TDMS Study 05019-04 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst CI PIGMENT RED 3 DATE: 09/03/94
EXPERIMENT: 05019 TEST: 04 TIME: 16:44:25
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: NOIES9565102 ROUTE: DOSED FEED NTP C#: 60366
PATHOLOGIST: H. GILES S. EUSTIS CAS: 2425-85-6
------------------------------------------------------------------------------------------------------------------------------------
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 3 DATE: 09/03/94
EXPERIMENT: 05019 TEST: 04 TIME: 16:44:25
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NOIES9565102 ROUTE: DOSED FEED NTP C#: 60366
PATHOLOGIST: H. GILES S. EUSTIS CAS: 2425-85-6
MICE(B6C3F1)
----------------------------
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
Epididymis
Gallbladder
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 3 DATE: 09/03/94
EXPERIMENT: 05019 TEST: 04 TIME: 16:44:25
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NOIES9565102 ROUTE: DOSED FEED NTP C#: 60366
PATHOLOGIST: H. GILES S. EUSTIS CAS: 2425-85-6
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF THE STUDY OF CI PIGMENT RED 3
====================================================================================================
MALE MICE
-------------
ORGAN MORPHOLOGY
------- ------------
Kidney Adenoma
Liver Hepatocellular Adenoma
Hepatocellular Carcinoma or Hepatocellular Adenoma
Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
Lung Alveolar/Bronchiolar Adenoma
Alveolar/Bronchiolar Carcinoma
Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
Skin: Subcutaneous Tissue Neurofibrosarcoma, Fibrosarcoma, Sarcoma,
Neurofibroma, or Fibroma
Thyroid Gland: Follicular Cell
Adenoma
Carcinoma or Adenoma
All Organs Malignant Lymphoma And Histiocytic Sarcoma
Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,
NOS, or Undifferentiated Cell Type
Benign Tumors
Malignant and Benign Tumors
====================================================================================================
FEMALE MICE
-------------
ORGAN MORPHOLOGY
------- ------------
Adrenal Medulla Pheochromocytoma: Benign, Complex, Malignant, NOS
Liver Hepatocellular Carcinoma
Ovary Adenoma
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
All Organs Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,
NOS, or Undifferentiated Cell Type
Benign Tumors
Malignant and Benign Tumors
====================================================================================================
DATE: 09/03/94 EXPERIMENT: 05019 TEST: 04 PAGE 1
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CI PIGMENT RED 3
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 1.25% 2.5% 5.0% | UNTREATD 1.25% 2.5% 5.0% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/21 (5%) 0/18 (0%) 0/50 (0%) | 1/50 (2%) 2/14 (14%) 0/18 (0%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 2.6% 100.0% 0.0% 0.0% |
|TERMINAL (d) | 0/33 (0%) 0/0 0/0 0/33 (0%) | 1/39 (3%) 1/1 (100%) 0/0 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | --- 576 --- --- | 729 (T) 540 --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.594N P=0.475 (e) (e) | P=0.272N P=0.043 * (e) P=0.589N |
|INCIDENTAL TUMOR | P=0.406N P=0.419 (e) (e) | P=0.299N P=0.016 * (e) P=0.589N |
|LOGISTIC REGRESSION | P=0.534N P=0.348 (e) (e) | P=0.188N P=0.113 (e) P=0.589N |
|COCHRAN-ARMITAGE | P=0.535N | P=0.188N |
|FISHER EXACT | P=0.296 (e) (e) | P=0.118 P=0.735N P=0.500N |
|=================================================================================================================================|
| |
|Harderian Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 1/50 (2%) 1/50 (2%) | 3/50 (6%) 1/50 (2%) 1/50 (2%) 1/50 (2%) |
|ADJUSTED (b) | 5.4% 6.7% 3.2% 3.0% | 7.2% 2.4% 3.2% 2.6% |
|TERMINAL (d) | 1/33 (3%) 1/28 (4%) 1/31 (3%) 1/33 (3%) | 2/39 (5%) 0/37 (0%) 1/31 (3%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | 630 703 729 (T) 729 (T) | 630 680 729 (T) 625 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.338N P=0.642 P=0.520N P=0.522N | P=0.364N P=0.330N P=0.385N P=0.451N |
|INCIDENTAL TUMOR | P=0.324N P=0.639 P=0.481N P=0.406N | P=0.118N P=0.195N P=0.214N P=0.058N |
|LOGISTIC REGRESSION | P=0.357N P=0.658 P=0.506N P=0.526N | P=0.243N P=0.305N P=0.309N P=0.306N |
|COCHRAN-ARMITAGE | P=0.337N | P=0.242N |
|FISHER EXACT | P=0.691N P=0.500N P=0.500N | P=0.309N P=0.309N P=0.309N |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05019 TEST: 04 PAGE 2
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CI PIGMENT RED 3
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 1.25% 2.5% 5.0% | UNTREATD 1.25% 2.5% 5.0% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Harderian Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 1/50 (2%) 1/50 (2%) | 3/50 (6%) 2/50 (4%) 1/50 (2%) 1/50 (2%) |
|ADJUSTED (b) | 5.4% 6.7% 3.2% 3.0% | 7.2% 5.1% 3.2% 2.6% |
|TERMINAL (d) | 1/33 (3%) 1/28 (4%) 1/31 (3%) 1/33 (3%) | 2/39 (5%) 1/37 (3%) 1/31 (3%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | 630 703 729 (T) 729 (T) | 630 680 729 (T) 625 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.338N P=0.642 P=0.520N P=0.522N | P=0.323N P=0.527N P=0.385N P=0.451N |
|INCIDENTAL TUMOR | P=0.324N P=0.639 P=0.481N P=0.406N | P=0.108N P=0.391N P=0.214N P=0.058N |
|LOGISTIC REGRESSION | P=0.357N P=0.658 P=0.506N P=0.526N | P=0.204N P=0.497N P=0.309N P=0.306N |
|COCHRAN-ARMITAGE | P=0.337N | P=0.199N |
|FISHER EXACT | P=0.691N P=0.500N P=0.500N | P=0.500N P=0.309N P=0.309N |
|=================================================================================================================================|
| |
|Kidney |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 6/50 (12%) | 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 18.2% | 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/33 (0%) 0/28 (0%) 0/31 (0%) 6/33 (18%) | 0/39 (0%) 0/37 (0%) 0/31 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- 729 (T) | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** (e) (e) P=0.017 * | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P<0.001 ** (e) (e) P=0.017 * | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P<0.001 ** (e) (e) P=0.016 * | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P<0.001 ** | (e) |
|FISHER EXACT | (e) (e) P=0.013 * | (e) (e) (e) |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05019 TEST: 04 PAGE 3
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CI PIGMENT RED 3
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 1.25% 2.5% 5.0% | UNTREATD 1.25% 2.5% 5.0% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 12/48 (25%) 11/50 (22%) 16/49 (33%) | 7/50 (14%) 8/50 (16%) 2/49 (4%) 8/50 (16%) |
|ADJUSTED (b) | 23.3% 38.1% 30.7% 45.4% | 17.3% 19.2% 6.5% 26.1% |
|TERMINAL (d) | 7/33 (21%) 9/28 (32%) 7/31 (23%) 14/33 (42%) | 6/39 (15%) 5/37 (14%) 2/31 (6%) 5/25 (20%) |
|FIRST INCIDENCE (DAYS) | 681 650 521 557 | 653 599 729 (T) 616 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.059 P=0.124 P=0.266 P=0.043 * | P=0.248 P=0.461 P=0.145N P=0.209 |
|INCIDENTAL TUMOR | P=0.027 * P=0.149 P=0.302 P=0.041 * | P=0.510N P=0.608N P=0.128N P=0.510 |
|LOGISTIC REGRESSION | P=0.026 * P=0.126 P=0.279 P=0.021 * | P=0.482 P=0.506 P=0.107N P=0.406 |
|COCHRAN-ARMITAGE | P=0.046 * | P=0.541 |
|FISHER EXACT | P=0.197 P=0.306 P=0.044 * | P=0.500 P=0.085N P=0.500 |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 10/48 (21%) 8/50 (16%) 4/49 (8%) | 4/50 (8%) 8/50 (16%) 2/49 (4%) 1/50 (2%) |
|ADJUSTED (b) | 12.9% 30.1% 25.0% 11.4% | 10.3% 20.0% 6.5% 4.0% |
|TERMINAL (d) | 1/33 (3%) 6/28 (21%) 7/31 (23%) 3/33 (9%) | 4/39 (10%) 6/37 (16%) 2/31 (6%) 1/25 (4%) |
|FIRST INCIDENCE (DAYS) | 653 512 724 557 | 729 (T) 627 729 (T) 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.280N P=0.084 P=0.249 P=0.541N | P=0.138N P=0.157 P=0.447N P=0.334N |
|INCIDENTAL TUMOR | P=0.507N P=0.118 P=0.244 P=0.390 | P=0.085N P=0.210 P=0.447N P=0.334N |
|LOGISTIC REGRESSION | P=0.319N P=0.091 P=0.254 P=0.451 | P=0.086N P=0.176 P=0.447N P=0.334N |
|COCHRAN-ARMITAGE | P=0.281N | P=0.047N* |
|FISHER EXACT | P=0.113 P=0.277 P=0.513N | P=0.178 P=0.349N P=0.181N |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05019 TEST: 04 PAGE 4
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CI PIGMENT RED 3
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 1.25% 2.5% 5.0% | UNTREATD 1.25% 2.5% 5.0% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 12/50 (24%) 16/48 (33%) 16/50 (32%) 19/49 (39%) | 10/50 (20%) 14/50 (28%) 4/49 (8%) 9/50 (18%) |
|ADJUSTED (b) | 32.0% 49.2% 45.2% 52.4% | 24.8% 33.5% 12.9% 29.8% |
|TERMINAL (d) | 8/33 (24%) 12/28 (43%) 12/31 (39%) 16/33 (48%) | 9/39 (23%) 10/37 (27%) 4/31 (13%) 6/25 (24%) |
|FIRST INCIDENCE (DAYS) | 653 512 521 557 | 653 599 729 (T) 616 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.116 P=0.129 P=0.212 P=0.087 | P=0.475 P=0.207 P=0.156N P=0.325 |
|INCIDENTAL TUMOR | P=0.043 * P=0.175 P=0.232 P=0.031 * | P=0.299N P=0.304 P=0.141N P=0.589N |
|LOGISTIC REGRESSION | P=0.050 * P=0.137 P=0.219 P=0.043 * | P=0.354N P=0.246 P=0.119N P=0.550 |
|COCHRAN-ARMITAGE | P=0.090 | P=0.242N |
|FISHER EXACT | P=0.212 P=0.252 P=0.085 | P=0.241 P=0.080N P=0.500N |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 12/50 (24%) 16/48 (33%) 16/50 (32%) 19/49 (39%) | 10/50 (20%) 14/50 (28%) 4/49 (8%) 9/50 (18%) |
|ADJUSTED (b) | 32.0% 49.2% 45.2% 52.4% | 24.8% 33.5% 12.9% 29.8% |
|TERMINAL (d) | 8/33 (24%) 12/28 (43%) 12/31 (39%) 16/33 (48%) | 9/39 (23%) 10/37 (27%) 4/31 (13%) 6/25 (24%) |
|FIRST INCIDENCE (DAYS) | 653 512 521 557 | 653 599 729 (T) 616 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.116 P=0.129 P=0.212 P=0.087 | P=0.475 P=0.207 P=0.156N P=0.325 |
|INCIDENTAL TUMOR | P=0.043 * P=0.175 P=0.232 P=0.031 * | P=0.299N P=0.304 P=0.141N P=0.589N |
|LOGISTIC REGRESSION | P=0.050 * P=0.137 P=0.219 P=0.043 * | P=0.354N P=0.246 P=0.119N P=0.550 |
|COCHRAN-ARMITAGE | P=0.090 | P=0.242N |
|FISHER EXACT | P=0.212 P=0.252 P=0.085 | P=0.241 P=0.080N P=0.500N |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05019 TEST: 04 PAGE 5
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CI PIGMENT RED 3
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 1.25% 2.5% 5.0% | UNTREATD 1.25% 2.5% 5.0% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 5/25 (20%) 7/26 (27%) 5/50 (10%) | 3/50 (6%) 0/13 (0%) 0/21 (0%) 3/50 (6%) |
|ADJUSTED (b) | 5.7% 69.7% 73.0% 14.3% | 7.7% 0.0% 0.0% 10.8% |
|TERMINAL (d) | 1/33 (3%) 2/3 (67%) 5/7 (71%) 4/33 (12%) | 3/39 (8%) 0/0 0/2 (0%) 2/25 (8%) |
|FIRST INCIDENCE (DAYS) | 697 650 541 557 | 729 (T) --- --- 627 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.370 P=0.015 * P<0.001 ** P=0.211 | P=0.362 (e) P=0.835N P=0.456 |
|INCIDENTAL TUMOR | P=0.222 P=0.017 * P<0.001 ** P=0.168 | P=0.480 (e) P=0.835N P=0.645 |
|LOGISTIC REGRESSION | P=0.313 P<0.001 ** P<0.001 ** P=0.184 | P=0.425 (e) P=0.835N P=0.565 |
|COCHRAN-ARMITAGE | P=0.322 | P=0.540 |
|FISHER EXACT | P=0.037 * P=0.006 ** P=0.218 | P=0.494N P=0.343N P=0.661N |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/25 (8%) 0/26 (0%) 0/50 (0%) | 1/50 (2%) 0/13 (0%) 1/21 (5%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 35.6% 0.0% 0.0% | 2.6% 0.0% 50.0% 0.0% |
|TERMINAL (d) | 0/33 (0%) 1/3 (33%) 0/7 (0%) 0/33 (0%) | 1/39 (3%) 0/0 1/2 (50%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | --- 710 --- --- | 729 (T) --- 729 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.382N P=0.047 * (e) (e) | P=0.478N (e) P=0.090 P=0.589N |
|INCIDENTAL TUMOR | P=0.483N P=0.061 (e) (e) | P=0.478N (e) P=0.090 P=0.589N |
|LOGISTIC REGRESSION | P=0.393N P=0.007 ** (e) (e) | P=0.478N (e) P=0.090 P=0.589N |
|COCHRAN-ARMITAGE | P=0.388N | P=0.372N |
|FISHER EXACT | P=0.108 (e) (e) | P=0.794N P=0.507 P=0.500N |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05019 TEST: 04 PAGE 6
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CI PIGMENT RED 3
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 1.25% 2.5% 5.0% | UNTREATD 1.25% 2.5% 5.0% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 5/25 (20%) 7/26 (27%) 5/50 (10%) | 4/50 (8%) 0/13 (0%) 1/21 (5%) 3/50 (6%) |
|ADJUSTED (b) | 5.7% 69.7% 73.0% 14.3% | 10.3% 0.0% 50.0% 10.8% |
|TERMINAL (d) | 1/33 (3%) 2/3 (67%) 5/7 (71%) 4/33 (12%) | 4/39 (10%) 0/0 1/2 (50%) 2/25 (8%) |
|FIRST INCIDENCE (DAYS) | 697 650 541 557 | 729 (T) --- 729 (T) 627 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.370 P=0.015 * P<0.001 ** P=0.211 | P=0.469 (e) P=0.288 P=0.583 |
|INCIDENTAL TUMOR | P=0.222 P=0.017 * P<0.001 ** P=0.168 | P=0.574 (e) P=0.288 P=0.571N |
|LOGISTIC REGRESSION | P=0.313 P<0.001 ** P<0.001 ** P=0.184 | P=0.526 (e) P=0.288 P=0.636N |
|COCHRAN-ARMITAGE | P=0.322 | P=0.481N |
|FISHER EXACT | P=0.037 * P=0.006 ** P=0.218 | P=0.387N P=0.534N P=0.500N |
|=================================================================================================================================|
| |
|Ovary |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | | 0/50 (0%) 0/49 (0%) 1/50 (2%) 2/50 (4%) |
|ADJUSTED (b) | | 0.0% 0.0% 3.2% 8.0% |
|TERMINAL (d) | | 0/39 (0%) 0/37 (0%) 1/31 (3%) 2/25 (8%) |
|FIRST INCIDENCE (DAYS) | | --- --- 729 (T) 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.032 * (e) P=0.454 P=0.147 |
|INCIDENTAL TUMOR | | P=0.032 * (e) P=0.454 P=0.147 |
|LOGISTIC REGRESSION | | P=0.032 * (e) P=0.454 P=0.147 |
|COCHRAN-ARMITAGE | | P=0.071 |
|FISHER EXACT | | (e) P=0.500 P=0.247 |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05019 TEST: 04 PAGE 7
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CI PIGMENT RED 3
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 1.25% 2.5% 5.0% | UNTREATD 1.25% 2.5% 5.0% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/46 (0%) 0/20 (0%) 0/18 (0%) 0/49 (0%) | 8/49 (16%) 2/14 (14%) 0/17 (0%) 2/50 (4%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 19.9% 100.0% 0.0% 8.0% |
|TERMINAL (d) | 0/30 (0%) 0/0 0/0 0/33 (0%) | 7/39 (18%) 2/2 (100%) 0/0 2/25 (8%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- | 703 729 (T) --- 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) (e) | P=0.107N P=0.224 P=0.542N P=0.166N |
|INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.104N P=0.231 P=0.443N P=0.165N |
|LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.100N P=0.257 P=0.402N P=0.154N |
|COCHRAN-ARMITAGE | (e) | P=0.021N* |
|FISHER EXACT | (e) (e) (e) | P=0.610N P=0.079N P=0.043N* |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Fibroma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 1/50 (2%) 3/50 (6%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|ADJUSTED (b) | 15.2% 3.6% 9.7% 3.0% | 0.0% 0.0% 0.0% 2.3% |
|TERMINAL (d) | 5/33 (15%) 1/28 (4%) 3/31 (10%) 1/33 (3%) | 0/39 (0%) 0/37 (0%) 0/31 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 729 (T) 729 (T) | --- --- --- 599 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.105N P=0.142N P=0.389N P=0.101N | P=0.190 (e) (e) P=0.487 |
|INCIDENTAL TUMOR | P=0.105N P=0.142N P=0.389N P=0.101N | P=0.471 (e) (e) P=0.977 |
|LOGISTIC REGRESSION | P=0.105N P=0.142N P=0.389N P=0.100N | P=0.193 (e) (e) P=0.494 |
|COCHRAN-ARMITAGE | P=0.114N | P=0.198 |
|FISHER EXACT | P=0.102N P=0.357N P=0.102N | (e) (e) P=0.500 |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05019 TEST: 04 PAGE 8
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CI PIGMENT RED 3
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 1.25% 2.5% 5.0% | UNTREATD 1.25% 2.5% 5.0% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Fibrosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 12/50 (24%) 7/50 (14%) 8/50 (16%) 5/50 (10%) | 2/50 (4%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |
|ADJUSTED (b) | 30.0% 21.8% 21.7% 13.2% | 4.5% 0.0% 3.0% 2.5% |
|TERMINAL (d) | 6/33 (18%) 4/28 (14%) 3/31 (10%) 3/33 (9%) | 0/39 (0%) 0/37 (0%) 0/31 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | 450 648 541 294 | 508 --- 724 616 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.072N P=0.272N P=0.282N P=0.080N | P=0.580N P=0.243N P=0.544N P=0.570N |
|INCIDENTAL TUMOR | P=0.138N P=0.193N P=0.182N P=0.087N | P=0.402N P=0.314N P=0.385N P=0.400N |
|LOGISTIC REGRESSION | P=0.066N P=0.204N P=0.233N P=0.059N | P=0.496N P=0.261N P=0.515N P=0.501N |
|COCHRAN-ARMITAGE | P=0.059N | P=0.500N |
|FISHER EXACT | P=0.154N P=0.227N P=0.054N | P=0.247N P=0.500N P=0.500N |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Neurofibroma or Fibroma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 2/50 (4%) 3/50 (6%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|ADJUSTED (b) | 15.2% 7.1% 9.7% 3.0% | 0.0% 0.0% 0.0% 2.3% |
|TERMINAL (d) | 5/33 (15%) 2/28 (7%) 3/31 (10%) 1/33 (3%) | 0/39 (0%) 0/37 (0%) 0/31 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 729 (T) 729 (T) | --- --- --- 599 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.087N P=0.284N P=0.389N P=0.101N | P=0.190 (e) (e) P=0.487 |
|INCIDENTAL TUMOR | P=0.087N P=0.284N P=0.389N P=0.101N | P=0.471 (e) (e) P=0.977 |
|LOGISTIC REGRESSION | P=0.087N P=0.284N P=0.389N P=0.100N | P=0.193 (e) (e) P=0.494 |
|COCHRAN-ARMITAGE | P=0.095N | P=0.198 |
|FISHER EXACT | P=0.218N P=0.357N P=0.102N | (e) (e) P=0.500 |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05019 TEST: 04 PAGE 9
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CI PIGMENT RED 3
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 1.25% 2.5% 5.0% | UNTREATD 1.25% 2.5% 5.0% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Neurofibrosarcoma, Fibrosarcoma, Sarcoma, |
| Neurofibroma, or Fibroma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 15/50 (30%) 8/50 (16%) 10/50 (20%) 7/50 (14%) | 3/50 (6%) 0/50 (0%) 2/50 (4%) 2/50 (4%) |
|ADJUSTED (b) | 37.8% 25.1% 27.3% 18.3% | 7.0% 0.0% 5.7% 4.8% |
|TERMINAL (d) | 9/33 (27%) 5/28 (18%) 5/31 (16%) 4/33 (12%) | 1/39 (3%) 0/37 (0%) 0/31 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | 450 648 541 294 | 508 --- 679 599 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.072N P=0.173N P=0.238N P=0.069N | P=0.517 P=0.129N P=0.570N P=0.599N |
|INCIDENTAL TUMOR | P=0.115N P=0.114N P=0.153N P=0.058N | P=0.426N P=0.167N P=0.404N P=0.280N |
|LOGISTIC REGRESSION | P=0.070N P=0.117N P=0.186N P=0.052N | P=0.567N P=0.127N P=0.505N P=0.494N |
|COCHRAN-ARMITAGE | P=0.060N | P=0.577N |
|FISHER EXACT | P=0.077N P=0.178N P=0.045N* | P=0.121N P=0.500N P=0.500N |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Neurofibrosarcoma, Fibrosarcoma, or Sarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 12/50 (24%) 7/50 (14%) 8/50 (16%) 6/50 (12%) | 3/50 (6%) 0/50 (0%) 2/50 (4%) 1/50 (2%) |
|ADJUSTED (b) | 30.0% 21.8% 21.7% 15.5% | 7.0% 0.0% 5.7% 2.5% |
|TERMINAL (d) | 6/33 (18%) 4/28 (14%) 3/31 (10%) 3/33 (9%) | 1/39 (3%) 0/37 (0%) 0/31 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | 450 648 541 294 | 508 --- 679 616 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.122N P=0.272N P=0.282N P=0.133N | P=0.448N P=0.129N P=0.570N P=0.404N |
|INCIDENTAL TUMOR | P=0.200N P=0.193N P=0.182N P=0.120N | P=0.293N P=0.167N P=0.404N P=0.255N |
|LOGISTIC REGRESSION | P=0.105N P=0.204N P=0.233N P=0.099N | P=0.330N P=0.127N P=0.505N P=0.300N |
|COCHRAN-ARMITAGE | P=0.105N | P=0.337N |
|FISHER EXACT | P=0.154N P=0.227N P=0.096N | P=0.121N P=0.500N P=0.309N |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05019 TEST: 04 PAGE 10
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CI PIGMENT RED 3
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 1.25% 2.5% 5.0% | UNTREATD 1.25% 2.5% 5.0% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Schwannoma Malignant |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 6.2% 0.0% 0.0% | 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/33 (0%) 1/28 (4%) 0/31 (0%) 0/33 (0%) | 0/39 (0%) 0/37 (0%) 0/31 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | --- 588 --- --- | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.419N P=0.208 (e) (e) | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.299N P=0.180 (e) (e) | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.408N P=0.228 (e) (e) | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.405N | (e) |
|FISHER EXACT | P=0.247 (e) (e) | (e) (e) (e) |
|=================================================================================================================================|
| |
|Spleen |
| Hemangiosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 0/47 (0%) 1/49 (2%) 0/48 (0%) | 1/50 (2%) 2/49 (4%) 2/49 (4%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 3.2% 0.0% | 2.2% 5.4% 6.5% 0.0% |
|TERMINAL (d) | 0/33 (0%) 0/28 (0%) 1/31 (3%) 0/32 (0%) | 0/39 (0%) 2/37 (5%) 2/31 (6%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 729 (T) --- | 653 729 (T) 729 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.693 (e) P=0.488 (e) | P=0.430N P=0.483 P=0.431 P=0.588N |
|INCIDENTAL TUMOR | P=0.693 (e) P=0.488 (e) | P=0.421N P=0.488 P=0.480 P=0.581N |
|LOGISTIC REGRESSION | P=0.693 (e) P=0.488 (e) | P=0.354N P=0.497 P=0.492 P=0.497N |
|COCHRAN-ARMITAGE | P=0.696 | P=0.295N |
|FISHER EXACT | (e) P=0.505 (e) | P=0.492 P=0.492 P=0.500N |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05019 TEST: 04 PAGE 11
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CI PIGMENT RED 3
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 1.25% 2.5% 5.0% | UNTREATD 1.25% 2.5% 5.0% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 1/50 (2%) 5/50 (10%) | 4/50 (8%) 1/50 (2%) 0/49 (0%) 3/50 (6%) |
|ADJUSTED (b) | 0.0% 0.0% 2.6% 14.3% | 9.9% 2.7% 0.0% 12.0% |
|TERMINAL (d) | 0/33 (0%) 0/28 (0%) 0/31 (0%) 4/33 (12%) | 3/39 (8%) 1/37 (3%) 0/31 (0%) 3/25 (12%) |
|FIRST INCIDENCE (DAYS) | --- --- 658 557 | 703 729 (T) --- 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.002 ** (e) P=0.495 P=0.033 * | P=0.507 P=0.199N P=0.097N P=0.575 |
|INCIDENTAL TUMOR | P=0.002 ** (e) P=0.500 P=0.048 * | P=0.514 P=0.194N P=0.077N P=0.577 |
|LOGISTIC REGRESSION | P=0.001 ** (e) P=0.500 P=0.027 * | P=0.525 P=0.190N P=0.079N P=0.596 |
|COCHRAN-ARMITAGE | P=0.002 ** | P=0.501N |
|FISHER EXACT | (e) P=0.500 P=0.028 * | P=0.181N P=0.061N P=0.500N |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 1/50 (2%) 5/50 (10%) | 4/50 (8%) 2/50 (4%) 0/49 (0%) 3/50 (6%) |
|ADJUSTED (b) | 0.0% 0.0% 2.6% 14.3% | 9.9% 5.4% 0.0% 12.0% |
|TERMINAL (d) | 0/33 (0%) 0/28 (0%) 0/31 (0%) 4/33 (12%) | 3/39 (8%) 2/37 (5%) 0/31 (0%) 3/25 (12%) |
|FIRST INCIDENCE (DAYS) | --- --- 658 557 | 703 729 (T) --- 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.002 ** (e) P=0.495 P=0.033 * | P=0.555 P=0.364N P=0.097N P=0.575 |
|INCIDENTAL TUMOR | P=0.002 ** (e) P=0.500 P=0.048 * | P=0.563 P=0.358N P=0.077N P=0.577 |
|LOGISTIC REGRESSION | P=0.001 ** (e) P=0.500 P=0.027 * | P=0.573 P=0.357N P=0.079N P=0.596 |
|COCHRAN-ARMITAGE | P=0.002 ** | P=0.433N |
|FISHER EXACT | (e) P=0.500 P=0.028 * | P=0.339N P=0.061N P=0.500N |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05019 TEST: 04 PAGE 12
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CI PIGMENT RED 3
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 1.25% 2.5% 5.0% | UNTREATD 1.25% 2.5% 5.0% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # # |
|----------- | | |
|OVERALL (a) | | 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | | 5.1% 2.7% 0.0% 0.0% |
|TERMINAL (d) | | 2/39 (5%) 1/37 (3%) 0/31 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | | 729 (T) 729 (T) --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.148N P=0.518N P=0.290N P=0.341N |
|INCIDENTAL TUMOR | | P=0.148N P=0.518N P=0.290N P=0.341N |
|LOGISTIC REGRESSION | | P=0.148N P=0.518N P=0.290N P=0.341N |
|COCHRAN-ARMITAGE | | P=0.101N |
|FISHER EXACT | | P=0.500N P=0.247N P=0.247N |
|=================================================================================================================================|
| |
|All Organs |
| Hemangioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | 2/50 (4%) 1/50 (2%) 0/50 (0%) 2/50 (4%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 5.1% 2.7% 0.0% 8.0% |
|TERMINAL (d) | 0/33 (0%) 0/28 (0%) 0/31 (0%) 0/33 (0%) | 2/39 (5%) 1/37 (3%) 0/31 (0%) 2/25 (8%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- | 729 (T) 729 (T) --- 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) (e) | P=0.441 P=0.518N P=0.290N P=0.526 |
|INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.441 P=0.518N P=0.290N P=0.526 |
|LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.441 P=0.518N P=0.290N P=0.526 |
|COCHRAN-ARMITAGE | (e) | P=0.591 |
|FISHER EXACT | (e) (e) (e) | P=0.500N P=0.247N P=0.691N |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05019 TEST: 04 PAGE 13
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CI PIGMENT RED 3
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 1.25% 2.5% 5.0% | UNTREATD 1.25% 2.5% 5.0% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | 2/50 (4%) 3/50 (6%) 2/50 (4%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 3.4% 3.2% 0.0% | 4.7% 7.8% 6.5% 0.0% |
|TERMINAL (d) | 0/33 (0%) 0/28 (0%) 1/31 (3%) 0/33 (0%) | 1/39 (3%) 2/37 (5%) 2/31 (6%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | --- 710 729 (T) --- | 653 719 729 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.587N P=0.468 P=0.488 (e) | P=0.244N P=0.477 P=0.617 P=0.341N |
|INCIDENTAL TUMOR | P=0.692 P=0.527 P=0.488 (e) | P=0.226N P=0.486 P=0.658 P=0.337N |
|LOGISTIC REGRESSION | P=0.678 P=0.475 P=0.488 (e) | P=0.186N P=0.501 P=0.684 P=0.243N |
|COCHRAN-ARMITAGE | P=0.595N | P=0.134N |
|FISHER EXACT | P=0.500 P=0.500 (e) | P=0.500 P=0.691N P=0.247N |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma or Hemangioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | 3/50 (6%) 4/50 (8%) 2/50 (4%) 2/50 (4%) |
|ADJUSTED (b) | 0.0% 3.4% 3.2% 0.0% | 7.2% 10.5% 6.5% 8.0% |
|TERMINAL (d) | 0/33 (0%) 0/28 (0%) 1/31 (3%) 0/33 (0%) | 2/39 (5%) 3/37 (8%) 2/31 (6%) 2/25 (8%) |
|FIRST INCIDENCE (DAYS) | --- 710 729 (T) --- | 653 719 729 (T) 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.587N P=0.468 P=0.488 (e) | P=0.538N P=0.472 P=0.596N P=0.664 |
|INCIDENTAL TUMOR | P=0.692 P=0.527 P=0.488 (e) | P=0.524N P=0.479 P=0.557N P=0.667 |
|LOGISTIC REGRESSION | P=0.678 P=0.475 P=0.488 (e) | P=0.474N P=0.495 P=0.527N P=0.610N |
|COCHRAN-ARMITAGE | P=0.595N | P=0.319N |
|FISHER EXACT | P=0.500 P=0.500 (e) | P=0.500 P=0.500N P=0.500N |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05019 TEST: 04 PAGE 14
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CI PIGMENT RED 3
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 1.25% 2.5% 5.0% | UNTREATD 1.25% 2.5% 5.0% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Histiocytic Sarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) | 0/50 (0%) 2/50 (4%) 2/50 (4%) 3/50 (6%) |
|ADJUSTED (b) | 0.0% 0.0% 4.8% 0.0% | 0.0% 4.5% 4.6% 7.6% |
|TERMINAL (d) | 0/33 (0%) 0/28 (0%) 0/31 (0%) 0/33 (0%) | 0/39 (0%) 0/37 (0%) 0/31 (0%) 0/25 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 553 --- | --- 568 568 358 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.576 (e) P=0.229 (e) | P=0.077 P=0.234 P=0.224 P=0.097 |
|INCIDENTAL TUMOR | P=0.546N (e) P=0.288 (e) | P=0.455 P=0.395 P=0.748 P=0.187 |
|LOGISTIC REGRESSION | P=0.604 (e) P=0.243 (e) | P=0.094 P=0.204 P=0.194 P=0.094 |
|COCHRAN-ARMITAGE | P=0.595 | P=0.108 |
|FISHER EXACT | (e) P=0.247 (e) | P=0.247 P=0.247 P=0.121 |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Lymphoma And Histiocytic Sarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 8/50 (16%) 7/50 (14%) | 15/50 (30%) 11/50 (22%) 10/50 (20%) 10/50 (20%) |
|ADJUSTED (b) | 6.1% 7.1% 22.1% 19.2% | 36.3% 25.8% 24.8% 29.2% |
|TERMINAL (d) | 2/33 (6%) 2/28 (7%) 5/31 (16%) 4/33 (12%) | 13/39 (33%) 7/37 (19%) 4/31 (13%) 4/25 (16%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 553 555 | 528 540 474 358 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.032 * P=0.635 P=0.042 * P=0.075 | P=0.509N P=0.295N P=0.352N P=0.551N |
|INCIDENTAL TUMOR | P=0.071 P=0.635 P=0.048 * P=0.074 | P=0.128N P=0.233N P=0.107N P=0.310N |
|LOGISTIC REGRESSION | P=0.024 * P=0.635 P=0.046 * P=0.067 | P=0.157N P=0.241N P=0.177N P=0.194N |
|COCHRAN-ARMITAGE | P=0.028 * | P=0.167N |
|FISHER EXACT | P=0.691N P=0.046 * P=0.080 | P=0.247N P=0.178N P=0.178N |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05019 TEST: 04 PAGE 15
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CI PIGMENT RED 3
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 1.25% 2.5% 5.0% | UNTREATD 1.25% 2.5% 5.0% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, |
| NOS, or Undifferentiated Cell Type |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 6/50 (12%) 7/50 (14%) | 15/50 (30%) 9/50 (18%) 8/50 (16%) 7/50 (14%) |
|ADJUSTED (b) | 6.1% 7.1% 18.2% 19.2% | 36.3% 22.3% 21.2% 23.2% |
|TERMINAL (d) | 2/33 (6%) 2/28 (7%) 5/31 (16%) 4/33 (12%) | 13/39 (33%) 7/37 (19%) 4/31 (13%) 4/25 (16%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 556 555 | 528 540 474 599 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.032 * P=0.635 P=0.115 P=0.075 | P=0.222N P=0.151N P=0.190N P=0.259N |
|INCIDENTAL TUMOR | P=0.050 * P=0.635 P=0.128 P=0.074 | P=0.079N P=0.142N P=0.086N P=0.132N |
|LOGISTIC REGRESSION | P=0.022 * P=0.635 P=0.125 P=0.067 | P=0.051N P=0.116N P=0.078N P=0.079N |
|COCHRAN-ARMITAGE | P=0.027 * | P=0.043N* |
|FISHER EXACT | P=0.691N P=0.134 P=0.080 | P=0.121N P=0.077N P=0.045N* |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 16/50 (32%) 17/50 (34%) 20/50 (40%) 28/50 (56%) | 21/50 (42%) 15/50 (30%) 6/50 (12%) 23/50 (46%) |
|ADJUSTED (b) | 42.8% 52.8% 53.3% 75.5% | 49.7% 34.9% 19.4% 67.5% |
|TERMINAL (d) | 12/33 (36%) 13/28 (46%) 14/31 (45%) 24/33 (73%) | 18/39 (46%) 10/37 (27%) 6/31 (19%) 15/25 (60%) |
|FIRST INCIDENCE (DAYS) | 630 650 521 557 | 630 540 729 (T) 557 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.008 ** P=0.288 P=0.218 P=0.010 * | P=0.031 * P=0.209N P=0.006N** P=0.032 * |
|INCIDENTAL TUMOR | P=0.002 ** P=0.345 P=0.262 P=0.006 ** | P=0.319 P=0.107N P=0.002N** P=0.447 |
|LOGISTIC REGRESSION | P=0.001 ** P=0.302 P=0.230 P=0.002 ** | P=0.213 P=0.140N P=0.002N** P=0.244 |
|COCHRAN-ARMITAGE | P=0.005 ** | P=0.332 |
|FISHER EXACT | P=0.500 P=0.266 P=0.013 * | P=0.149N P<0.001N** P=0.420 |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05019 TEST: 04 PAGE 16
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CI PIGMENT RED 3
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 1.25% 2.5% 5.0% | UNTREATD 1.25% 2.5% 5.0% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 18/50 (36%) 23/50 (46%) 25/50 (50%) 17/50 (34%) | 21/50 (42%) 20/50 (40%) 19/50 (38%) 15/50 (30%) |
|ADJUSTED (b) | 42.6% 60.3% 60.5% 42.0% | 46.4% 43.7% 46.6% 40.1% |
|TERMINAL (d) | 9/33 (27%) 13/28 (46%) 15/31 (48%) 10/33 (30%) | 15/39 (38%) 12/37 (32%) 10/31 (32%) 5/25 (20%) |
|FIRST INCIDENCE (DAYS) | 450 512 521 294 | 508 540 474 358 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.396N P=0.106 P=0.112 P=0.563N | P=0.480 P=0.559N P=0.449 P=0.545 |
|INCIDENTAL TUMOR | P=0.543 P=0.103 P=0.127 P=0.442 | P=0.068N P=0.419N P=0.307N P=0.179N |
|LOGISTIC REGRESSION | P=0.422N P=0.111 P=0.133 P=0.557N | P=0.112N P=0.497N P=0.419N P=0.158N |
|COCHRAN-ARMITAGE | P=0.376N | P=0.113N |
|FISHER EXACT | P=0.208 P=0.113 P=0.500N | P=0.500N P=0.419N P=0.149N |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 25/50 (50%) 27/50 (54%) 33/50 (66%) 35/50 (70%) | 36/50 (72%) 29/50 (58%) 23/50 (46%) 33/50 (66%) |
|ADJUSTED (b) | 59.4% 70.9% 78.3% 83.3% | 76.6% 61.3% 56.8% 79.7% |
|TERMINAL (d) | 16/33 (48%) 17/28 (61%) 22/31 (71%) 26/33 (79%) | 28/39 (72%) 19/37 (51%) 14/31 (45%) 17/25 (68%) |
|FIRST INCIDENCE (DAYS) | 450 512 521 294 | 508 540 474 358 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.041 * P=0.193 P=0.076 P=0.042 * | P=0.060 P=0.224N P=0.144N P=0.071 |
|INCIDENTAL TUMOR | P=0.004 ** P=0.225 P=0.076 P=0.006 ** | P=0.279N P=0.044N* P=0.004N** P=0.358N |
|LOGISTIC REGRESSION | P=0.003 ** P=0.227 P=0.077 P=0.007 ** | P=0.415N P=0.091N P=0.007N** P=0.407N |
|COCHRAN-ARMITAGE | P=0.016 * | P=0.357N |
|FISHER EXACT | P=0.421 P=0.078 P=0.033 * | P=0.104N P=0.007N** P=0.333N |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05019 TEST: 04 PAGE 17
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- CI PIGMENT RED 3
TERMINAL SACRIFICE AT 105 WEEKS
(a) Number of tumor-bearing animals / number of animals examined at site.
(b) Kaplan-Meier estimated lifetime tumor incidence after adjustment for
intercurrent mortality.
(d) Observed incidence at terminal kill.
(f) Beneath the control incidence are the P-values associated with the trend
test. Beneath the dosed group incidence are the P-values corresponding to
pairwise comparisons between the controls and that dosed group. The life
table analysis regards tumors in animals dying prior to terminal kill as
being (directly or indirectly) the cause of death. The incidental tumor
test regards these lesions as non-fatal. Logistic regression is an alternative
method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage
and Fisher's exact tests compare directly the overall incidence rates.
For all tests, a negative trend is indicated by "N".
(e) Value of Statistic cannot be computed.
(I) Interim sacrifice
(T) Terminal sacrifice
# Tumor rates based on number of animals necropsied.
* To the right of any statistical result, indicates significance at (P<=0.05).
** To the right of any statistical result, indicates significance at (P<=0.01).
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