TDMS Study 05068-09 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Microbiological Assoc. CODEINE DATE: 04/02/96
EXPERIMENT: 05068 TEST: 09 TIME: 17:43:44
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-75178 ROUTE: DOSED FEED NTP C#: 61541B
PATHOLOGIST: L. BRENNECKE CAS: 76-57-3
------------------------------------------------------------------------------------------------------------------------------------
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Microbiological Assoc. CODEINE DATE: 04/02/96
EXPERIMENT: 05068 TEST: 09 TIME: 17:43:44
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-75178 ROUTE: DOSED FEED NTP C#: 61541B
PATHOLOGIST: L. BRENNECKE CAS: 76-57-3
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: Microbiological Assoc. CODEINE DATE: 04/02/96
EXPERIMENT: 05068 TEST: 09 TIME: 17:43:44
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-75178 ROUTE: DOSED FEED NTP C#: 61541B
PATHOLOGIST: L. BRENNECKE CAS: 76-57-3
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF THE STUDY OF CODEINE
====================================================================================================
MALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Adrenal Medulla Pheochromocytoma Benign
Pheochromocytoma: Benign, Complex, Malignant, NOS
Clitoral/Preputial Gland Carcinoma or Adenoma
Testes Adenoma
All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated
====================================================================================================
FEMALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Clitoral/Preputial Gland Adenoma
Carcinoma or Adenoma
Mammary Gland Fibroadenoma
Fibroma, Fibroadenoma, Carcinoma, or Adenoma
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
Carcinoma or Adenoma
Uterus Polyp Stromal
Sarcoma Stromal or Polyp Stromal
All Organs Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
====================================================================================================
DATE: 04/02/96 EXPERIMENT: 05068 TEST: 09 PAGE 1
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CODEINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 400 PPM 800 PPM 1600 | 0 PPM 400 PPM 800 PPM 1600 |
| | PPM | PPM |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 16/59 (27%) 7/60 (12%) 6/59 (10%) 3/60 (5%) | 2/60 (3%) 5/60 (8%) 1/59 (2%) 1/60 (2%) |
|ADJUSTED (b) | 49.1% 26.2% 21.7% 13.6% | 6.6% 12.2% 2.7% 3.1% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 1/10 (10%) 0/9 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) |
|TERMINAL (d) | 12/28 (43%) 3/20 (15%) 3/21 (14%) 2/20 (10%) | 1/28 (4%) 3/38 (8%) 0/28 (0%) 1/32 (3%) |
|FIRST INCIDENCE (DAYS) | 599 455 (I) 608 708 | 677 689 686 733 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.005N** P=0.114N P=0.051N P=0.007N** | P=0.171N P=0.362 P=0.457N P=0.438N |
|INCIDENTAL TUMOR | P=0.001N** P=0.025N* P=0.012N* P=0.002N** | P=0.104N P=0.320 P=0.310N P=0.391N |
|LOGISTIC REGRESSION | P<0.001N** P=0.025N* P=0.011N* P=0.001N** | P=0.155N P=0.314 P=0.464N P=0.432N |
|COCHRAN-ARMITAGE | P<0.001N** | P=0.196N |
|FISHER EXACT | P=0.028N* P=0.016N* P<0.001N** | P=0.219 P=0.506N P=0.500N |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 16/59 (27%) 7/60 (12%) 7/59 (12%) 3/60 (5%) | 3/60 (5%) 5/60 (8%) 1/59 (2%) 1/60 (2%) |
|ADJUSTED (b) | 49.1% 26.2% 24.5% 13.6% | 10.0% 12.2% 2.7% 3.1% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 1/10 (10%) 0/9 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) |
|TERMINAL (d) | 12/28 (43%) 3/20 (15%) 3/21 (14%) 2/20 (10%) | 2/28 (7%) 3/38 (8%) 0/28 (0%) 1/32 (3%) |
|FIRST INCIDENCE (DAYS) | 599 455 (I) 608 708 | 677 689 686 733 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.006N** P=0.114N P=0.089N P=0.007N** | P=0.099N P=0.535 P=0.275N P=0.249N |
|INCIDENTAL TUMOR | P=0.001N** P=0.025N* P=0.020N* P=0.002N** | P=0.056N P=0.498 P=0.170N P=0.215N |
|LOGISTIC REGRESSION | P=0.001N** P=0.025N* P=0.022N* P=0.001N** | P=0.085N P=0.490 P=0.264N P=0.233N |
|COCHRAN-ARMITAGE | P=0.001N** | P=0.116N |
|FISHER EXACT | P=0.028N* P=0.031N* P<0.001N** | P=0.359 P=0.316N P=0.309N |
|=================================================================================================================================|
DATE: 04/02/96 EXPERIMENT: 05068 TEST: 09 PAGE 2
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CODEINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 400 PPM 800 PPM 1600 | 0 PPM 400 PPM 800 PPM 1600 |
| | PPM | PPM |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/59 (5%) 6/60 (10%) 7/58 (12%) 2/59 (3%) | 5/57 (9%) 6/57 (11%) 12/59 (20%) 1/60 (2%) |
|ADJUSTED (b) | 9.1% 20.6% 26.8% 7.4% | 16.7% 15.7% 37.8% 3.1% |
|INTERIM SACRIFICE 1 (c)| 0/9 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) |
|TERMINAL (d) | 2/29 (7%) 2/20 (10%) 3/20 (15%) 1/20 (5%) | 3/27 (11%) 5/36 (14%) 10/29 (34%) 1/32 (3%) |
|FIRST INCIDENCE (DAYS) | 567 586 655 582 | 663 546 662 733 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.463N P=0.171 P=0.090 P=0.604N | P=0.115N P=0.566N P=0.081 P=0.071N |
|INCIDENTAL TUMOR | P=0.331N P=0.325 P=0.193 P=0.549N | P=0.084N P=0.611N P=0.154 P=0.036N* |
|LOGISTIC REGRESSION | P=0.363N P=0.246 P=0.136 P=0.507N | P=0.077N P=0.627 P=0.113 P=0.053N |
|COCHRAN-ARMITAGE | P=0.344N | P=0.130N |
|FISHER EXACT | P=0.254 P=0.154 P=0.500N | P=0.500 P=0.066 P=0.092N |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/59 (5%) 6/60 (10%) 8/58 (14%) 2/59 (3%) | 6/57 (11%) 6/57 (11%) 12/59 (20%) 1/60 (2%) |
|ADJUSTED (b) | 9.1% 20.6% 31.1% 7.4% | 19.0% 15.7% 37.8% 3.1% |
|INTERIM SACRIFICE 1 (c)| 0/9 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) |
|TERMINAL (d) | 2/29 (7%) 2/20 (10%) 4/20 (20%) 1/20 (5%) | 3/27 (11%) 5/36 (14%) 10/29 (34%) 1/32 (3%) |
|FIRST INCIDENCE (DAYS) | 567 586 655 582 | 587 546 662 733 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.491N P=0.171 P=0.049 * P=0.604N | P=0.075N P=0.430N P=0.145 P=0.037N* |
|INCIDENTAL TUMOR | P=0.361N P=0.325 P=0.111 P=0.549N | P=0.060N P=0.581N P=0.219 P=0.026N* |
|LOGISTIC REGRESSION | P=0.385N P=0.246 P=0.081 P=0.507N | P=0.049N* P=0.514N P=0.190 P=0.031N* |
|COCHRAN-ARMITAGE | P=0.363N | P=0.087N |
|FISHER EXACT | P=0.254 P=0.097 P=0.500N | P=0.619N P=0.114 P=0.049N* |
|=================================================================================================================================|
DATE: 04/02/96 EXPERIMENT: 05068 TEST: 09 PAGE 3
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CODEINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 400 PPM 800 PPM 1600 | 0 PPM 400 PPM 800 PPM 1600 |
| | PPM | PPM |
|=================================================================================================================================|
| |
|Ear |
| Schwannoma Malignant |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 1/60 (2%) 1/60 (2%) 2/60 (3%) | 0/60 (0%) 0/60 (0%) 2/60 (3%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 3.7% 3.8% 8.4% | 0.0% 0.0% 6.9% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) |
|TERMINAL (d) | 0/29 (0%) 0/20 (0%) 0/21 (0%) 1/20 (5%) | 0/28 (0%) 0/38 (0%) 2/29 (7%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | --- 695 720 701 | --- --- 733 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.133 P=0.472 P=0.471 P=0.192 | P=0.601 (e) P=0.246 (e) |
|INCIDENTAL TUMOR | P=0.179 P=0.650 P=0.625 P=0.260 | P=0.601 (e) P=0.246 (e) |
|LOGISTIC REGRESSION | P=0.139 P=0.496 P=0.490 P=0.216 | P=0.601 (e) P=0.246 (e) |
|COCHRAN-ARMITAGE | P=0.153 | P=0.595 |
|FISHER EXACT | P=0.500 P=0.500 P=0.248 | (e) P=0.248 (e) |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 3/60 (5%) 0/60 (0%) 0/60 (0%) | 0/60 (0%) 1/60 (2%) 1/60 (2%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 11.3% 0.0% 0.0% | 0.0% 2.0% 3.4% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) |
|TERMINAL (d) | 0/29 (0%) 1/20 (5%) 0/21 (0%) 0/20 (0%) | 0/28 (0%) 0/38 (0%) 1/29 (3%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | --- 658 --- --- | --- 479 733 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.339N P=0.094 (e) (e) | P=0.590N P=0.513 P=0.507 (e) |
|INCIDENTAL TUMOR | P=0.276N P=0.184 (e) (e) | P=0.673N P=0.419 P=0.507 (e) |
|LOGISTIC REGRESSION | P=0.320N P=0.116 (e) (e) | P=0.614N P=0.422 P=0.507 (e) |
|COCHRAN-ARMITAGE | P=0.312N | P=0.595N |
|FISHER EXACT | P=0.122 (e) (e) | P=0.500 P=0.500 (e) |
|=================================================================================================================================|
DATE: 04/02/96 EXPERIMENT: 05068 TEST: 09 PAGE 4
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CODEINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 400 PPM 800 PPM 1600 | 0 PPM 400 PPM 800 PPM 1600 |
| | PPM | PPM |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 3/60 (5%) 0/60 (0%) 0/60 (0%) | 1/60 (2%) 1/60 (2%) 1/60 (2%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 11.3% 0.0% 0.0% | 3.6% 2.0% 3.4% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) |
|TERMINAL (d) | 0/29 (0%) 1/20 (5%) 0/21 (0%) 0/20 (0%) | 1/28 (4%) 0/38 (0%) 1/29 (3%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | --- 658 --- --- | 733 (T) 479 733 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.339N P=0.094 (e) (e) | P=0.305N P=0.719N P=0.754N P=0.473N |
|INCIDENTAL TUMOR | P=0.276N P=0.184 (e) (e) | P=0.376N P=0.753 P=0.754N P=0.473N |
|LOGISTIC REGRESSION | P=0.320N P=0.116 (e) (e) | P=0.314N P=0.742 P=0.754N P=0.473N |
|COCHRAN-ARMITAGE | P=0.312N | P=0.312N |
|FISHER EXACT | P=0.122 (e) (e) | P=0.752N P=0.752N P=0.500N |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/60 (3%) 0/60 (0%) 0/60 (0%) 1/60 (2%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 6.9% 0.0% 0.0% 5.0% | 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%) 0/10 (0%) 0/9 (0%) 0/9 (0%) |
|TERMINAL (d) | 2/29 (7%) 0/20 (0%) 0/21 (0%) 1/20 (5%) | 0/28 (0%) 0/38 (0%) 0/29 (0%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | 732 (T) --- --- 732 (T) | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.542N P=0.323N P=0.311N P=0.630N | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.542N P=0.323N P=0.311N P=0.630N | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.542N P=0.323N P=0.311N P=0.630N | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.461N | (e) |
|FISHER EXACT | P=0.248N P=0.248N P=0.500N | (e) (e) (e) |
|=================================================================================================================================|
DATE: 04/02/96 EXPERIMENT: 05068 TEST: 09 PAGE 5
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CODEINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 400 PPM 800 PPM 1600 | 0 PPM 400 PPM 800 PPM 1600 |
| | PPM | PPM |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/60 (5%) 0/60 (0%) 0/60 (0%) 1/60 (2%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 10.3% 0.0% 0.0% 5.0% | 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%) 0/10 (0%) 0/9 (0%) 0/9 (0%) |
|TERMINAL (d) | 3/29 (10%) 0/20 (0%) 0/21 (0%) 1/20 (5%) | 0/28 (0%) 0/38 (0%) 0/29 (0%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | 732 (T) --- --- 732 (T) | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.327N P=0.192N P=0.182N P=0.445N | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.327N P=0.192N P=0.182N P=0.445N | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.327N P=0.192N P=0.182N P=0.445N | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.248N | (e) |
|FISHER EXACT | P=0.122N P=0.122N P=0.309N | (e) (e) (e) |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/60 (5%) 0/60 (0%) 0/60 (0%) 1/60 (2%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 10.3% 0.0% 0.0% 5.0% | 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%) 0/10 (0%) 0/9 (0%) 0/9 (0%) |
|TERMINAL (d) | 3/29 (10%) 0/20 (0%) 0/21 (0%) 1/20 (5%) | 0/28 (0%) 0/38 (0%) 0/29 (0%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | 732 (T) --- --- 732 (T) | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.327N P=0.192N P=0.182N P=0.445N | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.327N P=0.192N P=0.182N P=0.445N | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.327N P=0.192N P=0.182N P=0.445N | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.248N | (e) |
|FISHER EXACT | P=0.122N P=0.122N P=0.309N | (e) (e) (e) |
|=================================================================================================================================|
DATE: 04/02/96 EXPERIMENT: 05068 TEST: 09 PAGE 6
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CODEINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 400 PPM 800 PPM 1600 | 0 PPM 400 PPM 800 PPM 1600 |
| | PPM | PPM |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/60 (3%) 0/59 (0%) 0/60 (0%) 0/60 (0%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 1/60 (2%) |
|ADJUSTED (b) | 3.5% 0.0% 0.0% 0.0% | 0.0% 0.0% 0.0% 2.9% |
|INTERIM SACRIFICE 1 (c)| 1/10 (10%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) |
|TERMINAL (d) | 0/29 (0%) 0/20 (0%) 0/21 (0%) 0/20 (0%) | 0/28 (0%) 0/38 (0%) 0/29 (0%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | 446 --- --- --- | --- --- --- 719 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.115N P=0.253N P=0.236N P=0.240N | P=0.207 (e) (e) P=0.538 |
|INCIDENTAL TUMOR | P=0.110N P=0.350N P=0.295N P=0.220N | P=0.269 (e) (e) P=0.638 |
|LOGISTIC REGRESSION | P=0.157N P=0.308N P=0.354N P=0.289N | P=0.210 (e) (e) P=0.542 |
|COCHRAN-ARMITAGE | P=0.115N | P=0.199 |
|FISHER EXACT | P=0.252N P=0.248N P=0.248N | (e) (e) P=0.500 |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 2/59 (3%) 0/60 (0%) 0/60 (0%) | 1/60 (2%) 0/60 (0%) 0/60 (0%) 1/60 (2%) |
|ADJUSTED (b) | 0.0% 6.6% 0.0% 0.0% | 3.6% 0.0% 0.0% 3.1% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) |
|TERMINAL (d) | 0/29 (0%) 1/20 (5%) 0/21 (0%) 0/20 (0%) | 1/28 (4%) 0/38 (0%) 0/29 (0%) 1/32 (3%) |
|FIRST INCIDENCE (DAYS) | --- 336 --- --- | 733 (T) --- --- 733 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.435N P=0.203 (e) (e) | P=0.601 P=0.439N P=0.493N P=0.732N |
|INCIDENTAL TUMOR | P=0.531N P=0.133 (e) (e) | P=0.601 P=0.439N P=0.493N P=0.732N |
|LOGISTIC REGRESSION | P=0.423N P=0.204 (e) (e) | P=0.601 P=0.439N P=0.493N P=0.732N |
|COCHRAN-ARMITAGE | P=0.404N | P=0.595 |
|FISHER EXACT | P=0.244 (e) (e) | P=0.500N P=0.500N P=0.752N |
|=================================================================================================================================|
DATE: 04/02/96 EXPERIMENT: 05068 TEST: 09 PAGE 7
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CODEINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 400 PPM 800 PPM 1600 | 0 PPM 400 PPM 800 PPM 1600 |
| | PPM | PPM |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/60 (3%) 2/59 (3%) 0/60 (0%) 0/60 (0%) | 1/60 (2%) 0/60 (0%) 0/60 (0%) 2/60 (3%) |
|ADJUSTED (b) | 3.5% 6.6% 0.0% 0.0% | 3.6% 0.0% 0.0% 5.9% |
|INTERIM SACRIFICE 1 (c)| 1/10 (10%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) |
|TERMINAL (d) | 0/29 (0%) 1/20 (5%) 0/21 (0%) 0/20 (0%) | 1/28 (4%) 0/38 (0%) 0/29 (0%) 1/32 (3%) |
|FIRST INCIDENCE (DAYS) | 446 336 --- --- | 733 (T) --- --- 719 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.096N P=0.651 P=0.236N P=0.240N | P=0.254 P=0.439N P=0.493N P=0.553 |
|INCIDENTAL TUMOR | P=0.128N P=0.500 P=0.295N P=0.220N | P=0.295 P=0.439N P=0.493N P=0.609 |
|LOGISTIC REGRESSION | P=0.111N P=0.618 P=0.354N P=0.289N | P=0.269 P=0.439N P=0.493N P=0.577 |
|COCHRAN-ARMITAGE | P=0.086N | P=0.246 |
|FISHER EXACT | P=0.684 P=0.248N P=0.248N | P=0.500N P=0.500N P=0.500 |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | 3/60 (5%) 2/60 (3%) 3/60 (5%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 8.5% 5.3% 10.3% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) |
|TERMINAL (d) | 0/29 (0%) 0/20 (0%) 0/21 (0%) 0/20 (0%) | 1/28 (4%) 2/38 (5%) 3/29 (10%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- | 495 733 (T) 733 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) (e) | P=0.101N P=0.388N P=0.629N P=0.100N |
|INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.110N P=0.440N P=0.631 P=0.107N |
|LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.094N P=0.468N P=0.622N P=0.125N |
|COCHRAN-ARMITAGE | (e) | P=0.112N |
|FISHER EXACT | (e) (e) (e) | P=0.500N P=0.660N P=0.122N |
|=================================================================================================================================|
DATE: 04/02/96 EXPERIMENT: 05068 TEST: 09 PAGE 8
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CODEINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 400 PPM 800 PPM 1600 | 0 PPM 400 PPM 800 PPM 1600 |
| | PPM | PPM |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 0/60 (0%) 1/60 (2%) 1/60 (2%) | 27/60 (45%) 21/60 (35%) 27/60 (45%) 8/60 (13%) |
|ADJUSTED (b) | 3.4% 0.0% 3.6% 4.0% | 70.3% 47.3% 68.2% 23.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) |
|TERMINAL (d) | 1/29 (3%) 0/20 (0%) 0/21 (0%) 0/20 (0%) | 17/28 (61%) 15/38 (39%) 17/29 (59%) 6/32 (19%) |
|FIRST INCIDENCE (DAYS) | 732 (T) --- 707 708 | 475 400 641 645 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.492 P=0.574N P=0.717 P=0.698 | P<0.001N** P=0.019N* P=0.419N P<0.001N** |
|INCIDENTAL TUMOR | P=0.575 P=0.574N P=0.734N P=0.740N | P<0.001N** P=0.062N P=0.396N P<0.001N** |
|LOGISTIC REGRESSION | P=0.520 P=0.574N P=0.753 P=0.741 | P<0.001N** P=0.046N* P=0.296N P<0.001N** |
|COCHRAN-ARMITAGE | P=0.539 | P<0.001N** |
|FISHER EXACT | P=0.500N P=0.752N P=0.752N | P=0.176N P=0.573N P<0.001N** |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 0/60 (0%) 1/60 (2%) 1/60 (2%) | 30/60 (50%) 23/60 (38%) 29/60 (48%) 8/60 (13%) |
|ADJUSTED (b) | 3.4% 0.0% 3.6% 4.0% | 74.4% 51.8% 73.5% 23.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) |
|TERMINAL (d) | 1/29 (3%) 0/20 (0%) 0/21 (0%) 0/20 (0%) | 18/28 (64%) 17/38 (45%) 19/29 (66%) 6/32 (19%) |
|FIRST INCIDENCE (DAYS) | 732 (T) --- 707 708 | 475 400 641 645 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.492 P=0.574N P=0.717 P=0.698 | P<0.001N** P=0.011N* P=0.344N P<0.001N** |
|INCIDENTAL TUMOR | P=0.575 P=0.574N P=0.734N P=0.740N | P<0.001N** P=0.033N* P=0.334N P<0.001N** |
|LOGISTIC REGRESSION | P=0.520 P=0.574N P=0.753 P=0.741 | P<0.001N** P=0.029N* P=0.216N P<0.001N** |
|COCHRAN-ARMITAGE | P=0.539 | P<0.001N** |
|FISHER EXACT | P=0.500N P=0.752N P=0.752N | P=0.135N P=0.500N P<0.001N** |
|=================================================================================================================================|
DATE: 04/02/96 EXPERIMENT: 05068 TEST: 09 PAGE 9
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CODEINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 400 PPM 800 PPM 1600 | 0 PPM 400 PPM 800 PPM 1600 |
| | PPM | PPM |
|=================================================================================================================================|
| |
|Nose |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 2/60 (3%) 0/60 (0%) 0/60 (0%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 6.7% 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%) 0/10 (0%) 0/9 (0%) 0/9 (0%) |
|TERMINAL (d) | 0/29 (0%) 0/20 (0%) 0/21 (0%) 0/20 (0%) | 0/28 (0%) 0/38 (0%) 0/29 (0%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | --- 627 --- --- | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.432N P=0.213 (e) (e) | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.346N P=0.386 (e) (e) | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.408N P=0.238 (e) (e) | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.405N | (e) |
|FISHER EXACT | P=0.248 (e) (e) | (e) (e) (e) |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 10/60 (17%) 5/60 (8%) 6/58 (10%) 4/57 (7%) | 17/56 (30%) 18/60 (30%) 20/59 (34%) 12/60 (20%) |
|ADJUSTED (b) | 30.1% 16.1% 24.4% 13.0% | 51.4% 43.2% 50.0% 34.3% |
|INTERIM SACRIFICE 1 (c)| 1/10 (10%) 1/10 (10%) 0/10 (0%) 0/10 (0%) | 1/10 (10%) 1/10 (10%) 1/9 (11%) 0/9 (0%) |
|TERMINAL (d) | 8/29 (28%) 1/20 (5%) 4/20 (20%) 0/20 (0%) | 12/27 (44%) 15/38 (39%) 11/29 (38%) 10/32 (31%) |
|FIRST INCIDENCE (DAYS) | 449 455 (I) 526 594 | 456 (I) 456 (I) 427 631 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.162N P=0.275N P=0.406N P=0.176N | P=0.107N P=0.248N P=0.475 P=0.077N |
|INCIDENTAL TUMOR | P=0.107N P=0.208N P=0.436N P=0.103N | P=0.056N P=0.208N P=0.427N P=0.041N* |
|LOGISTIC REGRESSION | P=0.106N P=0.132N P=0.224N P=0.101N | P=0.050N* P=0.304N P=0.552N P=0.038N* |
|COCHRAN-ARMITAGE | P=0.098N | P=0.117N |
|FISHER EXACT | P=0.135N P=0.232N P=0.092N | P=0.563N P=0.418 P=0.142N |
|=================================================================================================================================|
DATE: 04/02/96 EXPERIMENT: 05068 TEST: 09 PAGE 10
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CODEINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 400 PPM 800 PPM 1600 | 0 PPM 400 PPM 800 PPM 1600 |
| | PPM | PPM |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 10/60 (17%) 5/60 (8%) 6/58 (10%) 4/57 (7%) | 18/56 (32%) 19/60 (32%) 20/59 (34%) 12/60 (20%) |
|ADJUSTED (b) | 30.1% 16.1% 24.4% 13.0% | 54.7% 44.6% 50.0% 34.3% |
|INTERIM SACRIFICE 1 (c)| 1/10 (10%) 1/10 (10%) 0/10 (0%) 0/10 (0%) | 1/10 (10%) 1/10 (10%) 1/9 (11%) 0/9 (0%) |
|TERMINAL (d) | 8/29 (28%) 1/20 (5%) 4/20 (20%) 0/20 (0%) | 13/27 (48%) 15/38 (39%) 11/29 (38%) 10/32 (31%) |
|FIRST INCIDENCE (DAYS) | 449 455 (I) 526 594 | 456 (I) 456 (I) 427 631 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.162N P=0.275N P=0.406N P=0.176N | P=0.070N P=0.233N P=0.554 P=0.049N* |
|INCIDENTAL TUMOR | P=0.107N P=0.208N P=0.436N P=0.103N | P=0.029N* P=0.176N P=0.339N P=0.024N* |
|LOGISTIC REGRESSION | P=0.106N P=0.132N P=0.224N P=0.101N | P=0.028N* P=0.281N P=0.455N P=0.021N* |
|COCHRAN-ARMITAGE | P=0.098N | P=0.077N |
|FISHER EXACT | P=0.135N P=0.232N P=0.092N | P=0.557N P=0.500 P=0.100N |
|=================================================================================================================================|
| |
|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) | 2/60 (3%) 3/60 (5%) 4/60 (7%) 3/60 (5%) | 1/60 (2%) 1/60 (2%) 1/60 (2%) 0/60 (0%) |
|ADJUSTED (b) | 6.9% 14.3% 17.2% 12.4% | 3.6% 2.6% 1.7% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 1/9 (11%) 0/9 (0%) |
|TERMINAL (d) | 2/29 (7%) 2/20 (10%) 3/21 (14%) 2/20 (10%) | 1/28 (4%) 1/38 (3%) 0/29 (0%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | 732 (T) 729 706 594 | 733 (T) 733 (T) 456 (I) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.288 P=0.338 P=0.219 P=0.360 | P=0.316N P=0.692N P=0.753 P=0.473N |
|INCIDENTAL TUMOR | P=0.335 P=0.430 P=0.260 P=0.391 | P=0.316N P=0.692N P=0.753 P=0.473N |
|LOGISTIC REGRESSION | P=0.377 P=0.359 P=0.283 P=0.472 | P=0.317N P=0.692N P=0.740 P=0.473N |
|COCHRAN-ARMITAGE | P=0.421 | P=0.312N |
|FISHER EXACT | P=0.500 P=0.340 P=0.500 | P=0.752N P=0.752N P=0.500N |
|=================================================================================================================================|
DATE: 04/02/96 EXPERIMENT: 05068 TEST: 09 PAGE 11
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CODEINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 400 PPM 800 PPM 1600 | 0 PPM 400 PPM 800 PPM 1600 |
| | PPM | PPM |
|=================================================================================================================================|
| |
|Skin |
| Fibroma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 5/60 (8%) 2/60 (3%) 3/60 (5%) 1/60 (2%) | 2/60 (3%) 1/60 (2%) 3/60 (5%) 1/60 (2%) |
|ADJUSTED (b) | 15.8% 8.4% 11.8% 3.0% | 5.8% 2.6% 7.8% 3.1% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) |
|TERMINAL (d) | 4/29 (14%) 1/20 (5%) 2/21 (10%) 0/20 (0%) | 1/28 (4%) 1/38 (3%) 0/29 (0%) 1/32 (3%) |
|FIRST INCIDENCE (DAYS) | 567 693 635 670 | 547 733 (T) 659 733 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.153N P=0.336N P=0.487N P=0.173N | P=0.445N P=0.422N P=0.557 P=0.456N |
|INCIDENTAL TUMOR | P=0.117N P=0.249N P=0.406N P=0.124N | P=0.383N P=0.629N P=0.684N P=0.560N |
|LOGISTIC REGRESSION | P=0.103N P=0.228N P=0.353N P=0.113N | P=0.449N P=0.476N P=0.523 P=0.476N |
|COCHRAN-ARMITAGE | P=0.096N | P=0.474N |
|FISHER EXACT | P=0.219N P=0.359N P=0.103N | P=0.500N P=0.500 P=0.500N |
|=================================================================================================================================|
| |
|Skin |
| Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 5/60 (8%) 3/60 (5%) 3/60 (5%) 1/60 (2%) | 3/60 (5%) 1/60 (2%) 4/60 (7%) 1/60 (2%) |
|ADJUSTED (b) | 15.8% 10.0% 11.8% 3.0% | 7.4% 2.6% 10.7% 3.1% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) |
|TERMINAL (d) | 4/29 (14%) 1/20 (5%) 2/21 (10%) 0/20 (0%) | 1/28 (4%) 1/38 (3%) 0/29 (0%) 1/32 (3%) |
|FIRST INCIDENCE (DAYS) | 567 426 635 670 | 313 733 (T) 659 733 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.129N P=0.489N P=0.487N P=0.173N | P=0.317N P=0.250N P=0.553 P=0.275N |
|INCIDENTAL TUMOR | P=0.093N P=0.461N P=0.406N P=0.124N | P=0.293N P=0.629N P=0.596N P=0.560N |
|LOGISTIC REGRESSION | P=0.083N P=0.355N P=0.353N P=0.113N | P=0.350N P=0.361N P=0.471 P=0.358N |
|COCHRAN-ARMITAGE | P=0.080N | P=0.344N |
|FISHER EXACT | P=0.359N P=0.359N P=0.103N | P=0.309N P=0.500 P=0.309N |
|=================================================================================================================================|
DATE: 04/02/96 EXPERIMENT: 05068 TEST: 09 PAGE 12
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CODEINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 400 PPM 800 PPM 1600 | 0 PPM 400 PPM 800 PPM 1600 |
| | PPM | PPM |
|=================================================================================================================================|
| |
|Skin |
| Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 2/60 (3%) 2/60 (3%) 2/60 (3%) | 0/60 (0%) 1/60 (2%) 1/60 (2%) 0/60 (0%) |
|ADJUSTED (b) | 3.4% 9.5% 9.5% 7.5% | 0.0% 2.6% 1.7% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 1/9 (11%) 0/9 (0%) |
|TERMINAL (d) | 1/29 (3%) 1/20 (5%) 2/21 (10%) 1/20 (5%) | 0/28 (0%) 1/38 (3%) 0/29 (0%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | 732 (T) 729 732 (T) 594 | --- 733 (T) 456 (I) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.324 P=0.378 P=0.387 P=0.406 | P=0.605N P=0.561 P=0.479 (e) |
|INCIDENTAL TUMOR | P=0.362 P=0.498 P=0.387 P=0.447 | P=0.605N P=0.561 P=0.479 (e) |
|LOGISTIC REGRESSION | P=0.395 P=0.398 P=0.387 P=0.488 | P=0.618N P=0.561 P=0.422 (e) |
|COCHRAN-ARMITAGE | P=0.423 | P=0.595N |
|FISHER EXACT | P=0.500 P=0.500 P=0.500 | P=0.500 P=0.500 (e) |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, Squamous Cell Carcinoma or Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 3/60 (5%) 3/60 (5%) 3/60 (5%) | 1/60 (2%) 1/60 (2%) 1/60 (2%) 0/60 (0%) |
|ADJUSTED (b) | 3.4% 14.3% 14.3% 12.4% | 3.6% 2.6% 1.7% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 1/9 (11%) 0/9 (0%) |
|TERMINAL (d) | 1/29 (3%) 2/20 (10%) 3/21 (14%) 2/20 (10%) | 1/28 (4%) 1/38 (3%) 0/29 (0%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | 732 (T) 729 732 (T) 594 | 733 (T) 733 (T) 456 (I) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.188 P=0.189 P=0.196 P=0.207 | P=0.316N P=0.692N P=0.753 P=0.473N |
|INCIDENTAL TUMOR | P=0.211 P=0.266 P=0.196 P=0.234 | P=0.316N P=0.692N P=0.753 P=0.473N |
|LOGISTIC REGRESSION | P=0.257 P=0.200 P=0.196 P=0.287 | P=0.317N P=0.692N P=0.740 P=0.473N |
|COCHRAN-ARMITAGE | P=0.293 | P=0.312N |
|FISHER EXACT | P=0.309 P=0.309 P=0.309 | P=0.752N P=0.752N P=0.500N |
|=================================================================================================================================|
DATE: 04/02/96 EXPERIMENT: 05068 TEST: 09 PAGE 13
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CODEINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 400 PPM 800 PPM 1600 | 0 PPM 400 PPM 800 PPM 1600 |
| | PPM | PPM |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, or Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 3/60 (5%) 2/60 (3%) 3/60 (5%) | 1/60 (2%) 1/60 (2%) 1/60 (2%) 0/60 (0%) |
|ADJUSTED (b) | 3.4% 14.3% 9.5% 12.4% | 3.6% 2.6% 1.7% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 1/9 (11%) 0/9 (0%) |
|TERMINAL (d) | 1/29 (3%) 2/20 (10%) 2/21 (10%) 2/20 (10%) | 1/28 (4%) 1/38 (3%) 0/29 (0%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | 732 (T) 729 732 (T) 594 | 733 (T) 733 (T) 456 (I) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.203 P=0.189 P=0.387 P=0.207 | P=0.316N P=0.692N P=0.753 P=0.473N |
|INCIDENTAL TUMOR | P=0.229 P=0.266 P=0.387 P=0.234 | P=0.316N P=0.692N P=0.753 P=0.473N |
|LOGISTIC REGRESSION | P=0.270 P=0.200 P=0.387 P=0.287 | P=0.317N P=0.692N P=0.740 P=0.473N |
|COCHRAN-ARMITAGE | P=0.303 | P=0.312N |
|FISHER EXACT | P=0.309 P=0.500 P=0.309 | P=0.752N P=0.752N P=0.500N |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 53/60 (88%) 57/60 (95%) 56/60 (93%) 57/60 (95%) | |
|ADJUSTED (b) | 98.1% 100.0% 100.0% 100.0% | |
|INTERIM SACRIFICE 1 (c)| 6/10 (60%) 10/10 (100%) 7/10 (70%) 9/10 (90%) | |
|TERMINAL (d) | 28/29 (97%) 20/20 (100%) 21/21 (100%) 20/20 (100%)| |
|FIRST INCIDENCE (DAYS) | 334 426 455 (I) 455 (I) | |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.055 P=0.036 * P=0.085 P=0.034 * | |
|INCIDENTAL TUMOR | P=0.175 P=0.287 P=0.450 P=0.199 | |
|LOGISTIC REGRESSION | P=0.217 P=0.216 P=0.513 P=0.196 | |
|COCHRAN-ARMITAGE | P=0.164 | |
|FISHER EXACT | P=0.161 P=0.264 P=0.161 | |
|=================================================================================================================================|
DATE: 04/02/96 EXPERIMENT: 05068 TEST: 09 PAGE 14
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CODEINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 400 PPM 800 PPM 1600 | 0 PPM 400 PPM 800 PPM 1600 |
| | PPM | PPM |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/60 (5%) 3/60 (5%) 2/60 (3%) 2/60 (3%) | 4/60 (7%) 3/60 (5%) 5/60 (8%) 3/60 (5%) |
|ADJUSTED (b) | 9.7% 12.0% 9.5% 8.5% | 12.6% 6.9% 16.1% 8.7% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) |
|TERMINAL (d) | 2/29 (7%) 1/20 (5%) 2/21 (10%) 1/20 (5%) | 3/28 (11%) 1/38 (3%) 4/29 (14%) 2/32 (6%) |
|FIRST INCIDENCE (DAYS) | 681 684 732 (T) 705 | 475 606 686 702 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.472N P=0.543 P=0.619N P=0.614N | P=0.444N P=0.360N P=0.531 P=0.430N |
|INCIDENTAL TUMOR | P=0.390N P=0.582N P=0.562N P=0.489N | P=0.445N P=0.551N P=0.472 P=0.448N |
|LOGISTIC REGRESSION | P=0.406N P=0.638 P=0.528N P=0.542N | P=0.425N P=0.461N P=0.579 P=0.431N |
|COCHRAN-ARMITAGE | P=0.372N | P=0.482N |
|FISHER EXACT | P=0.660N P=0.500N P=0.500N | P=0.500N P=0.500 P=0.500N |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/60 (3%) 2/60 (3%) 4/60 (7%) 3/60 (5%) | 2/60 (3%) 1/60 (2%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 6.9% 10.0% 17.3% 9.9% | 6.8% 2.6% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) |
|TERMINAL (d) | 2/29 (7%) 2/20 (10%) 3/21 (14%) 0/20 (0%) | 1/28 (4%) 1/38 (3%) 0/29 (0%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | 732 (T) 732 (T) 707 659 | 712 733 (T) --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.260 P=0.555 P=0.216 P=0.411 | P=0.094N P=0.397N P=0.236N P=0.203N |
|INCIDENTAL TUMOR | P=0.321 P=0.555 P=0.260 P=0.603 | P=0.072N P=0.412N P=0.148N P=0.154N |
|LOGISTIC REGRESSION | P=0.318 P=0.555 P=0.281 P=0.472 | P=0.084N P=0.403N P=0.206N P=0.191N |
|COCHRAN-ARMITAGE | P=0.357 | P=0.101N |
|FISHER EXACT | P=0.691N P=0.340 P=0.500 | P=0.500N P=0.248N P=0.248N |
|=================================================================================================================================|
DATE: 04/02/96 EXPERIMENT: 05068 TEST: 09 PAGE 15
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CODEINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 400 PPM 800 PPM 1600 | 0 PPM 400 PPM 800 PPM 1600 |
| | PPM | PPM |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/60 (8%) 5/60 (8%) 5/60 (8%) 5/60 (8%) | 6/60 (10%) 4/60 (7%) 5/60 (8%) 3/60 (5%) |
|ADJUSTED (b) | 16.4% 21.3% 21.9% 17.6% | 18.9% 9.4% 16.1% 8.7% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) |
|TERMINAL (d) | 4/29 (14%) 3/20 (15%) 4/21 (19%) 1/20 (5%) | 4/28 (14%) 2/38 (5%) 4/29 (14%) 2/32 (6%) |
|FIRST INCIDENCE (DAYS) | 681 684 707 659 | 475 606 686 702 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.416 P=0.437 P=0.455 P=0.483 | P=0.198N P=0.219N P=0.470N P=0.183N |
|INCIDENTAL TUMOR | P=0.532 P=0.609 P=0.545 P=0.555N | P=0.182N P=0.358N P=0.470N P=0.167N |
|LOGISTIC REGRESSION | P=0.511 P=0.568 P=0.584 P=0.585 | P=0.176N P=0.295N P=0.406N P=0.174N |
|COCHRAN-ARMITAGE | P=0.563 | P=0.228N |
|FISHER EXACT | P=0.628N P=0.628N P=0.628N | P=0.372N P=0.500N P=0.245N |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 1/60 (2%) 0/60 (0%) 0/60 (0%) | 1/60 (2%) 0/60 (0%) 2/60 (3%) 2/60 (3%) |
|ADJUSTED (b) | 3.4% 2.7% 0.0% 0.0% | 2.1% 0.0% 5.6% 6.3% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) |
|TERMINAL (d) | 1/29 (3%) 0/20 (0%) 0/21 (0%) 0/20 (0%) | 0/28 (0%) 0/38 (0%) 1/29 (3%) 2/32 (6%) |
|FIRST INCIDENCE (DAYS) | 732 (T) 651 --- --- | 475 --- 643 733 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.268N P=0.720 P=0.564N P=0.574N | P=0.258 P=0.496N P=0.536 P=0.531 |
|INCIDENTAL TUMOR | P=0.229N P=0.728N P=0.564N P=0.574N | P=0.185 P=0.581N P=0.283 P=0.453 |
|LOGISTIC REGRESSION | P=0.240N P=0.760 P=0.564N P=0.574N | P=0.250 P=0.580N P=0.479 P=0.502 |
|COCHRAN-ARMITAGE | P=0.236N | P=0.246 |
|FISHER EXACT | P=0.752N P=0.500N P=0.500N | P=0.500N P=0.500 P=0.500 |
|=================================================================================================================================|
DATE: 04/02/96 EXPERIMENT: 05068 TEST: 09 PAGE 16
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CODEINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 400 PPM 800 PPM 1600 | 0 PPM 400 PPM 800 PPM 1600 |
| | PPM | PPM |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # # |
|----------- | | |
|OVERALL (a) | | 1/60 (2%) 7/60 (12%) 7/60 (12%) 3/60 (5%) |
|ADJUSTED (b) | | 3.6% 16.4% 20.6% 6.9% |
|INTERIM SACRIFICE 1 (c)| | 0/10 (0%) 1/10 (10%) 1/9 (11%) 0/9 (0%) |
|TERMINAL (d) | | 1/28 (4%) 5/38 (13%) 5/29 (17%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | | 733 (T) 456 (I) 456 (I) 473 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.490 P=0.069 P=0.038 * P=0.368 |
|INCIDENTAL TUMOR | | P=0.482 P=0.057 P=0.046 * P=0.375 |
|LOGISTIC REGRESSION | | P=0.487 P=0.041 * P=0.045 * P=0.304 |
|COCHRAN-ARMITAGE | | P=0.467 |
|FISHER EXACT | | P=0.031 * P=0.031 * P=0.309 |
|=================================================================================================================================|
| |
|Uterus |
| Sarcoma Stromal or Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # # |
|----------- | | |
|OVERALL (a) | | 1/60 (2%) 7/60 (12%) 8/60 (13%) 3/60 (5%) |
|ADJUSTED (b) | | 3.6% 16.4% 22.7% 6.9% |
|INTERIM SACRIFICE 1 (c)| | 0/10 (0%) 1/10 (10%) 1/9 (11%) 0/9 (0%) |
|TERMINAL (d) | | 1/28 (4%) 5/38 (13%) 5/29 (17%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | | 733 (T) 456 (I) 456 (I) 473 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.481 P=0.069 P=0.024 * P=0.368 |
|INCIDENTAL TUMOR | | P=0.491 P=0.057 P=0.035 * P=0.375 |
|LOGISTIC REGRESSION | | P=0.474 P=0.041 * P=0.026 * P=0.304 |
|COCHRAN-ARMITAGE | | P=0.452 |
|FISHER EXACT | | P=0.031 * P=0.016 * P=0.309 |
|=================================================================================================================================|
DATE: 04/02/96 EXPERIMENT: 05068 TEST: 09 PAGE 17
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CODEINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 400 PPM 800 PPM 1600 | 0 PPM 400 PPM 800 PPM 1600 |
| | PPM | PPM |
|=================================================================================================================================|
| |
|Zymbal's Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | 0/60 (0%) 1/60 (2%) 3/60 (5%) 1/60 (2%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 0.0% 2.4% 7.1% 2.8% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) |
|TERMINAL (d) | 0/29 (0%) 0/20 (0%) 0/21 (0%) 0/20 (0%) | 0/28 (0%) 0/38 (0%) 0/29 (0%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- | --- 705 606 718 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) (e) | P=0.401 P=0.567 P=0.169 P=0.543 |
|INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.495 P=0.531 P=0.190 P=0.638 |
|LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.366 P=0.537 P=0.124 P=0.541 |
|COCHRAN-ARMITAGE | (e) | P=0.351 |
|FISHER EXACT | (e) (e) (e) | P=0.500 P=0.122 P=0.500 |
|=================================================================================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 33/60 (55%) 27/60 (45%) 37/60 (62%) 37/60 (62%) | 15/60 (25%) 16/60 (27%) 18/60 (30%) 12/60 (20%) |
|ADJUSTED (b) | 73.1% 64.1% 79.2% 81.4% | 36.2% 34.3% 52.1% 27.3% |
|INTERIM SACRIFICE 1 (c)| 1/10 (10%) 0/10 (0%) 1/10 (10%) 0/10 (0%) | 1/10 (10%) 0/10 (0%) 0/9 (0%) 0/9 (0%) |
|TERMINAL (d) | 17/29 (59%) 7/20 (35%) 12/21 (57%) 12/20 (60%) | 5/28 (18%) 8/38 (21%) 13/29 (45%) 2/32 (6%) |
|FIRST INCIDENCE (DAYS) | 455 (I) 404 455 (I) 355 | 432 479 635 617 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.055 P=0.495N P=0.146 P=0.094 | P=0.220N P=0.369N P=0.440 P=0.197N |
|INCIDENTAL TUMOR | P=0.180 P=0.020N* P=0.512N P=0.499 | P=0.164N P=0.353 P=0.343 P=0.216N |
|LOGISTIC REGRESSION | P=0.178 P=0.038N* P=0.494N P=0.448 | P=0.228N P=0.311 P=0.441 P=0.434N |
|COCHRAN-ARMITAGE | P=0.118 | P=0.282N |
|FISHER EXACT | P=0.181N P=0.289 P=0.289 | P=0.500 P=0.342 P=0.331N |
|=================================================================================================================================|
DATE: 04/02/96 EXPERIMENT: 05068 TEST: 09 PAGE 18
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CODEINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 400 PPM 800 PPM 1600 | 0 PPM 400 PPM 800 PPM 1600 |
| | PPM | PPM |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma: Benign, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 2/60 (3%) 3/60 (5%) 3/60 (5%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 3.4% 5.7% 9.9% 7.7% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) |
|TERMINAL (d) | 1/29 (3%) 0/20 (0%) 0/21 (0%) 0/20 (0%) | 0/28 (0%) 0/38 (0%) 0/29 (0%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | 732 (T) 574 455 (I) 484 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.205 P=0.459 P=0.245 P=0.274 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.301 P=0.601 P=0.387 P=0.371 | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.228 P=0.501 P=0.311 P=0.306 | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.228 | (e) |
|FISHER EXACT | P=0.500 P=0.309 P=0.309 | (e) (e) (e) |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 56/60 (93%) 57/60 (95%) 57/60 (95%) 57/60 (95%) | 39/60 (65%) 42/60 (70%) 44/60 (73%) 27/60 (45%) |
|ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | 90.5% 83.8% 91.3% 65.1% |
|INTERIM SACRIFICE 1 (c)| 7/10 (70%) 10/10 (100%) 7/10 (70%) 9/10 (90%) | 1/10 (10%) 2/10 (20%) 3/9 (33%) 0/9 (0%) |
|TERMINAL (d) | 29/29 (100%) 20/20 (100%) 21/21 (100%) 20/20 (100%)| 24/28 (86%) 30/38 (79%) 25/29 (86%) 18/32 (56%) |
|FIRST INCIDENCE (DAYS) | 334 426 455 (I) 455 (I) | 456 (I) 400 427 473 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.100 P=0.080 P=0.135 P=0.075 | P=0.007N** P=0.129N P=0.437 P=0.004N** |
|INCIDENTAL TUMOR | P=0.514 P=0.643 P=0.683 P=0.599 | P<0.001N** P=0.529N P=0.339 P=0.001N** |
|LOGISTIC REGRESSION | P=0.576N P=0.665 P=0.467N P=0.669 | P<0.001N** P=0.490N P=0.497 P=0.001N** |
|COCHRAN-ARMITAGE | P=0.443 | P=0.007N** |
|FISHER EXACT | P=0.500 P=0.500 P=0.500 | P=0.348 P=0.215 P=0.022N* |
|=================================================================================================================================|
DATE: 04/02/96 EXPERIMENT: 05068 TEST: 09 PAGE 19
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CODEINE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 PPM 400 PPM 800 PPM 1600 | 0 PPM 400 PPM 800 PPM 1600 |
| | PPM | PPM |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 37/60 (62%) 33/60 (55%) 41/60 (68%) 41/60 (68%) | 28/60 (47%) 20/60 (33%) 28/60 (47%) 17/60 (28%) |
|ADJUSTED (b) | 80.2% 74.3% 82.9% 83.5% | 62.1% 41.6% 66.0% 36.7% |
|INTERIM SACRIFICE 1 (c)| 1/10 (10%) 0/10 (0%) 2/10 (20%) 0/10 (0%) | 1/10 (10%) 0/10 (0%) 0/9 (0%) 0/9 (0%) |
|TERMINAL (d) | 20/29 (69%) 10/20 (50%) 13/21 (62%) 12/20 (60%) | 12/28 (43%) 10/38 (26%) 15/29 (52%) 4/32 (13%) |
|FIRST INCIDENCE (DAYS) | 203 336 455 (I) 355 | 313 479 365 444 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.064 P=0.442 P=0.132 P=0.088 | P=0.047N* P=0.020N* P=0.416N P=0.016N* |
|INCIDENTAL TUMOR | P=0.196 P=0.108N P=0.525 P=0.490 | P=0.010N* P=0.171N P=0.405N P=0.009N** |
|LOGISTIC REGRESSION | P=0.124 P=0.256N P=0.353 P=0.266 | P=0.038N* P=0.066N P=0.455N P=0.022N* |
|COCHRAN-ARMITAGE | P=0.139 | P=0.056N |
|FISHER EXACT | P=0.289N P=0.283 P=0.283 | P=0.096N P=0.573N P=0.029N* |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 57/60 (95%) 60/60 (100%) 59/60 (98%) 59/60 (98%) | 48/60 (80%) 46/60 (77%) 50/60 (83%) 37/60 (62%) |
|ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | 95.9% 88.4% 96.1% 75.4% |
|INTERIM SACRIFICE 1 (c)| 7/10 (70%) 10/10 (100%) 9/10 (90%) 9/10 (90%) | 2/10 (20%) 2/10 (20%) 3/9 (33%) 0/9 (0%) |
|TERMINAL (d) | 29/29 (100%) 20/20 (100%) 21/21 (100%) 20/20 (100%)| 26/28 (93%) 32/38 (84%) 27/29 (93%) 20/32 (63%) |
|FIRST INCIDENCE (DAYS) | 203 336 455 (I) 355 | 313 400 365 444 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.094 P=0.053 P=0.108 P=0.063 | P=0.026N* P=0.023N* P=0.461N P=0.010N** |
|INCIDENTAL TUMOR | P=0.288 P=0.111 P=0.293 P=0.293 | P<0.001N** P=0.338N P=0.484 P=0.002N** |
|LOGISTIC REGRESSION | P=0.391 P=0.160 P=0.497 P=0.381 | P=0.001N** P=0.163N P=0.529N P=0.002N** |
|COCHRAN-ARMITAGE | P=0.296 | P=0.014N* |
|FISHER EXACT | P=0.122 P=0.309 P=0.309 | P=0.412N P=0.407 P=0.022N* |
|=================================================================================================================================|
DATE: 04/02/96 EXPERIMENT: 05068 TEST: 09 PAGE 20
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CODEINE
TERMINAL SACRIFICE AT 105 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): 455
Female interim sacrifices(days): 456
(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).