TDMS Study 05058-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst ROXARSONE DATE: 09/08/94
EXPERIMENT: 05058 TEST: 01 TIME: 07:46:37
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: NOI-ES-28024 ROUTE: DOSED FEED NTP C#: C56508
PATHOLOGIST: H. GILES CAS: 121-19-7
------------------------------------------------------------------------------------------------------------------------------------
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst ROXARSONE DATE: 09/08/94
EXPERIMENT: 05058 TEST: 01 TIME: 07:46:37
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NOI-ES-28024 ROUTE: DOSED FEED NTP C#: C56508
PATHOLOGIST: H. GILES CAS: 121-19-7
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 ROXARSONE DATE: 09/08/94
EXPERIMENT: 05058 TEST: 01 TIME: 07:46:37
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NOI-ES-28024 ROUTE: DOSED FEED NTP C#: C56508
PATHOLOGIST: H. GILES CAS: 121-19-7
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF THE STUDY OF ROXARSONE
====================================================================================================
MALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Bone Osteosarcoma
Islets, Pancreatic Adenoma
Pancreas Adenoma
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
Carcinoma or Adenoma
All Organs Osteosarcoma
Osteosarcoma or Osteoma
Benign Tumors
====================================================================================================
FEMALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Clitoral/Preputial Gland Adenoma
Mammary Gland Carcinoma
Fibroma, Fibroadenoma, Carcinoma, or Adenoma
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
Carcinoma or Adenoma
====================================================================================================
DATE: 09/08/94 EXPERIMENT: 05058 TEST: 01 PAGE 1
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ROXARSONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.005% 0.01% | UNTREATD 0.005% 0.01% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 15/50 (30%) 14/49 (29%) 16/50 (32%) | 0/49 (0%) 1/48 (2%) 2/50 (4%) |
|ADJUSTED (b) | 43.5% 47.6% 61.1% | 0.0% 2.9% 4.7% |
|TERMINAL (d) | 7/24 (29%) 5/18 (28%) 9/18 (50%) | 0/26 (0%) 1/34 (3%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | 616 629 637 | --- 729 (T) 677 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.274 P=0.449 P=0.295 | P=0.173 P=0.554 P=0.280 |
|INCIDENTAL TUMOR | P=0.469 P=0.550N P=0.488 | P=0.183 P=0.554 P=0.253 |
|LOGISTIC REGRESSION | P=0.449 P=0.546N P=0.491 | P=0.151 P=0.554 P=0.239 |
|COCHRAN-ARMITAGE | P=0.457 | P=0.146 |
|FISHER EXACT | P=0.526N P=0.500 | P=0.495 P=0.253 |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Malignant |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 4/49 (8%) 4/50 (8%) | 0/49 (0%) 0/48 (0%) 0/50 (0%) |
|ADJUSTED (b) | 17.1% 18.9% 14.0% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/24 (8%) 3/18 (17%) 0/18 (0%) | 0/26 (0%) 0/34 (0%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | 675 637 671 | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.530N P=0.628N P=0.586N | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.379N P=0.565N P=0.363N | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.441N P=0.545N P=0.508N | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.430N | (e) |
|FISHER EXACT | P=0.513N P=0.500N | (e) (e) |
|=================================================================================================================================|
DATE: 09/08/94 EXPERIMENT: 05058 TEST: 01 PAGE 2
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ROXARSONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.005% 0.01% | UNTREATD 0.005% 0.01% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 19/50 (38%) 16/49 (33%) 17/50 (34%) | 0/49 (0%) 1/48 (2%) 2/50 (4%) |
|ADJUSTED (b) | 51.9% 55.7% 62.7% | 0.0% 2.9% 4.7% |
|TERMINAL (d) | 8/24 (33%) 7/18 (39%) 9/18 (50%) | 0/26 (0%) 1/34 (3%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | 616 629 637 | --- 729 (T) 677 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.461 P=0.553 P=0.494 | P=0.173 P=0.554 P=0.280 |
|INCIDENTAL TUMOR | P=0.347N P=0.407N P=0.379N | P=0.183 P=0.554 P=0.253 |
|LOGISTIC REGRESSION | P=0.385N P=0.393N P=0.426N | P=0.151 P=0.554 P=0.239 |
|COCHRAN-ARMITAGE | P=0.376N | P=0.146 |
|FISHER EXACT | P=0.365N P=0.418N | P=0.495 P=0.253 |
|=================================================================================================================================|
| |
|Bone |
| Osteosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|ADJUSTED (b) | 7.5% 0.0% 0.0% | 0.0% 0.0% 5.8% |
|TERMINAL (d) | 0/24 (0%) 0/18 (0%) 0/18 (0%) | 0/27 (0%) 0/35 (0%) 1/32 (3%) |
|FIRST INCIDENCE (DAYS) | 283 --- --- | --- --- 724 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.041N* P=0.133N P=0.130N | P=0.112 (e) P=0.287 |
|INCIDENTAL TUMOR | P=0.065N P=0.223N P=0.161N | P=0.121 (e) P=0.268 |
|LOGISTIC REGRESSION | P=0.061N P=0.146N P=0.196N | P=0.112 (e) P=0.280 |
|COCHRAN-ARMITAGE | P=0.037N* | P=0.095 |
|FISHER EXACT | P=0.121N P=0.121N | (e) P=0.247 |
|=================================================================================================================================|
DATE: 09/08/94 EXPERIMENT: 05058 TEST: 01 PAGE 3
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ROXARSONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.005% 0.01% | UNTREATD 0.005% 0.01% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 7/49 (14%) 3/48 (6%) 2/48 (4%) | 1/44 (2%) 3/47 (6%) 6/48 (13%) |
|ADJUSTED (b) | 23.0% 11.1% 8.0% | 4.2% 8.9% 16.8% |
|TERMINAL (d) | 4/24 (17%) 1/17 (6%) 1/17 (6%) | 1/24 (4%) 2/32 (6%) 3/30 (10%) |
|FIRST INCIDENCE (DAYS) | 581 637 630 | 729 (T) 728 530 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.089N P=0.261N P=0.141N | P=0.057 P=0.410 P=0.100 |
|INCIDENTAL TUMOR | P=0.068N P=0.178N P=0.121N | P=0.070 P=0.311 P=0.116 |
|LOGISTIC REGRESSION | P=0.051N P=0.166N P=0.085N | P=0.049 * P=0.393 P=0.074 |
|COCHRAN-ARMITAGE | P=0.052N | P=0.045 * |
|FISHER EXACT | P=0.167N P=0.084N | P=0.334 P=0.070 |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 4/48 (8%) 0/48 (0%) | 1/44 (2%) 1/47 (2%) 1/48 (2%) |
|ADJUSTED (b) | 0.0% 13.7% 0.0% | 3.0% 2.0% 3.3% |
|TERMINAL (d) | 0/24 (0%) 1/17 (6%) 0/17 (0%) | 0/24 (0%) 0/32 (0%) 1/30 (3%) |
|FIRST INCIDENCE (DAYS) | --- 581 --- | 701 486 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.580 P=0.052 (e) | P=0.606N P=0.745N P=0.716N |
|INCIDENTAL TUMOR | P=0.597N P=0.065 (e) | P=0.556N P=0.755N P=0.716N |
|LOGISTIC REGRESSION | P=0.623N P=0.067 (e) | P=0.605N P=0.687N P=0.730N |
|COCHRAN-ARMITAGE | P=0.615 | P=0.617N |
|FISHER EXACT | P=0.056 (e) | P=0.736N P=0.731N |
|=================================================================================================================================|
DATE: 09/08/94 EXPERIMENT: 05058 TEST: 01 PAGE 4
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ROXARSONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.005% 0.01% | UNTREATD 0.005% 0.01% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 7/49 (14%) 7/48 (15%) 2/48 (4%) | 2/44 (5%) 4/47 (9%) 7/48 (15%) |
|ADJUSTED (b) | 23.0% 23.6% 8.0% | 7.1% 10.7% 19.9% |
|TERMINAL (d) | 4/24 (17%) 2/17 (12%) 1/17 (6%) | 1/24 (4%) 2/32 (6%) 4/30 (13%) |
|FIRST INCIDENCE (DAYS) | 581 581 630 | 701 486 530 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.132N P=0.469 P=0.141N | P=0.091 P=0.438 P=0.142 |
|INCIDENTAL TUMOR | P=0.090N P=0.589 P=0.121N | P=0.112 P=0.359 P=0.158 |
|LOGISTIC REGRESSION | P=0.075N P=0.613 P=0.085N | P=0.070 P=0.370 P=0.106 |
|COCHRAN-ARMITAGE | P=0.077N | P=0.070 |
|FISHER EXACT | P=0.597 P=0.084N | P=0.371 P=0.101 |
|=================================================================================================================================|
| |
|Intestine Small: Jejunum |
| Leiomyosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 8.6% 0.0% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/24 (0%) 1/18 (6%) 0/18 (0%) | 0/27 (0%) 0/35 (0%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | --- 681 --- | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.631 P=0.205 (e) | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.658N P=0.214 (e) | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.663 P=0.224 (e) | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.669 | (e) |
|FISHER EXACT | P=0.247 (e) | (e) (e) |
|=================================================================================================================================|
DATE: 09/08/94 EXPERIMENT: 05058 TEST: 01 PAGE 5
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ROXARSONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.005% 0.01% | UNTREATD 0.005% 0.01% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 3/50 (6%) 4/50 (8%) | 1/50 (2%) 2/50 (4%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 11.6% 12.0% | 2.9% 5.7% 0.0% |
|TERMINAL (d) | 0/24 (0%) 1/18 (6%) 0/18 (0%) | 0/27 (0%) 2/35 (6%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | --- 681 638 | 687 729 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.046 * P=0.102 P=0.063 | P=0.318N P=0.569 P=0.473N |
|INCIDENTAL TUMOR | P=0.078 P=0.111 P=0.102 | P=0.328N P=0.463 P=0.484N |
|LOGISTIC REGRESSION | P=0.049 * P=0.114 P=0.060 | P=0.335N P=0.518 P=0.502N |
|COCHRAN-ARMITAGE | P=0.049 * | P=0.360N |
|FISHER EXACT | P=0.121 P=0.059 | P=0.500 P=0.500N |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 7.3% 5.0% 0.0% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/24 (4%) 0/18 (0%) 0/18 (0%) | 0/27 (0%) 0/35 (0%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | 695 723 --- | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.184N P=0.579N P=0.292N | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.123N P=0.519N P=0.229N | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.154N P=0.535N P=0.246N | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.142N | (e) |
|FISHER EXACT | P=0.500N P=0.247N | (e) (e) |
|=================================================================================================================================|
DATE: 09/08/94 EXPERIMENT: 05058 TEST: 01 PAGE 6
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ROXARSONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.005% 0.01% | UNTREATD 0.005% 0.01% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 4/50 (8%) 4/50 (8%) | 1/50 (2%) 2/50 (4%) 0/50 (0%) |
|ADJUSTED (b) | 7.3% 16.1% 12.0% | 2.9% 5.7% 0.0% |
|TERMINAL (d) | 1/24 (4%) 1/18 (6%) 0/18 (0%) | 0/27 (0%) 2/35 (6%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | 695 681 638 | 687 729 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.233 P=0.264 P=0.299 | P=0.318N P=0.569 P=0.473N |
|INCIDENTAL TUMOR | P=0.370 P=0.310 P=0.428 | P=0.328N P=0.463 P=0.484N |
|LOGISTIC REGRESSION | P=0.274 P=0.307 P=0.337 | P=0.335N P=0.518 P=0.502N |
|COCHRAN-ARMITAGE | P=0.274 | P=0.360N |
|FISHER EXACT | P=0.339 P=0.339 | P=0.500 P=0.500N |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 3.1% 11.1% 5.6% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/24 (0%) 2/18 (11%) 1/18 (6%) | 0/27 (0%) 0/35 (0%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | 693 729 (T) 729 (T) | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.532 P=0.414 P=0.704 | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.579 P=0.440 P=0.755N | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.592 P=0.463 P=0.755 | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.622N | (e) |
|FISHER EXACT | P=0.500 P=0.753N | (e) (e) |
|=================================================================================================================================|
DATE: 09/08/94 EXPERIMENT: 05058 TEST: 01 PAGE 7
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ROXARSONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.005% 0.01% | UNTREATD 0.005% 0.01% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 7.2% 11.1% 5.6% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/24 (4%) 2/18 (11%) 1/18 (6%) | 0/27 (0%) 0/35 (0%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | 693 729 (T) 729 (T) | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.494N P=0.599 P=0.590N | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.451N P=0.621 P=0.525N | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.429N P=0.654 P=0.525N | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.390N | (e) |
|FISHER EXACT | P=0.691N P=0.500N | (e) (e) |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) | 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 4.6% 0.0% | 0.0% 2.9% 0.0% |
|TERMINAL (d) | 0/24 (0%) 0/18 (0%) 0/18 (0%) | 0/27 (0%) 1/35 (3%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | --- 580 --- | --- 729 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.657N P=0.234 (e) | P=0.714N P=0.552 (e) |
|INCIDENTAL TUMOR | P=0.683 P=0.328 (e) | P=0.714N P=0.552 (e) |
|LOGISTIC REGRESSION | P=0.604 P=0.204 (e) | P=0.714N P=0.552 (e) |
|COCHRAN-ARMITAGE | P=0.669 | P=0.731 |
|FISHER EXACT | P=0.247 (e) | P=0.500 (e) |
|=================================================================================================================================|
DATE: 09/08/94 EXPERIMENT: 05058 TEST: 01 PAGE 8
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ROXARSONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.005% 0.01% | UNTREATD 0.005% 0.01% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 6.1% 0.0% 4.5% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/24 (0%) 0/18 (0%) 0/18 (0%) | 0/27 (0%) 0/35 (0%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | 671 --- 723 | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.393N P=0.266N P=0.536N | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.266N P=0.223N P=0.373N | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.363N P=0.239N P=0.502N | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.360N | (e) |
|FISHER EXACT | P=0.247N P=0.500N | (e) (e) |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 1/50 (2%) | 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|ADJUSTED (b) | 6.1% 4.6% 4.5% | 0.0% 2.9% 0.0% |
|TERMINAL (d) | 0/24 (0%) 0/18 (0%) 0/18 (0%) | 0/27 (0%) 1/35 (3%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | 671 580 723 | --- 729 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.410N P=0.666 P=0.536N | P=0.714N P=0.552 (e) |
|INCIDENTAL TUMOR | P=0.309N P=0.610N P=0.373N | P=0.714N P=0.552 (e) |
|LOGISTIC REGRESSION | P=0.406N P=0.691 P=0.502N | P=0.714N P=0.552 (e) |
|COCHRAN-ARMITAGE | P=0.390N | P=0.731 |
|FISHER EXACT | P=0.691N P=0.500N | P=0.500 (e) |
|=================================================================================================================================|
DATE: 09/08/94 EXPERIMENT: 05058 TEST: 01 PAGE 9
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ROXARSONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.005% 0.01% | UNTREATD 0.005% 0.01% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 1/50 (2%) | 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|ADJUSTED (b) | 6.1% 4.6% 4.5% | 0.0% 2.9% 0.0% |
|TERMINAL (d) | 0/24 (0%) 0/18 (0%) 0/18 (0%) | 0/27 (0%) 1/35 (3%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | 671 580 723 | --- 729 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.410N P=0.666 P=0.536N | P=0.714N P=0.552 (e) |
|INCIDENTAL TUMOR | P=0.309N P=0.610N P=0.373N | P=0.714N P=0.552 (e) |
|LOGISTIC REGRESSION | P=0.406N P=0.691 P=0.502N | P=0.714N P=0.552 (e) |
|COCHRAN-ARMITAGE | P=0.390N | P=0.731 |
|FISHER EXACT | P=0.691N P=0.500N | P=0.500 (e) |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|ADJUSTED (b) | 8.3% 8.0% 0.0% | 0.0% 0.0% 3.1% |
|TERMINAL (d) | 2/24 (8%) 1/18 (6%) 0/18 (0%) | 0/27 (0%) 0/35 (0%) 1/32 (3%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 633 --- | --- --- 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.229N P=0.608 P=0.303N | P=0.286 (e) P=0.534 |
|INCIDENTAL TUMOR | P=0.227N P=0.655 P=0.303N | P=0.286 (e) P=0.534 |
|LOGISTIC REGRESSION | P=0.182N P=0.675 P=0.303N | P=0.286 (e) P=0.534 |
|COCHRAN-ARMITAGE | P=0.176N | P=0.269 |
|FISHER EXACT | P=0.691N P=0.247N | (e) P=0.500 |
|=================================================================================================================================|
DATE: 09/08/94 EXPERIMENT: 05058 TEST: 01 PAGE 10
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ROXARSONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.005% 0.01% | UNTREATD 0.005% 0.01% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | 4/50 (8%) 0/50 (0%) 1/50 (2%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% | 9.9% 0.0% 2.3% |
|TERMINAL (d) | 0/24 (0%) 0/18 (0%) 0/18 (0%) | 1/27 (4%) 0/35 (0%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- | 404 --- 678 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) | P=0.072N P=0.058N P=0.159N |
|INCIDENTAL TUMOR | (e) (e) (e) | P=0.074N P=0.048N* P=0.157N |
|LOGISTIC REGRESSION | (e) (e) (e) | P=0.078N P=0.054N P=0.183N |
|COCHRAN-ARMITAGE | (e) | P=0.082N |
|FISHER EXACT | (e) (e) | P=0.059N P=0.181N |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 3/50 (6%) | 21/50 (42%) 17/50 (34%) 21/50 (42%) |
|ADJUSTED (b) | 6.1% 0.0% 13.1% | 58.5% 42.5% 56.2% |
|TERMINAL (d) | 1/24 (4%) 0/18 (0%) 1/18 (6%) | 13/27 (48%) 12/35 (34%) 16/32 (50%) |
|FIRST INCIDENCE (DAYS) | 538 --- 695 | 526 685 685 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.332 P=0.276N P=0.422 | P=0.311N P=0.097N P=0.326N |
|INCIDENTAL TUMOR | P=0.399 P=0.151N P=0.513 | P=0.362N P=0.314N P=0.409N |
|LOGISTIC REGRESSION | P=0.390 P=0.244N P=0.498 | P=0.406N P=0.230N P=0.463N |
|COCHRAN-ARMITAGE | P=0.390 | P=0.541 |
|FISHER EXACT | P=0.247N P=0.500 | P=0.268N P=0.580N |
|=================================================================================================================================|
DATE: 09/08/94 EXPERIMENT: 05058 TEST: 01 PAGE 11
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ROXARSONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.005% 0.01% | UNTREATD 0.005% 0.01% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 3/50 (6%) | 24/50 (48%) 17/50 (34%) 22/50 (44%) |
|ADJUSTED (b) | 6.1% 0.0% 13.1% | 61.2% 42.5% 57.2% |
|TERMINAL (d) | 1/24 (4%) 0/18 (0%) 1/18 (6%) | 13/27 (48%) 12/35 (34%) 16/32 (50%) |
|FIRST INCIDENCE (DAYS) | 538 --- 695 | 404 685 678 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.332 P=0.276N P=0.422 | P=0.195N P=0.038N* P=0.212N |
|INCIDENTAL TUMOR | P=0.399 P=0.151N P=0.513 | P=0.218N P=0.132N P=0.258N |
|LOGISTIC REGRESSION | P=0.390 P=0.244N P=0.498 | P=0.320N P=0.105N P=0.392N |
|COCHRAN-ARMITAGE | P=0.390 | P=0.381N |
|FISHER EXACT | P=0.247N P=0.500 | P=0.111N P=0.421N |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip) |
| Papilloma Squamous or Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) | 1/50 (2%) 0/50 (0%) 1/50 (2%) |
|ADJUSTED (b) | 7.2% 0.0% 2.8% | 2.9% 0.0% 2.7% |
|TERMINAL (d) | 0/24 (0%) 0/18 (0%) 0/18 (0%) | 0/27 (0%) 0/35 (0%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | 703 --- 671 | 700 --- 723 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.395N P=0.270N P=0.541N | P=0.626N P=0.478N P=0.714N |
|INCIDENTAL TUMOR | P=0.266N P=0.223N P=0.373N | P=0.634N P=0.674N P=0.747N |
|LOGISTIC REGRESSION | P=0.362N P=0.253N P=0.501N | P=0.653N P=0.497N P=0.747N |
|COCHRAN-ARMITAGE | P=0.360N | P=0.669N |
|FISHER EXACT | P=0.247N P=0.500N | P=0.500N P=0.753N |
|=================================================================================================================================|
DATE: 09/08/94 EXPERIMENT: 05058 TEST: 01 PAGE 12
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ROXARSONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.005% 0.01% | UNTREATD 0.005% 0.01% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip) |
| Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) | 1/50 (2%) 0/50 (0%) 1/50 (2%) |
|ADJUSTED (b) | 7.2% 0.0% 2.8% | 2.9% 0.0% 2.7% |
|TERMINAL (d) | 0/24 (0%) 0/18 (0%) 0/18 (0%) | 0/27 (0%) 0/35 (0%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | 703 --- 671 | 700 --- 723 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.395N P=0.270N P=0.541N | P=0.626N P=0.478N P=0.714N |
|INCIDENTAL TUMOR | P=0.266N P=0.223N P=0.373N | P=0.634N P=0.674N P=0.747N |
|LOGISTIC REGRESSION | P=0.362N P=0.253N P=0.501N | P=0.653N P=0.497N P=0.747N |
|COCHRAN-ARMITAGE | P=0.360N | P=0.669N |
|FISHER EXACT | P=0.247N P=0.500N | P=0.500N P=0.753N |
|=================================================================================================================================|
| |
|Pancreas |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 5/50 (10%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 4.2% 5.6% 18.8% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/24 (4%) 1/18 (6%) 1/18 (6%) | 0/27 (0%) 0/35 (0%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 664 | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.035 * P=0.697 P=0.075 | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.061 P=0.697 P=0.136 | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.046 * P=0.697 P=0.099 | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.049 * | (e) |
|FISHER EXACT | P=0.753N P=0.102 | (e) (e) |
|=================================================================================================================================|
DATE: 09/08/94 EXPERIMENT: 05058 TEST: 01 PAGE 13
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ROXARSONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.005% 0.01% | UNTREATD 0.005% 0.01% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Pharynx |
| Squamous Cell Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) | 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 7.2% 0.0% 2.8% | 2.9% 0.0% 0.0% |
|TERMINAL (d) | 0/24 (0%) 0/18 (0%) 0/18 (0%) | 0/27 (0%) 0/35 (0%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | 703 --- 671 | 700 --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.395N P=0.270N P=0.541N | P=0.250N P=0.478N P=0.473N |
|INCIDENTAL TUMOR | P=0.266N P=0.223N P=0.373N | P=0.279N P=0.674N P=0.484N |
|LOGISTIC REGRESSION | P=0.362N P=0.253N P=0.501N | P=0.265N P=0.497N P=0.495N |
|COCHRAN-ARMITAGE | P=0.360N | P=0.269N |
|FISHER EXACT | P=0.247N P=0.500N | P=0.500N P=0.500N |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 13/48 (27%) 8/48 (17%) | 27/50 (54%) 28/49 (57%) 18/48 (38%) |
|ADJUSTED (b) | 21.4% 49.3% 34.4% | 69.5% 67.7% 46.5% |
|TERMINAL (d) | 4/24 (17%) 7/18 (39%) 4/17 (24%) | 16/27 (59%) 21/34 (62%) 11/31 (35%) |
|FIRST INCIDENCE (DAYS) | 616 495 671 | 485 486 678 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.188 P=0.026 * P=0.224 | P=0.019N* P=0.320N P=0.025N* |
|INCIDENTAL TUMOR | P=0.266 P=0.044 * P=0.323 | P=0.031N* P=0.576 P=0.043N* |
|LOGISTIC REGRESSION | P=0.307 P=0.049 * P=0.325 | P=0.049N* P=0.463 P=0.060N |
|COCHRAN-ARMITAGE | P=0.313 | P=0.065N |
|FISHER EXACT | P=0.051 P=0.355 | P=0.455 P=0.075N |
|=================================================================================================================================|
DATE: 09/08/94 EXPERIMENT: 05058 TEST: 01 PAGE 14
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ROXARSONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.005% 0.01% | UNTREATD 0.005% 0.01% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 13/48 (27%) 8/48 (17%) | 28/50 (56%) 28/49 (57%) 18/48 (38%) |
|ADJUSTED (b) | 21.4% 49.3% 34.4% | 70.4% 67.7% 46.5% |
|TERMINAL (d) | 4/24 (17%) 7/18 (39%) 4/17 (24%) | 16/27 (59%) 21/34 (62%) 11/31 (35%) |
|FIRST INCIDENCE (DAYS) | 616 495 671 | 485 486 678 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.188 P=0.026 * P=0.224 | P=0.013N* P=0.260N P=0.017N* |
|INCIDENTAL TUMOR | P=0.266 P=0.044 * P=0.323 | P=0.019N* P=0.541N P=0.027N* |
|LOGISTIC REGRESSION | P=0.307 P=0.049 * P=0.325 | P=0.032N* P=0.544 P=0.039N* |
|COCHRAN-ARMITAGE | P=0.313 | P=0.043N* |
|FISHER EXACT | P=0.051 P=0.355 | P=0.535 P=0.051N |
|=================================================================================================================================|
| |
|Skin |
| Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 4/50 (8%) 4/50 (8%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 13.3% 13.7% 13.7% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/24 (8%) 1/18 (6%) 1/18 (6%) | 0/27 (0%) 0/35 (0%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | 651 633 651 | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.504 P=0.558 P=0.572 | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.504N P=0.629 P=0.579N | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.571N P=0.637 P=0.642N | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.573 | (e) |
|FISHER EXACT | P=0.643N P=0.643N | (e) (e) |
|=================================================================================================================================|
DATE: 09/08/94 EXPERIMENT: 05058 TEST: 01 PAGE 15
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ROXARSONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.005% 0.01% | UNTREATD 0.005% 0.01% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|ADJUSTED (b) | 2.1% 0.0% 11.1% | 0.0% 0.0% 3.1% |
|TERMINAL (d) | 0/24 (0%) 0/18 (0%) 2/18 (11%) | 0/27 (0%) 0/35 (0%) 1/32 (3%) |
|FIRST INCIDENCE (DAYS) | 564 --- 729 (T) | --- --- 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.312 P=0.504N P=0.434 | P=0.286 (e) P=0.534 |
|INCIDENTAL TUMOR | P=0.307 P=0.419N P=0.434 | P=0.286 (e) P=0.534 |
|LOGISTIC REGRESSION | P=0.357 P=0.559N P=0.494 | P=0.286 (e) P=0.534 |
|COCHRAN-ARMITAGE | P=0.360 | P=0.269 |
|FISHER EXACT | P=0.500N P=0.500 | (e) P=0.500 |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|ADJUSTED (b) | 0.0% 0.0% 11.1% | 0.0% 0.0% 3.1% |
|TERMINAL (d) | 0/24 (0%) 0/18 (0%) 2/18 (11%) | 0/27 (0%) 0/35 (0%) 1/32 (3%) |
|FIRST INCIDENCE (DAYS) | --- --- 729 (T) | --- --- 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.072 (e) P=0.176 | P=0.286 (e) P=0.534 |
|INCIDENTAL TUMOR | P=0.072 (e) P=0.176 | P=0.286 (e) P=0.534 |
|LOGISTIC REGRESSION | P=0.072 (e) P=0.176 | P=0.286 (e) P=0.534 |
|COCHRAN-ARMITAGE | P=0.095 | P=0.269 |
|FISHER EXACT | (e) P=0.247 | (e) P=0.500 |
|=================================================================================================================================|
DATE: 09/08/94 EXPERIMENT: 05058 TEST: 01 PAGE 16
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ROXARSONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.005% 0.01% | UNTREATD 0.005% 0.01% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma, |
| Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 5/50 (10%) 6/50 (12%) | 0/50 (0%) 1/50 (2%) 2/50 (4%) |
|ADJUSTED (b) | 15.1% 18.8% 23.8% | 0.0% 2.9% 6.3% |
|TERMINAL (d) | 2/24 (8%) 2/18 (11%) 3/18 (17%) | 0/27 (0%) 1/35 (3%) 2/32 (6%) |
|FIRST INCIDENCE (DAYS) | 564 633 651 | --- 729 (T) 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.347 P=0.532 P=0.404 | P=0.161 P=0.552 P=0.276 |
|INCIDENTAL TUMOR | P=0.458 P=0.624 P=0.523 | P=0.161 P=0.552 P=0.276 |
|LOGISTIC REGRESSION | P=0.438 P=0.631 P=0.501 | P=0.161 P=0.552 P=0.276 |
|COCHRAN-ARMITAGE | P=0.436 | P=0.142 |
|FISHER EXACT | P=0.630N P=0.500 | P=0.500 P=0.247 |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Fibroma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 3/50 (6%) | 1/50 (2%) 0/50 (0%) 1/50 (2%) |
|ADJUSTED (b) | 3.1% 5.6% 12.1% | 3.7% 0.0% 3.1% |
|TERMINAL (d) | 0/24 (0%) 1/18 (6%) 1/18 (6%) | 1/27 (4%) 0/35 (0%) 1/32 (3%) |
|FIRST INCIDENCE (DAYS) | 693 729 (T) 581 | 729 (T) --- 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.159 P=0.709 P=0.249 | P=0.638N P=0.448N P=0.724N |
|INCIDENTAL TUMOR | P=0.211 P=0.736 P=0.345 | P=0.638N P=0.448N P=0.724N |
|LOGISTIC REGRESSION | P=0.203 P=0.746 P=0.304 | P=0.638N P=0.448N P=0.724N |
|COCHRAN-ARMITAGE | P=0.202 | P=0.669N |
|FISHER EXACT | P=0.753N P=0.309 | P=0.500N P=0.753N |
|=================================================================================================================================|
DATE: 09/08/94 EXPERIMENT: 05058 TEST: 01 PAGE 17
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ROXARSONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.005% 0.01% | UNTREATD 0.005% 0.01% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Fibrosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 1/50 (2%) | 1/50 (2%) 1/50 (2%) 0/50 (0%) |
|ADJUSTED (b) | 8.3% 5.6% 2.2% | 2.0% 2.3% 0.0% |
|TERMINAL (d) | 2/24 (8%) 1/18 (6%) 0/18 (0%) | 0/27 (0%) 0/35 (0%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 630 | 404 581 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.446N P=0.601N P=0.559N | P=0.335N P=0.753 P=0.504N |
|INCIDENTAL TUMOR | P=0.450N P=0.601N P=0.566N | P=0.500N P=0.750 P=0.500N |
|LOGISTIC REGRESSION | P=0.385N P=0.601N P=0.500N | P=0.268N P=0.745 P=0.323N |
|COCHRAN-ARMITAGE | P=0.378N | P=0.331N |
|FISHER EXACT | P=0.500N P=0.500N | P=0.753N P=0.500N |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Neurofibrosarcoma, Fibrosarcoma, Sarcoma, |
| Neurofibroma, or Fibroma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 2/50 (4%) 4/50 (8%) | 3/50 (6%) 1/50 (2%) 1/50 (2%) |
|ADJUSTED (b) | 11.2% 11.1% 14.1% | 9.3% 2.3% 3.1% |
|TERMINAL (d) | 2/24 (8%) 2/18 (11%) 1/18 (6%) | 2/27 (7%) 0/35 (0%) 1/32 (3%) |
|FIRST INCIDENCE (DAYS) | 693 729 (T) 581 | 404 581 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.323 P=0.620N P=0.409 | P=0.177N P=0.269N P=0.264N |
|INCIDENTAL TUMOR | P=0.376 P=0.599N P=0.489 | P=0.245N P=0.272N P=0.262N |
|LOGISTIC REGRESSION | P=0.415 P=0.558N P=0.501 | P=0.215N P=0.311N P=0.324N |
|COCHRAN-ARMITAGE | P=0.417 | P=0.202N |
|FISHER EXACT | P=0.500N P=0.500 | P=0.309N P=0.309N |
|=================================================================================================================================|
DATE: 09/08/94 EXPERIMENT: 05058 TEST: 01 PAGE 18
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ROXARSONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.005% 0.01% | UNTREATD 0.005% 0.01% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Neurofibrosarcoma, Fibrosarcoma, or Sarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 1/50 (2%) | 2/50 (4%) 1/50 (2%) 0/50 (0%) |
|ADJUSTED (b) | 8.3% 5.6% 2.2% | 5.6% 2.3% 0.0% |
|TERMINAL (d) | 2/24 (8%) 1/18 (6%) 0/18 (0%) | 1/27 (4%) 0/35 (0%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 630 | 404 581 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.446N P=0.601N P=0.559N | P=0.135N P=0.478N P=0.223N |
|INCIDENTAL TUMOR | P=0.450N P=0.601N P=0.566N | P=0.203N P=0.487N P=0.221N |
|LOGISTIC REGRESSION | P=0.385N P=0.601N P=0.500N | P=0.134N P=0.518N P=0.231N |
|COCHRAN-ARMITAGE | P=0.378N | P=0.142N |
|FISHER EXACT | P=0.500N P=0.500N | P=0.500N P=0.247N |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 46/50 (92%) 48/50 (96%) 43/50 (86%) | |
|ADJUSTED (b) | 100.0% 100.0% 93.0% | |
|TERMINAL (d) | 24/24 (100%) 18/18 (100%) 15/18 (83%) | |
|FIRST INCIDENCE (DAYS) | 538 495 534 | |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.322 P=0.099 P=0.352 | |
|INCIDENTAL TUMOR | P=0.118N P=0.343 P=0.199N | |
|LOGISTIC REGRESSION | P=0.138N P=0.332 P=0.212N | |
|COCHRAN-ARMITAGE | P=0.187N | |
|FISHER EXACT | P=0.339 P=0.262N | |
|=================================================================================================================================|
DATE: 09/08/94 EXPERIMENT: 05058 TEST: 01 PAGE 19
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ROXARSONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.005% 0.01% | UNTREATD 0.005% 0.01% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 2/50 (4%) 3/50 (6%) | 8/50 (16%) 6/50 (12%) 9/50 (18%) |
|ADJUSTED (b) | 15.7% 7.8% 11.6% | 25.4% 16.4% 28.1% |
|TERMINAL (d) | 3/24 (13%) 0/18 (0%) 1/18 (6%) | 5/27 (19%) 5/35 (14%) 9/32 (28%) |
|FIRST INCIDENCE (DAYS) | 710 637 678 | 630 685 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.506N P=0.441N P=0.606N | P=0.538N P=0.241N P=0.569N |
|INCIDENTAL TUMOR | P=0.401N P=0.364N P=0.505N | P=0.513 P=0.409N P=0.557 |
|LOGISTIC REGRESSION | P=0.429N P=0.372N P=0.525N | P=0.553N P=0.344N P=0.587N |
|COCHRAN-ARMITAGE | P=0.417N | P=0.445 |
|FISHER EXACT | P=0.339N P=0.500N | P=0.387N P=0.500 |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 2/50 (4%) | 2/50 (4%) 4/50 (8%) 1/50 (2%) |
|ADJUSTED (b) | 4.2% 7.8% 5.1% | 5.4% 11.4% 3.1% |
|TERMINAL (d) | 1/24 (4%) 1/18 (6%) 0/18 (0%) | 0/27 (0%) 4/35 (11%) 1/32 (3%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 625 647 | 582 729 (T) 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.357 P=0.434 P=0.470 | P=0.344N P=0.427 P=0.456N |
|INCIDENTAL TUMOR | P=0.402 P=0.480 P=0.551 | P=0.442N P=0.309 P=0.656N |
|LOGISTIC REGRESSION | P=0.389 P=0.491 P=0.499 | P=0.383N P=0.346 P=0.510N |
|COCHRAN-ARMITAGE | P=0.390 | P=0.406N |
|FISHER EXACT | P=0.500 P=0.500 | P=0.339 P=0.500N |
|=================================================================================================================================|
DATE: 09/08/94 EXPERIMENT: 05058 TEST: 01 PAGE 20
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ROXARSONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.005% 0.01% | UNTREATD 0.005% 0.01% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 4/50 (8%) 5/50 (10%) | 10/50 (20%) 10/50 (20%) 10/50 (20%) |
|ADJUSTED (b) | 19.8% 15.0% 16.1% | 29.5% 27.6% 31.3% |
|TERMINAL (d) | 4/24 (17%) 1/18 (6%) 1/18 (6%) | 5/27 (19%) 9/35 (26%) 10/32 (31%) |
|FIRST INCIDENCE (DAYS) | 710 625 647 | 582 685 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.472 P=0.626N P=0.523 | P=0.399N P=0.400N P=0.446N |
|INCIDENTAL TUMOR | P=0.547N P=0.535N P=0.609N | P=0.509N P=0.563 P=0.592 |
|LOGISTIC REGRESSION | P=0.566 P=0.536N P=0.623 | P=0.439N P=0.563N P=0.509N |
|COCHRAN-ARMITAGE | P=0.568 | P=0.550 |
|FISHER EXACT | P=0.500N P=0.630N | P=0.598N P=0.598N |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) | 1/50 (2%) 0/50 (0%) 1/50 (2%) |
|ADJUSTED (b) | 0.0% 0.0% 7.7% | 2.8% 0.0% 3.1% |
|TERMINAL (d) | 0/24 (0%) 0/18 (0%) 1/18 (6%) | 0/27 (0%) 0/35 (0%) 1/32 (3%) |
|FIRST INCIDENCE (DAYS) | --- --- 634 | 686 --- 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.090 (e) P=0.213 | P=0.639N P=0.484N P=0.727N |
|INCIDENTAL TUMOR | P=0.077 (e) P=0.208 | P=0.634N P=0.674N P=0.732N |
|LOGISTIC REGRESSION | P=0.095 (e) P=0.237 | P=0.657N P=0.500N P=0.752N |
|COCHRAN-ARMITAGE | P=0.095 | P=0.669N |
|FISHER EXACT | (e) P=0.247 | P=0.500N P=0.753N |
|=================================================================================================================================|
DATE: 09/08/94 EXPERIMENT: 05058 TEST: 01 PAGE 21
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ROXARSONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.005% 0.01% | UNTREATD 0.005% 0.01% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Uterus |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # |
|----------- | | |
|OVERALL (a) | | 1/50 (2%) 2/50 (4%) 1/50 (2%) |
|ADJUSTED (b) | | 2.8% 5.7% 2.9% |
|TERMINAL (d) | | 0/27 (0%) 2/35 (6%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | | 686 729 (T) 727 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.572N P=0.569 P=0.724N |
|INCIDENTAL TUMOR | | P=0.577N P=0.463 P=0.747N |
|LOGISTIC REGRESSION | | P=0.587N P=0.518 P=0.753N |
|COCHRAN-ARMITAGE | | P=0.622N |
|FISHER EXACT | | P=0.500 P=0.753N |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # |
|----------- | | |
|OVERALL (a) | | 10/50 (20%) 18/50 (36%) 13/50 (26%) |
|ADJUSTED (b) | | 28.3% 44.0% 34.4% |
|TERMINAL (d) | | 5/27 (19%) 13/35 (37%) 9/32 (28%) |
|FIRST INCIDENCE (DAYS) | | 404 481 517 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.440 P=0.170 P=0.471 |
|INCIDENTAL TUMOR | | P=0.212 P=0.077 P=0.235 |
|LOGISTIC REGRESSION | | P=0.266 P=0.057 P=0.291 |
|COCHRAN-ARMITAGE | | P=0.287 |
|FISHER EXACT | | P=0.059 P=0.318 |
|=================================================================================================================================|
DATE: 09/08/94 EXPERIMENT: 05058 TEST: 01 PAGE 22
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ROXARSONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.005% 0.01% | UNTREATD 0.005% 0.01% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Uterus |
| Sarcoma Stromal or Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # |
|----------- | | |
|OVERALL (a) | | 10/50 (20%) 18/50 (36%) 14/50 (28%) |
|ADJUSTED (b) | | 28.3% 44.0% 36.1% |
|TERMINAL (d) | | 5/27 (19%) 13/35 (37%) 9/32 (28%) |
|FIRST INCIDENCE (DAYS) | | 404 481 517 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.365 P=0.170 P=0.396 |
|INCIDENTAL TUMOR | | P=0.157 P=0.077 P=0.174 |
|LOGISTIC REGRESSION | | P=0.200 P=0.057 P=0.219 |
|COCHRAN-ARMITAGE | | P=0.218 |
|FISHER EXACT | | P=0.059 P=0.241 |
|=================================================================================================================================|
| |
|Zymbal's Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 1/50 (2%) | 0/50 (0%) 1/50 (2%) 1/50 (2%) |
|ADJUSTED (b) | 4.6% 3.2% 2.3% | 0.0% 2.4% 2.0% |
|TERMINAL (d) | 0/24 (0%) 0/18 (0%) 0/18 (0%) | 0/27 (0%) 0/35 (0%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | 581 681 637 | --- 608 407 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.374N P=0.521N P=0.486N | P=0.341 P=0.490 P=0.500 |
|INCIDENTAL TUMOR | P=0.315N P=0.439N P=0.458N | P=0.157 P=0.388 P=0.500 |
|LOGISTIC REGRESSION | P=0.423N P=0.512N P=0.568N | P=0.361 P=0.492 P=0.663 |
|COCHRAN-ARMITAGE | P=0.378N | P=0.331 |
|FISHER EXACT | P=0.500N P=0.500N | P=0.500 P=0.500 |
|=================================================================================================================================|
DATE: 09/08/94 EXPERIMENT: 05058 TEST: 01 PAGE 23
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ROXARSONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.005% 0.01% | UNTREATD 0.005% 0.01% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, |
| or Undifferentiated |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 27/50 (54%) 28/50 (56%) 25/50 (50%) | 14/50 (28%) 12/50 (24%) 11/50 (22%) |
|ADJUSTED (b) | 64.1% 71.1% 68.7% | 34.1% 26.7% 26.0% |
|TERMINAL (d) | 10/24 (42%) 8/18 (44%) 9/18 (50%) | 3/27 (11%) 4/35 (11%) 4/32 (13%) |
|FIRST INCIDENCE (DAYS) | 538 535 534 | 582 481 517 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.445 P=0.274 P=0.478 | P=0.201N P=0.325N P=0.221N |
|INCIDENTAL TUMOR | P=0.285N P=0.525N P=0.338N | P=0.548N P=0.386 P=0.551 |
|LOGISTIC REGRESSION | P=0.387N P=0.558 P=0.428N | P=0.444 P=0.565 P=0.490 |
|COCHRAN-ARMITAGE | P=0.382N | P=0.281N |
|FISHER EXACT | P=0.500 P=0.421N | P=0.410N P=0.322N |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma Benign, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 4.2% 4.2% 5.6% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/24 (4%) 0/18 (0%) 0/18 (0%) | 0/27 (0%) 0/35 (0%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 710 651 | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.349 P=0.715 P=0.466 | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.445 P=0.736 P=0.551 | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.379 P=0.738 P=0.501 | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.378 | (e) |
|FISHER EXACT | P=0.753N P=0.500 | (e) (e) |
|=================================================================================================================================|
DATE: 09/08/94 EXPERIMENT: 05058 TEST: 01 PAGE 24
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ROXARSONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.005% 0.01% | UNTREATD 0.005% 0.01% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Osteosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|ADJUSTED (b) | 7.5% 0.0% 0.0% | 0.0% 0.0% 5.8% |
|TERMINAL (d) | 0/24 (0%) 0/18 (0%) 0/18 (0%) | 0/27 (0%) 0/35 (0%) 1/32 (3%) |
|FIRST INCIDENCE (DAYS) | 283 --- --- | --- --- 724 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.041N* P=0.133N P=0.130N | P=0.112 (e) P=0.287 |
|INCIDENTAL TUMOR | P=0.065N P=0.223N P=0.161N | P=0.121 (e) P=0.268 |
|LOGISTIC REGRESSION | P=0.061N P=0.146N P=0.196N | P=0.112 (e) P=0.280 |
|COCHRAN-ARMITAGE | P=0.037N* | P=0.095 |
|FISHER EXACT | P=0.121N P=0.121N | (e) P=0.247 |
|=================================================================================================================================|
| |
|All Organs |
| Osteosarcoma or Osteoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|ADJUSTED (b) | 7.5% 0.0% 0.0% | 0.0% 0.0% 5.8% |
|TERMINAL (d) | 0/24 (0%) 0/18 (0%) 0/18 (0%) | 0/27 (0%) 0/35 (0%) 1/32 (3%) |
|FIRST INCIDENCE (DAYS) | 283 --- --- | --- --- 724 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.041N* P=0.133N P=0.130N | P=0.112 (e) P=0.287 |
|INCIDENTAL TUMOR | P=0.065N P=0.223N P=0.161N | P=0.121 (e) P=0.268 |
|LOGISTIC REGRESSION | P=0.061N P=0.146N P=0.196N | P=0.112 (e) P=0.280 |
|COCHRAN-ARMITAGE | P=0.037N* | P=0.095 |
|FISHER EXACT | P=0.121N P=0.121N | (e) P=0.247 |
|=================================================================================================================================|
DATE: 09/08/94 EXPERIMENT: 05058 TEST: 01 PAGE 25
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ROXARSONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.005% 0.01% | UNTREATD 0.005% 0.01% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 47/50 (94%) 50/50 (100%) 50/50 (100%) | 44/50 (88%) 44/50 (88%) 42/50 (84%) |
|ADJUSTED (b) | 100.0% 100.0% 100.0% | 91.6% 93.6% 91.2% |
|TERMINAL (d) | 24/24 (100%) 18/18 (100%) 18/18 (100%) | 23/27 (85%) 32/35 (91%) 28/32 (88%) |
|FIRST INCIDENCE (DAYS) | 538 495 534 | 404 481 517 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.099 P=0.082 P=0.101 | P=0.104N P=0.134N P=0.119N |
|INCIDENTAL TUMOR | P=0.073 P=0.190 P=0.200 | P=0.189N P=0.608N P=0.303N |
|LOGISTIC REGRESSION | P=0.066 P=0.138 P=0.214 | P=0.286N P=0.615N P=0.340N |
|COCHRAN-ARMITAGE | P=0.037 * | P=0.330N |
|FISHER EXACT | P=0.121 P=0.121 | P=0.620N P=0.387N |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 36/50 (72%) 35/50 (70%) 33/50 (66%) | 21/50 (42%) 20/50 (40%) 20/50 (40%) |
|ADJUSTED (b) | 77.6% 78.7% 75.7% | 47.7% 42.6% 44.3% |
|TERMINAL (d) | 14/24 (58%) 9/18 (50%) 9/18 (50%) | 6/27 (22%) 9/35 (26%) 8/32 (25%) |
|FIRST INCIDENCE (DAYS) | 283 496 534 | 404 481 407 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.463 P=0.335 P=0.491 | P=0.305N P=0.352N P=0.317N |
|INCIDENTAL TUMOR | P=0.197N P=0.385N P=0.244N | P=0.356 P=0.336 P=0.440 |
|LOGISTIC REGRESSION | P=0.278N P=0.459N P=0.294N | P=0.317 P=0.549N P=0.377 |
|COCHRAN-ARMITAGE | P=0.294N | P=0.459N |
|FISHER EXACT | P=0.500N P=0.333N | P=0.500N P=0.500N |
|=================================================================================================================================|
DATE: 09/08/94 EXPERIMENT: 05058 TEST: 01 PAGE 26
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ROXARSONE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.005% 0.01% | UNTREATD 0.005% 0.01% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 50/50 (100%) 50/50 (100%) 50/50 (100%) | 48/50 (96%) 47/50 (94%) 46/50 (92%) |
|ADJUSTED (b) | 100.0% 100.0% 100.0% | 96.0% 94.0% 93.9% |
|TERMINAL (d) | 24/24 (100%) 18/18 (100%) 18/18 (100%) | 25/27 (93%) 32/35 (91%) 29/32 (91%) |
|FIRST INCIDENCE (DAYS) | 283 495 534 | 404 481 407 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.189 P=0.166 P=0.199 | P=0.103N P=0.106N P=0.109N |
|INCIDENTAL TUMOR | (e) (e) (e) | P=0.319N P=0.618N P=0.404N |
|LOGISTIC REGRESSION | (e) (e) (e) | P=0.265N P=0.618N P=0.320N |
|COCHRAN-ARMITAGE | (e) | P=0.264N |
|FISHER EXACT | P=1.000N P=1.000N | P=0.500N P=0.339N |
|=================================================================================================================================|
(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).
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