TDMS Study 05021-03 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst CI PIGMENT RED 23 DATE: 09/03/94
EXPERIMENT: 05021 TEST: 03 TIME: 21:21:19
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01ES9565102 ROUTE: DOSED FEED NTP C#: 60377
PATHOLOGIST: P. HILDEBRANDT S. EUSTIS CAS: 6471-49-4
------------------------------------------------------------------------------------------------------------------------------------
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst CI PIGMENT RED 23 DATE: 09/03/94
EXPERIMENT: 05021 TEST: 03 TIME: 21:21:19
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01ES9565102 ROUTE: DOSED FEED NTP C#: 60377
PATHOLOGIST: P. HILDEBRANDT S. EUSTIS CAS: 6471-49-4
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 CI PIGMENT RED 23 DATE: 09/03/94
EXPERIMENT: 05021 TEST: 03 TIME: 21:21:19
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01ES9565102 ROUTE: DOSED FEED NTP C#: 60377
PATHOLOGIST: P. HILDEBRANDT S. EUSTIS CAS: 6471-49-4
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF THE STUDY OF CI PIGMENT RED 23
====================================================================================================
MALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Adrenal Medulla Pheochromocytoma Benign
Pheochromocytoma: Benign, Complex, Malignant, NOS
Brain Astrocytoma NOS
Clitoral/Preputial Gland Adenoma
Carcinoma or Adenoma
Islets, Pancreatic Carcinoma
Carcinoma or Adenoma
Kidney: Renal Tubule Adenoma
Carcinoma or Adenoma
Mammary Gland Fibroma
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
Carcinoma or Adenoma
Skin Basal Cell Carcinoma
Skin: Subcutaneous Tissue Neurofibrosarcoma, Fibrosarcoma, Sarcoma,
Neurofibroma, or Fibroma
Testes Adenoma
All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear,
or Undifferentiated
Mesothelioma Benign, Malignant, NOS
Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
====================================================================================================
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst CI PIGMENT RED 23 DATE: 09/03/94
EXPERIMENT: 05021 TEST: 03 TIME: 21:21:19
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01ES9565102 ROUTE: DOSED FEED NTP C#: 60377
PATHOLOGIST: P. HILDEBRANDT S. EUSTIS CAS: 6471-49-4
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF THE STUDY OF CI PIGMENT RED 23
====================================================================================================
FEMALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Clitoral/Preputial Gland Carcinoma or Adenoma
Islets, Pancreatic Carcinoma or Adenoma
Lung Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
Mammary Gland Fibroadenoma
Fibroma, Fibroadenoma or Adenoma
Fibroma, Fibroadenoma, Carcinoma, or Adenoma
Ovary Thecoma NOS
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
Carcinoma or Adenoma
Thyroid Gland: Follicular Cell
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: 09/03/94 EXPERIMENT: 05021 TEST: 03 PAGE 1
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 23
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 1.0% 2.5% 5.0% | UNTREATD 1.0% 2.5% 5.0% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/48 (2%) 0/2 (0%) 0/0 (0%) 0/50 (0%) | 2/50 (4%) 0/1 (0%) 0/0 (0%) 2/50 (4%) |
|ADJUSTED (b) | 4.0% 0.0% 0.0% 0.0% | 6.9% 0.0% 0.0% 5.0% |
|TERMINAL (d) | 0/22 (0%) 0/0 0/0 0/35 (0%) | 2/29 (7%) 0/1 (0%) 0/0 2/40 (5%) |
|FIRST INCIDENCE (DAYS) | 707 --- --- --- | 729 (T) --- --- 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.276N P=0.445N P=0.416N P=0.422N | P=0.480N P=0.959N (e) P=0.574N |
|INCIDENTAL TUMOR | P=0.318N P=0.892N (e) P=0.500N | P=0.480N P=0.959N (e) P=0.574N |
|LOGISTIC REGRESSION | P=0.318N P=0.892N (e) P=0.500N | P=0.480N P=0.959N (e) P=0.574N |
|COCHRAN-ARMITAGE | P=0.304N | P=0.596 |
|FISHER EXACT | P=0.960N P=1.000N P=0.490N | P=0.961N P=1.000N P=0.691N |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 30/48 (63%) 4/6 (67%) 3/5 (60%) 26/50 (52%) | 4/49 (8%) 0/1 (0%) 0/1 (0%) 6/50 (12%) |
|ADJUSTED (b) | 77.8% 75.6% 67.4% 59.8% | 10.9% 0.0% 0.0% 15.0% |
|TERMINAL (d) | 14/22 (64%) 3/4 (75%) 2/3 (67%) 18/35 (51%) | 2/29 (7%) 0/1 (0%) 0/0 6/40 (15%) |
|FIRST INCIDENCE (DAYS) | 502 592 617 513 | 378 --- --- 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.034N* P<0.001N** P<0.001N** P=0.014N* | P=0.419 P=0.216N P=0.240N P=0.545 |
|INCIDENTAL TUMOR | P=0.157N P=0.650 P=0.603N P=0.181N | P=0.421 P=0.959N P=0.814N P=0.502 |
|LOGISTIC REGRESSION | P=0.132N P=0.653 P=0.603N P=0.156N | P=0.288 P=0.974N P=0.915N P=0.356 |
|COCHRAN-ARMITAGE | P=0.157N | P=0.312 |
|FISHER EXACT | P=0.609 P=0.632N P=0.199N | P=0.920N P=0.920N P=0.383 |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05021 TEST: 03 PAGE 2
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 23
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 1.0% 2.5% 5.0% | UNTREATD 1.0% 2.5% 5.0% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 30/48 (63%) 4/6 (67%) 5/5 (100%) 26/50 (52%) | 5/49 (10%) 1/1 (100%) 1/1 (100%) 6/50 (12%) |
|ADJUSTED (b) | 77.8% 75.6% 100.0% 59.8% | 14.2% 100.0% 0.0% 15.0% |
|TERMINAL (d) | 14/22 (64%) 3/4 (75%) 3/3 (100%) 18/35 (51%) | 3/29 (10%) 1/1 (100%) 0/0 6/40 (15%) |
|FIRST INCIDENCE (DAYS) | 502 592 617 513 | 378 729 (T) 595 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.033N* P<0.001N** P=0.001N** P=0.014N* | P=0.476N P=0.670N P=0.492N P=0.564N |
|INCIDENTAL TUMOR | P=0.148N P=0.650 P=0.143 P=0.181N | P=0.444N P=0.140 P=0.362 P=0.606N |
|LOGISTIC REGRESSION | P=0.121N P=0.653 P=0.148 P=0.156N | P=0.496 P=0.096 P=0.151 P=0.503 |
|COCHRAN-ARMITAGE | P=0.157N | P=0.518 |
|FISHER EXACT | P=0.609 P=0.113 P=0.199N | P=0.120 P=0.120 P=0.514 |
|=================================================================================================================================|
| |
|Brain |
| Astrocytoma NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/3 (33%) 0/4 (0%) 2/50 (4%) | 0/50 (0%) 1/5 (20%) 0/3 (0%) 3/50 (6%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 5.5% | 0.0% 0.0% 0.0% 7.2% |
|TERMINAL (d) | 0/22 (0%) 0/0 0/2 (0%) 1/35 (3%) | 0/29 (0%) 0/0 0/0 2/40 (5%) |
|FIRST INCIDENCE (DAYS) | --- 686 --- 718 | --- 673 --- 627 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.294 P=0.559 (e) P=0.348 | P=0.146 P=0.531 (e) P=0.172 |
|INCIDENTAL TUMOR | P=0.309 P=0.227 (e) P=0.290 | P=0.113 P=0.282 (e) P=0.174 |
|LOGISTIC REGRESSION | P=0.357 P=0.014 * (e) P=0.321 | P=0.150 P=0.065 (e) P=0.124 |
|COCHRAN-ARMITAGE | P=0.283 | P=0.146 |
|FISHER EXACT | P=0.057 (e) P=0.247 | P=0.091 (e) P=0.121 |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05021 TEST: 03 PAGE 3
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 23
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 1.0% 2.5% 5.0% | UNTREATD 1.0% 2.5% 5.0% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Brain |
| Oligodendroglioma, Glioma, or Astrocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/3 (0%) 1/4 (25%) 0/50 (0%) | 2/50 (4%) 1/5 (20%) 0/3 (0%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 2.0% 0.0% | 4.6% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/22 (0%) 0/0 0/2 (0%) 0/35 (0%) | 0/29 (0%) 0/0 0/0 0/40 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 479 --- | 249 407 --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.680 (e) P=0.504 (e) | P=0.101N P=0.483N P=0.237N P=0.231N |
|INCIDENTAL TUMOR | P=0.657 (e) P=0.227 (e) | P=0.485N P=0.442 P=0.718N P=0.909N |
|LOGISTIC REGRESSION | P=0.612 (e) P=0.226 (e) | P=0.427N P=0.444 P=0.988N P=0.582N |
|COCHRAN-ARMITAGE | P=0.691 | P=0.112N |
|FISHER EXACT | (e) P=0.074 (e) | P=0.253 P=0.889N P=0.247N |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/49 (6%) 5/9 (56%) 8/8 (100%) 7/49 (14%) | 5/47 (11%) 4/48 (8%) 3/47 (6%) 2/49 (4%) |
|ADJUSTED (b) | 9.9% 80.5% 100.0% 17.6% | 17.6% 11.2% 9.4% 5.1% |
|TERMINAL (d) | 1/22 (5%) 4/5 (80%) 6/6 (100%) 4/35 (11%) | 4/26 (15%) 3/33 (9%) 3/32 (9%) 2/39 (5%) |
|FIRST INCIDENCE (DAYS) | 612 675 618 514 | 648 673 729 (T) 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.494N P=0.049 * P=0.003 ** P=0.342 | P=0.074N P=0.364N P=0.259N P=0.099N |
|INCIDENTAL TUMOR | P=0.423 P<0.001 ** P<0.001 ** P=0.129 | P=0.112N P=0.371N P=0.284N P=0.157N |
|LOGISTIC REGRESSION | P=0.407 P=0.001 ** P<0.001 ** P=0.138 | P=0.099N P=0.397N P=0.294N P=0.132N |
|COCHRAN-ARMITAGE | P=0.347 | P=0.141N |
|FISHER EXACT | P=0.001 ** P<0.001 ** P=0.159 | P=0.486N P=0.357N P=0.201N |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05021 TEST: 03 PAGE 4
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 23
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 1.0% 2.5% 5.0% | UNTREATD 1.0% 2.5% 5.0% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 0/9 (0%) 0/8 (0%) 1/49 (2%) | 3/47 (6%) 0/48 (0%) 1/47 (2%) 0/49 (0%) |
|ADJUSTED (b) | 9.1% 0.0% 0.0% 2.9% | 8.6% 0.0% 3.1% 0.0% |
|TERMINAL (d) | 2/22 (9%) 0/5 (0%) 0/6 (0%) 1/35 (3%) | 1/26 (4%) 0/33 (0%) 1/32 (3%) 0/39 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) --- --- 729 (T) | 578 --- 729 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.274N P=0.595N P=0.550N P=0.340N | P=0.081N P=0.099N P=0.271N P=0.091N |
|INCIDENTAL TUMOR | P=0.274N P=0.595N P=0.550N P=0.340N | P=0.101N P=0.156N P=0.321N P=0.166N |
|LOGISTIC REGRESSION | P=0.274N P=0.595N P=0.550N P=0.340N | P=0.101N P=0.125N P=0.305N P=0.130N |
|COCHRAN-ARMITAGE | P=0.411N | P=0.098N |
|FISHER EXACT | P=0.711N P=0.737N P=0.500N | P=0.117N P=0.308N P=0.113N |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/49 (10%) 5/9 (56%) 8/8 (100%) 8/49 (16%) | 7/47 (15%) 4/48 (8%) 4/47 (9%) 2/49 (4%) |
|ADJUSTED (b) | 18.5% 80.5% 100.0% 20.2% | 21.7% 11.2% 12.5% 5.1% |
|TERMINAL (d) | 3/22 (14%) 4/5 (80%) 6/6 (100%) 5/35 (14%) | 4/26 (15%) 3/33 (9%) 4/32 (13%) 2/39 (5%) |
|FIRST INCIDENCE (DAYS) | 612 675 618 514 | 578 673 729 (T) 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.353N P=0.103 P=0.011 * P=0.552 | P=0.031N* P=0.165N P=0.184N P=0.032N* |
|INCIDENTAL TUMOR | P=0.532N P=0.002 ** P<0.001 ** P=0.312 | P=0.055N P=0.211N P=0.227N P=0.081N |
|LOGISTIC REGRESSION | P=0.531 P=0.010 ** P<0.001 ** P=0.297 | P=0.049N* P=0.215N P=0.227N P=0.056N |
|COCHRAN-ARMITAGE | P=0.432 | P=0.065N |
|FISHER EXACT | P=0.005 ** P<0.001 ** P=0.276 | P=0.249N P=0.261N P=0.070N |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05021 TEST: 03 PAGE 5
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 23
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 1.0% 2.5% 5.0% | UNTREATD 1.0% 2.5% 5.0% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/0 (0%) 0/2 (0%) 3/49 (6%) | 0/50 (0%) 2/49 (4%) 1/49 (2%) 3/50 (6%) |
|ADJUSTED (b) | 3.7% 0.0% 0.0% 7.7% | 0.0% 5.9% 3.1% 7.5% |
|TERMINAL (d) | 0/22 (0%) 0/0 0/0 1/35 (3%) | 0/29 (0%) 2/34 (6%) 1/32 (3%) 3/40 (8%) |
|FIRST INCIDENCE (DAYS) | 681 --- --- 648 | --- 729 (T) 729 (T) 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.187 P=0.443N P=0.427N P=0.466 | P=0.177 P=0.274 P=0.520 P=0.183 |
|INCIDENTAL TUMOR | P=0.213 (e) P=0.892N P=0.302 | P=0.177 P=0.274 P=0.520 P=0.183 |
|LOGISTIC REGRESSION | P=0.213 (e) P=0.892N P=0.302 | P=0.177 P=0.274 P=0.520 P=0.183 |
|COCHRAN-ARMITAGE | P=0.214 | P=0.115 |
|FISHER EXACT | P=1.000N P=0.962N P=0.301 | P=0.242 P=0.495 P=0.121 |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/0 (0%) 2/2 (100%) 1/49 (2%) | 0/50 (0%) 0/49 (0%) 0/49 (0%) 1/50 (2%) |
|ADJUSTED (b) | 4.5% 0.0% 0.0% 2.9% | 0.0% 0.0% 0.0% 2.5% |
|TERMINAL (d) | 1/22 (5%) 0/0 0/0 1/35 (3%) | 0/29 (0%) 0/34 (0%) 0/32 (0%) 1/40 (3%) |
|FIRST INCIDENCE (DAYS) | 729 (T) --- 479 729 (T) | --- --- --- 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.560N (e) P=0.285 P=0.655N | P=0.230 (e) (e) P=0.564 |
|INCIDENTAL TUMOR | P=0.548N (e) P=0.010 ** P=0.655N | P=0.230 (e) (e) P=0.564 |
|LOGISTIC REGRESSION | P=0.548N (e) P=0.010 ** P=0.655N | P=0.230 (e) (e) P=0.564 |
|COCHRAN-ARMITAGE | P=0.594 | P=0.195 |
|FISHER EXACT | P=1.000N P=0.002 ** P=0.747 | (e) (e) P=0.500 |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05021 TEST: 03 PAGE 6
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 23
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 1.0% 2.5% 5.0% | UNTREATD 1.0% 2.5% 5.0% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/0 (0%) 2/2 (100%) 4/49 (8%) | 0/50 (0%) 2/49 (4%) 1/49 (2%) 4/50 (8%) |
|ADJUSTED (b) | 8.1% 0.0% 0.0% 10.4% | 0.0% 5.9% 3.1% 10.0% |
|TERMINAL (d) | 1/22 (5%) 0/0 0/0 2/35 (6%) | 0/29 (0%) 2/34 (6%) 1/32 (3%) 4/40 (10%) |
|FIRST INCIDENCE (DAYS) | 681 --- 479 648 | --- 729 (T) 729 (T) 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.305 P=0.443N P=0.589 P=0.549 | P=0.081 P=0.274 P=0.520 P=0.111 |
|INCIDENTAL TUMOR | P=0.321 (e) P=0.031 * P=0.411 | P=0.081 P=0.274 P=0.520 P=0.111 |
|LOGISTIC REGRESSION | P=0.321 (e) P=0.031 * P=0.411 | P=0.081 P=0.274 P=0.520 P=0.111 |
|COCHRAN-ARMITAGE | P=0.278 | P=0.045 * |
|FISHER EXACT | P=1.000N P=0.005 ** P=0.329 | P=0.242 P=0.495 P=0.059 |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/48 (0%) 0/50 (0%) 2/50 (4%) | 0/50 (0%) 0/45 (0%) 0/44 (0%) 1/50 (2%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 5.7% | 0.0% 0.0% 0.0% 2.5% |
|TERMINAL (d) | 0/22 (0%) 0/28 (0%) 0/36 (0%) 2/35 (6%) | 0/29 (0%) 0/32 (0%) 0/32 (0%) 1/40 (3%) |
|FIRST INCIDENCE (DAYS) | --- --- --- 729 (T) | --- --- --- 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.068 (e) (e) P=0.345 | P=0.234 (e) (e) P=0.564 |
|INCIDENTAL TUMOR | P=0.068 (e) (e) P=0.345 | P=0.234 (e) (e) P=0.564 |
|LOGISTIC REGRESSION | P=0.068 (e) (e) P=0.345 | P=0.234 (e) (e) P=0.564 |
|COCHRAN-ARMITAGE | P=0.046 * | P=0.202 |
|FISHER EXACT | (e) (e) P=0.247 | (e) (e) P=0.500 |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05021 TEST: 03 PAGE 7
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 23
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 1.0% 2.5% 5.0% | UNTREATD 1.0% 2.5% 5.0% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/48 (0%) 1/50 (2%) 3/50 (6%) | 0/50 (0%) 0/45 (0%) 0/44 (0%) 1/50 (2%) |
|ADJUSTED (b) | 0.0% 0.0% 2.8% 8.6% | 0.0% 0.0% 0.0% 2.5% |
|TERMINAL (d) | 0/22 (0%) 0/28 (0%) 1/36 (3%) 3/35 (9%) | 0/29 (0%) 0/32 (0%) 0/32 (0%) 1/40 (3%) |
|FIRST INCIDENCE (DAYS) | --- --- 729 (T) 729 (T) | --- --- --- 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.037 * (e) P=0.598 P=0.213 | P=0.234 (e) (e) P=0.564 |
|INCIDENTAL TUMOR | P=0.037 * (e) P=0.598 P=0.213 | P=0.234 (e) (e) P=0.564 |
|LOGISTIC REGRESSION | P=0.037 * (e) P=0.598 P=0.213 | P=0.234 (e) (e) P=0.564 |
|COCHRAN-ARMITAGE | P=0.020 * | P=0.202 |
|FISHER EXACT | (e) P=0.500 P=0.121 | (e) (e) P=0.500 |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 1/50 (2%) 2/50 (4%) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |
|ADJUSTED (b) | 8.1% 2.2% 2.3% 5.7% | 3.4% 0.0% 3.0% 2.5% |
|TERMINAL (d) | 1/22 (5%) 0/29 (0%) 0/36 (0%) 2/35 (6%) | 1/29 (3%) 0/34 (0%) 1/33 (3%) 1/40 (3%) |
|FIRST INCIDENCE (DAYS) | 681 557 620 729 (T) | 729 (T) --- 729 (T) 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.566N P=0.432N P=0.370N P=0.525N | P=0.588 P=0.468N P=0.733N P=0.688N |
|INCIDENTAL TUMOR | P=0.454 P=0.534N P=0.585N P=0.565N | P=0.588 P=0.468N P=0.733N P=0.688N |
|LOGISTIC REGRESSION | P=0.517 P=0.511N P=0.520N P=0.586N | P=0.588 P=0.468N P=0.733N P=0.688N |
|COCHRAN-ARMITAGE | P=0.544 | P=0.515 |
|FISHER EXACT | P=0.500N P=0.500N P=0.691N | P=0.500N P=0.753N P=0.753N |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05021 TEST: 03 PAGE 8
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 23
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 1.0% 2.5% 5.0% | UNTREATD 1.0% 2.5% 5.0% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) 1/50 (2%) 3/50 (6%) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |
|ADJUSTED (b) | 10.4% 2.2% 2.3% 8.6% | 3.4% 0.0% 3.0% 2.5% |
|TERMINAL (d) | 1/22 (5%) 0/29 (0%) 0/36 (0%) 3/35 (9%) | 1/29 (3%) 0/34 (0%) 1/33 (3%) 1/40 (3%) |
|FIRST INCIDENCE (DAYS) | 612 557 620 729 (T) | 729 (T) --- 729 (T) 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.581N P=0.256N P=0.202N P=0.466N | P=0.588 P=0.468N P=0.733N P=0.688N |
|INCIDENTAL TUMOR | P=0.354 P=0.403N P=0.472N P=0.618N | P=0.588 P=0.468N P=0.733N P=0.688N |
|LOGISTIC REGRESSION | P=0.447 P=0.319N P=0.363N P=0.596N | P=0.588 P=0.468N P=0.733N P=0.688N |
|COCHRAN-ARMITAGE | P=0.481 | P=0.515 |
|FISHER EXACT | P=0.309N P=0.309N P=0.661N | P=0.500N P=0.753N P=0.753N |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) 1/50 (2%) 3/50 (6%) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |
|ADJUSTED (b) | 10.4% 2.2% 2.3% 8.6% | 3.4% 0.0% 3.0% 2.5% |
|TERMINAL (d) | 1/22 (5%) 0/29 (0%) 0/36 (0%) 3/35 (9%) | 1/29 (3%) 0/34 (0%) 1/33 (3%) 1/40 (3%) |
|FIRST INCIDENCE (DAYS) | 612 557 620 729 (T) | 729 (T) --- 729 (T) 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.581N P=0.256N P=0.202N P=0.466N | P=0.588 P=0.468N P=0.733N P=0.688N |
|INCIDENTAL TUMOR | P=0.354 P=0.403N P=0.472N P=0.618N | P=0.588 P=0.468N P=0.733N P=0.688N |
|LOGISTIC REGRESSION | P=0.447 P=0.319N P=0.363N P=0.596N | P=0.588 P=0.468N P=0.733N P=0.688N |
|COCHRAN-ARMITAGE | P=0.481 | P=0.515 |
|FISHER EXACT | P=0.309N P=0.309N P=0.661N | P=0.500N P=0.753N P=0.753N |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05021 TEST: 03 PAGE 9
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 23
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 1.0% 2.5% 5.0% | UNTREATD 1.0% 2.5% 5.0% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/6 (17%) 0/3 (0%) 2/50 (4%) | 1/50 (2%) 2/4 (50%) 1/8 (13%) 0/50 (0%) |
|ADJUSTED (b) | 3.7% 2.3% 0.0% 5.7% | 3.4% 100.0% 33.3% 0.0% |
|TERMINAL (d) | 0/22 (0%) 0/1 (0%) 0/1 (0%) 2/35 (6%) | 1/29 (3%) 2/2 (100%) 1/3 (33%) 0/40 (0%) |
|FIRST INCIDENCE (DAYS) | 681 592 --- 729 (T) | 729 (T) 729 (T) 729 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.580 P=0.723N P=0.422N P=0.651 | P=0.118N P<0.001 ** P=0.220 P=0.436N |
|INCIDENTAL TUMOR | P=0.475 P=0.266 P=0.892N P=0.606 | P=0.118N P<0.001 ** P=0.220 P=0.436N |
|LOGISTIC REGRESSION | P=0.513 P=0.286 P=0.979N P=0.591 | P=0.118N P<0.001 ** P=0.220 P=0.436N |
|COCHRAN-ARMITAGE | P=0.493 | P=0.194N |
|FISHER EXACT | P=0.205 P=0.943N P=0.500 | P=0.012 * P=0.259 P=0.500N |
|=================================================================================================================================|
| |
|Mammary Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 2/50 (4%) 2/50 (4%) 1/50 (2%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 0.0% 5.9% 6.1% 2.5% |
|TERMINAL (d) | 0/22 (0%) 0/29 (0%) 0/36 (0%) 0/35 (0%) | 0/29 (0%) 2/34 (6%) 2/33 (6%) 1/40 (3%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- | --- 729 (T) 729 (T) 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) (e) | P=0.583 P=0.274 P=0.267 P=0.564 |
|INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.583 P=0.274 P=0.267 P=0.564 |
|LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.583 P=0.274 P=0.267 P=0.564 |
|COCHRAN-ARMITAGE | (e) | P=0.488 |
|FISHER EXACT | (e) (e) (e) | P=0.247 P=0.247 P=0.500 |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05021 TEST: 03 PAGE 10
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 23
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 1.0% 2.5% 5.0% | UNTREATD 1.0% 2.5% 5.0% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | 1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 3.4% 5.0% 0.0% 0.0% |
|TERMINAL (d) | 0/22 (0%) 0/29 (0%) 0/36 (0%) 0/35 (0%) | 1/29 (3%) 1/34 (3%) 0/33 (0%) 0/40 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- | 729 (T) 514 --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) (e) | P=0.140N P=0.544 P=0.474N P=0.436N |
|INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.169N P=0.436 P=0.474N P=0.436N |
|LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.180N P=0.481 P=0.474N P=0.436N |
|COCHRAN-ARMITAGE | (e) | P=0.167N |
|FISHER EXACT | (e) (e) (e) | P=0.500 P=0.500N P=0.500N |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | 1/50 (2%) 4/50 (8%) 2/50 (4%) 1/50 (2%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 3.4% 10.7% 6.1% 2.5% |
|TERMINAL (d) | 0/22 (0%) 0/29 (0%) 0/36 (0%) 0/35 (0%) | 1/29 (3%) 3/34 (9%) 2/33 (6%) 1/40 (3%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- | 729 (T) 514 729 (T) 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) (e) | P=0.273N P=0.225 P=0.545 P=0.688N |
|INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.302N P=0.162 P=0.545 P=0.688N |
|LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.345N P=0.182 P=0.545 P=0.688N |
|COCHRAN-ARMITAGE | (e) | P=0.369N |
|FISHER EXACT | (e) (e) (e) | P=0.181 P=0.500 P=0.753N |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05021 TEST: 03 PAGE 11
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 23
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 1.0% 2.5% 5.0% | UNTREATD 1.0% 2.5% 5.0% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 2/50 (4%) 3/50 (6%) | 23/50 (46%) 24/50 (48%) 14/50 (28%) 19/50 (38%) |
|ADJUSTED (b) | 9.1% 6.9% 5.6% 8.1% | 64.7% 62.8% 35.1% 41.7% |
|TERMINAL (d) | 2/22 (9%) 2/29 (7%) 2/36 (6%) 2/35 (6%) | 17/29 (59%) 20/34 (59%) 8/33 (24%) 14/40 (35%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 729 (T) 687 | 507 651 491 535 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.567 P=0.593N P=0.507N P=0.659N | P=0.022N* P=0.373N P=0.028N* P=0.048N* |
|INCIDENTAL TUMOR | P=0.542 P=0.593N P=0.507N P=0.665 | P=0.069N P=0.533N P=0.044N* P=0.101N |
|LOGISTIC REGRESSION | P=0.525 P=0.593N P=0.507N P=0.654 | P=0.083N P=0.474N P=0.039N* P=0.199N |
|COCHRAN-ARMITAGE | P=0.384 | P=0.129N |
|FISHER EXACT | P=0.691N P=0.691N P=0.500 | P=0.500 P=0.048N* P=0.272N |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 5.0% | 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/22 (0%) 0/29 (0%) 0/36 (0%) 1/35 (3%) | 0/29 (0%) 0/34 (0%) 0/33 (0%) 0/40 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- 618 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.064 (e) (e) P=0.327 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.021 * (e) (e) P=0.138 | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.039 * (e) (e) P=0.220 | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.045 * | (e) |
|FISHER EXACT | (e) (e) P=0.247 | (e) (e) (e) |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05021 TEST: 03 PAGE 12
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 23
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 1.0% 2.5% 5.0% | UNTREATD 1.0% 2.5% 5.0% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 2/50 (4%) 5/50 (10%) | 23/50 (46%) 25/50 (50%) 15/50 (30%) 20/50 (40%) |
|ADJUSTED (b) | 9.1% 6.9% 5.6% 12.8% | 64.7% 65.5% 37.7% 44.0% |
|TERMINAL (d) | 2/22 (9%) 2/29 (7%) 2/36 (6%) 3/35 (9%) | 17/29 (59%) 21/34 (62%) 9/33 (27%) 15/40 (38%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 729 (T) 618 | 507 651 491 535 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.234 P=0.593N P=0.507N P=0.422 | P=0.028N* P=0.444N P=0.042N* P=0.066N |
|INCIDENTAL TUMOR | P=0.165 P=0.593N P=0.507N P=0.276 | P=0.087N P=0.558 P=0.066N P=0.137N |
|LOGISTIC REGRESSION | P=0.169 P=0.593N P=0.507N P=0.297 | P=0.107N P=0.551N P=0.060N P=0.255N |
|COCHRAN-ARMITAGE | P=0.112 | P=0.168N |
|FISHER EXACT | P=0.691N P=0.691N P=0.218 | P=0.421 P=0.074N P=0.343N |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 2/50 (4%) 5/50 (10%) | 23/50 (46%) 27/50 (54%) 15/50 (30%) 20/50 (40%) |
|ADJUSTED (b) | 9.1% 6.9% 5.6% 12.8% | 64.7% 68.8% 37.7% 44.0% |
|TERMINAL (d) | 2/22 (9%) 2/29 (7%) 2/36 (6%) 3/35 (9%) | 17/29 (59%) 22/34 (65%) 9/33 (27%) 15/40 (38%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 729 (T) 618 | 507 514 491 535 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.234 P=0.593N P=0.507N P=0.422 | P=0.020N* P=0.564 P=0.042N* P=0.066N |
|INCIDENTAL TUMOR | P=0.165 P=0.593N P=0.507N P=0.276 | P=0.066N P=0.363 P=0.066N P=0.137N |
|LOGISTIC REGRESSION | P=0.169 P=0.593N P=0.507N P=0.297 | P=0.083N P=0.424 P=0.060N P=0.255N |
|COCHRAN-ARMITAGE | P=0.112 | P=0.129N |
|FISHER EXACT | P=0.691N P=0.691N P=0.218 | P=0.274 P=0.074N P=0.343N |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05021 TEST: 03 PAGE 13
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 23
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 1.0% 2.5% 5.0% | UNTREATD 1.0% 2.5% 5.0% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Ovary |
| Thecoma NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | | 0/50 (0%) 2/4 (50%) 0/1 (0%) 0/50 (0%) |
|ADJUSTED (b) | | 0.0% 100.0% 0.0% 0.0% |
|TERMINAL (d) | | 0/29 (0%) 1/1 (100%) 0/0 0/40 (0%) |
|FIRST INCIDENCE (DAYS) | | --- 514 --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.282N P=0.037 * (e) (e) |
|INCIDENTAL TUMOR | | P=0.379N P<0.001 ** (e) (e) |
|LOGISTIC REGRESSION | | P=0.389N P<0.001 ** (e) (e) |
|COCHRAN-ARMITAGE | | P=0.317N |
|FISHER EXACT | | P=0.004 ** (e) (e) |
|=================================================================================================================================|
| |
|Pancreas |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/0 (0%) 1/2 (50%) 1/49 (2%) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 9.1% 0.0% 100.0% 2.9% | 0.0% 5.9% 0.0% 0.0% |
|TERMINAL (d) | 2/22 (9%) 0/0 1/1 (100%) 1/35 (3%) | 0/29 (0%) 2/34 (6%) 0/33 (0%) 0/40 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) --- 729 (T) 729 (T) | --- 729 (T) --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.229N (e) P=0.136 P=0.340N | P=0.302N P=0.274 (e) (e) |
|INCIDENTAL TUMOR | P=0.229N (e) P=0.136 P=0.340N | P=0.302N P=0.274 (e) (e) |
|LOGISTIC REGRESSION | P=0.229N (e) P=0.136 P=0.340N | P=0.302N P=0.274 (e) (e) |
|COCHRAN-ARMITAGE | P=0.406N | P=0.353N |
|FISHER EXACT | P=1.000N P=0.113 P=0.508N | P=0.247 (e) (e) |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05021 TEST: 03 PAGE 14
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 23
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 1.0% 2.5% 5.0% | UNTREATD 1.0% 2.5% 5.0% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Parathyroid Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 0/1 (0%) 0/1 (0%) 2/49 (4%) | 0/50 (0%) 0/1 (0%) 0/0 (0%) 0/50 (0%) |
|ADJUSTED (b) | 9.1% 0.0% 0.0% 5.2% | 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/22 (9%) 0/0 0/0 1/35 (3%) | 0/29 (0%) 0/0 0/0 0/40 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) --- --- 676 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.475N (e) (e) P=0.530N | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.481N (e) (e) P=0.578N | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.497N (e) (e) P=0.595N | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.597 | (e) |
|FISHER EXACT | P=0.960N P=0.960N P=0.691N | (e) (e) (e) |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 12/50 (24%) 12/16 (75%) 8/9 (89%) 8/49 (16%) | 29/50 (58%) 23/50 (46%) 28/50 (56%) 18/50 (36%) |
|ADJUSTED (b) | 38.3% 75.8% 86.4% 22.3% | 74.2% 56.5% 66.3% 41.6% |
|TERMINAL (d) | 6/22 (27%) 8/11 (73%) 6/7 (86%) 7/34 (21%) | 19/29 (66%) 17/34 (50%) 19/33 (58%) 15/40 (38%) |
|FIRST INCIDENCE (DAYS) | 502 686 591 618 | 582 612 501 592 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.006N** P=0.247 P=0.448 P=0.058N | P=0.004N** P=0.053N P=0.306N P=0.001N** |
|INCIDENTAL TUMOR | P=0.031N* P=0.001 ** P<0.001 ** P=0.208N | P=0.026N* P=0.068N P=0.505N P=0.013N* |
|LOGISTIC REGRESSION | P=0.038N* P<0.001 ** P<0.001 ** P=0.231N | P=0.019N* P=0.062N P=0.426N P=0.005N** |
|COCHRAN-ARMITAGE | P=0.063N | P=0.036N* |
|FISHER EXACT | P<0.001 ** P<0.001 ** P=0.242N | P=0.158N P=0.500N P=0.022N* |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05021 TEST: 03 PAGE 15
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 23
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 1.0% 2.5% 5.0% | UNTREATD 1.0% 2.5% 5.0% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/16 (0%) 0/9 (0%) 0/49 (0%) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 0.0% 5.0% 0.0% 0.0% |
|TERMINAL (d) | 0/22 (0%) 0/11 (0%) 0/7 (0%) 0/34 (0%) | 0/29 (0%) 1/34 (3%) 0/33 (0%) 0/40 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- | --- 592 --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) (e) | P=0.316N P=0.276 (e) (e) |
|INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.289N P=0.141 (e) (e) |
|LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.370N P=0.226 (e) (e) |
|COCHRAN-ARMITAGE | (e) | P=0.353N |
|FISHER EXACT | (e) (e) (e) | P=0.247 (e) (e) |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 12/50 (24%) 12/16 (75%) 8/9 (89%) 8/49 (16%) | 29/50 (58%) 25/50 (50%) 28/50 (56%) 18/50 (36%) |
|ADJUSTED (b) | 38.3% 75.8% 86.4% 22.3% | 74.2% 59.9% 66.3% 41.6% |
|TERMINAL (d) | 6/22 (27%) 8/11 (73%) 6/7 (86%) 7/34 (21%) | 19/29 (66%) 18/34 (53%) 19/33 (58%) 15/40 (38%) |
|FIRST INCIDENCE (DAYS) | 502 686 591 618 | 582 592 501 592 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.006N** P=0.247 P=0.448 P=0.058N | P=0.002N** P=0.102N P=0.306N P=0.001N** |
|INCIDENTAL TUMOR | P=0.031N* P=0.001 ** P<0.001 ** P=0.208N | P=0.015N* P=0.162N P=0.505N P=0.013N* |
|LOGISTIC REGRESSION | P=0.038N* P<0.001 ** P<0.001 ** P=0.231N | P=0.012N* P=0.138N P=0.426N P=0.005N** |
|COCHRAN-ARMITAGE | P=0.063N | P=0.024N* |
|FISHER EXACT | P<0.001 ** P<0.001 ** P=0.242N | P=0.274N P=0.500N P=0.022N* |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05021 TEST: 03 PAGE 16
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 23
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 1.0% 2.5% 5.0% | UNTREATD 1.0% 2.5% 5.0% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Basal Cell Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 5.7% | 0.0% 2.0% 0.0% 0.0% |
|TERMINAL (d) | 0/22 (0%) 0/29 (0%) 0/36 (0%) 2/35 (6%) | 0/29 (0%) 0/34 (0%) 0/33 (0%) 0/40 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- 729 (T) | --- 407 --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.066 (e) (e) P=0.345 | P=0.521N P=0.504 (e) (e) |
|INCIDENTAL TUMOR | P=0.066 (e) (e) P=0.345 | P=0.625N P=0.318 (e) (e) |
|LOGISTIC REGRESSION | P=0.066 (e) (e) P=0.345 | P=0.781N P=0.451 (e) (e) |
|COCHRAN-ARMITAGE | P=0.045 * | P=0.527N |
|FISHER EXACT | (e) (e) P=0.247 | P=0.500 (e) (e) |
|=================================================================================================================================|
| |
|Skin |
| Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 3/50 (6%) 3/50 (6%) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|ADJUSTED (b) | 4.5% 0.0% 8.3% 8.6% | 2.7% 0.0% 0.0% 2.0% |
|TERMINAL (d) | 1/22 (5%) 0/29 (0%) 3/36 (8%) 3/35 (9%) | 0/29 (0%) 0/34 (0%) 0/33 (0%) 0/40 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) --- 729 (T) 729 (T) | 655 --- --- 505 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.180 P=0.445N P=0.493 P=0.482 | P=0.586 P=0.470N P=0.495N P=0.740N |
|INCIDENTAL TUMOR | P=0.180 P=0.445N P=0.493 P=0.482 | P=0.333 P=0.460N P=0.581N P=0.417 |
|LOGISTIC REGRESSION | P=0.180 P=0.445N P=0.493 P=0.482 | P=0.481 P=0.512N P=0.505N P=0.652 |
|COCHRAN-ARMITAGE | P=0.096 | P=0.575 |
|FISHER EXACT | P=0.500N P=0.309 P=0.309 | P=0.500N P=0.500N P=0.753N |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05021 TEST: 03 PAGE 17
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 23
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 1.0% 2.5% 5.0% | UNTREATD 1.0% 2.5% 5.0% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 1/50 (2%) 1/50 (2%) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 9.1% 6.9% 2.5% 2.5% | 0.0% 5.9% 0.0% 0.0% |
|TERMINAL (d) | 2/22 (9%) 2/29 (7%) 0/36 (0%) 0/35 (0%) | 0/29 (0%) 2/34 (6%) 0/33 (0%) 0/40 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 681 687 | --- 729 (T) --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.212N P=0.593N P=0.343N P=0.345N | P=0.302N P=0.274 (e) (e) |
|INCIDENTAL TUMOR | P=0.254N P=0.593N P=0.403N P=0.394N | P=0.302N P=0.274 (e) (e) |
|LOGISTIC REGRESSION | P=0.261N P=0.593N P=0.406N P=0.402N | P=0.302N P=0.274 (e) (e) |
|COCHRAN-ARMITAGE | P=0.330N | P=0.353N |
|FISHER EXACT | P=0.691N P=0.500N P=0.500N | P=0.247 (e) (e) |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 0/50 (0%) 1/50 (2%) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 4.5% 6.9% 0.0% 2.5% | 0.0% 5.9% 0.0% 0.0% |
|TERMINAL (d) | 1/22 (5%) 2/29 (7%) 0/36 (0%) 0/35 (0%) | 0/29 (0%) 2/34 (6%) 0/33 (0%) 0/40 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) --- 687 | --- 729 (T) --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.356N P=0.597 P=0.402N P=0.658N | P=0.302N P=0.274 (e) (e) |
|INCIDENTAL TUMOR | P=0.391N P=0.597 P=0.402N P=0.710N | P=0.302N P=0.274 (e) (e) |
|LOGISTIC REGRESSION | P=0.398N P=0.597 P=0.402N P=0.721N | P=0.302N P=0.274 (e) (e) |
|COCHRAN-ARMITAGE | P=0.473N | P=0.353N |
|FISHER EXACT | P=0.500 P=0.500N P=0.753N | P=0.247 (e) (e) |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05021 TEST: 03 PAGE 18
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 23
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 1.0% 2.5% 5.0% | UNTREATD 1.0% 2.5% 5.0% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Trichoepithelioma, Basal Cell Carcinoma, or Basal Cell Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 2/50 (4%) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 2.6% 0.0% 2.8% 5.7% | 0.0% 2.0% 0.0% 0.0% |
|TERMINAL (d) | 0/22 (0%) 0/29 (0%) 1/36 (3%) 2/35 (6%) | 0/29 (0%) 0/34 (0%) 0/33 (0%) 0/40 (0%) |
|FIRST INCIDENCE (DAYS) | 612 --- 729 (T) 729 (T) | --- 407 --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.318 P=0.495N P=0.687N P=0.627 | P=0.521N P=0.504 (e) (e) |
|INCIDENTAL TUMOR | P=0.220 P=0.665N P=0.711 P=0.464 | P=0.625N P=0.318 (e) (e) |
|LOGISTIC REGRESSION | P=0.247 P=0.503N P=0.749 P=0.520 | P=0.781N P=0.451 (e) (e) |
|COCHRAN-ARMITAGE | P=0.230 | P=0.527N |
|FISHER EXACT | P=0.500N P=0.753N P=0.500 | P=0.500 (e) (e) |
|=================================================================================================================================|
| |
|Skin |
| Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma, |
| Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 2/50 (4%) 5/50 (10%) 6/50 (12%) | 1/50 (2%) 3/50 (6%) 0/50 (0%) 1/50 (2%) |
|ADJUSTED (b) | 15.9% 6.9% 13.3% 16.4% | 2.7% 7.8% 0.0% 2.0% |
|TERMINAL (d) | 3/22 (14%) 2/29 (7%) 4/36 (11%) 5/35 (14%) | 0/29 (0%) 2/34 (6%) 0/33 (0%) 0/40 (0%) |
|FIRST INCIDENCE (DAYS) | 612 729 (T) 681 687 | 655 407 --- 505 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.365 P=0.235N P=0.505N P=0.617N | P=0.329N P=0.352 P=0.495N P=0.740N |
|INCIDENTAL TUMOR | P=0.282 P=0.288N P=0.628N P=0.531 | P=0.507N P=0.273 P=0.581N P=0.417 |
|LOGISTIC REGRESSION | P=0.274 P=0.262N P=0.632N P=0.537 | P=0.477N P=0.267 P=0.505N P=0.652 |
|COCHRAN-ARMITAGE | P=0.169 | P=0.370N |
|FISHER EXACT | P=0.339N P=0.500 P=0.370 | P=0.309 P=0.500N P=0.753N |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05021 TEST: 03 PAGE 19
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 23
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 1.0% 2.5% 5.0% | UNTREATD 1.0% 2.5% 5.0% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Fibroma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 3/50 (6%) 4/50 (8%) 2/50 (4%) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 7.8% 10.2% 5.6% | 0.0% 2.9% 0.0% 0.0% |
|TERMINAL (d) | 0/22 (0%) 1/29 (3%) 3/36 (8%) 1/35 (3%) | 0/29 (0%) 1/34 (3%) 0/33 (0%) 0/40 (0%) |
|FIRST INCIDENCE (DAYS) | --- 592 535 727 | --- 729 (T) --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.448 P=0.150 P=0.121 P=0.344 | P=0.484N P=0.532 (e) (e) |
|INCIDENTAL TUMOR | P=0.273 P=0.050 P=0.085 P=0.290 | P=0.484N P=0.532 (e) (e) |
|LOGISTIC REGRESSION | P=0.294 P=0.113 P=0.053 P=0.336 | P=0.484N P=0.532 (e) (e) |
|COCHRAN-ARMITAGE | P=0.317 | P=0.527N |
|FISHER EXACT | P=0.121 P=0.059 P=0.247 | P=0.500 (e) (e) |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Fibrosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|ADJUSTED (b) | 0.0% 6.4% 0.0% 0.0% | 3.1% 0.0% 0.0% 2.5% |
|TERMINAL (d) | 0/22 (0%) 1/29 (3%) 0/36 (0%) 0/35 (0%) | 0/29 (0%) 0/34 (0%) 0/33 (0%) 1/40 (3%) |
|FIRST INCIDENCE (DAYS) | --- 711 --- --- | 693 --- --- 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.277N P=0.312 (e) (e) | P=0.621 P=0.466N P=0.488N P=0.696N |
|INCIDENTAL TUMOR | P=0.324N P=0.296 (e) (e) | P=0.452 P=0.460N P=0.581N P=0.622 |
|LOGISTIC REGRESSION | P=0.300N P=0.289 (e) (e) | P=0.594 P=0.493N P=0.495N P=0.736N |
|COCHRAN-ARMITAGE | P=0.353N | P=0.575 |
|FISHER EXACT | P=0.247 (e) (e) | P=0.500N P=0.500N P=0.753N |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05021 TEST: 03 PAGE 20
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 23
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 1.0% 2.5% 5.0% | UNTREATD 1.0% 2.5% 5.0% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Neurofibrosarcoma, Fibrosarcoma, Sarcoma, |
| Neurofibroma, or Fibroma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 5/50 (10%) 4/50 (8%) 2/50 (4%) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |
|ADJUSTED (b) | 0.0% 13.8% 10.2% 5.6% | 3.1% 2.9% 0.0% 2.5% |
|TERMINAL (d) | 0/22 (0%) 2/29 (7%) 3/36 (8%) 1/35 (3%) | 0/29 (0%) 1/34 (3%) 0/33 (0%) 1/40 (3%) |
|FIRST INCIDENCE (DAYS) | --- 592 535 727 | 693 729 (T) --- 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.527N P=0.058 P=0.121 P=0.344 | P=0.540N P=0.723N P=0.488N P=0.696N |
|INCIDENTAL TUMOR | P=0.446 P=0.019 * P=0.085 P=0.290 | P=0.639 P=0.720N P=0.581N P=0.622 |
|LOGISTIC REGRESSION | P=0.471 P=0.032 * P=0.053 P=0.336 | P=0.576N P=0.741N P=0.495N P=0.736N |
|COCHRAN-ARMITAGE | P=0.475 | P=0.607N |
|FISHER EXACT | P=0.028 * P=0.059 P=0.247 | P=0.753N P=0.500N P=0.753N |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 48/50 (96%) 44/44 (100%) 44/44 (100%) 46/49 (94%) | |
|ADJUSTED (b) | 100.0% 100.0% 100.0% 97.9% | |
|TERMINAL (d) | 22/22 (100%) 26/26 (100%) 33/33 (100%) 34/35 (97%) | |
|FIRST INCIDENCE (DAYS) | 448 513 479 513 | |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001N** P=0.059N P<0.001N** P=0.001N** | |
|INCIDENTAL TUMOR | P=0.150N P=0.390 P=0.581 P=0.335N | |
|LOGISTIC REGRESSION | P=0.147N P=0.459 P=0.520 P=0.291N | |
|COCHRAN-ARMITAGE | P=0.234N | |
|FISHER EXACT | P=0.280 P=0.280 P=0.490N | |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05021 TEST: 03 PAGE 21
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 23
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 1.0% 2.5% 5.0% | UNTREATD 1.0% 2.5% 5.0% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 6/50 (12%) 5/49 (10%) 7/50 (14%) | 5/50 (10%) 5/50 (10%) 5/50 (10%) 2/50 (4%) |
|ADJUSTED (b) | 9.1% 18.7% 12.5% 19.1% | 15.9% 14.1% 13.6% 4.9% |
|TERMINAL (d) | 1/22 (5%) 4/29 (14%) 3/36 (8%) 6/35 (17%) | 4/29 (14%) 4/34 (12%) 2/33 (6%) 1/40 (3%) |
|FIRST INCIDENCE (DAYS) | 564 675 620 648 | 606 693 651 707 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.383 P=0.365 P=0.557 P=0.355 | P=0.091N P=0.528N P=0.561N P=0.119N |
|INCIDENTAL TUMOR | P=0.202 P=0.254 P=0.247 P=0.181 | P=0.232N P=0.602N P=0.604 P=0.197N |
|LOGISTIC REGRESSION | P=0.219 P=0.270 P=0.297 P=0.184 | P=0.129N P=0.559N P=0.611N P=0.172N |
|COCHRAN-ARMITAGE | P=0.174 | P=0.160N |
|FISHER EXACT | P=0.243 P=0.346 P=0.159 | P=0.630N P=0.630N P=0.218N |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) 1/49 (2%) 3/50 (6%) | 1/50 (2%) 0/50 (0%) 4/50 (8%) 3/50 (6%) |
|ADJUSTED (b) | 4.3% 9.0% 2.8% 7.9% | 3.4% 0.0% 12.1% 7.5% |
|TERMINAL (d) | 0/22 (0%) 2/29 (7%) 1/36 (3%) 2/35 (6%) | 1/29 (3%) 0/34 (0%) 4/33 (12%) 3/40 (8%) |
|FIRST INCIDENCE (DAYS) | 728 592 729 (T) 648 | 729 (T) --- 729 (T) 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.479 P=0.391 P=0.652N P=0.467 | P=0.166 P=0.468N P=0.218 P=0.426 |
|INCIDENTAL TUMOR | P=0.356 P=0.302 P=0.742N P=0.389 | P=0.166 P=0.468N P=0.218 P=0.426 |
|LOGISTIC REGRESSION | P=0.371 P=0.331 P=0.663N P=0.380 | P=0.166 P=0.468N P=0.218 P=0.426 |
|COCHRAN-ARMITAGE | P=0.333 | P=0.098 |
|FISHER EXACT | P=0.309 P=0.747 P=0.309 | P=0.500N P=0.181 P=0.309 |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05021 TEST: 03 PAGE 22
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 23
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 1.0% 2.5% 5.0% | UNTREATD 1.0% 2.5% 5.0% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 9/50 (18%) 6/49 (12%) 9/50 (18%) | 5/50 (10%) 5/50 (10%) 8/50 (16%) 5/50 (10%) |
|ADJUSTED (b) | 13.0% 26.9% 15.2% 24.7% | 15.9% 14.1% 22.0% 12.2% |
|TERMINAL (d) | 1/22 (5%) 6/29 (21%) 4/36 (11%) 8/35 (23%) | 4/29 (14%) 4/34 (12%) 5/33 (15%) 4/40 (10%) |
|FIRST INCIDENCE (DAYS) | 564 592 620 648 | 606 693 651 707 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.444 P=0.231 P=0.610 P=0.333 | P=0.420N P=0.528N P=0.355 P=0.434N |
|INCIDENTAL TUMOR | P=0.223 P=0.121 P=0.282 P=0.164 | P=0.452 P=0.602N P=0.274 P=0.562N |
|LOGISTIC REGRESSION | P=0.251 P=0.140 P=0.356 P=0.171 | P=0.531N P=0.559N P=0.300 P=0.538N |
|COCHRAN-ARMITAGE | P=0.185 | P=0.506 |
|FISHER EXACT | P=0.117 P=0.357 P=0.117 | P=0.630N P=0.277 P=0.630N |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 0/49 (0%) 1/50 (2%) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 3/50 (6%) |
|ADJUSTED (b) | 7.4% 5.3% 0.0% 2.9% | 0.0% 2.9% 0.0% 7.1% |
|TERMINAL (d) | 1/22 (5%) 0/29 (0%) 0/36 (0%) 1/35 (3%) | 0/29 (0%) 1/34 (3%) 0/33 (0%) 2/40 (5%) |
|FIRST INCIDENCE (DAYS) | 630 675 --- 729 (T) | --- 729 (T) --- 618 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.199N P=0.597N P=0.164N P=0.367N | P=0.072 P=0.532 (e) P=0.173 |
|INCIDENTAL TUMOR | P=0.324N P=0.693 P=0.289N P=0.536N | P=0.086 P=0.532 (e) P=0.174 |
|LOGISTIC REGRESSION | P=0.277N P=0.690N P=0.240N P=0.463N | P=0.051 P=0.532 (e) P=0.121 |
|COCHRAN-ARMITAGE | P=0.285N | P=0.047 * |
|FISHER EXACT | P=0.691N P=0.253N P=0.500N | P=0.500 (e) P=0.121 |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05021 TEST: 03 PAGE 23
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 23
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 1.0% 2.5% 5.0% | UNTREATD 1.0% 2.5% 5.0% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 1/49 (2%) 3/50 (6%) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|ADJUSTED (b) | 4.5% 6.9% 2.8% 8.6% | 3.4% 0.0% 0.0% 2.5% |
|TERMINAL (d) | 1/22 (5%) 2/29 (7%) 1/36 (3%) 3/35 (9%) | 1/29 (3%) 0/34 (0%) 0/33 (0%) 1/40 (3%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 729 (T) 729 (T) | 729 (T) --- --- 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.387 P=0.597 P=0.648N P=0.482 | P=0.631 P=0.468N P=0.474N P=0.688N |
|INCIDENTAL TUMOR | P=0.387 P=0.597 P=0.648N P=0.482 | P=0.631 P=0.468N P=0.474N P=0.688N |
|LOGISTIC REGRESSION | P=0.387 P=0.597 P=0.648N P=0.482 | P=0.631 P=0.468N P=0.474N P=0.688N |
|COCHRAN-ARMITAGE | P=0.245 | P=0.575 |
|FISHER EXACT | P=0.500 P=0.747 P=0.309 | P=0.500N P=0.500N P=0.753N |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 4/50 (8%) 1/49 (2%) 4/50 (8%) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 4/50 (8%) |
|ADJUSTED (b) | 11.8% 11.9% 2.8% 11.4% | 3.4% 2.9% 0.0% 9.6% |
|TERMINAL (d) | 2/22 (9%) 2/29 (7%) 1/36 (3%) 4/35 (11%) | 1/29 (3%) 1/34 (3%) 0/33 (0%) 3/40 (8%) |
|FIRST INCIDENCE (DAYS) | 630 675 729 (T) 729 (T) | 729 (T) 729 (T) --- 618 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.444N P=0.640 P=0.170N P=0.582N | P=0.101 P=0.726N P=0.474N P=0.276 |
|INCIDENTAL TUMOR | P=0.549N P=0.560 P=0.259N P=0.625 | P=0.115 P=0.726N P=0.474N P=0.277 |
|LOGISTIC REGRESSION | P=0.541N P=0.561 P=0.244N P=0.651 | P=0.073 P=0.726N P=0.474N P=0.209 |
|COCHRAN-ARMITAGE | P=0.514 | P=0.062 |
|FISHER EXACT | P=0.500 P=0.316N P=0.500 | P=0.753N P=0.500N P=0.181 |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05021 TEST: 03 PAGE 24
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 23
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 1.0% 2.5% 5.0% | UNTREATD 1.0% 2.5% 5.0% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Tissue NOS |
| Fibroma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 8.2% 0.0% 0.0% 0.0% | 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/22 (5%) 0/29 (0%) 0/36 (0%) 0/35 (0%) | 0/29 (0%) 0/34 (0%) 0/33 (0%) 0/40 (0%) |
|FIRST INCIDENCE (DAYS) | 700 --- --- --- | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.092N P=0.185N P=0.150N P=0.156N | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.112N P=0.187N P=0.199N P=0.189N | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.103N P=0.193N P=0.173N P=0.175N | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.129N | (e) |
|FISHER EXACT | P=0.247N P=0.247N P=0.247N | (e) (e) (e) |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # # |
|----------- | | |
|OVERALL (a) | | 7/50 (14%) 4/50 (8%) 8/50 (16%) 13/50 (26%) |
|ADJUSTED (b) | | 22.1% 10.2% 22.3% 30.0% |
|TERMINAL (d) | | 5/29 (17%) 2/34 (6%) 6/33 (18%) 10/40 (25%) |
|FIRST INCIDENCE (DAYS) | | 655 592 546 535 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.082 P=0.184N P=0.588 P=0.300 |
|INCIDENTAL TUMOR | | P=0.017 * P=0.225N P=0.500 P=0.078 |
|LOGISTIC REGRESSION | | P=0.030 * P=0.221N P=0.533 P=0.158 |
|COCHRAN-ARMITAGE | | P=0.022 * |
|FISHER EXACT | | P=0.262N P=0.500 P=0.105 |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05021 TEST: 03 PAGE 25
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 23
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 1.0% 2.5% 5.0% | UNTREATD 1.0% 2.5% 5.0% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Uterus |
| Sarcoma Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # # |
|----------- | | |
|OVERALL (a) | | 1/50 (2%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |
|ADJUSTED (b) | | 3.3% 5.6% 3.0% 0.0% |
|TERMINAL (d) | | 0/29 (0%) 1/34 (3%) 1/33 (3%) 0/40 (0%) |
|FIRST INCIDENCE (DAYS) | | 718 703 729 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.180N P=0.557 P=0.735N P=0.443N |
|INCIDENTAL TUMOR | | P=0.352N P=0.565 P=0.732 P=0.909N |
|LOGISTIC REGRESSION | | P=0.171N P=0.546 P=0.748N P=0.467N |
|COCHRAN-ARMITAGE | | P=0.230N |
|FISHER EXACT | | P=0.500 P=0.753N P=0.500N |
|=================================================================================================================================|
| |
|Uterus |
| Sarcoma Stromal or Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # # |
|----------- | | |
|OVERALL (a) | | 8/50 (16%) 6/50 (12%) 8/50 (16%) 13/50 (26%) |
|ADJUSTED (b) | | 24.7% 15.5% 22.3% 30.0% |
|TERMINAL (d) | | 5/29 (17%) 3/34 (9%) 6/33 (18%) 10/40 (25%) |
|FIRST INCIDENCE (DAYS) | | 655 592 546 535 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.193 P=0.277N P=0.515N P=0.406 |
|INCIDENTAL TUMOR | | P=0.036 * P=0.316N P=0.587 P=0.087 |
|LOGISTIC REGRESSION | | P=0.087 P=0.323N P=0.575N P=0.237 |
|COCHRAN-ARMITAGE | | P=0.064 |
|FISHER EXACT | | P=0.387N P=0.607N P=0.163 |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05021 TEST: 03 PAGE 26
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 23
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 1.0% 2.5% 5.0% | UNTREATD 1.0% 2.5% 5.0% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Zymbal's Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 0.0% 5.1% 3.0% 0.0% |
|TERMINAL (d) | 0/22 (0%) 0/29 (0%) 0/36 (0%) 0/35 (0%) | 0/29 (0%) 1/34 (3%) 1/33 (3%) 0/40 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- | --- 612 729 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) (e) | P=0.371N P=0.276 P=0.526 (e) |
|INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.342N P=0.141 P=0.526 (e) |
|LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.420N P=0.230 P=0.526 (e) |
|COCHRAN-ARMITAGE | (e) | P=0.423N |
|FISHER EXACT | (e) (e) (e) | P=0.247 P=0.500 (e) |
|=================================================================================================================================|
| |
|Zymbal's Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |
|ADJUSTED (b) | 3.7% 0.0% 0.0% 0.0% | 0.0% 5.1% 3.0% 0.0% |
|TERMINAL (d) | 0/22 (0%) 0/29 (0%) 0/36 (0%) 0/35 (0%) | 0/29 (0%) 1/34 (3%) 1/33 (3%) 0/40 (0%) |
|FIRST INCIDENCE (DAYS) | 681 --- --- --- | --- 612 729 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.279N P=0.437N P=0.422N P=0.422N | P=0.371N P=0.276 P=0.526 (e) |
|INCIDENTAL TUMOR | P=0.335N P=0.455N P=0.527N P=0.500N | P=0.342N P=0.141 P=0.526 (e) |
|LOGISTIC REGRESSION | P=0.323N P=0.495N P=0.504N P=0.501N | P=0.420N P=0.230 P=0.526 (e) |
|COCHRAN-ARMITAGE | P=0.321N | P=0.423N |
|FISHER EXACT | P=0.500N P=0.500N P=0.500N | P=0.247 P=0.500 (e) |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05021 TEST: 03 PAGE 27
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 23
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 1.0% 2.5% 5.0% | UNTREATD 1.0% 2.5% 5.0% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, |
| or Undifferentiated |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 28/50 (56%) 22/50 (44%) 10/50 (20%) 4/50 (8%) | 14/50 (28%) 7/50 (14%) 3/50 (6%) 3/50 (6%) |
|ADJUSTED (b) | 63.7% 53.5% 25.3% 10.4% | 41.2% 18.3% 7.8% 6.9% |
|TERMINAL (d) | 8/22 (36%) 11/29 (38%) 7/36 (19%) 3/35 (9%) | 10/29 (34%) 4/34 (12%) 1/33 (3%) 1/40 (3%) |
|FIRST INCIDENCE (DAYS) | 502 301 617 412 | 507 242 572 610 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001N** P=0.072N P<0.001N** P<0.001N** | P<0.001N** P=0.038N* P=0.003N** P<0.001N** |
|INCIDENTAL TUMOR | P<0.001N** P=0.273N P=0.004N** P<0.001N** | P=0.003N** P=0.055N P=0.004N** P=0.005N** |
|LOGISTIC REGRESSION | P<0.001N** P=0.232N P=0.001N** P<0.001N** | P=0.002N** P=0.065N P=0.003N** P=0.002N** |
|COCHRAN-ARMITAGE | P<0.001N** | P=0.002N** |
|FISHER EXACT | P=0.159N P<0.001N** P<0.001N** | P=0.070N P=0.003N** P=0.003N** |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma Benign, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 0/50 (0%) 3/50 (6%) 3/50 (6%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 12.2% 0.0% 7.7% 7.6% | 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/22 (5%) 0/29 (0%) 2/36 (6%) 2/35 (6%) | 0/29 (0%) 0/34 (0%) 0/33 (0%) 0/40 (0%) |
|FIRST INCIDENCE (DAYS) | 585 --- 620 513 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.533N P=0.049N* P=0.324N P=0.348N | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.393 P=0.096N P=0.649N P=0.607N | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.437 P=0.068N P=0.578N P=0.594N | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.500 | (e) |
|FISHER EXACT | P=0.059N P=0.500N P=0.500N | (e) (e) (e) |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05021 TEST: 03 PAGE 28
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 23
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 1.0% 2.5% 5.0% | UNTREATD 1.0% 2.5% 5.0% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 50/50 (100%) 48/50 (96%) 48/50 (96%) 49/50 (98%) | 43/50 (86%) 43/50 (86%) 41/50 (82%) 41/50 (82%) |
|ADJUSTED (b) | 100.0% 100.0% 96.0% 100.0% | 95.5% 93.4% 87.2% 83.6% |
|TERMINAL (d) | 22/22 (100%) 29/29 (100%) 34/36 (94%) 35/35 (100%)| 27/29 (93%) 31/34 (91%) 27/33 (82%) 32/40 (80%) |
|FIRST INCIDENCE (DAYS) | 448 513 479 513 | 378 592 325 505 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.003N** P=0.046N* P=0.001N** P=0.002N** | P=0.018N* P=0.162N P=0.199N P=0.016N* |
|INCIDENTAL TUMOR | P=0.384N P=0.443N P=0.352N P=0.443N | P=0.279N P=0.340N P=0.398N P=0.328N |
|LOGISTIC REGRESSION | P=0.306N P=0.338N P=0.352N P=0.443N | P=0.146N P=0.348N P=0.315N P=0.195N |
|COCHRAN-ARMITAGE | P=0.488N | P=0.295N |
|FISHER EXACT | P=0.247N P=0.247N P=0.500N | P=0.613N P=0.393N P=0.393N |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 33/50 (66%) 30/50 (60%) 22/50 (44%) 22/50 (44%) | 22/50 (44%) 15/50 (30%) 14/50 (28%) 10/50 (20%) |
|ADJUSTED (b) | 71.8% 67.4% 48.4% 51.4% | 53.9% 36.1% 34.0% 23.6% |
|TERMINAL (d) | 10/22 (45%) 15/29 (52%) 13/36 (36%) 15/35 (43%) | 11/29 (38%) 9/34 (26%) 8/33 (24%) 8/40 (20%) |
|FIRST INCIDENCE (DAYS) | 448 301 479 412 | 494 242 325 610 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001N** P=0.132N P=0.002N** P=0.002N** | P=0.003N** P=0.063N P=0.061N P=0.002N** |
|INCIDENTAL TUMOR | P=0.054N P=0.524N P=0.155N P=0.123N | P=0.022N* P=0.160N P=0.096N P=0.044N* |
|LOGISTIC REGRESSION | P=0.034N* P=0.482N P=0.109N P=0.086N | P=0.017N* P=0.134N P=0.079N P=0.007N** |
|COCHRAN-ARMITAGE | P=0.010N** | P=0.010N* |
|FISHER EXACT | P=0.339N P=0.022N* P=0.022N* | P=0.107N P=0.072N P=0.009N** |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05021 TEST: 03 PAGE 29
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 23
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 1.0% 2.5% 5.0% | UNTREATD 1.0% 2.5% 5.0% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 50/50 (100%) 50/50 (100%) 48/50 (96%) 50/50 (100%)| 48/50 (96%) 48/50 (96%) 44/50 (88%) 44/50 (88%) |
|ADJUSTED (b) | 100.0% 100.0% 96.0% 100.0% | 98.0% 96.0% 89.7% 88.0% |
|TERMINAL (d) | 22/22 (100%) 29/29 (100%) 34/36 (94%) 35/35 (100%)| 28/29 (97%) 32/34 (94%) 28/33 (85%) 34/40 (85%) |
|FIRST INCIDENCE (DAYS) | 448 301 479 412 | 249 242 325 505 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.003N** P=0.087N P=0.001N** P=0.004N** | P=0.006N** P=0.169N P=0.128N P=0.006N** |
|INCIDENTAL TUMOR | P=0.659N (e) P=0.352N (e) | P=0.110N P=0.663N P=0.160N P=0.192N |
|LOGISTIC REGRESSION | P=0.659N (e) P=0.352N (e) | P=0.063N P=0.672N P=0.135N P=0.135N |
|COCHRAN-ARMITAGE | P=0.575N | P=0.052N |
|FISHER EXACT | P=1.000N P=0.247N P=1.000N | P=0.691N P=0.134N P=0.134N |
|=================================================================================================================================|
(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).