TDMS Study 05063-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Mason PHENYLBUTAZONE DATE: 09/08/94
EXPERIMENT: 05063 TEST: 01 TIME: 19:32:24
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-28033 ROUTE: GAVAGE NTP C#: 56531
PATHOLOGIST: R. FLEISCHMAN CAS: 50-33-9
------------------------------------------------------------------------------------------------------------------------------------
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Mason PHENYLBUTAZONE DATE: 09/08/94
EXPERIMENT: 05063 TEST: 01 TIME: 19:32:24
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-28033 ROUTE: GAVAGE NTP C#: 56531
PATHOLOGIST: R. FLEISCHMAN CAS: 50-33-9
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: Mason PHENYLBUTAZONE DATE: 09/08/94
EXPERIMENT: 05063 TEST: 01 TIME: 19:32:24
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-28033 ROUTE: GAVAGE NTP C#: 56531
PATHOLOGIST: R. FLEISCHMAN CAS: 50-33-9
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF THE STUDY OF PHENYLBUTAZONE
====================================================================================================
MALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Adrenal Medulla Pheochromocytoma Benign
Pheochromocytoma: Benign, Complex, Malignant, NOS
Clitoral/Preputial Gland Adenoma
Carcinoma or Adenoma
Islets, Pancreatic Carcinoma or Adenoma
Kidney: Renal Tubule Adenoma
Lung Alveolar/Bronchiolar Adenoma
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
Urinary Bladder Papilloma
All Organs Benign Tumors
Malignant and Benign Tumors
====================================================================================================
FEMALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Clitoral/Preputial Gland Adenoma
Carcinoma
Carcinoma or Adenoma
Mammary Gland Fibroadenoma
Fibroma, Fibroadenoma, Carcinoma, or Adenoma
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
Uterus Polyp Stromal
Sarcoma Stromal or Polyp Stromal
All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear,
or Undifferentiated
Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
====================================================================================================
DATE: 09/08/94 EXPERIMENT: 05063 TEST: 01 PAGE 1
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PHENYLBUTAZONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 0.05G/KG 0.1 G/KG | VEHICLE 0.05G/KG 0.1 G/KG |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 16/50 (32%) 18/49 (37%) 19/49 (39%) | 3/50 (6%) 1/50 (2%) 2/50 (4%) |
|ADJUSTED (b) | 42.9% 67.4% 54.7% | 8.8% 2.9% 9.1% |
|TERMINAL (d) | 12/33 (36%) 11/19 (58%) 11/26 (42%) | 2/31 (6%) 1/35 (3%) 2/22 (9%) |
|FIRST INCIDENCE (DAYS) | 618 536 658 | 637 732 (T) 732 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.141 P=0.035 * P=0.177 | P=0.517N P=0.269N P=0.643N |
|INCIDENTAL TUMOR | P=0.315 P=0.172 P=0.412 | P=0.453N P=0.317N P=0.573N |
|LOGISTIC REGRESSION | P=0.228 P=0.146 P=0.354 | P=0.464N P=0.294N P=0.581N |
|COCHRAN-ARMITAGE | P=0.275 | P=0.399N |
|FISHER EXACT | P=0.388 P=0.310 | P=0.309N P=0.500N |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Complex |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/49 (0%) 2/49 (4%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 3.0% 0.0% 6.0% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/33 (3%) 0/19 (0%) 1/26 (4%) | 0/31 (0%) 0/35 (0%) 0/22 (0%) |
|FIRST INCIDENCE (DAYS) | 730 (T) --- 567 | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.319 P=0.610N P=0.440 | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.317 P=0.610N P=0.445 | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.356 P=0.610N P=0.496 | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.356 | (e) |
|FISHER EXACT | P=0.505N P=0.492 | (e) (e) |
|=================================================================================================================================|
DATE: 09/08/94 EXPERIMENT: 05063 TEST: 01 PAGE 2
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PHENYLBUTAZONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 0.05G/KG 0.1 G/KG | VEHICLE 0.05G/KG 0.1 G/KG |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Malignant |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 2/49 (4%) 2/49 (4%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 10.5% 8.6% 5.6% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/33 (3%) 1/19 (5%) 0/26 (0%) | 0/31 (0%) 0/35 (0%) 0/22 (0%) |
|FIRST INCIDENCE (DAYS) | 618 654 692 | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.288N P=0.507N P=0.355N | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.142N P=0.246N P=0.187N | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.225N P=0.367N P=0.349N | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.260N | (e) |
|FISHER EXACT | P=0.349N P=0.349N | (e) (e) |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 19/50 (38%) 20/49 (41%) 21/49 (43%) | 3/50 (6%) 1/50 (2%) 3/50 (6%) |
|ADJUSTED (b) | 49.6% 72.5% 58.6% | 8.8% 2.9% 13.6% |
|TERMINAL (d) | 14/33 (42%) 12/19 (63%) 12/26 (46%) | 2/31 (6%) 1/35 (3%) 3/22 (14%) |
|FIRST INCIDENCE (DAYS) | 618 536 567 | 637 732 (T) 732 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.179 P=0.040 * P=0.221 | P=0.464 P=0.269N P=0.507 |
|INCIDENTAL TUMOR | P=0.389 P=0.224 P=0.471 | P=0.525 P=0.317N P=0.575 |
|LOGISTIC REGRESSION | P=0.298 P=0.186 P=0.342 | P=0.518 P=0.294N P=0.572 |
|COCHRAN-ARMITAGE | P=0.348 | P=0.593N |
|FISHER EXACT | P=0.468 P=0.387 | P=0.309N P=0.661N |
|=================================================================================================================================|
DATE: 09/08/94 EXPERIMENT: 05063 TEST: 01 PAGE 3
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PHENYLBUTAZONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 0.05G/KG 0.1 G/KG | VEHICLE 0.05G/KG 0.1 G/KG |
| | | |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/43 (5%) 4/25 (16%) 0/47 (0%) | 5/36 (14%) 4/11 (36%) 0/41 (0%) |
|ADJUSTED (b) | 6.3% 51.1% 0.0% | 20.8% 51.3% 0.0% |
|TERMINAL (d) | 2/32 (6%) 3/6 (50%) 0/27 (0%) | 5/24 (21%) 3/6 (50%) 0/18 (0%) |
|FIRST INCIDENCE (DAYS) | 730 (T) 536 --- | 732 (T) 683 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.308N P=0.008 ** P=0.276N | P=0.089N P=0.108 P=0.059N |
|INCIDENTAL TUMOR | P=0.319N P=0.012 * P=0.276N | P=0.066N P=0.076 P=0.059N |
|LOGISTIC REGRESSION | P=0.222N P=0.026 * P=0.276N | P=0.055N P=0.072 P=0.059N |
|COCHRAN-ARMITAGE | P=0.210N | P=0.030N* |
|FISHER EXACT | P=0.127 P=0.225N | P=0.114 P=0.019N* |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/43 (0%) 1/25 (4%) 2/47 (4%) | 0/36 (0%) 2/11 (18%) 2/41 (5%) |
|ADJUSTED (b) | 0.0% 4.2% 6.3% | 0.0% 33.3% 7.0% |
|TERMINAL (d) | 0/32 (0%) 0/6 (0%) 1/27 (4%) | 0/24 (0%) 2/6 (33%) 0/18 (0%) |
|FIRST INCIDENCE (DAYS) | --- 704 689 | --- 732 (T) 673 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.158 P=0.436 P=0.230 | P=0.133 P=0.024 * P=0.189 |
|INCIDENTAL TUMOR | P=0.321 P=0.227 P=0.321 | P=0.283 P=0.024 * P=0.454 |
|LOGISTIC REGRESSION | P=0.180 P=0.269 P=0.251 | P=0.202 P=0.024 * P=0.251 |
|COCHRAN-ARMITAGE | P=0.178 | P=0.242 |
|FISHER EXACT | P=0.368 P=0.270 | P=0.051 P=0.280 |
|=================================================================================================================================|
DATE: 09/08/94 EXPERIMENT: 05063 TEST: 01 PAGE 4
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PHENYLBUTAZONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 0.05G/KG 0.1 G/KG | VEHICLE 0.05G/KG 0.1 G/KG |
| | | |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/43 (5%) 5/25 (20%) 2/47 (4%) | 5/36 (14%) 6/11 (55%) 2/41 (5%) |
|ADJUSTED (b) | 6.3% 53.1% 6.3% | 20.8% 83.8% 7.0% |
|TERMINAL (d) | 2/32 (6%) 3/6 (50%) 1/27 (4%) | 5/24 (21%) 5/6 (83%) 0/18 (0%) |
|FIRST INCIDENCE (DAYS) | 730 (T) 536 689 | 732 (T) 683 673 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.509 P=0.004 ** P=0.656 | P=0.366N P=0.005 ** P=0.339N |
|INCIDENTAL TUMOR | P=0.528N P=0.002 ** P=0.660N | P=0.213N P=0.003 ** P=0.189N |
|LOGISTIC REGRESSION | P=0.544N P=0.005 ** P=0.685N | P=0.237N P=0.003 ** P=0.230N |
|COCHRAN-ARMITAGE | P=0.530N | P=0.149N |
|FISHER EXACT | P=0.058 P=0.657N | P=0.011 * P=0.165N |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/22 (5%) 0/50 (0%) | 0/50 (0%) 0/7 (0%) 0/50 (0%) |
|ADJUSTED (b) | 6.1% 50.0% 0.0% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/33 (6%) 1/2 (50%) 0/27 (0%) | 0/31 (0%) 0/0 0/22 (0%) |
|FIRST INCIDENCE (DAYS) | 730 (T) 730 (T) --- | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.235N P=0.200 P=0.283N | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.235N P=0.200 P=0.283N | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.235N P=0.200 P=0.283N | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.167N | (e) |
|FISHER EXACT | P=0.671 P=0.247N | (e) (e) |
|=================================================================================================================================|
DATE: 09/08/94 EXPERIMENT: 05063 TEST: 01 PAGE 5
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PHENYLBUTAZONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 0.05G/KG 0.1 G/KG | VEHICLE 0.05G/KG 0.1 G/KG |
| | | |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/22 (0%) 0/50 (0%) | 0/50 (0%) 0/7 (0%) 0/50 (0%) |
|ADJUSTED (b) | 6.1% 0.0% 0.0% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/33 (6%) 0/2 (0%) 0/27 (0%) | 0/31 (0%) 0/0 0/22 (0%) |
|FIRST INCIDENCE (DAYS) | 730 (T) --- --- | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.171N P=0.884N P=0.283N | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.171N P=0.884N P=0.283N | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.171N P=0.884N P=0.283N | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.119N | (e) |
|FISHER EXACT | P=0.479N P=0.247N | (e) (e) |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 1/22 (5%) 0/50 (0%) | 0/50 (0%) 0/7 (0%) 0/50 (0%) |
|ADJUSTED (b) | 12.1% 50.0% 0.0% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 4/33 (12%) 1/2 (50%) 0/27 (0%) | 0/31 (0%) 0/0 0/22 (0%) |
|FIRST INCIDENCE (DAYS) | 730 (T) 730 (T) --- | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.077N P=0.330 P=0.090N | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.077N P=0.330 P=0.090N | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.077N P=0.330 P=0.090N | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.039N* | (e) |
|FISHER EXACT | P=0.514N P=0.059N | (e) (e) |
|=================================================================================================================================|
DATE: 09/08/94 EXPERIMENT: 05063 TEST: 01 PAGE 6
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PHENYLBUTAZONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 0.05G/KG 0.1 G/KG | VEHICLE 0.05G/KG 0.1 G/KG |
| | | |
|=================================================================================================================================|
| |
|Kidney: Pelvis and Transitional Epithelium |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% | 0.0% 0.0% 7.0% |
|TERMINAL (d) | 0/33 (0%) 0/20 (0%) 0/27 (0%) | 0/31 (0%) 0/35 (0%) 1/22 (5%) |
|FIRST INCIDENCE (DAYS) | --- --- --- | --- --- 578 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) | P=0.071 (e) P=0.193 |
|INCIDENTAL TUMOR | (e) (e) (e) | P=0.121 (e) P=0.260 |
|LOGISTIC REGRESSION | (e) (e) (e) | P=0.099 (e) P=0.240 |
|COCHRAN-ARMITAGE | (e) | P=0.096 |
|FISHER EXACT | (e) (e) | (e) P=0.247 |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 3/50 (6%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 10.5% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/33 (0%) 0/20 (0%) 2/27 (7%) | 0/31 (0%) 0/35 (0%) 0/22 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 716 | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.035 * (e) P=0.095 | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.046 * (e) P=0.138 | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.040 * (e) P=0.111 | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.038 * | (e) |
|FISHER EXACT | (e) P=0.121 | (e) (e) |
|=================================================================================================================================|
DATE: 09/08/94 EXPERIMENT: 05063 TEST: 01 PAGE 7
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PHENYLBUTAZONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 0.05G/KG 0.1 G/KG | VEHICLE 0.05G/KG 0.1 G/KG |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/49 (2%) 3/50 (6%) | 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 5.0% 10.5% | 0.0% 2.9% 0.0% |
|TERMINAL (d) | 0/33 (0%) 1/20 (5%) 2/27 (7%) | 0/31 (0%) 1/35 (3%) 0/22 (0%) |
|FIRST INCIDENCE (DAYS) | --- 730 (T) 716 | --- 732 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.053 P=0.400 P=0.095 | P=0.697 P=0.524 (e) |
|INCIDENTAL TUMOR | P=0.067 P=0.400 P=0.138 | P=0.697 P=0.524 (e) |
|LOGISTIC REGRESSION | P=0.061 P=0.400 P=0.111 | P=0.697 P=0.524 (e) |
|COCHRAN-ARMITAGE | P=0.061 | P=0.730 |
|FISHER EXACT | P=0.495 P=0.121 | P=0.500 (e) |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) | 1/50 (2%) 2/27 (7%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 2.8% 3.7% | 3.2% 8.8% 0.0% |
|TERMINAL (d) | 0/33 (0%) 0/20 (0%) 1/27 (4%) | 1/31 (3%) 1/15 (7%) 0/22 (0%) |
|FIRST INCIDENCE (DAYS) | --- 620 730 (T) | 732 (T) 655 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.316 P=0.479 P=0.460 | P=0.454N P=0.350 P=0.568N |
|INCIDENTAL TUMOR | P=0.306 P=0.612 P=0.460 | P=0.416N P=0.285 P=0.568N |
|LOGISTIC REGRESSION | P=0.331 P=0.548 P=0.460 | P=0.413N P=0.268 P=0.568N |
|COCHRAN-ARMITAGE | P=0.332 | P=0.372N |
|FISHER EXACT | P=0.500 P=0.500 | P=0.280 P=0.500N |
|=================================================================================================================================|
DATE: 09/08/94 EXPERIMENT: 05063 TEST: 01 PAGE 8
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PHENYLBUTAZONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 0.05G/KG 0.1 G/KG | VEHICLE 0.05G/KG 0.1 G/KG |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 3/34 (9%) 0/50 (0%) | 1/50 (2%) 0/20 (0%) 2/50 (4%) |
|ADJUSTED (b) | 0.0% 17.3% 0.0% | 3.2% 0.0% 7.9% |
|TERMINAL (d) | 0/33 (0%) 1/9 (11%) 0/27 (0%) | 1/31 (3%) 0/10 (0%) 0/22 (0%) |
|FIRST INCIDENCE (DAYS) | --- 616 --- | 732 (T) --- 703 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.590 P=0.042 * (e) | P=0.287 P=0.725N P=0.400 |
|INCIDENTAL TUMOR | P=0.580N P=0.067 (e) | P=0.386 P=0.725N P=0.512 |
|LOGISTIC REGRESSION | P=0.626 P=0.028 * (e) | P=0.309 P=0.725N P=0.423 |
|COCHRAN-ARMITAGE | P=0.631 | P=0.375 |
|FISHER EXACT | P=0.063 (e) | P=0.714N P=0.500 |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/34 (0%) 0/50 (0%) | 0/50 (0%) 0/20 (0%) 1/50 (2%) |
|ADJUSTED (b) | 6.1% 0.0% 0.0% | 0.0% 0.0% 4.2% |
|TERMINAL (d) | 2/33 (6%) 0/9 (0%) 0/27 (0%) | 0/31 (0%) 0/10 (0%) 0/22 (0%) |
|FIRST INCIDENCE (DAYS) | 730 (T) --- --- | --- --- 721 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.155N P=0.550N P=0.283N | P=0.226 (e) P=0.443 |
|INCIDENTAL TUMOR | P=0.155N P=0.550N P=0.283N | P=0.331 (e) P=0.545 |
|LOGISTIC REGRESSION | P=0.155N P=0.550N P=0.283N | P=0.257 (e) P=0.456 |
|COCHRAN-ARMITAGE | P=0.108N | P=0.292 |
|FISHER EXACT | P=0.351N P=0.247N | (e) P=0.500 |
|=================================================================================================================================|
DATE: 09/08/94 EXPERIMENT: 05063 TEST: 01 PAGE 9
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PHENYLBUTAZONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 0.05G/KG 0.1 G/KG | VEHICLE 0.05G/KG 0.1 G/KG |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/34 (9%) 0/50 (0%) | 1/50 (2%) 0/20 (0%) 3/50 (6%) |
|ADJUSTED (b) | 6.1% 17.3% 0.0% | 3.2% 0.0% 11.7% |
|TERMINAL (d) | 2/33 (6%) 1/9 (11%) 0/27 (0%) | 1/31 (3%) 0/10 (0%) 0/22 (0%) |
|FIRST INCIDENCE (DAYS) | 730 (T) 616 --- | 732 (T) --- 703 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.278N P=0.162 P=0.283N | P=0.123 P=0.725N P=0.213 |
|INCIDENTAL TUMOR | P=0.214N P=0.214 P=0.283N | P=0.221 P=0.725N P=0.329 |
|LOGISTIC REGRESSION | P=0.231N P=0.151 P=0.283N | P=0.147 P=0.725N P=0.228 |
|COCHRAN-ARMITAGE | P=0.215N | P=0.202 |
|FISHER EXACT | P=0.322 P=0.247N | P=0.714N P=0.309 |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 5/50 (10%) 3/50 (6%) | 22/50 (44%) 15/50 (30%) 7/50 (14%) |
|ADJUSTED (b) | 5.1% 20.0% 11.1% | 62.5% 36.0% 24.7% |
|TERMINAL (d) | 1/33 (3%) 2/20 (10%) 3/27 (11%) | 18/31 (58%) 9/35 (26%) 3/22 (14%) |
|FIRST INCIDENCE (DAYS) | 526 623 730 (T) | 485 578 590 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.348 P=0.108 P=0.425 | P=0.010N* P=0.057N P=0.017N* |
|INCIDENTAL TUMOR | P=0.426 P=0.250 P=0.427 | P=0.001N** P=0.076N P=0.003N** |
|LOGISTIC REGRESSION | P=0.414 P=0.193 P=0.499 | P=0.002N** P=0.076N P=0.003N** |
|COCHRAN-ARMITAGE | P=0.420 | P<0.001N** |
|FISHER EXACT | P=0.218 P=0.500 | P=0.107N P<0.001N** |
|=================================================================================================================================|
DATE: 09/08/94 EXPERIMENT: 05063 TEST: 01 PAGE 10
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PHENYLBUTAZONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 0.05G/KG 0.1 G/KG | VEHICLE 0.05G/KG 0.1 G/KG |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 5/50 (10%) 3/50 (6%) | 23/50 (46%) 15/50 (30%) 7/50 (14%) |
|ADJUSTED (b) | 5.1% 20.0% 11.1% | 63.6% 36.0% 24.7% |
|TERMINAL (d) | 1/33 (3%) 2/20 (10%) 3/27 (11%) | 18/31 (58%) 9/35 (26%) 3/22 (14%) |
|FIRST INCIDENCE (DAYS) | 526 623 730 (T) | 485 578 590 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.348 P=0.108 P=0.425 | P=0.007N** P=0.041N* P=0.012N* |
|INCIDENTAL TUMOR | P=0.426 P=0.250 P=0.427 | P<0.001N** P=0.049N* P=0.002N** |
|LOGISTIC REGRESSION | P=0.414 P=0.193 P=0.499 | P<0.001N** P=0.051N P=0.002N** |
|COCHRAN-ARMITAGE | P=0.420 | P<0.001N** |
|FISHER EXACT | P=0.218 P=0.500 | P=0.074N P<0.001N** |
|=================================================================================================================================|
| |
|Pancreas |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 3/27 (11%) 4/50 (8%) | 1/50 (2%) 0/9 (0%) 0/50 (0%) |
|ADJUSTED (b) | 9.1% 41.4% 14.8% | 3.0% 0.0% 0.0% |
|TERMINAL (d) | 3/33 (9%) 2/5 (40%) 4/27 (15%) | 0/31 (0%) 0/0 0/22 (0%) |
|FIRST INCIDENCE (DAYS) | 730 (T) 542 730 (T) | 714 --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.317 P=0.060 P=0.390 | P=0.299N P=0.488N P=0.555N |
|INCIDENTAL TUMOR | P=0.316 P=0.076 P=0.390 | P=0.263N P=0.773N P=0.455N |
|LOGISTIC REGRESSION | P=0.413 P=0.116 P=0.390 | P=0.338N P=0.988N P=0.537N |
|COCHRAN-ARMITAGE | P=0.426 | P=0.300N |
|FISHER EXACT | P=0.351 P=0.500 | P=0.847N P=0.500N |
|=================================================================================================================================|
DATE: 09/08/94 EXPERIMENT: 05063 TEST: 01 PAGE 11
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PHENYLBUTAZONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 0.05G/KG 0.1 G/KG | VEHICLE 0.05G/KG 0.1 G/KG |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 16/48 (33%) 10/26 (38%) 21/47 (45%) | 30/48 (63%) 24/49 (49%) 22/50 (44%) |
|ADJUSTED (b) | 44.2% 100.0% 59.7% | 78.3% 61.3% 64.7% |
|TERMINAL (d) | 12/31 (39%) 4/4 (100%) 12/25 (48%) | 22/30 (73%) 20/35 (57%) 11/22 (50%) |
|FIRST INCIDENCE (DAYS) | 521 623 564 | 485 557 504 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.073 P=0.038 * P=0.092 | P=0.404N P=0.048N* P=0.490N |
|INCIDENTAL TUMOR | P=0.159 P=0.073 P=0.152 | P=0.082N P=0.093N P=0.098N |
|LOGISTIC REGRESSION | P=0.143 P=0.052 P=0.174 | P=0.087N P=0.080N P=0.099N |
|COCHRAN-ARMITAGE | P=0.152 | P=0.042N* |
|FISHER EXACT | P=0.423 P=0.178 | P=0.128N P=0.051N |
|=================================================================================================================================|
| |
|Skin |
| Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 5.3% 4.8% 2.9% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/33 (3%) 0/20 (0%) 0/27 (0%) | 0/31 (0%) 0/35 (0%) 0/22 (0%) |
|FIRST INCIDENCE (DAYS) | 599 728 703 | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.422N P=0.619N P=0.528N | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.279N P=0.426N P=0.435N | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.383N P=0.527N P=0.498N | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.378N | (e) |
|FISHER EXACT | P=0.500N P=0.500N | (e) (e) |
|=================================================================================================================================|
DATE: 09/08/94 EXPERIMENT: 05063 TEST: 01 PAGE 12
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PHENYLBUTAZONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 0.05G/KG 0.1 G/KG | VEHICLE 0.05G/KG 0.1 G/KG |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma, |
| Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 2/50 (4%) | 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|ADJUSTED (b) | 5.3% 7.6% 5.6% | 0.0% 2.9% 0.0% |
|TERMINAL (d) | 1/33 (3%) 0/20 (0%) 0/27 (0%) | 0/31 (0%) 1/35 (3%) 0/22 (0%) |
|FIRST INCIDENCE (DAYS) | 599 623 692 | --- 732 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.568 P=0.581 P=0.675 | P=0.697 P=0.524 (e) |
|INCIDENTAL TUMOR | P=0.469N P=0.586N P=0.573N | P=0.697 P=0.524 (e) |
|LOGISTIC REGRESSION | P=0.599 P=0.698 P=0.694N | P=0.697 P=0.524 (e) |
|COCHRAN-ARMITAGE | P=0.601 | P=0.730 |
|FISHER EXACT | P=0.691N P=0.691N | P=0.500 (e) |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Fibroma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 3/50 (6%) 4/50 (8%) | 1/50 (2%) 1/50 (2%) 1/50 (2%) |
|ADJUSTED (b) | 7.1% 8.3% 13.3% | 3.2% 2.9% 2.4% |
|TERMINAL (d) | 1/33 (3%) 0/20 (0%) 3/27 (11%) | 1/31 (3%) 1/35 (3%) 0/22 (0%) |
|FIRST INCIDENCE (DAYS) | 521 536 598 | 732 (T) 732 (T) 527 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.372 P=0.581 P=0.429 | P=0.580 P=0.735N P=0.715 |
|INCIDENTAL TUMOR | P=0.409 P=0.515N P=0.438 | P=0.634N P=0.735N P=0.751N |
|LOGISTIC REGRESSION | P=0.429 P=0.506N P=0.515 | P=0.636N P=0.735N P=0.749N |
|COCHRAN-ARMITAGE | P=0.421 | P=0.640 |
|FISHER EXACT | P=0.661N P=0.500 | P=0.753N P=0.753N |
|=================================================================================================================================|
DATE: 09/08/94 EXPERIMENT: 05063 TEST: 01 PAGE 13
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PHENYLBUTAZONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 0.05G/KG 0.1 G/KG | VEHICLE 0.05G/KG 0.1 G/KG |
| | | |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Fibrosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 5.0% 0.0% 0.0% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/33 (3%) 0/20 (0%) 0/27 (0%) | 0/31 (0%) 0/35 (0%) 0/22 (0%) |
|FIRST INCIDENCE (DAYS) | 456 --- --- | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.116N P=0.302N P=0.262N | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.107N P=0.244N P=0.262N | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.075N P=0.150N P=0.220N | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.095N | (e) |
|FISHER EXACT | P=0.247N P=0.247N | (e) (e) |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Neurofibrosarcoma, Fibrosarcoma, Sarcoma, |
| Neurofibroma, or Fibroma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 3/50 (6%) 4/50 (8%) | 2/50 (4%) 1/50 (2%) 1/50 (2%) |
|ADJUSTED (b) | 8.9% 8.3% 13.3% | 5.2% 2.9% 2.4% |
|TERMINAL (d) | 1/33 (3%) 0/20 (0%) 3/27 (11%) | 1/31 (3%) 1/35 (3%) 0/22 (0%) |
|FIRST INCIDENCE (DAYS) | 456 536 598 | 421 732 (T) 527 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.520 P=0.581N P=0.576 | P=0.433N P=0.479N P=0.550N |
|INCIDENTAL TUMOR | P=0.570 P=0.315N P=0.590 | P=0.333N P=0.634N P=0.430N |
|LOGISTIC REGRESSION | P=0.565N P=0.268N P=0.622N | P=0.338N P=0.505N P=0.437N |
|COCHRAN-ARMITAGE | P=0.576N | P=0.378N |
|FISHER EXACT | P=0.500N P=0.643N | P=0.500N P=0.500N |
|=================================================================================================================================|
DATE: 09/08/94 EXPERIMENT: 05063 TEST: 01 PAGE 14
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PHENYLBUTAZONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 0.05G/KG 0.1 G/KG | VEHICLE 0.05G/KG 0.1 G/KG |
| | | |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Neurofibrosarcoma, Fibrosarcoma, or Sarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) | 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 5.0% 0.0% 0.0% | 2.0% 0.0% 0.0% |
|TERMINAL (d) | 1/33 (3%) 0/20 (0%) 0/27 (0%) | 0/31 (0%) 0/35 (0%) 0/22 (0%) |
|FIRST INCIDENCE (DAYS) | 456 --- --- | 421 --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.116N P=0.302N P=0.262N | P=0.275N P=0.513N P=0.504N |
|INCIDENTAL TUMOR | P=0.107N P=0.244N P=0.262N | P=0.224N P=0.814N P=0.406N |
|LOGISTIC REGRESSION | P=0.075N P=0.150N P=0.220N | P=0.208N P=0.508N P=0.422N |
|COCHRAN-ARMITAGE | P=0.095N | P=0.270N |
|FISHER EXACT | P=0.247N P=0.247N | P=0.500N P=0.500N |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 46/50 (92%) 41/49 (84%) 48/50 (96%) | |
|ADJUSTED (b) | 93.9% 95.1% 100.0% | |
|TERMINAL (d) | 30/33 (91%) 18/20 (90%) 27/27 (100%) | |
|FIRST INCIDENCE (DAYS) | 456 381 494 | |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.127 P=0.077 P=0.129 | |
|INCIDENTAL TUMOR | P=0.282 P=0.249N P=0.385 | |
|LOGISTIC REGRESSION | P=0.275 P=0.270N P=0.319 | |
|COCHRAN-ARMITAGE | P=0.305 | |
|FISHER EXACT | P=0.168N P=0.339 | |
|=================================================================================================================================|
DATE: 09/08/94 EXPERIMENT: 05063 TEST: 01 PAGE 15
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PHENYLBUTAZONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 0.05G/KG 0.1 G/KG | VEHICLE 0.05G/KG 0.1 G/KG |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 6/49 (12%) 1/21 (5%) 2/49 (4%) | 2/50 (4%) 4/49 (8%) 0/50 (0%) |
|ADJUSTED (b) | 17.9% 2.9% 7.7% | 4.8% 10.6% 0.0% |
|TERMINAL (d) | 5/32 (16%) 0/1 (0%) 2/26 (8%) | 0/31 (0%) 3/35 (9%) 0/22 (0%) |
|FIRST INCIDENCE (DAYS) | 672 622 730 (T) | 619 619 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.155N P=0.724N P=0.198N | P=0.302N P=0.381 P=0.289N |
|INCIDENTAL TUMOR | P=0.124N P=0.673 P=0.159N | P=0.164N P=0.239 P=0.114N |
|LOGISTIC REGRESSION | P=0.110N P=0.696 P=0.143N | P=0.228N P=0.327 P=0.220N |
|COCHRAN-ARMITAGE | P=0.091N | P=0.224N |
|FISHER EXACT | P=0.317N P=0.134N | P=0.329 P=0.247N |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 7/49 (14%) 2/21 (10%) 2/49 (4%) | 3/50 (6%) 5/49 (10%) 0/50 (0%) |
|ADJUSTED (b) | 20.9% 5.1% 7.7% | 7.9% 13.4% 0.0% |
|TERMINAL (d) | 6/32 (19%) 0/1 (0%) 2/26 (8%) | 1/31 (3%) 4/35 (11%) 0/22 (0%) |
|FIRST INCIDENCE (DAYS) | 672 577 730 (T) | 619 619 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.111N P=0.519 P=0.130N | P=0.206N P=0.412 P=0.174N |
|INCIDENTAL TUMOR | P=0.085N P=0.459 P=0.102N | P=0.111N P=0.288 P=0.071N |
|LOGISTIC REGRESSION | P=0.070N P=0.487 P=0.087N | P=0.147N P=0.349 P=0.118N |
|COCHRAN-ARMITAGE | P=0.058N | P=0.134N |
|FISHER EXACT | P=0.455N P=0.080N | P=0.346 P=0.121N |
|=================================================================================================================================|
DATE: 09/08/94 EXPERIMENT: 05063 TEST: 01 PAGE 16
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PHENYLBUTAZONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 0.05G/KG 0.1 G/KG | VEHICLE 0.05G/KG 0.1 G/KG |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 0/21 (0%) 1/49 (2%) | 0/50 (0%) 0/49 (0%) 0/50 (0%) |
|ADJUSTED (b) | 6.0% 0.0% 3.8% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/32 (3%) 0/1 (0%) 1/26 (4%) | 0/31 (0%) 0/35 (0%) 0/22 (0%) |
|FIRST INCIDENCE (DAYS) | 701 --- 730 (T) | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.428N P=0.543N P=0.548N | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.344N P=0.997N P=0.460N | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.395N P=0.850N P=0.512N | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.374N | (e) |
|FISHER EXACT | P=0.487N P=0.500N | (e) (e) |
|=================================================================================================================================|
| |
|Urinary Bladder |
| Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/45 (0%) 2/22 (9%) 0/48 (0%) | 0/50 (0%) 1/49 (2%) 0/49 (0%) |
|ADJUSTED (b) | 0.0% 51.3% 0.0% | 0.0% 2.9% 0.0% |
|TERMINAL (d) | 0/28 (0%) 1/2 (50%) 0/25 (0%) | 0/31 (0%) 1/35 (3%) 0/22 (0%) |
|FIRST INCIDENCE (DAYS) | --- 597 --- | --- 732 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.628 P=0.043 * (e) | P=0.697 P=0.524 (e) |
|INCIDENTAL TUMOR | P=0.641 P=0.068 (e) | P=0.697 P=0.524 (e) |
|LOGISTIC REGRESSION | P=0.640N P=0.039 * (e) | P=0.698 P=0.524 (e) |
|COCHRAN-ARMITAGE | P=0.640N | P=0.727 |
|FISHER EXACT | P=0.104 (e) | P=0.495 (e) |
|=================================================================================================================================|
DATE: 09/08/94 EXPERIMENT: 05063 TEST: 01 PAGE 17
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PHENYLBUTAZONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 0.05G/KG 0.1 G/KG | VEHICLE 0.05G/KG 0.1 G/KG |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # |
|----------- | | |
|OVERALL (a) | | 16/50 (32%) 7/50 (14%) 12/50 (24%) |
|ADJUSTED (b) | | 40.8% 20.0% 38.3% |
|TERMINAL (d) | | 9/31 (29%) 7/35 (20%) 5/22 (23%) |
|FIRST INCIDENCE (DAYS) | | 485 732 (T) 508 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.446N P=0.019N* P=0.552N |
|INCIDENTAL TUMOR | | P=0.207N P=0.043N* P=0.238N |
|LOGISTIC REGRESSION | | P=0.241N P=0.026N* P=0.290N |
|COCHRAN-ARMITAGE | | P=0.203N |
|FISHER EXACT | | P=0.028N* P=0.252N |
|=================================================================================================================================|
| |
|Uterus |
| Sarcoma Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # |
|----------- | | |
|OVERALL (a) | | 2/50 (4%) 3/50 (6%) 0/50 (0%) |
|ADJUSTED (b) | | 5.5% 6.3% 0.0% |
|TERMINAL (d) | | 0/31 (0%) 0/35 (0%) 0/22 (0%) |
|FIRST INCIDENCE (DAYS) | | 651 359 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.230N P=0.514 P=0.293N |
|INCIDENTAL TUMOR | | P=0.126N P=0.419 P=0.185N |
|LOGISTIC REGRESSION | | P=0.141N P=0.505 P=0.247N |
|COCHRAN-ARMITAGE | | P=0.202N |
|FISHER EXACT | | P=0.500 P=0.247N |
|=================================================================================================================================|
DATE: 09/08/94 EXPERIMENT: 05063 TEST: 01 PAGE 18
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PHENYLBUTAZONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 0.05G/KG 0.1 G/KG | VEHICLE 0.05G/KG 0.1 G/KG |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Sarcoma Stromal or Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # |
|----------- | | |
|OVERALL (a) | | 18/50 (36%) 10/50 (20%) 12/50 (24%) |
|ADJUSTED (b) | | 44.1% 25.0% 38.3% |
|TERMINAL (d) | | 9/31 (29%) 7/35 (20%) 5/22 (23%) |
|FIRST INCIDENCE (DAYS) | | 485 359 508 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.302N P=0.047N* P=0.412N |
|INCIDENTAL TUMOR | | P=0.086N P=0.099N P=0.114N |
|LOGISTIC REGRESSION | | P=0.104N P=0.062N P=0.165N |
|COCHRAN-ARMITAGE | | P=0.107N |
|FISHER EXACT | | P=0.059N P=0.138N |
|=================================================================================================================================|
| |
|Zymbal's Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|ADJUSTED (b) | 5.2% 2.6% 3.7% | 0.0% 0.0% 4.4% |
|TERMINAL (d) | 1/33 (3%) 0/20 (0%) 1/27 (4%) | 0/31 (0%) 0/35 (0%) 0/22 (0%) |
|FIRST INCIDENCE (DAYS) | 598 607 730 (T) | --- --- 508 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.425N P=0.579N P=0.555N | P=0.095 (e) P=0.237 |
|INCIDENTAL TUMOR | P=0.412N P=0.428N P=0.546N | P=0.201 (e) P=0.341 |
|LOGISTIC REGRESSION | P=0.376N P=0.459N P=0.500N | P=0.124 (e) P=0.287 |
|COCHRAN-ARMITAGE | P=0.378N | P=0.096 |
|FISHER EXACT | P=0.500N P=0.500N | (e) P=0.247 |
|=================================================================================================================================|
DATE: 09/08/94 EXPERIMENT: 05063 TEST: 01 PAGE 19
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PHENYLBUTAZONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 0.05G/KG 0.1 G/KG | VEHICLE 0.05G/KG 0.1 G/KG |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, |
| or Undifferentiated |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 2/50 (4%) | 11/50 (22%) 6/50 (12%) 4/50 (8%) |
|ADJUSTED (b) | 5.0% 8.3% 5.7% | 26.9% 15.0% 18.2% |
|TERMINAL (d) | 0/33 (0%) 1/20 (5%) 1/27 (4%) | 3/31 (10%) 3/35 (9%) 4/22 (18%) |
|FIRST INCIDENCE (DAYS) | 589 646 505 | 504 557 732 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.565 P=0.582 P=0.669 | P=0.086N P=0.119N P=0.147N |
|INCIDENTAL TUMOR | P=0.535N P=0.584N P=0.644N | P=0.022N* P=0.200N P=0.040N* |
|LOGISTIC REGRESSION | P=0.598N P=0.688N P=0.682N | P=0.035N* P=0.236N P=0.057N |
|COCHRAN-ARMITAGE | P=0.601 | P=0.030N* |
|FISHER EXACT | P=0.691N P=0.691N | P=0.143N P=0.045N* |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma Benign, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 4/50 (8%) 3/50 (6%) | 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 7.5% 17.0% 7.6% | 3.2% 0.0% 0.0% |
|TERMINAL (d) | 1/33 (3%) 3/20 (15%) 1/27 (4%) | 1/31 (3%) 0/35 (0%) 0/22 (0%) |
|FIRST INCIDENCE (DAYS) | 598 584 494 | 732 (T) --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.508 P=0.326 P=0.621 | P=0.303N P=0.476N P=0.568N |
|INCIDENTAL TUMOR | P=0.520 P=0.474 P=0.633 | P=0.303N P=0.476N P=0.568N |
|LOGISTIC REGRESSION | P=0.574N P=0.488 P=0.642N | P=0.303N P=0.476N P=0.568N |
|COCHRAN-ARMITAGE | P=0.579 | P=0.270N |
|FISHER EXACT | P=0.500 P=0.661N | P=0.500N P=0.500N |
|=================================================================================================================================|
DATE: 09/08/94 EXPERIMENT: 05063 TEST: 01 PAGE 20
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PHENYLBUTAZONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 0.05G/KG 0.1 G/KG | VEHICLE 0.05G/KG 0.1 G/KG |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 49/50 (98%) 47/50 (94%) 49/50 (98%) | 43/50 (86%) 39/50 (78%) 35/50 (70%) |
|ADJUSTED (b) | 98.0% 100.0% 100.0% | 97.7% 86.6% 83.0% |
|TERMINAL (d) | 32/33 (97%) 20/20 (100%) 27/27 (100%) | 30/31 (97%) 29/35 (83%) 15/22 (68%) |
|FIRST INCIDENCE (DAYS) | 456 381 494 | 485 299 504 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.188 P=0.019 * P=0.198 | P=0.398 P=0.086N P=0.397 |
|INCIDENTAL TUMOR | P=0.610N P=0.538N P=0.738N | P=0.062N P=0.154N P=0.075N |
|LOGISTIC REGRESSION | P=0.617 P=0.642N P=0.757 | P=0.073N P=0.175N P=0.094N |
|COCHRAN-ARMITAGE | P=0.609N | P=0.035N* |
|FISHER EXACT | P=0.309N P=0.753N | P=0.218N P=0.045N* |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 21/50 (42%) 14/50 (28%) 15/50 (30%) | 19/50 (38%) 16/50 (32%) 12/50 (24%) |
|ADJUSTED (b) | 48.4% 44.9% 38.1% | 42.9% 38.1% 39.7% |
|TERMINAL (d) | 11/33 (33%) 6/20 (30%) 6/27 (22%) | 6/31 (19%) 10/35 (29%) 6/22 (27%) |
|FIRST INCIDENCE (DAYS) | 456 448 494 | 421 359 508 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.254N P=0.498N P=0.278N | P=0.285N P=0.264N P=0.343N |
|INCIDENTAL TUMOR | P=0.077N P=0.072N P=0.078N | P=0.049N* P=0.458N P=0.050N* |
|LOGISTIC REGRESSION | P=0.118N P=0.109N P=0.138N | P=0.077N P=0.348N P=0.104N |
|COCHRAN-ARMITAGE | P=0.121N | P=0.081N |
|FISHER EXACT | P=0.104N P=0.149N | P=0.338N P=0.097N |
|=================================================================================================================================|
DATE: 09/08/94 EXPERIMENT: 05063 TEST: 01 PAGE 21
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- PHENYLBUTAZONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 0.05G/KG 0.1 G/KG | VEHICLE 0.05G/KG 0.1 G/KG |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 50/50 (100%) 48/50 (96%) 50/50 (100%) | 46/50 (92%) 46/50 (92%) 36/50 (72%) |
|ADJUSTED (b) | 100.0% 100.0% 100.0% | 97.9% 93.9% 85.4% |
|TERMINAL (d) | 33/33 (100%) 20/20 (100%) 27/27 (100%) | 30/31 (97%) 32/35 (91%) 16/22 (73%) |
|FIRST INCIDENCE (DAYS) | 456 381 494 | 421 299 504 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.186 P=0.017 * P=0.192 | P=0.488 P=0.263N P=0.501 |
|INCIDENTAL TUMOR | P=0.746N P=0.581N (e) | P=0.006N** P=0.606 P=0.012N* |
|LOGISTIC REGRESSION | P=0.765N P=0.639N (e) | P=0.007N** P=0.647N P=0.018N* |
|COCHRAN-ARMITAGE | P=0.668N | P=0.004N** |
|FISHER EXACT | P=0.247N P=1.000N | P=0.643N P=0.009N** |
|=================================================================================================================================|
(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).