TDMS Study 05150-02 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Mason METHYLPHENIDATE HYDROCHLORIDE DATE: 05/20/95
EXPERIMENT: 05150 TEST: 02 TIME: 10:16:51
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-65132 ROUTE: DOSED FEED NTP C#: 56280B
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 METHYLPHENIDATE HYDROCHLORIDE DATE: 05/20/95
EXPERIMENT: 05150 TEST: 02 TIME: 10:16:51
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-65132 ROUTE: DOSED FEED NTP C#: 56280B
PATHOLOGIST: A. RUSSFIELD CAS: 298-59-9
MICE(B6C3F1)
----------------------------
FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED.
IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED.
----------------
Adrenal Cortex
Adrenal Medulla
Bone Marrow
Brain
Clitoral Gland
Epididymis
Gallbladder
Heart
Islets, Pancreatic
Kidney
Liver
Lung
Nose
Ovary
Pancreas
Parathyroid Gland
Pituitary Gland
Preputial Gland
Prostate
Salivary Glands
Spleen
Testes
Thymus
Thyroid Gland
Urinary Bladder
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Mason METHYLPHENIDATE HYDROCHLORIDE DATE: 05/20/95
EXPERIMENT: 05150 TEST: 02 TIME: 10:16:51
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-65132 ROUTE: DOSED FEED NTP C#: 56280B
PATHOLOGIST: A. RUSSFIELD CAS: 298-59-9
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF THE STUDY OF METHYLPHENIDATE HYDROCHLORIDE
====================================================================================================
MALE MICE
-------------
ORGAN MORPHOLOGY
------- ------------
Harderian Gland Carcinoma or Adenoma
Liver Hepatoblastoma
Hepatocellular Adenoma
Hepatocellular Carcinoma or Hepatocellular Adenoma
Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
Lung Alveolar/Bronchiolar Adenoma
Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
All Organs Malignant Lymphoma And Histiocytic Sarcoma
Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated
Cell Type
Benign Tumors
====================================================================================================
FEMALE MICE
-------------
ORGAN MORPHOLOGY
------- ------------
Liver Hepatocellular Adenoma
Hepatocellular Carcinoma or Hepatocellular Adenoma
Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
Lung Alveolar/Bronchiolar Adenoma
Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
Thyroid Gland: Follicular Cell
Adenoma
Carcinoma or Adenoma
All Organs Benign Tumors
====================================================================================================
DATE: 05/20/95 EXPERIMENT: 05150 TEST: 02 PAGE 1
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- METHYLPHENIDATE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 50 PPM 250 PPM 500 PPM | 0 PPM 50 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/69 (3%) 2/69 (3%) 1/70 (1%) 0/70 (0%) | 0/69 (0%) 0/67 (0%) 0/68 (0%) 1/70 (1%) |
|ADJUSTED (b) | 4.4% 4.4% 2.3% 0.0% | 0.0% 0.0% 0.0% 2.3% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/9 (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%) 0/9 (0%) 0/10 (0%) |
|TERMINAL (d) | 2/45 (4%) 2/45 (4%) 1/44 (2%) 0/41 (0%) | 0/37 (0%) 0/35 (0%) 0/37 (0%) 1/44 (2%) |
|FIRST INCIDENCE (DAYS) | 730 (T) 730 (T) 730 (T) --- | --- --- --- 739 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.127N P=0.694 P=0.508N P=0.259N | P=0.216 (e) (e) P=0.535 |
|INCIDENTAL TUMOR | P=0.127N P=0.695 P=0.508N P=0.259N | P=0.216 (e) (e) P=0.535 |
|LOGISTIC REGRESSION | P=0.127N P=0.695 P=0.508N P=0.259N | P=0.216 (e) (e) P=0.535 |
|COCHRAN-ARMITAGE | P=0.112N | P=0.191 |
|FISHER EXACT | P=0.690N P=0.495N P=0.245N | (e) (e) P=0.504 |
|=================================================================================================================================|
| |
|Bone Marrow |
| Hemangiosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/70 (0%) 1/70 (1%) 1/70 (1%) 2/69 (3%) | 0/69 (0%) 0/68 (0%) 1/67 (1%) 0/70 (0%) |
|ADJUSTED (b) | 0.0% 2.2% 2.3% 4.9% | 0.0% 0.0% 2.7% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/9 (0%) 0/9 (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) | 0/45 (0%) 1/45 (2%) 1/44 (2%) 2/41 (5%) | 0/37 (0%) 0/35 (0%) 1/37 (3%) 0/44 (0%) |
|FIRST INCIDENCE (DAYS) | --- 730 (T) 730 (T) 730 (T) | --- --- 739 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.147 P=0.500 P=0.496 P=0.218 | P=0.673 (e) P=0.500 (e) |
|INCIDENTAL TUMOR | P=0.147 P=0.500 P=0.496 P=0.218 | P=0.673 (e) P=0.500 (e) |
|LOGISTIC REGRESSION | P=0.147 P=0.500 P=0.496 P=0.218 | P=0.673 (e) P=0.500 (e) |
|COCHRAN-ARMITAGE | P=0.165 | P=0.650 |
|FISHER EXACT | P=0.500 P=0.500 P=0.245 | (e) P=0.493 (e) |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05150 TEST: 02 PAGE 2
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- METHYLPHENIDATE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 50 PPM 250 PPM 500 PPM | 0 PPM 50 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Harderian Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 4/70 (6%) 1/70 (1%) 0/70 (0%) 1/70 (1%) | 1/69 (1%) 0/68 (0%) 3/70 (4%) 1/70 (1%) |
|ADJUSTED (b) | 8.9% 2.2% 0.0% 2.4% | 2.7% 0.0% 7.8% 2.3% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/9 (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) | 4/45 (9%) 1/45 (2%) 0/44 (0%) 1/41 (2%) | 1/37 (3%) 0/35 (0%) 2/37 (5%) 1/44 (2%) |
|FIRST INCIDENCE (DAYS) | 730 (T) 730 (T) --- 730 (T) | 739 (T) --- 708 739 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.152N P=0.180N P=0.066N P=0.209N | P=0.455 P=0.511N P=0.307 P=0.723N |
|INCIDENTAL TUMOR | P=0.152N P=0.180N P=0.066N P=0.209N | P=0.453 P=0.511N P=0.332 P=0.723N |
|LOGISTIC REGRESSION | P=0.152N P=0.180N P=0.066N P=0.209N | P=0.442 P=0.511N P=0.314 P=0.723N |
|COCHRAN-ARMITAGE | P=0.136N | P=0.395 |
|FISHER EXACT | P=0.183N P=0.060N P=0.183N | P=0.504N P=0.315 P=0.748N |
|=================================================================================================================================|
| |
|Harderian Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/70 (1%) 0/70 (0%) 0/70 (0%) 1/70 (1%) | 0/69 (0%) 1/68 (1%) 0/70 (0%) 3/70 (4%) |
|ADJUSTED (b) | 2.2% 0.0% 0.0% 2.4% | 0.0% 2.9% 0.0% 6.6% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/9 (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) | 1/45 (2%) 0/45 (0%) 0/44 (0%) 1/41 (2%) | 0/37 (0%) 1/35 (3%) 0/37 (0%) 2/44 (5%) |
|FIRST INCIDENCE (DAYS) | 730 (T) --- --- 730 (T) | --- 739 (T) --- 677 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.516 P=0.500N P=0.504N P=0.741 | P=0.079 P=0.489 (e) P=0.152 |
|INCIDENTAL TUMOR | P=0.516 P=0.500N P=0.504N P=0.741 | P=0.077 P=0.489 (e) P=0.144 |
|LOGISTIC REGRESSION | P=0.516 P=0.500N P=0.504N P=0.741 | P=0.071 P=0.489 (e) P=0.138 |
|COCHRAN-ARMITAGE | P=0.536 | P=0.057 |
|FISHER EXACT | P=0.500N P=0.500N P=0.752N | P=0.496 (e) P=0.125 |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05150 TEST: 02 PAGE 3
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- METHYLPHENIDATE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 50 PPM 250 PPM 500 PPM | 0 PPM 50 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Harderian Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 5/70 (7%) 1/70 (1%) 0/70 (0%) 2/70 (3%) | 1/69 (1%) 1/68 (1%) 3/70 (4%) 4/70 (6%) |
|ADJUSTED (b) | 11.1% 2.2% 0.0% 4.9% | 2.7% 2.9% 7.8% 8.8% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/9 (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) | 5/45 (11%) 1/45 (2%) 0/44 (0%) 2/41 (5%) | 1/37 (3%) 1/35 (3%) 2/37 (5%) 3/44 (7%) |
|FIRST INCIDENCE (DAYS) | 730 (T) 730 (T) --- 730 (T) | 739 (T) 739 (T) 708 677 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.247N P=0.104N P=0.036N* P=0.256N | P=0.107 P=0.749 P=0.307 P=0.233 |
|INCIDENTAL TUMOR | P=0.247N P=0.104N P=0.036N* P=0.256N | P=0.103 P=0.749 P=0.332 P=0.226 |
|LOGISTIC REGRESSION | P=0.247N P=0.104N P=0.036N* P=0.256N | P=0.094 P=0.749 P=0.314 P=0.214 |
|COCHRAN-ARMITAGE | P=0.219N | P=0.070 |
|FISHER EXACT | P=0.104N P=0.029N* P=0.221N | P=0.748 P=0.315 P=0.187 |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/70 (1%) 1/68 (1%) 1/69 (1%) 1/70 (1%) | 1/68 (1%) 2/67 (3%) 2/69 (3%) 1/70 (1%) |
|ADJUSTED (b) | 2.2% 2.2% 2.3% 2.4% | 2.7% 4.8% 4.7% 2.3% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | 0/10 (0%) 0/9 (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) | 1/45 (2%) 1/45 (2%) 1/44 (2%) 1/41 (2%) | 1/37 (3%) 0/35 (0%) 0/37 (0%) 1/44 (2%) |
|FIRST INCIDENCE (DAYS) | 730 (T) 730 (T) 730 (T) 730 (T) | 739 (T) 588 689 739 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.599 P=0.761 P=0.757 P=0.741 | P=0.458N P=0.488 P=0.511 P=0.723N |
|INCIDENTAL TUMOR | P=0.599 P=0.761 P=0.757 P=0.741 | P=0.597N P=0.473 P=0.568 P=0.723N |
|LOGISTIC REGRESSION | P=0.599 P=0.761 P=0.757 P=0.741 | P=0.478N P=0.485 P=0.506 P=0.723N |
|COCHRAN-ARMITAGE | P=0.622N | P=0.506N |
|FISHER EXACT | P=0.745 P=0.748 P=0.752N | P=0.494 P=0.506 P=0.745N |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05150 TEST: 02 PAGE 4
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- METHYLPHENIDATE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 50 PPM 250 PPM 500 PPM | 0 PPM 50 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hemangiosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/70 (4%) 2/70 (3%) 1/70 (1%) 0/70 (0%) | 1/69 (1%) 1/67 (1%) 1/69 (1%) 0/70 (0%) |
|ADJUSTED (b) | 6.7% 4.4% 2.3% 0.0% | 2.4% 2.3% 2.7% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/9 (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) | 3/45 (7%) 2/45 (4%) 1/44 (2%) 0/41 (0%) | 0/37 (0%) 0/35 (0%) 1/37 (3%) 0/44 (0%) |
|FIRST INCIDENCE (DAYS) | 730 (T) 730 (T) 730 (T) --- | 685 603 739 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.073N P=0.500N P=0.314N P=0.138N | P=0.271N P=0.750 P=0.753N P=0.477N |
|INCIDENTAL TUMOR | P=0.073N P=0.500N P=0.314N P=0.138N | P=0.430N P=0.707 P=0.729N P=0.500N |
|LOGISTIC REGRESSION | P=0.073N P=0.500N P=0.314N P=0.138N | P=0.284N P=0.752 P=0.760N P=0.487N |
|COCHRAN-ARMITAGE | P=0.064N | P=0.297N |
|FISHER EXACT | P=0.500N P=0.310N P=0.122N | P=0.744 P=0.752N P=0.496N |
|=================================================================================================================================|
| |
|Liver |
| Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/70 (0%) 1/70 (1%) 1/70 (1%) 5/70 (7%) | 0/69 (0%) 0/67 (0%) 0/69 (0%) 0/70 (0%) |
|ADJUSTED (b) | 0.0% 2.2% 2.3% 12.2% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/9 (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) | 0/45 (0%) 1/45 (2%) 1/44 (2%) 5/41 (12%) | 0/37 (0%) 0/35 (0%) 0/37 (0%) 0/44 (0%) |
|FIRST INCIDENCE (DAYS) | --- 730 (T) 730 (T) 730 (T) | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.004 ** P=0.500 P=0.496 P=0.026 * | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.004 ** P=0.500 P=0.496 P=0.026 * | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.004 ** P=0.500 P=0.496 P=0.026 * | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.007 ** | (e) |
|FISHER EXACT | P=0.500 P=0.500 P=0.029 * | (e) (e) (e) |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05150 TEST: 02 PAGE 5
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- METHYLPHENIDATE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 50 PPM 250 PPM 500 PPM | 0 PPM 50 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 20/70 (29%) 18/70 (26%) 18/70 (26%) 31/70 (44%) | 7/69 (10%) 11/67 (16%) 11/69 (16%) 29/70 (41%) |
|ADJUSTED (b) | 41.2% 39.1% 37.5% 65.4% | 17.7% 28.0% 27.4% 62.8% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) | 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 2/10 (20%) 0/10 (0%) 1/10 (10%) 2/10 (20%) | 1/10 (10%) 1/10 (10%) 1/10 (10%) 1/10 (10%) |
|TERMINAL (d) | 17/45 (38%) 17/45 (38%) 15/44 (34%) 25/41 (61%) | 6/37 (16%) 8/35 (23%) 9/37 (24%) 27/44 (61%) |
|FIRST INCIDENCE (DAYS) | 454 (I) 720 274 (I) 454 (I) | 455 (I) 455 (I) 455 (I) 455 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.003 ** P=0.419N P=0.453N P=0.015 * | P<0.001 ** P=0.190 P=0.222 P<0.001 ** |
|INCIDENTAL TUMOR | P=0.008 ** P=0.328N P=0.439N P=0.031 * | P<0.001 ** P=0.177 P=0.230 P<0.001 ** |
|LOGISTIC REGRESSION | P=0.007 ** P=0.382N P=0.434N P=0.026 * | P<0.001 ** P=0.178 P=0.224 P<0.001 ** |
|COCHRAN-ARMITAGE | P=0.013 * | P<0.001 ** |
|FISHER EXACT | P=0.425N P=0.425N P=0.039 * | P=0.205 P=0.225 P<0.001 ** |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 10/70 (14%) 9/70 (13%) 17/70 (24%) 12/70 (17%) | 5/69 (7%) 3/67 (4%) 2/69 (3%) 6/70 (9%) |
|ADJUSTED (b) | 20.7% 19.5% 34.7% 24.7% | 13.5% 8.3% 5.4% 13.2% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/9 (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) | 7/45 (16%) 8/45 (18%) 12/44 (27%) 6/41 (15%) | 5/37 (14%) 2/35 (6%) 2/37 (5%) 5/44 (11%) |
|FIRST INCIDENCE (DAYS) | 537 707 541 454 (I) | 739 (T) 730 739 (T) 660 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.162 P=0.494N P=0.095 P=0.357 | P=0.460 P=0.386N P=0.215N P=0.617 |
|INCIDENTAL TUMOR | P=0.271 P=0.532N P=0.086 P=0.452 | P=0.456 P=0.396N P=0.215N P=0.609 |
|LOGISTIC REGRESSION | P=0.337 P=0.543N P=0.088 P=0.514 | P=0.434 P=0.383N P=0.215N P=0.585 |
|COCHRAN-ARMITAGE | P=0.216 | P=0.353 |
|FISHER EXACT | P=0.500N P=0.099 P=0.408 | P=0.376N P=0.220N P=0.510 |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05150 TEST: 02 PAGE 6
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- METHYLPHENIDATE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 50 PPM 250 PPM 500 PPM | 0 PPM 50 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 10/70 (14%) 10/70 (14%) 18/70 (26%) 15/70 (21%) | 5/69 (7%) 3/67 (4%) 2/69 (3%) 6/70 (9%) |
|ADJUSTED (b) | 20.7% 21.7% 36.7% 31.1% | 13.5% 8.3% 5.4% 13.2% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/9 (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) | 7/45 (16%) 9/45 (20%) 13/44 (30%) 9/41 (22%) | 5/37 (14%) 2/35 (6%) 2/37 (5%) 5/44 (11%) |
|FIRST INCIDENCE (DAYS) | 537 707 541 454 (I) | 739 (T) 730 739 (T) 660 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.055 P=0.589N P=0.067 P=0.155 | P=0.460 P=0.386N P=0.215N P=0.617 |
|INCIDENTAL TUMOR | P=0.099 P=0.572 P=0.057 P=0.189 | P=0.456 P=0.396N P=0.215N P=0.609 |
|LOGISTIC REGRESSION | P=0.136 P=0.563 P=0.059 P=0.244 | P=0.434 P=0.383N P=0.215N P=0.585 |
|COCHRAN-ARMITAGE | P=0.084 | P=0.353 |
|FISHER EXACT | P=0.595N P=0.069 P=0.189 | P=0.376N P=0.220N P=0.510 |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 26/70 (37%) 23/70 (33%) 28/70 (40%) 37/70 (53%) | 10/69 (14%) 12/67 (18%) 12/69 (17%) 31/70 (44%) |
|ADJUSTED (b) | 51.6% 48.9% 54.5% 72.2% | 25.7% 30.0% 30.0% 65.7% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) | 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 2/10 (20%) 0/10 (0%) 1/10 (10%) 3/10 (30%) | 1/10 (10%) 1/10 (10%) 1/10 (10%) 1/10 (10%) |
|TERMINAL (d) | 21/45 (47%) 21/45 (47%) 21/44 (48%) 27/41 (66%) | 9/37 (24%) 8/35 (23%) 10/37 (27%) 28/44 (64%) |
|FIRST INCIDENCE (DAYS) | 454 (I) 707 274 (I) 454 (I) | 455 (I) 455 (I) 455 (I) 455 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.003 ** P=0.351N P=0.395 P=0.020 * | P<0.001 ** P=0.359 P=0.408 P<0.001 ** |
|INCIDENTAL TUMOR | P=0.007 ** P=0.327N P=0.433 P=0.033 * | P<0.001 ** P=0.335 P=0.418 P<0.001 ** |
|LOGISTIC REGRESSION | P=0.005 ** P=0.310N P=0.411 P=0.028 * | P<0.001 ** P=0.341 P=0.414 P<0.001 ** |
|COCHRAN-ARMITAGE | P=0.011 * | P<0.001 ** |
|FISHER EXACT | P=0.362N P=0.431 P=0.044 * | P=0.379 P=0.408 P<0.001 ** |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05150 TEST: 02 PAGE 7
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- METHYLPHENIDATE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 50 PPM 250 PPM 500 PPM | 0 PPM 50 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 26/70 (37%) 23/70 (33%) 28/70 (40%) 37/70 (53%) | 10/69 (14%) 12/67 (18%) 12/69 (17%) 31/70 (44%) |
|ADJUSTED (b) | 51.6% 48.9% 54.5% 72.2% | 25.7% 30.0% 30.0% 65.7% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) | 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 2/10 (20%) 0/10 (0%) 1/10 (10%) 3/10 (30%) | 1/10 (10%) 1/10 (10%) 1/10 (10%) 1/10 (10%) |
|TERMINAL (d) | 21/45 (47%) 21/45 (47%) 21/44 (48%) 27/41 (66%) | 9/37 (24%) 8/35 (23%) 10/37 (27%) 28/44 (64%) |
|FIRST INCIDENCE (DAYS) | 454 (I) 707 274 (I) 454 (I) | 455 (I) 455 (I) 455 (I) 455 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.003 ** P=0.351N P=0.395 P=0.020 * | P<0.001 ** P=0.359 P=0.408 P<0.001 ** |
|INCIDENTAL TUMOR | P=0.007 ** P=0.327N P=0.433 P=0.033 * | P<0.001 ** P=0.335 P=0.418 P<0.001 ** |
|LOGISTIC REGRESSION | P=0.005 ** P=0.310N P=0.411 P=0.028 * | P<0.001 ** P=0.341 P=0.414 P<0.001 ** |
|COCHRAN-ARMITAGE | P=0.011 * | P<0.001 ** |
|FISHER EXACT | P=0.362N P=0.431 P=0.044 * | P=0.379 P=0.408 P<0.001 ** |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 14/70 (20%) 7/69 (10%) 7/70 (10%) 5/70 (7%) | 2/68 (3%) 1/68 (1%) 4/69 (6%) 6/70 (9%) |
|ADJUSTED (b) | 29.6% 14.8% 15.9% 12.2% | 4.5% 2.9% 10.8% 13.3% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 1/9 (11%) 0/10 (0%) 0/10 (0%) | 1/10 (10%) 0/10 (0%) 0/9 (0%) 0/10 (0%) |
|TERMINAL (d) | 12/45 (27%) 6/45 (13%) 7/44 (16%) 5/41 (12%) | 1/36 (3%) 1/35 (3%) 4/37 (11%) 5/44 (11%) |
|FIRST INCIDENCE (DAYS) | 537 454 (I) 730 (T) 730 (T) | 455 (I) 739 (T) 739 (T) 690 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.053N P=0.078N P=0.082N P=0.035N* | P=0.056 P=0.507N P=0.340 P=0.198 |
|INCIDENTAL TUMOR | P=0.056N P=0.135N P=0.076N P=0.053N | P=0.055 P=0.507N P=0.340 P=0.191 |
|LOGISTIC REGRESSION | P=0.041N* P=0.068N P=0.076N P=0.023N* | P=0.044 * P=0.505N P=0.351 P=0.169 |
|COCHRAN-ARMITAGE | P=0.037N* | P=0.031 * |
|FISHER EXACT | P=0.082N P=0.077N P=0.023N* | P=0.500N P=0.347 P=0.147 |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05150 TEST: 02 PAGE 8
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- METHYLPHENIDATE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 50 PPM 250 PPM 500 PPM | 0 PPM 50 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/70 (6%) 5/69 (7%) 2/70 (3%) 1/70 (1%) | 0/68 (0%) 0/68 (0%) 2/69 (3%) 2/70 (3%) |
|ADJUSTED (b) | 8.9% 11.1% 4.5% 2.2% | 0.0% 0.0% 5.3% 4.5% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) |
|TERMINAL (d) | 4/45 (9%) 5/45 (11%) 2/44 (5%) 0/41 (0%) | 0/36 (0%) 0/35 (0%) 1/37 (3%) 2/44 (5%) |
|FIRST INCIDENCE (DAYS) | 730 (T) 730 (T) 730 (T) 684 | --- --- 728 739 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.075N P=0.500 P=0.347N P=0.205N | P=0.103 (e) P=0.246 P=0.284 |
|INCIDENTAL TUMOR | P=0.059N P=0.500 P=0.348N P=0.112N | P=0.098 (e) P=0.274 P=0.284 |
|LOGISTIC REGRESSION | P=0.069N P=0.500 P=0.348N P=0.187N | P=0.096 (e) P=0.249 P=0.284 |
|COCHRAN-ARMITAGE | P=0.061N | P=0.075 |
|FISHER EXACT | P=0.491 P=0.340N P=0.183N | (e) P=0.252 P=0.255 |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 16/70 (23%) 11/69 (16%) 9/70 (13%) 6/70 (9%) | 2/68 (3%) 1/68 (1%) 6/69 (9%) 7/70 (10%) |
|ADJUSTED (b) | 33.9% 23.5% 20.5% 14.1% | 4.5% 2.9% 15.8% 15.5% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 1/9 (11%) 0/10 (0%) 0/10 (0%) | 1/10 (10%) 0/10 (0%) 0/9 (0%) 0/10 (0%) |
|TERMINAL (d) | 14/45 (31%) 10/45 (22%) 9/44 (20%) 5/41 (12%) | 1/36 (3%) 1/35 (3%) 5/37 (14%) 6/44 (14%) |
|FIRST INCIDENCE (DAYS) | 537 454 (I) 730 (T) 684 | 455 (I) 739 (T) 728 690 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.026N* P=0.193N P=0.097N P=0.028N* | P=0.029 * P=0.507N P=0.141 P=0.133 |
|INCIDENTAL TUMOR | P=0.023N* P=0.290N P=0.090N P=0.027N* | P=0.028 * P=0.507N P=0.152 P=0.127 |
|LOGISTIC REGRESSION | P=0.018N* P=0.173N P=0.090N P=0.017N* | P=0.022 * P=0.505N P=0.146 P=0.109 |
|COCHRAN-ARMITAGE | P=0.017N* | P=0.014 * |
|FISHER EXACT | P=0.207N P=0.092N P=0.017N* | P=0.500N P=0.142 P=0.090 |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05150 TEST: 02 PAGE 9
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- METHYLPHENIDATE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 50 PPM 250 PPM 500 PPM | 0 PPM 50 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node |
| Sarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/70 (0%) 2/70 (3%) 0/70 (0%) 0/70 (0%) | 0/69 (0%) 0/68 (0%) 0/70 (0%) 0/70 (0%) |
|ADJUSTED (b) | 0.0% 4.4% 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%) 0/10 (0%) | 0/10 (0%) 0/9 (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) | 0/45 (0%) 2/45 (4%) 0/44 (0%) 0/41 (0%) | 0/37 (0%) 0/35 (0%) 0/37 (0%) 0/44 (0%) |
|FIRST INCIDENCE (DAYS) | --- 730 (T) --- --- | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.279N P=0.239 (e) (e) | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.279N P=0.239 (e) (e) | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.279N P=0.239 (e) (e) | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.264N | (e) |
|FISHER EXACT | P=0.248 (e) (e) | (e) (e) (e) |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Sarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/70 (0%) 2/70 (3%) 0/70 (0%) 0/70 (0%) | 0/69 (0%) 0/68 (0%) 0/70 (0%) 0/70 (0%) |
|ADJUSTED (b) | 0.0% 4.4% 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%) 0/10 (0%) | 0/10 (0%) 0/9 (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) | 0/45 (0%) 2/45 (4%) 0/44 (0%) 0/41 (0%) | 0/37 (0%) 0/35 (0%) 0/37 (0%) 0/44 (0%) |
|FIRST INCIDENCE (DAYS) | --- 730 (T) --- --- | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.279N P=0.239 (e) (e) | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.279N P=0.239 (e) (e) | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.279N P=0.239 (e) (e) | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.264N | (e) |
|FISHER EXACT | P=0.248 (e) (e) | (e) (e) (e) |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05150 TEST: 02 PAGE 10
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- METHYLPHENIDATE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 50 PPM 250 PPM 500 PPM | 0 PPM 50 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/70 (0%) 0/70 (0%) 0/70 (0%) 0/70 (0%) | 0/69 (0%) 0/68 (0%) 2/70 (3%) 0/70 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 0.0% 0.0% 4.7% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/9 (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) | 0/45 (0%) 0/45 (0%) 0/44 (0%) 0/41 (0%) | 0/37 (0%) 0/35 (0%) 1/37 (3%) 0/44 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- | --- --- 469 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) (e) | P=0.567 (e) P=0.242 (e) |
|INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.424 (e) P=0.500 (e) |
|LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.541 (e) P=0.241 (e) |
|COCHRAN-ARMITAGE | (e) | P=0.541 |
|FISHER EXACT | (e) (e) (e) | (e) P=0.252 (e) |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/70 (0%) 0/70 (0%) 0/70 (0%) 0/70 (0%) | 0/69 (0%) 0/68 (0%) 2/70 (3%) 0/70 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 0.0% 0.0% 4.7% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/9 (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) | 0/45 (0%) 0/45 (0%) 0/44 (0%) 0/41 (0%) | 0/37 (0%) 0/35 (0%) 1/37 (3%) 0/44 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- | --- --- 469 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) (e) | P=0.567 (e) P=0.242 (e) |
|INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.424 (e) P=0.500 (e) |
|LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.541 (e) P=0.241 (e) |
|COCHRAN-ARMITAGE | (e) | P=0.541 |
|FISHER EXACT | (e) (e) (e) | (e) P=0.252 (e) |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05150 TEST: 02 PAGE 11
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- METHYLPHENIDATE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 50 PPM 250 PPM 500 PPM | 0 PPM 50 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Ovary |
| Cystadenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | | 2/65 (3%) 5/67 (7%) 1/69 (1%) 2/67 (3%) |
|ADJUSTED (b) | | 4.6% 11.9% 2.7% 3.8% |
|INTERIM SACRIFICE 1 (c)| | 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) |
|INTERIM SACRIFICE 2 (c)| | 1/9 (11%) 0/10 (0%) 0/10 (0%) 1/10 (10%) |
|TERMINAL (d) | | 1/35 (3%) 2/35 (6%) 1/37 (3%) 0/43 (0%) |
|FIRST INCIDENCE (DAYS) | | 455 (I) 391 739 (T) 455 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.219N P=0.223 P=0.475N P=0.646N |
|INCIDENTAL TUMOR | | P=0.340N P=0.327 P=0.475N P=0.656N |
|LOGISTIC REGRESSION | | P=0.252N P=0.228 P=0.478N P=0.695 |
|COCHRAN-ARMITAGE | | P=0.259N |
|FISHER EXACT | | P=0.233 P=0.477N P=0.679N |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/68 (0%) 0/68 (0%) 0/64 (0%) 0/64 (0%) | 7/67 (10%) 10/66 (15%) 15/68 (22%) 9/67 (13%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 18.3% 29.4% 37.9% 19.8% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/9 (0%) 0/9 (0%) 0/10 (0%) 1/10 (10%) |
|TERMINAL (d) | 0/44 (0%) 0/44 (0%) 0/38 (0%) 0/37 (0%) | 6/37 (16%) 10/34 (29%) 12/36 (33%) 7/42 (17%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- | 708 739 (T) 686 455 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) (e) | P=0.531 P=0.229 P=0.045 * P=0.499 |
|INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.522 P=0.234 P=0.060 P=0.487 |
|LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.468 P=0.234 P=0.047 * P=0.443 |
|COCHRAN-ARMITAGE | (e) | P=0.367 |
|FISHER EXACT | (e) (e) (e) | P=0.291 P=0.055 P=0.395 |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05150 TEST: 02 PAGE 12
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- METHYLPHENIDATE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 50 PPM 250 PPM 500 PPM | 0 PPM 50 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Seminal Vesicle |
| Sarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | |
|----------- | | |
|OVERALL (a) | 0/70 (0%) 2/70 (3%) 0/70 (0%) 0/70 (0%) | |
|ADJUSTED (b) | 0.0% 4.4% 0.0% 0.0% | |
|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) | 0/45 (0%) 2/45 (4%) 0/44 (0%) 0/41 (0%) | |
|FIRST INCIDENCE (DAYS) | --- 730 (T) --- --- | |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.279N P=0.239 (e) (e) | |
|INCIDENTAL TUMOR | P=0.279N P=0.239 (e) (e) | |
|LOGISTIC REGRESSION | P=0.279N P=0.239 (e) (e) | |
|COCHRAN-ARMITAGE | P=0.264N | |
|FISHER EXACT | P=0.248 (e) (e) | |
|=================================================================================================================================|
| |
|Skin |
| Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/70 (3%) 0/70 (0%) 0/70 (0%) 1/70 (1%) | 0/69 (0%) 1/68 (1%) 1/70 (1%) 1/70 (1%) |
|ADJUSTED (b) | 4.3% 0.0% 0.0% 2.4% | 0.0% 2.9% 2.7% 2.3% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/9 (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) | 1/45 (2%) 0/45 (0%) 0/44 (0%) 1/41 (2%) | 0/37 (0%) 1/35 (3%) 1/37 (3%) 1/44 (2%) |
|FIRST INCIDENCE (DAYS) | 640 --- --- 730 (T) | --- 739 (T) 739 (T) 739 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.549N P=0.235N P=0.247N P=0.522N | P=0.468 P=0.489 P=0.500 P=0.535 |
|INCIDENTAL TUMOR | P=0.509N P=0.353N P=0.211N P=0.522N | P=0.468 P=0.489 P=0.500 P=0.535 |
|LOGISTIC REGRESSION | P=0.536N P=0.235N P=0.240N P=0.505N | P=0.468 P=0.489 P=0.500 P=0.535 |
|COCHRAN-ARMITAGE | P=0.529N | P=0.419 |
|FISHER EXACT | P=0.248N P=0.248N P=0.500N | P=0.496 P=0.504 P=0.504 |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05150 TEST: 02 PAGE 13
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- METHYLPHENIDATE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 50 PPM 250 PPM 500 PPM | 0 PPM 50 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Sarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/70 (3%) 0/70 (0%) 0/70 (0%) 0/70 (0%) | 0/69 (0%) 1/68 (1%) 1/70 (1%) 1/70 (1%) |
|ADJUSTED (b) | 4.3% 0.0% 0.0% 0.0% | 0.0% 2.9% 2.7% 2.3% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/9 (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) | 1/45 (2%) 0/45 (0%) 0/44 (0%) 0/41 (0%) | 0/37 (0%) 1/35 (3%) 1/37 (3%) 1/44 (2%) |
|FIRST INCIDENCE (DAYS) | 640 --- --- --- | --- 739 (T) 739 (T) 739 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.169N P=0.235N P=0.247N P=0.250N | P=0.468 P=0.489 P=0.500 P=0.535 |
|INCIDENTAL TUMOR | P=0.137N P=0.353N P=0.211N P=0.250N | P=0.468 P=0.489 P=0.500 P=0.535 |
|LOGISTIC REGRESSION | P=0.163N P=0.235N P=0.240N P=0.240N | P=0.468 P=0.489 P=0.500 P=0.535 |
|COCHRAN-ARMITAGE | P=0.161N | P=0.419 |
|FISHER EXACT | P=0.248N P=0.248N P=0.248N | P=0.496 P=0.504 P=0.504 |
|=================================================================================================================================|
| |
|Spleen |
| Hemangiosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/69 (1%) 0/69 (0%) 1/69 (1%) 3/70 (4%) | 2/68 (3%) 0/67 (0%) 1/68 (1%) 0/70 (0%) |
|ADJUSTED (b) | 2.2% 0.0% 2.3% 7.0% | 5.4% 0.0% 2.7% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/45 (2%) 0/45 (0%) 1/43 (2%) 2/41 (5%) | 2/37 (5%) 0/35 (0%) 1/37 (3%) 0/44 (0%) |
|FIRST INCIDENCE (DAYS) | 730 (T) --- 730 (T) 684 | 739 (T) --- 739 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.065 P=0.500N P=0.751 P=0.283 | P=0.218N P=0.251N P=0.500N P=0.201N |
|INCIDENTAL TUMOR | P=0.101 P=0.500N P=0.751 P=0.409 | P=0.218N P=0.251N P=0.500N P=0.201N |
|LOGISTIC REGRESSION | P=0.070 P=0.500N P=0.751 P=0.297 | P=0.218N P=0.251N P=0.500N P=0.201N |
|COCHRAN-ARMITAGE | P=0.078 | P=0.247N |
|FISHER EXACT | P=0.500N P=0.752N P=0.315 | P=0.252N P=0.500N P=0.241N |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05150 TEST: 02 PAGE 14
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- METHYLPHENIDATE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 50 PPM 250 PPM 500 PPM | 0 PPM 50 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/70 (0%) 0/70 (0%) 2/70 (3%) 0/70 (0%) | |
|ADJUSTED (b) | 0.0% 0.0% 4.5% 0.0% | |
|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) | 0/45 (0%) 0/45 (0%) 2/44 (5%) 0/41 (0%) | |
|FIRST INCIDENCE (DAYS) | --- --- 730 (T) --- | |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.516 (e) P=0.234 (e) | |
|INCIDENTAL TUMOR | P=0.516 (e) P=0.234 (e) | |
|LOGISTIC REGRESSION | P=0.516 (e) P=0.234 (e) | |
|COCHRAN-ARMITAGE | P=0.536 | |
|FISHER EXACT | (e) P=0.248 (e) | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/70 (1%) 1/69 (1%) 0/69 (0%) 0/70 (0%) | 0/69 (0%) 6/66 (9%) 0/68 (0%) 4/69 (6%) |
|ADJUSTED (b) | 2.2% 2.2% 0.0% 0.0% | 0.0% 17.1% 0.0% 9.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/45 (2%) 1/45 (2%) 0/44 (0%) 0/41 (0%) | 0/37 (0%) 6/35 (17%) 0/37 (0%) 3/43 (7%) |
|FIRST INCIDENCE (DAYS) | 730 (T) 730 (T) --- --- | --- 739 (T) --- 677 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.221N P=0.761 P=0.504N P=0.519N | P=0.475 P=0.014 * (e) P=0.084 |
|INCIDENTAL TUMOR | P=0.221N P=0.761 P=0.504N P=0.519N | P=0.474 P=0.014 * (e) P=0.080 |
|LOGISTIC REGRESSION | P=0.221N P=0.761 P=0.504N P=0.519N | P=0.454 P=0.014 * (e) P=0.074 |
|COCHRAN-ARMITAGE | P=0.208N | P=0.397 |
|FISHER EXACT | P=0.748 P=0.504N P=0.500N | P=0.012 * (e) P=0.060 |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05150 TEST: 02 PAGE 15
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- METHYLPHENIDATE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 50 PPM 250 PPM 500 PPM | 0 PPM 50 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/70 (1%) 1/69 (1%) 0/69 (0%) 0/70 (0%) | 0/69 (0%) 6/66 (9%) 1/68 (1%) 4/69 (6%) |
|ADJUSTED (b) | 2.2% 2.2% 0.0% 0.0% | 0.0% 17.1% 2.7% 9.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/45 (2%) 1/45 (2%) 0/44 (0%) 0/41 (0%) | 0/37 (0%) 6/35 (17%) 1/37 (3%) 3/43 (7%) |
|FIRST INCIDENCE (DAYS) | 730 (T) 730 (T) --- --- | --- 739 (T) 739 (T) 677 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.221N P=0.761 P=0.504N P=0.519N | P=0.454 P=0.014 * P=0.500 P=0.084 |
|INCIDENTAL TUMOR | P=0.221N P=0.761 P=0.504N P=0.519N | P=0.453 P=0.014 * P=0.500 P=0.080 |
|LOGISTIC REGRESSION | P=0.221N P=0.761 P=0.504N P=0.519N | P=0.433 P=0.014 * P=0.500 P=0.074 |
|COCHRAN-ARMITAGE | P=0.208N | P=0.373 |
|FISHER EXACT | P=0.748 P=0.504N P=0.500N | P=0.012 * P=0.496 P=0.060 |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # # |
|----------- | | |
|OVERALL (a) | | 2/69 (3%) 0/68 (0%) 6/70 (9%) 1/70 (1%) |
|ADJUSTED (b) | | 5.1% 0.0% 15.6% 2.3% |
|INTERIM SACRIFICE 1 (c)| | 0/10 (0%) 0/9 (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) | | 1/37 (3%) 0/35 (0%) 5/37 (14%) 1/44 (2%) |
|FIRST INCIDENCE (DAYS) | | 708 --- 705 739 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.538 P=0.258N P=0.139 P=0.449N |
|INCIDENTAL TUMOR | | P=0.537 P=0.266N P=0.159 P=0.460N |
|LOGISTIC REGRESSION | | P=0.522 P=0.250N P=0.142 P=0.460N |
|COCHRAN-ARMITAGE | | P=0.460 |
|FISHER EXACT | | P=0.252N P=0.142 P=0.495N |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05150 TEST: 02 PAGE 16
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- METHYLPHENIDATE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 50 PPM 250 PPM 500 PPM | 0 PPM 50 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Hemangioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/70 (0%) 0/70 (0%) 1/70 (1%) 0/70 (0%) | 2/69 (3%) 0/68 (0%) 3/70 (4%) 1/70 (1%) |
|ADJUSTED (b) | 0.0% 0.0% 2.3% 0.0% | 5.4% 0.0% 7.5% 2.3% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/9 (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) | 0/45 (0%) 0/45 (0%) 1/44 (2%) 0/41 (0%) | 2/37 (5%) 0/35 (0%) 2/37 (5%) 1/44 (2%) |
|FIRST INCIDENCE (DAYS) | --- --- 730 (T) --- | 739 (T) --- 656 739 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.637 (e) P=0.496 (e) | P=0.567N P=0.251N P=0.504 P=0.440N |
|INCIDENTAL TUMOR | P=0.637 (e) P=0.496 (e) | P=0.571N P=0.251N P=0.526 P=0.440N |
|LOGISTIC REGRESSION | P=0.637 (e) P=0.496 (e) | P=0.590N P=0.251N P=0.510 P=0.440N |
|COCHRAN-ARMITAGE | P=0.649 | P=0.571 |
|FISHER EXACT | (e) P=0.500 (e) | P=0.252N P=0.507 P=0.495N |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 4/70 (6%) 3/70 (4%) 1/70 (1%) 3/70 (4%) | 3/69 (4%) 1/68 (1%) 2/70 (3%) 0/70 (0%) |
|ADJUSTED (b) | 8.9% 6.7% 2.3% 7.0% | 7.7% 2.3% 5.4% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/9 (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) | 4/45 (9%) 3/45 (7%) 1/44 (2%) 2/41 (5%) | 2/37 (5%) 0/35 (0%) 2/37 (5%) 0/44 (0%) |
|FIRST INCIDENCE (DAYS) | 730 (T) 730 (T) 730 (T) 684 | 685 603 739 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.436N P=0.500N P=0.187N P=0.543N | P=0.107N P=0.326N P=0.494N P=0.097N |
|INCIDENTAL TUMOR | P=0.382N P=0.500N P=0.187N P=0.430N | P=0.151N P=0.334N P=0.474N P=0.103N |
|LOGISTIC REGRESSION | P=0.419N P=0.500N P=0.187N P=0.517N | P=0.115N P=0.322N P=0.489N P=0.103N |
|COCHRAN-ARMITAGE | P=0.392N | P=0.131N |
|FISHER EXACT | P=0.500N P=0.183N P=0.500N | P=0.315N P=0.493N P=0.120N |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05150 TEST: 02 PAGE 17
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- METHYLPHENIDATE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 50 PPM 250 PPM 500 PPM | 0 PPM 50 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma or Hemangioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 4/70 (6%) 3/70 (4%) 2/70 (3%) 3/70 (4%) | 4/69 (6%) 1/68 (1%) 5/70 (7%) 1/70 (1%) |
|ADJUSTED (b) | 8.9% 6.7% 4.5% 7.0% | 10.3% 2.3% 12.8% 2.3% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/9 (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) | 4/45 (9%) 3/45 (7%) 2/44 (5%) 2/41 (5%) | 3/37 (8%) 0/35 (0%) 4/37 (11%) 1/44 (2%) |
|FIRST INCIDENCE (DAYS) | 730 (T) 730 (T) 730 (T) 684 | 685 603 656 739 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.473N P=0.500N P=0.347N P=0.543N | P=0.254N P=0.200N P=0.508 P=0.137N |
|INCIDENTAL TUMOR | P=0.420N P=0.500N P=0.348N P=0.430N | P=0.321N P=0.205N P=0.540 P=0.143N |
|LOGISTIC REGRESSION | P=0.456N P=0.500N P=0.348N P=0.517N | P=0.278N P=0.195N P=0.515 P=0.147N |
|COCHRAN-ARMITAGE | P=0.426N | P=0.323N |
|FISHER EXACT | P=0.500N P=0.340N P=0.500N | P=0.187N P=0.509 P=0.178N |
|=================================================================================================================================|
| |
|All Organs |
| Histiocytic Sarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/70 (0%) 1/70 (1%) 0/70 (0%) 1/70 (1%) | 2/69 (3%) 1/68 (1%) 2/70 (3%) 2/70 (3%) |
|ADJUSTED (b) | 0.0% 2.0% 0.0% 2.4% | 5.4% 2.9% 4.3% 4.5% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/9 (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) | 0/45 (0%) 0/45 (0%) 0/44 (0%) 0/41 (0%) | 2/37 (5%) 1/35 (3%) 0/37 (0%) 2/44 (5%) |
|FIRST INCIDENCE (DAYS) | --- 674 --- 707 | 739 (T) 739 (T) 578 739 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.447 P=0.513 (e) P=0.486 | P=0.556 P=0.519N P=0.686N P=0.631N |
|INCIDENTAL TUMOR | P=0.632N P=0.773 (e) P=0.846 | P=0.446 P=0.519N P=0.660 P=0.631N |
|LOGISTIC REGRESSION | P=0.460 P=0.502 (e) P=0.497 | P=0.527 P=0.519N P=0.689N P=0.631N |
|COCHRAN-ARMITAGE | P=0.464 | P=0.490 |
|FISHER EXACT | P=0.500 (e) P=0.500 | P=0.506N P=0.685N P=0.685N |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05150 TEST: 02 PAGE 18
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- METHYLPHENIDATE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 50 PPM 250 PPM 500 PPM | 0 PPM 50 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Lymphoma And Histiocytic Sarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 3/70 (4%) 6/70 (9%) 3/70 (4%) 10/70 (14%) | 14/69 (20%) 14/68 (21%) 10/70 (14%) 18/70 (26%) |
|ADJUSTED (b) | 6.4% 12.6% 6.6% 22.6% | 33.8% 36.4% 23.0% 40.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/9 (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) | 2/45 (4%) 4/45 (9%) 2/44 (5%) 7/41 (17%) | 10/37 (27%) 11/35 (31%) 6/37 (16%) 17/44 (39%) |
|FIRST INCIDENCE (DAYS) | 617 674 626 654 | 621 625 183 690 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.031 * P=0.255 P=0.645 P=0.032 * | P=0.484 P=0.515 P=0.248N P=0.466 |
|INCIDENTAL TUMOR | P=0.095 P=0.316 P=0.627N P=0.089 | P=0.313 P=0.497 P=0.239N P=0.358 |
|LOGISTIC REGRESSION | P=0.076 P=0.255 P=0.658 P=0.035 * | P=0.394 P=0.519 P=0.230N P=0.400 |
|COCHRAN-ARMITAGE | P=0.043 * | P=0.278 |
|FISHER EXACT | P=0.247 P=0.660N P=0.039 * | P=0.567 P=0.238N P=0.289 |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated |
| Cell Type |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 3/70 (4%) 5/70 (7%) 3/70 (4%) 9/70 (13%) | 12/69 (17%) 13/68 (19%) 8/70 (11%) 17/70 (24%) |
|ADJUSTED (b) | 6.4% 10.8% 6.6% 20.7% | 28.9% 33.8% 19.5% 37.7% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/9 (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) | 2/45 (4%) 4/45 (9%) 2/44 (5%) 7/41 (17%) | 8/37 (22%) 10/35 (29%) 6/37 (16%) 16/44 (36%) |
|FIRST INCIDENCE (DAYS) | 617 708 626 654 | 621 625 183 690 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.038 * P=0.363 P=0.645 P=0.052 | P=0.410 P=0.436 P=0.232N P=0.361 |
|INCIDENTAL TUMOR | P=0.085 P=0.367 P=0.627N P=0.103 | P=0.281 P=0.412 P=0.212N P=0.256 |
|LOGISTIC REGRESSION | P=0.044 * P=0.371 P=0.658 P=0.059 | P=0.330 P=0.435 P=0.216N P=0.299 |
|COCHRAN-ARMITAGE | P=0.053 | P=0.229 |
|FISHER EXACT | P=0.359 P=0.660N P=0.064 | P=0.484 P=0.224N P=0.215 |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05150 TEST: 02 PAGE 19
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- METHYLPHENIDATE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 50 PPM 250 PPM 500 PPM | 0 PPM 50 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 33/70 (47%) 24/70 (34%) 25/70 (36%) 35/70 (50%) | 22/69 (32%) 26/68 (38%) 31/70 (44%) 38/70 (54%) |
|ADJUSTED (b) | 65.7% 50.8% 52.6% 74.0% | 51.4% 62.6% 71.7% 75.7% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) | 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 2/10 (20%) 1/10 (10%) 1/10 (10%) 2/10 (20%) | 3/10 (30%) 1/10 (10%) 1/10 (10%) 3/10 (30%) |
|TERMINAL (d) | 28/45 (62%) 22/45 (49%) 22/44 (50%) 29/41 (71%) | 17/37 (46%) 20/35 (57%) 25/37 (68%) 32/44 (73%) |
|FIRST INCIDENCE (DAYS) | 454 (I) 454 (I) 274 (I) 454 (I) | 455 (I) 391 455 (I) 455 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.072 P=0.068N P=0.122N P=0.252 | P=0.030 * P=0.214 P=0.071 P=0.025 * |
|INCIDENTAL TUMOR | P=0.116 P=0.069N P=0.108N P=0.310 | P=0.011 * P=0.253 P=0.083 P=0.019 * |
|LOGISTIC REGRESSION | P=0.135 P=0.050N* P=0.102N P=0.402 | P=0.007 ** P=0.205 P=0.069 P=0.008 ** |
|COCHRAN-ARMITAGE | P=0.190 | P=0.004 ** |
|FISHER EXACT | P=0.084N P=0.115N P=0.433 | P=0.274 P=0.092 P=0.006 ** |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 19/70 (27%) 24/70 (34%) 22/70 (31%) 25/70 (36%) | 22/69 (32%) 21/68 (31%) 16/70 (23%) 26/70 (37%) |
|ADJUSTED (b) | 38.0% 48.9% 44.0% 50.6% | 52.2% 50.8% 36.1% 54.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/9 (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) | 14/45 (31%) 20/45 (44%) 16/44 (36%) 17/41 (41%) | 17/37 (46%) 15/35 (43%) 10/37 (27%) 22/44 (50%) |
|FIRST INCIDENCE (DAYS) | 537 628 541 454 (I) | 621 462 183 648 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.151 P=0.244 P=0.329 P=0.129 | P=0.484N P=0.558 P=0.167N P=0.565 |
|INCIDENTAL TUMOR | P=0.333 P=0.164 P=0.383 P=0.204 | P=0.335 P=0.544N P=0.096N P=0.448 |
|LOGISTIC REGRESSION | P=0.387 P=0.246 P=0.333 P=0.242 | P=0.456 P=0.566 P=0.141N P=0.465 |
|COCHRAN-ARMITAGE | P=0.242 | P=0.305 |
|FISHER EXACT | P=0.232 P=0.355 P=0.181 | P=0.523N P=0.158N P=0.318 |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05150 TEST: 02 PAGE 20
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- METHYLPHENIDATE HYDROCHLORIDE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 50 PPM 250 PPM 500 PPM | 0 PPM 50 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 43/70 (61%) 36/70 (51%) 35/70 (50%) 46/70 (66%) | 37/69 (54%) 37/68 (54%) 41/70 (59%) 44/70 (63%) |
|ADJUSTED (b) | 82.6% 70.5% 67.0% 88.3% | 78.4% 76.8% 85.2% 86.1% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) | 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 2/10 (20%) 1/10 (10%) 1/10 (10%) 3/10 (30%) | 3/10 (30%) 1/10 (10%) 1/10 (10%) 3/10 (30%) |
|TERMINAL (d) | 36/45 (80%) 30/45 (67%) 27/44 (61%) 35/41 (85%) | 27/37 (73%) 24/35 (69%) 30/37 (81%) 37/44 (84%) |
|FIRST INCIDENCE (DAYS) | 454 (I) 454 (I) 274 (I) 454 (I) | 455 (I) 103 183 455 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.063 P=0.132N P=0.143N P=0.163 | P=0.507 P=0.440 P=0.317 P=0.509 |
|INCIDENTAL TUMOR | P=0.178 P=0.092N P=0.061N P=0.312 | P=0.115 P=0.574 P=0.390 P=0.292 |
|LOGISTIC REGRESSION | P=0.114 P=0.073N P=0.089N P=0.305 | P=0.230 P=0.439 P=0.302 P=0.267 |
|COCHRAN-ARMITAGE | P=0.191 | P=0.122 |
|FISHER EXACT | P=0.153N P=0.117N P=0.363 | P=0.531 P=0.338 P=0.176 |
|=================================================================================================================================|
(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): 274 454
Female interim sacrifices(days): 280 455
(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).