TDMS Study 05002-05 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst GAMMA-BUTYROLACTONE DATE: 09/02/94
EXPERIMENT: 05002 TEST: 05 TIME: 18:09:28
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: NO1CP9565101 ROUTE: GAVAGE NTP C#: 55878
PATHOLOGIST: R. THOMPSON S. EUSTIS CAS: 96-48-0
------------------------------------------------------------------------------------------------------------------------------------
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst GAMMA-BUTYROLACTONE DATE: 09/02/94
EXPERIMENT: 05002 TEST: 05 TIME: 18:09:28
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1CP9565101 ROUTE: GAVAGE NTP C#: 55878
PATHOLOGIST: R. THOMPSON S. EUSTIS CAS: 96-48-0
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 Gland
Bone Marrow
Brain
Clitoral Gland
Epididymis
Heart
Islets, Pancreatic
Kidney
Liver
Lung
Nose
Ovary
Pancreas
Parathyroid Gland
Pituitary Gland
Preputial Gland
Prostate
Salivary Glands
Spleen
Testes
Thymus
Thyroid Gland
Urinary Bladder
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst GAMMA-BUTYROLACTONE DATE: 09/02/94
EXPERIMENT: 05002 TEST: 05 TIME: 18:09:28
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1CP9565101 ROUTE: GAVAGE NTP C#: 55878
PATHOLOGIST: R. THOMPSON S. EUSTIS CAS: 96-48-0
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF THE STUDY OF GAMMA-BUTYROLACTONE
====================================================================================================
MALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Adrenal Medulla Pheochromocytoma Benign
Pheochromocytoma Malignant
Pheochromocytoma: Benign, Complex, Malignant, NOS
Clitoral/Preputial Gland Adenoma
Carcinoma
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
Skin Keratoacanthoma
Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma,
Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma
Skin: Subcutaneous Tissue Fibrosarcoma
Neurofibrosarcoma, Fibrosarcoma, or Sarcoma
Testes Adenoma
Thyroid Gland: C-Cell Carcinoma or Adenoma
All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear,
or Undifferentiated
Mesothelioma Benign, Malignant, NOS
Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
====================================================================================================
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst GAMMA-BUTYROLACTONE DATE: 09/02/94
EXPERIMENT: 05002 TEST: 05 TIME: 18:09:28
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1CP9565101 ROUTE: GAVAGE NTP C#: 55878
PATHOLOGIST: R. THOMPSON S. EUSTIS CAS: 96-48-0
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF THE STUDY OF GAMMA-BUTYROLACTONE
====================================================================================================
FEMALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Adrenal Medulla Pheochromocytoma Malignant
Clitoral/Preputial Gland Adenoma
Carcinoma or Adenoma
Mammary Gland Carcinoma
Fibroadenoma
Fibroma, Fibroadenoma or Adenoma
Fibroma, Fibroadenoma, Carcinoma, or Adenoma
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
Carcinoma or Adenoma
All Organs Hemangiosarcoma
Hemangiosarcoma or Hemangioma
====================================================================================================
DATE: 09/02/94 EXPERIMENT: 05002 TEST: 05 PAGE 1
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- GAMMA-BUTYROLACTONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 112. 225. | VEHICLE 225. 450. |
| | CONTROL MG/KG MG/KG | CONTROL MG/KG MG/KG |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/48 (2%) 0/24 (0%) 1/49 (2%) | 1/50 (2%) 0/25 (0%) 2/50 (4%) |
|ADJUSTED (b) | 4.2% 0.0% 3.2% | 3.6% 0.0% 6.2% |
|TERMINAL (d) | 1/24 (4%) 0/1 (0%) 1/31 (3%) | 1/28 (4%) 0/2 (0%) 1/28 (4%) |
|FIRST INCIDENCE (DAYS) | 729 (T) --- 729 (T) | 730 (T) --- 653 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.573N P=0.991N P=0.704N | P=0.371 P=0.959N P=0.491 |
|INCIDENTAL TUMOR | P=0.573N P=0.991N P=0.704N | P=0.349 P=0.959N P=0.458 |
|LOGISTIC REGRESSION | P=0.573N P=0.991N P=0.704N | P=0.358 P=0.961N P=0.480 |
|COCHRAN-ARMITAGE | P=0.651N | P=0.372 |
|FISHER EXACT | P=0.667N P=0.747N | P=0.667N P=0.500 |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 15/48 (31%) 10/23 (43%) 14/49 (29%) | 1/50 (2%) 0/25 (0%) 4/49 (8%) |
|ADJUSTED (b) | 59.8% 100.0% 36.9% | 3.3% 0.0% 13.7% |
|TERMINAL (d) | 14/24 (58%) 1/1 (100%) 9/31 (29%) | 0/28 (0%) 0/2 (0%) 3/28 (11%) |
|FIRST INCIDENCE (DAYS) | 681 489 365 | 716 --- 726 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.181N P=0.013 * P=0.216N | P=0.111 P=0.514N P=0.185 |
|INCIDENTAL TUMOR | P=0.244N P=0.002 ** P=0.213N | P=0.086 P=0.485N P=0.139 |
|LOGISTIC REGRESSION | P=0.356N P=0.025 * P=0.218N | P=0.109 P=0.749N P=0.090 |
|COCHRAN-ARMITAGE | P=0.428N | P=0.097 |
|FISHER EXACT | P=0.227 P=0.473N | P=0.667N P=0.175 |
|=================================================================================================================================|
DATE: 09/02/94 EXPERIMENT: 05002 TEST: 05 PAGE 2
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- GAMMA-BUTYROLACTONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 112. 225. | VEHICLE 225. 450. |
| | CONTROL MG/KG MG/KG | CONTROL MG/KG MG/KG |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Malignant |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 1/23 (4%) 5/49 (10%) | 0/50 (0%) 1/25 (4%) 0/49 (0%) |
|ADJUSTED (b) | 0.0% 2.4% 15.4% | 0.0% 50.0% 0.0% |
|TERMINAL (d) | 0/24 (0%) 0/1 (0%) 4/31 (13%) | 0/28 (0%) 1/2 (50%) 0/28 (0%) |
|FIRST INCIDENCE (DAYS) | --- 590 704 | --- 730 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.042 * P=0.515 P=0.061 | P=0.695 P=0.041 * (e) |
|INCIDENTAL TUMOR | P=0.030 * P=0.450 P=0.054 | P=0.695 P=0.041 * (e) |
|LOGISTIC REGRESSION | P=0.030 * P=0.427 P=0.056 | P=0.695 P=0.039 * (e) |
|COCHRAN-ARMITAGE | P=0.019 * | P=0.710 |
|FISHER EXACT | P=0.324 P=0.030 * | P=0.333 (e) |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 15/48 (31%) 10/23 (43%) 19/49 (39%) | 1/50 (2%) 1/25 (4%) 4/49 (8%) |
|ADJUSTED (b) | 59.8% 100.0% 49.9% | 3.3% 50.0% 13.7% |
|TERMINAL (d) | 14/24 (58%) 1/1 (100%) 13/31 (42%) | 0/28 (0%) 1/2 (50%) 3/28 (11%) |
|FIRST INCIDENCE (DAYS) | 681 489 365 | 716 730 (T) 726 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.498N P=0.013 * P=0.578N | P=0.134 P=0.535 P=0.185 |
|INCIDENTAL TUMOR | P=0.470 P=0.002 ** P=0.579 | P=0.108 P=0.561 P=0.139 |
|LOGISTIC REGRESSION | P=0.342 P=0.025 * P=0.581 | P=0.130 P=0.394 P=0.090 |
|COCHRAN-ARMITAGE | P=0.255 | P=0.116 |
|FISHER EXACT | P=0.227 P=0.287 | P=0.559 P=0.175 |
|=================================================================================================================================|
DATE: 09/02/94 EXPERIMENT: 05002 TEST: 05 PAGE 3
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- GAMMA-BUTYROLACTONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 112. 225. | VEHICLE 225. 450. |
| | CONTROL MG/KG MG/KG | CONTROL MG/KG MG/KG |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 6/48 (13%) 1/24 (4%) 2/50 (4%) | 6/48 (13%) 5/22 (23%) 5/46 (11%) |
|ADJUSTED (b) | 18.3% 50.0% 6.3% | 20.3% 76.4% 17.7% |
|TERMINAL (d) | 1/24 (4%) 1/2 (50%) 2/32 (6%) | 5/28 (18%) 3/4 (75%) 4/27 (15%) |
|FIRST INCIDENCE (DAYS) | 481 729 (T) 729 (T) | 683 652 726 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.049N* P=0.144N P=0.081N | P=0.471N P=0.049 * P=0.525N |
|INCIDENTAL TUMOR | P=0.076N P=0.169N P=0.148N | P=0.522N P=0.048 * P=0.573N |
|LOGISTIC REGRESSION | P=0.071N P=0.276N P=0.125N | P=0.491N P=0.113 P=0.537N |
|COCHRAN-ARMITAGE | P=0.080N | P=0.473N |
|FISHER EXACT | P=0.250N P=0.121N | P=0.227 P=0.530N |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/48 (2%) 4/24 (17%) 3/50 (6%) | 0/48 (0%) 0/22 (0%) 1/46 (2%) |
|ADJUSTED (b) | 4.2% 54.1% 6.7% | 0.0% 0.0% 2.9% |
|TERMINAL (d) | 1/24 (4%) 1/2 (50%) 0/32 (0%) | 0/28 (0%) 0/4 (0%) 0/27 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 593 550 | --- --- 670 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.359 P=0.029 * P=0.379 | P=0.264 (e) P=0.500 |
|INCIDENTAL TUMOR | P=0.204 P=0.016 * P=0.236 | P=0.210 (e) P=0.419 |
|LOGISTIC REGRESSION | P=0.269 P=0.015 * P=0.280 | P=0.278 (e) P=0.488 |
|COCHRAN-ARMITAGE | P=0.290 | P=0.282 |
|FISHER EXACT | P=0.039 * P=0.324 | (e) P=0.489 |
|=================================================================================================================================|
DATE: 09/02/94 EXPERIMENT: 05002 TEST: 05 PAGE 4
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- GAMMA-BUTYROLACTONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 112. 225. | VEHICLE 225. 450. |
| | CONTROL MG/KG MG/KG | CONTROL MG/KG MG/KG |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 7/48 (15%) 5/24 (21%) 5/50 (10%) | 6/48 (13%) 5/22 (23%) 6/46 (13%) |
|ADJUSTED (b) | 21.9% 100.0% 12.6% | 20.3% 76.4% 20.1% |
|TERMINAL (d) | 2/24 (8%) 2/2 (100%) 2/32 (6%) | 5/28 (18%) 3/4 (75%) 4/27 (15%) |
|FIRST INCIDENCE (DAYS) | 481 593 550 | 683 652 670 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.199N P=0.491 P=0.251N | P=0.529 P=0.049 * P=0.598 |
|INCIDENTAL TUMOR | P=0.351N P=0.393 P=0.447N | P=0.464 P=0.048 * P=0.529 |
|LOGISTIC REGRESSION | P=0.300N P=0.266 P=0.388N | P=0.498 P=0.113 P=0.573 |
|COCHRAN-ARMITAGE | P=0.301N | P=0.524 |
|FISHER EXACT | P=0.361 P=0.351N | P=0.227 P=0.590 |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/49 (6%) 0/22 (0%) 3/50 (6%) | 1/49 (2%) 0/24 (0%) 0/50 (0%) |
|ADJUSTED (b) | 10.7% 0.0% 7.8% | 3.6% 0.0% 0.0% |
|TERMINAL (d) | 2/24 (8%) 0/0 1/32 (3%) | 1/28 (4%) 0/1 (0%) 0/28 (0%) |
|FIRST INCIDENCE (DAYS) | 596 --- 609 | 730 (T) --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.482N P=0.495N P=0.550N | P=0.307N P=0.995N P=0.500N |
|INCIDENTAL TUMOR | P=0.575N P=0.523N P=0.651 | P=0.307N P=0.995N P=0.500N |
|LOGISTIC REGRESSION | P=0.561N P=0.369N P=0.653N | P=0.307N P=0.995N P=0.500N |
|COCHRAN-ARMITAGE | P=0.584N | P=0.285N |
|FISHER EXACT | P=0.322N P=0.651N | P=0.671N P=0.495N |
|=================================================================================================================================|
DATE: 09/02/94 EXPERIMENT: 05002 TEST: 05 PAGE 5
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- GAMMA-BUTYROLACTONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 112. 225. | VEHICLE 225. 450. |
| | CONTROL MG/KG MG/KG | CONTROL MG/KG MG/KG |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 1/22 (5%) 0/50 (0%) | 0/49 (0%) 0/24 (0%) 1/50 (2%) |
|ADJUSTED (b) | 5.7% 0.0% 0.0% | 0.0% 0.0% 3.6% |
|TERMINAL (d) | 0/24 (0%) 0/0 0/32 (0%) | 0/28 (0%) 0/1 (0%) 1/28 (4%) |
|FIRST INCIDENCE (DAYS) | 641 712 --- | --- --- 730 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.111N P=0.472N P=0.198N | P=0.307 (e) P=0.500 |
|INCIDENTAL TUMOR | P=0.158N P=0.514N P=0.290N | P=0.307 (e) P=0.500 |
|LOGISTIC REGRESSION | P=0.157N P=0.672 P=0.250N | P=0.307 (e) P=0.500 |
|COCHRAN-ARMITAGE | P=0.162N | P=0.291 |
|FISHER EXACT | P=0.678 P=0.242N | (e) P=0.505 |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/49 (10%) 1/22 (5%) 3/50 (6%) | 1/49 (2%) 0/24 (0%) 1/50 (2%) |
|ADJUSTED (b) | 15.8% 0.0% 7.8% | 3.6% 0.0% 3.6% |
|TERMINAL (d) | 2/24 (8%) 0/0 1/32 (3%) | 1/28 (4%) 0/1 (0%) 1/28 (4%) |
|FIRST INCIDENCE (DAYS) | 596 712 609 | 730 (T) --- 730 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.186N P=0.285N P=0.249N | P=0.641N P=0.995N P=0.762 |
|INCIDENTAL TUMOR | P=0.278N P=0.324N P=0.399N | P=0.641N P=0.995N P=0.762 |
|LOGISTIC REGRESSION | P=0.255N P=0.476N P=0.463N | P=0.641N P=0.995N P=0.762 |
|COCHRAN-ARMITAGE | P=0.274N | P=0.650N |
|FISHER EXACT | P=0.391N P=0.346N | P=0.671N P=0.747N |
|=================================================================================================================================|
DATE: 09/02/94 EXPERIMENT: 05002 TEST: 05 PAGE 6
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- GAMMA-BUTYROLACTONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 112. 225. | VEHICLE 225. 450. |
| | CONTROL MG/KG MG/KG | CONTROL MG/KG MG/KG |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/29 (3%) 3/50 (6%) | 0/50 (0%) 1/30 (3%) 2/50 (4%) |
|ADJUSTED (b) | 5.7% 16.7% 9.4% | 0.0% 2.4% 7.1% |
|TERMINAL (d) | 0/24 (0%) 1/6 (17%) 3/32 (9%) | 0/28 (0%) 0/7 (0%) 2/28 (7%) |
|FIRST INCIDENCE (DAYS) | 641 729 (T) 729 (T) | --- 652 730 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.528 P=0.637N P=0.612 | P=0.162 P=0.505 P=0.238 |
|INCIDENTAL TUMOR | P=0.470 P=0.669N P=0.526 | P=0.147 P=0.515 P=0.238 |
|LOGISTIC REGRESSION | P=0.475 P=0.726N P=0.541 | P=0.152 P=0.401 P=0.238 |
|COCHRAN-ARMITAGE | P=0.406 | P=0.159 |
|FISHER EXACT | P=0.697N P=0.500 | P=0.375 P=0.247 |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/29 (3%) 4/50 (8%) | 1/50 (2%) 1/30 (3%) 2/50 (4%) |
|ADJUSTED (b) | 5.7% 16.7% 12.5% | 3.6% 2.4% 7.1% |
|TERMINAL (d) | 0/24 (0%) 1/6 (17%) 4/32 (13%) | 1/28 (4%) 0/7 (0%) 2/28 (7%) |
|FIRST INCIDENCE (DAYS) | 641 729 (T) 729 (T) | 730 (T) 652 730 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.380 P=0.637N P=0.461 | P=0.385 P=0.626 P=0.500 |
|INCIDENTAL TUMOR | P=0.329 P=0.669N P=0.382 | P=0.366 P=0.634 P=0.500 |
|LOGISTIC REGRESSION | P=0.329 P=0.726N P=0.391 | P=0.370 P=0.614 P=0.500 |
|COCHRAN-ARMITAGE | P=0.254 | P=0.386 |
|FISHER EXACT | P=0.697N P=0.339 | P=0.612 P=0.500 |
|=================================================================================================================================|
DATE: 09/02/94 EXPERIMENT: 05002 TEST: 05 PAGE 7
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- GAMMA-BUTYROLACTONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 112. 225. | VEHICLE 225. 450. |
| | CONTROL MG/KG MG/KG | CONTROL MG/KG MG/KG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) | 4/50 (8%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 3.1% 0.0% | 12.4% 0.0% 0.0% |
|TERMINAL (d) | 0/24 (0%) 0/27 (0%) 0/32 (0%) | 2/28 (7%) 0/27 (0%) 0/28 (0%) |
|FIRST INCIDENCE (DAYS) | --- 690 --- | 574 --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.687N P=0.534 (e) | P=0.016N* P=0.071N P=0.065N |
|INCIDENTAL TUMOR | P=0.726N P=0.479 (e) | P=0.014N* P=0.087N P=0.058N |
|LOGISTIC REGRESSION | P=0.722N P=0.506 (e) | P=0.016N* P=0.064N P=0.068N |
|COCHRAN-ARMITAGE | P=0.730N | P=0.015N* |
|FISHER EXACT | P=0.500 (e) | P=0.059N P=0.059N |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) | 4/50 (8%) 0/50 (0%) 1/50 (2%) |
|ADJUSTED (b) | 0.0% 3.1% 0.0% | 12.4% 0.0% 2.8% |
|TERMINAL (d) | 0/24 (0%) 0/27 (0%) 0/32 (0%) | 2/28 (7%) 0/27 (0%) 0/28 (0%) |
|FIRST INCIDENCE (DAYS) | --- 690 --- | 574 --- 668 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.687N P=0.534 (e) | P=0.084N P=0.071N P=0.182N |
|INCIDENTAL TUMOR | P=0.726N P=0.479 (e) | P=0.083N P=0.087N P=0.190N |
|LOGISTIC REGRESSION | P=0.722N P=0.506 (e) | P=0.086N P=0.064N P=0.191N |
|COCHRAN-ARMITAGE | P=0.730N | P=0.082N |
|FISHER EXACT | P=0.500 (e) | P=0.059N P=0.181N |
|=================================================================================================================================|
DATE: 09/02/94 EXPERIMENT: 05002 TEST: 05 PAGE 8
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- GAMMA-BUTYROLACTONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 112. 225. | VEHICLE 225. 450. |
| | CONTROL MG/KG MG/KG | CONTROL MG/KG MG/KG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 1/50 (2%) 3/50 (6%) | 22/50 (44%) 14/50 (28%) 6/50 (12%) |
|ADJUSTED (b) | 14.3% 3.7% 8.8% | 62.0% 41.4% 17.1% |
|TERMINAL (d) | 2/24 (8%) 1/27 (4%) 2/32 (6%) | 15/28 (54%) 8/27 (30%) 2/28 (7%) |
|FIRST INCIDENCE (DAYS) | 668 729 (T) 695 | 556 682 578 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.293N P=0.148N P=0.354N | P<0.001N** P=0.093N P<0.001N** |
|INCIDENTAL TUMOR | P=0.333N P=0.171N P=0.411N | P<0.001N** P=0.088N P<0.001N** |
|LOGISTIC REGRESSION | P=0.335N P=0.158N P=0.415N | P<0.001N** P=0.064N P<0.001N** |
|COCHRAN-ARMITAGE | P=0.414N | P<0.001N** |
|FISHER EXACT | P=0.181N P=0.500N | P=0.072N P<0.001N** |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 1/50 (2%) 3/50 (6%) | 22/50 (44%) 14/50 (28%) 6/50 (12%) |
|ADJUSTED (b) | 14.3% 3.7% 8.8% | 62.0% 41.4% 17.1% |
|TERMINAL (d) | 2/24 (8%) 1/27 (4%) 2/32 (6%) | 15/28 (54%) 8/27 (30%) 2/28 (7%) |
|FIRST INCIDENCE (DAYS) | 668 729 (T) 695 | 556 682 578 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.293N P=0.148N P=0.354N | P<0.001N** P=0.093N P<0.001N** |
|INCIDENTAL TUMOR | P=0.333N P=0.171N P=0.411N | P<0.001N** P=0.088N P<0.001N** |
|LOGISTIC REGRESSION | P=0.335N P=0.158N P=0.415N | P<0.001N** P=0.064N P<0.001N** |
|COCHRAN-ARMITAGE | P=0.414N | P<0.001N** |
|FISHER EXACT | P=0.181N P=0.500N | P=0.072N P<0.001N** |
|=================================================================================================================================|
DATE: 09/02/94 EXPERIMENT: 05002 TEST: 05 PAGE 9
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- GAMMA-BUTYROLACTONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 112. 225. | VEHICLE 225. 450. |
| | CONTROL MG/KG MG/KG | CONTROL MG/KG MG/KG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 2/50 (4%) 3/50 (6%) | 24/50 (48%) 14/50 (28%) 6/50 (12%) |
|ADJUSTED (b) | 14.3% 6.7% 8.8% | 67.9% 41.4% 17.1% |
|TERMINAL (d) | 2/24 (8%) 1/27 (4%) 2/32 (6%) | 17/28 (61%) 8/27 (30%) 2/28 (7%) |
|FIRST INCIDENCE (DAYS) | 668 690 695 | 556 682 578 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.289N P=0.283N P=0.354N | P<0.001N** P=0.045N* P<0.001N** |
|INCIDENTAL TUMOR | P=0.340N P=0.332N P=0.411N | P<0.001N** P=0.039N* P<0.001N** |
|LOGISTIC REGRESSION | P=0.340N P=0.309N P=0.415N | P<0.001N** P=0.025N* P<0.001N** |
|COCHRAN-ARMITAGE | P=0.418N | P<0.001N** |
|FISHER EXACT | P=0.339N P=0.500N | P=0.032N* P<0.001N** |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip) |
| Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) | 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 3.7% 0.0% | 0.0% 5.7% 0.0% |
|TERMINAL (d) | 0/24 (0%) 1/27 (4%) 0/32 (0%) | 0/28 (0%) 0/27 (0%) 0/28 (0%) |
|FIRST INCIDENCE (DAYS) | --- 729 (T) --- | --- 689 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.689N P=0.523 (e) | P=0.664 P=0.263 (e) |
|INCIDENTAL TUMOR | P=0.689N P=0.523 (e) | P=0.602 P=0.252 (e) |
|LOGISTIC REGRESSION | P=0.689N P=0.523 (e) | P=0.658 P=0.235 (e) |
|COCHRAN-ARMITAGE | P=0.730N | P=0.669 |
|FISHER EXACT | P=0.500 (e) | P=0.247 (e) |
|=================================================================================================================================|
DATE: 09/02/94 EXPERIMENT: 05002 TEST: 05 PAGE 10
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- GAMMA-BUTYROLACTONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 112. 225. | VEHICLE 225. 450. |
| | CONTROL MG/KG MG/KG | CONTROL MG/KG MG/KG |
|=================================================================================================================================|
| |
|Pancreas |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 0/22 (0%) 5/50 (10%) | 2/49 (4%) 0/24 (0%) 0/50 (0%) |
|ADJUSTED (b) | 26.9% 0.0% 14.9% | 7.1% 0.0% 0.0% |
|TERMINAL (d) | 5/24 (21%) 0/1 (0%) 4/32 (13%) | 2/28 (7%) 0/1 (0%) 0/28 (0%) |
|FIRST INCIDENCE (DAYS) | 708 --- 695 | 730 (T) --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.160N P=0.168N P=0.200N | P=0.140N P=0.956N P=0.238N |
|INCIDENTAL TUMOR | P=0.184N P=0.228N P=0.237N | P=0.140N P=0.956N P=0.238N |
|LOGISTIC REGRESSION | P=0.156N P=0.307N P=0.203N | P=0.140N P=0.956N P=0.238N |
|COCHRAN-ARMITAGE | P=0.309N | P=0.114N |
|FISHER EXACT | P=0.068N P=0.380N | P=0.447N P=0.242N |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 11/48 (23%) 11/28 (39%) 16/49 (33%) | 22/49 (45%) 24/37 (65%) 16/48 (33%) |
|ADJUSTED (b) | 37.4% 72.8% 41.7% | 63.7% 77.1% 44.1% |
|TERMINAL (d) | 7/24 (29%) 4/6 (67%) 10/31 (32%) | 16/28 (57%) 10/15 (67%) 8/27 (30%) |
|FIRST INCIDENCE (DAYS) | 577 489 414 | 512 287 578 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.424 P=0.098 P=0.425 | P=0.208N P=0.057 P=0.202N |
|INCIDENTAL TUMOR | P=0.221 P=0.043 * P=0.239 | P=0.262N P=0.042 * P=0.273N |
|LOGISTIC REGRESSION | P=0.222 P=0.040 * P=0.234 | P=0.211N P=0.036 * P=0.237N |
|COCHRAN-ARMITAGE | P=0.178 | P=0.153N |
|FISHER EXACT | P=0.105 P=0.200 | P=0.052 P=0.169N |
|=================================================================================================================================|
DATE: 09/02/94 EXPERIMENT: 05002 TEST: 05 PAGE 11
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- GAMMA-BUTYROLACTONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 112. 225. | VEHICLE 225. 450. |
| | CONTROL MG/KG MG/KG | CONTROL MG/KG MG/KG |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 12/48 (25%) 12/28 (43%) 16/49 (33%) | 22/49 (45%) 24/37 (65%) 16/48 (33%) |
|ADJUSTED (b) | 38.9% 73.3% 41.7% | 63.7% 77.1% 44.1% |
|TERMINAL (d) | 7/24 (29%) 4/6 (67%) 10/31 (32%) | 16/28 (57%) 10/15 (67%) 8/27 (30%) |
|FIRST INCIDENCE (DAYS) | 575 399 414 | 512 287 578 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.507 P=0.112 P=0.514 | P=0.208N P=0.057 P=0.202N |
|INCIDENTAL TUMOR | P=0.263 P=0.050 P=0.294 | P=0.262N P=0.042 * P=0.273N |
|LOGISTIC REGRESSION | P=0.268 P=0.053 P=0.299 | P=0.211N P=0.036 * P=0.237N |
|COCHRAN-ARMITAGE | P=0.246 | P=0.153N |
|FISHER EXACT | P=0.088 P=0.272 | P=0.052 P=0.169N |
|=================================================================================================================================|
| |
|Skin |
| Basal Cell Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 4/50 (8%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 14.8% 0.0% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/24 (0%) 4/27 (15%) 0/32 (0%) | 0/28 (0%) 0/27 (0%) 0/28 (0%) |
|FIRST INCIDENCE (DAYS) | --- 729 (T) --- | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.526N P=0.077 (e) | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.526N P=0.077 (e) | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.526N P=0.077 (e) | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.619N | (e) |
|FISHER EXACT | P=0.059 (e) | (e) (e) |
|=================================================================================================================================|
DATE: 09/02/94 EXPERIMENT: 05002 TEST: 05 PAGE 12
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- GAMMA-BUTYROLACTONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 112. 225. | VEHICLE 225. 450. |
| | CONTROL MG/KG MG/KG | CONTROL MG/KG MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 4/50 (8%) 6/50 (12%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 4.2% 14.8% 18.8% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/24 (4%) 4/27 (15%) 6/32 (19%) | 0/28 (0%) 0/27 (0%) 0/28 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 729 (T) | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.088 P=0.213 P=0.112 | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.088 P=0.213 P=0.112 | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.088 P=0.213 P=0.112 | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.042 * | (e) |
|FISHER EXACT | P=0.181 P=0.056 | (e) (e) |
|=================================================================================================================================|
| |
|Skin |
| Trichoepithelioma, Basal Cell Carcinoma, or Basal Cell Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 4/50 (8%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 14.8% 3.1% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/24 (0%) 4/27 (15%) 1/32 (3%) | 0/28 (0%) 0/27 (0%) 0/28 (0%) |
|FIRST INCIDENCE (DAYS) | --- 729 (T) 729 (T) | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.499 P=0.077 P=0.557 | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.499 P=0.077 P=0.557 | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.499 P=0.077 P=0.557 | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.393 | (e) |
|FISHER EXACT | P=0.059 P=0.500 | (e) (e) |
|=================================================================================================================================|
DATE: 09/02/94 EXPERIMENT: 05002 TEST: 05 PAGE 13
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- GAMMA-BUTYROLACTONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 112. 225. | VEHICLE 225. 450. |
| | CONTROL MG/KG MG/KG | CONTROL MG/KG MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma, |
| Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 8/50 (16%) 7/50 (14%) | 1/50 (2%) 0/50 (0%) 1/50 (2%) |
|ADJUSTED (b) | 4.2% 29.6% 21.9% | 3.3% 0.0% 2.9% |
|TERMINAL (d) | 1/24 (4%) 8/27 (30%) 7/32 (22%) | 0/28 (0%) 0/27 (0%) 0/28 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 729 (T) | 716 --- 669 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.091 P=0.023 * P=0.070 | P=0.666N P=0.514N P=0.757N |
|INCIDENTAL TUMOR | P=0.091 P=0.023 * P=0.070 | P=0.602 P=0.485N P=0.680 |
|LOGISTIC REGRESSION | P=0.091 P=0.023 * P=0.068 | P=0.659 P=0.497N P=0.752 |
|COCHRAN-ARMITAGE | P=0.038 * | P=0.669N |
|FISHER EXACT | P=0.015 * P=0.030 * | P=0.500N P=0.753N |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Fibroma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 6/50 (12%) 4/50 (8%) | 1/50 (2%) 1/50 (2%) 0/50 (0%) |
|ADJUSTED (b) | 11.9% 19.6% 10.9% | 3.3% 3.7% 0.0% |
|TERMINAL (d) | 2/24 (8%) 4/27 (15%) 2/32 (6%) | 0/28 (0%) 1/27 (4%) 0/28 (0%) |
|FIRST INCIDENCE (DAYS) | 708 555 663 | 716 730 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.547N P=0.308 P=0.643 | P=0.334N P=0.749 P=0.500N |
|INCIDENTAL TUMOR | P=0.514 P=0.264 P=0.589 | P=0.365N P=0.756N P=0.573N |
|LOGISTIC REGRESSION | P=0.511 P=0.273 P=0.586 | P=0.338N P=0.758N P=0.510N |
|COCHRAN-ARMITAGE | P=0.431 | P=0.331N |
|FISHER EXACT | P=0.243 P=0.500 | P=0.753N P=0.500N |
|=================================================================================================================================|
DATE: 09/02/94 EXPERIMENT: 05002 TEST: 05 PAGE 14
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- GAMMA-BUTYROLACTONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 112. 225. | VEHICLE 225. 450. |
| | CONTROL MG/KG MG/KG | CONTROL MG/KG MG/KG |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Fibrosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 1/50 (2%) 1/50 (2%) |
|ADJUSTED (b) | 13.0% 0.0% 0.0% | 0.0% 2.7% 2.9% |
|TERMINAL (d) | 2/24 (8%) 0/27 (0%) 0/32 (0%) | 0/28 (0%) 0/27 (0%) 0/28 (0%) |
|FIRST INCIDENCE (DAYS) | 574 --- --- | --- 689 670 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.011N* P=0.058N P=0.043N* | P=0.321 P=0.529 P=0.500 |
|INCIDENTAL TUMOR | P=0.017N* P=0.062N P=0.077N | P=0.252 P=0.515 P=0.427 |
|LOGISTIC REGRESSION | P=0.015N* P=0.063N P=0.066N | P=0.324 P=0.498 P=0.496 |
|COCHRAN-ARMITAGE | P=0.015N* | P=0.331 |
|FISHER EXACT | P=0.059N P=0.059N | P=0.500 P=0.500 |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Lipoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 6.3% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/24 (0%) 0/27 (0%) 2/32 (6%) | 0/28 (0%) 0/27 (0%) 0/28 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 729 (T) | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.127 (e) P=0.303 | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.127 (e) P=0.303 | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.127 (e) P=0.303 | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.095 | (e) |
|FISHER EXACT | (e) P=0.247 | (e) (e) |
|=================================================================================================================================|
DATE: 09/02/94 EXPERIMENT: 05002 TEST: 05 PAGE 15
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- GAMMA-BUTYROLACTONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 112. 225. | VEHICLE 225. 450. |
| | CONTROL MG/KG MG/KG | CONTROL MG/KG MG/KG |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Neurofibrosarcoma, Fibrosarcoma, Sarcoma, |
| Neurofibroma, or Fibroma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 6/50 (12%) 4/50 (8%) | 1/50 (2%) 3/50 (6%) 2/50 (4%) |
|ADJUSTED (b) | 24.0% 19.6% 10.9% | 3.3% 8.6% 5.5% |
|TERMINAL (d) | 4/24 (17%) 4/27 (15%) 2/32 (6%) | 0/28 (0%) 1/27 (4%) 0/28 (0%) |
|FIRST INCIDENCE (DAYS) | 574 555 663 | 716 678 599 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.114N P=0.422N P=0.149N | P=0.385 P=0.326 P=0.491 |
|INCIDENTAL TUMOR | P=0.178N P=0.478N P=0.232N | P=0.354 P=0.320 P=0.478 |
|LOGISTIC REGRESSION | P=0.171N P=0.472N P=0.219N | P=0.386 P=0.302 P=0.500 |
|COCHRAN-ARMITAGE | P=0.215N | P=0.399 |
|FISHER EXACT | P=0.500N P=0.262N | P=0.309 P=0.500 |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Neurofibrosarcoma, Fibrosarcoma, or Sarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 2/50 (4%) 2/50 (4%) |
|ADJUSTED (b) | 13.0% 0.0% 0.0% | 0.0% 5.1% 5.5% |
|TERMINAL (d) | 2/24 (8%) 0/27 (0%) 0/32 (0%) | 0/28 (0%) 0/27 (0%) 0/28 (0%) |
|FIRST INCIDENCE (DAYS) | 574 --- --- | --- 678 599 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.011N* P=0.058N P=0.043N* | P=0.161 P=0.274 P=0.231 |
|INCIDENTAL TUMOR | P=0.017N* P=0.062N P=0.077N | P=0.155 P=0.252 P=0.254 |
|LOGISTIC REGRESSION | P=0.015N* P=0.063N P=0.066N | P=0.169 P=0.236 P=0.247 |
|COCHRAN-ARMITAGE | P=0.015N* | P=0.176 |
|FISHER EXACT | P=0.059N P=0.059N | P=0.247 P=0.247 |
|=================================================================================================================================|
DATE: 09/02/94 EXPERIMENT: 05002 TEST: 05 PAGE 16
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- GAMMA-BUTYROLACTONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 112. 225. | VEHICLE 225. 450. |
| | CONTROL MG/KG MG/KG | CONTROL MG/KG MG/KG |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 44/50 (88%) 46/50 (92%) 44/50 (88%) | |
|ADJUSTED (b) | 97.7% 100.0% 100.0% | |
|TERMINAL (d) | 23/24 (96%) 27/27 (100%) 32/32 (100%) | |
|FIRST INCIDENCE (DAYS) | 465 381 365 | |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.039N* P=0.422N P=0.047N* | |
|INCIDENTAL TUMOR | P=0.198N P=0.437 P=0.250N | |
|LOGISTIC REGRESSION | P=0.388N P=0.325 P=0.249N | |
|COCHRAN-ARMITAGE | P=0.564N | |
|FISHER EXACT | P=0.370 P=0.620N | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 1/25 (4%) 5/50 (10%) | 7/50 (14%) 2/27 (7%) 3/50 (6%) |
|ADJUSTED (b) | 27.0% 33.3% 13.1% | 23.5% 5.6% 10.7% |
|TERMINAL (d) | 6/24 (25%) 1/3 (33%) 2/32 (6%) | 6/28 (21%) 0/4 (0%) 3/28 (11%) |
|FIRST INCIDENCE (DAYS) | 596 729 (T) 550 | 667 641 730 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.172N P=0.596N P=0.221N | P=0.128N P=0.580N P=0.157N |
|INCIDENTAL TUMOR | P=0.225N P=0.612N P=0.313N | P=0.124N P=0.633N P=0.169N |
|LOGISTIC REGRESSION | P=0.230N P=0.354N P=0.311N | P=0.135N P=0.485N P=0.168N |
|COCHRAN-ARMITAGE | P=0.313N | P=0.116N |
|FISHER EXACT | P=0.180N P=0.380N | P=0.323N P=0.159N |
|=================================================================================================================================|
DATE: 09/02/94 EXPERIMENT: 05002 TEST: 05 PAGE 17
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- GAMMA-BUTYROLACTONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 112. 225. | VEHICLE 225. 450. |
| | CONTROL MG/KG MG/KG | CONTROL MG/KG MG/KG |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 1/25 (4%) 2/50 (4%) | 1/50 (2%) 1/27 (4%) 1/50 (2%) |
|ADJUSTED (b) | 13.5% 33.3% 6.3% | 3.6% 25.0% 3.6% |
|TERMINAL (d) | 2/24 (8%) 1/3 (33%) 2/32 (6%) | 1/28 (4%) 1/4 (25%) 1/28 (4%) |
|FIRST INCIDENCE (DAYS) | 580 729 (T) 729 (T) | 730 (T) 730 (T) 730 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.168N P=0.560N P=0.232N | P=0.619 P=0.293 P=0.762 |
|INCIDENTAL TUMOR | P=0.200N P=0.600N P=0.294N | P=0.619 P=0.293 P=0.762 |
|LOGISTIC REGRESSION | P=0.207N P=0.529N P=0.299N | P=0.619 P=0.293 P=0.762 |
|COCHRAN-ARMITAGE | P=0.258N | P=0.629 |
|FISHER EXACT | P=0.456N P=0.339N | P=0.581 P=0.753N |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 11/50 (22%) 2/25 (8%) 6/50 (12%) | 8/50 (16%) 3/27 (11%) 4/50 (8%) |
|ADJUSTED (b) | 38.7% 66.7% 16.0% | 27.0% 29.2% 14.3% |
|TERMINAL (d) | 8/24 (33%) 2/3 (67%) 3/32 (9%) | 7/28 (25%) 1/4 (25%) 4/28 (14%) |
|FIRST INCIDENCE (DAYS) | 580 729 (T) 550 | 667 641 730 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.036N* P=0.449N P=0.055N | P=0.150N P=0.506 P=0.174N |
|INCIDENTAL TUMOR | P=0.058N P=0.491N P=0.102N | P=0.146N P=0.456 P=0.186N |
|LOGISTIC REGRESSION | P=0.061N P=0.256N P=0.102N | P=0.160N P=0.641N P=0.187N |
|COCHRAN-ARMITAGE | P=0.106N | P=0.139N |
|FISHER EXACT | P=0.115N P=0.143N | P=0.414N P=0.178N |
|=================================================================================================================================|
DATE: 09/02/94 EXPERIMENT: 05002 TEST: 05 PAGE 18
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- GAMMA-BUTYROLACTONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 112. 225. | VEHICLE 225. 450. |
| | CONTROL MG/KG MG/KG | CONTROL MG/KG MG/KG |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/25 (4%) 0/50 (0%) | 1/50 (2%) 1/27 (4%) 2/50 (4%) |
|ADJUSTED (b) | 4.2% 33.3% 0.0% | 3.6% 25.0% 6.8% |
|TERMINAL (d) | 1/24 (4%) 1/3 (33%) 0/32 (0%) | 1/28 (4%) 1/4 (25%) 1/28 (4%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) --- | 730 (T) 730 (T) 726 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.284N P=0.262 P=0.443N | P=0.395 P=0.293 P=0.504 |
|INCIDENTAL TUMOR | P=0.284N P=0.262 P=0.443N | P=0.368 P=0.293 P=0.458 |
|LOGISTIC REGRESSION | P=0.284N P=0.262 P=0.443N | P=0.397 P=0.293 P=0.498 |
|COCHRAN-ARMITAGE | P=0.345N | P=0.387 |
|FISHER EXACT | P=0.559 P=0.500N | P=0.581 P=0.500 |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/25 (4%) 0/50 (0%) | 1/50 (2%) 1/27 (4%) 2/50 (4%) |
|ADJUSTED (b) | 7.7% 33.3% 0.0% | 3.6% 25.0% 6.8% |
|TERMINAL (d) | 1/24 (4%) 1/3 (33%) 0/32 (0%) | 1/28 (4%) 1/4 (25%) 1/28 (4%) |
|FIRST INCIDENCE (DAYS) | 700 729 (T) --- | 730 (T) 730 (T) 726 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.118N P=0.651 P=0.179N | P=0.395 P=0.293 P=0.504 |
|INCIDENTAL TUMOR | P=0.132N P=0.616 P=0.208N | P=0.368 P=0.293 P=0.458 |
|LOGISTIC REGRESSION | P=0.123N P=0.586 P=0.192N | P=0.397 P=0.293 P=0.498 |
|COCHRAN-ARMITAGE | P=0.164N | P=0.387 |
|FISHER EXACT | P=0.744N P=0.247N | P=0.581 P=0.500 |
|=================================================================================================================================|
DATE: 09/02/94 EXPERIMENT: 05002 TEST: 05 PAGE 19
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- GAMMA-BUTYROLACTONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 112. 225. | VEHICLE 225. 450. |
| | CONTROL MG/KG MG/KG | CONTROL MG/KG MG/KG |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # |
|----------- | | |
|OVERALL (a) | | 10/50 (20%) 9/50 (18%) 13/50 (26%) |
|ADJUSTED (b) | | 30.9% 28.4% 42.4% |
|TERMINAL (d) | | 7/28 (25%) 6/27 (22%) 11/28 (39%) |
|FIRST INCIDENCE (DAYS) | | 556 501 325 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.263 P=0.510N P=0.309 |
|INCIDENTAL TUMOR | | P=0.256 P=0.531N P=0.346 |
|LOGISTIC REGRESSION | | P=0.223 P=0.510N P=0.262 |
|COCHRAN-ARMITAGE | | P=0.271 |
|FISHER EXACT | | P=0.500N P=0.318 |
|=================================================================================================================================|
| |
|Uterus |
| Sarcoma Stromal or Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # |
|----------- | | |
|OVERALL (a) | | 11/50 (22%) 9/50 (18%) 13/50 (26%) |
|ADJUSTED (b) | | 34.2% 28.4% 42.4% |
|TERMINAL (d) | | 8/28 (29%) 6/27 (22%) 11/28 (39%) |
|FIRST INCIDENCE (DAYS) | | 556 501 325 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.349 P=0.414N P=0.399 |
|INCIDENTAL TUMOR | | P=0.344 P=0.433N P=0.441 |
|LOGISTIC REGRESSION | | P=0.303 P=0.409N P=0.344 |
|COCHRAN-ARMITAGE | | P=0.359 |
|FISHER EXACT | | P=0.402N P=0.408 |
|=================================================================================================================================|
DATE: 09/02/94 EXPERIMENT: 05002 TEST: 05 PAGE 20
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- GAMMA-BUTYROLACTONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 112. 225. | VEHICLE 225. 450. |
| | CONTROL MG/KG MG/KG | CONTROL MG/KG MG/KG |
|=================================================================================================================================|
| |
|Zymbal's Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) | 0/50 (0%) 2/50 (4%) 1/50 (2%) |
|ADJUSTED (b) | 2.0% 0.0% 2.5% | 0.0% 4.8% 2.3% |
|TERMINAL (d) | 0/24 (0%) 0/27 (0%) 0/32 (0%) | 0/28 (0%) 0/27 (0%) 0/28 (0%) |
|FIRST INCIDENCE (DAYS) | 465 --- 667 | --- 337 574 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.646N P=0.512N P=0.737N | P=0.350 P=0.250 P=0.505 |
|INCIDENTAL TUMOR | P=0.561 P=0.531N P=0.634 | P=0.535 P=0.323 P=0.612 |
|LOGISTIC REGRESSION | P=0.647 P=0.355N P=0.738 | P=0.479 P=0.309 P=0.550 |
|COCHRAN-ARMITAGE | P=0.668 | P=0.360 |
|FISHER EXACT | P=0.500N P=0.753N | P=0.247 P=0.500 |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|ADJUSTED (b) | 4.2% 0.0% 0.0% | 0.0% 0.0% 5.7% |
|TERMINAL (d) | 1/24 (4%) 0/27 (0%) 0/32 (0%) | 0/28 (0%) 0/27 (0%) 1/28 (4%) |
|FIRST INCIDENCE (DAYS) | 729 (T) --- --- | --- --- 452 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.234N P=0.477N P=0.443N | P=0.094 (e) P=0.230 |
|INCIDENTAL TUMOR | P=0.234N P=0.477N P=0.443N | P=0.042 * (e) P=0.106 |
|LOGISTIC REGRESSION | P=0.234N P=0.477N P=0.443N | P=0.110 (e) P=0.270 |
|COCHRAN-ARMITAGE | P=0.271N | P=0.095 |
|FISHER EXACT | P=0.500N P=0.500N | (e) P=0.247 |
|=================================================================================================================================|
DATE: 09/02/94 EXPERIMENT: 05002 TEST: 05 PAGE 21
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- GAMMA-BUTYROLACTONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 112. 225. | VEHICLE 225. 450. |
| | CONTROL MG/KG MG/KG | CONTROL MG/KG MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma or Hemangioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|ADJUSTED (b) | 4.2% 0.0% 0.0% | 0.0% 0.0% 5.7% |
|TERMINAL (d) | 1/24 (4%) 0/27 (0%) 0/32 (0%) | 0/28 (0%) 0/27 (0%) 1/28 (4%) |
|FIRST INCIDENCE (DAYS) | 729 (T) --- --- | --- --- 452 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.234N P=0.477N P=0.443N | P=0.094 (e) P=0.230 |
|INCIDENTAL TUMOR | P=0.234N P=0.477N P=0.443N | P=0.042 * (e) P=0.106 |
|LOGISTIC REGRESSION | P=0.234N P=0.477N P=0.443N | P=0.110 (e) P=0.270 |
|COCHRAN-ARMITAGE | P=0.271N | P=0.095 |
|FISHER EXACT | P=0.500N P=0.500N | (e) P=0.247 |
|=================================================================================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, |
| or Undifferentiated |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 16/50 (32%) 15/50 (30%) 9/50 (18%) | 13/50 (26%) 9/50 (18%) 11/50 (22%) |
|ADJUSTED (b) | 44.9% 43.9% 23.2% | 31.3% 26.5% 30.7% |
|TERMINAL (d) | 7/24 (29%) 9/27 (33%) 4/32 (13%) | 3/28 (11%) 5/27 (19%) 4/28 (14%) |
|FIRST INCIDENCE (DAYS) | 469 533 577 | 498 569 596 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.023N* P=0.383N P=0.033N* | P=0.392N P=0.252N P=0.443N |
|INCIDENTAL TUMOR | P=0.078N P=0.497N P=0.131N | P=0.469N P=0.271N P=0.502 |
|LOGISTIC REGRESSION | P=0.063N P=0.492N P=0.096N | P=0.451N P=0.450N P=0.417N |
|COCHRAN-ARMITAGE | P=0.071N | P=0.359N |
|FISHER EXACT | P=0.500N P=0.083N | P=0.235N P=0.408N |
|=================================================================================================================================|
DATE: 09/02/94 EXPERIMENT: 05002 TEST: 05 PAGE 22
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- GAMMA-BUTYROLACTONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 112. 225. | VEHICLE 225. 450. |
| | CONTROL MG/KG MG/KG | CONTROL MG/KG MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma Benign, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 4/50 (8%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 2.4% 10.7% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/24 (0%) 0/27 (0%) 1/32 (3%) | 0/28 (0%) 0/27 (0%) 0/28 (0%) |
|FIRST INCIDENCE (DAYS) | --- 588 529 | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.044 * P=0.520 P=0.104 | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.013 * P=0.477 P=0.035 * | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.023 * P=0.510 P=0.062 | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.026 * | (e) |
|FISHER EXACT | P=0.500 P=0.059 | (e) (e) |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 46/50 (92%) 48/50 (96%) 50/50 (100%) | 38/50 (76%) 42/50 (84%) 33/50 (66%) |
|ADJUSTED (b) | 100.0% 100.0% 100.0% | 92.5% 91.3% 86.5% |
|TERMINAL (d) | 24/24 (100%) 27/27 (100%) 32/32 (100%) | 25/28 (89%) 23/27 (85%) 23/28 (82%) |
|FIRST INCIDENCE (DAYS) | 465 381 365 | 512 287 325 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.135N P=0.409N P=0.153N | P=0.249N P=0.292 P=0.249N |
|INCIDENTAL TUMOR | P=0.136 P=0.397 P=0.220 | P=0.245N P=0.174 P=0.227N |
|LOGISTIC REGRESSION | P=0.017 * P=0.174 P=0.062 | P=0.293N P=0.142 P=0.336N |
|COCHRAN-ARMITAGE | P=0.037 * | P=0.148N |
|FISHER EXACT | P=0.339 P=0.059 | P=0.227 P=0.189N |
|=================================================================================================================================|
DATE: 09/02/94 EXPERIMENT: 05002 TEST: 05 PAGE 23
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- GAMMA-BUTYROLACTONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 112. 225. | VEHICLE 225. 450. |
| | CONTROL MG/KG MG/KG | CONTROL MG/KG MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 30/50 (60%) 30/50 (60%) 23/50 (46%) | 22/50 (44%) 19/50 (38%) 19/50 (38%) |
|ADJUSTED (b) | 69.7% 65.9% 51.5% | 52.0% 46.2% 47.9% |
|TERMINAL (d) | 12/24 (50%) 12/27 (44%) 11/32 (34%) | 9/28 (32%) 7/27 (26%) 8/28 (29%) |
|FIRST INCIDENCE (DAYS) | 465 392 529 | 498 337 452 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.032N* P=0.412N P=0.037N* | P=0.367N P=0.365N P=0.396N |
|INCIDENTAL TUMOR | P=0.230N P=0.519 P=0.254N | P=0.422N P=0.358N P=0.560 |
|LOGISTIC REGRESSION | P=0.264N P=0.431 P=0.298N | P=0.465N P=0.480N P=0.511N |
|COCHRAN-ARMITAGE | P=0.095N | P=0.305N |
|FISHER EXACT | P=0.581N P=0.115N | P=0.342N P=0.342N |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 50/50 (100%) 50/50 (100%) 50/50 (100%) | 46/50 (92%) 46/50 (92%) 41/50 (82%) |
|ADJUSTED (b) | 100.0% 100.0% 100.0% | 95.8% 93.9% 91.1% |
|TERMINAL (d) | 24/24 (100%) 27/27 (100%) 32/32 (100%) | 26/28 (93%) 24/27 (89%) 24/28 (86%) |
|FIRST INCIDENCE (DAYS) | 465 381 365 | 498 287 325 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.048N* P=0.309N P=0.055N | P=0.287N P=0.532 P=0.300N |
|INCIDENTAL TUMOR | (e) (e) (e) | P=0.225N P=0.588 P=0.419N |
|LOGISTIC REGRESSION | (e) (e) (e) | P=0.187N P=0.612 P=0.297N |
|COCHRAN-ARMITAGE | (e) | P=0.078N |
|FISHER EXACT | P=1.000N P=1.000N | P=0.643N P=0.117N |
|=================================================================================================================================|
DATE: 09/02/94 EXPERIMENT: 05002 TEST: 05 PAGE 24
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- GAMMA-BUTYROLACTONE
TERMINAL SACRIFICE AT 105 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.
(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).