |
| Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 3/70 (4%) 5/60 (8%) 11/60 (18%) 16/60 (27%) 10/70 (14%) |
|ADJUSTED (b) | 9.7% 23.6% 41.0% 83.0% 69.4% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/7 (0%) 0/9 (0%) 0/5 (0%) 0/0 |
|TERMINAL (d) | 2/26 (8%) 4/20 (20%) 2/13 (15%) 0/1 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | 619 725 633 495 507 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P<0.001 ** P=0.227 P=0.004 ** P<0.001 ** P<0.001 ** |
|INCIDENTAL TUMOR | P=0.021 * P=0.275 P=0.037 * P=0.011 * P=0.051 |
|LOGISTIC REGRESSION | P=0.004 ** P=0.253 P=0.012 * P<0.001 ** P=0.003 ** |
|COCHRAN-ARMITAGE | P=0.043 * |
|FISHER EXACT | P=0.277 P=0.010 * P<0.001 ** P=0.039 * |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 PAGE 25
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE | UNTREATD 0.25% 0.50% 1.00% 2.00% |
| | CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Lipoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 0/70 (0%) 0/60 (0%) 1/60 (2%) 0/60 (0%) 0/70 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 7.7% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/7 (0%) 0/9 (0%) 0/5 (0%) 0/0 |
|TERMINAL (d) | 0/26 (0%) 0/20 (0%) 1/13 (8%) 0/1 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- --- 736 (T) --- --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.829 (e) P=0.362 (e) (e) |
|INCIDENTAL TUMOR | P=0.829 (e) P=0.362 (e) (e) |
|LOGISTIC REGRESSION | P=0.829 (e) P=0.362 (e) (e) |
|COCHRAN-ARMITAGE | P=0.626N |
|FISHER EXACT | (e) P=0.462 (e) (e) |
|=================================================================================================================================|
| |
|Skin |
| Sarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 0/70 (0%) 0/60 (0%) 2/60 (3%) 3/60 (5%) 2/70 (3%) |
|ADJUSTED (b) | 0.0% 0.0% 6.2% 56.5% 6.5% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/7 (0%) 0/9 (0%) 0/5 (0%) 0/0 |
|TERMINAL (d) | 0/26 (0%) 0/20 (0%) 0/13 (0%) 0/1 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- --- 621 577 439 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.002 ** (e) P=0.203 P=0.004 ** P=0.143 |
|INCIDENTAL TUMOR | P=0.244 (e) P=0.374 P=0.202 P=0.609 |
|LOGISTIC REGRESSION | P=0.068 (e) P=0.219 P=0.046 * P=0.238 |
|COCHRAN-ARMITAGE | P=0.132 |
|FISHER EXACT | (e) P=0.211 P=0.096 P=0.248 |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 PAGE 26
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE | UNTREATD 0.25% 0.50% 1.00% 2.00% |
| | CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Schwannoma Malignant |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 0/70 (0%) 2/60 (3%) 0/60 (0%) 0/60 (0%) 0/70 (0%) |
|ADJUSTED (b) | 0.0% 8.3% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/7 (0%) 0/9 (0%) 0/5 (0%) 0/0 |
|TERMINAL (d) | 0/26 (0%) 1/20 (5%) 0/13 (0%) 0/1 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- 681 --- --- --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.801N P=0.192 (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.565N P=0.218 (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.586N P=0.203 (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.303N |
|FISHER EXACT | P=0.211 (e) (e) (e) |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Carcinoma, Basal Cell Carcinoma, Basosquamous Tumor |
| (malignant or NOS), or Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 0/70 (0%) 0/60 (0%) 2/60 (3%) 2/60 (3%) 1/70 (1%) |
|ADJUSTED (b) | 0.0% 0.0% 8.7% 40.0% 100.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/7 (0%) 0/9 (0%) 0/5 (0%) 0/0 |
|TERMINAL (d) | 0/26 (0%) 0/20 (0%) 0/13 (0%) 0/1 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- --- 694 709 726 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P<0.001 ** (e) P=0.155 P=0.004 ** P=0.006 ** |
|INCIDENTAL TUMOR | P=0.218 (e) P=0.314 P=0.250 P=0.455 |
|LOGISTIC REGRESSION | P=0.013 * (e) P=0.202 P=0.029 * P=0.046 * |
|COCHRAN-ARMITAGE | P=0.339 |
|FISHER EXACT | (e) P=0.211 P=0.211 P=0.500 |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 PAGE 27
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE | UNTREATD 0.25% 0.50% 1.00% 2.00% |
| | CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 1/70 (1%) 1/60 (2%) 2/60 (3%) 6/60 (10%) 11/70 (16%) |
|ADJUSTED (b) | 3.8% 1.8% 10.5% 100.0% 60.9% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 1/7 (14%) 0/9 (0%) 1/5 (20%) 0/0 |
|TERMINAL (d) | 1/26 (4%) 0/20 (0%) 1/13 (8%) 1/1 (100%) 0/0 |
|FIRST INCIDENCE (DAYS) | 736 (T) 456 (I) 654 393 425 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P<0.001 ** P=0.702 P=0.319 P=0.001 ** P<0.001 ** |
|INCIDENTAL TUMOR | P<0.001 ** P=0.702 P=0.381 P=0.016 * P=0.014 * |
|LOGISTIC REGRESSION | P<0.001 ** P=0.729 P=0.415 P=0.038 * P<0.001 ** |
|COCHRAN-ARMITAGE | P<0.001 ** |
|FISHER EXACT | P=0.712 P=0.442 P=0.037 * P=0.002 ** |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, Squamous Cell Carcinoma or Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 4/70 (6%) 6/60 (10%) 13/60 (22%) 21/60 (35%) 19/70 (27%) |
|ADJUSTED (b) | 13.5% 25.0% 48.0% 100.0% 100.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 1/7 (14%) 0/9 (0%) 1/5 (20%) 0/0 |
|TERMINAL (d) | 3/26 (12%) 4/20 (20%) 3/13 (23%) 1/1 (100%) 0/0 |
|FIRST INCIDENCE (DAYS) | 619 456 (I) 633 393 425 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P<0.001 ** P=0.224 P=0.002 ** P<0.001 ** P<0.001 ** |
|INCIDENTAL TUMOR | P<0.001 ** P=0.266 P=0.020 * P<0.001 ** P=0.002 ** |
|LOGISTIC REGRESSION | P<0.001 ** P=0.295 P=0.007 ** P<0.001 ** P<0.001 ** |
|COCHRAN-ARMITAGE | P<0.001 ** |
|FISHER EXACT | P=0.279 P=0.007 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 PAGE 28
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE | UNTREATD 0.25% 0.50% 1.00% 2.00% |
| | CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, or Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 4/70 (6%) 6/60 (10%) 13/60 (22%) 21/60 (35%) 18/70 (26%) |
|ADJUSTED (b) | 13.5% 25.0% 48.0% 100.0% 80.7% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 1/7 (14%) 0/9 (0%) 1/5 (20%) 0/0 |
|TERMINAL (d) | 3/26 (12%) 4/20 (20%) 3/13 (23%) 1/1 (100%) 0/0 |
|FIRST INCIDENCE (DAYS) | 619 456 (I) 633 393 425 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P<0.001 ** P=0.224 P=0.002 ** P<0.001 ** P<0.001 ** |
|INCIDENTAL TUMOR | P<0.001 ** P=0.266 P=0.020 * P<0.001 ** P=0.004 ** |
|LOGISTIC REGRESSION | P<0.001 ** P=0.295 P=0.007 ** P<0.001 ** P<0.001 ** |
|COCHRAN-ARMITAGE | P<0.001 ** |
|FISHER EXACT | P=0.279 P=0.007 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| |
|Skin: Sebaceous Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 0/70 (0%) 1/60 (2%) 0/60 (0%) 2/60 (3%) 2/70 (3%) |
|ADJUSTED (b) | 0.0% 5.0% 0.0% 19.6% 22.1% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/7 (0%) 0/9 (0%) 0/5 (0%) 0/0 |
|TERMINAL (d) | 0/26 (0%) 1/20 (5%) 0/13 (0%) 0/1 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- 736 (T) --- 654 653 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P<0.001 ** P=0.448 (e) P=0.037 * P=0.018 * |
|INCIDENTAL TUMOR | P=0.014 * P=0.448 (e) P=0.250 P=0.188 |
|LOGISTIC REGRESSION | P=0.007 ** P=0.448 (e) P=0.110 P=0.090 |
|COCHRAN-ARMITAGE | P=0.118 |
|FISHER EXACT | P=0.462 (e) P=0.211 P=0.248 |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 PAGE 29
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE | UNTREATD 0.25% 0.50% 1.00% 2.00% |
| | CONTROL |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Squamous Cell Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 0/70 (0%) 0/60 (0%) 0/60 (0%) 1/60 (2%) 5/70 (7%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 3.8% 26.7% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/7 (0%) 0/9 (0%) 0/5 (0%) 0/0 |
|TERMINAL (d) | 0/26 (0%) 0/20 (0%) 0/13 (0%) 0/1 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- --- --- 604 511 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) P=0.382 P=0.002 ** |
|INCIDENTAL TUMOR | P=0.002 ** (e) (e) P=0.773 P=0.157 |
|LOGISTIC REGRESSION | P<0.001 ** (e) (e) P=0.466 P=0.013 * |
|COCHRAN-ARMITAGE | P<0.001 ** |
|FISHER EXACT | (e) (e) P=0.462 P=0.029 * |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 57/70 (81%) 54/60 (90%) 60/60 (100%) 56/60 (93%) 59/70 (84%) |
|ADJUSTED (b) | 100.0% 96.3% 100.0% 100.0% 100.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 8/9 (89%) 6/7 (86%) 9/9 (100%) 5/5 (100%) 0/0 |
|TERMINAL (d) | 26/26 (100%) 18/20 (90%) 13/13 (100%) 1/1 (100%) 0/0 |
|FIRST INCIDENCE (DAYS) | 456 (I) 450 451 432 365 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P<0.001 ** P=0.149 P=0.002 ** P<0.001 ** P<0.001 ** |
|INCIDENTAL TUMOR | P=0.077 P=0.173N P=0.203 P=0.687 P=0.343 |
|LOGISTIC REGRESSION | P=0.032 * P=0.488N P=0.130 P=0.669N P=0.043 * |
|COCHRAN-ARMITAGE | P=0.405N |
|FISHER EXACT | P=0.129 P<0.001 ** P=0.038 * P=0.411 |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 PAGE 30
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE | UNTREATD 0.25% 0.50% 1.00% 2.00% |
| | CONTROL |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 7/70 (10%) 5/60 (8%) 4/60 (7%) 4/60 (7%) 4/69 (6%) |
|ADJUSTED (b) | 23.1% 19.8% 20.4% 70.5% 17.5% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 1/7 (14%) 0/9 (0%) 1/5 (20%) 0/0 |
|TERMINAL (d) | 5/26 (19%) 3/20 (15%) 2/13 (15%) 0/1 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | 619 456 (I) 641 456 (I) 471 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P<0.001 ** P=0.559N P=0.593N P=0.028 * P=0.062 |
|INCIDENTAL TUMOR | P=0.252 P=0.495N P=0.393N P=0.469 P=0.627N |
|LOGISTIC REGRESSION | P=0.440 P=0.468N P=0.386N P=0.571 P=0.631 |
|COCHRAN-ARMITAGE | P=0.231N |
|FISHER EXACT | P=0.493N P=0.361N P=0.361N P=0.274N |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/70 (1%) 1/60 (2%) 1/60 (2%) 3/60 (5%) 0/69 (0%) |
|ADJUSTED (b) | 3.4% 4.0% 3.2% 20.5% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/7 (0%) 0/9 (0%) 0/5 (0%) 0/0 |
|TERMINAL (d) | 0/26 (0%) 0/20 (0%) 0/13 (0%) 0/1 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | 722 711 662 604 --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.210 P=0.710 P=0.667 P=0.030 * P=0.995N |
|INCIDENTAL TUMOR | P=0.396N P=0.750N P=0.686N P=0.559 P=0.545N |
|LOGISTIC REGRESSION | P=0.559 P=0.723 P=0.733 P=0.152 P=0.927N |
|COCHRAN-ARMITAGE | P=0.428N |
|FISHER EXACT | P=0.712 P=0.712 P=0.254 P=0.504N |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 PAGE 31
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE | UNTREATD 0.25% 0.50% 1.00% 2.00% |
| | CONTROL |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 8/70 (11%) 5/60 (8%) 5/60 (8%) 7/60 (12%) 4/69 (6%) |
|ADJUSTED (b) | 25.7% 19.8% 23.0% 76.6% 17.5% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 1/7 (14%) 0/9 (0%) 1/5 (20%) 0/0 |
|TERMINAL (d) | 5/26 (19%) 3/20 (15%) 2/13 (15%) 0/1 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | 619 456 (I) 641 456 (I) 471 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P<0.001 ** P=0.453N P=0.604 P=0.001 ** P=0.068 |
|INCIDENTAL TUMOR | P=0.342 P=0.376N P=0.363N P=0.375 P=0.457N |
|LOGISTIC REGRESSION | P=0.382 P=0.362N P=0.407N P=0.232 P=0.599N |
|COCHRAN-ARMITAGE | P=0.224N |
|FISHER EXACT | P=0.387N P=0.387N P=0.590 P=0.190N |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/70 (0%) 1/60 (2%) 2/60 (3%) 2/60 (3%) 7/69 (10%) |
|ADJUSTED (b) | 0.0% 5.0% 8.4% 8.8% 39.9% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/7 (0%) 0/9 (0%) 0/5 (0%) 0/0 |
|TERMINAL (d) | 0/26 (0%) 1/20 (5%) 0/13 (0%) 0/1 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- 736 (T) 666 608 432 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P<0.001 ** P=0.448 P=0.158 P=0.103 P<0.001 ** |
|INCIDENTAL TUMOR | P=0.004 ** P=0.448 P=0.314 P=0.571 P=0.086 |
|LOGISTIC REGRESSION | P<0.001 ** P=0.448 P=0.213 P=0.196 P=0.005 ** |
|COCHRAN-ARMITAGE | P=0.001 ** |
|FISHER EXACT | P=0.462 P=0.211 P=0.211 P=0.006 ** |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 PAGE 32
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE | UNTREATD 0.25% 0.50% 1.00% 2.00% |
| | CONTROL |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/70 (0%) 1/60 (2%) 4/60 (7%) 1/60 (2%) 2/69 (3%) |
|ADJUSTED (b) | 0.0% 2.6% 20.8% 5.9% 26.3% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/7 (0%) 0/9 (0%) 0/5 (0%) 0/0 |
|TERMINAL (d) | 0/26 (0%) 0/20 (0%) 2/13 (15%) 0/1 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- 610 633 647 388 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.008 ** P=0.462 P=0.023 * P=0.325 P=0.064 |
|INCIDENTAL TUMOR | P=0.267 P=0.557 P=0.050 * P=0.513 P=0.396 |
|LOGISTIC REGRESSION | P=0.194 P=0.473 P=0.042 * P=0.437 P=0.218 |
|COCHRAN-ARMITAGE | P=0.374 |
|FISHER EXACT | P=0.462 P=0.043 * P=0.462 P=0.245 |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/70 (0%) 2/60 (3%) 6/60 (10%) 3/60 (5%) 9/69 (13%) |
|ADJUSTED (b) | 0.0% 7.5% 27.5% 14.2% 55.7% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/7 (0%) 0/9 (0%) 0/5 (0%) 0/0 |
|TERMINAL (d) | 0/26 (0%) 1/20 (5%) 2/13 (15%) 0/1 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- 610 633 608 388 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P<0.001 ** P=0.191 P=0.004 ** P=0.027 * P<0.001 ** |
|INCIDENTAL TUMOR | P=0.003 ** P=0.240 P=0.019 * P=0.304 P=0.038 * |
|LOGISTIC REGRESSION | P<0.001 ** P=0.217 P=0.010 * P=0.083 P=0.001 ** |
|COCHRAN-ARMITAGE | P=0.003 ** |
|FISHER EXACT | P=0.211 P=0.008 ** P=0.096 P=0.001 ** |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 PAGE 33
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE | UNTREATD 0.25% 0.50% 1.00% 2.00% |
| | CONTROL |
|=================================================================================================================================|
| |
|Tongue |
| Squamous Cell Carcinoma or Papilloma Squamous |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 0/70 (0%) 2/60 (3%) 5/60 (8%) 8/60 (13%) 6/70 (9%) |
|ADJUSTED (b) | 0.0% 10.0% 24.5% 31.5% 100.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/7 (0%) 0/9 (0%) 0/5 (0%) 0/0 |
|TERMINAL (d) | 0/26 (0%) 2/20 (10%) 2/13 (15%) 0/1 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- 736 (T) 536 381 511 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P<0.001 ** P=0.182 P=0.009 ** P<0.001 ** P<0.001 ** |
|INCIDENTAL TUMOR | P=0.050 P=0.182 P=0.022 * P=0.105 P=0.176 |
|LOGISTIC REGRESSION | P=0.004 ** P=0.182 P=0.025 * P=0.003 ** P=0.009 ** |
|COCHRAN-ARMITAGE | P=0.024 * |
|FISHER EXACT | P=0.211 P=0.019 * P=0.002 ** P=0.014 * |
|=================================================================================================================================|
| |
|Tongue |
| Squamous Cell Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 0/70 (0%) 2/60 (3%) 5/60 (8%) 8/60 (13%) 6/70 (9%) |
|ADJUSTED (b) | 0.0% 10.0% 24.5% 31.5% 100.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/7 (0%) 0/9 (0%) 0/5 (0%) 0/0 |
|TERMINAL (d) | 0/26 (0%) 2/20 (10%) 2/13 (15%) 0/1 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- 736 (T) 536 381 511 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P<0.001 ** P=0.182 P=0.009 ** P<0.001 ** P<0.001 ** |
|INCIDENTAL TUMOR | P=0.050 P=0.182 P=0.022 * P=0.105 P=0.176 |
|LOGISTIC REGRESSION | P=0.004 ** P=0.182 P=0.025 * P=0.003 ** P=0.009 ** |
|COCHRAN-ARMITAGE | P=0.024 * |
|FISHER EXACT | P=0.211 P=0.019 * P=0.002 ** P=0.014 * |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 PAGE 34
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE | UNTREATD 0.25% 0.50% 1.00% 2.00% |
| | CONTROL |
|=================================================================================================================================|
| |
|Urinary Bladder |
| Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/70 (0%) 0/60 (0%) 1/60 (2%) 3/60 (5%) 1/69 (1%) |
|ADJUSTED (b) | 0.0% 0.0% 7.7% 7.7% 14.3% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/7 (0%) 0/9 (0%) 1/5 (20%) 0/0 |
|TERMINAL (d) | 0/26 (0%) 0/20 (0%) 1/13 (8%) 0/1 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- --- 736 (T) 456 (I) 660 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.007 ** (e) P=0.362 P=0.059 P=0.162 |
|INCIDENTAL TUMOR | P=0.069 (e) P=0.362 P=0.230 P=0.455 |
|LOGISTIC REGRESSION | P=0.186 (e) P=0.362 P=0.089 P=0.356 |
|COCHRAN-ARMITAGE | P=0.231 |
|FISHER EXACT | (e) P=0.462 P=0.096 P=0.496 |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | |
|ADJUSTED (b) | |
|INTERIM SACRIFICE 1 (c)| |
|INTERIM SACRIFICE 2 (c)| |
|TERMINAL (d) | |
|FIRST INCIDENCE (DAYS) | |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | |
|INCIDENTAL TUMOR | |
|LOGISTIC REGRESSION | |
|COCHRAN-ARMITAGE | |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 PAGE 35
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE | UNTREATD 0.25% 0.50% 1.00% 2.00% |
| | CONTROL |
|=================================================================================================================================|
| |
|Uterus |
| Sarcoma Stromal or Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | |
|ADJUSTED (b) | |
|INTERIM SACRIFICE 1 (c)| |
|INTERIM SACRIFICE 2 (c)| |
|TERMINAL (d) | |
|FIRST INCIDENCE (DAYS) | |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | |
|INCIDENTAL TUMOR | |
|LOGISTIC REGRESSION | |
|COCHRAN-ARMITAGE | |
|=================================================================================================================================|
| |
|Zymbal's Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 0/70 (0%) 0/60 (0%) 1/60 (2%) 3/60 (5%) 2/70 (3%) |
|ADJUSTED (b) | 0.0% 0.0% 4.3% 52.6% 7.9% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/7 (0%) 0/9 (0%) 0/5 (0%) 0/0 |
|TERMINAL (d) | 0/26 (0%) 0/20 (0%) 0/13 (0%) 0/1 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- --- 694 556 513 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.002 ** (e) P=0.422 P=0.020 * P=0.129 |
|INCIDENTAL TUMOR | P=0.197 (e) P=0.567 P=0.304 P=0.609 |
|LOGISTIC REGRESSION | P=0.045 * (e) P=0.470 P=0.086 P=0.207 |
|COCHRAN-ARMITAGE | P=0.088 |
|FISHER EXACT | (e) P=0.462 P=0.096 P=0.248 |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 PAGE 36
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE | UNTREATD 0.25% 0.50% 1.00% 2.00% |
| | CONTROL |
|=================================================================================================================================|
| |
|Zymbal's Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 2/70 (3%) 1/60 (2%) 3/60 (5%) 2/60 (3%) 15/70 (21%) |
|ADJUSTED (b) | 3.8% 3.8% 7.2% 5.8% 44.7% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/7 (0%) 0/9 (0%) 0/5 (0%) 0/0 |
|TERMINAL (d) | 0/26 (0%) 0/20 (0%) 0/13 (0%) 0/1 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | 334 696 592 516 222 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P<0.001 ** P=0.558N P=0.467 P=0.574 P<0.001 ** |
|INCIDENTAL TUMOR | P=0.006 ** P=0.460N P=0.581 P=0.312N P=0.260 |
|LOGISTIC REGRESSION | P<0.001 ** P=0.590N P=0.381 P=0.619 P=0.030 * |
|COCHRAN-ARMITAGE | P<0.001 ** |
|FISHER EXACT | P=0.558N P=0.427 P=0.630 P<0.001 ** |
|=================================================================================================================================|
| |
|Zymbal's Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 2/70 (3%) 1/60 (2%) 4/60 (7%) 5/60 (8%) 15/70 (21%) |
|ADJUSTED (b) | 3.8% 3.8% 11.2% 55.4% 44.7% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/7 (0%) 0/9 (0%) 0/5 (0%) 0/0 |
|TERMINAL (d) | 0/26 (0%) 0/20 (0%) 0/13 (0%) 0/1 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | 334 696 592 516 222 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P<0.001 ** P=0.558N P=0.286 P=0.065 P<0.001 ** |
|INCIDENTAL TUMOR | P=0.008 ** P=0.460N P=0.409 P=0.665N P=0.260 |
|LOGISTIC REGRESSION | P<0.001 ** P=0.590N P=0.246 P=0.159 P=0.030 * |
|COCHRAN-ARMITAGE | P<0.001 ** |
|FISHER EXACT | P=0.558N P=0.270 P=0.162 P<0.001 ** |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 PAGE 37
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE | UNTREATD 0.25% 0.50% 1.00% 2.00% |
| | CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma or Hemangioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 0/70 (0%) 0/60 (0%) 1/60 (2%) 2/60 (3%) 1/70 (1%) |
|ADJUSTED (b) | 0.0% 0.0% 1.7% 58.3% 1.8% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/7 (0%) 0/9 (0%) 0/5 (0%) 0/0 |
|TERMINAL (d) | 0/26 (0%) 0/20 (0%) 0/13 (0%) 0/1 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- --- 451 697 396 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.035 * (e) P=0.503 P=0.002 ** P=0.490 |
|INCIDENTAL TUMOR | P=0.507 (e) P=0.500 P=0.250 P=0.918 |
|LOGISTIC REGRESSION | P=0.260 (e) P=0.367 P=0.020 * P=0.533 |
|COCHRAN-ARMITAGE | P=0.259 |
|FISHER EXACT | (e) P=0.462 P=0.211 P=0.500 |
|=================================================================================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 28/70 (40%) 29/60 (48%) 40/60 (67%) 34/60 (57%) 25/70 (36%) |
|ADJUSTED (b) | 59.7% 76.3% 97.3% 100.0% 92.5% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 1/9 (11%) 0/7 (0%) 0/9 (0%) 0/5 (0%) 0/0 |
|TERMINAL (d) | 8/26 (31%) 12/20 (60%) 12/13 (92%) 1/1 (100%) 0/0 |
|FIRST INCIDENCE (DAYS) | 456 (I) 480 536 432 366 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P<0.001 ** P=0.200 P<0.001 ** P<0.001 ** P<0.001 ** |
|INCIDENTAL TUMOR | P=0.194N P=0.503N P=0.057 P=0.334N P=0.054N |
|LOGISTIC REGRESSION | P=0.442 P=0.542 P=0.054 P=0.497 P=0.356N |
|COCHRAN-ARMITAGE | P=0.120N |
|FISHER EXACT | P=0.218 P=0.002 ** P=0.043 * P=0.364N |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 PAGE 38
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE | UNTREATD 0.25% 0.50% 1.00% 2.00% |
| | CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma: Benign, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 0/70 (0%) 4/60 (7%) 9/60 (15%) 9/60 (15%) 26/70 (37%) |
|ADJUSTED (b) | 0.0% 9.3% 44.3% 100.0% 91.5% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 1/7 (14%) 1/9 (11%) 0/5 (0%) 0/0 |
|TERMINAL (d) | 0/26 (0%) 0/20 (0%) 4/13 (31%) 1/1 (100%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- 456 (I) 456 (I) 495 365 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P<0.001 ** P=0.045 * P<0.001 ** P<0.001 ** P<0.001 ** |
|INCIDENTAL TUMOR | P<0.001 ** P=0.075 P<0.001 ** P=0.008 ** P<0.001 ** |
|LOGISTIC REGRESSION | P<0.001 ** P=0.038 * P=0.001 ** P<0.001 ** P<0.001 ** |
|COCHRAN-ARMITAGE | P<0.001 ** |
|FISHER EXACT | P=0.043 * P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 59/70 (84%) 59/60 (98%) 60/60 (100%) 59/60 (98%) 59/70 (84%) |
|ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% 100.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 9/9 (100%) 7/7 (100%) 9/9 (100%) 5/5 (100%) 0/0 |
|TERMINAL (d) | 26/26 (100%) 20/20 (100%) 13/13 (100%) 1/1 (100%) 0/0 |
|FIRST INCIDENCE (DAYS) | 456 (I) 450 451 381 365 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P<0.001 ** P=0.059 P=0.003 ** P<0.001 ** P<0.001 ** |
|INCIDENTAL TUMOR | P=0.297 (e) (e) (e) P=0.638 |
|LOGISTIC REGRESSION | P=0.297 (e) (e) (e) P=0.638 |
|COCHRAN-ARMITAGE | P=0.102N |
|FISHER EXACT | P=0.005 ** P<0.001 ** P=0.005 ** P=0.592N |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 PAGE 39
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE | UNTREATD 0.25% 0.50% 1.00% 2.00% |
| | CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 33/70 (47%) 37/60 (62%) 47/60 (78%) 50/60 (83%) 55/70 (79%) |
|ADJUSTED (b) | 65.3% 83.1% 97.9% 100.0% 100.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 1/9 (11%) 1/7 (14%) 1/9 (11%) 1/5 (20%) 0/0 |
|TERMINAL (d) | 9/26 (35%) 13/20 (65%) 12/13 (92%) 1/1 (100%) 0/0 |
|FIRST INCIDENCE (DAYS) | 334 450 451 432 222 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P<0.001 ** P=0.096 P<0.001 ** P<0.001 ** P<0.001 ** |
|INCIDENTAL TUMOR | P=0.002 ** P=0.494 P=0.019 * P=0.580 P=0.599 |
|LOGISTIC REGRESSION | P<0.001 ** P=0.329 P=0.018 * P=0.048 * P<0.001 ** |
|COCHRAN-ARMITAGE | P<0.001 ** |
|FISHER EXACT | P=0.069 P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # |
|----------- | |
|OVERALL (a) | 60/70 (86%) 59/60 (98%) 60/60 (100%) 59/60 (98%) 60/70 (86%) |
|ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% 100.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/0 0/0 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 9/9 (100%) 7/7 (100%) 9/9 (100%) 5/5 (100%) 0/0 |
|TERMINAL (d) | 26/26 (100%) 20/20 (100%) 13/13 (100%) 1/1 (100%) 0/0 |
|FIRST INCIDENCE (DAYS) | 334 450 451 381 222 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P<0.001 ** P=0.078 P=0.005 ** P<0.001 ** P<0.001 ** |
|INCIDENTAL TUMOR | P=0.367 P=0.500N (e) P=0.500N (e) |
|LOGISTIC REGRESSION | P=0.212 P=0.500N (e) P=0.500N (e) |
|COCHRAN-ARMITAGE | P=0.119N |
|FISHER EXACT | P=0.009 ** P=0.001 ** P=0.009 ** P=0.595N |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 PAGE 40
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE | UNTREATD 0.25% 0.50% 1.00% |
| | CONTROL |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/60 (2%) 1/60 (2%) 1/60 (2%) 0/60 (0%) |
|ADJUSTED (b) | 2.8% 3.7% 4.3% 0.0% |
|INTERIM SACRIFICE 1 (c)| |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/7 (0%) 0/8 (0%) |
|TERMINAL (d) | 1/36 (3%) 1/27 (4%) 1/23 (4%) 0/5 (0%) |
|FIRST INCIDENCE (DAYS) | 738 (T) 738 (T) 738 (T) --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.695N P=0.697 P=0.659 P=0.876N |
|INCIDENTAL TUMOR | P=0.695N P=0.697 P=0.659 P=0.876N |
|LOGISTIC REGRESSION | P=0.695N P=0.697 P=0.659 P=0.876N |
|COCHRAN-ARMITAGE | P=0.312N |
|FISHER EXACT | P=0.752N P=0.752N P=0.500N |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Malignant |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/7 (0%) 0/8 (0%) |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 0/23 (0%) 0/5 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | (e) |
|FISHER EXACT | (e) (e) (e) |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 PAGE 41
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE | UNTREATD 0.25% 0.50% 1.00% |
| | CONTROL |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/60 (3%) 1/60 (2%) 1/60 (2%) 0/60 (0%) |
|ADJUSTED (b) | 5.0% 3.7% 4.3% 0.0% |
|INTERIM SACRIFICE 1 (c)| |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/7 (0%) 0/8 (0%) |
|TERMINAL (d) | 1/36 (3%) 1/27 (4%) 1/23 (4%) 0/5 (0%) |
|FIRST INCIDENCE (DAYS) | 690 738 (T) 738 (T) --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.451N P=0.578N P=0.633N P=0.619N |
|INCIDENTAL TUMOR | P=0.317N P=0.483N P=0.532N P=0.291N |
|LOGISTIC REGRESSION | P=0.310N P=0.518N P=0.565N P=0.396N |
|COCHRAN-ARMITAGE | P=0.153N |
|FISHER EXACT | P=0.500N P=0.500N P=0.248N |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 4/58 (7%) 3/58 (5%) 7/56 (13%) 3/60 (5%) |
|ADJUSTED (b) | 10.6% 11.1% 24.4% 15.6% |
|INTERIM SACRIFICE 1 (c)| |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 1/7 (14%) 0/8 (0%) |
|TERMINAL (d) | 3/34 (9%) 3/27 (11%) 4/21 (19%) 0/5 (0%) |
|FIRST INCIDENCE (DAYS) | 460 738 (T) 456 (I) 610 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.067 P=0.607N P=0.104 P=0.272 |
|INCIDENTAL TUMOR | P=0.388 P=0.607N P=0.185 P=0.541N |
|LOGISTIC REGRESSION | P=0.508 P=0.508N P=0.233 P=0.581N |
|COCHRAN-ARMITAGE | P=0.497N |
|FISHER EXACT | P=0.500N P=0.244 P=0.481N |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 PAGE 42
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE | UNTREATD 0.25% 0.50% 1.00% |
| | CONTROL |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/58 (2%) 0/58 (0%) 0/56 (0%) 1/60 (2%) |
|ADJUSTED (b) | 2.9% 0.0% 0.0% 2.0% |
|INTERIM SACRIFICE 1 (c)| |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/7 (0%) 0/8 (0%) |
|TERMINAL (d) | 1/34 (3%) 0/27 (0%) 0/21 (0%) 0/5 (0%) |
|FIRST INCIDENCE (DAYS) | 738 (T) --- --- 474 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.451 P=0.546N P=0.596N P=0.584 |
|INCIDENTAL TUMOR | P=0.583 P=0.546N P=0.596N P=0.738 |
|LOGISTIC REGRESSION | P=0.633 P=0.546N P=0.596N P=0.731N |
|COCHRAN-ARMITAGE | P=0.600 |
|FISHER EXACT | P=0.500N P=0.509N P=0.744N |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 5/58 (9%) 3/58 (5%) 7/56 (13%) 4/60 (7%) |
|ADJUSTED (b) | 13.5% 11.1% 24.4% 17.4% |
|INTERIM SACRIFICE 1 (c)| |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 1/7 (14%) 0/8 (0%) |
|TERMINAL (d) | 4/34 (12%) 3/27 (11%) 4/21 (19%) 0/5 (0%) |
|FIRST INCIDENCE (DAYS) | 460 738 (T) 456 (I) 474 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.050 * P=0.471N P=0.163 P=0.202 |
|INCIDENTAL TUMOR | P=0.350 P=0.471N P=0.266 P=0.587N |
|LOGISTIC REGRESSION | P=0.500 P=0.367N P=0.336 P=0.536N |
|COCHRAN-ARMITAGE | P=0.527N |
|FISHER EXACT | P=0.358N P=0.356 P=0.478N |
|=================================================================================================================================|
| |
|Esophagus |
| Squamous Cell Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/60 (0%) 1/60 (2%) 10/60 (17%) | |
|ADJUSTED (b) | 0.0% 0.0% 4.3% 42.4% | |
|INTERIM SACRIFICE 1 (c)| | |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/7 (0%) 0/8 (0%) | |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 1/23 (4%) 0/5 (0%) | |
|FIRST INCIDENCE (DAYS) | --- --- 738 (T) 474 | |
DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 PAGE 43
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
TERMINAL SACRIFICE AT 106 WEEKS
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** (e) P=0.411 P<0.001 ** | |
|INCIDENTAL TUMOR | P<0.001 ** (e) P=0.411 P=0.058 | |
|LOGISTIC REGRESSION | P<0.001 ** (e) P=0.411 P<0.001 ** | |
|COCHRAN-ARMITAGE | P<0.001 ** | |
|FISHER EXACT | (e) P=0.500 P<0.001 ** | |
|Intestine Large: Colon/Rectum |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/7 (0%) 0/8 (0%) |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 0/23 (0%) 0/5 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | (e) |
|FISHER EXACT | (e) (e) (e) |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 PAGE 44
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE | UNTREATD 0.25% 0.50% 1.00% |
| | CONTROL |
|=================================================================================================================================|
| |
|Intestine Large: Colon/Rectum |
| Polyp Adenomatous |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 0/60 (0%) 1/60 (2%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 2.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/7 (0%) 0/8 (0%) |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 0/23 (0%) 0/5 (0%) |
|FIRST INCIDENCE (DAYS) | --- 509 --- --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.568N P=0.504 (e) (e) |
|INCIDENTAL TUMOR | P=0.405N P=0.500 (e) (e) |
|LOGISTIC REGRESSION | P=0.510N P=0.505 (e) (e) |
|COCHRAN-ARMITAGE | P=0.567N |
|FISHER EXACT | P=0.500 (e) (e) |
|=================================================================================================================================|
| |
|Intestine Small: Ileum |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/7 (0%) 0/8 (0%) |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 0/23 (0%) 0/5 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | (e) |
|FISHER EXACT | (e) (e) (e) |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 PAGE 45
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE | UNTREATD 0.25% 0.50% 1.00% |
| | CONTROL |
|=================================================================================================================================|
| |
|Intestine Small: Jejunum |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 0/60 (0%) 0/60 (0%) 1/60 (2%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 2.8% 0.0% |
|INTERIM SACRIFICE 1 (c)| |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/7 (0%) 0/8 (0%) |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 0/23 (0%) 0/5 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 673 --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.610 (e) P=0.460 (e) |
|INCIDENTAL TUMOR | P=0.746N (e) P=0.627 (e) |
|LOGISTIC REGRESSION | P=0.683 (e) P=0.495 (e) |
|COCHRAN-ARMITAGE | P=0.694 |
|FISHER EXACT | (e) P=0.500 (e) |
|=================================================================================================================================|
| |
|Intestine Small: Site Unspecified |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 0/60 (0%) 0/60 (0%) 1/60 (2%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 2.8% 0.0% |
|INTERIM SACRIFICE 1 (c)| |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/7 (0%) 0/8 (0%) |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 0/23 (0%) 0/5 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 673 --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.610 (e) P=0.460 (e) |
|INCIDENTAL TUMOR | P=0.746N (e) P=0.627 (e) |
|LOGISTIC REGRESSION | P=0.683 (e) P=0.495 (e) |
|COCHRAN-ARMITAGE | P=0.694 |
|FISHER EXACT | (e) P=0.500 (e) |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 PAGE 46
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE | UNTREATD 0.25% 0.50% 1.00% |
| | CONTROL |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/60 (0%) 2/60 (3%) 1/60 (2%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 6.2% 2.6% 0.0% |
|INTERIM SACRIFICE 1 (c)| |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/7 (0%) 0/8 (0%) |
|TERMINAL (d) | 0/36 (0%) 1/27 (4%) 0/23 (0%) 0/5 (0%) |
|FIRST INCIDENCE (DAYS) | --- 695 670 --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.613 P=0.203 P=0.471 (e) |
|INCIDENTAL TUMOR | P=0.480N P=0.282 P=0.627 (e) |
|LOGISTIC REGRESSION | P=0.573N P=0.229 P=0.497 (e) |
|COCHRAN-ARMITAGE | P=0.461N |
|FISHER EXACT | P=0.248 P=0.500 (e) |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/60 (2%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 2.4% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/7 (0%) 0/8 (0%) |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 0/23 (0%) 0/5 (0%) |
|FIRST INCIDENCE (DAYS) | 696 --- --- --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.445N P=0.520N P=0.562N P=0.778N |
|INCIDENTAL TUMOR | P=0.234N P=0.351N P=0.373N P=0.341N |
|LOGISTIC REGRESSION | P=0.339N P=0.503N P=0.515N P=0.598N |
|COCHRAN-ARMITAGE | P=0.306N |
|FISHER EXACT | P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 PAGE 47
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE | UNTREATD 0.25% 0.50% 1.00% |
| | CONTROL |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/60 (2%) 2/60 (3%) 1/60 (2%) 0/60 (0%) |
|ADJUSTED (b) | 2.4% 6.2% 2.6% 0.0% |
|INTERIM SACRIFICE 1 (c)| |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/7 (0%) 0/8 (0%) |
|TERMINAL (d) | 0/36 (0%) 1/27 (4%) 0/23 (0%) 0/5 (0%) |
|FIRST INCIDENCE (DAYS) | 696 695 670 --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.544N P=0.449 P=0.709 P=0.778N |
|INCIDENTAL TUMOR | P=0.210N P=0.637 P=0.615N P=0.341N |
|LOGISTIC REGRESSION | P=0.333N P=0.491 P=0.754 P=0.598N |
|COCHRAN-ARMITAGE | P=0.248N |
|FISHER EXACT | P=0.500 P=0.752N P=0.500N |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/60 (0%) 1/60 (2%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 3.7% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/7 (0%) 0/8 (0%) |
|TERMINAL (d) | 0/36 (0%) 1/27 (4%) 0/23 (0%) 0/5 (0%) |
|FIRST INCIDENCE (DAYS) | --- 738 (T) --- --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.820N P=0.443 (e) (e) |
|INCIDENTAL TUMOR | P=0.820N P=0.443 (e) (e) |
|LOGISTIC REGRESSION | P=0.820N P=0.443 (e) (e) |
|COCHRAN-ARMITAGE | P=0.567N |
|FISHER EXACT | P=0.500 (e) (e) |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 PAGE 48
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE | UNTREATD 0.25% 0.50% 1.00% |
| | CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/7 (0%) 0/8 (0%) |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 0/23 (0%) 0/5 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | (e) |
|FISHER EXACT | (e) (e) (e) |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/7 (0%) 0/8 (0%) |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 0/23 (0%) 0/5 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | (e) |
|FISHER EXACT | (e) (e) (e) |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 PAGE 49
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE | UNTREATD 0.25% 0.50% 1.00% |
| | CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/7 (0%) 0/8 (0%) |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 0/23 (0%) 0/5 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | (e) |
|FISHER EXACT | (e) (e) (e) |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 1/60 (2%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 5.9% |
|INTERIM SACRIFICE 1 (c)| |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/7 (0%) 0/8 (0%) |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 0/23 (0%) 0/5 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- 683 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.089 (e) (e) P=0.311 |
|INCIDENTAL TUMOR | P=0.254 (e) (e) P=0.659 |
|LOGISTIC REGRESSION | P=0.158 (e) (e) P=0.433 |
|COCHRAN-ARMITAGE | P=0.199 |
|FISHER EXACT | (e) (e) P=0.500 |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 PAGE 50
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE | UNTREATD 0.25% 0.50% 1.00% |
| | CONTROL |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/60 (0%) 1/60 (2%) 0/60 (0%) 2/60 (3%) |
|ADJUSTED (b) | 0.0% 3.7% 0.0% 8.4% |
|INTERIM SACRIFICE 1 (c)| |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/7 (0%) 0/8 (0%) |
|TERMINAL (d) | 0/36 (0%) 1/27 (4%) 0/23 (0%) 0/5 (0%) |
|FIRST INCIDENCE (DAYS) | --- 738 (T) --- 594 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.031 * P=0.443 (e) P=0.122 |
|INCIDENTAL TUMOR | P=0.196 P=0.443 (e) P=0.568 |
|LOGISTIC REGRESSION | P=0.108 P=0.443 (e) P=0.228 |
|COCHRAN-ARMITAGE | P=0.140 |
|FISHER EXACT | P=0.500 (e) P=0.248 |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/60 (0%) 1/60 (2%) 0/60 (0%) 2/60 (3%) |
|ADJUSTED (b) | 0.0% 3.7% 0.0% 8.4% |
|INTERIM SACRIFICE 1 (c)| |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/7 (0%) 0/8 (0%) |
|TERMINAL (d) | 0/36 (0%) 1/27 (4%) 0/23 (0%) 0/5 (0%) |
|FIRST INCIDENCE (DAYS) | --- 738 (T) --- 594 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.031 * P=0.443 (e) P=0.122 |
|INCIDENTAL TUMOR | P=0.196 P=0.443 (e) P=0.568 |
|LOGISTIC REGRESSION | P=0.108 P=0.443 (e) P=0.228 |
|COCHRAN-ARMITAGE | P=0.140 |
|FISHER EXACT | P=0.500 (e) P=0.248 |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 PAGE 51
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE | UNTREATD 0.25% 0.50% 1.00% |
| | CONTROL |
|=================================================================================================================================|
| |
|Lung |
| Squamous Cell Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/7 (0%) 0/8 (0%) |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 0/23 (0%) 0/5 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | (e) |
|FISHER EXACT | (e) (e) (e) |
|=================================================================================================================================|
| |
|Mammary Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 0/60 (0%) 2/60 (3%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 7.4% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/7 (0%) 0/8 (0%) |
|TERMINAL (d) | 0/36 (0%) 2/27 (7%) 0/23 (0%) 0/5 (0%) |
|FIRST INCIDENCE (DAYS) | --- 738 (T) --- --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.738N P=0.177 (e) (e) |
|INCIDENTAL TUMOR | P=0.738N P=0.177 (e) (e) |
|LOGISTIC REGRESSION | P=0.738N P=0.177 (e) (e) |
|COCHRAN-ARMITAGE | P=0.405N |
|FISHER EXACT | P=0.248 (e) (e) |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 PAGE 52
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE | UNTREATD 0.25% 0.50% 1.00% |
| | CONTROL |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 4/60 (7%) 4/60 (7%) 3/60 (5%) 4/60 (7%) |
|ADJUSTED (b) | 9.7% 12.6% 7.0% 10.3% |
|INTERIM SACRIFICE 1 (c)| |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/7 (0%) 0/8 (0%) |
|TERMINAL (d) | 1/36 (3%) 3/27 (11%) 0/23 (0%) 0/5 (0%) |
|FIRST INCIDENCE (DAYS) | 624 404 388 432 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.193 P=0.540 P=0.621N P=0.275 |
|INCIDENTAL TUMOR | P=0.330N P=0.624N P=0.218N P=0.245N |
|LOGISTIC REGRESSION | P=0.474N P=0.641 P=0.491N P=0.587N |
|COCHRAN-ARMITAGE | P=0.554N |
|FISHER EXACT | P=0.641N P=0.500N P=0.641N |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 4/60 (7%) 6/60 (10%) 3/60 (5%) 4/60 (7%) |
|ADJUSTED (b) | 9.7% 19.9% 7.0% 10.3% |
|INTERIM SACRIFICE 1 (c)| |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/7 (0%) 0/8 (0%) |
|TERMINAL (d) | 1/36 (3%) 5/27 (19%) 0/23 (0%) 0/5 (0%) |
|FIRST INCIDENCE (DAYS) | 624 404 388 432 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.204 P=0.256 P=0.621N P=0.275 |
|INCIDENTAL TUMOR | P=0.333N P=0.352 P=0.218N P=0.245N |
|LOGISTIC REGRESSION | P=0.403N P=0.365 P=0.491N P=0.587N |
|COCHRAN-ARMITAGE | P=0.449N |
|FISHER EXACT | P=0.372 P=0.500N P=0.641N |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 PAGE 53
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE | UNTREATD 0.25% 0.50% 1.00% |
| | CONTROL |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 26/60 (43%) 46/60 (77%) 46/60 (77%) 48/60 (80%) |
|ADJUSTED (b) | 61.3% 95.8% 97.9% 100.0% |
|INTERIM SACRIFICE 1 (c)| |
|INTERIM SACRIFICE 2 (c)| 1/10 (10%) 1/9 (11%) 0/7 (0%) 3/8 (38%) |
|TERMINAL (d) | 20/36 (56%) 25/27 (93%) 22/23 (96%) 5/5 (100%) |
|FIRST INCIDENCE (DAYS) | 456 (I) 456 (I) 565 456 (I) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|INCIDENTAL TUMOR | 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 ** |
|COCHRAN-ARMITAGE | P<0.001 ** |
|FISHER EXACT | P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 26/60 (43%) 46/60 (77%) 46/60 (77%) 48/60 (80%) |
|ADJUSTED (b) | 61.3% 95.8% 97.9% 100.0% |
|INTERIM SACRIFICE 1 (c)| |
|INTERIM SACRIFICE 2 (c)| 1/10 (10%) 1/9 (11%) 0/7 (0%) 3/8 (38%) |
|TERMINAL (d) | 20/36 (56%) 25/27 (93%) 22/23 (96%) 5/5 (100%) |
|FIRST INCIDENCE (DAYS) | 456 (I) 456 (I) 565 456 (I) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|INCIDENTAL TUMOR | 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 ** |
|COCHRAN-ARMITAGE | P<0.001 ** |
|FISHER EXACT | P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 PAGE 54
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE | UNTREATD 0.25% 0.50% 1.00% |
| | CONTROL |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 28/60 (47%) 48/60 (80%) 47/60 (78%) 50/60 (83%) |
|ADJUSTED (b) | 63.1% 97.9% 97.9% 100.0% |
|INTERIM SACRIFICE 1 (c)| |
|INTERIM SACRIFICE 2 (c)| 1/10 (10%) 1/9 (11%) 0/7 (0%) 3/8 (38%) |
|TERMINAL (d) | 20/36 (56%) 26/27 (96%) 22/23 (96%) 5/5 (100%) |
|FIRST INCIDENCE (DAYS) | 456 (I) 404 388 432 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|INCIDENTAL TUMOR | 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 ** |
|COCHRAN-ARMITAGE | P<0.001 ** |
|FISHER EXACT | P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| |
|Mesentery |
| Sarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/7 (0%) 0/8 (0%) |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 0/23 (0%) 0/5 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | (e) |
|FISHER EXACT | (e) (e) (e) |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 PAGE 55
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE | UNTREATD 0.25% 0.50% 1.00% |
| | CONTROL |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) |
| Papilloma Squamous or Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 2/60 (3%) 2/60 (3%) 4/60 (7%) 5/60 (8%) |
|ADJUSTED (b) | 5.6% 7.4% 11.5% 47.0% |
|INTERIM SACRIFICE 1 (c)| |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/7 (0%) 0/8 (0%) |
|TERMINAL (d) | 2/36 (6%) 2/27 (7%) 1/23 (4%) 2/5 (40%) |
|FIRST INCIDENCE (DAYS) | 738 (T) 738 (T) 627 577 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.001 ** P=0.588 P=0.219 P=0.003 ** |
|INCIDENTAL TUMOR | P=0.061 P=0.588 P=0.422 P=0.043 * |
|LOGISTIC REGRESSION | P=0.033 * P=0.588 P=0.302 P=0.071 |
|COCHRAN-ARMITAGE | P=0.114 |
|FISHER EXACT | P=0.691N P=0.340 P=0.219 |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) |
| Squamous Cell Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 0/60 (0%) 1/60 (2%) 1/60 (2%) 1/60 (2%) |
|ADJUSTED (b) | 0.0% 3.2% 2.6% 3.6% |
|INTERIM SACRIFICE 1 (c)| |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/7 (0%) 0/8 (0%) |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 0/23 (0%) 0/5 (0%) |
|FIRST INCIDENCE (DAYS) | --- 723 662 631 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.184 P=0.470 P=0.476 P=0.401 |
|INCIDENTAL TUMOR | P=0.642N P=0.649 P=0.627 P=0.916 |
|LOGISTIC REGRESSION | P=0.340 P=0.489 P=0.499 P=0.507 |
|COCHRAN-ARMITAGE | P=0.384 |
|FISHER EXACT | P=0.500 P=0.500 P=0.500 |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 PAGE 56
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE | UNTREATD 0.25% 0.50% 1.00% |
| | CONTROL |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) |
| Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 2/60 (3%) 3/60 (5%) 5/60 (8%) 6/60 (10%) |
|ADJUSTED (b) | 5.6% 10.4% 13.8% 48.9% |
|INTERIM SACRIFICE 1 (c)| |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/7 (0%) 0/8 (0%) |
|TERMINAL (d) | 2/36 (6%) 2/27 (7%) 1/23 (4%) 2/5 (40%) |
|FIRST INCIDENCE (DAYS) | 738 (T) 723 627 577 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P<0.001 ** P=0.383 P=0.131 P=0.001 ** |
|INCIDENTAL TUMOR | P=0.090 P=0.460 P=0.320 P=0.040 * |
|LOGISTIC REGRESSION | P=0.022 * P=0.424 P=0.192 P=0.043 * |
|COCHRAN-ARMITAGE | P=0.081 |
|FISHER EXACT | P=0.500 P=0.219 P=0.136 |
|=================================================================================================================================|
| |
|Pancreas |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/7 (0%) 0/8 (0%) |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 0/23 (0%) 0/5 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | (e) |
|FISHER EXACT | (e) (e) (e) |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 PAGE 57
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE | UNTREATD 0.25% 0.50% 1.00% |
| | CONTROL |
|=================================================================================================================================|
| |
|Pharynx |
| Squamous Cell Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 0/60 (0%) 1/60 (2%) 1/60 (2%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 3.2% 2.6% 0.0% |
|INTERIM SACRIFICE 1 (c)| |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/7 (0%) 0/8 (0%) |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 0/23 (0%) 0/5 (0%) |
|FIRST INCIDENCE (DAYS) | --- 723 662 --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.618 P=0.470 P=0.476 (e) |
|INCIDENTAL TUMOR | P=0.482N P=0.649 P=0.627 (e) |
|LOGISTIC REGRESSION | P=0.672N P=0.489 P=0.499 (e) |
|COCHRAN-ARMITAGE | P=0.595N |
|FISHER EXACT | P=0.500 P=0.500 (e) |
|=================================================================================================================================|
| |
|Pharynx |
| Squamous Cell Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 1/60 (2%) 0/60 (0%) 0/60 (0%) 1/60 (2%) |
|ADJUSTED (b) | 2.8% 0.0% 0.0% 20.0% |
|INTERIM SACRIFICE 1 (c)| |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/7 (0%) 0/8 (0%) |
|TERMINAL (d) | 1/36 (3%) 0/27 (0%) 0/23 (0%) 1/5 (20%) |
|FIRST INCIDENCE (DAYS) | 738 (T) --- --- 738 (T) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.262 P=0.557N P=0.589N P=0.288 |
|INCIDENTAL TUMOR | P=0.262 P=0.557N P=0.589N P=0.288 |
|LOGISTIC REGRESSION | P=0.262 P=0.557N P=0.589N P=0.288 |
|COCHRAN-ARMITAGE | P=0.595 |
|FISHER EXACT | P=0.500N P=0.500N P=0.752N |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 PAGE 58
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE | UNTREATD 0.25% 0.50% 1.00% |
| | CONTROL |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 16/58 (28%) 24/60 (40%) 24/59 (41%) 16/59 (27%) |
|ADJUSTED (b) | 38.8% 65.0% 69.8% 60.9% |
|INTERIM SACRIFICE 1 (c)| |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/9 (0%) 0/7 (0%) 1/8 (13%) |
|TERMINAL (d) | 11/35 (31%) 15/27 (56%) 13/22 (59%) 1/5 (20%) |
|FIRST INCIDENCE (DAYS) | 460 619 481 456 (I) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P<0.001 ** P=0.023 * P=0.006 ** P=0.002 ** |
|INCIDENTAL TUMOR | P=0.533 P=0.078 P=0.103 P=0.428N |
|LOGISTIC REGRESSION | P=0.260 P=0.080 P=0.047 * P=0.401 |
|COCHRAN-ARMITAGE | P=0.378N |
|FISHER EXACT | P=0.109 P=0.097 P=0.560N |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 16/58 (28%) 24/60 (40%) 24/59 (41%) 16/59 (27%) |
|ADJUSTED (b) | 38.8% 65.0% 69.8% 60.9% |
|INTERIM SACRIFICE 1 (c)| |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/9 (0%) 0/7 (0%) 1/8 (13%) |
|TERMINAL (d) | 11/35 (31%) 15/27 (56%) 13/22 (59%) 1/5 (20%) |
|FIRST INCIDENCE (DAYS) | 460 619 481 456 (I) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P<0.001 ** P=0.023 * P=0.006 ** P=0.002 ** |
|INCIDENTAL TUMOR | P=0.533 P=0.078 P=0.103 P=0.428N |
|LOGISTIC REGRESSION | P=0.260 P=0.080 P=0.047 * P=0.401 |
|COCHRAN-ARMITAGE | P=0.378N |
|FISHER EXACT | P=0.109 P=0.097 P=0.560N |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 PAGE 59
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE | UNTREATD 0.25% 0.50% 1.00% |
| | CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Basal Cell Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/7 (0%) 0/8 (0%) |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 0/23 (0%) 0/5 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | (e) |
|FISHER EXACT | (e) (e) (e) |
|=================================================================================================================================|
| |
|Skin |
| Basal Cell Adenoma, Basosquamous Tumor Benign, or Trichoepithelioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 1/60 (2%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 2.8% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/7 (0%) 0/8 (0%) |
|TERMINAL (d) | 1/36 (3%) 0/27 (0%) 0/23 (0%) 0/5 (0%) |
|FIRST INCIDENCE (DAYS) | 738 (T) --- --- --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.492N P=0.557N P=0.589N P=0.876N |
|INCIDENTAL TUMOR | P=0.492N P=0.557N P=0.589N P=0.876N |
|LOGISTIC REGRESSION | P=0.492N P=0.557N P=0.589N P=0.876N |
|COCHRAN-ARMITAGE | P=0.306N |
|FISHER EXACT | P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 PAGE 60
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE | UNTREATD 0.25% 0.50% 1.00% |
| | CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Basal Cell Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/7 (0%) 0/8 (0%) |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 0/23 (0%) 0/5 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | (e) |
|FISHER EXACT | (e) (e) (e) |
|=================================================================================================================================|
| |
|Skin |
| Basal Cell Carcinoma, Basal Cell Adenoma, Basosquamous Tumor (benign, |
| malignant or NOS), or Trichoepithelioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 1/60 (2%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 2.8% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/7 (0%) 0/8 (0%) |
|TERMINAL (d) | 1/36 (3%) 0/27 (0%) 0/23 (0%) 0/5 (0%) |
|FIRST INCIDENCE (DAYS) | 738 (T) --- --- --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.492N P=0.557N P=0.589N P=0.876N |
|INCIDENTAL TUMOR | P=0.492N P=0.557N P=0.589N P=0.876N |
|LOGISTIC REGRESSION | P=0.492N P=0.557N P=0.589N P=0.876N |
|COCHRAN-ARMITAGE | P=0.306N |
|FISHER EXACT | P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 PAGE 61
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE | UNTREATD 0.25% 0.50% 1.00% |
| | CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor (M or B), Basal |
| Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepithelioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 4/60 (7%) 1/60 (2%) 2/60 (3%) 0/60 (0%) |
|ADJUSTED (b) | 10.5% 2.9% 7.2% 0.0% |
|INTERIM SACRIFICE 1 (c)| |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/7 (0%) 0/8 (0%) |
|TERMINAL (d) | 3/36 (8%) 0/27 (0%) 1/23 (4%) 0/5 (0%) |
|FIRST INCIDENCE (DAYS) | 690 704 683 --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.277N P=0.252N P=0.524N P=0.452N |
|INCIDENTAL TUMOR | P=0.096N P=0.141N P=0.375N P=0.220N |
|LOGISTIC REGRESSION | P=0.125N P=0.193N P=0.418N P=0.236N |
|COCHRAN-ARMITAGE | P=0.053N |
|FISHER EXACT | P=0.182N P=0.340N P=0.059N |
|=================================================================================================================================|
| |
|Skin |
| Fibroma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 1/60 (2%) 4/60 (7%) 1/60 (2%) 2/60 (3%) |
|ADJUSTED (b) | 2.8% 12.7% 4.3% 21.9% |
|INTERIM SACRIFICE 1 (c)| |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/7 (0%) 0/8 (0%) |
|TERMINAL (d) | 1/36 (3%) 2/27 (7%) 1/23 (4%) 1/5 (20%) |
|FIRST INCIDENCE (DAYS) | 738 (T) 683 738 (T) 577 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.122 P=0.122 P=0.659 P=0.123 |
|INCIDENTAL TUMOR | P=0.410 P=0.210 P=0.659 P=0.259 |
|LOGISTIC REGRESSION | P=0.364 P=0.162 P=0.659 P=0.379 |
|COCHRAN-ARMITAGE | P=0.596 |
|FISHER EXACT | P=0.182 P=0.752N P=0.500 |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 PAGE 62
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE | UNTREATD 0.25% 0.50% 1.00% |
| | CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 2/60 (3%) 4/60 (7%) 1/60 (2%) 6/60 (10%) |
|ADJUSTED (b) | 5.6% 12.7% 4.3% 37.3% |
|INTERIM SACRIFICE 1 (c)| |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/7 (0%) 0/8 (0%) |
|TERMINAL (d) | 2/36 (6%) 2/27 (7%) 1/23 (4%) 1/5 (20%) |
|FIRST INCIDENCE (DAYS) | 738 (T) 683 738 (T) 516 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.002 ** P=0.238 P=0.655N P=0.004 ** |
|INCIDENTAL TUMOR | P=0.117 P=0.356 P=0.655N P=0.152 |
|LOGISTIC REGRESSION | P=0.052 P=0.305 P=0.655N P=0.092 |
|COCHRAN-ARMITAGE | P=0.114 |
|FISHER EXACT | P=0.340 P=0.500N P=0.136 |
|=================================================================================================================================|
| |
|Skin |
| Fibrosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 2/60 (3%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 14.4% |
|INTERIM SACRIFICE 1 (c)| |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/7 (0%) 0/8 (0%) |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 0/23 (0%) 0/5 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- 516 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.014 * (e) (e) P=0.096 |
|INCIDENTAL TUMOR | P=0.109 (e) (e) P=0.449 |
|LOGISTIC REGRESSION | P=0.053 (e) (e) P=0.249 |
|COCHRAN-ARMITAGE | P=0.046 * |
|FISHER EXACT | (e) (e) P=0.248 |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 PAGE 63
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE | UNTREATD 0.25% 0.50% 1.00% |
| | CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 1/60 (2%) 0/60 (0%) 0/60 (0%) 4/60 (7%) |
|ADJUSTED (b) | 2.8% 0.0% 0.0% 19.7% |
|INTERIM SACRIFICE 1 (c)| |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/7 (0%) 0/8 (0%) |
|TERMINAL (d) | 1/36 (3%) 0/27 (0%) 0/23 (0%) 0/5 (0%) |
|FIRST INCIDENCE (DAYS) | 738 (T) --- --- 516 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.003 ** P=0.557N P=0.589N P=0.030 * |
|INCIDENTAL TUMOR | P=0.120 P=0.557N P=0.589N P=0.427 |
|LOGISTIC REGRESSION | P=0.028 * P=0.557N P=0.589N P=0.167 |
|COCHRAN-ARMITAGE | P=0.028 * |
|FISHER EXACT | P=0.500N P=0.500N P=0.182 |
|=================================================================================================================================|
| |
|Skin |
| Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 0/60 (0%) 0/60 (0%) 2/60 (3%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 7.2% 0.0% |
|INTERIM SACRIFICE 1 (c)| |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/7 (0%) 0/8 (0%) |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 1/23 (4%) 0/5 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 683 --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.341 (e) P=0.166 (e) |
|INCIDENTAL TUMOR | P=0.515 (e) P=0.252 (e) |
|LOGISTIC REGRESSION | P=0.482 (e) P=0.209 (e) |
|COCHRAN-ARMITAGE | P=0.595 |
|FISHER EXACT | (e) P=0.248 (e) |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 PAGE 64
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE | UNTREATD 0.25% 0.50% 1.00% |
| | CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Lipoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 0/60 (0%) 2/60 (3%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 6.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/7 (0%) 0/8 (0%) |
|TERMINAL (d) | 0/36 (0%) 1/27 (4%) 0/23 (0%) 0/5 (0%) |
|FIRST INCIDENCE (DAYS) | --- 683 --- --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.659N P=0.204 (e) (e) |
|INCIDENTAL TUMOR | P=0.485N P=0.282 (e) (e) |
|LOGISTIC REGRESSION | P=0.518N P=0.231 (e) (e) |
|COCHRAN-ARMITAGE | P=0.405N |
|FISHER EXACT | P=0.248 (e) (e) |
|=================================================================================================================================|
| |
|Skin |
| Sarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 1/60 (2%) 0/60 (0%) 0/60 (0%) 2/60 (3%) |
|ADJUSTED (b) | 2.8% 0.0% 0.0% 6.2% |
|INTERIM SACRIFICE 1 (c)| |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/7 (0%) 0/8 (0%) |
|TERMINAL (d) | 1/36 (3%) 0/27 (0%) 0/23 (0%) 0/5 (0%) |
|FIRST INCIDENCE (DAYS) | 738 (T) --- --- 585 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.103 P=0.557N P=0.589N P=0.238 |
|INCIDENTAL TUMOR | P=0.516 P=0.557N P=0.589N P=0.796 |
|LOGISTIC REGRESSION | P=0.234 P=0.557N P=0.589N P=0.470 |
|COCHRAN-ARMITAGE | P=0.246 |
|FISHER EXACT | P=0.500N P=0.500N P=0.500 |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 PAGE 65
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE | UNTREATD 0.25% 0.50% 1.00% |
| | CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Schwannoma Malignant |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/7 (0%) 0/8 (0%) |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 0/23 (0%) 0/5 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | (e) |
|FISHER EXACT | (e) (e) (e) |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Carcinoma, Basal Cell Carcinoma, Basosquamous Tumor |
| (malignant or NOS), or Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 0/60 (0%) 1/60 (2%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 2.9% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/7 (0%) 0/8 (0%) |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 0/23 (0%) 0/5 (0%) |
|FIRST INCIDENCE (DAYS) | --- 704 --- --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.762N P=0.478 (e) (e) |
|INCIDENTAL TUMOR | P=0.487N P=0.649 (e) (e) |
|LOGISTIC REGRESSION | P=0.647N P=0.496 (e) (e) |
|COCHRAN-ARMITAGE | P=0.567N |
|FISHER EXACT | P=0.500 (e) (e) |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 PAGE 66
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE | UNTREATD 0.25% 0.50% 1.00% |
| | CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 3/60 (5%) 0/60 (0%) 1/60 (2%) 0/60 (0%) |
|ADJUSTED (b) | 7.8% 0.0% 2.9% 0.0% |
|INTERIM SACRIFICE 1 (c)| |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/7 (0%) 0/8 (0%) |
|TERMINAL (d) | 2/36 (6%) 0/27 (0%) 0/23 (0%) 0/5 (0%) |
|FIRST INCIDENCE (DAYS) | 690 --- 683 --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.250N P=0.165N P=0.439N P=0.525N |
|INCIDENTAL TUMOR | P=0.107N P=0.108N P=0.268N P=0.252N |
|LOGISTIC REGRESSION | P=0.136N P=0.129N P=0.350N P=0.298N |
|COCHRAN-ARMITAGE | P=0.086N |
|FISHER EXACT | P=0.122N P=0.309N P=0.122N |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, Squamous Cell Carcinoma or Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 3/60 (5%) 1/60 (2%) 2/60 (3%) 0/60 (0%) |
|ADJUSTED (b) | 7.8% 2.9% 7.2% 0.0% |
|INTERIM SACRIFICE 1 (c)| |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/7 (0%) 0/8 (0%) |
|TERMINAL (d) | 2/36 (6%) 0/27 (0%) 1/23 (4%) 0/5 (0%) |
|FIRST INCIDENCE (DAYS) | 690 704 683 --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.396N P=0.379N P=0.664N P=0.525N |
|INCIDENTAL TUMOR | P=0.148N P=0.226N P=0.509N P=0.252N |
|LOGISTIC REGRESSION | P=0.204N P=0.319N P=0.570N P=0.298N |
|COCHRAN-ARMITAGE | P=0.104N |
|FISHER EXACT | P=0.309N P=0.500N P=0.122N |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 PAGE 67
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE | UNTREATD 0.25% 0.50% 1.00% |
| | CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, or Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 3/60 (5%) 0/60 (0%) 2/60 (3%) 0/60 (0%) |
|ADJUSTED (b) | 7.8% 0.0% 7.2% 0.0% |
|INTERIM SACRIFICE 1 (c)| |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/7 (0%) 0/8 (0%) |
|TERMINAL (d) | 2/36 (6%) 0/27 (0%) 1/23 (4%) 0/5 (0%) |
|FIRST INCIDENCE (DAYS) | 690 --- 683 --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.411N P=0.165N P=0.664N P=0.525N |
|INCIDENTAL TUMOR | P=0.214N P=0.108N P=0.509N P=0.252N |
|LOGISTIC REGRESSION | P=0.235N P=0.129N P=0.570N P=0.298N |
|COCHRAN-ARMITAGE | P=0.126N |
|FISHER EXACT | P=0.122N P=0.500N P=0.122N |
|=================================================================================================================================|
| |
|Skin: Sebaceous Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/7 (0%) 0/8 (0%) |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 0/23 (0%) 0/5 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | (e) |
|FISHER EXACT | (e) (e) (e) |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 PAGE 68
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE | UNTREATD 0.25% 0.50% 1.00% |
| | CONTROL |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Squamous Cell Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 1/60 (2%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 20.0% |
|INTERIM SACRIFICE 1 (c)| |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/7 (0%) 0/8 (0%) |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 0/23 (0%) 1/5 (20%) |
|FIRST INCIDENCE (DAYS) | --- --- --- 738 (T) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.032 * (e) (e) P=0.124 |
|INCIDENTAL TUMOR | P=0.032 * (e) (e) P=0.124 |
|LOGISTIC REGRESSION | P=0.032 * (e) (e) P=0.124 |
|COCHRAN-ARMITAGE | P=0.199 |
|FISHER EXACT | (e) (e) P=0.500 |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | |
|ADJUSTED (b) | |
|INTERIM SACRIFICE 1 (c)| |
|INTERIM SACRIFICE 2 (c)| |
|TERMINAL (d) | |
|FIRST INCIDENCE (DAYS) | |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | |
|INCIDENTAL TUMOR | |
|LOGISTIC REGRESSION | |
|COCHRAN-ARMITAGE | |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 PAGE 69
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE | UNTREATD 0.25% 0.50% 1.00% |
| | CONTROL |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 6/60 (10%) 5/60 (8%) 7/60 (12%) 4/60 (7%) |
|ADJUSTED (b) | 15.0% 15.2% 19.6% 44.5% |
|INTERIM SACRIFICE 1 (c)| |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 2/7 (29%) 0/8 (0%) |
|TERMINAL (d) | 4/36 (11%) 3/27 (11%) 3/23 (13%) 2/5 (40%) |
|FIRST INCIDENCE (DAYS) | 633 645 456 (I) 594 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.113 P=0.613 P=0.271 P=0.117 |
|INCIDENTAL TUMOR | P=0.560N P=0.491N P=0.483 P=0.653 |
|LOGISTIC REGRESSION | P=0.449N P=0.519N P=0.509 P=0.570 |
|COCHRAN-ARMITAGE | P=0.353N |
|FISHER EXACT | P=0.500N P=0.500 P=0.372N |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/60 (3%) 3/60 (5%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 5.6% 10.3% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/7 (0%) 0/8 (0%) |
|TERMINAL (d) | 2/36 (6%) 2/27 (7%) 0/23 (0%) 0/5 (0%) |
|FIRST INCIDENCE (DAYS) | 738 (T) 722 --- --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.304N P=0.384 P=0.341N P=0.712N |
|INCIDENTAL TUMOR | P=0.201N P=0.460 P=0.341N P=0.712N |
|LOGISTIC REGRESSION | P=0.252N P=0.426 P=0.341N P=0.712N |
|COCHRAN-ARMITAGE | P=0.073N |
|FISHER EXACT | P=0.500 P=0.248N P=0.248N |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 PAGE 70
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE | UNTREATD 0.25% 0.50% 1.00% |
| | CONTROL |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 8/60 (13%) 8/60 (13%) 7/60 (12%) 4/60 (7%) |
|ADJUSTED (b) | 20.3% 24.7% 19.6% 44.5% |
|INTERIM SACRIFICE 1 (c)| |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 2/7 (29%) 0/8 (0%) |
|TERMINAL (d) | 6/36 (17%) 5/27 (19%) 3/23 (13%) 2/5 (40%) |
|FIRST INCIDENCE (DAYS) | 633 645 456 (I) 594 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.225 P=0.423 P=0.441 P=0.173 |
|INCIDENTAL TUMOR | P=0.353N P=0.593 P=0.566N P=0.616N |
|LOGISTIC REGRESSION | P=0.235N P=0.576 P=0.505N P=0.574N |
|COCHRAN-ARMITAGE | P=0.127N |
|FISHER EXACT | P=0.605N P=0.500N P=0.181N |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/60 (0%) 0/60 (0%) 2/60 (3%) 4/60 (7%) |
|ADJUSTED (b) | 0.0% 0.0% 6.3% 36.5% |
|INTERIM SACRIFICE 1 (c)| |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/7 (0%) 1/8 (13%) |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 1/23 (4%) 1/5 (20%) |
|FIRST INCIDENCE (DAYS) | --- --- 508 456 (I) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P<0.001 ** (e) P=0.193 P=0.001 ** |
|INCIDENTAL TUMOR | P=0.004 ** (e) P=0.240 P=0.038 * |
|LOGISTIC REGRESSION | P=0.008 ** (e) P=0.247 P=0.045 * |
|COCHRAN-ARMITAGE | P=0.009 ** |
|FISHER EXACT | (e) P=0.248 P=0.059 |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 PAGE 71
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE | UNTREATD 0.25% 0.50% 1.00% |
| | CONTROL |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 1/60 (2%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 20.0% |
|INTERIM SACRIFICE 1 (c)| |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/7 (0%) 0/8 (0%) |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 0/23 (0%) 1/5 (20%) |
|FIRST INCIDENCE (DAYS) | --- --- --- 738 (T) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.032 * (e) (e) P=0.124 |
|INCIDENTAL TUMOR | P=0.032 * (e) (e) P=0.124 |
|LOGISTIC REGRESSION | P=0.032 * (e) (e) P=0.124 |
|COCHRAN-ARMITAGE | P=0.199 |
|FISHER EXACT | (e) (e) P=0.500 |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/60 (0%) 0/60 (0%) 2/60 (3%) 5/60 (8%) |
|ADJUSTED (b) | 0.0% 0.0% 6.3% 52.4% |
|INTERIM SACRIFICE 1 (c)| |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/7 (0%) 1/8 (13%) |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 1/23 (4%) 2/5 (40%) |
|FIRST INCIDENCE (DAYS) | --- --- 508 456 (I) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P<0.001 ** (e) P=0.193 P<0.001 ** |
|INCIDENTAL TUMOR | P<0.001 ** (e) P=0.240 P=0.005 ** |
|LOGISTIC REGRESSION | P=0.002 ** (e) P=0.247 P=0.002 ** |
|COCHRAN-ARMITAGE | P=0.003 ** |
|FISHER EXACT | (e) P=0.248 P=0.029 * |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 PAGE 72
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE | UNTREATD 0.25% 0.50% 1.00% |
| | CONTROL |
|=================================================================================================================================|
| |
|Tongue |
| Squamous Cell Carcinoma or Papilloma Squamous |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 1/60 (2%) 2/60 (3%) 4/60 (7%) 5/60 (8%) |
|ADJUSTED (b) | 2.8% 7.4% 11.5% 31.8% |
|INTERIM SACRIFICE 1 (c)| |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/7 (0%) 0/8 (0%) |
|TERMINAL (d) | 1/36 (3%) 2/27 (7%) 1/23 (4%) 1/5 (20%) |
|FIRST INCIDENCE (DAYS) | 738 (T) 738 (T) 627 577 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P<0.001 ** P=0.400 P=0.116 P=0.005 ** |
|INCIDENTAL TUMOR | P=0.090 P=0.400 P=0.276 P=0.146 |
|LOGISTIC REGRESSION | P=0.021 * P=0.400 P=0.162 P=0.057 |
|COCHRAN-ARMITAGE | P=0.055 |
|FISHER EXACT | P=0.500 P=0.182 P=0.103 |
|=================================================================================================================================|
| |
|Tongue |
| Squamous Cell Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 1/60 (2%) 2/60 (3%) 4/60 (7%) 4/60 (7%) |
|ADJUSTED (b) | 2.8% 7.4% 11.5% 29.3% |
|INTERIM SACRIFICE 1 (c)| |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/7 (0%) 0/8 (0%) |
|TERMINAL (d) | 1/36 (3%) 2/27 (7%) 1/23 (4%) 1/5 (20%) |
|FIRST INCIDENCE (DAYS) | 738 (T) 738 (T) 627 577 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.003 ** P=0.400 P=0.116 P=0.012 * |
|INCIDENTAL TUMOR | P=0.124 P=0.400 P=0.276 P=0.162 |
|LOGISTIC REGRESSION | P=0.049 * P=0.400 P=0.162 P=0.102 |
|COCHRAN-ARMITAGE | P=0.115 |
|FISHER EXACT | P=0.500 P=0.182 P=0.182 |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 PAGE 73
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE | UNTREATD 0.25% 0.50% 1.00% |
| | CONTROL |
|=================================================================================================================================|
| |
|Urinary Bladder |
| Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/60 (0%) 1/60 (2%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 3.7% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/7 (0%) 0/8 (0%) |
|TERMINAL (d) | 0/36 (0%) 1/27 (4%) 0/23 (0%) 0/5 (0%) |
|FIRST INCIDENCE (DAYS) | --- 738 (T) --- --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.820N P=0.443 (e) (e) |
|INCIDENTAL TUMOR | P=0.820N P=0.443 (e) (e) |
|LOGISTIC REGRESSION | P=0.820N P=0.443 (e) (e) |
|COCHRAN-ARMITAGE | P=0.567N |
|FISHER EXACT | P=0.500 (e) (e) |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 5/60 (8%) 8/60 (13%) 7/60 (12%) 7/60 (12%) |
|ADJUSTED (b) | 13.2% 25.0% 22.0% 39.5% |
|INTERIM SACRIFICE 1 (c)| |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 1/7 (14%) 1/8 (13%) |
|TERMINAL (d) | 4/36 (11%) 5/27 (19%) 3/23 (13%) 1/5 (20%) |
|FIRST INCIDENCE (DAYS) | 690 684 456 (I) 369 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.003 ** P=0.155 P=0.166 P=0.008 ** |
|INCIDENTAL TUMOR | P=0.184 P=0.286 P=0.320 P=0.259 |
|LOGISTIC REGRESSION | P=0.244 P=0.237 P=0.328 P=0.116 |
|COCHRAN-ARMITAGE | P=0.405 |
|FISHER EXACT | P=0.279 P=0.381 P=0.381 |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 PAGE 74
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE | UNTREATD 0.25% 0.50% 1.00% |
| | CONTROL |
|=================================================================================================================================|
| |
|Uterus |
| Sarcoma Stromal or Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 5/60 (8%) 9/60 (15%) 7/60 (12%) 7/60 (12%) |
|ADJUSTED (b) | 13.2% 28.4% 22.0% 39.5% |
|INTERIM SACRIFICE 1 (c)| |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 1/7 (14%) 1/8 (13%) |
|TERMINAL (d) | 4/36 (11%) 6/27 (22%) 3/23 (13%) 1/5 (20%) |
|FIRST INCIDENCE (DAYS) | 690 684 456 (I) 369 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.004 ** P=0.095 P=0.166 P=0.008 ** |
|INCIDENTAL TUMOR | P=0.188 P=0.188 P=0.320 P=0.259 |
|LOGISTIC REGRESSION | P=0.265 P=0.158 P=0.328 P=0.116 |
|COCHRAN-ARMITAGE | P=0.446 |
|FISHER EXACT | P=0.197 P=0.381 P=0.381 |
|=================================================================================================================================|
| |
|Zymbal's Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 0/60 (0%) 1/60 (2%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 3.7% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/7 (0%) 0/8 (0%) |
|TERMINAL (d) | 0/36 (0%) 1/27 (4%) 0/23 (0%) 0/5 (0%) |
|FIRST INCIDENCE (DAYS) | --- 738 (T) --- --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.820N P=0.443 (e) (e) |
|INCIDENTAL TUMOR | P=0.820N P=0.443 (e) (e) |
|LOGISTIC REGRESSION | P=0.820N P=0.443 (e) (e) |
|COCHRAN-ARMITAGE | P=0.567N |
|FISHER EXACT | P=0.500 (e) (e) |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 PAGE 75
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE | UNTREATD 0.25% 0.50% 1.00% |
| | CONTROL |
|=================================================================================================================================|
| |
|Zymbal's Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 0/60 (0%) 0/60 (0%) 2/60 (3%) 1/60 (2%) |
|ADJUSTED (b) | 0.0% 0.0% 6.3% 2.4% |
|INTERIM SACRIFICE 1 (c)| |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/7 (0%) 0/8 (0%) |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 1/23 (4%) 0/5 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 481 577 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.136 (e) P=0.193 P=0.478 |
|INCIDENTAL TUMOR | P=0.400 (e) P=0.240 P=0.916 |
|LOGISTIC REGRESSION | P=0.291 (e) P=0.250 P=0.547 |
|COCHRAN-ARMITAGE | P=0.246 |
|FISHER EXACT | (e) P=0.248 P=0.500 |
|=================================================================================================================================|
| |
|Zymbal's Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 0/60 (0%) 1/60 (2%) 2/60 (3%) 1/60 (2%) |
|ADJUSTED (b) | 0.0% 3.7% 6.3% 2.4% |
|INTERIM SACRIFICE 1 (c)| |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/7 (0%) 0/8 (0%) |
|TERMINAL (d) | 0/36 (0%) 1/27 (4%) 1/23 (4%) 0/5 (0%) |
|FIRST INCIDENCE (DAYS) | --- 738 (T) 481 577 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.161 P=0.443 P=0.193 P=0.478 |
|INCIDENTAL TUMOR | P=0.412 P=0.443 P=0.240 P=0.916 |
|LOGISTIC REGRESSION | P=0.385 P=0.443 P=0.250 P=0.547 |
|COCHRAN-ARMITAGE | P=0.367 |
|FISHER EXACT | P=0.500 P=0.248 P=0.500 |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 PAGE 76
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE | UNTREATD 0.25% 0.50% 1.00% |
| | CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma or Hemangioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 0/60 (0%) 0/60 (0%) 1/60 (2%) 1/60 (2%) |
|ADJUSTED (b) | 0.0% 0.0% 3.0% 2.7% |
|INTERIM SACRIFICE 1 (c)| |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/7 (0%) 0/8 (0%) |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 0/23 (0%) 0/5 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 694 594 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.121 (e) P=0.452 P=0.452 |
|INCIDENTAL TUMOR | P=0.516 (e) P=0.627 P=0.916 |
|LOGISTIC REGRESSION | P=0.234 (e) P=0.486 P=0.537 |
|COCHRAN-ARMITAGE | P=0.236 |
|FISHER EXACT | (e) P=0.500 P=0.500 |
|=================================================================================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 15/60 (25%) 13/60 (22%) 19/60 (32%) 19/60 (32%) |
|ADJUSTED (b) | 35.6% 32.5% 47.2% 75.2% |
|INTERIM SACRIFICE 1 (c)| |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/7 (0%) 0/8 (0%) |
|TERMINAL (d) | 9/36 (25%) 4/27 (15%) 5/23 (22%) 2/5 (40%) |
|FIRST INCIDENCE (DAYS) | 654 609 409 540 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P<0.001 ** P=0.546 P=0.066 P<0.001 ** |
|INCIDENTAL TUMOR | P=0.486 P=0.162N P=0.569 P=0.507 |
|LOGISTIC REGRESSION | P=0.390 P=0.443N P=0.221 P=0.441 |
|COCHRAN-ARMITAGE | P=0.152 |
|FISHER EXACT | P=0.415N P=0.272 P=0.272 |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 PAGE 77
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE | UNTREATD 0.25% 0.50% 1.00% |
| | CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma: Benign, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/7 (0%) 0/8 (0%) |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 0/23 (0%) 0/5 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | (e) |
|FISHER EXACT | (e) (e) (e) |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 41/60 (68%) 50/60 (83%) 52/60 (87%) 53/60 (88%) |
|ADJUSTED (b) | 85.2% 98.0% 100.0% 100.0% |
|INTERIM SACRIFICE 1 (c)| |
|INTERIM SACRIFICE 2 (c)| 1/10 (10%) 1/9 (11%) 3/7 (43%) 5/8 (63%) |
|TERMINAL (d) | 29/36 (81%) 26/27 (96%) 23/23 (100%) 5/5 (100%) |
|FIRST INCIDENCE (DAYS) | 456 (I) 456 (I) 456 (I) 369 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P<0.001 ** P=0.004 ** P<0.001 ** P<0.001 ** |
|INCIDENTAL TUMOR | P<0.001 ** P=0.028 * P=0.012 * P=0.012 * |
|LOGISTIC REGRESSION | P<0.001 ** P=0.021 * P=0.001 ** P<0.001 ** |
|COCHRAN-ARMITAGE | P=0.007 ** |
|FISHER EXACT | P=0.043 * P=0.014 * P=0.007 ** |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 PAGE 78
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
|DOSE | UNTREATD 0.25% 0.50% 1.00% |
| | CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 21/60 (35%) 22/60 (37%) 27/60 (45%) 31/60 (52%) |
|ADJUSTED (b) | 46.4% 54.0% 59.5% 89.7% |
|INTERIM SACRIFICE 1 (c)| |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/7 (0%) 0/8 (0%) |
|TERMINAL (d) | 12/36 (33%) 10/27 (37%) 7/23 (30%) 3/5 (60%) |
|FIRST INCIDENCE (DAYS) | 481 404 388 432 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P<0.001 ** P=0.256 P=0.032 * P<0.001 ** |
|INCIDENTAL TUMOR | P=0.212 P=0.424N P=0.549 P=0.345 |
|LOGISTIC REGRESSION | P=0.080 P=0.562N P=0.149 P=0.202 |
|COCHRAN-ARMITAGE | P=0.025 * |
|FISHER EXACT | P=0.500 P=0.176 P=0.048 * |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 46/60 (77%) 52/60 (87%) 56/60 (93%) 57/60 (95%) |
|ADJUSTED (b) | 90.2% 100.0% 100.0% 100.0% |
|INTERIM SACRIFICE 1 (c)| |
|INTERIM SACRIFICE 2 (c)| 1/10 (10%) 1/9 (11%) 3/7 (43%) 5/8 (63%) |
|TERMINAL (d) | 31/36 (86%) 27/27 (100%) 23/23 (100%) 5/5 (100%) |
|FIRST INCIDENCE (DAYS) | 456 (I) 404 388 369 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P<0.001 ** P=0.014 * P<0.001 ** P<0.001 ** |
|INCIDENTAL TUMOR | P<0.001 ** P=0.091 P=0.021 * P=0.024 * |
|LOGISTIC REGRESSION | P<0.001 ** P=0.063 P=0.002 ** P<0.001 ** |
|COCHRAN-ARMITAGE | P=0.002 ** |
|FISHER EXACT | P=0.119 P=0.010 ** P=0.004 ** |
|=================================================================================================================================|
DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 PAGE 79
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL
TERMINAL SACRIFICE AT 106 WEEKS
(a) Number of tumor-bearing animals / number of animals examined at site.
(b) Kaplan-Meier estimated lifetime tumor incidence after adjustment for
intercurrent mortality.
(c) Observed incidence at interim kill.
Male interim sacrifices(days): 92 456
Female interim sacrifices(days): 456
(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).