TDMS Study 88035-05 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus PRIMACLONE DATE: 12/27/96
EXPERIMENT: 88035 TEST: 05 TIME: 13:17:01
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-05295 ROUTE: DOSED FEED NTP C#: C88035
PATHOLOGIST: TOFT, J. CAS: 0000125-33-7
------------------------------------------------------------------------------------------------------------------------------------
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: MERGE 001 001 0 PPM
MERGE 002 002 0 PPM
MERGE 003 003 600 PPM
MERGE 004 004 600 PPM
MERGE 005 005 1300 PPM
MERGE 006 006 1300 PPM
MERGE 007 007 2500 PPM
MERGE 008 008 2500 PPM
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus PRIMACLONE DATE: 12/27/96
EXPERIMENT: 88035 TEST: 05 TIME: 13:17:01
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-05295 ROUTE: DOSED FEED NTP C#: C88035
PATHOLOGIST: TOFT, J. CAS: 0000125-33-7
RATS(FISCHER344)
----------------------------
FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED.
IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED.
----------------
Adrenal Cortex
Adrenal Medulla
Bone Marrow
Brain
Clitoral Gland
Clitoral/Preputial 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: Battelle Columbus PRIMACLONE DATE: 12/27/96
EXPERIMENT: 88035 TEST: 05 TIME: 13:17:01
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-05295 ROUTE: DOSED FEED NTP C#: C88035
PATHOLOGIST: TOFT, J. CAS: 0000125-33-7
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF THE STUDY OF 3-7PRIMACLONE
====================================================================================================
MALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Adrenal Medulla Pheochromocytoma Benign
Pheochromocytoma: Benign, Complex, Malignant, NOS
Brain Astrocytoma Malignant
Mammary Gland Fibroma, Fibroadenoma, Carcinoma, or Adenoma
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
Carcinoma or Adenoma
Skin Fibroma
Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma
Spleen Fibrosarcoma
Testes Adenoma
Thyroid Gland: C-Cell Adenoma
Carcinoma or Adenoma
Thyroid Gland: Follicular Cell
Adenoma
Carcinoma or Adenoma
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: Battelle Columbus PRIMACLONE DATE: 12/27/96
EXPERIMENT: 88035 TEST: 05 TIME: 13:17:01
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-05295 ROUTE: DOSED FEED NTP C#: C88035
PATHOLOGIST: TOFT, J. CAS: 0000125-33-7
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF THE STUDY OF 3-7PRIMACLONE
====================================================================================================
FEMALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Mammary Gland Fibroadenoma
Fibroma, Fibroadenoma or Adenoma
Fibroma, Fibroadenoma, Carcinoma, or Adenoma
Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva)
Squamous Cell Carcinoma
Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma
Oral Mucosa Squamous Cell Carcinoma
All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated
Malignant and Benign Tumors
====================================================================================================
DATE: 12/27/96 EXPERIMENT: 88035 TEST: 05 PAGE 1
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3-7PRIMACLONE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 600 PPM 1300 PPM 2500 PPM | 0 PPM 600 PPM 1300 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | 1/50 (2%) 2/50 (4%) 0/50 (0%) 1/50 (2%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 4.2% 7.4% 0.0% 3.6% |
|TERMINAL (d) | 0/13 (0%) 0/7 (0%) 0/4 (0%) 0/0 | 1/24 (4%) 2/27 (7%) 0/31 (0%) 1/28 (4%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- | 722 (T) 722 (T) --- 722 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) (e) | P=0.434N P=0.541 P=0.449N P=0.728N |
|INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.434N P=0.541 P=0.449N P=0.728N |
|LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.434N P=0.541 P=0.449N P=0.728N |
|COCHRAN-ARMITAGE | (e) | P=0.478N |
|FISHER EXACT | (e) (e) (e) | P=0.500 P=0.500N P=0.753N |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 23/50 (46%) 28/50 (56%) 24/50 (48%) 12/49 (24%) | 2/50 (4%) 0/50 (0%) 2/49 (4%) 3/50 (6%) |
|ADJUSTED (b) | 79.6% 83.3% 87.0% 85.0% | 6.8% 0.0% 5.2% 10.7% |
|TERMINAL (d) | 8/13 (62%) 3/7 (43%) 2/4 (50%) 0/0 | 1/24 (4%) 0/27 (0%) 1/31 (3%) 3/28 (11%) |
|FIRST INCIDENCE (DAYS) | 305 562 529 522 | 660 --- 389 722 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.066 P=0.017 * P<0.001 ** | P=0.263 P=0.236N P=0.635N P=0.559 |
|INCIDENTAL TUMOR | P=0.170N P=0.175 P=0.392 P=0.627N | P=0.243 P=0.291N P=0.691N P=0.523 |
|LOGISTIC REGRESSION | P=0.231N P=0.213 P=0.413 P=0.367N | P=0.226 P=0.251N P=0.666 P=0.519 |
|COCHRAN-ARMITAGE | P=0.006N** | P=0.228 |
|FISHER EXACT | P=0.212 P=0.500 P=0.021N* | P=0.247N P=0.684 P=0.500 |
|=================================================================================================================================|
DATE: 12/27/96 EXPERIMENT: 88035 TEST: 05 PAGE 2
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3-7PRIMACLONE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 600 PPM 1300 PPM 2500 PPM | 0 PPM 600 PPM 1300 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 23/50 (46%) 28/50 (56%) 24/50 (48%) 12/49 (24%) | 2/50 (4%) 0/50 (0%) 2/49 (4%) 3/50 (6%) |
|ADJUSTED (b) | 79.6% 83.3% 87.0% 85.0% | 6.8% 0.0% 5.2% 10.7% |
|TERMINAL (d) | 8/13 (62%) 3/7 (43%) 2/4 (50%) 0/0 | 1/24 (4%) 0/27 (0%) 1/31 (3%) 3/28 (11%) |
|FIRST INCIDENCE (DAYS) | 305 562 529 522 | 660 --- 389 722 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.066 P=0.017 * P<0.001 ** | P=0.263 P=0.236N P=0.635N P=0.559 |
|INCIDENTAL TUMOR | P=0.170N P=0.175 P=0.392 P=0.627N | P=0.243 P=0.291N P=0.691N P=0.523 |
|LOGISTIC REGRESSION | P=0.231N P=0.213 P=0.413 P=0.367N | P=0.226 P=0.251N P=0.666 P=0.519 |
|COCHRAN-ARMITAGE | P=0.006N** | P=0.228 |
|FISHER EXACT | P=0.212 P=0.500 P=0.021N* | P=0.247N P=0.684 P=0.500 |
|=================================================================================================================================|
| |
|Brain |
| Astrocytoma Malignant |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/49 (0%) 2/49 (4%) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 21.3% | 2.1% 0.0% 3.2% 0.0% |
|TERMINAL (d) | 0/13 (0%) 0/7 (0%) 0/4 (0%) 0/0 | 0/24 (0%) 0/27 (0%) 1/31 (3%) 0/28 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- 589 | 536 --- 722 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.004 ** (e) (e) P=0.039 * | P=0.395N P=0.527N P=0.735N P=0.508N |
|INCIDENTAL TUMOR | P=0.143 (e) (e) P=0.524 | P=0.401N P=0.362N P=0.732N P=0.455N |
|LOGISTIC REGRESSION | P=0.048 * (e) (e) P=0.196 | P=0.420N P=0.420N P=0.749 P=0.522N |
|COCHRAN-ARMITAGE | P=0.045 * | P=0.409N |
|FISHER EXACT | (e) (e) P=0.242 | P=0.500N P=0.753N P=0.500N |
|=================================================================================================================================|
DATE: 12/27/96 EXPERIMENT: 88035 TEST: 05 PAGE 3
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3-7PRIMACLONE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 600 PPM 1300 PPM 2500 PPM | 0 PPM 600 PPM 1300 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 2/50 (4%) 0/49 (0%) | 4/49 (8%) 1/49 (2%) 4/50 (8%) 1/50 (2%) |
|ADJUSTED (b) | 10.8% 4.5% 8.0% 0.0% | 14.9% 3.7% 10.7% 2.5% |
|TERMINAL (d) | 1/13 (8%) 0/7 (0%) 0/4 (0%) 0/0 | 3/24 (13%) 1/27 (4%) 2/31 (6%) 0/28 (0%) |
|FIRST INCIDENCE (DAYS) | 655 673 613 --- | 660 722 (T) 501 605 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.575 P=0.592N P=0.522 P=0.996N | P=0.196N P=0.157N P=0.529N P=0.160N |
|INCIDENTAL TUMOR | P=0.485N P=0.548N P=0.672 P=0.983N | P=0.221N P=0.192N P=0.585N P=0.183N |
|LOGISTIC REGRESSION | P=0.405N P=0.514N P=0.663 P=0.748N | P=0.221N P=0.199N P=0.631N P=0.175N |
|COCHRAN-ARMITAGE | P=0.208N | P=0.224N |
|FISHER EXACT | P=0.500N P=0.691N P=0.253N | P=0.181N P=0.631N P=0.175N |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | 1/49 (2%) 0/49 (0%) 1/50 (2%) 2/50 (4%) |
|ADJUSTED (b) | 2.3% 0.0% 0.0% 0.0% | 3.4% 0.0% 2.0% 6.3% |
|TERMINAL (d) | 0/13 (0%) 0/7 (0%) 0/4 (0%) 0/0 | 0/24 (0%) 0/27 (0%) 0/31 (0%) 1/28 (4%) |
|FIRST INCIDENCE (DAYS) | 526 --- --- --- | 702 --- 456 675 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.298N P=0.491N P=0.483N P=0.509N | P=0.269 P=0.507N P=0.740N P=0.543 |
|INCIDENTAL TUMOR | P=0.191N P=0.464N P=0.682N P=0.295N | P=0.229 P=0.654N P=0.755 P=0.432 |
|LOGISTIC REGRESSION | P=0.254N P=0.552N P=0.545N P=0.436N | P=0.236 P=0.517N P=0.753 P=0.506 |
|COCHRAN-ARMITAGE | P=0.297N | P=0.246 |
|FISHER EXACT | P=0.500N P=0.500N P=0.505N | P=0.500N P=0.747N P=0.508 |
|=================================================================================================================================|
DATE: 12/27/96 EXPERIMENT: 88035 TEST: 05 PAGE 4
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3-7PRIMACLONE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 600 PPM 1300 PPM 2500 PPM | 0 PPM 600 PPM 1300 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) 2/50 (4%) 0/49 (0%) | 5/49 (10%) 1/49 (2%) 5/50 (10%) 3/50 (6%) |
|ADJUSTED (b) | 12.8% 4.5% 8.0% 0.0% | 17.9% 3.7% 12.6% 8.7% |
|TERMINAL (d) | 1/13 (8%) 0/7 (0%) 0/4 (0%) 0/0 | 3/24 (13%) 1/27 (4%) 2/31 (6%) 1/28 (4%) |
|FIRST INCIDENCE (DAYS) | 526 673 613 --- | 660 722 (T) 456 605 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.468N P=0.376N P=0.653N P=0.484N | P=0.417N P=0.093N P=0.514N P=0.309N |
|INCIDENTAL TUMOR | P=0.186N P=0.326N P=0.613N P=0.280N | P=0.472N P=0.141N P=0.583N P=0.398N |
|LOGISTIC REGRESSION | P=0.134N P=0.304N P=0.501N P=0.156N | P=0.464N P=0.118N P=0.630 P=0.349N |
|COCHRAN-ARMITAGE | P=0.109N | P=0.463N |
|FISHER EXACT | P=0.309N P=0.500N P=0.125N | P=0.102N P=0.617N P=0.346N |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|ADJUSTED (b) | 11.9% 0.0% 0.0% 0.0% | 0.0% 0.0% 3.2% 0.0% |
|TERMINAL (d) | 1/13 (8%) 0/7 (0%) 0/4 (0%) 0/0 | 0/24 (0%) 0/27 (0%) 1/31 (3%) 0/28 (0%) |
|FIRST INCIDENCE (DAYS) | 683 --- --- --- | --- --- 722 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.333N P=0.325N P=0.445N (e) | P=0.689 (e) P=0.551 (e) |
|INCIDENTAL TUMOR | P=0.276N P=0.294N P=0.367N P=0.983N | P=0.689 (e) P=0.551 (e) |
|LOGISTIC REGRESSION | P=0.257N P=0.269N P=0.376N P=0.921N | P=0.689 (e) P=0.551 (e) |
|COCHRAN-ARMITAGE | P=0.112N | P=0.667 |
|FISHER EXACT | P=0.247N P=0.247N P=0.253N | (e) P=0.500 (e) |
|=================================================================================================================================|
DATE: 12/27/96 EXPERIMENT: 88035 TEST: 05 PAGE 5
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3-7PRIMACLONE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 600 PPM 1300 PPM 2500 PPM | 0 PPM 600 PPM 1300 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 1/50 (2%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 10.3% 3.6% 2.9% 2.4% | 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/13 (8%) 0/7 (0%) 0/4 (0%) 0/0 | 0/24 (0%) 0/27 (0%) 0/31 (0%) 0/28 (0%) |
|FIRST INCIDENCE (DAYS) | 619 654 613 529 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.424 P=0.572N P=0.639N P=0.589 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.369N P=0.520N P=0.424N P=0.494N | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.435N P=0.501N P=0.513N P=0.616N | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.404N | (e) |
|FISHER EXACT | P=0.500N P=0.500N P=0.500N | (e) (e) (e) |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 1/50 (2%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 10.3% 3.6% 2.9% 16.3% | 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/13 (8%) 0/7 (0%) 0/4 (0%) 0/0 | 0/24 (0%) 0/27 (0%) 0/31 (0%) 0/28 (0%) |
|FIRST INCIDENCE (DAYS) | 619 654 613 529 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.107 P=0.572N P=0.639N P=0.163 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.573N P=0.520N P=0.424N P=0.617N | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.528 P=0.501N P=0.513N P=0.629 | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.553 | (e) |
|FISHER EXACT | P=0.500N P=0.500N P=0.691N | (e) (e) (e) |
|=================================================================================================================================|
DATE: 12/27/96 EXPERIMENT: 88035 TEST: 05 PAGE 6
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3-7PRIMACLONE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 600 PPM 1300 PPM 2500 PPM | 0 PPM 600 PPM 1300 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | 0/49 (0%) 0/50 (0%) 1/50 (2%) 2/50 (4%) |
|ADJUSTED (b) | 2.6% 2.4% 0.0% 0.0% | 0.0% 0.0% 2.5% 7.1% |
|TERMINAL (d) | 0/13 (0%) 0/7 (0%) 0/4 (0%) 0/0 | 0/24 (0%) 0/27 (0%) 0/31 (0%) 2/28 (7%) |
|FIRST INCIDENCE (DAYS) | 583 583 --- --- | --- --- 668 722 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.277N P=0.751N P=0.490N P=0.597N | P=0.077 (e) P=0.532 P=0.272 |
|INCIDENTAL TUMOR | P=0.077N P=0.688N P=0.326N P=0.258N | P=0.068 (e) P=0.427 P=0.272 |
|LOGISTIC REGRESSION | P=0.183N P=0.745 P=0.509N P=0.474N | P=0.071 (e) P=0.501 P=0.272 |
|COCHRAN-ARMITAGE | P=0.222N | P=0.068 |
|FISHER EXACT | P=0.753N P=0.500N P=0.500N | (e) P=0.505 P=0.253 |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 1/50 (2%) 1/50 (2%) | 0/49 (0%) 0/50 (0%) 1/50 (2%) 2/50 (4%) |
|ADJUSTED (b) | 2.6% 2.4% 2.1% 5.6% | 0.0% 0.0% 2.5% 7.1% |
|TERMINAL (d) | 0/13 (0%) 0/7 (0%) 0/4 (0%) 0/0 | 0/24 (0%) 0/27 (0%) 0/31 (0%) 2/28 (7%) |
|FIRST INCIDENCE (DAYS) | 583 583 551 589 | --- --- 668 722 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.506 P=0.751N P=0.745N P=0.621 | P=0.077 (e) P=0.532 P=0.272 |
|INCIDENTAL TUMOR | P=0.274N P=0.688N P=0.555N P=0.469N | P=0.068 (e) P=0.427 P=0.272 |
|LOGISTIC REGRESSION | P=0.531N P=0.745 P=0.749 P=0.755N | P=0.071 (e) P=0.501 P=0.272 |
|COCHRAN-ARMITAGE | P=0.628 | P=0.068 |
|FISHER EXACT | P=0.753N P=0.753N P=0.753N | (e) P=0.505 P=0.253 |
|=================================================================================================================================|
DATE: 12/27/96 EXPERIMENT: 88035 TEST: 05 PAGE 7
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3-7PRIMACLONE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 600 PPM 1300 PPM 2500 PPM | 0 PPM 600 PPM 1300 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 2.4% 0.0% 0.0% | 6.3% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/13 (0%) 0/7 (0%) 0/4 (0%) 0/0 | 1/24 (4%) 0/27 (0%) 0/31 (0%) 0/28 (0%) |
|FIRST INCIDENCE (DAYS) | --- 583 --- --- | 566 --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.616N P=0.510 (e) (e) | P=0.104N P=0.234N P=0.212N P=0.230N |
|INCIDENTAL TUMOR | P=0.364N P=0.567 (e) (e) | P=0.114N P=0.239N P=0.253N P=0.235N |
|LOGISTIC REGRESSION | P=0.500N P=0.481 (e) (e) | P=0.113N P=0.224N P=0.248N P=0.236N |
|COCHRAN-ARMITAGE | P=0.543N | P=0.111N |
|FISHER EXACT | P=0.500 (e) (e) | P=0.247N P=0.247N P=0.247N |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | 1/50 (2%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |
|ADJUSTED (b) | 12.8% 0.0% 0.0% 0.0% | 3.4% 5.6% 2.0% 0.0% |
|TERMINAL (d) | 1/13 (8%) 0/7 (0%) 0/4 (0%) 0/0 | 0/24 (0%) 1/27 (4%) 0/31 (0%) 0/28 (0%) |
|FIRST INCIDENCE (DAYS) | 704 --- --- --- | 702 367 389 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.388N P=0.347N P=0.532N (e) | P=0.223N P=0.514 P=0.741N P=0.474N |
|INCIDENTAL TUMOR | P=0.276N P=0.294N P=0.367N P=0.983N | P=0.253N P=0.522 P=0.720 P=0.573N |
|LOGISTIC REGRESSION | P=0.321N P=0.297N P=0.450N P=0.997N | P=0.284N P=0.569 P=0.739 P=0.497N |
|COCHRAN-ARMITAGE | P=0.111N | P=0.240N |
|FISHER EXACT | P=0.247N P=0.247N P=0.247N | P=0.500 P=0.753N P=0.500N |
|=================================================================================================================================|
DATE: 12/27/96 EXPERIMENT: 88035 TEST: 05 PAGE 8
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3-7PRIMACLONE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 600 PPM 1300 PPM 2500 PPM | 0 PPM 600 PPM 1300 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | 3/50 (6%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |
|ADJUSTED (b) | 12.8% 2.4% 0.0% 0.0% | 9.5% 5.6% 2.0% 0.0% |
|TERMINAL (d) | 1/13 (8%) 0/7 (0%) 0/4 (0%) 0/0 | 1/24 (4%) 1/27 (4%) 0/31 (0%) 0/28 (0%) |
|FIRST INCIDENCE (DAYS) | 704 583 --- --- | 566 367 389 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.307N P=0.601N P=0.532N (e) | P=0.053N P=0.485N P=0.271N P=0.111N |
|INCIDENTAL TUMOR | P=0.124N P=0.520N P=0.367N P=0.983N | P=0.064N P=0.483N P=0.353N P=0.143N |
|LOGISTIC REGRESSION | P=0.145N P=0.503N P=0.450N P=0.997N | P=0.068N P=0.438N P=0.335N P=0.120N |
|COCHRAN-ARMITAGE | P=0.095N | P=0.059N |
|FISHER EXACT | P=0.500N P=0.247N P=0.247N | P=0.500N P=0.309N P=0.121N |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 3/50 (6%) 3/50 (6%) 0/50 (0%) | 22/50 (44%) 25/50 (50%) 16/50 (32%) 12/50 (24%) |
|ADJUSTED (b) | 13.8% 25.4% 35.8% 0.0% | 61.7% 72.9% 40.9% 35.5% |
|TERMINAL (d) | 1/13 (8%) 1/7 (14%) 1/4 (25%) 0/0 | 11/24 (46%) 18/27 (67%) 9/31 (29%) 8/28 (29%) |
|FIRST INCIDENCE (DAYS) | 627 697 669 --- | 415 578 550 489 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.296 P=0.530 P=0.339 P=0.878N | P=0.003N** P=0.450 P=0.057N P=0.017N* |
|INCIDENTAL TUMOR | P=0.580N P=0.618 P=0.549 P=0.248N | P=0.005N** P=0.223 P=0.180N P=0.029N* |
|LOGISTIC REGRESSION | P=0.632N P=0.634 P=0.537 P=0.373N | P=0.004N** P=0.209 P=0.128N P=0.028N* |
|COCHRAN-ARMITAGE | P=0.093N | P=0.006N** |
|FISHER EXACT | P=0.661N P=0.661N P=0.121N | P=0.344 P=0.151N P=0.028N* |
|=================================================================================================================================|
DATE: 12/27/96 EXPERIMENT: 88035 TEST: 05 PAGE 9
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3-7PRIMACLONE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 600 PPM 1300 PPM 2500 PPM | 0 PPM 600 PPM 1300 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 4/50 (8%) 3/50 (6%) 0/50 (0%) | 24/50 (48%) 25/50 (50%) 16/50 (32%) 12/50 (24%) |
|ADJUSTED (b) | 13.8% 27.2% 35.8% 0.0% | 65.4% 72.9% 40.9% 35.5% |
|TERMINAL (d) | 1/13 (8%) 1/7 (14%) 1/4 (25%) 0/0 | 12/24 (50%) 18/27 (67%) 9/31 (29%) 8/28 (29%) |
|FIRST INCIDENCE (DAYS) | 627 583 669 --- | 415 578 550 489 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.396 P=0.379 P=0.339 P=0.878N | P=0.001N** P=0.548N P=0.027N* P=0.007N** |
|INCIDENTAL TUMOR | P=0.385N P=0.481 P=0.549 P=0.248N | P=0.002N** P=0.367 P=0.096N P=0.011N* |
|LOGISTIC REGRESSION | P=0.427N P=0.492 P=0.537 P=0.373N | P=0.001N** P=0.350 P=0.065N P=0.011N* |
|COCHRAN-ARMITAGE | P=0.076N | P=0.002N** |
|FISHER EXACT | P=0.500 P=0.661N P=0.121N | P=0.500 P=0.076N P=0.011N* |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 4/50 (8%) 3/50 (6%) 0/50 (0%) | 25/50 (50%) 26/50 (52%) 17/50 (34%) 12/50 (24%) |
|ADJUSTED (b) | 25.4% 27.2% 35.8% 0.0% | 66.7% 73.4% 42.0% 35.5% |
|TERMINAL (d) | 2/13 (15%) 1/7 (14%) 1/4 (25%) 0/0 | 12/24 (50%) 18/27 (67%) 9/31 (29%) 8/28 (29%) |
|FIRST INCIDENCE (DAYS) | 627 583 669 --- | 415 367 389 489 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.573 P=0.601 P=0.495 P=0.878N | P<0.001N** P=0.546N P=0.030N* P=0.005N** |
|INCIDENTAL TUMOR | P=0.216N P=0.553N P=0.544N P=0.236N | P=0.001N** P=0.371 P=0.105N P=0.007N** |
|LOGISTIC REGRESSION | P=0.261N P=0.524N P=0.576N P=0.362N | P<0.001N** P=0.372 P=0.074N P=0.006N** |
|COCHRAN-ARMITAGE | P=0.022N* | P=0.001N** |
|FISHER EXACT | P=0.500N P=0.357N P=0.028N* | P=0.500 P=0.078N P=0.006N** |
|=================================================================================================================================|
DATE: 12/27/96 EXPERIMENT: 88035 TEST: 05 PAGE 10
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3-7PRIMACLONE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 600 PPM 1300 PPM 2500 PPM | 0 PPM 600 PPM 1300 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) |
| Squamous Cell Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|ADJUSTED (b) | 2.1% 0.0% 0.0% 0.0% | 0.0% 0.0% 0.0% 5.2% |
|TERMINAL (d) | 0/13 (0%) 0/7 (0%) 0/4 (0%) 0/0 | 0/24 (0%) 0/27 (0%) 0/31 (0%) 0/28 (0%) |
|FIRST INCIDENCE (DAYS) | 463 --- --- --- | --- --- --- 433 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.300N P=0.492N P=0.496N P=0.509N | P=0.056 (e) (e) P=0.273 |
|INCIDENTAL TUMOR | P=0.191N P=0.464N P=0.682N P=0.295N | P=0.039 * (e) (e) P=0.222 |
|LOGISTIC REGRESSION | P=0.253N P=0.598N P=0.602N P=0.427N | P=0.032 * (e) (e) P=0.225 |
|COCHRAN-ARMITAGE | P=0.295N | P=0.046 * |
|FISHER EXACT | P=0.500N P=0.500N P=0.500N | (e) (e) P=0.247 |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) |
| Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|ADJUSTED (b) | 2.1% 0.0% 5.3% 0.0% | 0.0% 0.0% 0.0% 5.2% |
|TERMINAL (d) | 0/13 (0%) 0/7 (0%) 0/4 (0%) 0/0 | 0/24 (0%) 0/27 (0%) 0/31 (0%) 0/28 (0%) |
|FIRST INCIDENCE (DAYS) | 463 --- 664 --- | --- --- --- 433 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.586N P=0.492N P=0.724 P=0.509N | P=0.056 (e) (e) P=0.273 |
|INCIDENTAL TUMOR | P=0.409N P=0.464N P=0.657 P=0.295N | P=0.039 * (e) (e) P=0.222 |
|LOGISTIC REGRESSION | P=0.339N P=0.598N P=0.747 P=0.427N | P=0.032 * (e) (e) P=0.225 |
|COCHRAN-ARMITAGE | P=0.409N | P=0.046 * |
|FISHER EXACT | P=0.500N P=0.753N P=0.500N | (e) (e) P=0.247 |
|=================================================================================================================================|
DATE: 12/27/96 EXPERIMENT: 88035 TEST: 05 PAGE 11
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3-7PRIMACLONE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 600 PPM 1300 PPM 2500 PPM | 0 PPM 600 PPM 1300 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Oral Mucosa |
| Squamous Cell Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|ADJUSTED (b) | 2.1% 0.0% 0.0% 0.0% | 0.0% 0.0% 0.0% 5.2% |
|TERMINAL (d) | 0/13 (0%) 0/7 (0%) 0/4 (0%) 0/0 | 0/24 (0%) 0/27 (0%) 0/31 (0%) 0/28 (0%) |
|FIRST INCIDENCE (DAYS) | 463 --- --- --- | --- --- --- 433 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.300N P=0.492N P=0.496N P=0.509N | P=0.056 (e) (e) P=0.273 |
|INCIDENTAL TUMOR | P=0.191N P=0.464N P=0.682N P=0.295N | P=0.039 * (e) (e) P=0.222 |
|LOGISTIC REGRESSION | P=0.253N P=0.598N P=0.602N P=0.427N | P=0.032 * (e) (e) P=0.225 |
|COCHRAN-ARMITAGE | P=0.295N | P=0.046 * |
|FISHER EXACT | P=0.500N P=0.500N P=0.500N | (e) (e) P=0.247 |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 17/49 (35%) 12/50 (24%) 11/48 (23%) 4/49 (8%) | 16/49 (33%) 21/50 (42%) 14/49 (29%) 20/50 (40%) |
|ADJUSTED (b) | 61.1% 37.7% 73.5% 22.9% | 47.9% 56.7% 36.2% 54.5% |
|TERMINAL (d) | 5/13 (38%) 0/7 (0%) 2/4 (50%) 0/0 | 8/23 (35%) 12/27 (44%) 7/30 (23%) 12/28 (43%) |
|FIRST INCIDENCE (DAYS) | 281 526 437 436 | 541 410 543 491 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.318 P=0.391N P=0.434 P=0.445 | P=0.510N P=0.281 P=0.223N P=0.460 |
|INCIDENTAL TUMOR | P=0.005N** P=0.141N P=0.259N P=0.012N* | P=0.380 P=0.195 P=0.456N P=0.284 |
|LOGISTIC REGRESSION | P=0.003N** P=0.172N P=0.152N P=0.003N** | P=0.413 P=0.184 P=0.399N P=0.289 |
|COCHRAN-ARMITAGE | P=0.001N** | P=0.389 |
|FISHER EXACT | P=0.172N P=0.146N P=0.001N** | P=0.226 P=0.413N P=0.291 |
|=================================================================================================================================|
DATE: 12/27/96 EXPERIMENT: 88035 TEST: 05 PAGE 12
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3-7PRIMACLONE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 600 PPM 1300 PPM 2500 PPM | 0 PPM 600 PPM 1300 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 17/49 (35%) 12/50 (24%) 11/48 (23%) 4/49 (8%) | 16/49 (33%) 21/50 (42%) 14/49 (29%) 21/50 (42%) |
|ADJUSTED (b) | 61.1% 37.7% 73.5% 22.9% | 47.9% 56.7% 36.2% 56.0% |
|TERMINAL (d) | 5/13 (38%) 0/7 (0%) 2/4 (50%) 0/0 | 8/23 (35%) 12/27 (44%) 7/30 (23%) 12/28 (43%) |
|FIRST INCIDENCE (DAYS) | 281 526 437 436 | 541 410 543 491 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.318 P=0.391N P=0.434 P=0.445 | P=0.482 P=0.281 P=0.223N P=0.394 |
|INCIDENTAL TUMOR | P=0.005N** P=0.141N P=0.259N P=0.012N* | P=0.295 P=0.195 P=0.456N P=0.208 |
|LOGISTIC REGRESSION | P=0.003N** P=0.172N P=0.152N P=0.003N** | P=0.330 P=0.184 P=0.399N P=0.223 |
|COCHRAN-ARMITAGE | P=0.001N** | P=0.307 |
|FISHER EXACT | P=0.172N P=0.146N P=0.001N** | P=0.226 P=0.413N P=0.226 |
|=================================================================================================================================|
| |
|Skin |
| Basal Cell Carcinoma, Basal Cell Adenoma, Basosquamous Tumor (benign, |
| malignant or NOS), or Trichoepithelioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 15.4% 7.7% 0.0% 2.8% | 3.4% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/13 (15%) 0/7 (0%) 0/4 (0%) 0/0 | 0/24 (0%) 0/27 (0%) 0/31 (0%) 0/28 (0%) |
|FIRST INCIDENCE (DAYS) | 723 (T) 709 --- 544 | 702 --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.413 P=0.672N P=0.520N P=0.465 | P=0.276N P=0.500N P=0.468N P=0.474N |
|INCIDENTAL TUMOR | P=0.631 P=0.631N P=0.520N P=0.705 | P=0.335N P=0.623N P=0.573N P=0.573N |
|LOGISTIC REGRESSION | P=0.671 P=0.641N P=0.520N P=0.713 | P=0.288N P=0.513N P=0.486N P=0.497N |
|COCHRAN-ARMITAGE | P=0.352N | P=0.295N |
|FISHER EXACT | P=0.500N P=0.247N P=0.500N | P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
DATE: 12/27/96 EXPERIMENT: 88035 TEST: 05 PAGE 13
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3-7PRIMACLONE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 600 PPM 1300 PPM 2500 PPM | 0 PPM 600 PPM 1300 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor (M or B), Basal |
| Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepithelioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 3/50 (6%) 1/50 (2%) 2/50 (4%) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|ADJUSTED (b) | 23.1% 13.3% 14.3% 6.1% | 3.4% 0.0% 3.2% 0.0% |
|TERMINAL (d) | 3/13 (23%) 0/7 (0%) 0/4 (0%) 0/0 | 0/24 (0%) 0/27 (0%) 1/31 (3%) 0/28 (0%) |
|FIRST INCIDENCE (DAYS) | 723 (T) 562 697 544 | 702 --- 722 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.158 P=0.496 P=0.716 P=0.182 | P=0.379N P=0.500N P=0.714N P=0.474N |
|INCIDENTAL TUMOR | P=0.537 P=0.562 P=0.641N P=0.506 | P=0.422N P=0.623N P=0.751 P=0.573N |
|LOGISTIC REGRESSION | P=0.605 P=0.645 P=0.704N P=0.517 | P=0.391N P=0.513N P=0.734N P=0.497N |
|COCHRAN-ARMITAGE | P=0.330N | P=0.409N |
|FISHER EXACT | P=0.661N P=0.309N P=0.500N | P=0.500N P=0.753N P=0.500N |
|=================================================================================================================================|
| |
|Skin |
| Fibroma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 3/50 (6%) 3/50 (6%) 0/50 (0%) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |
|ADJUSTED (b) | 8.8% 8.8% 19.9% 0.0% | 2.4% 3.7% 0.0% 3.6% |
|TERMINAL (d) | 0/13 (0%) 0/7 (0%) 0/4 (0%) 0/0 | 0/24 (0%) 1/27 (4%) 0/31 (0%) 1/28 (4%) |
|FIRST INCIDENCE (DAYS) | 619 610 627 --- | 634 722 (T) --- 722 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.610 P=0.645 P=0.504 P=0.723N | P=0.580N P=0.751 P=0.500N P=0.758N |
|INCIDENTAL TUMOR | P=0.011N* P=0.521N P=0.395N P=0.040N* | P=0.586N P=0.761N P=0.581N P=0.757N |
|LOGISTIC REGRESSION | P=0.083N P=0.661 P=0.655 P=0.163N | P=0.592N P=0.754 P=0.512N P=0.762 |
|COCHRAN-ARMITAGE | P=0.093N | P=0.599N |
|FISHER EXACT | P=0.661N P=0.661N P=0.121N | P=0.753N P=0.500N P=0.753N |
|=================================================================================================================================|
DATE: 12/27/96 EXPERIMENT: 88035 TEST: 05 PAGE 14
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3-7PRIMACLONE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 600 PPM 1300 PPM 2500 PPM | 0 PPM 600 PPM 1300 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 3/50 (6%) 5/50 (10%) 0/50 (0%) | 3/50 (6%) 2/50 (4%) 1/50 (2%) 3/50 (6%) |
|ADJUSTED (b) | 8.8% 8.8% 24.7% 0.0% | 7.0% 6.6% 2.2% 10.0% |
|TERMINAL (d) | 0/13 (0%) 0/7 (0%) 0/4 (0%) 0/0 | 0/24 (0%) 1/27 (4%) 0/31 (0%) 2/28 (7%) |
|FIRST INCIDENCE (DAYS) | 619 610 576 --- | 367 675 603 702 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.400 P=0.645 P=0.231 P=0.723N | P=0.568N P=0.513N P=0.297N P=0.633N |
|INCIDENTAL TUMOR | P=0.013N* P=0.521N P=0.592N P=0.040N* | P=0.537 P=0.549N P=0.415N P=0.637 |
|LOGISTIC REGRESSION | P=0.079N P=0.661 P=0.356 P=0.163N | P=0.560 P=0.432N P=0.339N P=0.661N |
|COCHRAN-ARMITAGE | P=0.143N | P=0.573 |
|FISHER EXACT | P=0.661N P=0.357 P=0.121N | P=0.500N P=0.309N P=0.661N |
|=================================================================================================================================|
| |
|Skin |
| Fibrosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) | 1/50 (2%) 1/50 (2%) 1/50 (2%) 2/50 (4%) |
|ADJUSTED (b) | 0.0% 0.0% 5.9% 0.0% | 2.8% 3.0% 2.2% 6.5% |
|TERMINAL (d) | 0/13 (0%) 0/7 (0%) 0/4 (0%) 0/0 | 0/24 (0%) 0/27 (0%) 0/31 (0%) 1/28 (4%) |
|FIRST INCIDENCE (DAYS) | --- --- 576 --- | 660 675 603 702 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.345 (e) P=0.226 (e) | P=0.376 P=0.754 P=0.746N P=0.536 |
|INCIDENTAL TUMOR | P=0.550N (e) P=0.445 (e) | P=0.305 P=0.620 P=0.672 P=0.432 |
|LOGISTIC REGRESSION | P=0.590 (e) P=0.236 (e) | P=0.350 P=0.760 P=0.750 P=0.501 |
|COCHRAN-ARMITAGE | P=0.561 | P=0.348 |
|FISHER EXACT | (e) P=0.247 (e) | P=0.753N P=0.753N P=0.500 |
|=================================================================================================================================|
DATE: 12/27/96 EXPERIMENT: 88035 TEST: 05 PAGE 15
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3-7PRIMACLONE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 600 PPM 1300 PPM 2500 PPM | 0 PPM 600 PPM 1300 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) | 2/50 (4%) 1/50 (2%) 1/50 (2%) 2/50 (4%) |
|ADJUSTED (b) | 0.0% 0.0% 5.9% 0.0% | 4.7% 3.0% 2.2% 6.5% |
|TERMINAL (d) | 0/13 (0%) 0/7 (0%) 0/4 (0%) 0/0 | 0/24 (0%) 0/27 (0%) 0/31 (0%) 1/28 (4%) |
|FIRST INCIDENCE (DAYS) | --- --- 576 --- | 367 675 603 702 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.345 (e) P=0.226 (e) | P=0.579 P=0.506N P=0.485N P=0.664N |
|INCIDENTAL TUMOR | P=0.550N (e) P=0.445 (e) | P=0.501 P=0.566N P=0.588N P=0.663 |
|LOGISTIC REGRESSION | P=0.590 (e) P=0.236 (e) | P=0.530 P=0.395N P=0.552N P=0.696N |
|COCHRAN-ARMITAGE | P=0.561 | P=0.553 |
|FISHER EXACT | (e) P=0.247 (e) | P=0.500N P=0.500N P=0.691N |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, Squamous Cell Carcinoma or Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 1/50 (2%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|ADJUSTED (b) | 7.7% 6.1% 14.3% 3.4% | 0.0% 0.0% 3.2% 0.0% |
|TERMINAL (d) | 1/13 (8%) 0/7 (0%) 0/4 (0%) 0/0 | 0/24 (0%) 0/27 (0%) 1/31 (3%) 0/28 (0%) |
|FIRST INCIDENCE (DAYS) | 723 (T) 562 697 562 | --- --- 722 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.241 P=0.433 P=0.496 P=0.426 | P=0.689 (e) P=0.551 (e) |
|INCIDENTAL TUMOR | P=0.583 P=0.480 P=0.633 P=0.742 | P=0.689 (e) P=0.551 (e) |
|LOGISTIC REGRESSION | P=0.619 P=0.501 P=0.578 P=0.666 | P=0.689 (e) P=0.551 (e) |
|COCHRAN-ARMITAGE | P=0.519N | P=0.667 |
|FISHER EXACT | P=0.500 P=0.753N P=0.753N | (e) P=0.500 (e) |
|=================================================================================================================================|
DATE: 12/27/96 EXPERIMENT: 88035 TEST: 05 PAGE 16
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3-7PRIMACLONE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 600 PPM 1300 PPM 2500 PPM | 0 PPM 600 PPM 1300 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, or Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 1/50 (2%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|ADJUSTED (b) | 7.7% 6.1% 14.3% 3.4% | 0.0% 0.0% 3.2% 0.0% |
|TERMINAL (d) | 1/13 (8%) 0/7 (0%) 0/4 (0%) 0/0 | 0/24 (0%) 0/27 (0%) 1/31 (3%) 0/28 (0%) |
|FIRST INCIDENCE (DAYS) | 723 (T) 562 697 562 | --- --- 722 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.241 P=0.433 P=0.496 P=0.426 | P=0.689 (e) P=0.551 (e) |
|INCIDENTAL TUMOR | P=0.583 P=0.480 P=0.633 P=0.742 | P=0.689 (e) P=0.551 (e) |
|LOGISTIC REGRESSION | P=0.619 P=0.501 P=0.578 P=0.666 | P=0.689 (e) P=0.551 (e) |
|COCHRAN-ARMITAGE | P=0.519N | P=0.667 |
|FISHER EXACT | P=0.500 P=0.753N P=0.753N | (e) P=0.500 (e) |
|=================================================================================================================================|
| |
|Spleen |
| Fibrosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) 0/50 (0%) 0/49 (0%) | 0/49 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|ADJUSTED (b) | 12.9% 3.7% 0.0% 0.0% | 0.0% 0.0% 0.0% 2.3% |
|TERMINAL (d) | 1/13 (8%) 0/7 (0%) 0/4 (0%) 0/0 | 0/24 (0%) 0/27 (0%) 0/31 (0%) 0/28 (0%) |
|FIRST INCIDENCE (DAYS) | 575 661 --- --- | --- --- --- 550 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.147N P=0.367N P=0.210N P=0.565N | P=0.194 (e) (e) P=0.491 |
|INCIDENTAL TUMOR | P=0.062N P=0.312N P=0.122N P=0.253N | P=0.189 (e) (e) P=0.477 |
|LOGISTIC REGRESSION | P=0.045N* P=0.304N P=0.124N P=0.210N | P=0.161 (e) (e) P=0.494 |
|COCHRAN-ARMITAGE | P=0.042N* | P=0.196 |
|FISHER EXACT | P=0.309N P=0.121N P=0.125N | (e) (e) P=0.505 |
|=================================================================================================================================|
DATE: 12/27/96 EXPERIMENT: 88035 TEST: 05 PAGE 17
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3-7PRIMACLONE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 600 PPM 1300 PPM 2500 PPM | 0 PPM 600 PPM 1300 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 41/50 (82%) 44/50 (88%) 42/50 (84%) 43/48 (90%) | |
|ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | |
|TERMINAL (d) | 13/13 (100%) 7/7 (100%) 4/4 (100%) 0/0 | |
|FIRST INCIDENCE (DAYS) | 463 502 551 437 | |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.070 P=0.003 ** P<0.001 ** | |
|INCIDENTAL TUMOR | P=0.042 * P=0.235 P=0.545 P=0.032 * | |
|LOGISTIC REGRESSION | P=0.009 ** P=0.387 P=0.559 P=0.009 ** | |
|COCHRAN-ARMITAGE | P=0.233 | |
|FISHER EXACT | P=0.288 P=0.500 P=0.217 | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 3/50 (6%) 7/49 (14%) 1/49 (2%) | 5/49 (10%) 2/50 (4%) 7/50 (14%) 4/50 (8%) |
|ADJUSTED (b) | 43.3% 30.3% 46.7% 16.7% | 19.4% 5.1% 22.6% 12.6% |
|TERMINAL (d) | 5/13 (38%) 2/7 (29%) 0/4 (0%) 0/0 | 4/24 (17%) 0/27 (0%) 7/31 (23%) 3/28 (11%) |
|FIRST INCIDENCE (DAYS) | 505 583 529 619 | 682 578 722 (T) 491 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.171 P=0.396N P=0.114 P=0.589 | P=0.541N P=0.210N P=0.565 P=0.420N |
|INCIDENTAL TUMOR | P=0.351N P=0.328N P=0.281 P=0.468N | P=0.560N P=0.238N P=0.528 P=0.415N |
|LOGISTIC REGRESSION | P=0.365N P=0.173N P=0.510 P=0.546N | P=0.535 P=0.227N P=0.536 P=0.493N |
|COCHRAN-ARMITAGE | P=0.066N | P=0.521 |
|FISHER EXACT | P=0.159N P=0.597 P=0.032N* | P=0.210N P=0.394 P=0.487N |
|=================================================================================================================================|
DATE: 12/27/96 EXPERIMENT: 88035 TEST: 05 PAGE 18
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3-7PRIMACLONE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 600 PPM 1300 PPM 2500 PPM | 0 PPM 600 PPM 1300 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 3/50 (6%) 8/49 (16%) 1/49 (2%) | 5/49 (10%) 2/50 (4%) 7/50 (14%) 4/50 (8%) |
|ADJUSTED (b) | 45.4% 30.3% 48.5% 16.7% | 19.4% 5.1% 22.6% 12.6% |
|TERMINAL (d) | 5/13 (38%) 2/7 (29%) 0/4 (0%) 0/0 | 4/24 (17%) 0/27 (0%) 7/31 (23%) 3/28 (11%) |
|FIRST INCIDENCE (DAYS) | 505 583 529 619 | 682 578 722 (T) 491 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.177 P=0.279N P=0.118 P=0.607 | P=0.541N P=0.210N P=0.565 P=0.420N |
|INCIDENTAL TUMOR | P=0.259N P=0.217N P=0.333 P=0.442N | P=0.560N P=0.238N P=0.528 P=0.415N |
|LOGISTIC REGRESSION | P=0.298N P=0.108N P=0.509 P=0.415N | P=0.535 P=0.227N P=0.536 P=0.493N |
|COCHRAN-ARMITAGE | P=0.049N* | P=0.521 |
|FISHER EXACT | P=0.100N P=0.590 P=0.017N* | P=0.210N P=0.394 P=0.487N |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 6/49 (12%) 3/49 (6%) | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 5.0% 4.5% 21.7% 10.7% | 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/13 (0%) 0/7 (0%) 0/4 (0%) 0/0 | 0/24 (0%) 0/27 (0%) 0/31 (0%) 0/28 (0%) |
|FIRST INCIDENCE (DAYS) | 697 673 354 529 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.003 ** P=0.726 P=0.026 * P=0.069 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.160 P=0.742N P=0.052 P=0.407 | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.227 P=0.754 P=0.047 * P=0.280 | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.136 | (e) |
|FISHER EXACT | P=0.753N P=0.053 P=0.301 | (e) (e) (e) |
|=================================================================================================================================|
DATE: 12/27/96 EXPERIMENT: 88035 TEST: 05 PAGE 19
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3-7PRIMACLONE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 600 PPM 1300 PPM 2500 PPM | 0 PPM 600 PPM 1300 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) 1/49 (2%) 1/49 (2%) | 1/49 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 7.7% 20.6% 5.6% 5.6% | 4.2% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/13 (8%) 1/7 (14%) 0/4 (0%) 0/0 | 1/24 (4%) 0/27 (0%) 0/31 (0%) 0/28 (0%) |
|FIRST INCIDENCE (DAYS) | 723 (T) 641 667 589 | 722 (T) --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.135 P=0.196 P=0.583 P=0.356 | P=0.273N P=0.477N P=0.449N P=0.469N |
|INCIDENTAL TUMOR | P=0.526 P=0.235 P=0.633 P=0.737 | P=0.273N P=0.477N P=0.449N P=0.469N |
|LOGISTIC REGRESSION | P=0.461 P=0.281 P=0.662 P=0.583 | P=0.273N P=0.477N P=0.449N P=0.469N |
|COCHRAN-ARMITAGE | P=0.438N | P=0.293N |
|FISHER EXACT | P=0.309 P=0.747 P=0.747 | P=0.495N P=0.495N P=0.495N |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 4/50 (8%) 7/49 (14%) 4/49 (8%) | 1/49 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 12.3% 24.2% 26.1% 15.7% | 4.2% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/13 (8%) 1/7 (14%) 0/4 (0%) 0/0 | 1/24 (4%) 0/27 (0%) 0/31 (0%) 0/28 (0%) |
|FIRST INCIDENCE (DAYS) | 697 641 354 529 | 722 (T) --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.225 P=0.024 * P=0.023 * | P=0.273N P=0.477N P=0.449N P=0.469N |
|INCIDENTAL TUMOR | P=0.155 P=0.292 P=0.049 * P=0.317 | P=0.273N P=0.477N P=0.449N P=0.469N |
|LOGISTIC REGRESSION | P=0.266 P=0.309 P=0.076 P=0.207 | P=0.273N P=0.477N P=0.449N P=0.469N |
|COCHRAN-ARMITAGE | P=0.262 | P=0.293N |
|FISHER EXACT | P=0.339 P=0.075 P=0.329 | P=0.495N P=0.495N P=0.495N |
|=================================================================================================================================|
DATE: 12/27/96 EXPERIMENT: 88035 TEST: 05 PAGE 20
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3-7PRIMACLONE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 600 PPM 1300 PPM 2500 PPM | 0 PPM 600 PPM 1300 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # # |
|----------- | | |
|OVERALL (a) | | 8/50 (16%) 7/50 (14%) 6/50 (12%) 7/50 (14%) |
|ADJUSTED (b) | | 24.9% 21.1% 19.4% 19.9% |
|TERMINAL (d) | | 4/24 (17%) 3/27 (11%) 6/31 (19%) 3/28 (11%) |
|FIRST INCIDENCE (DAYS) | | 415 612 722 (T) 489 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.356N P=0.488N P=0.245N P=0.433N |
|INCIDENTAL TUMOR | | P=0.438N P=0.570N P=0.312N P=0.496N |
|LOGISTIC REGRESSION | | P=0.429N P=0.517N P=0.375N P=0.498N |
|COCHRAN-ARMITAGE | | P=0.439N |
|FISHER EXACT | | P=0.500N P=0.387N P=0.500N |
|=================================================================================================================================|
| |
|Uterus |
| Sarcoma Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # # |
|----------- | | |
|OVERALL (a) | | 0/50 (0%) 3/50 (6%) 0/50 (0%) 3/50 (6%) |
|ADJUSTED (b) | | 0.0% 7.9% 0.0% 9.3% |
|TERMINAL (d) | | 0/24 (0%) 1/27 (4%) 0/31 (0%) 2/28 (7%) |
|FIRST INCIDENCE (DAYS) | | --- 415 --- 561 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.192 P=0.123 (e) P=0.137 |
|INCIDENTAL TUMOR | | P=0.177 P=0.215 (e) P=0.134 |
|LOGISTIC REGRESSION | | P=0.149 P=0.178 (e) P=0.121 |
|COCHRAN-ARMITAGE | | P=0.175 |
|FISHER EXACT | | P=0.121 (e) P=0.121 |
|=================================================================================================================================|
DATE: 12/27/96 EXPERIMENT: 88035 TEST: 05 PAGE 21
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3-7PRIMACLONE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 600 PPM 1300 PPM 2500 PPM | 0 PPM 600 PPM 1300 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Sarcoma Stromal or Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # # |
|----------- | | |
|OVERALL (a) | | 8/50 (16%) 10/50 (20%) 6/50 (12%) 10/50 (20%) |
|ADJUSTED (b) | | 24.9% 27.7% 19.4% 28.1% |
|TERMINAL (d) | | 4/24 (17%) 4/27 (15%) 6/31 (19%) 5/28 (18%) |
|FIRST INCIDENCE (DAYS) | | 415 415 722 (T) 489 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.529 P=0.414 P=0.245N P=0.476 |
|INCIDENTAL TUMOR | | P=0.441 P=0.407 P=0.312N P=0.412 |
|LOGISTIC REGRESSION | | P=0.433 P=0.427 P=0.375N P=0.399 |
|COCHRAN-ARMITAGE | | P=0.436 |
|FISHER EXACT | | P=0.398 P=0.387N P=0.398 |
|=================================================================================================================================|
| |
|Vagina |
| Polyp |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # # |
|----------- | | |
|OVERALL (a) | | 1/50 (2%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|ADJUSTED (b) | | 2.7% 0.0% 0.0% 5.9% |
|TERMINAL (d) | | 0/24 (0%) 0/27 (0%) 0/31 (0%) 1/28 (4%) |
|FIRST INCIDENCE (DAYS) | | 646 --- --- 596 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.258 P=0.523N P=0.484N P=0.510 |
|INCIDENTAL TUMOR | | P=0.234 P=0.623N P=0.573N P=0.462 |
|LOGISTIC REGRESSION | | P=0.242 P=0.492N P=0.509N P=0.501 |
|COCHRAN-ARMITAGE | | P=0.246 |
|FISHER EXACT | | P=0.500N P=0.500N P=0.500 |
|=================================================================================================================================|
DATE: 12/27/96 EXPERIMENT: 88035 TEST: 05 PAGE 22
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3-7PRIMACLONE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 600 PPM 1300 PPM 2500 PPM | 0 PPM 600 PPM 1300 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 35/50 (70%) 30/50 (60%) 24/50 (48%) 12/50 (24%) | 13/50 (26%) 13/50 (26%) 13/50 (26%) 22/50 (44%) |
|ADJUSTED (b) | 84.4% 79.3% 100.0% 100.0% | 38.3% 31.7% 31.3% 53.0% |
|TERMINAL (d) | 7/13 (54%) 2/7 (29%) 4/4 (100%) 0/0 | 6/24 (25%) 4/27 (15%) 5/31 (16%) 10/28 (36%) |
|FIRST INCIDENCE (DAYS) | 505 502 354 380 | 561 367 501 477 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.043 * P=0.529 P=0.414 P=0.039 * | P=0.068 P=0.574 P=0.415N P=0.114 |
|INCIDENTAL TUMOR | P<0.001N** P=0.068N P=0.003N** P<0.001N** | P=0.016 * P=0.555N P=0.475 P=0.041 * |
|LOGISTIC REGRESSION | P<0.001N** P=0.059N P=0.023N* P<0.001N** | P=0.018 * P=0.483N P=0.582 P=0.047 * |
|COCHRAN-ARMITAGE | P<0.001N** | P=0.024 * |
|FISHER EXACT | P=0.201N P=0.021N* P<0.001N** | P=0.590N P=0.590N P=0.046 * |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma: Benign, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) 2/50 (4%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 15.4% 18.4% 13.9% 2.5% | 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/13 (15%) 1/7 (14%) 0/4 (0%) 0/0 | 0/24 (0%) 0/27 (0%) 0/31 (0%) 0/28 (0%) |
|FIRST INCIDENCE (DAYS) | 723 (T) 544 627 533 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.261 P=0.341 P=0.389 P=0.486 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.424N P=0.380 P=0.573 P=0.705 | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.472N P=0.499 P=0.555 P=0.739 | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.307N | (e) |
|FISHER EXACT | P=0.500 P=0.691N P=0.500N | (e) (e) (e) |
|=================================================================================================================================|
DATE: 12/27/96 EXPERIMENT: 88035 TEST: 05 PAGE 23
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3-7PRIMACLONE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 600 PPM 1300 PPM 2500 PPM | 0 PPM 600 PPM 1300 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 49/50 (98%) 49/50 (98%) 49/50 (98%) 44/50 (88%) | 39/50 (78%) 35/50 (70%) 35/50 (70%) 33/50 (66%) |
|ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | 90.5% 87.2% 77.5% 79.8% |
|TERMINAL (d) | 13/13 (100%) 7/7 (100%) 4/4 (100%) 0/0 | 20/24 (83%) 22/27 (81%) 21/31 (68%) 20/28 (71%) |
|FIRST INCIDENCE (DAYS) | 281 502 354 436 | 415 410 389 489 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.158 P=0.008 ** P<0.001 ** | P=0.069N P=0.240N P=0.060N P=0.083N |
|INCIDENTAL TUMOR | P=0.080N P=0.729N P=0.555 P=0.283N | P=0.121N P=0.410N P=0.248N P=0.138N |
|LOGISTIC REGRESSION | P=0.043N* P=0.666N P=0.761N P=0.127N | P=0.102N P=0.439N P=0.216N P=0.134N |
|COCHRAN-ARMITAGE | P=0.009N** | P=0.134N |
|FISHER EXACT | P=0.753N P=0.753N P=0.056N | P=0.247N P=0.247N P=0.133N |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 41/50 (82%) 35/50 (70%) 29/50 (58%) 15/50 (30%) | 21/50 (42%) 20/50 (40%) 17/50 (34%) 28/50 (56%) |
|ADJUSTED (b) | 90.6% 88.8% 100.0% 100.0% | 52.1% 46.7% 39.1% 63.6% |
|TERMINAL (d) | 9/13 (69%) 4/7 (57%) 4/4 (100%) 0/0 | 7/24 (29%) 7/27 (26%) 7/31 (23%) 13/28 (46%) |
|FIRST INCIDENCE (DAYS) | 305 502 354 380 | 367 367 389 433 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.026 * P=0.518 P=0.392 P=0.032 * | P=0.213 P=0.508N P=0.165N P=0.258 |
|INCIDENTAL TUMOR | P<0.001N** P=0.062N P=0.004N** P<0.001N** | P=0.052 P=0.490N P=0.401N P=0.086 |
|LOGISTIC REGRESSION | P<0.001N** P=0.061N P=0.008N** P<0.001N** | P=0.059 P=0.351N P=0.327N P=0.114 |
|COCHRAN-ARMITAGE | P<0.001N** | P=0.086 |
|FISHER EXACT | P=0.121N P=0.008N** P<0.001N** | P=0.500N P=0.268N P=0.115 |
|=================================================================================================================================|
DATE: 12/27/96 EXPERIMENT: 88035 TEST: 05 PAGE 24
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 3-7PRIMACLONE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 600 PPM 1300 PPM 2500 PPM | 0 PPM 600 PPM 1300 PPM 2500 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 50/50 (100%) 49/50 (98%) 50/50 (100%) 47/50 (94%) | 47/50 (94%) 44/50 (88%) 41/50 (82%) 46/50 (92%) |
|ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | 94.0% 89.7% 82.0% 92.0% |
|TERMINAL (d) | 13/13 (100%) 7/7 (100%) 4/4 (100%) 0/0 | 21/24 (88%) 22/27 (81%) 22/31 (71%) 24/28 (86%) |
|FIRST INCIDENCE (DAYS) | 281 502 354 380 | 367 367 389 433 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.189 P=0.008 ** P<0.001 ** | P=0.243N P=0.352N P=0.042N* P=0.288N |
|INCIDENTAL TUMOR | P=0.069N P=0.362N (e) P=0.196N | P=0.547N P=0.256N P=0.129N P=0.586N |
|LOGISTIC REGRESSION | P=0.091N P=0.248N (e) P=0.172N | P=0.551 P=0.237N P=0.129N P=0.586N |
|COCHRAN-ARMITAGE | P=0.046N* | P=0.452N |
|FISHER EXACT | P=0.500N P=1.000N P=0.121N | P=0.243N P=0.061N P=0.500N |
|=================================================================================================================================|
(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).