TR 387 Rat Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Microbiological Assoc. DL AMPHETAMINE SULFATE DATE: 09/04/94
EXPERIMENT: 05029 TEST: 01 TIME: 11:18:15
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01CP9565001 ROUTE: DOSED FEED NTP C#: 55710
PATHOLOGIST: R. KOVATCH CAS: 60-13-9
------------------------------------------------------------------------------------------------------------------------------------
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Microbiological Assoc. DL AMPHETAMINE SULFATE DATE: 09/04/94
EXPERIMENT: 05029 TEST: 01 TIME: 11:18:15
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01CP9565001 ROUTE: DOSED FEED NTP C#: 55710
PATHOLOGIST: R. KOVATCH CAS: 60-13-9
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
Larynx
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: Microbiological Assoc. DL AMPHETAMINE SULFATE DATE: 09/04/94
EXPERIMENT: 05029 TEST: 01 TIME: 11:18:15
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01CP9565001 ROUTE: DOSED FEED NTP C#: 55710
PATHOLOGIST: R. KOVATCH CAS: 60-13-9
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF THE STUDY OF DL AMPHETAMINE SULFATE
====================================================================================================
MALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Adrenal Medulla Pheochromocytoma Benign
Pheochromocytoma: Benign, Complex, Malignant, NOS
Testes Adenoma
Thyroid Gland: C-Cell Carcinoma or Adenoma
====================================================================================================
FEMALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Mammary Gland Fibroadenoma
Fibroma, Fibroadenoma or Adenoma
Fibroma, Fibroadenoma, Carcinoma, or Adenoma
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
Carcinoma or Adenoma
Skin: Subcutaneous Tissue Neurofibrosarcoma, Fibrosarcoma, Sarcoma,
Neurofibroma, or Fibroma
Uterus Polyp Stromal
Sarcoma Stromal or Polyp Stromal
All Organs Benign Tumors
Malignant and Benign Tumors
====================================================================================================
DATE: 09/04/94 EXPERIMENT: 05029 TEST: 01 PAGE 1
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DL AMPHETAMINE SULFATE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE LOW M/F HIGH M/F | VEHICLE LOW M/F HIGH M/F |
| | CONTROL 20PPM 100 PPM | CONTROL 20PPM 100 PPM |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/48 (0%) 1/50 (2%) | 0/50 (0%) 2/48 (4%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 3.0% | 0.0% 5.0% 0.0% |
|TERMINAL (d) | 0/29 (0%) 0/30 (0%) 1/33 (3%) | 0/33 (0%) 2/40 (5%) 0/37 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 729 (T) | --- 731 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.344 (e) P=0.526 | P=0.488N P=0.282 (e) |
|INCIDENTAL TUMOR | P=0.344 (e) P=0.526 | P=0.488N P=0.282 (e) |
|LOGISTIC REGRESSION | P=0.344 (e) P=0.526 | P=0.488N P=0.282 (e) |
|COCHRAN-ARMITAGE | P=0.327 | P=0.496N |
|FISHER EXACT | (e) P=0.505 | P=0.237 (e) |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 23/49 (47%) 15/44 (34%) 6/50 (12%) | 2/49 (4%) 4/47 (9%) 2/49 (4%) |
|ADJUSTED (b) | 59.5% 50.2% 16.7% | 6.3% 9.7% 5.2% |
|TERMINAL (d) | 14/29 (48%) 12/26 (46%) 4/33 (12%) | 2/32 (6%) 3/39 (8%) 1/37 (3%) |
|FIRST INCIDENCE (DAYS) | 579 655 666 | 731 (T) 666 710 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001N** P=0.143N P<0.001N** | P=0.469N P=0.419 P=0.649N |
|INCIDENTAL TUMOR | P<0.001N** P=0.155N P<0.001N** | P=0.507N P=0.315 P=0.687 |
|LOGISTIC REGRESSION | P<0.001N** P=0.204N P<0.001N** | P=0.491N P=0.341 P=0.676N |
|COCHRAN-ARMITAGE | P<0.001N** | P=0.493N |
|FISHER EXACT | P=0.147N P<0.001N** | P=0.319 P=0.691N |
|=================================================================================================================================|
DATE: 09/04/94 EXPERIMENT: 05029 TEST: 01 PAGE 2
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DL AMPHETAMINE SULFATE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE LOW M/F HIGH M/F | VEHICLE LOW M/F HIGH M/F |
| | CONTROL 20PPM 100 PPM | CONTROL 20PPM 100 PPM |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 23/49 (47%) 15/44 (34%) 7/50 (14%) | 2/49 (4%) 4/47 (9%) 2/49 (4%) |
|ADJUSTED (b) | 59.5% 50.2% 19.6% | 6.3% 9.7% 5.2% |
|TERMINAL (d) | 14/29 (48%) 12/26 (46%) 5/33 (15%) | 2/32 (6%) 3/39 (8%) 1/37 (3%) |
|FIRST INCIDENCE (DAYS) | 579 655 666 | 731 (T) 666 710 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001N** P=0.143N P<0.001N** | P=0.469N P=0.419 P=0.649N |
|INCIDENTAL TUMOR | P<0.001N** P=0.155N P<0.001N** | P=0.507N P=0.315 P=0.687 |
|LOGISTIC REGRESSION | P<0.001N** P=0.204N P<0.001N** | P=0.491N P=0.341 P=0.676N |
|COCHRAN-ARMITAGE | P<0.001N** | P=0.493N |
|FISHER EXACT | P=0.147N P<0.001N** | P=0.319 P=0.691N |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/48 (4%) 5/47 (11%) 1/49 (2%) | 2/39 (5%) 1/37 (3%) 0/39 (0%) |
|ADJUSTED (b) | 6.7% 15.9% 3.0% | 7.0% 3.3% 0.0% |
|TERMINAL (d) | 2/30 (7%) 4/29 (14%) 1/33 (3%) | 1/24 (4%) 1/30 (3%) 0/29 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 660 729 (T) | 726 731 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.214N P=0.206 P=0.467N | P=0.192N P=0.424N P=0.210N |
|INCIDENTAL TUMOR | P=0.224N P=0.205 P=0.467N | P=0.217N P=0.577N P=0.272N |
|LOGISTIC REGRESSION | P=0.225N P=0.180 P=0.467N | P=0.194N P=0.462N P=0.216N |
|COCHRAN-ARMITAGE | P=0.240N | P=0.206N |
|FISHER EXACT | P=0.209 P=0.492N | P=0.520N P=0.247N |
|=================================================================================================================================|
DATE: 09/04/94 EXPERIMENT: 05029 TEST: 01 PAGE 3
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DL AMPHETAMINE SULFATE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE LOW M/F HIGH M/F | VEHICLE LOW M/F HIGH M/F |
| | CONTROL 20PPM 100 PPM | CONTROL 20PPM 100 PPM |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 1/47 (2%) 2/49 (4%) | 0/39 (0%) 0/37 (0%) 0/39 (0%) |
|ADJUSTED (b) | 0.0% 2.4% 6.1% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/30 (0%) 0/29 (0%) 2/33 (6%) | 0/24 (0%) 0/30 (0%) 0/29 (0%) |
|FIRST INCIDENCE (DAYS) | --- 655 729 (T) | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.232 P=0.505 P=0.259 | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.211 P=0.500 P=0.259 | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.221 P=0.520 P=0.259 | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.217 | (e) |
|FISHER EXACT | P=0.495 P=0.253 | (e) (e) |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/48 (4%) 6/47 (13%) 3/49 (6%) | 2/39 (5%) 1/37 (3%) 0/39 (0%) |
|ADJUSTED (b) | 6.7% 17.9% 9.1% | 7.0% 3.3% 0.0% |
|TERMINAL (d) | 2/30 (7%) 4/29 (14%) 3/33 (9%) | 1/24 (4%) 1/30 (3%) 0/29 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 655 729 (T) | 726 731 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.499N P=0.130 P=0.544 | P=0.192N P=0.424N P=0.210N |
|INCIDENTAL TUMOR | P=0.526N P=0.127 P=0.544 | P=0.217N P=0.577N P=0.272N |
|LOGISTIC REGRESSION | P=0.522N P=0.107 P=0.544 | P=0.194N P=0.462N P=0.216N |
|COCHRAN-ARMITAGE | P=0.540N | P=0.206N |
|FISHER EXACT | P=0.127 P=0.510 | P=0.520N P=0.247N |
|=================================================================================================================================|
DATE: 09/04/94 EXPERIMENT: 05029 TEST: 01 PAGE 4
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DL AMPHETAMINE SULFATE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE LOW M/F HIGH M/F | VEHICLE LOW M/F HIGH M/F |
| | CONTROL 20PPM 100 PPM | CONTROL 20PPM 100 PPM |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/47 (2%) 2/50 (4%) | 1/50 (2%) 1/48 (2%) 0/50 (0%) |
|ADJUSTED (b) | 3.3% 3.2% 6.1% | 3.0% 2.5% 0.0% |
|TERMINAL (d) | 1/30 (3%) 1/31 (3%) 2/33 (6%) | 1/33 (3%) 1/40 (3%) 0/37 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 729 (T) | 731 (T) 731 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.439 P=0.755N P=0.533 | P=0.359N P=0.718N P=0.477N |
|INCIDENTAL TUMOR | P=0.439 P=0.755N P=0.533 | P=0.359N P=0.718N P=0.477N |
|LOGISTIC REGRESSION | P=0.439 P=0.755N P=0.533 | P=0.359N P=0.718N P=0.477N |
|COCHRAN-ARMITAGE | P=0.415 | P=0.368N |
|FISHER EXACT | P=0.737 P=0.500 | P=0.742 P=0.500N |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/47 (4%) 3/50 (6%) | 1/50 (2%) 1/48 (2%) 0/50 (0%) |
|ADJUSTED (b) | 6.7% 6.2% 8.7% | 3.0% 2.5% 0.0% |
|TERMINAL (d) | 2/30 (7%) 1/31 (3%) 2/33 (6%) | 1/33 (3%) 1/40 (3%) 0/37 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 705 722 | 731 (T) 731 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.471 P=0.688N P=0.543 | P=0.359N P=0.718N P=0.477N |
|INCIDENTAL TUMOR | P=0.436 P=0.693N P=0.516 | P=0.359N P=0.718N P=0.477N |
|LOGISTIC REGRESSION | P=0.461 P=0.679 P=0.533 | P=0.359N P=0.718N P=0.477N |
|COCHRAN-ARMITAGE | P=0.439 | P=0.368N |
|FISHER EXACT | P=0.668 P=0.500 | P=0.742 P=0.500N |
|=================================================================================================================================|
DATE: 09/04/94 EXPERIMENT: 05029 TEST: 01 PAGE 5
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DL AMPHETAMINE SULFATE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE LOW M/F HIGH M/F | VEHICLE LOW M/F HIGH M/F |
| | CONTROL 20PPM 100 PPM | CONTROL 20PPM 100 PPM |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 2/50 (4%) 2/50 (4%) | 0/50 (0%) 3/50 (6%) 2/50 (4%) |
|ADJUSTED (b) | 9.2% 5.6% 6.1% | 0.0% 7.1% 5.2% |
|TERMINAL (d) | 1/30 (3%) 1/31 (3%) 2/33 (6%) | 0/33 (0%) 3/42 (7%) 1/37 (3%) |
|FIRST INCIDENCE (DAYS) | 708 660 729 (T) | --- 731 (T) 710 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.463N P=0.497N P=0.461N | P=0.426 P=0.167 P=0.258 |
|INCIDENTAL TUMOR | P=0.517N P=0.494N P=0.510N | P=0.403 P=0.167 P=0.193 |
|LOGISTIC REGRESSION | P=0.483N P=0.516N P=0.478N | P=0.415 P=0.167 P=0.239 |
|COCHRAN-ARMITAGE | P=0.500N | P=0.417 |
|FISHER EXACT | P=0.500N P=0.500N | P=0.121 P=0.247 |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 3/50 (6%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 9.7% 0.0% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/30 (0%) 3/31 (10%) 0/33 (0%) | 0/33 (0%) 0/42 (0%) 0/37 (0%) |
|FIRST INCIDENCE (DAYS) | --- 729 (T) --- | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.368N P=0.126 (e) | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.368N P=0.126 (e) | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.368N P=0.126 (e) | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.394N | (e) |
|FISHER EXACT | P=0.121 (e) | (e) (e) |
|=================================================================================================================================|
DATE: 09/04/94 EXPERIMENT: 05029 TEST: 01 PAGE 6
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DL AMPHETAMINE SULFATE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE LOW M/F HIGH M/F | VEHICLE LOW M/F HIGH M/F |
| | CONTROL 20PPM 100 PPM | CONTROL 20PPM 100 PPM |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 5/50 (10%) 2/50 (4%) | 0/50 (0%) 3/50 (6%) 2/50 (4%) |
|ADJUSTED (b) | 9.2% 15.0% 6.1% | 0.0% 7.1% 5.2% |
|TERMINAL (d) | 1/30 (3%) 4/31 (13%) 2/33 (6%) | 0/33 (0%) 3/42 (7%) 1/37 (3%) |
|FIRST INCIDENCE (DAYS) | 708 660 729 (T) | --- 731 (T) 710 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.287N P=0.368 P=0.461N | P=0.426 P=0.167 P=0.258 |
|INCIDENTAL TUMOR | P=0.323N P=0.368 P=0.510N | P=0.403 P=0.167 P=0.193 |
|LOGISTIC REGRESSION | P=0.303N P=0.338 P=0.478N | P=0.415 P=0.167 P=0.239 |
|COCHRAN-ARMITAGE | P=0.325N | P=0.417 |
|FISHER EXACT | P=0.357 P=0.500N | P=0.121 P=0.247 |
|=================================================================================================================================|
| |
|Mammary Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | 2/50 (4%) 1/50 (2%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% | 6.1% 2.4% 0.0% |
|TERMINAL (d) | 0/30 (0%) 0/31 (0%) 0/33 (0%) | 2/33 (6%) 1/42 (2%) 0/37 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- | 731 (T) 731 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) | P=0.199N P=0.416N P=0.213N |
|INCIDENTAL TUMOR | (e) (e) (e) | P=0.199N P=0.416N P=0.213N |
|LOGISTIC REGRESSION | (e) (e) (e) | P=0.199N P=0.416N P=0.213N |
|COCHRAN-ARMITAGE | (e) | P=0.209N |
|FISHER EXACT | (e) (e) | P=0.500N P=0.247N |
|=================================================================================================================================|
DATE: 09/04/94 EXPERIMENT: 05029 TEST: 01 PAGE 7
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DL AMPHETAMINE SULFATE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE LOW M/F HIGH M/F | VEHICLE LOW M/F HIGH M/F |
| | CONTROL 20PPM 100 PPM | CONTROL 20PPM 100 PPM |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | 3/50 (6%) 1/50 (2%) 1/50 (2%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% | 7.4% 2.4% 2.7% |
|TERMINAL (d) | 0/30 (0%) 0/31 (0%) 0/33 (0%) | 1/33 (3%) 1/42 (2%) 1/37 (3%) |
|FIRST INCIDENCE (DAYS) | --- --- --- | 547 731 (T) 731 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) | P=0.336N P=0.259N P=0.292N |
|INCIDENTAL TUMOR | (e) (e) (e) | P=0.406N P=0.301N P=0.395N |
|LOGISTIC REGRESSION | (e) (e) (e) | P=0.321N P=0.316N P=0.287N |
|COCHRAN-ARMITAGE | (e) | P=0.337N |
|FISHER EXACT | (e) (e) | P=0.309N P=0.309N |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | 5/50 (10%) 2/50 (4%) 1/50 (2%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% | 13.2% 4.8% 2.7% |
|TERMINAL (d) | 0/30 (0%) 0/31 (0%) 0/33 (0%) | 3/33 (9%) 2/42 (5%) 1/37 (3%) |
|FIRST INCIDENCE (DAYS) | --- --- --- | 547 731 (T) 731 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) | P=0.116N P=0.153N P=0.092N |
|INCIDENTAL TUMOR | (e) (e) (e) | P=0.143N P=0.174N P=0.134N |
|LOGISTIC REGRESSION | (e) (e) (e) | P=0.119N P=0.223N P=0.101N |
|COCHRAN-ARMITAGE | (e) | P=0.120N |
|FISHER EXACT | (e) (e) | P=0.218N P=0.102N |
|=================================================================================================================================|
DATE: 09/04/94 EXPERIMENT: 05029 TEST: 01 PAGE 8
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DL AMPHETAMINE SULFATE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE LOW M/F HIGH M/F | VEHICLE LOW M/F HIGH M/F |
| | CONTROL 20PPM 100 PPM | CONTROL 20PPM 100 PPM |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) 0/50 (0%) | 21/50 (42%) 11/50 (22%) 2/50 (4%) |
|ADJUSTED (b) | 10.0% 0.0% 0.0% | 51.0% 26.2% 5.4% |
|TERMINAL (d) | 3/30 (10%) 0/31 (0%) 0/33 (0%) | 13/33 (39%) 11/42 (26%) 2/37 (5%) |
|FIRST INCIDENCE (DAYS) | 729 (T) --- --- | 666 731 (T) 731 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.127N P=0.114N P=0.104N | P<0.001N** P=0.006N** P<0.001N** |
|INCIDENTAL TUMOR | P=0.127N P=0.114N P=0.104N | P<0.001N** P=0.052N P<0.001N** |
|LOGISTIC REGRESSION | P=0.126N P=0.114N P=0.104N | P<0.001N** P=0.014N* P<0.001N** |
|COCHRAN-ARMITAGE | P=0.140N | P<0.001N** |
|FISHER EXACT | P=0.121N P=0.121N | P=0.026N* P<0.001N** |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) 0/50 (0%) | 23/50 (46%) 11/50 (22%) 2/50 (4%) |
|ADJUSTED (b) | 10.0% 0.0% 0.0% | 55.9% 26.2% 5.4% |
|TERMINAL (d) | 3/30 (10%) 0/31 (0%) 0/33 (0%) | 15/33 (45%) 11/42 (26%) 2/37 (5%) |
|FIRST INCIDENCE (DAYS) | 729 (T) --- --- | 666 731 (T) 731 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.127N P=0.114N P=0.104N | P<0.001N** P=0.002N** P<0.001N** |
|INCIDENTAL TUMOR | P=0.127N P=0.114N P=0.104N | P<0.001N** P=0.017N* P<0.001N** |
|LOGISTIC REGRESSION | P=0.126N P=0.114N P=0.104N | P<0.001N** P=0.004N** P<0.001N** |
|COCHRAN-ARMITAGE | P=0.140N | P<0.001N** |
|FISHER EXACT | P=0.121N P=0.121N | P=0.010N** P<0.001N** |
|=================================================================================================================================|
DATE: 09/04/94 EXPERIMENT: 05029 TEST: 01 PAGE 9
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DL AMPHETAMINE SULFATE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE LOW M/F HIGH M/F | VEHICLE LOW M/F HIGH M/F |
| | CONTROL 20PPM 100 PPM | CONTROL 20PPM 100 PPM |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) 0/50 (0%) | 25/50 (50%) 12/50 (24%) 3/50 (6%) |
|ADJUSTED (b) | 10.0% 0.0% 0.0% | 59.3% 28.6% 8.1% |
|TERMINAL (d) | 3/30 (10%) 0/31 (0%) 0/33 (0%) | 16/33 (48%) 12/42 (29%) 3/37 (8%) |
|FIRST INCIDENCE (DAYS) | 729 (T) --- --- | 547 731 (T) 731 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.127N P=0.114N P=0.104N | P<0.001N** P=0.001N** P<0.001N** |
|INCIDENTAL TUMOR | P=0.127N P=0.114N P=0.104N | P<0.001N** P=0.009N** P<0.001N** |
|LOGISTIC REGRESSION | P=0.126N P=0.114N P=0.104N | P<0.001N** P=0.003N** P<0.001N** |
|COCHRAN-ARMITAGE | P=0.140N | P<0.001N** |
|FISHER EXACT | P=0.121N P=0.121N | P=0.006N** P<0.001N** |
|=================================================================================================================================|
| |
|Nose |
| Squamous Cell Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 4.8% 2.2% 0.0% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/30 (0%) 0/31 (0%) 0/33 (0%) | 0/33 (0%) 0/42 (0%) 0/37 (0%) |
|FIRST INCIDENCE (DAYS) | 637 524 --- | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.211N P=0.510N P=0.240N | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.219N P=0.518N P=0.283N | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.226N P=0.440N P=0.245N | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.209N | (e) |
|FISHER EXACT | P=0.500N P=0.247N | (e) (e) |
|=================================================================================================================================|
DATE: 09/04/94 EXPERIMENT: 05029 TEST: 01 PAGE 10
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DL AMPHETAMINE SULFATE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE LOW M/F HIGH M/F | VEHICLE LOW M/F HIGH M/F |
| | CONTROL 20PPM 100 PPM | CONTROL 20PPM 100 PPM |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 15/49 (31%) 15/48 (31%) 9/49 (18%) | 31/50 (62%) 24/48 (50%) 19/50 (38%) |
|ADJUSTED (b) | 43.1% 44.7% 25.4% | 77.0% 55.4% 45.0% |
|TERMINAL (d) | 11/30 (37%) 12/30 (40%) 7/33 (21%) | 24/33 (73%) 21/40 (53%) 14/37 (38%) |
|FIRST INCIDENCE (DAYS) | 533 660 660 | 541 340 504 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.052N P=0.579 P=0.085N | P=0.017N* P=0.021N* P=0.007N** |
|INCIDENTAL TUMOR | P=0.061N P=0.582N P=0.097N | P=0.018N* P=0.036N* P=0.016N* |
|LOGISTIC REGRESSION | P=0.059N P=0.526 P=0.103N | P=0.020N* P=0.150N P=0.015N* |
|COCHRAN-ARMITAGE | P=0.080N | P=0.017N* |
|FISHER EXACT | P=0.560 P=0.120N | P=0.160N P=0.014N* |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/48 (0%) 0/49 (0%) | 0/50 (0%) 2/48 (4%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% | 0.0% 4.6% 0.0% |
|TERMINAL (d) | 0/30 (0%) 0/30 (0%) 0/33 (0%) | 0/33 (0%) 1/40 (3%) 0/37 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- | --- 624 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) | P=0.499N P=0.266 (e) |
|INCIDENTAL TUMOR | (e) (e) (e) | P=0.599N P=0.339 (e) |
|LOGISTIC REGRESSION | (e) (e) (e) | P=0.482N P=0.223 (e) |
|COCHRAN-ARMITAGE | (e) | P=0.496N |
|FISHER EXACT | (e) (e) | P=0.237 (e) |
|=================================================================================================================================|
DATE: 09/04/94 EXPERIMENT: 05029 TEST: 01 PAGE 11
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DL AMPHETAMINE SULFATE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE LOW M/F HIGH M/F | VEHICLE LOW M/F HIGH M/F |
| | CONTROL 20PPM 100 PPM | CONTROL 20PPM 100 PPM |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 15/49 (31%) 15/48 (31%) 9/49 (18%) | 31/50 (62%) 26/48 (54%) 19/50 (38%) |
|ADJUSTED (b) | 43.1% 44.7% 25.4% | 77.0% 58.7% 45.0% |
|TERMINAL (d) | 11/30 (37%) 12/30 (40%) 7/33 (21%) | 24/33 (73%) 22/40 (55%) 14/37 (38%) |
|FIRST INCIDENCE (DAYS) | 533 660 660 | 541 340 504 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.052N P=0.579 P=0.085N | P=0.013N* P=0.049N* P=0.007N** |
|INCIDENTAL TUMOR | P=0.061N P=0.582N P=0.097N | P=0.014N* P=0.070N P=0.016N* |
|LOGISTIC REGRESSION | P=0.059N P=0.526 P=0.103N | P=0.013N* P=0.271N P=0.015N* |
|COCHRAN-ARMITAGE | P=0.080N | P=0.011N* |
|FISHER EXACT | P=0.560 P=0.120N | P=0.281N P=0.014N* |
|=================================================================================================================================|
| |
|Salivary Glands |
| Schwannoma Malignant |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/48 (0%) 2/50 (4%) | 0/48 (0%) 0/49 (0%) 1/49 (2%) |
|ADJUSTED (b) | 3.3% 0.0% 4.9% | 0.0% 0.0% 2.8% |
|TERMINAL (d) | 1/30 (3%) 0/30 (0%) 0/33 (0%) | 0/31 (0%) 0/41 (0%) 1/36 (3%) |
|FIRST INCIDENCE (DAYS) | 729 (T) --- 627 | --- --- 731 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.318 P=0.500N P=0.521 | P=0.327 (e) P=0.530 |
|INCIDENTAL TUMOR | P=0.302 P=0.500N P=0.467 | P=0.327 (e) P=0.530 |
|LOGISTIC REGRESSION | P=0.299 P=0.500N P=0.499 | P=0.327 (e) P=0.530 |
|COCHRAN-ARMITAGE | P=0.299 | P=0.324 |
|FISHER EXACT | P=0.510N P=0.500 | (e) P=0.505 |
|=================================================================================================================================|
DATE: 09/04/94 EXPERIMENT: 05029 TEST: 01 PAGE 12
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DL AMPHETAMINE SULFATE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE LOW M/F HIGH M/F | VEHICLE LOW M/F HIGH M/F |
| | CONTROL 20PPM 100 PPM | CONTROL 20PPM 100 PPM |
|=================================================================================================================================|
| |
|Skin |
| Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma, |
| Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 4/50 (8%) 2/50 (4%) | 1/50 (2%) 1/50 (2%) 0/50 (0%) |
|ADJUSTED (b) | 6.7% 11.9% 5.5% | 2.6% 2.4% 0.0% |
|TERMINAL (d) | 2/30 (7%) 3/31 (10%) 1/33 (3%) | 0/33 (0%) 1/42 (2%) 0/37 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 666 675 | 701 731 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.464N P=0.352 P=0.668N | P=0.369N P=0.719N P=0.495N |
|INCIDENTAL TUMOR | P=0.492N P=0.350 P=0.686N | P=0.404N P=0.658 P=0.607N |
|LOGISTIC REGRESSION | P=0.483N P=0.322 P=0.687N | P=0.374N P=0.756N P=0.501N |
|COCHRAN-ARMITAGE | P=0.500N | P=0.371N |
|FISHER EXACT | P=0.339 P=0.691N | P=0.753N P=0.500N |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Fibroma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 3/50 (6%) 1/50 (2%) | 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 9.4% 8.9% 2.9% | 5.3% 0.0% 0.0% |
|TERMINAL (d) | 2/30 (7%) 2/31 (6%) 0/33 (0%) | 1/33 (3%) 0/42 (0%) 0/37 (0%) |
|FIRST INCIDENCE (DAYS) | 708 667 722 | 666 --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.215N P=0.656N P=0.279N | P=0.251N P=0.209N P=0.225N |
|INCIDENTAL TUMOR | P=0.248N P=0.652N P=0.324N | P=0.286N P=0.342N P=0.284N |
|LOGISTIC REGRESSION | P=0.224N P=0.648 P=0.290N | P=0.253N P=0.240N P=0.238N |
|COCHRAN-ARMITAGE | P=0.237N | P=0.255N |
|FISHER EXACT | P=0.661N P=0.309N | P=0.247N P=0.247N |
|=================================================================================================================================|
DATE: 09/04/94 EXPERIMENT: 05029 TEST: 01 PAGE 13
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DL AMPHETAMINE SULFATE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE LOW M/F HIGH M/F | VEHICLE LOW M/F HIGH M/F |
| | CONTROL 20PPM 100 PPM | CONTROL 20PPM 100 PPM |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Neurofibrosarcoma, Fibrosarcoma, Sarcoma, |
| Neurofibroma, or Fibroma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 4/50 (8%) 1/50 (2%) | 4/50 (8%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 12.6% 10.8% 2.9% | 9.5% 0.0% 0.0% |
|TERMINAL (d) | 3/30 (10%) 2/31 (6%) 0/33 (0%) | 1/33 (3%) 0/42 (0%) 0/37 (0%) |
|FIRST INCIDENCE (DAYS) | 708 437 722 | 541 --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.120N P=0.637N P=0.158N | P=0.082N P=0.056N P=0.064N |
|INCIDENTAL TUMOR | P=0.136N P=0.571N P=0.187N | P=0.080N P=0.266N P=0.083N |
|LOGISTIC REGRESSION | P=0.132N P=0.644N P=0.165N | P=0.060N P=0.063N P=0.048N* |
|COCHRAN-ARMITAGE | P=0.133N | P=0.080N |
|FISHER EXACT | P=0.643N P=0.181N | P=0.059N P=0.059N |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Neurofibrosarcoma, Fibrosarcoma, or Sarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 0/50 (0%) | 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 3.3% 2.1% 0.0% | 4.4% 0.0% 0.0% |
|TERMINAL (d) | 1/30 (3%) 0/31 (0%) 0/33 (0%) | 0/33 (0%) 0/42 (0%) 0/37 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 437 --- | 541 --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.363N P=0.759 P=0.481N | P=0.261N P=0.232N P=0.244N |
|INCIDENTAL TUMOR | P=0.357N P=0.660N P=0.481N | P=0.220N P=0.773N P=0.262N |
|LOGISTIC REGRESSION | P=0.407N P=0.717N P=0.481N | P=0.186N P=0.220N P=0.173N |
|COCHRAN-ARMITAGE | P=0.371N | P=0.255N |
|FISHER EXACT | P=0.753N P=0.500N | P=0.247N P=0.247N |
|=================================================================================================================================|
DATE: 09/04/94 EXPERIMENT: 05029 TEST: 01 PAGE 14
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DL AMPHETAMINE SULFATE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE LOW M/F HIGH M/F | VEHICLE LOW M/F HIGH M/F |
| | CONTROL 20PPM 100 PPM | CONTROL 20PPM 100 PPM |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 43/50 (86%) 43/50 (86%) 48/50 (96%) | |
|ADJUSTED (b) | 97.7% 97.7% 100.0% | |
|TERMINAL (d) | 29/30 (97%) 30/31 (97%) 33/33 (100%) | |
|FIRST INCIDENCE (DAYS) | 558 467 498 | |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.405 P=0.528N P=0.459 | |
|INCIDENTAL TUMOR | P=0.064 P=0.474 P=0.051 | |
|LOGISTIC REGRESSION | P=0.047 * P=0.349 P=0.034 * | |
|COCHRAN-ARMITAGE | P=0.056 | |
|FISHER EXACT | P=0.613N P=0.080 | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 10/50 (20%) 4/50 (8%) 5/50 (10%) | 5/50 (10%) 2/50 (4%) 2/50 (4%) |
|ADJUSTED (b) | 29.1% 12.9% 13.5% | 14.6% 4.8% 5.4% |
|TERMINAL (d) | 7/30 (23%) 4/31 (13%) 3/33 (9%) | 4/33 (12%) 2/42 (5%) 2/37 (5%) |
|FIRST INCIDENCE (DAYS) | 634 729 (T) 436 | 719 731 (T) 731 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.175N P=0.070N P=0.107N | P=0.248N P=0.136N P=0.177N |
|INCIDENTAL TUMOR | P=0.193N P=0.087N P=0.119N | P=0.264N P=0.196N P=0.207N |
|LOGISTIC REGRESSION | P=0.201N P=0.082N P=0.130N | P=0.254N P=0.161N P=0.189N |
|COCHRAN-ARMITAGE | P=0.213N | P=0.262N |
|FISHER EXACT | P=0.074N P=0.131N | P=0.218N P=0.218N |
|=================================================================================================================================|
DATE: 09/04/94 EXPERIMENT: 05029 TEST: 01 PAGE 15
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DL AMPHETAMINE SULFATE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE LOW M/F HIGH M/F | VEHICLE LOW M/F HIGH M/F |
| | CONTROL 20PPM 100 PPM | CONTROL 20PPM 100 PPM |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 8.2% 0.0% 2.9% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/30 (3%) 0/31 (0%) 0/33 (0%) | 0/33 (0%) 0/42 (0%) 0/37 (0%) |
|FIRST INCIDENCE (DAYS) | 634 --- 726 | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.388N P=0.127N P=0.289N | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.429N P=0.180N P=0.350N | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.404N P=0.120N P=0.304N | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.407N | (e) |
|FISHER EXACT | P=0.121N P=0.309N | (e) (e) |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 12/50 (24%) 4/50 (8%) 5/50 (10%) | 5/50 (10%) 2/50 (4%) 2/50 (4%) |
|ADJUSTED (b) | 34.1% 12.9% 13.5% | 14.6% 4.8% 5.4% |
|TERMINAL (d) | 8/30 (27%) 4/31 (13%) 3/33 (9%) | 4/33 (12%) 2/42 (5%) 2/37 (5%) |
|FIRST INCIDENCE (DAYS) | 634 729 (T) 436 | 719 731 (T) 731 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.092N P=0.027N* P=0.044N* | P=0.248N P=0.136N P=0.177N |
|INCIDENTAL TUMOR | P=0.106N P=0.033N* P=0.051N | P=0.264N P=0.196N P=0.207N |
|LOGISTIC REGRESSION | P=0.107N P=0.031N* P=0.054N | P=0.254N P=0.161N P=0.189N |
|COCHRAN-ARMITAGE | P=0.115N | P=0.262N |
|FISHER EXACT | P=0.027N* P=0.054N | P=0.218N P=0.218N |
|=================================================================================================================================|
DATE: 09/04/94 EXPERIMENT: 05029 TEST: 01 PAGE 16
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DL AMPHETAMINE SULFATE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE LOW M/F HIGH M/F | VEHICLE LOW M/F HIGH M/F |
| | CONTROL 20PPM 100 PPM | CONTROL 20PPM 100 PPM |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) | 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|ADJUSTED (b) | 3.3% 0.0% 3.0% | 0.0% 4.8% 0.0% |
|TERMINAL (d) | 1/30 (3%) 0/31 (0%) 1/33 (3%) | 0/33 (0%) 2/42 (5%) 0/37 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) --- 729 (T) | --- 731 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.649 P=0.493N P=0.741N | P=0.493N P=0.293 (e) |
|INCIDENTAL TUMOR | P=0.649 P=0.493N P=0.741N | P=0.493N P=0.293 (e) |
|LOGISTIC REGRESSION | P=0.649 P=0.493N P=0.741N | P=0.493N P=0.293 (e) |
|COCHRAN-ARMITAGE | P=0.629 | P=0.500N |
|FISHER EXACT | P=0.500N P=0.753N | P=0.247 (e) |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) | 0/50 (0%) 3/50 (6%) 0/50 (0%) |
|ADJUSTED (b) | 3.3% 0.0% 3.0% | 0.0% 7.1% 0.0% |
|TERMINAL (d) | 1/30 (3%) 0/31 (0%) 1/33 (3%) | 0/33 (0%) 3/42 (7%) 0/37 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) --- 729 (T) | --- 731 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.649 P=0.493N P=0.741N | P=0.384N P=0.167 (e) |
|INCIDENTAL TUMOR | P=0.649 P=0.493N P=0.741N | P=0.384N P=0.167 (e) |
|LOGISTIC REGRESSION | P=0.649 P=0.493N P=0.741N | P=0.384N P=0.167 (e) |
|COCHRAN-ARMITAGE | P=0.629 | P=0.394N |
|FISHER EXACT | P=0.500N P=0.753N | P=0.121 (e) |
|=================================================================================================================================|
DATE: 09/04/94 EXPERIMENT: 05029 TEST: 01 PAGE 17
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DL AMPHETAMINE SULFATE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE LOW M/F HIGH M/F | VEHICLE LOW M/F HIGH M/F |
| | CONTROL 20PPM 100 PPM | CONTROL 20PPM 100 PPM |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # |
|----------- | | |
|OVERALL (a) | | 10/50 (20%) 6/50 (12%) 3/50 (6%) |
|ADJUSTED (b) | | 26.3% 13.5% 8.1% |
|TERMINAL (d) | | 7/33 (21%) 4/42 (10%) 3/37 (8%) |
|FIRST INCIDENCE (DAYS) | | 541 666 731 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.043N* P=0.121N P=0.028N* |
|INCIDENTAL TUMOR | | P=0.048N* P=0.296N P=0.035N* |
|LOGISTIC REGRESSION | | P=0.044N* P=0.217N P=0.037N* |
|COCHRAN-ARMITAGE | | P=0.044N* |
|FISHER EXACT | | P=0.207N P=0.036N* |
|=================================================================================================================================|
| |
|Uterus |
| Sarcoma Stromal or Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # |
|----------- | | |
|OVERALL (a) | | 11/50 (22%) 6/50 (12%) 3/50 (6%) |
|ADJUSTED (b) | | 27.8% 13.5% 8.1% |
|TERMINAL (d) | | 7/33 (21%) 4/42 (10%) 3/37 (8%) |
|FIRST INCIDENCE (DAYS) | | 478 666 731 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.030N* P=0.083N P=0.018N* |
|INCIDENTAL TUMOR | | P=0.027N* P=0.296N P=0.019N* |
|LOGISTIC REGRESSION | | P=0.026N* P=0.161N P=0.019N* |
|COCHRAN-ARMITAGE | | P=0.029N* |
|FISHER EXACT | | P=0.143N P=0.020N* |
|=================================================================================================================================|
DATE: 09/04/94 EXPERIMENT: 05029 TEST: 01 PAGE 18
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DL AMPHETAMINE SULFATE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE LOW M/F HIGH M/F | VEHICLE LOW M/F HIGH M/F |
| | CONTROL 20PPM 100 PPM | CONTROL 20PPM 100 PPM |
|=================================================================================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, |
| or Undifferentiated |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 20/50 (40%) 16/50 (32%) 18/50 (36%) | 7/50 (14%) 8/50 (16%) 7/50 (14%) |
|ADJUSTED (b) | 47.5% 38.4% 44.9% | 18.3% 17.7% 15.3% |
|TERMINAL (d) | 9/30 (30%) 7/31 (23%) 12/33 (36%) | 4/33 (12%) 5/42 (12%) 2/37 (5%) |
|FIRST INCIDENCE (DAYS) | 512 236 498 | 655 590 453 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.412N P=0.301N P=0.349N | P=0.533N P=0.576N P=0.572N |
|INCIDENTAL TUMOR | P=0.549N P=0.294N P=0.423N | P=0.552N P=0.317 P=0.545 |
|LOGISTIC REGRESSION | P=0.519N P=0.230N P=0.418N | P=0.476N P=0.498 P=0.554N |
|COCHRAN-ARMITAGE | P=0.500N | P=0.543N |
|FISHER EXACT | P=0.266N P=0.418N | P=0.500 P=0.613N |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma Benign, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 5.8% 2.6% 6.1% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/30 (3%) 0/31 (0%) 2/33 (6%) | 0/33 (0%) 0/42 (0%) 0/37 (0%) |
|FIRST INCIDENCE (DAYS) | 664 674 729 (T) | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.603 P=0.499N P=0.668N | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.573 P=0.496N P=0.686N | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.592 P=0.504N P=0.689N | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.583 | (e) |
|FISHER EXACT | P=0.500N P=0.691N | (e) (e) |
|=================================================================================================================================|
DATE: 09/04/94 EXPERIMENT: 05029 TEST: 01 PAGE 19
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DL AMPHETAMINE SULFATE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE LOW M/F HIGH M/F | VEHICLE LOW M/F HIGH M/F |
| | CONTROL 20PPM 100 PPM | CONTROL 20PPM 100 PPM |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 48/50 (96%) 45/50 (90%) 49/50 (98%) | 42/50 (84%) 36/50 (72%) 23/50 (46%) |
|ADJUSTED (b) | 100.0% 100.0% 100.0% | 95.4% 78.2% 54.5% |
|TERMINAL (d) | 30/30 (100%) 31/31 (100%) 33/33 (100%) | 31/33 (94%) 32/42 (76%) 18/37 (49%) |
|FIRST INCIDENCE (DAYS) | 533 467 436 | 541 340 504 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.451N P=0.327N P=0.397N | P<0.001N** P=0.004N** P<0.001N** |
|INCIDENTAL TUMOR | P=0.419 P=0.430N P=0.691 | P<0.001N** P=0.021N* P<0.001N** |
|LOGISTIC REGRESSION | P=0.303 P=0.632N P=0.392 | P<0.001N** P=0.042N* P<0.001N** |
|COCHRAN-ARMITAGE | P=0.251 | P<0.001N** |
|FISHER EXACT | P=0.218N P=0.500 | P=0.114N P<0.001N** |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 25/50 (50%) 25/50 (50%) 28/50 (56%) | 16/50 (32%) 14/50 (28%) 10/50 (20%) |
|ADJUSTED (b) | 57.1% 54.3% 61.9% | 36.2% 29.6% 22.5% |
|TERMINAL (d) | 12/30 (40%) 11/31 (35%) 16/33 (48%) | 7/33 (21%) 9/42 (21%) 5/37 (14%) |
|FIRST INCIDENCE (DAYS) | 512 236 498 | 478 578 453 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.445 P=0.562N P=0.478 | P=0.135N P=0.261N P=0.126N |
|INCIDENTAL TUMOR | P=0.241 P=0.546N P=0.302 | P=0.122N P=0.447 P=0.172N |
|LOGISTIC REGRESSION | P=0.270 P=0.513N P=0.252 | P=0.132N P=0.542 P=0.093N |
|COCHRAN-ARMITAGE | P=0.298 | P=0.116N |
|FISHER EXACT | P=0.579N P=0.344 | P=0.414N P=0.127N |
|=================================================================================================================================|
DATE: 09/04/94 EXPERIMENT: 05029 TEST: 01 PAGE 20
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- DL AMPHETAMINE SULFATE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE LOW M/F HIGH M/F | VEHICLE LOW M/F HIGH M/F |
| | CONTROL 20PPM 100 PPM | CONTROL 20PPM 100 PPM |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 49/50 (98%) 50/50 (100%) 49/50 (98%) | 48/50 (96%) 42/50 (84%) 30/50 (60%) |
|ADJUSTED (b) | 100.0% 100.0% 100.0% | 98.0% 85.7% 63.6% |
|TERMINAL (d) | 30/30 (100%) 31/31 (100%) 33/33 (100%) | 32/33 (97%) 35/42 (83%) 20/37 (54%) |
|FIRST INCIDENCE (DAYS) | 512 236 436 | 478 340 453 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.287N P=0.531 P=0.336N | P<0.001N** P=0.006N** P<0.001N** |
|INCIDENTAL TUMOR | P=0.404N P=0.500 P=0.581N | P<0.001N** P=0.048N* P<0.001N** |
|LOGISTIC REGRESSION | P=0.430N P=0.266 P=0.581N | P<0.001N** P=0.045N* P<0.001N** |
|COCHRAN-ARMITAGE | P=0.629N | P<0.001N** |
|FISHER EXACT | P=0.500 P=0.753N | P=0.046N* P<0.001N** |
|=================================================================================================================================|
(a) Number of tumor-bearing animals / number of animals examined at site.
(b) Kaplan-Meier estimated lifetime tumor incidence after adjustment for
intercurrent mortality.
(d) Observed incidence at terminal kill.
(f) Beneath the control incidence are the P-values associated with the trend
test. Beneath the dosed group incidence are the P-values corresponding to
pairwise comparisons between the controls and that dosed group. The life
table analysis regards tumors in animals dying prior to terminal kill as
being (directly or indirectly) the cause of death. The incidental tumor
test regards these lesions as non-fatal. Logistic regression is an alternative
method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage
and Fisher's exact tests compare directly the overall incidence rates.
For all tests, a negative trend is indicated by "N".
(e) Value of Statistic cannot be computed.
(I) Interim sacrifice
(T) Terminal sacrifice
# Tumor rates based on number of animals necropsied.
* To the right of any statistical result, indicates significance at (P<=0.05).
** To the right of any statistical result, indicates significance at (P<=0.01).
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