TDMS Study 05019-03 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: 03 TIME: 14:50:15
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: 03 TIME: 14:50:15
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
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 3 DATE: 09/03/94
EXPERIMENT: 05019 TEST: 03 TIME: 14:50:15
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 RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Adrenal Medulla Pheochromocytoma Benign
Pheochromocytoma: Benign, Complex, Malignant, NOS
Clitoral/Preputial Gland Adenoma
Carcinoma or Adenoma
Ear Schwannoma Benign
Islets, Pancreatic Adenoma
Carcinoma or Adenoma
Mammary Gland Fibroma, Fibroadenoma, Carcinoma, or Adenoma
Pituitary Gland: Pars Distalis or Unspecified Site
Carcinoma or Adenoma
Skin Squamous Cell Papilloma
Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma,
Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma
Skin: Subcutaneous Tissue Fibroma
Neurofibrosarcoma, Fibrosarcoma, or Sarcoma
Testes Adenoma
Zymbal's Gland Carcinoma
All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear,
or Undifferentiated
Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
====================================================================================================
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst CI PIGMENT RED 3 DATE: 09/03/94
EXPERIMENT: 05019 TEST: 03 TIME: 14:50:15
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
====================================================================================================
FEMALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Adrenal Medulla Pheochromocytoma: Benign, Complex, Malignant, NOS
Brain Ependymoma Malignant
Clitoral/Preputial Gland Adenoma
Carcinoma or Adenoma
Liver Hepatocellular Adenoma
Hepatocellular Carcinoma or Hepatocellular Adenoma
Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
Mammary Gland Carcinoma
Fibroadenoma
Fibroma, Fibroadenoma or Adenoma
Fibroma, Fibroadenoma, Carcinoma, or Adenoma
Skin Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma,
Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma
Thyroid Gland: C-Cell Carcinoma
All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear,
or Undifferentiated
Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
====================================================================================================
DATE: 09/03/94 EXPERIMENT: 05019 TEST: 03 PAGE 1
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 3
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.6% 1.25% 2.5% | UNTREATD 0.6% 1.25% 2.5% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | 2/50 (4%) 1/16 (6%) 0/13 (0%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 2.5% 3.6% 0.0% | 6.3% 14.3% 0.0% 0.0% |
|TERMINAL (d) | 0/28 (0%) 1/40 (3%) 1/28 (4%) 0/20 (0%) | 2/32 (6%) 1/7 (14%) 0/2 (0%) 0/40 (0%) |
|FIRST INCIDENCE (DAYS) | --- 729 (T) 729 (T) --- | 729 (T) 729 (T) --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.694N P=0.571 P=0.500 (e) | P=0.091N P=0.524 P=0.878N P=0.191N |
|INCIDENTAL TUMOR | P=0.694N P=0.571 P=0.500 (e) | P=0.091N P=0.524 P=0.878N P=0.191N |
|LOGISTIC REGRESSION | P=0.694N P=0.571 P=0.500 (e) | P=0.091N P=0.524 P=0.878N P=0.191N |
|COCHRAN-ARMITAGE | P=0.591N | P=0.117N |
|FISHER EXACT | P=0.500 P=0.500 (e) | P=0.572 P=0.627N P=0.247N |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 22/50 (44%) 29/50 (58%) 35/50 (70%) 34/50 (68%) | 4/49 (8%) 3/16 (19%) 0/13 (0%) 4/50 (8%) |
|ADJUSTED (b) | 60.2% 65.7% 89.3% 79.9% | 12.0% 42.9% 0.0% 10.0% |
|TERMINAL (d) | 14/28 (50%) 25/40 (63%) 24/28 (86%) 12/20 (60%) | 2/31 (6%) 3/7 (43%) 0/2 (0%) 4/40 (10%) |
|FIRST INCIDENCE (DAYS) | 653 605 529 486 | 723 729 (T) --- 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.527N P=0.019 * P=0.005 ** | P=0.305N P=0.326 P=0.187N P=0.508N |
|INCIDENTAL TUMOR | P=0.004 ** P=0.136 P=0.005 ** P=0.013 * | P=0.377N P=0.086 P=0.346N P=0.614 |
|LOGISTIC REGRESSION | P=0.004 ** P=0.191 P=0.006 ** P=0.010 ** | P=0.303N P=0.080 P=0.648N P=0.548N |
|COCHRAN-ARMITAGE | P=0.010 ** | P=0.440N |
|FISHER EXACT | P=0.115 P=0.007 ** P=0.013 * | P=0.227 P=0.380N P=0.631N |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05019 TEST: 03 PAGE 2
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 3
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.6% 1.25% 2.5% | UNTREATD 0.6% 1.25% 2.5% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Malignant |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 7/50 (14%) 10/50 (20%) 4/50 (8%) | 0/49 (0%) 1/16 (6%) 0/13 (0%) 0/50 (0%) |
|ADJUSTED (b) | 19.4% 17.0% 25.8% 11.5% | 0.0% 14.3% 0.0% 0.0% |
|TERMINAL (d) | 4/28 (14%) 6/40 (15%) 3/28 (11%) 1/20 (5%) | 0/31 (0%) 1/7 (14%) 0/2 (0%) 0/40 (0%) |
|FIRST INCIDENCE (DAYS) | 666 660 529 567 | --- 729 (T) --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.553N P=0.499N P=0.247 P=0.498N | P=0.464N P=0.208 (e) (e) |
|INCIDENTAL TUMOR | P=0.278N P=0.503 P=0.201 P=0.370N | P=0.464N P=0.208 (e) (e) |
|LOGISTIC REGRESSION | P=0.318N P=0.588 P=0.207 P=0.358N | P=0.464N P=0.208 (e) (e) |
|COCHRAN-ARMITAGE | P=0.325N | P=0.517N |
|FISHER EXACT | P=0.500 P=0.207 P=0.370N | P=0.246 (e) (e) |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 24/50 (48%) 32/50 (64%) 37/50 (74%) 36/50 (72%) | 5/49 (10%) 4/16 (25%) 1/13 (8%) 4/50 (8%) |
|ADJUSTED (b) | 64.1% 71.0% 89.9% 82.8% | 15.0% 57.1% 50.0% 10.0% |
|TERMINAL (d) | 15/28 (54%) 27/40 (68%) 24/28 (86%) 13/20 (65%) | 3/31 (10%) 4/7 (57%) 1/2 (50%) 4/40 (10%) |
|FIRST INCIDENCE (DAYS) | 653 605 529 486 | 723 729 (T) 729 (T) 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.555N P=0.025 * P=0.005 ** | P=0.161N P=0.170 P=0.590N P=0.354N |
|INCIDENTAL TUMOR | P=0.005 ** P=0.070 P=0.003 ** P=0.012 * | P=0.207N P=0.034 * P=0.698 P=0.516N |
|LOGISTIC REGRESSION | P=0.005 ** P=0.133 P=0.005 ** P=0.010 ** | P=0.162N P=0.027 * P=0.450 P=0.388N |
|COCHRAN-ARMITAGE | P=0.010 * | P=0.287N |
|FISHER EXACT | P=0.079 P=0.007 ** P=0.012 * | P=0.143 P=0.631N P=0.487N |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05019 TEST: 03 PAGE 3
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 3
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.6% 1.25% 2.5% | UNTREATD 0.6% 1.25% 2.5% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Brain |
| Ependymoma Malignant |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/11 (0%) 0/22 (0%) 0/50 (0%) | 0/50 (0%) 0/10 (0%) 2/13 (15%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 0.0% 0.0% 4.1% 0.0% |
|TERMINAL (d) | 0/28 (0%) 0/1 (0%) 0/0 0/20 (0%) | 0/32 (0%) 0/1 (0%) 0/2 (0%) 0/40 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- | --- --- 429 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) (e) | P=0.590 (e) P=0.244 (e) |
|INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.603 (e) P=0.240 (e) |
|LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.498 (e) P=0.039 * (e) |
|COCHRAN-ARMITAGE | (e) | P=0.627 |
|FISHER EXACT | (e) (e) (e) | (e) P=0.040 * (e) |
|=================================================================================================================================|
| |
|Brain |
| Oligodendroglioma, Glioma, or Astrocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/11 (0%) 2/22 (9%) 0/50 (0%) | 1/50 (2%) 1/10 (10%) 1/13 (8%) 0/50 (0%) |
|ADJUSTED (b) | 3.6% 0.0% 0.0% 0.0% | 2.9% 2.3% 50.0% 0.0% |
|TERMINAL (d) | 1/28 (4%) 0/1 (0%) 0/0 0/20 (0%) | 0/32 (0%) 0/1 (0%) 1/2 (50%) 0/40 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) --- 540 --- | 723 665 729 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.493N P=0.995N P=0.252 P=0.567N | P=0.265N P=0.742N P=0.567 P=0.463N |
|INCIDENTAL TUMOR | P=0.424N P=0.995N P=0.295 P=0.567N | P=0.398N P=0.326 P=0.419 P=0.718N |
|LOGISTIC REGRESSION | P=0.396N P=0.995N P=0.324 P=0.567N | P=0.272N P=0.287 P=0.165 P=0.488N |
|COCHRAN-ARMITAGE | P=0.403N | P=0.284N |
|FISHER EXACT | P=0.820N P=0.219 P=0.500N | P=0.308 P=0.373 P=0.500N |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05019 TEST: 03 PAGE 4
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 3
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.6% 1.25% 2.5% | UNTREATD 0.6% 1.25% 2.5% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 6/49 (12%) 0/13 (0%) 1/25 (4%) 1/50 (2%) | 9/47 (19%) 1/14 (7%) 0/14 (0%) 1/50 (2%) |
|ADJUSTED (b) | 18.0% 0.0% 33.3% 2.9% | 29.1% 2.1% 0.0% 2.5% |
|TERMINAL (d) | 3/28 (11%) 0/3 (0%) 1/3 (33%) 0/20 (0%) | 8/29 (28%) 0/6 (0%) 0/3 (0%) 1/40 (3%) |
|FIRST INCIDENCE (DAYS) | 658 --- 729 (T) 679 | 532 518 --- 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.087N P=0.080N P=0.338N P=0.100N | P=0.001N** P=0.235N P=0.197N P=0.002N** |
|INCIDENTAL TUMOR | P=0.049N* P=0.305N P=0.390N P=0.053N | P=0.001N** P=0.170N P=0.197N P=0.002N** |
|LOGISTIC REGRESSION | P=0.048N* P=0.289N P=0.345N P=0.061N | P=0.003N** P=0.269N P=0.127N P=0.007N** |
|COCHRAN-ARMITAGE | P=0.040N* | P=0.004N** |
|FISHER EXACT | P=0.227N P=0.242N P=0.053N | P=0.269N P=0.079N P=0.006N** |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 7/49 (14%) 0/13 (0%) 1/25 (4%) 1/50 (2%) | 9/47 (19%) 1/14 (7%) 0/14 (0%) 1/50 (2%) |
|ADJUSTED (b) | 21.2% 0.0% 33.3% 2.9% | 29.1% 2.1% 0.0% 2.5% |
|TERMINAL (d) | 4/28 (14%) 0/3 (0%) 1/3 (33%) 0/20 (0%) | 8/29 (28%) 0/6 (0%) 0/3 (0%) 1/40 (3%) |
|FIRST INCIDENCE (DAYS) | 658 --- 729 (T) 679 | 532 518 --- 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.054N P=0.073N P=0.310N P=0.066N | P=0.001N** P=0.235N P=0.197N P=0.002N** |
|INCIDENTAL TUMOR | P=0.030N* P=0.276N P=0.358N P=0.034N* | P=0.001N** P=0.170N P=0.197N P=0.002N** |
|LOGISTIC REGRESSION | P=0.027N* P=0.260N P=0.285N P=0.035N* | P=0.003N** P=0.269N P=0.127N P=0.007N** |
|COCHRAN-ARMITAGE | P=0.020N* | P=0.004N** |
|FISHER EXACT | P=0.175N P=0.172N P=0.028N* | P=0.269N P=0.079N P=0.006N** |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05019 TEST: 03 PAGE 5
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 3
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.6% 1.25% 2.5% | UNTREATD 0.6% 1.25% 2.5% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Ear |
| Schwannoma Benign |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|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% 8.4% | 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/28 (0%) 0/40 (0%) 0/28 (0%) 1/20 (5%) | 0/32 (0%) 0/41 (0%) 0/39 (0%) 0/40 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- 708 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.023 * (e) (e) P=0.196 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.056 (e) (e) P=0.232 | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.034 * (e) (e) P=0.212 | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.046 * | (e) |
|FISHER EXACT | (e) (e) P=0.247 | (e) (e) (e) |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 0/50 (0%) 3/49 (6%) 0/50 (0%) | 0/49 (0%) 1/50 (2%) 0/50 (0%) 0/49 (0%) |
|ADJUSTED (b) | 14.4% 0.0% 9.1% 0.0% | 0.0% 2.4% 0.0% 0.0% |
|TERMINAL (d) | 3/28 (11%) 0/40 (0%) 2/28 (7%) 0/20 (0%) | 0/32 (0%) 1/41 (2%) 0/39 (0%) 0/40 (0%) |
|FIRST INCIDENCE (DAYS) | 534 --- 576 --- | --- 729 (T) --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.072N P=0.020N* P=0.369N P=0.057N | P=0.537N P=0.549 (e) (e) |
|INCIDENTAL TUMOR | P=0.051N P=0.022N* P=0.311N P=0.045N* | P=0.537N P=0.549 (e) (e) |
|LOGISTIC REGRESSION | P=0.039N* P=0.034N* P=0.358N P=0.026N* | P=0.537N P=0.549 (e) (e) |
|COCHRAN-ARMITAGE | P=0.047N* | P=0.560N |
|FISHER EXACT | P=0.028N* P=0.369N P=0.028N* | P=0.505 (e) (e) |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05019 TEST: 03 PAGE 6
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 3
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.6% 1.25% 2.5% | UNTREATD 0.6% 1.25% 2.5% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 0/50 (0%) 3/49 (6%) 0/50 (0%) | 0/49 (0%) 2/50 (4%) 0/50 (0%) 0/49 (0%) |
|ADJUSTED (b) | 14.4% 0.0% 9.1% 0.0% | 0.0% 4.9% 0.0% 0.0% |
|TERMINAL (d) | 3/28 (11%) 0/40 (0%) 2/28 (7%) 0/20 (0%) | 0/32 (0%) 2/41 (5%) 0/39 (0%) 0/40 (0%) |
|FIRST INCIDENCE (DAYS) | 534 --- 576 --- | --- 729 (T) --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.072N P=0.020N* P=0.369N P=0.057N | P=0.362N P=0.294 (e) (e) |
|INCIDENTAL TUMOR | P=0.051N P=0.022N* P=0.311N P=0.045N* | P=0.362N P=0.294 (e) (e) |
|LOGISTIC REGRESSION | P=0.039N* P=0.034N* P=0.358N P=0.026N* | P=0.362N P=0.294 (e) (e) |
|COCHRAN-ARMITAGE | P=0.047N* | P=0.395N |
|FISHER EXACT | P=0.028N* P=0.369N P=0.028N* | P=0.253 (e) (e) |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 3/50 (6%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 10/50 (20%) |
|ADJUSTED (b) | 0.0% 2.5% 10.7% 2.2% | 0.0% 0.0% 2.6% 23.0% |
|TERMINAL (d) | 0/28 (0%) 1/40 (3%) 3/28 (11%) 0/20 (0%) | 0/32 (0%) 0/41 (0%) 1/39 (3%) 7/40 (18%) |
|FIRST INCIDENCE (DAYS) | --- 729 (T) 729 (T) 612 | --- --- 729 (T) 553 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.232 P=0.571 P=0.120 P=0.500 | P<0.001 ** (e) P=0.539 P=0.004 ** |
|INCIDENTAL TUMOR | P=0.266 P=0.571 P=0.120 P=0.581 | P<0.001 ** (e) P=0.539 P=0.002 ** |
|LOGISTIC REGRESSION | P=0.334 P=0.571 P=0.120 P=0.558 | P<0.001 ** (e) P=0.539 P=0.001 ** |
|COCHRAN-ARMITAGE | P=0.350 | P<0.001 ** |
|FISHER EXACT | P=0.500 P=0.121 P=0.500 | (e) P=0.500 P<0.001 ** |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05019 TEST: 03 PAGE 7
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 3
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.6% 1.25% 2.5% | UNTREATD 0.6% 1.25% 2.5% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 4/50 (8%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 10/50 (20%) |
|ADJUSTED (b) | 0.0% 2.5% 14.3% 2.2% | 0.0% 0.0% 2.6% 23.0% |
|TERMINAL (d) | 0/28 (0%) 1/40 (3%) 4/28 (14%) 0/20 (0%) | 0/32 (0%) 0/41 (0%) 1/39 (3%) 7/40 (18%) |
|FIRST INCIDENCE (DAYS) | --- 729 (T) 729 (T) 612 | --- --- 729 (T) 553 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.205 P=0.571 P=0.061 P=0.500 | P<0.001 ** (e) P=0.539 P=0.004 ** |
|INCIDENTAL TUMOR | P=0.234 P=0.571 P=0.061 P=0.581 | P<0.001 ** (e) P=0.539 P=0.002 ** |
|LOGISTIC REGRESSION | P=0.310 P=0.571 P=0.061 P=0.558 | P<0.001 ** (e) P=0.539 P=0.001 ** |
|COCHRAN-ARMITAGE | P=0.336 | P<0.001 ** |
|FISHER EXACT | P=0.500 P=0.059 P=0.500 | (e) P=0.500 P<0.001 ** |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 4/50 (8%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 10/50 (20%) |
|ADJUSTED (b) | 0.0% 2.5% 14.3% 2.2% | 0.0% 0.0% 2.6% 23.0% |
|TERMINAL (d) | 0/28 (0%) 1/40 (3%) 4/28 (14%) 0/20 (0%) | 0/32 (0%) 0/41 (0%) 1/39 (3%) 7/40 (18%) |
|FIRST INCIDENCE (DAYS) | --- 729 (T) 729 (T) 612 | --- --- 729 (T) 553 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.205 P=0.571 P=0.061 P=0.500 | P<0.001 ** (e) P=0.539 P=0.004 ** |
|INCIDENTAL TUMOR | P=0.234 P=0.571 P=0.061 P=0.581 | P<0.001 ** (e) P=0.539 P=0.002 ** |
|LOGISTIC REGRESSION | P=0.310 P=0.571 P=0.061 P=0.558 | P<0.001 ** (e) P=0.539 P=0.001 ** |
|COCHRAN-ARMITAGE | P=0.336 | P<0.001 ** |
|FISHER EXACT | P=0.500 P=0.059 P=0.500 | (e) P=0.500 P<0.001 ** |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05019 TEST: 03 PAGE 8
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 3
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.6% 1.25% 2.5% | UNTREATD 0.6% 1.25% 2.5% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 2/50 (4%) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|ADJUSTED (b) | 0.0% 4.4% 0.0% 9.3% | 3.1% 0.0% 0.0% 5.0% |
|TERMINAL (d) | 0/28 (0%) 1/40 (3%) 0/28 (0%) 1/20 (5%) | 1/32 (3%) 0/41 (0%) 0/39 (0%) 2/40 (5%) |
|FIRST INCIDENCE (DAYS) | --- 420 --- 723 | 729 (T) --- --- 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.170 P=0.279 (e) P=0.179 | P=0.273 P=0.451N P=0.461N P=0.578 |
|INCIDENTAL TUMOR | P=0.240 P=0.279 (e) P=0.232 | P=0.273 P=0.451N P=0.461N P=0.578 |
|LOGISTIC REGRESSION | P=0.284 P=0.275 (e) P=0.195 | P=0.273 P=0.451N P=0.461N P=0.578 |
|COCHRAN-ARMITAGE | P=0.252 | P=0.243 |
|FISHER EXACT | P=0.247 (e) P=0.247 | P=0.500N P=0.500N P=0.500 |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|ADJUSTED (b) | 2.9% 0.0% 2.3% 0.0% | 0.0% 0.0% 5.1% 0.0% |
|TERMINAL (d) | 0/28 (0%) 0/40 (0%) 0/28 (0%) 0/20 (0%) | 0/32 (0%) 0/41 (0%) 2/39 (5%) 0/40 (0%) |
|FIRST INCIDENCE (DAYS) | 690 --- 598 --- | --- --- 729 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.427N P=0.458N P=0.755N P=0.518N | P=0.623 (e) P=0.283 (e) |
|INCIDENTAL TUMOR | P=0.308N P=0.761N P=0.760N P=0.443N | P=0.623 (e) P=0.283 (e) |
|LOGISTIC REGRESSION | P=0.383N P=0.505N P=0.746N P=0.499N | P=0.623 (e) P=0.283 (e) |
|COCHRAN-ARMITAGE | P=0.409N | P=0.591 |
|FISHER EXACT | P=0.500N P=0.753N P=0.500N | (e) P=0.247 (e) |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05019 TEST: 03 PAGE 9
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 3
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.6% 1.25% 2.5% | UNTREATD 0.6% 1.25% 2.5% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 1/50 (2%) 2/50 (4%) | 1/50 (2%) 0/50 (0%) 2/50 (4%) 2/50 (4%) |
|ADJUSTED (b) | 2.9% 4.4% 2.3% 9.3% | 3.1% 0.0% 5.1% 5.0% |
|TERMINAL (d) | 0/28 (0%) 1/40 (3%) 0/28 (0%) 1/20 (5%) | 1/32 (3%) 0/41 (0%) 2/39 (5%) 2/40 (5%) |
|FIRST INCIDENCE (DAYS) | 690 420 598 723 | 729 (T) --- 729 (T) 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.358 P=0.565 P=0.755N P=0.423 | P=0.281 P=0.451N P=0.569 P=0.578 |
|INCIDENTAL TUMOR | P=0.515 P=0.402 P=0.760N P=0.528 | P=0.281 P=0.451N P=0.569 P=0.578 |
|LOGISTIC REGRESSION | P=0.496 P=0.530 P=0.746N P=0.470 | P=0.281 P=0.451N P=0.569 P=0.578 |
|COCHRAN-ARMITAGE | P=0.447 | P=0.241 |
|FISHER EXACT | P=0.500 P=0.753N P=0.500 | P=0.500N P=0.500 P=0.500 |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | 4/50 (8%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 3.6% 0.0% 0.0% 0.0% | 10.1% 2.0% 0.0% 0.0% |
|TERMINAL (d) | 1/28 (4%) 0/40 (0%) 0/28 (0%) 0/20 (0%) | 2/32 (6%) 0/41 (0%) 0/39 (0%) 0/40 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) --- --- --- | 158 390 --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.353N P=0.429N P=0.500N P=0.567N | P=0.018N* P=0.157N P=0.054N P=0.054N |
|INCIDENTAL TUMOR | P=0.353N P=0.429N P=0.500N P=0.567N | P=0.038N* P=0.210N P=0.100N P=0.098N |
|LOGISTIC REGRESSION | P=0.353N P=0.429N P=0.500N P=0.567N | P=0.033N* P=0.209N P=0.094N P=0.087N |
|COCHRAN-ARMITAGE | P=0.309N | P=0.020N* |
|FISHER EXACT | P=0.500N P=0.500N P=0.500N | P=0.181N P=0.059N P=0.059N |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05019 TEST: 03 PAGE 10
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 3
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.6% 1.25% 2.5% | UNTREATD 0.6% 1.25% 2.5% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | 4/50 (8%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |
|ADJUSTED (b) | 3.6% 0.0% 0.0% 0.0% | 10.1% 2.0% 0.0% 2.5% |
|TERMINAL (d) | 1/28 (4%) 0/40 (0%) 0/28 (0%) 0/20 (0%) | 2/32 (6%) 0/41 (0%) 0/39 (0%) 1/40 (3%) |
|FIRST INCIDENCE (DAYS) | 729 (T) --- --- --- | 158 390 --- 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.353N P=0.429N P=0.500N P=0.567N | P=0.095N P=0.157N P=0.054N P=0.148N |
|INCIDENTAL TUMOR | P=0.353N P=0.429N P=0.500N P=0.567N | P=0.176N P=0.210N P=0.100N P=0.249N |
|LOGISTIC REGRESSION | P=0.353N P=0.429N P=0.500N P=0.567N | P=0.163N P=0.209N P=0.094N P=0.232N |
|COCHRAN-ARMITAGE | P=0.309N | P=0.105N |
|FISHER EXACT | P=0.500N P=0.500N P=0.500N | P=0.181N P=0.059N P=0.181N |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) 1/50 (2%) 2/50 (4%) | 23/50 (46%) 16/50 (32%) 20/50 (40%) 12/50 (24%) |
|ADJUSTED (b) | 10.7% 0.0% 2.9% 7.1% | 56.6% 35.4% 45.4% 27.8% |
|TERMINAL (d) | 3/28 (11%) 0/40 (0%) 0/28 (0%) 1/20 (5%) | 15/32 (47%) 12/41 (29%) 15/39 (38%) 9/40 (23%) |
|FIRST INCIDENCE (DAYS) | 729 (T) --- 708 605 | 604 518 611 553 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.546 P=0.066N P=0.292N P=0.623N | P=0.013N* P=0.038N* P=0.173N P=0.006N** |
|INCIDENTAL TUMOR | P=0.596N P=0.066N P=0.319N P=0.586N | P=0.045N* P=0.197N P=0.368N P=0.029N* |
|LOGISTIC REGRESSION | P=0.578N P=0.066N P=0.284N P=0.520N | P=0.024N* P=0.103N P=0.310N P=0.015N* |
|COCHRAN-ARMITAGE | P=0.562N | P=0.028N* |
|FISHER EXACT | P=0.121N P=0.309N P=0.500N | P=0.109N P=0.343N P=0.018N* |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05019 TEST: 03 PAGE 11
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 3
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.6% 1.25% 2.5% | UNTREATD 0.6% 1.25% 2.5% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) 1/50 (2%) 2/50 (4%) | 23/50 (46%) 16/50 (32%) 20/50 (40%) 13/50 (26%) |
|ADJUSTED (b) | 10.7% 0.0% 2.9% 7.1% | 56.6% 35.4% 45.4% 30.1% |
|TERMINAL (d) | 3/28 (11%) 0/40 (0%) 0/28 (0%) 1/20 (5%) | 15/32 (47%) 12/41 (29%) 15/39 (38%) 10/40 (25%) |
|FIRST INCIDENCE (DAYS) | 729 (T) --- 708 605 | 604 518 611 553 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.546 P=0.066N P=0.292N P=0.623N | P=0.022N* P=0.038N* P=0.173N P=0.010N** |
|INCIDENTAL TUMOR | P=0.596N P=0.066N P=0.319N P=0.586N | P=0.070N P=0.197N P=0.368N P=0.046N* |
|LOGISTIC REGRESSION | P=0.578N P=0.066N P=0.284N P=0.520N | P=0.041N* P=0.103N P=0.310N P=0.025N* |
|COCHRAN-ARMITAGE | P=0.562N | P=0.047N* |
|FISHER EXACT | P=0.121N P=0.309N P=0.500N | P=0.109N P=0.343N P=0.030N* |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 0/50 (0%) 1/50 (2%) 2/50 (4%) | 26/50 (52%) 17/50 (34%) 20/50 (40%) 13/50 (26%) |
|ADJUSTED (b) | 14.3% 0.0% 2.9% 7.1% | 60.9% 36.7% 45.4% 30.1% |
|TERMINAL (d) | 4/28 (14%) 0/40 (0%) 0/28 (0%) 1/20 (5%) | 16/32 (50%) 12/41 (29%) 15/39 (38%) 10/40 (25%) |
|FIRST INCIDENCE (DAYS) | 729 (T) --- 708 605 | 158 390 611 553 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.512N P=0.027N* P=0.171N P=0.473N | P=0.006N** P=0.020N* P=0.073N P=0.002N** |
|INCIDENTAL TUMOR | P=0.430N P=0.027N* P=0.189N P=0.437N | P=0.029N* P=0.125N P=0.220N P=0.016N* |
|LOGISTIC REGRESSION | P=0.401N P=0.027N* P=0.160N P=0.364N | P=0.013N* P=0.056N P=0.157N P=0.007N** |
|COCHRAN-ARMITAGE | P=0.380N | P=0.012N* |
|FISHER EXACT | P=0.059N P=0.181N P=0.339N | P=0.053N P=0.158N P=0.007N** |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05019 TEST: 03 PAGE 12
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 3
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.6% 1.25% 2.5% | UNTREATD 0.6% 1.25% 2.5% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip) |
| Squamous Cell Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 2.5% 0.0% 0.0% | 0.0% 0.0% 4.5% 0.0% |
|TERMINAL (d) | 0/28 (0%) 1/40 (3%) 0/28 (0%) 0/20 (0%) | 0/32 (0%) 0/41 (0%) 0/39 (0%) 0/40 (0%) |
|FIRST INCIDENCE (DAYS) | --- 729 (T) --- --- | --- --- 491 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.634N P=0.571 (e) (e) | P=0.603 (e) P=0.254 (e) |
|INCIDENTAL TUMOR | P=0.634N P=0.571 (e) (e) | P=0.510 (e) P=0.166 (e) |
|LOGISTIC REGRESSION | P=0.634N P=0.571 (e) (e) | P=0.528 (e) P=0.171 (e) |
|COCHRAN-ARMITAGE | P=0.559N | P=0.591 |
|FISHER EXACT | P=0.500 (e) (e) | (e) P=0.247 (e) |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip) |
| Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 1/50 (2%) 2/50 (4%) 0/50 (0%) |
|ADJUSTED (b) | 3.6% 2.5% 0.0% 0.0% | 0.0% 2.4% 4.5% 0.0% |
|TERMINAL (d) | 1/28 (4%) 1/40 (3%) 0/28 (0%) 0/20 (0%) | 0/32 (0%) 1/41 (2%) 0/39 (0%) 0/40 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) --- --- | --- 729 (T) 491 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.289N P=0.680N P=0.500N P=0.567N | P=0.591N P=0.549 P=0.254 (e) |
|INCIDENTAL TUMOR | P=0.289N P=0.680N P=0.500N P=0.567N | P=0.640 P=0.549 P=0.166 (e) |
|LOGISTIC REGRESSION | P=0.289N P=0.680N P=0.500N P=0.567N | P=0.652N P=0.549 P=0.171 (e) |
|COCHRAN-ARMITAGE | P=0.233N | P=0.614N |
|FISHER EXACT | P=0.753N P=0.500N P=0.500N | P=0.500 P=0.247 (e) |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05019 TEST: 03 PAGE 13
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 3
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.6% 1.25% 2.5% | UNTREATD 0.6% 1.25% 2.5% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 17/50 (34%) 9/16 (56%) 8/25 (32%) 12/50 (24%) | 25/50 (50%) 13/22 (59%) 12/20 (60%) 22/50 (44%) |
|ADJUSTED (b) | 47.9% 73.9% 71.7% 35.3% | 60.3% 78.5% 89.9% 49.9% |
|TERMINAL (d) | 11/28 (39%) 5/7 (71%) 2/3 (67%) 3/20 (15%) | 16/32 (50%) 10/13 (77%) 8/9 (89%) 18/40 (45%) |
|FIRST INCIDENCE (DAYS) | 637 581 529 577 | 604 639 611 477 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.428N P=0.471 P=0.474 P=0.419N | P=0.081N P=0.470N P=0.569 P=0.128N |
|INCIDENTAL TUMOR | P=0.108N P=0.094 P=0.426 P=0.183N | P=0.227N P=0.108 P=0.219 P=0.420N |
|LOGISTIC REGRESSION | P=0.093N P=0.071 P=0.547 P=0.195N | P=0.177N P=0.127 P=0.141 P=0.313N |
|COCHRAN-ARMITAGE | P=0.088N | P=0.250N |
|FISHER EXACT | P=0.099 P=0.538N P=0.189N | P=0.325 P=0.312 P=0.344N |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 17/50 (34%) 10/16 (63%) 8/25 (32%) 12/50 (24%) | 25/50 (50%) 13/22 (59%) 13/20 (65%) 22/50 (44%) |
|ADJUSTED (b) | 47.9% 86.9% 71.7% 35.3% | 60.3% 78.5% 90.1% 49.9% |
|TERMINAL (d) | 11/28 (39%) 6/7 (86%) 2/3 (67%) 3/20 (15%) | 16/32 (50%) 10/13 (77%) 8/9 (89%) 18/40 (45%) |
|FIRST INCIDENCE (DAYS) | 637 581 529 577 | 604 639 611 477 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.403N P=0.317 P=0.474 P=0.419N | P=0.087N P=0.470N P=0.481 P=0.128N |
|INCIDENTAL TUMOR | P=0.097N P=0.037 * P=0.426 P=0.183N | P=0.250N P=0.108 P=0.124 P=0.420N |
|LOGISTIC REGRESSION | P=0.080N P=0.026 * P=0.547 P=0.195N | P=0.183N P=0.127 P=0.076 P=0.313N |
|COCHRAN-ARMITAGE | P=0.075N | P=0.255N |
|FISHER EXACT | P=0.043 * P=0.538N P=0.189N | P=0.325 P=0.192 P=0.344N |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05019 TEST: 03 PAGE 14
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 3
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.6% 1.25% 2.5% | UNTREATD 0.6% 1.25% 2.5% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Basal Cell Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 1/50 (2%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 3.2% 5.0% 3.6% 0.0% | 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/28 (0%) 2/40 (5%) 1/28 (4%) 0/20 (0%) | 0/32 (0%) 0/41 (0%) 0/39 (0%) 0/40 (0%) |
|FIRST INCIDENCE (DAYS) | 706 729 (T) 729 (T) --- | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.322N P=0.611 P=0.744N P=0.520N | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.274N P=0.444 P=0.745 P=0.443N | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.279N P=0.554 P=0.757N P=0.510N | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.244N | (e) |
|FISHER EXACT | P=0.500 P=0.753N P=0.500N | (e) (e) (e) |
|=================================================================================================================================|
| |
|Skin |
| Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 2/50 (4%) 2/50 (4%) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 6.0% 0.0% 7.1% 10.0% | 6.3% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/28 (4%) 0/40 (0%) 2/28 (7%) 2/20 (10%) | 2/32 (6%) 0/41 (0%) 0/39 (0%) 0/40 (0%) |
|FIRST INCIDENCE (DAYS) | 663 --- 729 (T) 729 (T) | 729 (T) --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.293 P=0.193N P=0.689N P=0.596 | P=0.100N P=0.186N P=0.196N P=0.191N |
|INCIDENTAL TUMOR | P=0.342 P=0.320N P=0.681 P=0.630 | P=0.100N P=0.186N P=0.196N P=0.191N |
|LOGISTIC REGRESSION | P=0.387 P=0.240N P=0.690N P=0.668 | P=0.100N P=0.186N P=0.196N P=0.191N |
|COCHRAN-ARMITAGE | P=0.438 | P=0.118N |
|FISHER EXACT | P=0.247N P=0.691N P=0.691N | P=0.247N P=0.247N P=0.247N |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05019 TEST: 03 PAGE 15
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 3
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.6% 1.25% 2.5% | UNTREATD 0.6% 1.25% 2.5% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 4/50 (8%) 2/50 (4%) 6/50 (12%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 10.0% 5.9% 25.0% | 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/28 (0%) 4/40 (10%) 1/28 (4%) 4/20 (20%) | 0/32 (0%) 0/41 (0%) 0/39 (0%) 0/40 (0%) |
|FIRST INCIDENCE (DAYS) | --- 729 (T) 641 679 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.004 ** P=0.117 P=0.235 P=0.008 ** | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.010 * P=0.117 P=0.257 P=0.011 * | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.014 * P=0.117 P=0.239 P=0.013 * | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.023 * | (e) |
|FISHER EXACT | P=0.059 P=0.247 P=0.013 * | (e) (e) (e) |
|=================================================================================================================================|
| |
|Skin |
| Trichoepithelioma, Basal Cell Carcinoma, or Basal Cell Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) 1/50 (2%) 0/50 (0%) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 6.7% 7.5% 3.6% 0.0% | 3.1% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/28 (4%) 3/40 (8%) 1/28 (4%) 0/20 (0%) | 1/32 (3%) 0/41 (0%) 0/39 (0%) 0/40 (0%) |
|FIRST INCIDENCE (DAYS) | 706 729 (T) 729 (T) --- | 729 (T) --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.156N P=0.650 P=0.483N P=0.289N | P=0.287N P=0.451N P=0.461N P=0.455N |
|INCIDENTAL TUMOR | P=0.133N P=0.524 P=0.517N P=0.242N | P=0.287N P=0.451N P=0.461N P=0.455N |
|LOGISTIC REGRESSION | P=0.126N P=0.592 P=0.484N P=0.259N | P=0.287N P=0.451N P=0.461N P=0.455N |
|COCHRAN-ARMITAGE | P=0.101N | P=0.309N |
|FISHER EXACT | P=0.500 P=0.500N P=0.247N | P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05019 TEST: 03 PAGE 16
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 3
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.6% 1.25% 2.5% | UNTREATD 0.6% 1.25% 2.5% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma, |
| Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 7/50 (14%) 5/50 (10%) 8/50 (16%) | 3/50 (6%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 12.4% 17.5% 16.3% 34.3% | 9.4% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/28 (7%) 7/40 (18%) 4/28 (14%) 6/20 (30%) | 3/32 (9%) 0/41 (0%) 0/39 (0%) 0/40 (0%) |
|FIRST INCIDENCE (DAYS) | 663 729 (T) 641 679 | 729 (T) --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.042 * P=0.468 P=0.510 P=0.085 | P=0.038N* P=0.081N P=0.088N P=0.085N |
|INCIDENTAL TUMOR | P=0.089 P=0.300 P=0.491 P=0.119 | P=0.038N* P=0.081N P=0.088N P=0.085N |
|LOGISTIC REGRESSION | P=0.120 P=0.347 P=0.505 P=0.136 | P=0.038N* P=0.081N P=0.088N P=0.085N |
|COCHRAN-ARMITAGE | P=0.191 | P=0.049N* |
|FISHER EXACT | P=0.262 P=0.500 P=0.178 | P=0.121N P=0.121N P=0.121N |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Fibroma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 0/50 (0%) 2/50 (4%) 4/50 (8%) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |
|ADJUSTED (b) | 12.0% 0.0% 5.2% 13.2% | 0.0% 2.4% 2.6% 0.0% |
|TERMINAL (d) | 2/28 (7%) 0/40 (0%) 0/28 (0%) 0/20 (0%) | 0/32 (0%) 1/41 (2%) 1/39 (3%) 0/40 (0%) |
|FIRST INCIDENCE (DAYS) | 653 --- 687 581 | --- 729 (T) 729 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.260 P=0.040N* P=0.318N P=0.545 | P=0.560N P=0.549 P=0.539 (e) |
|INCIDENTAL TUMOR | P=0.568 P=0.109N P=0.380N P=0.562N | P=0.560N P=0.549 P=0.539 (e) |
|LOGISTIC REGRESSION | P=0.376 P=0.062N P=0.337N P=0.640N | P=0.560N P=0.549 P=0.539 (e) |
|COCHRAN-ARMITAGE | P=0.363 | P=0.591N |
|FISHER EXACT | P=0.059N P=0.339N P=0.643N | P=0.500 P=0.500 (e) |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05019 TEST: 03 PAGE 17
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 3
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.6% 1.25% 2.5% | UNTREATD 0.6% 1.25% 2.5% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Fibrosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | 1/50 (2%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |
|ADJUSTED (b) | 5.9% 5.0% 0.0% 0.0% | 2.4% 2.2% 2.6% 0.0% |
|TERMINAL (d) | 1/28 (4%) 2/40 (5%) 0/28 (0%) 0/20 (0%) | 0/32 (0%) 0/41 (0%) 1/39 (3%) 0/40 (0%) |
|FIRST INCIDENCE (DAYS) | 658 729 (T) --- --- | 687 612 729 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.114N P=0.593N P=0.242N P=0.285N | P=0.301N P=0.758 P=0.741N P=0.495N |
|INCIDENTAL TUMOR | P=0.095N P=0.695 P=0.255N P=0.242N | P=0.370N P=0.593 P=0.712 P=0.718N |
|LOGISTIC REGRESSION | P=0.089N P=0.678N P=0.237N P=0.238N | P=0.321N P=0.751 P=0.759N P=0.503N |
|COCHRAN-ARMITAGE | P=0.085N | P=0.311N |
|FISHER EXACT | P=0.691N P=0.247N P=0.247N | P=0.753N P=0.753N P=0.500N |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Neurofibrosarcoma, Fibrosarcoma, Sarcoma, |
| Neurofibroma, or Fibroma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 2/50 (4%) 2/50 (4%) 4/50 (8%) | 1/50 (2%) 2/50 (4%) 2/50 (4%) 0/50 (0%) |
|ADJUSTED (b) | 17.0% 5.0% 5.2% 13.2% | 2.4% 4.6% 5.1% 0.0% |
|TERMINAL (d) | 2/28 (7%) 2/40 (5%) 0/28 (0%) 0/20 (0%) | 0/32 (0%) 1/41 (2%) 2/39 (5%) 0/40 (0%) |
|FIRST INCIDENCE (DAYS) | 653 729 (T) 687 581 | 687 612 729 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.541N P=0.075N P=0.132N P=0.482N | P=0.269N P=0.526 P=0.543 P=0.495N |
|INCIDENTAL TUMOR | P=0.226N P=0.284N P=0.163N P=0.261N | P=0.319N P=0.354 P=0.468 P=0.718N |
|LOGISTIC REGRESSION | P=0.391N P=0.128N P=0.134N P=0.364N | P=0.294N P=0.492 P=0.509 P=0.503N |
|COCHRAN-ARMITAGE | P=0.394N | P=0.294N |
|FISHER EXACT | P=0.134N P=0.134N P=0.370N | P=0.500 P=0.500 P=0.500N |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05019 TEST: 03 PAGE 18
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 3
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.6% 1.25% 2.5% | UNTREATD 0.6% 1.25% 2.5% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Neurofibrosarcoma, Fibrosarcoma, or Sarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | 1/50 (2%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |
|ADJUSTED (b) | 9.1% 5.0% 0.0% 0.0% | 2.4% 2.2% 2.6% 0.0% |
|TERMINAL (d) | 1/28 (4%) 2/40 (5%) 0/28 (0%) 0/20 (0%) | 0/32 (0%) 0/41 (0%) 1/39 (3%) 0/40 (0%) |
|FIRST INCIDENCE (DAYS) | 658 729 (T) --- --- | 687 612 729 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.057N P=0.374N P=0.126N P=0.167N | P=0.301N P=0.758 P=0.741N P=0.495N |
|INCIDENTAL TUMOR | P=0.038N* P=0.622N P=0.138N P=0.106N | P=0.370N P=0.593 P=0.712 P=0.718N |
|LOGISTIC REGRESSION | P=0.042N* P=0.469N P=0.120N P=0.126N | P=0.321N P=0.751 P=0.759N P=0.503N |
|COCHRAN-ARMITAGE | P=0.039N* | P=0.311N |
|FISHER EXACT | P=0.500N P=0.121N P=0.121N | P=0.753N P=0.753N P=0.500N |
|=================================================================================================================================|
| |
|Spleen |
| Hemangiosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 1/50 (2%) 0/49 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 2.1% 4.6% 3.6% 0.0% | 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/28 (0%) 1/40 (3%) 1/28 (4%) 0/20 (0%) | 0/32 (0%) 0/41 (0%) 0/39 (0%) 0/40 (0%) |
|FIRST INCIDENCE (DAYS) | 587 610 729 (T) --- | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.297N P=0.541 P=0.751 P=0.508N | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.241N P=0.499 P=0.743N P=0.443N | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.229N P=0.505 P=0.752N P=0.425N | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.248N | (e) |
|FISHER EXACT | P=0.500 P=0.753N P=0.505N | (e) (e) (e) |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05019 TEST: 03 PAGE 19
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 3
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.6% 1.25% 2.5% | UNTREATD 0.6% 1.25% 2.5% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 47/50 (94%) 47/49 (96%) 45/48 (94%) 49/50 (98%) | |
|ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | |
|TERMINAL (d) | 28/28 (100%) 39/39 (100%) 26/26 (100%) 20/20 (100%)| |
|FIRST INCIDENCE (DAYS) | 534 420 540 486 | |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.002 ** P=0.016N* P=0.518N P=0.056 | |
|INCIDENTAL TUMOR | P=0.115 P=0.517N P=0.599 P=0.190 | |
|LOGISTIC REGRESSION | P=0.176 P=0.519 P=0.582 P=0.239 | |
|COCHRAN-ARMITAGE | P=0.265 | |
|FISHER EXACT | P=0.510 P=0.641N P=0.309 | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 0/11 (0%) 0/23 (0%) 4/50 (8%) | 6/50 (12%) 1/12 (8%) 1/13 (8%) 6/50 (12%) |
|ADJUSTED (b) | 11.5% 0.0% 0.0% 13.4% | 16.1% 33.3% 2.4% 15.0% |
|TERMINAL (d) | 2/28 (7%) 0/1 (0%) 0/1 (0%) 1/20 (5%) | 3/32 (9%) 1/3 (33%) 0/2 (0%) 6/40 (15%) |
|FIRST INCIDENCE (DAYS) | 610 --- --- 612 | 687 729 (T) 682 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.366 P=0.214N P=0.226N P=0.551 | P=0.452N P=0.350N P=0.257N P=0.486N |
|INCIDENTAL TUMOR | P=0.531 P=0.368N P=0.223N P=0.598N | P=0.544 P=0.637 P=0.496N P=0.563 |
|LOGISTIC REGRESSION | P=0.525 P=0.372N P=0.188N P=0.631N | P=0.511N P=0.684 P=0.658N P=0.597N |
|COCHRAN-ARMITAGE | P=0.526 | P=0.540 |
|FISHER EXACT | P=0.441N P=0.212N P=0.643N | P=0.591N P=0.554N P=0.620N |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05019 TEST: 03 PAGE 20
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 3
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.6% 1.25% 2.5% | UNTREATD 0.6% 1.25% 2.5% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/11 (9%) 0/23 (0%) 1/50 (2%) | 1/50 (2%) 2/12 (17%) 1/13 (8%) 0/50 (0%) |
|ADJUSTED (b) | 6.1% 100.0% 0.0% 3.6% | 3.1% 34.9% 50.0% 0.0% |
|TERMINAL (d) | 1/28 (4%) 1/1 (100%) 0/1 (0%) 0/20 (0%) | 1/32 (3%) 1/3 (33%) 1/2 (50%) 0/40 (0%) |
|FIRST INCIDENCE (DAYS) | 666 729 (T) --- 708 | 729 (T) 694 729 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.415N P=0.567 P=0.460N P=0.550N | P=0.176N P=0.104 P=0.122 P=0.455N |
|INCIDENTAL TUMOR | P=0.329N P=0.323 P=0.501N P=0.472N | P=0.218N P=0.012 * P=0.122 P=0.455N |
|LOGISTIC REGRESSION | P=0.328N P=0.362 P=0.464N P=0.511N | P=0.202N P=0.010 * P=0.122 P=0.455N |
|COCHRAN-ARMITAGE | P=0.311N | P=0.226N |
|FISHER EXACT | P=0.455 P=0.466N P=0.500N | P=0.093 P=0.373 P=0.500N |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 1/11 (9%) 0/23 (0%) 5/50 (10%) | 7/50 (14%) 3/12 (25%) 2/13 (15%) 6/50 (12%) |
|ADJUSTED (b) | 14.9% 100.0% 0.0% 16.5% | 19.0% 67.5% 51.2% 15.0% |
|TERMINAL (d) | 3/28 (11%) 1/1 (100%) 0/1 (0%) 1/20 (5%) | 4/32 (13%) 2/3 (67%) 1/2 (50%) 6/40 (15%) |
|FIRST INCIDENCE (DAYS) | 610 729 (T) --- 612 | 687 694 682 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.387 P=0.666N P=0.218N P=0.520 | P=0.238N P=0.532 P=0.564N P=0.360N |
|INCIDENTAL TUMOR | P=0.559 P=0.661 P=0.215N P=0.592N | P=0.361N P=0.054 P=0.551 P=0.548N |
|LOGISTIC REGRESSION | P=0.569 P=0.670 P=0.154N P=0.630N | P=0.297N P=0.071 P=0.430 P=0.471N |
|COCHRAN-ARMITAGE | P=0.564N | P=0.372N |
|FISHER EXACT | P=0.706N P=0.141N P=0.630N | P=0.295 P=0.599 P=0.500N |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05019 TEST: 03 PAGE 21
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 3
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.6% 1.25% 2.5% | UNTREATD 0.6% 1.25% 2.5% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/11 (0%) 1/23 (4%) 1/50 (2%) | 1/50 (2%) 0/12 (0%) 0/13 (0%) 2/50 (4%) |
|ADJUSTED (b) | 3.0% 0.0% 100.0% 4.2% | 3.1% 0.0% 0.0% 5.0% |
|TERMINAL (d) | 0/28 (0%) 0/1 (0%) 1/1 (100%) 0/20 (0%) | 1/32 (3%) 0/3 (0%) 0/2 (0%) 2/40 (5%) |
|FIRST INCIDENCE (DAYS) | 700 --- 729 (T) 718 | 729 (T) --- --- 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.480 P=0.462N P=0.542 P=0.721 | P=0.440 P=0.931N P=0.970N P=0.578 |
|INCIDENTAL TUMOR | P=0.615 P=0.761N P=0.499 P=0.698N | P=0.440 P=0.931N P=0.970N P=0.578 |
|LOGISTIC REGRESSION | P=0.577 P=0.882N P=0.460 P=0.750 | P=0.440 P=0.931N P=0.970N P=0.578 |
|COCHRAN-ARMITAGE | P=0.598 | P=0.338 |
|FISHER EXACT | P=0.820N P=0.534 P=0.753N | P=0.806N P=0.794N P=0.500 |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/11 (0%) 1/23 (4%) 2/50 (4%) | 0/50 (0%) 0/12 (0%) 0/13 (0%) 0/50 (0%) |
|ADJUSTED (b) | 3.6% 0.0% 2.6% 5.2% | 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/28 (4%) 0/1 (0%) 0/1 (0%) 0/20 (0%) | 0/32 (0%) 0/3 (0%) 0/2 (0%) 0/40 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) --- 687 626 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.236 P=0.995N P=0.551 P=0.454 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.375 P=0.995N P=0.499 P=0.541 | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.349 P=0.995N P=0.494 P=0.515 | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.349 | (e) |
|FISHER EXACT | P=0.820N P=0.534 P=0.500 | (e) (e) (e) |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05019 TEST: 03 PAGE 22
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 3
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.6% 1.25% 2.5% | UNTREATD 0.6% 1.25% 2.5% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/11 (0%) 2/23 (9%) 3/50 (6%) | 1/50 (2%) 0/12 (0%) 0/13 (0%) 2/50 (4%) |
|ADJUSTED (b) | 6.5% 0.0% 100.0% 9.1% | 3.1% 0.0% 0.0% 5.0% |
|TERMINAL (d) | 1/28 (4%) 0/1 (0%) 1/1 (100%) 0/20 (0%) | 1/32 (3%) 0/3 (0%) 0/2 (0%) 2/40 (5%) |
|FIRST INCIDENCE (DAYS) | 700 --- 687 626 | 729 (T) --- --- 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.207 P=0.438N P=0.309 P=0.433 | P=0.440 P=0.931N P=0.970N P=0.578 |
|INCIDENTAL TUMOR | P=0.394 P=0.716N P=0.248 P=0.584 | P=0.440 P=0.931N P=0.970N P=0.578 |
|LOGISTIC REGRESSION | P=0.357 P=0.810N P=0.239 P=0.502 | P=0.440 P=0.931N P=0.970N P=0.578 |
|COCHRAN-ARMITAGE | P=0.362 | P=0.338 |
|FISHER EXACT | P=0.669N P=0.374 P=0.500 | P=0.806N P=0.794N P=0.500 |
|=================================================================================================================================|
| |
|Tongue |
| Squamous Cell Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 0.0% 0.0% 4.5% 0.0% |
|TERMINAL (d) | 0/28 (0%) 0/40 (0%) 0/28 (0%) 0/20 (0%) | 0/32 (0%) 0/41 (0%) 0/39 (0%) 0/40 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- | --- --- 491 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) (e) | P=0.603 (e) P=0.254 (e) |
|INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.510 (e) P=0.166 (e) |
|LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.528 (e) P=0.171 (e) |
|COCHRAN-ARMITAGE | (e) | P=0.591 |
|FISHER EXACT | (e) (e) (e) | (e) P=0.247 (e) |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05019 TEST: 03 PAGE 23
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 3
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.6% 1.25% 2.5% | UNTREATD 0.6% 1.25% 2.5% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Tongue |
| Squamous Cell Carcinoma or Papilloma Squamous |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|ADJUSTED (b) | 3.6% 0.0% 0.0% 0.0% | 0.0% 0.0% 4.5% 0.0% |
|TERMINAL (d) | 1/28 (4%) 0/40 (0%) 0/28 (0%) 0/20 (0%) | 0/32 (0%) 0/41 (0%) 0/39 (0%) 0/40 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) --- --- --- | --- --- 491 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.353N P=0.429N P=0.500N P=0.567N | P=0.603 (e) P=0.254 (e) |
|INCIDENTAL TUMOR | P=0.353N P=0.429N P=0.500N P=0.567N | P=0.510 (e) P=0.166 (e) |
|LOGISTIC REGRESSION | P=0.353N P=0.429N P=0.500N P=0.567N | P=0.528 (e) P=0.171 (e) |
|COCHRAN-ARMITAGE | P=0.309N | P=0.591 |
|FISHER EXACT | P=0.500N P=0.500N P=0.500N | (e) P=0.247 (e) |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # # |
|----------- | | |
|OVERALL (a) | | 10/50 (20%) 7/50 (14%) 6/50 (12%) 10/50 (20%) |
|ADJUSTED (b) | | 25.6% 16.5% 14.7% 23.4% |
|TERMINAL (d) | | 6/32 (19%) 6/41 (15%) 5/39 (13%) 8/40 (20%) |
|FIRST INCIDENCE (DAYS) | | 409 587 611 477 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.511N P=0.189N P=0.141N P=0.449N |
|INCIDENTAL TUMOR | | P=0.529N P=0.197N P=0.149N P=0.454N |
|LOGISTIC REGRESSION | | P=0.473 P=0.304N P=0.221N P=0.575 |
|COCHRAN-ARMITAGE | | P=0.485 |
|FISHER EXACT | | P=0.298N P=0.207N P=0.598N |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05019 TEST: 03 PAGE 24
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 3
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.6% 1.25% 2.5% | UNTREATD 0.6% 1.25% 2.5% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Uterus |
| Sarcoma Stromal or Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # # |
|----------- | | |
|OVERALL (a) | | 11/50 (22%) 7/50 (14%) 6/50 (12%) 11/50 (22%) |
|ADJUSTED (b) | | 27.7% 16.5% 14.7% 25.0% |
|TERMINAL (d) | | 6/32 (19%) 6/41 (15%) 5/39 (13%) 8/40 (20%) |
|FIRST INCIDENCE (DAYS) | | 409 587 611 477 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.532N P=0.131N P=0.095N P=0.445N |
|INCIDENTAL TUMOR | | P=0.526 P=0.179N P=0.117N P=0.484N |
|LOGISTIC REGRESSION | | P=0.440 P=0.222N P=0.154N P=0.563 |
|COCHRAN-ARMITAGE | | P=0.459 |
|FISHER EXACT | | P=0.218N P=0.143N P=0.595N |
|=================================================================================================================================|
| |
|Zymbal's Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 3/50 (6%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 4.2% 9.6% | 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/28 (0%) 0/40 (0%) 0/28 (0%) 0/20 (0%) | 0/32 (0%) 0/41 (0%) 0/39 (0%) 0/40 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 575 624 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.021 * (e) P=0.237 P=0.103 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.089 (e) P=0.265 P=0.185 | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.035 * (e) P=0.308 P=0.126 | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.027 * | (e) |
|FISHER EXACT | (e) P=0.247 P=0.121 | (e) (e) (e) |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05019 TEST: 03 PAGE 25
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 3
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.6% 1.25% 2.5% | UNTREATD 0.6% 1.25% 2.5% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 2/50 (4%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|ADJUSTED (b) | 2.1% 4.6% 7.1% 0.0% | 0.0% 0.0% 0.0% 2.2% |
|TERMINAL (d) | 0/28 (0%) 1/40 (3%) 2/28 (7%) 0/20 (0%) | 0/32 (0%) 0/41 (0%) 0/39 (0%) 0/40 (0%) |
|FIRST INCIDENCE (DAYS) | 587 610 729 (T) --- | --- --- --- 611 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.373N P=0.541 P=0.490 P=0.508N | P=0.196 (e) (e) P=0.496 |
|INCIDENTAL TUMOR | P=0.300N P=0.499 P=0.518 P=0.419N | P=0.198 (e) (e) P=0.500 |
|LOGISTIC REGRESSION | P=0.275N P=0.505 P=0.504 P=0.416N | P=0.164 (e) (e) P=0.460 |
|COCHRAN-ARMITAGE | P=0.294N | P=0.197 |
|FISHER EXACT | P=0.500 P=0.500 P=0.500N | (e) (e) P=0.500 |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma or Hemangioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 2/50 (4%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|ADJUSTED (b) | 2.1% 4.6% 7.1% 0.0% | 0.0% 0.0% 0.0% 2.2% |
|TERMINAL (d) | 0/28 (0%) 1/40 (3%) 2/28 (7%) 0/20 (0%) | 0/32 (0%) 0/41 (0%) 0/39 (0%) 0/40 (0%) |
|FIRST INCIDENCE (DAYS) | 587 610 729 (T) --- | --- --- --- 611 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.373N P=0.541 P=0.490 P=0.508N | P=0.196 (e) (e) P=0.496 |
|INCIDENTAL TUMOR | P=0.300N P=0.499 P=0.518 P=0.419N | P=0.198 (e) (e) P=0.500 |
|LOGISTIC REGRESSION | P=0.275N P=0.505 P=0.504 P=0.416N | P=0.164 (e) (e) P=0.460 |
|COCHRAN-ARMITAGE | P=0.294N | P=0.197 |
|FISHER EXACT | P=0.500 P=0.500 P=0.500N | (e) (e) P=0.500 |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05019 TEST: 03 PAGE 26
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 3
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.6% 1.25% 2.5% | UNTREATD 0.6% 1.25% 2.5% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, |
| or Undifferentiated |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 22/50 (44%) 6/50 (12%) 2/50 (4%) 1/50 (2%) | 10/50 (20%) 1/50 (2%) 0/50 (0%) 2/50 (4%) |
|ADJUSTED (b) | 55.1% 12.9% 5.8% 2.6% | 25.6% 2.4% 0.0% 4.7% |
|TERMINAL (d) | 11/28 (39%) 2/40 (5%) 1/28 (4%) 0/20 (0%) | 4/32 (13%) 1/41 (2%) 0/39 (0%) 1/40 (3%) |
|FIRST INCIDENCE (DAYS) | 610 420 610 658 | 686 729 (T) --- 682 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001N** P<0.001N** P<0.001N** P<0.001N** | P=0.006N** P=0.003N** P=0.001N** P=0.010N* |
|INCIDENTAL TUMOR | P<0.001N** P=0.003N** P<0.001N** P<0.001N** | P=0.023N* P=0.044N* P=0.004N** P=0.073N |
|LOGISTIC REGRESSION | P<0.001N** P<0.001N** P<0.001N** P<0.001N** | P=0.007N** P=0.005N** P=0.001N** P=0.014N* |
|COCHRAN-ARMITAGE | P<0.001N** | P=0.007N** |
|FISHER EXACT | P<0.001N** P<0.001N** P<0.001N** | P=0.004N** P<0.001N** P=0.014N* |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma Benign, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) 2/50 (4%) 3/50 (6%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 8.0% 2.5% 5.9% 11.5% | 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/28 (4%) 1/40 (3%) 1/28 (4%) 1/20 (5%) | 0/32 (0%) 0/41 (0%) 0/39 (0%) 0/40 (0%) |
|FIRST INCIDENCE (DAYS) | 553 729 (T) 682 690 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.356 P=0.239N P=0.478N P=0.590 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.548 P=0.359N P=0.512N P=0.617N | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.482 P=0.316N P=0.489N P=0.646N | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.473 | (e) |
|FISHER EXACT | P=0.309N P=0.500N P=0.661N | (e) (e) (e) |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05019 TEST: 03 PAGE 27
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 3
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.6% 1.25% 2.5% | UNTREATD 0.6% 1.25% 2.5% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Osteosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 2/50 (4%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 2.9% 0.0% 4.7% 2.6% | 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/28 (0%) 0/40 (0%) 0/28 (0%) 0/20 (0%) | 0/32 (0%) 0/41 (0%) 0/39 (0%) 0/40 (0%) |
|FIRST INCIDENCE (DAYS) | 690 --- 598 658 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.465 P=0.458N P=0.527 P=0.742 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.578N P=0.761N P=0.485 P=0.698N | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.528 P=0.505N P=0.520 P=0.752N | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.495 | (e) |
|FISHER EXACT | P=0.500N P=0.500 P=0.753N | (e) (e) (e) |
|=================================================================================================================================|
| |
|All Organs |
| Osteosarcoma or Osteoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 2/50 (4%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 2.9% 0.0% 4.7% 2.6% | 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/28 (0%) 0/40 (0%) 0/28 (0%) 0/20 (0%) | 0/32 (0%) 0/41 (0%) 0/39 (0%) 0/40 (0%) |
|FIRST INCIDENCE (DAYS) | 690 --- 598 658 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.465 P=0.458N P=0.527 P=0.742 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.578N P=0.761N P=0.485 P=0.698N | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.528 P=0.505N P=0.520 P=0.752N | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.495 | (e) |
|FISHER EXACT | P=0.500N P=0.500 P=0.753N | (e) (e) (e) |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05019 TEST: 03 PAGE 28
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 3
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.6% 1.25% 2.5% | UNTREATD 0.6% 1.25% 2.5% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 49/50 (98%) 50/50 (100%) 50/50 (100%) 49/50 (98%) | 44/50 (88%) 31/50 (62%) 32/50 (64%) 38/50 (76%) |
|ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | 91.6% 67.4% 71.1% 82.6% |
|TERMINAL (d) | 28/28 (100%) 40/40 (100%) 28/28 (100%) 20/20 (100%)| 28/32 (88%) 26/41 (63%) 26/39 (67%) 32/40 (80%) |
|FIRST INCIDENCE (DAYS) | 534 420 529 486 | 409 518 611 477 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.008 ** P=0.021N* P=0.543 P=0.101 | P=0.088N P<0.001N** P=0.002N** P=0.014N* |
|INCIDENTAL TUMOR | P=0.647 P=0.761 P=0.529 P=0.681 | P=0.294N P=0.006N** P=0.004N** P=0.079N |
|LOGISTIC REGRESSION | P=0.621N P=0.507 P=0.498 P=0.717 | P=0.235N P=0.002N** P=0.003N** P=0.071N |
|COCHRAN-ARMITAGE | P=0.591N | P=0.277N |
|FISHER EXACT | P=0.500 P=0.500 P=0.753N | P=0.002N** P=0.005N** P=0.096N |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 32/50 (64%) 22/50 (44%) 22/50 (44%) 16/50 (32%) | 17/50 (34%) 10/50 (20%) 14/50 (28%) 7/50 (14%) |
|ADJUSTED (b) | 70.6% 45.5% 49.5% 42.7% | 39.4% 22.0% 29.7% 15.8% |
|TERMINAL (d) | 15/28 (54%) 14/40 (35%) 8/28 (29%) 3/20 (15%) | 7/32 (22%) 6/41 (15%) 7/39 (18%) 4/40 (10%) |
|FIRST INCIDENCE (DAYS) | 553 420 529 567 | 158 390 429 519 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.081N P=0.009N** P=0.078N P=0.046N* | P=0.024N* P=0.054N P=0.244N P=0.012N* |
|INCIDENTAL TUMOR | P<0.001N** P=0.159N P=0.030N* P<0.001N** | P=0.093N P=0.415N P=0.588N P=0.077N |
|LOGISTIC REGRESSION | P<0.001N** P=0.065N P=0.033N* P<0.001N** | P=0.034N* P=0.093N P=0.380N P=0.020N* |
|COCHRAN-ARMITAGE | P=0.002N** | P=0.030N* |
|FISHER EXACT | P=0.035N* P=0.035N* P=0.001N** | P=0.088N P=0.333N P=0.017N* |
|=================================================================================================================================|
DATE: 09/03/94 EXPERIMENT: 05019 TEST: 03 PAGE 29
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 3
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 0.6% 1.25% 2.5% | UNTREATD 0.6% 1.25% 2.5% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 49/50 (98%) 50/50 (100%) 50/50 (100%) 50/50 (100%)| 46/50 (92%) 35/50 (70%) 38/50 (76%) 41/50 (82%) |
|ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | 92.0% 72.9% 76.0% 85.4% |
|TERMINAL (d) | 28/28 (100%) 40/40 (100%) 28/28 (100%) 20/20 (100%)| 28/32 (88%) 28/41 (68%) 27/39 (69%) 33/40 (83%) |
|FIRST INCIDENCE (DAYS) | 534 420 529 486 | 158 390 429 477 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.005 ** P=0.021N* P=0.543 P=0.080 | P=0.125N P=0.002N** P=0.023N* P=0.027N* |
|INCIDENTAL TUMOR | P=0.252 P=0.761 P=0.529 P=0.443 | P=0.473N P=0.028N* P=0.062N P=0.222N |
|LOGISTIC REGRESSION | P=0.302 P=0.507 P=0.498 P=0.493 | P=0.333N P=0.006N** P=0.062N P=0.115N |
|COCHRAN-ARMITAGE | P=0.309 | P=0.325N |
|FISHER EXACT | P=0.500 P=0.500 P=0.500 | P=0.005N** P=0.027N* P=0.117N |
|=================================================================================================================================|
(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).