TDMS Study 05150-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Mason METHLYPHENIDATE HYDROCHLORIDE DATE: 05/20/95
EXPERIMENT: 05150 TEST: 01 TIME: 09:27:31
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01ES65132 ROUTE: DOSED FEED NTP C#: 266
PATHOLOGIST: A. RUSSFIELD CAS: 298-59-9
------------------------------------------------------------------------------------------------------------------------------------
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Mason METHLYPHENIDATE HYDROCHLORIDE DATE: 05/20/95
EXPERIMENT: 05150 TEST: 01 TIME: 09:27:31
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01ES65132 ROUTE: DOSED FEED NTP C#: 266
PATHOLOGIST: A. RUSSFIELD CAS: 298-59-9
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 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: Mason METHLYPHENIDATE HYDROCHLORIDE DATE: 05/20/95
EXPERIMENT: 05150 TEST: 01 TIME: 09:27:31
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01ES65132 ROUTE: DOSED FEED NTP C#: 266
PATHOLOGIST: A. RUSSFIELD CAS: 298-59-9
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF THE STUDY OF METHLYPHENIDATE HYDROCHLORIDE
====================================================================================================
MALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Adrenal Medulla Pheochromocytoma Benign
Pheochromocytoma: Benign, Complex, Malignant, NOS
Testes Adenoma
All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated
====================================================================================================
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
All Organs Benign Tumors
Malignant and Benign Tumors
====================================================================================================
DATE: 05/20/95 EXPERIMENT: 05150 TEST: 01 PAGE 1
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- METHLYPHENIDATE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 100 PPM 500 PPM 1000 PPM | 0 PPM 100 PPM 500 PPM 1000 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 17/69 (25%) 6/68 (9%) 5/69 (7%) 11/69 (16%) | 3/70 (4%) 3/69 (4%) 3/70 (4%) 3/70 (4%) |
|ADJUSTED (b) | 50.8% 17.9% 13.8% 31.6% | 9.7% 9.7% 7.6% 7.7% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 12/28 (43%) 5/32 (16%) 4/34 (12%) 10/33 (30%) | 3/31 (10%) 3/31 (10%) 2/36 (6%) 3/39 (8%) |
|FIRST INCIDENCE (DAYS) | 639 676 653 462 (I) | 737 (T) 737 (T) 546 737 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.191N P=0.004N** P=0.001N** P=0.059N | P=0.449N P=0.665 P=0.607N P=0.553N |
|INCIDENTAL TUMOR | P=0.218N P=0.006N** P=0.001N** P=0.084N | P=0.423N P=0.665 P=0.505N P=0.553N |
|LOGISTIC REGRESSION | P=0.235N P=0.005N** P=0.001N** P=0.096N | P=0.539N P=0.665 P=0.651N P=0.553N |
|COCHRAN-ARMITAGE | P=0.285N | P=0.570N |
|FISHER EXACT | P=0.011N* P=0.005N** P=0.145N | P=0.653 P=0.660N P=0.660N |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Malignant |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/69 (1%) 1/68 (1%) 1/69 (1%) 0/69 (0%) | 0/70 (0%) 1/69 (1%) 2/70 (3%) 0/70 (0%) |
|ADJUSTED (b) | 3.6% 3.1% 2.9% 0.0% | 0.0% 3.2% 5.6% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/28 (4%) 1/32 (3%) 1/34 (3%) 0/33 (0%) | 0/31 (0%) 1/31 (3%) 2/36 (6%) 0/39 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 729 (T) --- | --- 737 (T) 737 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.273N P=0.732N P=0.718N P=0.467N | P=0.520N P=0.500 P=0.272 (e) |
|INCIDENTAL TUMOR | P=0.273N P=0.732N P=0.718N P=0.467N | P=0.520N P=0.500 P=0.272 (e) |
|LOGISTIC REGRESSION | P=0.273N P=0.732N P=0.718N P=0.467N | P=0.520N P=0.500 P=0.272 (e) |
|COCHRAN-ARMITAGE | P=0.301N | P=0.586N |
|FISHER EXACT | P=0.748 P=0.752N P=0.500N | P=0.496 P=0.248 (e) |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05150 TEST: 01 PAGE 2
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- METHLYPHENIDATE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 100 PPM 500 PPM 1000 PPM | 0 PPM 100 PPM 500 PPM 1000 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 18/69 (26%) 7/68 (10%) 5/69 (7%) 11/69 (16%) | 3/70 (4%) 4/69 (6%) 5/70 (7%) 3/70 (4%) |
|ADJUSTED (b) | 53.9% 20.9% 13.8% 31.6% | 9.7% 12.9% 13.0% 7.7% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 13/28 (46%) 6/32 (19%) 4/34 (12%) 10/33 (30%) | 3/31 (10%) 4/31 (13%) 4/36 (11%) 3/39 (8%) |
|FIRST INCIDENCE (DAYS) | 639 676 653 462 (I) | 737 (T) 737 (T) 546 737 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.117N P=0.004N** P<0.001N** P=0.037N* | P=0.396N P=0.500 P=0.427 P=0.553N |
|INCIDENTAL TUMOR | P=0.135N P=0.007N** P<0.001N** P=0.053N | P=0.374N P=0.500 P=0.518 P=0.553N |
|LOGISTIC REGRESSION | P=0.148N P=0.006N** P<0.001N** P=0.062N | P=0.495N P=0.500 P=0.375 P=0.553N |
|COCHRAN-ARMITAGE | P=0.196N | P=0.536N |
|FISHER EXACT | P=0.014N* P=0.003N** P=0.105N | P=0.492 P=0.359 P=0.660N |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/70 (3%) 2/67 (3%) 2/70 (3%) 1/70 (1%) | 1/65 (2%) 1/68 (1%) 1/69 (1%) 0/69 (0%) |
|ADJUSTED (b) | 7.1% 4.8% 5.9% 2.9% | 3.7% 2.5% 2.2% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 2/28 (7%) 1/33 (3%) 2/34 (6%) 1/34 (3%) | 1/27 (4%) 0/30 (0%) 0/36 (0%) 0/39 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 462 (I) 729 (T) 729 (T) | 737 (T) 699 567 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.321N P=0.649N P=0.624N P=0.432N | P=0.271N P=0.727N P=0.731N P=0.427N |
|INCIDENTAL TUMOR | P=0.321N P=0.649N P=0.624N P=0.432N | P=0.378N P=0.749N P=0.723 P=0.427N |
|LOGISTIC REGRESSION | P=0.348N P=0.682 P=0.624N P=0.432N | P=0.285N P=0.732N P=0.744N P=0.427N |
|COCHRAN-ARMITAGE | P=0.359N | P=0.292N |
|FISHER EXACT | P=0.674 P=0.690N P=0.500N | P=0.740N P=0.737N P=0.485N |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05150 TEST: 01 PAGE 3
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- METHLYPHENIDATE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 100 PPM 500 PPM 1000 PPM | 0 PPM 100 PPM 500 PPM 1000 PPM |
| | | |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/70 (0%) 2/67 (3%) 4/70 (6%) 2/70 (3%) | 0/65 (0%) 0/68 (0%) 0/69 (0%) 0/69 (0%) |
|ADJUSTED (b) | 0.0% 6.1% 11.8% 5.3% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/28 (0%) 2/33 (6%) 4/34 (12%) 0/34 (0%) | 0/27 (0%) 0/30 (0%) 0/36 (0%) 0/39 (0%) |
|FIRST INCIDENCE (DAYS) | --- 729 (T) 729 (T) 675 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.297 P=0.275 P=0.089 P=0.280 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.283 P=0.275 P=0.089 P=0.178 | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.277 P=0.275 P=0.089 P=0.246 | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.255 | (e) |
|FISHER EXACT | P=0.237 P=0.060 P=0.248 | (e) (e) (e) |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/70 (3%) 4/67 (6%) 6/70 (9%) 3/70 (4%) | 1/65 (2%) 1/68 (1%) 1/69 (1%) 0/69 (0%) |
|ADJUSTED (b) | 7.1% 10.7% 17.6% 8.1% | 3.7% 2.5% 2.2% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 2/28 (7%) 3/33 (9%) 6/34 (18%) 1/34 (3%) | 1/27 (4%) 0/30 (0%) 0/36 (0%) 0/39 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 462 (I) 729 (T) 675 | 737 (T) 699 567 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.539 P=0.402 P=0.200 P=0.584 | P=0.271N P=0.727N P=0.731N P=0.427N |
|INCIDENTAL TUMOR | P=0.528 P=0.402 P=0.200 P=0.507 | P=0.378N P=0.749N P=0.723 P=0.427N |
|LOGISTIC REGRESSION | P=0.498 P=0.327 P=0.200 P=0.537 | P=0.285N P=0.732N P=0.744N P=0.427N |
|COCHRAN-ARMITAGE | P=0.473 | P=0.292N |
|FISHER EXACT | P=0.320 P=0.137 P=0.500 | P=0.740N P=0.737N P=0.485N |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05150 TEST: 01 PAGE 4
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- METHLYPHENIDATE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 100 PPM 500 PPM 1000 PPM | 0 PPM 100 PPM 500 PPM 1000 PPM |
| | | |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/69 (1%) 0/70 (0%) 1/70 (1%) 2/69 (3%) | 0/70 (0%) 2/69 (3%) 1/70 (1%) 2/70 (3%) |
|ADJUSTED (b) | 3.6% 0.0% 1.8% 5.6% | 0.0% 6.5% 2.8% 5.1% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/8 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/28 (4%) 0/33 (0%) 0/34 (0%) 1/34 (3%) | 0/31 (0%) 2/31 (6%) 1/36 (3%) 2/39 (5%) |
|FIRST INCIDENCE (DAYS) | 729 (T) --- 462 (I) 686 | --- 737 (T) 737 (T) 737 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.223 P=0.467N P=0.739N P=0.555 | P=0.386 P=0.238 P=0.530 P=0.290 |
|INCIDENTAL TUMOR | P=0.211 P=0.467N P=0.739N P=0.516 | P=0.386 P=0.238 P=0.530 P=0.290 |
|LOGISTIC REGRESSION | P=0.203 P=0.467N P=0.759N P=0.526 | P=0.386 P=0.238 P=0.530 P=0.290 |
|COCHRAN-ARMITAGE | P=0.201 | P=0.305 |
|FISHER EXACT | P=0.496N P=0.748N P=0.500 | P=0.245 P=0.500 P=0.248 |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/69 (0%) 2/70 (3%) 0/70 (0%) 2/69 (3%) | 0/70 (0%) 0/69 (0%) 0/70 (0%) 0/70 (0%) |
|ADJUSTED (b) | 0.0% 5.2% 0.0% 5.9% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/8 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/28 (0%) 1/33 (3%) 0/34 (0%) 2/34 (6%) | 0/31 (0%) 0/31 (0%) 0/36 (0%) 0/39 (0%) |
|FIRST INCIDENCE (DAYS) | --- 596 --- 729 (T) | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.357 P=0.263 (e) P=0.282 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.284 P=0.192 (e) P=0.282 | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.334 P=0.242 (e) P=0.282 | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.325 | (e) |
|FISHER EXACT | P=0.252 (e) P=0.248 | (e) (e) (e) |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05150 TEST: 01 PAGE 5
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- METHLYPHENIDATE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 100 PPM 500 PPM 1000 PPM | 0 PPM 100 PPM 500 PPM 1000 PPM |
| | | |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/69 (1%) 2/70 (3%) 1/70 (1%) 4/69 (6%) | 0/70 (0%) 2/69 (3%) 1/70 (1%) 2/70 (3%) |
|ADJUSTED (b) | 3.6% 5.2% 1.8% 11.4% | 0.0% 6.5% 2.8% 5.1% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/8 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/28 (4%) 1/33 (3%) 0/34 (0%) 3/34 (9%) | 0/31 (0%) 2/31 (6%) 1/36 (3%) 2/39 (5%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 596 462 (I) 686 | --- 737 (T) 737 (T) 737 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.151 P=0.543 P=0.739N P=0.236 | P=0.386 P=0.238 P=0.530 P=0.290 |
|INCIDENTAL TUMOR | P=0.113 P=0.471 P=0.739N P=0.213 | P=0.386 P=0.238 P=0.530 P=0.290 |
|LOGISTIC REGRESSION | P=0.129 P=0.510 P=0.759N P=0.207 | P=0.386 P=0.238 P=0.530 P=0.290 |
|COCHRAN-ARMITAGE | P=0.126 | P=0.305 |
|FISHER EXACT | P=0.505 P=0.748N P=0.183 | P=0.245 P=0.500 P=0.248 |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/69 (0%) 1/70 (1%) 0/70 (0%) 0/67 (0%) | 0/70 (0%) 1/69 (1%) 0/68 (0%) 2/69 (3%) |
|ADJUSTED (b) | 0.0% 3.0% 0.0% 0.0% | 0.0% 1.7% 0.0% 5.1% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/28 (0%) 1/33 (3%) 0/34 (0%) 0/34 (0%) | 0/31 (0%) 0/32 (0%) 0/36 (0%) 2/39 (5%) |
|FIRST INCIDENCE (DAYS) | --- 729 (T) --- --- | --- 463 (I) --- 737 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.428N P=0.533 (e) (e) | P=0.200 P=0.500 (e) P=0.290 |
|INCIDENTAL TUMOR | P=0.428N P=0.533 (e) (e) | P=0.200 P=0.500 (e) P=0.290 |
|LOGISTIC REGRESSION | P=0.428N P=0.533 (e) (e) | P=0.169 P=0.488 (e) P=0.290 |
|COCHRAN-ARMITAGE | P=0.454N | P=0.167 |
|FISHER EXACT | P=0.504 (e) (e) | P=0.496 (e) P=0.245 |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05150 TEST: 01 PAGE 6
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- METHLYPHENIDATE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 100 PPM 500 PPM 1000 PPM | 0 PPM 100 PPM 500 PPM 1000 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/70 (0%) 2/70 (3%) 0/70 (0%) 0/70 (0%) | 0/70 (0%) 1/70 (1%) 0/70 (0%) 0/70 (0%) |
|ADJUSTED (b) | 0.0% 5.7% 0.0% 0.0% | 0.0% 3.1% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/28 (0%) 1/33 (3%) 0/34 (0%) 0/34 (0%) | 0/31 (0%) 1/32 (3%) 0/36 (0%) 0/39 (0%) |
|FIRST INCIDENCE (DAYS) | --- 676 --- --- | --- 737 (T) --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.243N P=0.264 (e) (e) | P=0.415N P=0.506 (e) (e) |
|INCIDENTAL TUMOR | P=0.260N P=0.229 (e) (e) | P=0.415N P=0.506 (e) (e) |
|LOGISTIC REGRESSION | P=0.256N P=0.247 (e) (e) | P=0.415N P=0.506 (e) (e) |
|COCHRAN-ARMITAGE | P=0.264N | P=0.449N |
|FISHER EXACT | P=0.248 (e) (e) | P=0.500 (e) (e) |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/70 (3%) 1/70 (1%) 0/70 (0%) 0/70 (0%) | 0/70 (0%) 3/70 (4%) 0/70 (0%) 0/70 (0%) |
|ADJUSTED (b) | 5.3% 3.0% 0.0% 0.0% | 0.0% 7.8% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/28 (4%) 1/33 (3%) 0/34 (0%) 0/34 (0%) | 0/31 (0%) 2/32 (6%) 0/36 (0%) 0/39 (0%) |
|FIRST INCIDENCE (DAYS) | 462 (I) 729 (T) --- --- | --- 463 (I) --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.095N P=0.462N P=0.218N P=0.218N | P=0.147N P=0.127 (e) (e) |
|INCIDENTAL TUMOR | P=0.095N P=0.462N P=0.218N P=0.218N | P=0.147N P=0.127 (e) (e) |
|LOGISTIC REGRESSION | P=0.104N P=0.499N P=0.238N P=0.239N | P=0.168N P=0.124 (e) (e) |
|COCHRAN-ARMITAGE | P=0.105N | P=0.169N |
|FISHER EXACT | P=0.500N P=0.248N P=0.248N | P=0.122 (e) (e) |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05150 TEST: 01 PAGE 7
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- METHLYPHENIDATE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 100 PPM 500 PPM 1000 PPM | 0 PPM 100 PPM 500 PPM 1000 PPM |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/70 (0%) 0/70 (0%) 0/70 (0%) 0/70 (0%) | 1/70 (1%) 4/70 (6%) 1/70 (1%) 1/70 (1%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 3.2% 11.3% 2.8% 2.2% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/28 (0%) 0/33 (0%) 0/34 (0%) 0/34 (0%) | 1/31 (3%) 2/32 (6%) 1/36 (3%) 0/39 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- | 737 (T) 699 737 (T) 619 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) (e) | P=0.212N P=0.203 P=0.728N P=0.733N |
|INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.316N P=0.177 P=0.728N P=0.735N |
|LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.249N P=0.204 P=0.728N P=0.755N |
|COCHRAN-ARMITAGE | (e) | P=0.264N |
|FISHER EXACT | (e) (e) (e) | P=0.183 P=0.752N P=0.752N |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/70 (0%) 0/70 (0%) 0/70 (0%) 0/70 (0%) | 1/70 (1%) 4/70 (6%) 2/70 (3%) 1/70 (1%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 3.2% 11.3% 5.6% 2.2% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/28 (0%) 0/33 (0%) 0/34 (0%) 0/34 (0%) | 1/31 (3%) 2/32 (6%) 2/36 (6%) 0/39 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- | 737 (T) 699 737 (T) 619 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) (e) | P=0.244N P=0.203 P=0.552 P=0.733N |
|INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.350N P=0.177 P=0.552 P=0.735N |
|LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.290N P=0.204 P=0.552 P=0.755N |
|COCHRAN-ARMITAGE | (e) | P=0.308N |
|FISHER EXACT | (e) (e) (e) | P=0.183 P=0.500 P=0.752N |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05150 TEST: 01 PAGE 8
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- METHLYPHENIDATE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 100 PPM 500 PPM 1000 PPM | 0 PPM 100 PPM 500 PPM 1000 PPM |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/70 (1%) 2/70 (3%) 1/70 (1%) 2/70 (3%) | 15/70 (21%) 13/70 (19%) 6/70 (9%) 5/70 (7%) |
|ADJUSTED (b) | 3.6% 6.1% 2.9% 5.9% | 45.3% 38.0% 15.9% 11.7% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/28 (4%) 2/33 (6%) 1/34 (3%) 2/34 (6%) | 13/31 (42%) 11/32 (34%) 5/36 (14%) 3/39 (8%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 729 (T) 729 (T) | 680 720 638 559 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.532 P=0.558 P=0.718N P=0.568 | P<0.001N** P=0.361N P=0.010N** P=0.003N** |
|INCIDENTAL TUMOR | P=0.532 P=0.558 P=0.718N P=0.568 | P=0.001N** P=0.389N P=0.017N* P=0.006N** |
|LOGISTIC REGRESSION | P=0.532 P=0.558 P=0.718N P=0.568 | P=0.002N** P=0.280N P=0.013N* P=0.007N** |
|COCHRAN-ARMITAGE | P=0.479 | P=0.004N** |
|FISHER EXACT | P=0.500 P=0.752N P=0.500 | P=0.416N P=0.028N* P=0.014N* |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/70 (1%) 2/70 (3%) 1/70 (1%) 2/70 (3%) | 15/70 (21%) 13/70 (19%) 7/70 (10%) 5/70 (7%) |
|ADJUSTED (b) | 3.6% 6.1% 2.9% 5.9% | 45.3% 38.0% 18.6% 11.7% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/28 (4%) 2/33 (6%) 1/34 (3%) 2/34 (6%) | 13/31 (42%) 11/32 (34%) 6/36 (17%) 3/39 (8%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 729 (T) 729 (T) | 680 720 638 559 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.532 P=0.558 P=0.718N P=0.568 | P<0.001N** P=0.361N P=0.019N* P=0.003N** |
|INCIDENTAL TUMOR | P=0.532 P=0.558 P=0.718N P=0.568 | P=0.002N** P=0.389N P=0.031N* P=0.006N** |
|LOGISTIC REGRESSION | P=0.532 P=0.558 P=0.718N P=0.568 | P=0.002N** P=0.280N P=0.025N* P=0.007N** |
|COCHRAN-ARMITAGE | P=0.479 | P=0.005N** |
|FISHER EXACT | P=0.500 P=0.752N P=0.500 | P=0.416N P=0.051N P=0.014N* |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05150 TEST: 01 PAGE 9
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- METHLYPHENIDATE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 100 PPM 500 PPM 1000 PPM | 0 PPM 100 PPM 500 PPM 1000 PPM |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/70 (1%) 2/70 (3%) 1/70 (1%) 2/70 (3%) | 16/70 (23%) 17/70 (24%) 8/70 (11%) 5/70 (7%) |
|ADJUSTED (b) | 3.6% 6.1% 2.9% 5.9% | 48.3% 46.9% 21.3% 11.7% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/28 (4%) 2/33 (6%) 1/34 (3%) 2/34 (6%) | 14/31 (45%) 13/32 (41%) 7/36 (19%) 3/39 (8%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 729 (T) 729 (T) | 680 699 638 559 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.532 P=0.558 P=0.718N P=0.568 | P<0.001N** P=0.561 P=0.019N* P=0.002N** |
|INCIDENTAL TUMOR | P=0.532 P=0.558 P=0.718N P=0.568 | P<0.001N** P=0.517 P=0.032N* P=0.003N** |
|LOGISTIC REGRESSION | P=0.532 P=0.558 P=0.718N P=0.568 | P<0.001N** P=0.527N P=0.026N* P=0.004N** |
|COCHRAN-ARMITAGE | P=0.479 | P=0.001N** |
|FISHER EXACT | P=0.500 P=0.752N P=0.500 | P=0.500 P=0.058N P=0.008N** |
|=================================================================================================================================|
| |
|Pancreas |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/69 (0%) 0/70 (0%) 2/69 (3%) 1/69 (1%) | 0/70 (0%) 0/69 (0%) 0/70 (0%) 0/70 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 5.9% 2.9% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/8 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/28 (0%) 0/33 (0%) 2/34 (6%) 1/34 (3%) | 0/31 (0%) 0/31 (0%) 0/36 (0%) 0/39 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 729 (T) 729 (T) | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.236 (e) P=0.282 P=0.539 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.236 (e) P=0.282 P=0.539 | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.236 (e) P=0.282 P=0.539 | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.207 | (e) |
|FISHER EXACT | (e) P=0.248 P=0.500 | (e) (e) (e) |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05150 TEST: 01 PAGE 10
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- METHLYPHENIDATE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 100 PPM 500 PPM 1000 PPM | 0 PPM 100 PPM 500 PPM 1000 PPM |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 12/68 (18%) 11/69 (16%) 7/68 (10%) 11/70 (16%) | 28/70 (40%) 33/69 (48%) 22/69 (32%) 25/67 (37%) |
|ADJUSTED (b) | 35.5% 27.0% 21.2% 29.6% | 65.6% 75.8% 52.6% 59.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) |
|INTERIM SACRIFICE 2 (c)| 1/10 (10%) 1/10 (10%) 0/10 (0%) 1/10 (10%) | 2/10 (20%) 1/10 (10%) 2/10 (20%) 0/9 (0%) |
|TERMINAL (d) | 8/28 (29%) 6/33 (18%) 7/33 (21%) 9/34 (26%) | 17/31 (55%) 21/31 (68%) 17/36 (47%) 21/38 (55%) |
|FIRST INCIDENCE (DAYS) | 462 (I) 409 729 (T) 462 (I) | 463 (I) 450 463 (I) 404 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.298N P=0.388N P=0.084N P=0.336N | P=0.022N* P=0.301 P=0.085N P=0.136N |
|INCIDENTAL TUMOR | P=0.350N P=0.471N P=0.106N P=0.411N | P=0.115N P=0.222 P=0.243N P=0.384N |
|LOGISTIC REGRESSION | P=0.362N P=0.474N P=0.108N P=0.439N | P=0.096N P=0.240 P=0.154N P=0.325N |
|COCHRAN-ARMITAGE | P=0.385N | P=0.170N |
|FISHER EXACT | P=0.485N P=0.161N P=0.469N | P=0.224 P=0.206N P=0.442N |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 13/68 (19%) 11/69 (16%) 7/68 (10%) 11/70 (16%) | 28/70 (40%) 33/69 (48%) 23/69 (33%) 25/67 (37%) |
|ADJUSTED (b) | 37.0% 27.0% 21.2% 29.6% | 65.6% 75.8% 55.1% 59.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) |
|INTERIM SACRIFICE 2 (c)| 1/10 (10%) 1/10 (10%) 0/10 (0%) 1/10 (10%) | 2/10 (20%) 1/10 (10%) 2/10 (20%) 0/9 (0%) |
|TERMINAL (d) | 8/28 (29%) 6/33 (18%) 7/33 (21%) 9/34 (26%) | 17/31 (55%) 21/31 (68%) 18/36 (50%) 21/38 (55%) |
|FIRST INCIDENCE (DAYS) | 462 (I) 409 729 (T) 462 (I) | 463 (I) 450 463 (I) 404 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.244N P=0.310N P=0.056N P=0.261N | P=0.023N* P=0.301 P=0.114N P=0.136N |
|INCIDENTAL TUMOR | P=0.310N P=0.416N P=0.088N P=0.368N | P=0.120N P=0.222 P=0.303N P=0.384N |
|LOGISTIC REGRESSION | P=0.301N P=0.385N P=0.075N P=0.354N | P=0.101N P=0.240 P=0.204N P=0.325N |
|COCHRAN-ARMITAGE | P=0.322N | P=0.179N |
|FISHER EXACT | P=0.396N P=0.113N P=0.381N | P=0.224 P=0.261N P=0.442N |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05150 TEST: 01 PAGE 11
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- METHLYPHENIDATE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 100 PPM 500 PPM 1000 PPM | 0 PPM 100 PPM 500 PPM 1000 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Basal Cell Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/70 (0%) 2/70 (3%) 0/70 (0%) 0/70 (0%) | 1/70 (1%) 1/70 (1%) 0/70 (0%) 1/70 (1%) |
|ADJUSTED (b) | 0.0% 6.1% 0.0% 0.0% | 2.9% 3.1% 0.0% 2.6% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/28 (0%) 2/33 (6%) 0/34 (0%) 0/34 (0%) | 0/31 (0%) 1/32 (3%) 0/36 (0%) 1/39 (3%) |
|FIRST INCIDENCE (DAYS) | --- 729 (T) --- --- | 684 737 (T) --- 737 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.240N P=0.275 (e) (e) | P=0.537N P=0.736N P=0.473N P=0.716N |
|INCIDENTAL TUMOR | P=0.240N P=0.275 (e) (e) | P=0.646N P=0.755 P=0.654N P=0.673 |
|LOGISTIC REGRESSION | P=0.240N P=0.275 (e) (e) | P=0.574N P=0.751N P=0.497N P=0.749N |
|COCHRAN-ARMITAGE | P=0.264N | P=0.588N |
|FISHER EXACT | P=0.248 (e) (e) | P=0.752N P=0.500N P=0.752N |
|=================================================================================================================================|
| |
|Skin |
| Basal Cell Adenoma, Basosquamous Tumor Benign, or Trichoepithelioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/70 (0%) 2/70 (3%) 0/70 (0%) 0/70 (0%) | 2/70 (3%) 1/70 (1%) 0/70 (0%) 1/70 (1%) |
|ADJUSTED (b) | 0.0% 6.1% 0.0% 0.0% | 4.6% 3.1% 0.0% 2.6% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/28 (0%) 2/33 (6%) 0/34 (0%) 0/34 (0%) | 0/31 (0%) 1/32 (3%) 0/36 (0%) 1/39 (3%) |
|FIRST INCIDENCE (DAYS) | --- 729 (T) --- --- | 450 737 (T) --- 737 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.240N P=0.275 (e) (e) | P=0.338N P=0.473N P=0.227N P=0.457N |
|INCIDENTAL TUMOR | P=0.240N P=0.275 (e) (e) | P=0.375N P=0.387N P=0.158N P=0.478N |
|LOGISTIC REGRESSION | P=0.240N P=0.275 (e) (e) | P=0.372N P=0.498N P=0.238N P=0.498N |
|COCHRAN-ARMITAGE | P=0.264N | P=0.375N |
|FISHER EXACT | P=0.248 (e) (e) | P=0.500N P=0.248N P=0.500N |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05150 TEST: 01 PAGE 12
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- METHLYPHENIDATE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 100 PPM 500 PPM 1000 PPM | 0 PPM 100 PPM 500 PPM 1000 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Basal Cell Carcinoma, Basal Cell Adenoma, Basosquamous Tumor (benign, |
| malignant or NOS), or Trichoepithelioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/70 (0%) 2/70 (3%) 0/70 (0%) 0/70 (0%) | 2/70 (3%) 1/70 (1%) 0/70 (0%) 1/70 (1%) |
|ADJUSTED (b) | 0.0% 6.1% 0.0% 0.0% | 4.6% 3.1% 0.0% 2.6% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/28 (0%) 2/33 (6%) 0/34 (0%) 0/34 (0%) | 0/31 (0%) 1/32 (3%) 0/36 (0%) 1/39 (3%) |
|FIRST INCIDENCE (DAYS) | --- 729 (T) --- --- | 450 737 (T) --- 737 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.240N P=0.275 (e) (e) | P=0.338N P=0.473N P=0.227N P=0.457N |
|INCIDENTAL TUMOR | P=0.240N P=0.275 (e) (e) | P=0.375N P=0.387N P=0.158N P=0.478N |
|LOGISTIC REGRESSION | P=0.240N P=0.275 (e) (e) | P=0.372N P=0.498N P=0.238N P=0.498N |
|COCHRAN-ARMITAGE | P=0.264N | P=0.375N |
|FISHER EXACT | P=0.248 (e) (e) | P=0.500N P=0.248N P=0.500N |
|=================================================================================================================================|
| |
|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) | 2/70 (3%) 3/70 (4%) 4/70 (6%) 1/70 (1%) | 2/70 (3%) 1/70 (1%) 0/70 (0%) 2/70 (3%) |
|ADJUSTED (b) | 7.1% 9.1% 10.9% 2.9% | 4.6% 3.1% 0.0% 4.2% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) |
|TERMINAL (d) | 2/28 (7%) 3/33 (9%) 3/34 (9%) 1/34 (3%) | 0/31 (0%) 1/32 (3%) 0/36 (0%) 1/39 (3%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 653 729 (T) | 450 737 (T) --- 463 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.294N P=0.576 P=0.426 P=0.432N | P=0.603 P=0.473N P=0.227N P=0.658N |
|INCIDENTAL TUMOR | P=0.304N P=0.575 P=0.414 P=0.432N | P=0.565 P=0.387N P=0.158N P=0.689N |
|LOGISTIC REGRESSION | P=0.318N P=0.575 P=0.393 P=0.432N | P=0.569 P=0.498N P=0.238N P=0.692 |
|COCHRAN-ARMITAGE | P=0.356N | P=0.568 |
|FISHER EXACT | P=0.500 P=0.340 P=0.500N | P=0.500N P=0.248N P=0.690N |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05150 TEST: 01 PAGE 13
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- METHLYPHENIDATE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 100 PPM 500 PPM 1000 PPM | 0 PPM 100 PPM 500 PPM 1000 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Fibroma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/70 (1%) 3/70 (4%) 1/70 (1%) 3/70 (4%) | 0/70 (0%) 2/70 (3%) 0/70 (0%) 0/70 (0%) |
|ADJUSTED (b) | 2.1% 9.1% 2.9% 8.1% | 0.0% 6.3% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/28 (0%) 3/33 (9%) 1/34 (3%) 2/34 (6%) | 0/31 (0%) 2/32 (6%) 0/36 (0%) 0/39 (0%) |
|FIRST INCIDENCE (DAYS) | 524 729 (T) 729 (T) 639 | --- 737 (T) --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.420 P=0.349 P=0.739N P=0.346 | P=0.227N P=0.245 (e) (e) |
|INCIDENTAL TUMOR | P=0.365 P=0.351 P=0.739N P=0.248 | P=0.227N P=0.245 (e) (e) |
|LOGISTIC REGRESSION | P=0.385 P=0.312 P=0.759N P=0.308 | P=0.227N P=0.245 (e) (e) |
|COCHRAN-ARMITAGE | P=0.375 | P=0.264N |
|FISHER EXACT | P=0.310 P=0.752N P=0.310 | P=0.248 (e) (e) |
|=================================================================================================================================|
| |
|Skin |
| Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/70 (3%) 4/70 (6%) 2/70 (3%) 3/70 (4%) | 0/70 (0%) 4/70 (6%) 1/70 (1%) 0/70 (0%) |
|ADJUSTED (b) | 5.6% 11.3% 5.0% 8.1% | 0.0% 11.3% 2.3% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/28 (4%) 3/33 (9%) 1/34 (3%) 2/34 (6%) | 0/31 (0%) 3/32 (9%) 0/36 (0%) 0/39 (0%) |
|FIRST INCIDENCE (DAYS) | 524 623 542 639 | --- 579 588 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.531N P=0.390 P=0.656N P=0.555 | P=0.140N P=0.069 P=0.496 (e) |
|INCIDENTAL TUMOR | P=0.531 P=0.344 P=0.666N P=0.461 | P=0.133N P=0.058 P=0.443 (e) |
|LOGISTIC REGRESSION | P=0.571N P=0.346 P=0.688N P=0.506 | P=0.162N P=0.068 P=0.500 (e) |
|COCHRAN-ARMITAGE | P=0.577N | P=0.165N |
|FISHER EXACT | P=0.340 P=0.690N P=0.500 | P=0.060 P=0.500 (e) |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05150 TEST: 01 PAGE 14
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- METHLYPHENIDATE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 100 PPM 500 PPM 1000 PPM | 0 PPM 100 PPM 500 PPM 1000 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/70 (1%) 1/70 (1%) 1/70 (1%) 0/70 (0%) | 0/70 (0%) 2/70 (3%) 1/70 (1%) 0/70 (0%) |
|ADJUSTED (b) | 3.6% 2.4% 2.1% 0.0% | 0.0% 5.2% 2.3% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/28 (4%) 0/33 (0%) 0/34 (0%) 0/34 (0%) | 0/31 (0%) 1/32 (3%) 0/36 (0%) 0/39 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 623 542 --- | --- 579 588 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.292N P=0.739N P=0.737N P=0.461N | P=0.338N P=0.248 P=0.496 (e) |
|INCIDENTAL TUMOR | P=0.369N P=0.718 P=0.739N P=0.461N | P=0.324N P=0.212 P=0.443 (e) |
|LOGISTIC REGRESSION | P=0.302N P=0.758N P=0.758N P=0.461N | P=0.416N P=0.242 P=0.500 (e) |
|COCHRAN-ARMITAGE | P=0.303N | P=0.356N |
|FISHER EXACT | P=0.752N P=0.752N P=0.500N | P=0.248 P=0.500 (e) |
|=================================================================================================================================|
| |
|Skin |
| Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/70 (1%) 1/70 (1%) 4/70 (6%) 1/70 (1%) | 0/70 (0%) 0/70 (0%) 0/70 (0%) 1/70 (1%) |
|ADJUSTED (b) | 3.6% 3.0% 10.9% 2.9% | 0.0% 0.0% 0.0% 1.7% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) |
|TERMINAL (d) | 1/28 (4%) 1/33 (3%) 3/34 (9%) 1/34 (3%) | 0/31 (0%) 0/32 (0%) 0/36 (0%) 0/39 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 653 729 (T) | --- --- --- 463 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.536 P=0.725N P=0.240 P=0.718N | P=0.187 (e) (e) P=0.500 |
|INCIDENTAL TUMOR | P=0.522 P=0.725N P=0.230 P=0.718N | P=0.187 (e) (e) P=0.500 |
|LOGISTIC REGRESSION | P=0.508 P=0.725N P=0.214 P=0.718N | P=0.184 (e) (e) P=0.493 |
|COCHRAN-ARMITAGE | P=0.481 | P=0.187 |
|FISHER EXACT | P=0.752N P=0.183 P=0.752N | (e) (e) P=0.500 |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05150 TEST: 01 PAGE 15
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- METHLYPHENIDATE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 100 PPM 500 PPM 1000 PPM | 0 PPM 100 PPM 500 PPM 1000 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, Squamous Cell Carcinoma or Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/70 (3%) 1/70 (1%) 4/70 (6%) 1/70 (1%) | 0/70 (0%) 0/70 (0%) 0/70 (0%) 1/70 (1%) |
|ADJUSTED (b) | 7.1% 3.0% 10.9% 2.9% | 0.0% 0.0% 0.0% 1.7% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) |
|TERMINAL (d) | 2/28 (7%) 1/33 (3%) 3/34 (9%) 1/34 (3%) | 0/31 (0%) 0/32 (0%) 0/36 (0%) 0/39 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 653 729 (T) | --- --- --- 463 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.495N P=0.442N P=0.426 P=0.432N | P=0.187 (e) (e) P=0.500 |
|INCIDENTAL TUMOR | P=0.508N P=0.442N P=0.414 P=0.432N | P=0.187 (e) (e) P=0.500 |
|LOGISTIC REGRESSION | P=0.524N P=0.442N P=0.393 P=0.432N | P=0.184 (e) (e) P=0.493 |
|COCHRAN-ARMITAGE | P=0.554N | P=0.187 |
|FISHER EXACT | P=0.500N P=0.340 P=0.500N | (e) (e) P=0.500 |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, or Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/70 (3%) 1/70 (1%) 4/70 (6%) 1/70 (1%) | 0/70 (0%) 0/70 (0%) 0/70 (0%) 1/70 (1%) |
|ADJUSTED (b) | 7.1% 3.0% 10.9% 2.9% | 0.0% 0.0% 0.0% 1.7% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) |
|TERMINAL (d) | 2/28 (7%) 1/33 (3%) 3/34 (9%) 1/34 (3%) | 0/31 (0%) 0/32 (0%) 0/36 (0%) 0/39 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 653 729 (T) | --- --- --- 463 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.495N P=0.442N P=0.426 P=0.432N | P=0.187 (e) (e) P=0.500 |
|INCIDENTAL TUMOR | P=0.508N P=0.442N P=0.414 P=0.432N | P=0.187 (e) (e) P=0.500 |
|LOGISTIC REGRESSION | P=0.524N P=0.442N P=0.393 P=0.432N | P=0.184 (e) (e) P=0.493 |
|COCHRAN-ARMITAGE | P=0.554N | P=0.187 |
|FISHER EXACT | P=0.500N P=0.340 P=0.500N | (e) (e) P=0.500 |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05150 TEST: 01 PAGE 16
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- METHLYPHENIDATE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 100 PPM 500 PPM 1000 PPM | 0 PPM 100 PPM 500 PPM 1000 PPM |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Hemangiosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/70 (3%) 0/70 (0%) 0/70 (0%) 0/70 (0%) | 0/70 (0%) 0/69 (0%) 0/70 (0%) 0/70 (0%) |
|ADJUSTED (b) | 5.9% 0.0% 0.0% 0.0% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/28 (4%) 0/33 (0%) 0/34 (0%) 0/34 (0%) | 0/31 (0%) 0/31 (0%) 0/36 (0%) 0/39 (0%) |
|FIRST INCIDENCE (DAYS) | 612 --- --- --- | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.151N P=0.222N P=0.211N P=0.218N | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.214N P=0.282N P=0.326N P=0.326N | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.158N P=0.234N P=0.227N P=0.235N | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.161N | (e) |
|FISHER EXACT | P=0.248N P=0.248N P=0.248N | (e) (e) (e) |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 55/70 (79%) 56/69 (81%) 55/70 (79%) 57/70 (81%) | |
|ADJUSTED (b) | 98.2% 100.0% 100.0% 100.0% | |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/9 (11%) | |
|INTERIM SACRIFICE 2 (c)| 9/10 (90%) 10/10 (100%) 8/10 (80%) 10/10 (100%)| |
|TERMINAL (d) | 27/28 (96%) 33/33 (100%) 34/34 (100%) 34/34 (100%)| |
|FIRST INCIDENCE (DAYS) | 459 429 462 (I) 275 (I) | |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.251N P=0.262N P=0.125N P=0.251N | |
|INCIDENTAL TUMOR | P=0.165 P=0.199 P=0.595N P=0.126 | |
|LOGISTIC REGRESSION | P=0.037 * P=0.594N P=0.542 P=0.110 | |
|COCHRAN-ARMITAGE | P=0.438 | |
|FISHER EXACT | P=0.433 P=0.581N P=0.416 | |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05150 TEST: 01 PAGE 17
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- METHLYPHENIDATE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 100 PPM 500 PPM 1000 PPM | 0 PPM 100 PPM 500 PPM 1000 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/70 (6%) 5/69 (7%) 6/70 (9%) 9/69 (13%) | 4/70 (6%) 8/70 (11%) 7/70 (10%) 4/70 (6%) |
|ADJUSTED (b) | 14.3% 13.1% 16.9% 23.9% | 9.3% 22.5% 18.9% 10.3% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 1/10 (10%) 0/10 (0%) 1/10 (10%) | 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 4/28 (14%) 3/32 (9%) 5/34 (15%) 7/34 (21%) | 1/31 (3%) 6/32 (19%) 6/36 (17%) 4/39 (10%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 462 (I) 681 462 (I) | 463 (I) 660 730 737 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.115 P=0.566 P=0.494 P=0.193 | P=0.236N P=0.210 P=0.330 P=0.560N |
|INCIDENTAL TUMOR | P=0.080 P=0.525 P=0.483 P=0.149 | P=0.401N P=0.177 P=0.203 P=0.577 |
|LOGISTIC REGRESSION | P=0.082 P=0.501 P=0.473 P=0.132 | P=0.330N P=0.197 P=0.273 P=0.625N |
|COCHRAN-ARMITAGE | P=0.073 | P=0.360N |
|FISHER EXACT | P=0.491 P=0.372 P=0.116 | P=0.183 P=0.266 P=0.641N |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/70 (1%) 0/69 (0%) 2/70 (3%) 1/69 (1%) | 1/70 (1%) 2/70 (3%) 0/70 (0%) 1/70 (1%) |
|ADJUSTED (b) | 3.6% 0.0% 5.9% 2.9% | 3.2% 6.3% 0.0% 2.4% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/28 (4%) 0/32 (0%) 2/34 (6%) 1/34 (3%) | 1/31 (3%) 2/32 (6%) 0/36 (0%) 0/39 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) --- 729 (T) 729 (T) | 737 (T) 737 (T) --- 676 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.471 P=0.473N P=0.568 P=0.718N | P=0.368N P=0.511 P=0.470N P=0.720N |
|INCIDENTAL TUMOR | P=0.471 P=0.473N P=0.568 P=0.718N | P=0.451N P=0.511 P=0.470N P=0.673 |
|LOGISTIC REGRESSION | P=0.471 P=0.473N P=0.569 P=0.718N | P=0.407N P=0.511 P=0.470N P=0.750N |
|COCHRAN-ARMITAGE | P=0.422 | P=0.424N |
|FISHER EXACT | P=0.504N P=0.500 P=0.748 | P=0.500 P=0.500N P=0.752N |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05150 TEST: 01 PAGE 18
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- METHLYPHENIDATE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 100 PPM 500 PPM 1000 PPM | 0 PPM 100 PPM 500 PPM 1000 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/70 (7%) 5/69 (7%) 7/70 (10%) 10/69 (14%) | 5/70 (7%) 10/70 (14%) 7/70 (10%) 5/70 (7%) |
|ADJUSTED (b) | 17.9% 13.1% 19.8% 26.7% | 12.3% 28.5% 18.9% 12.4% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 1/10 (10%) 0/10 (0%) 1/10 (10%) | 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 5/28 (18%) 3/32 (9%) 6/34 (18%) 8/34 (24%) | 2/31 (6%) 8/32 (25%) 6/36 (17%) 4/39 (10%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 462 (I) 681 462 (I) | 463 (I) 660 730 676 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.103 P=0.560N P=0.519 P=0.222 | P=0.175N P=0.160 P=0.460 P=0.531N |
|INCIDENTAL TUMOR | P=0.072 P=0.599N P=0.508 P=0.176 | P=0.337N P=0.134 P=0.320 P=0.513 |
|LOGISTIC REGRESSION | P=0.071 P=0.628N P=0.499 P=0.151 | P=0.262N P=0.152 P=0.394 P=0.607N |
|COCHRAN-ARMITAGE | P=0.062 | P=0.295N |
|FISHER EXACT | P=0.619 P=0.382 P=0.131 | P=0.137 P=0.382 P=0.628N |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # # |
|----------- | | |
|OVERALL (a) | | 5/70 (7%) 9/70 (13%) 11/70 (16%) 9/70 (13%) |
|ADJUSTED (b) | | 15.2% 22.8% 23.6% 19.8% |
|INTERIM SACRIFICE 1 (c)| | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| | 0/10 (0%) 0/10 (0%) 4/10 (40%) 2/10 (20%) |
|TERMINAL (d) | | 4/31 (13%) 4/32 (13%) 5/36 (14%) 5/39 (13%) |
|FIRST INCIDENCE (DAYS) | | 668 494 463 (I) 463 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.363 P=0.236 P=0.133 P=0.306 |
|INCIDENTAL TUMOR | | P=0.210 P=0.223 P=0.112 P=0.192 |
|LOGISTIC REGRESSION | | P=0.243 P=0.219 P=0.093 P=0.215 |
|COCHRAN-ARMITAGE | | P=0.236 |
|FISHER EXACT | | P=0.199 P=0.091 P=0.199 |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05150 TEST: 01 PAGE 19
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- METHLYPHENIDATE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 100 PPM 500 PPM 1000 PPM | 0 PPM 100 PPM 500 PPM 1000 PPM |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Sarcoma Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # # |
|----------- | | |
|OVERALL (a) | | 2/70 (3%) 1/70 (1%) 1/70 (1%) 1/70 (1%) |
|ADJUSTED (b) | | 4.2% 3.1% 2.8% 2.6% |
|INTERIM SACRIFICE 1 (c)| | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | | 0/31 (0%) 1/32 (3%) 1/36 (3%) 1/39 (3%) |
|FIRST INCIDENCE (DAYS) | | 551 737 (T) 737 (T) 737 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.388N P=0.499N P=0.495N P=0.479N |
|INCIDENTAL TUMOR | | P=0.373N P=0.566N P=0.552N P=0.472N |
|LOGISTIC REGRESSION | | P=0.427N P=0.499N P=0.500N P=0.499N |
|COCHRAN-ARMITAGE | | P=0.432N |
|FISHER EXACT | | P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
| |
|Uterus |
| Sarcoma Stromal or Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # # |
|----------- | | |
|OVERALL (a) | | 7/70 (10%) 10/70 (14%) 11/70 (16%) 10/70 (14%) |
|ADJUSTED (b) | | 18.7% 25.5% 23.6% 22.1% |
|INTERIM SACRIFICE 1 (c)| | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| | 0/10 (0%) 0/10 (0%) 4/10 (40%) 2/10 (20%) |
|TERMINAL (d) | | 4/31 (13%) 5/32 (16%) 5/36 (14%) 6/39 (15%) |
|FIRST INCIDENCE (DAYS) | | 551 494 463 (I) 463 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.464 P=0.344 P=0.289 P=0.427 |
|INCIDENTAL TUMOR | | P=0.309 P=0.302 P=0.240 P=0.304 |
|LOGISTIC REGRESSION | | P=0.279 P=0.326 P=0.226 P=0.321 |
|COCHRAN-ARMITAGE | | P=0.321 |
|FISHER EXACT | | P=0.303 P=0.225 P=0.303 |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05150 TEST: 01 PAGE 20
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- METHLYPHENIDATE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 100 PPM 500 PPM 1000 PPM | 0 PPM 100 PPM 500 PPM 1000 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/70 (3%) 0/70 (0%) 0/70 (0%) 0/70 (0%) | 0/70 (0%) 0/70 (0%) 0/70 (0%) 0/70 (0%) |
|ADJUSTED (b) | 5.9% 0.0% 0.0% 0.0% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/28 (4%) 0/33 (0%) 0/34 (0%) 0/34 (0%) | 0/31 (0%) 0/32 (0%) 0/36 (0%) 0/39 (0%) |
|FIRST INCIDENCE (DAYS) | 612 --- --- --- | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.151N P=0.222N P=0.211N P=0.218N | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.214N P=0.282N P=0.326N P=0.326N | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.158N P=0.234N P=0.227N P=0.235N | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.161N | (e) |
|FISHER EXACT | P=0.248N P=0.248N P=0.248N | (e) (e) (e) |
|=================================================================================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 29/70 (41%) 25/70 (36%) 17/70 (24%) 23/70 (33%) | 13/70 (19%) 14/70 (20%) 14/70 (20%) 13/70 (19%) |
|ADJUSTED (b) | 69.9% 60.6% 41.7% 55.7% | 30.0% 35.1% 32.3% 29.5% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 16/28 (57%) 17/33 (52%) 11/34 (32%) 16/34 (47%) | 3/31 (10%) 8/32 (25%) 8/36 (22%) 8/39 (21%) |
|FIRST INCIDENCE (DAYS) | 549 533 638 518 | 575 488 425 637 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.060N P=0.149N P=0.006N** P=0.069N | P=0.341N P=0.559 P=0.567N P=0.437N |
|INCIDENTAL TUMOR | P=0.180N P=0.357N P=0.020N* P=0.310N | P=0.310 P=0.469 P=0.334 P=0.138 |
|LOGISTIC REGRESSION | P=0.168N P=0.352N P=0.016N* P=0.277N | P=0.405 P=0.287 P=0.312 P=0.229 |
|COCHRAN-ARMITAGE | P=0.141N | P=0.508N |
|FISHER EXACT | P=0.301N P=0.024N* P=0.191N | P=0.500 P=0.500 P=0.586N |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05150 TEST: 01 PAGE 21
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- METHLYPHENIDATE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 100 PPM 500 PPM 1000 PPM | 0 PPM 100 PPM 500 PPM 1000 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma: Benign, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/70 (1%) 0/70 (0%) 3/70 (4%) 2/70 (3%) | 0/70 (0%) 0/70 (0%) 0/70 (0%) 0/70 (0%) |
|ADJUSTED (b) | 2.4% 0.0% 8.3% 5.1% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/28 (0%) 0/33 (0%) 1/34 (3%) 0/34 (0%) | 0/31 (0%) 0/32 (0%) 0/36 (0%) 0/39 (0%) |
|FIRST INCIDENCE (DAYS) | 632 --- 701 653 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.214 P=0.500N P=0.369 P=0.525 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.121 P=0.617N P=0.230 P=0.321 | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.190 P=0.500N P=0.332 P=0.502 | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.186 | (e) |
|FISHER EXACT | P=0.500N P=0.310 P=0.500 | (e) (e) (e) |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 56/70 (80%) 57/70 (81%) 55/70 (79%) 57/70 (81%) | 43/70 (61%) 48/70 (69%) 42/70 (60%) 38/70 (54%) |
|ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | 93.3% 93.9% 87.1% 80.4% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/9 (11%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 9/10 (90%) 10/10 (100%) 8/10 (80%) 10/10 (100%)| 3/10 (30%) 4/10 (40%) 5/10 (50%) 3/10 (30%) |
|TERMINAL (d) | 28/28 (100%) 33/33 (100%) 34/34 (100%) 34/34 (100%)| 28/31 (90%) 29/32 (91%) 30/36 (83%) 30/39 (77%) |
|FIRST INCIDENCE (DAYS) | 459 409 462 (I) 275 (I) | 450 450 463 (I) 404 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.183N P=0.257N P=0.088N P=0.191N | P=0.003N** P=0.371 P=0.204N P=0.023N* |
|INCIDENTAL TUMOR | P=0.272 P=0.383 P=0.414N P=0.228 | P=0.017N* P=0.283 P=0.419N P=0.101N |
|LOGISTIC REGRESSION | P=0.061 P=0.463N P=0.647 P=0.149 | P=0.046N* P=0.312 P=0.506N P=0.144N |
|COCHRAN-ARMITAGE | P=0.508 | P=0.088N |
|FISHER EXACT | P=0.500 P=0.500N P=0.500 | P=0.239 P=0.500N P=0.247N |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05150 TEST: 01 PAGE 22
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- METHLYPHENIDATE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 100 PPM 500 PPM 1000 PPM | 0 PPM 100 PPM 500 PPM 1000 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 32/70 (46%) 28/70 (40%) 27/70 (39%) 30/70 (43%) | 19/70 (27%) 22/70 (31%) 20/70 (29%) 17/70 (24%) |
|ADJUSTED (b) | 73.7% 64.8% 59.7% 66.5% | 41.8% 52.4% 44.7% 36.6% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 17/28 (61%) 18/33 (55%) 16/34 (47%) 19/34 (56%) | 6/31 (19%) 13/32 (41%) 12/36 (33%) 10/39 (26%) |
|FIRST INCIDENCE (DAYS) | 549 533 406 439 | 551 488 425 442 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.265N P=0.153N P=0.086N P=0.200N | P=0.139N P=0.437 P=0.520N P=0.275N |
|INCIDENTAL TUMOR | P=0.397 P=0.432N P=0.319N P=0.443 | P=0.478N P=0.272 P=0.297 P=0.354 |
|LOGISTIC REGRESSION | P=0.424 P=0.422N P=0.278N P=0.474 | P=0.435N P=0.155 P=0.262 P=0.454 |
|COCHRAN-ARMITAGE | P=0.469N | P=0.277N |
|FISHER EXACT | P=0.304N P=0.247N P=0.432N | P=0.355 P=0.500 P=0.423N |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 57/70 (81%) 57/70 (81%) 56/70 (80%) 57/70 (81%) | 50/70 (71%) 51/70 (73%) 50/70 (71%) 46/70 (66%) |
|ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | 96.1% 94.4% 92.5% 88.3% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/9 (11%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 9/10 (90%) 10/10 (100%) 8/10 (80%) 10/10 (100%)| 3/10 (30%) 4/10 (40%) 5/10 (50%) 3/10 (30%) |
|TERMINAL (d) | 28/28 (100%) 33/33 (100%) 34/34 (100%) 34/34 (100%)| 29/31 (94%) 29/32 (91%) 32/36 (89%) 33/39 (85%) |
|FIRST INCIDENCE (DAYS) | 459 409 406 275 (I) | 450 450 425 404 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.163N P=0.208N P=0.093N P=0.151N | P=0.020N* P=0.481N P=0.262N P=0.042N* |
|INCIDENTAL TUMOR | P=0.303 P=0.529 P=0.500N P=0.289 | P=0.137N P=0.618 P=0.567 P=0.230N |
|LOGISTIC REGRESSION | P=0.083 P=0.332N P=0.621 P=0.225 | P=0.190N P=0.526N P=0.569 P=0.173N |
|COCHRAN-ARMITAGE | P=0.523N | P=0.208N |
|FISHER EXACT | P=0.586N P=0.500N P=0.586N | P=0.500 P=0.574N P=0.293N |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05150 TEST: 01 PAGE 23
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- METHLYPHENIDATE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
(a) Number of tumor-bearing animals / number of animals examined at site.
(b) Kaplan-Meier estimated lifetime tumor incidence after adjustment for
intercurrent mortality.
(c) Observed incidence at interim kill.
Male interim sacrifices(days): 275 462
Female interim sacrifices(days): 281 463
(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).