TDMS Study 05214-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Mason TRANS-DELTA-9-TETRAHYDROCANNABINOL DATE: 05/20/95
EXPERIMENT: 05214 TEST: 01 TIME: 12:27:22
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-85212 ROUTE: GAVAGE NTP C#: 56371B
PATHOLOGIST: K. MURTHY CAS: 1972-08-3
------------------------------------------------------------------------------------------------------------------------------------
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Mason TRANS-DELTA-9-TETRAHYDROCANNABINOL DATE: 05/20/95
EXPERIMENT: 05214 TEST: 01 TIME: 12:27:22
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-85212 ROUTE: GAVAGE NTP C#: 56371B
PATHOLOGIST: K. MURTHY CAS: 1972-08-3
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: Mason TRANS-DELTA-9-TETRAHYDROCANNABINOL DATE: 05/20/95
EXPERIMENT: 05214 TEST: 01 TIME: 12:27:22
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-85212 ROUTE: GAVAGE NTP C#: 56371B
PATHOLOGIST: K. MURTHY CAS: 1972-08-3
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF THE STUDY OF TRANS-DELTA-9-TETRAHYDROCANNABINOL
====================================================================================================
MALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Adrenal Medulla Pheochromocytoma Benign
Pheochromocytoma: Benign, Complex, Malignant, NOS
Liver Hepatocellular Carcinoma or Hepatocellular Adenoma
Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
Mammary Gland Fibroadenoma
Fibroma, Fibroadenoma or Adenoma
Fibroma, Fibroadenoma, Carcinoma, or Adenoma
Pancreas Adenoma
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
Carcinoma or Adenoma
Skin Basal Cell Adenoma, Basosquamous Tumor Benign, or Trichoepithelioma
Basal Cell Carcinoma, Basal Cell Adenoma, Basosquamous Tumor (benign,
malignant or NOS), or Trichoepithelioma
Testes Adenoma
All Organs Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
====================================================================================================
FEMALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Mammary Gland Fibroadenoma
Fibroma, Fibroadenoma or Adenoma
Fibroma, Fibroadenoma, Carcinoma, or Adenoma
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
Carcinoma or Adenoma
Thyroid Gland: C-Cell Carcinoma or Adenoma
Uterus Polyp Stromal
Sarcoma Stromal or Polyp Stromal
All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated
Benign Tumors
Malignant and Benign Tumors
====================================================================================================
DATE: 05/20/95 EXPERIMENT: 05214 TEST: 01 PAGE 1
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRANS-DELTA-9-TETRAHYDROCANNABINOL
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 12.5 25 50 | 0 12.5 25 50 |
| | MG/KG MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 9/62 (15%) 6/60 (10%) 4/61 (7%) 6/61 (10%) | 2/60 (3%) 2/60 (3%) 2/60 (3%) 1/60 (2%) |
|ADJUSTED (b) | 31.6% 15.7% 11.6% 16.7% | 8.7% 5.0% 6.1% 3.1% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) | 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) |
|TERMINAL (d) | 4/22 (18%) 4/35 (11%) 3/33 (9%) 3/31 (10%) | 2/23 (9%) 2/40 (5%) 2/33 (6%) 1/32 (3%) |
|FIRST INCIDENCE (DAYS) | 600 627 709 563 | 725 (T) 725 (T) 725 (T) 725 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.158N P=0.096N P=0.038N* P=0.146N | P=0.311N P=0.483N P=0.559N P=0.385N |
|INCIDENTAL TUMOR | P=0.243N P=0.288N P=0.100N P=0.290N | P=0.311N P=0.483N P=0.559N P=0.385N |
|LOGISTIC REGRESSION | P=0.207N P=0.177N P=0.064N P=0.220N | P=0.311N P=0.483N P=0.559N P=0.385N |
|COCHRAN-ARMITAGE | P=0.254N | P=0.373N |
|FISHER EXACT | P=0.315N P=0.126N P=0.303N | P=0.691N P=0.691N P=0.500N |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Malignant |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/62 (2%) 3/60 (5%) 0/61 (0%) 1/61 (2%) | 0/60 (0%) 1/60 (2%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 2.9% 8.1% 0.0% 3.2% | 0.0% 2.5% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) | 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/22 (0%) 2/35 (6%) 0/33 (0%) 1/31 (3%) | 0/23 (0%) 1/40 (3%) 0/33 (0%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | 647 676 --- 725 (T) | --- 725 (T) --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.352N P=0.437 P=0.458N P=0.704N | P=0.548N P=0.610 (e) (e) |
|INCIDENTAL TUMOR | P=0.394N P=0.287 P=0.557N P=0.757N | P=0.548N P=0.610 (e) (e) |
|LOGISTIC REGRESSION | P=0.389N P=0.353 P=0.500N P=0.747N | P=0.548N P=0.610 (e) (e) |
|COCHRAN-ARMITAGE | P=0.412N | P=0.567N |
|FISHER EXACT | P=0.297 P=0.504N P=0.748 | P=0.500 (e) (e) |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05214 TEST: 01 PAGE 2
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRANS-DELTA-9-TETRAHYDROCANNABINOL
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 12.5 25 50 | 0 12.5 25 50 |
| | MG/KG MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 9/62 (15%) 9/60 (15%) 4/61 (7%) 7/61 (11%) | 2/60 (3%) 3/60 (5%) 2/60 (3%) 1/60 (2%) |
|ADJUSTED (b) | 31.6% 23.2% 11.6% 19.7% | 8.7% 7.5% 6.1% 3.1% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) | 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) |
|TERMINAL (d) | 4/22 (18%) 6/35 (17%) 3/33 (9%) 4/31 (13%) | 2/23 (9%) 3/40 (8%) 2/33 (6%) 1/32 (3%) |
|FIRST INCIDENCE (DAYS) | 600 627 709 563 | 725 (T) 725 (T) 725 (T) 725 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.160N P=0.274N P=0.038N* P=0.209N | P=0.250N P=0.623N P=0.559N P=0.385N |
|INCIDENTAL TUMOR | P=0.246N P=0.593N P=0.100N P=0.380N | P=0.250N P=0.623N P=0.559N P=0.385N |
|LOGISTIC REGRESSION | P=0.214N P=0.444N P=0.064N P=0.308N | P=0.250N P=0.623N P=0.559N P=0.385N |
|COCHRAN-ARMITAGE | P=0.268N | P=0.313N |
|FISHER EXACT | P=0.571 P=0.126N P=0.408N | P=0.500 P=0.691N P=0.500N |
|=================================================================================================================================|
| |
|Brain |
| Oligodendroglioma, Glioma, or Astrocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/62 (0%) 1/59 (2%) 1/61 (2%) 0/61 (0%) | 2/60 (3%) 0/60 (0%) 0/60 (0%) 1/60 (2%) |
|ADJUSTED (b) | 0.0% 2.4% 2.2% 0.0% | 4.1% 0.0% 0.0% 3.1% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) | 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/22 (0%) 0/35 (0%) 0/33 (0%) 0/31 (0%) | 0/23 (0%) 0/40 (0%) 0/33 (0%) 1/32 (3%) |
|FIRST INCIDENCE (DAYS) | --- 674 592 --- | 405 --- --- 725 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.581N P=0.562 P=0.523 (e) | P=0.445N P=0.223N P=0.223N P=0.454N |
|INCIDENTAL TUMOR | P=0.642N P=0.362 P=0.282 (e) | P=0.556N P=0.563N P=0.455N P=0.622N |
|LOGISTIC REGRESSION | P=0.595N P=0.511 P=0.497 (e) | P=0.437N P=0.293N P=0.236N P=0.493N |
|COCHRAN-ARMITAGE | P=0.595N | P=0.461N |
|FISHER EXACT | P=0.488 P=0.496 (e) | P=0.248N P=0.248N P=0.500N |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05214 TEST: 01 PAGE 3
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRANS-DELTA-9-TETRAHYDROCANNABINOL
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 12.5 25 50 | 0 12.5 25 50 |
| | MG/KG MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/62 (3%) 2/60 (3%) 1/61 (2%) 1/59 (2%) | 4/57 (7%) 4/55 (7%) 2/60 (3%) 5/59 (8%) |
|ADJUSTED (b) | 8.2% 5.7% 1.8% 2.9% | 14.4% 11.1% 5.5% 14.4% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 1/9 (11%) 0/9 (0%) | 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/22 (5%) 2/35 (6%) 0/33 (0%) 0/31 (0%) | 2/21 (10%) 4/36 (11%) 1/33 (3%) 3/32 (9%) |
|FIRST INCIDENCE (DAYS) | 715 725 (T) 448 (I) 688 | 374 725 (T) 650 651 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.291N P=0.535N P=0.438N P=0.411N | P=0.563 P=0.382N P=0.201N P=0.585N |
|INCIDENTAL TUMOR | P=0.329N P=0.619N P=0.499N P=0.527N | P=0.496 P=0.598N P=0.305N P=0.522 |
|LOGISTIC REGRESSION | P=0.340N P=0.580N P=0.505N P=0.452N | P=0.505 P=0.582N P=0.294N P=0.563 |
|COCHRAN-ARMITAGE | P=0.351N | P=0.478 |
|FISHER EXACT | P=0.678 P=0.506N P=0.519N | P=0.622 P=0.315N P=0.522 |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/62 (8%) 3/60 (5%) 4/61 (7%) 3/61 (5%) | 1/60 (2%) 0/60 (0%) 0/60 (0%) 1/59 (2%) |
|ADJUSTED (b) | 18.6% 8.1% 11.5% 8.4% | 4.3% 0.0% 0.0% 3.1% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) | 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) |
|TERMINAL (d) | 3/22 (14%) 2/35 (6%) 3/33 (9%) 2/31 (6%) | 1/23 (4%) 0/40 (0%) 0/33 (0%) 1/32 (3%) |
|FIRST INCIDENCE (DAYS) | 585 675 668 531 | 725 (T) --- --- 725 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.252N P=0.181N P=0.306N P=0.228N | P=0.629 P=0.390N P=0.428N P=0.687N |
|INCIDENTAL TUMOR | P=0.331N P=0.309N P=0.441N P=0.332N | P=0.629 P=0.390N P=0.428N P=0.687N |
|LOGISTIC REGRESSION | P=0.316N P=0.277N P=0.427N P=0.325N | P=0.629 P=0.390N P=0.428N P=0.687N |
|COCHRAN-ARMITAGE | P=0.347N | P=0.592 |
|FISHER EXACT | P=0.377N P=0.510N P=0.368N | P=0.500N P=0.500N P=0.748 |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05214 TEST: 01 PAGE 4
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRANS-DELTA-9-TETRAHYDROCANNABINOL
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 12.5 25 50 | 0 12.5 25 50 |
| | MG/KG MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/62 (8%) 3/60 (5%) 4/61 (7%) 3/61 (5%) | 2/60 (3%) 0/60 (0%) 0/60 (0%) 1/59 (2%) |
|ADJUSTED (b) | 18.6% 8.1% 11.5% 8.4% | 7.9% 0.0% 0.0% 3.1% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) | 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) |
|TERMINAL (d) | 3/22 (14%) 2/35 (6%) 3/33 (9%) 2/31 (6%) | 1/23 (4%) 0/40 (0%) 0/33 (0%) 1/32 (3%) |
|FIRST INCIDENCE (DAYS) | 585 675 668 531 | 676 --- --- 725 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.252N P=0.181N P=0.306N P=0.228N | P=0.428N P=0.139N P=0.169N P=0.401N |
|INCIDENTAL TUMOR | P=0.331N P=0.309N P=0.441N P=0.332N | P=0.433N P=0.232N P=0.187N P=0.442N |
|LOGISTIC REGRESSION | P=0.316N P=0.277N P=0.427N P=0.325N | P=0.440N P=0.177N P=0.187N P=0.435N |
|COCHRAN-ARMITAGE | P=0.347N | P=0.465N |
|FISHER EXACT | P=0.377N P=0.510N P=0.368N | P=0.248N P=0.248N P=0.506N |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/62 (5%) 1/60 (2%) 1/61 (2%) 2/61 (3%) | 0/60 (0%) 0/60 (0%) 3/60 (5%) 0/60 (0%) |
|ADJUSTED (b) | 11.4% 1.7% 3.0% 5.8% | 0.0% 0.0% 7.6% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 1/9 (11%) 0/9 (0%) 0/9 (0%) | 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) |
|TERMINAL (d) | 2/22 (9%) 0/35 (0%) 1/33 (3%) 1/31 (3%) | 0/23 (0%) 0/40 (0%) 0/33 (0%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | 600 448 (I) 725 (T) 668 | --- --- 509 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.426N P=0.225N P=0.200N P=0.386N | P=0.558 (e) P=0.176 (e) |
|INCIDENTAL TUMOR | P=0.468N P=0.283N P=0.279N P=0.470N | P=0.475 (e) P=0.055 (e) |
|LOGISTIC REGRESSION | P=0.472N P=0.322N P=0.269N P=0.463N | P=0.539 (e) P=0.123 (e) |
|COCHRAN-ARMITAGE | P=0.477N | P=0.539 |
|FISHER EXACT | P=0.322N P=0.316N P=0.508N | (e) P=0.122 (e) |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05214 TEST: 01 PAGE 5
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRANS-DELTA-9-TETRAHYDROCANNABINOL
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 12.5 25 50 | 0 12.5 25 50 |
| | MG/KG MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/62 (3%) 0/60 (0%) 0/61 (0%) 0/61 (0%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 9.1% 0.0% 0.0% 0.0% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) | 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) |
|TERMINAL (d) | 2/22 (9%) 0/35 (0%) 0/33 (0%) 0/31 (0%) | 0/23 (0%) 0/40 (0%) 0/33 (0%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | 725 (T) --- --- --- | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.087N P=0.143N P=0.154N P=0.166N | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.087N P=0.143N P=0.154N P=0.166N | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.087N P=0.143N P=0.154N P=0.166N | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.116N | (e) |
|FISHER EXACT | P=0.256N P=0.252N P=0.252N | (e) (e) (e) |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/62 (8%) 1/60 (2%) 1/61 (2%) 2/61 (3%) | 0/60 (0%) 0/60 (0%) 3/60 (5%) 0/60 (0%) |
|ADJUSTED (b) | 20.2% 1.7% 3.0% 5.8% | 0.0% 0.0% 7.6% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 1/9 (11%) 0/9 (0%) 0/9 (0%) | 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) |
|TERMINAL (d) | 4/22 (18%) 0/35 (0%) 1/33 (3%) 1/31 (3%) | 0/23 (0%) 0/40 (0%) 0/33 (0%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | 600 448 (I) 725 (T) 668 | --- --- 509 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.149N P=0.048N* P=0.042N* P=0.121N | P=0.558 (e) P=0.176 (e) |
|INCIDENTAL TUMOR | P=0.176N P=0.064N P=0.062N P=0.161N | P=0.475 (e) P=0.055 (e) |
|LOGISTIC REGRESSION | P=0.187N P=0.097N P=0.072N P=0.172N | P=0.539 (e) P=0.123 (e) |
|COCHRAN-ARMITAGE | P=0.197N | P=0.539 |
|FISHER EXACT | P=0.111N P=0.107N P=0.226N | (e) P=0.122 (e) |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05214 TEST: 01 PAGE 6
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRANS-DELTA-9-TETRAHYDROCANNABINOL
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 12.5 25 50 | 0 12.5 25 50 |
| | MG/KG MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/62 (8%) 1/60 (2%) 1/61 (2%) 2/61 (3%) | 0/60 (0%) 0/60 (0%) 3/60 (5%) 0/60 (0%) |
|ADJUSTED (b) | 20.2% 1.7% 3.0% 5.8% | 0.0% 0.0% 7.6% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 1/9 (11%) 0/9 (0%) 0/9 (0%) | 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) |
|TERMINAL (d) | 4/22 (18%) 0/35 (0%) 1/33 (3%) 1/31 (3%) | 0/23 (0%) 0/40 (0%) 0/33 (0%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | 600 448 (I) 725 (T) 668 | --- --- 509 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.149N P=0.048N* P=0.042N* P=0.121N | P=0.558 (e) P=0.176 (e) |
|INCIDENTAL TUMOR | P=0.176N P=0.064N P=0.062N P=0.161N | P=0.475 (e) P=0.055 (e) |
|LOGISTIC REGRESSION | P=0.187N P=0.097N P=0.072N P=0.172N | P=0.539 (e) P=0.123 (e) |
|COCHRAN-ARMITAGE | P=0.197N | P=0.539 |
|FISHER EXACT | P=0.111N P=0.107N P=0.226N | (e) P=0.122 (e) |
|=================================================================================================================================|
| |
|Mammary Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/62 (0%) 0/60 (0%) 0/61 (0%) 0/61 (0%) | 0/60 (0%) 2/60 (3%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 0.0% 5.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) | 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/22 (0%) 0/35 (0%) 0/33 (0%) 0/31 (0%) | 0/23 (0%) 2/40 (5%) 0/33 (0%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- | --- 725 (T) --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) (e) | P=0.371N P=0.367 (e) (e) |
|INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.371N P=0.367 (e) (e) |
|LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.371N P=0.367 (e) (e) |
|COCHRAN-ARMITAGE | (e) | P=0.405N |
|FISHER EXACT | (e) (e) (e) | P=0.248 (e) (e) |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05214 TEST: 01 PAGE 7
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRANS-DELTA-9-TETRAHYDROCANNABINOL
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 12.5 25 50 | 0 12.5 25 50 |
| | MG/KG MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/62 (2%) 1/60 (2%) 0/61 (0%) 0/61 (0%) | 1/60 (2%) 3/60 (5%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 4.5% 2.9% 0.0% 0.0% | 4.3% 7.5% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) | 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/22 (5%) 1/35 (3%) 0/33 (0%) 0/31 (0%) | 1/23 (4%) 3/40 (8%) 0/33 (0%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | 725 (T) 725 (T) --- --- | 725 (T) 725 (T) --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.195N P=0.655N P=0.419N P=0.432N | P=0.118N P=0.517 P=0.428N P=0.434N |
|INCIDENTAL TUMOR | P=0.195N P=0.655N P=0.419N P=0.432N | P=0.118N P=0.517 P=0.428N P=0.434N |
|LOGISTIC REGRESSION | P=0.195N P=0.655N P=0.419N P=0.432N | P=0.118N P=0.517 P=0.428N P=0.434N |
|COCHRAN-ARMITAGE | P=0.237N | P=0.153N |
|FISHER EXACT | P=0.744 P=0.504N P=0.504N | P=0.309 P=0.500N P=0.500N |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 3/62 (5%) 0/60 (0%) 0/61 (0%) 0/61 (0%) | 16/60 (27%) 11/60 (18%) 11/60 (18%) 8/60 (13%) |
|ADJUSTED (b) | 12.2% 0.0% 0.0% 0.0% | 41.9% 24.8% 30.3% 23.5% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) | 1/9 (11%) 0/9 (0%) 0/9 (0%) 0/10 (0%) |
|TERMINAL (d) | 2/22 (9%) 0/35 (0%) 0/33 (0%) 0/31 (0%) | 4/23 (17%) 7/40 (18%) 9/33 (27%) 6/32 (19%) |
|FIRST INCIDENCE (DAYS) | 683 --- --- --- | 454 (I) 584 562 659 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.033N* P=0.063N P=0.070N P=0.074N | P=0.028N* P=0.032N* P=0.055N P=0.019N* |
|INCIDENTAL TUMOR | P=0.041N* P=0.095N P=0.091N P=0.098N | P=0.066N P=0.403N P=0.213N P=0.085N |
|LOGISTIC REGRESSION | P=0.039N* P=0.083N P=0.088N P=0.093N | P=0.062N P=0.320N P=0.200N P=0.075N |
|COCHRAN-ARMITAGE | P=0.048N* | P=0.054N |
|FISHER EXACT | P=0.128N P=0.125N P=0.125N | P=0.191N P=0.191N P=0.054N |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05214 TEST: 01 PAGE 8
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRANS-DELTA-9-TETRAHYDROCANNABINOL
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 12.5 25 50 | 0 12.5 25 50 |
| | MG/KG MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 3/62 (5%) 0/60 (0%) 0/61 (0%) 0/61 (0%) | 16/60 (27%) 13/60 (22%) 11/60 (18%) 8/60 (13%) |
|ADJUSTED (b) | 12.2% 0.0% 0.0% 0.0% | 41.9% 29.4% 30.3% 23.5% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) | 1/9 (11%) 0/9 (0%) 0/9 (0%) 0/10 (0%) |
|TERMINAL (d) | 2/22 (9%) 0/35 (0%) 0/33 (0%) 0/31 (0%) | 4/23 (17%) 9/40 (23%) 9/33 (27%) 6/32 (19%) |
|FIRST INCIDENCE (DAYS) | 683 --- --- --- | 454 (I) 584 562 659 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.033N* P=0.063N P=0.070N P=0.074N | P=0.020N* P=0.065N P=0.055N P=0.019N* |
|INCIDENTAL TUMOR | P=0.041N* P=0.095N P=0.091N P=0.098N | P=0.048N* P=0.543N P=0.213N P=0.085N |
|LOGISTIC REGRESSION | P=0.039N* P=0.083N P=0.088N P=0.093N | P=0.044N* P=0.465N P=0.200N P=0.075N |
|COCHRAN-ARMITAGE | P=0.048N* | P=0.040N* |
|FISHER EXACT | P=0.128N P=0.125N P=0.125N | P=0.335N P=0.191N P=0.054N |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 4/62 (6%) 1/60 (2%) 0/61 (0%) 0/61 (0%) | 17/60 (28%) 14/60 (23%) 11/60 (18%) 8/60 (13%) |
|ADJUSTED (b) | 16.6% 2.9% 0.0% 0.0% | 45.0% 31.6% 30.3% 23.5% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) | 1/9 (11%) 0/9 (0%) 0/9 (0%) 0/10 (0%) |
|TERMINAL (d) | 3/22 (14%) 1/35 (3%) 0/33 (0%) 0/31 (0%) | 5/23 (22%) 10/40 (25%) 9/33 (27%) 6/32 (19%) |
|FIRST INCIDENCE (DAYS) | 683 725 (T) --- --- | 454 (I) 584 562 659 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.011N* P=0.078N P=0.028N* P=0.031N* | P=0.010N* P=0.056N P=0.034N* P=0.011N* |
|INCIDENTAL TUMOR | P=0.013N* P=0.106N P=0.037N* P=0.042N* | P=0.026N* P=0.492N P=0.146N P=0.053N |
|LOGISTIC REGRESSION | P=0.014N* P=0.108N P=0.039N* P=0.042N* | P=0.024N* P=0.424N P=0.134N P=0.045N* |
|COCHRAN-ARMITAGE | P=0.020N* | P=0.023N* |
|FISHER EXACT | P=0.193N P=0.061N P=0.061N | P=0.339N P=0.140N P=0.035N* |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05214 TEST: 01 PAGE 9
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRANS-DELTA-9-TETRAHYDROCANNABINOL
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 12.5 25 50 | 0 12.5 25 50 |
| | MG/KG MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Pancreas |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 8/62 (13%) 0/60 (0%) 2/61 (3%) 0/61 (0%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/59 (0%) |
|ADJUSTED (b) | 33.8% 0.0% 5.7% 0.0% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) | 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) |
|TERMINAL (d) | 7/22 (32%) 0/35 (0%) 1/33 (3%) 0/31 (0%) | 0/23 (0%) 0/40 (0%) 0/33 (0%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | 647 --- 709 --- | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.001N** P<0.001N** P=0.010N** P<0.001N** | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.002N** P<0.001N** P=0.015N* P=0.001N** | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.002N** P=0.001N** P=0.019N* P=0.002N** | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.003N** | (e) |
|FISHER EXACT | P=0.004N** P=0.050N P=0.003N** | (e) (e) (e) |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 22/62 (35%) 21/60 (35%) 16/60 (27%) 9/61 (15%) | 26/60 (43%) 28/60 (47%) 32/60 (53%) 19/60 (32%) |
|ADJUSTED (b) | 71.0% 48.7% 37.4% 23.8% | 69.9% 60.6% 70.1% 51.5% |
|INTERIM SACRIFICE 1 (c)| 1/10 (10%) 2/9 (22%) 2/9 (22%) 0/9 (0%) | 3/9 (33%) 1/9 (11%) 1/9 (11%) 0/10 (0%) |
|TERMINAL (d) | 14/22 (64%) 14/35 (40%) 8/33 (24%) 4/31 (13%) | 13/23 (57%) 22/40 (55%) 20/33 (61%) 15/32 (47%) |
|FIRST INCIDENCE (DAYS) | 448 (I) 448 (I) 448 (I) 578 | 454 (I) 454 (I) 426 449 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001N** P=0.078N P=0.025N* P<0.001N** | P=0.030N* P=0.063N P=0.398N P=0.017N* |
|INCIDENTAL TUMOR | P=0.002N** P=0.274N P=0.107N P=0.002N** | P=0.078N P=0.411N P=0.327 P=0.070N |
|LOGISTIC REGRESSION | P=0.002N** P=0.350N P=0.125N P=0.002N** | P=0.089N P=0.477N P=0.282 P=0.097N |
|COCHRAN-ARMITAGE | P=0.003N** | P=0.097N |
|FISHER EXACT | P=0.553N P=0.196N P=0.007N** | P=0.427 P=0.181 P=0.129N |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05214 TEST: 01 PAGE 10
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRANS-DELTA-9-TETRAHYDROCANNABINOL
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 12.5 25 50 | 0 12.5 25 50 |
| | MG/KG MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 22/62 (35%) 21/60 (35%) 16/60 (27%) 9/61 (15%) | 26/60 (43%) 28/60 (47%) 32/60 (53%) 20/60 (33%) |
|ADJUSTED (b) | 71.0% 48.7% 37.4% 23.8% | 69.9% 60.6% 70.1% 54.4% |
|INTERIM SACRIFICE 1 (c)| 1/10 (10%) 2/9 (22%) 2/9 (22%) 0/9 (0%) | 3/9 (33%) 1/9 (11%) 1/9 (11%) 0/10 (0%) |
|TERMINAL (d) | 14/22 (64%) 14/35 (40%) 8/33 (24%) 4/31 (13%) | 13/23 (57%) 22/40 (55%) 20/33 (61%) 16/32 (50%) |
|FIRST INCIDENCE (DAYS) | 448 (I) 448 (I) 448 (I) 578 | 454 (I) 454 (I) 426 449 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001N** P=0.078N P=0.025N* P<0.001N** | P=0.046N* P=0.063N P=0.398N P=0.024N* |
|INCIDENTAL TUMOR | P=0.002N** P=0.274N P=0.107N P=0.002N** | P=0.112N P=0.411N P=0.327 P=0.095N |
|LOGISTIC REGRESSION | P=0.002N** P=0.350N P=0.125N P=0.002N** | P=0.127N P=0.477N P=0.282 P=0.132N |
|COCHRAN-ARMITAGE | P=0.003N** | P=0.136N |
|FISHER EXACT | P=0.553N P=0.196N P=0.007N** | P=0.427 P=0.181 P=0.174N |
|=================================================================================================================================|
| |
|Skin |
| Basal Cell Adenoma, Basosquamous Tumor Benign, or Trichoepithelioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/62 (0%) 0/60 (0%) 0/61 (0%) 2/61 (3%) | 1/60 (2%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 6.5% | 4.3% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) | 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/22 (0%) 0/35 (0%) 0/33 (0%) 2/31 (6%) | 1/23 (4%) 0/40 (0%) 0/33 (0%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- 725 (T) | 725 (T) --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.051 (e) (e) P=0.316 | P=0.279N P=0.390N P=0.428N P=0.434N |
|INCIDENTAL TUMOR | P=0.051 (e) (e) P=0.316 | P=0.279N P=0.390N P=0.428N P=0.434N |
|LOGISTIC REGRESSION | P=0.051 (e) (e) P=0.316 | P=0.279N P=0.390N P=0.428N P=0.434N |
|COCHRAN-ARMITAGE | P=0.046 * | P=0.306N |
|FISHER EXACT | (e) (e) P=0.244 | P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05214 TEST: 01 PAGE 11
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRANS-DELTA-9-TETRAHYDROCANNABINOL
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 12.5 25 50 | 0 12.5 25 50 |
| | MG/KG MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Basal Cell Carcinoma, Basal Cell Adenoma, Basosquamous Tumor (benign, |
| malignant or NOS), or Trichoepithelioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/62 (0%) 0/60 (0%) 0/61 (0%) 2/61 (3%) | 1/60 (2%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 6.5% | 4.3% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) | 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/22 (0%) 0/35 (0%) 0/33 (0%) 2/31 (6%) | 1/23 (4%) 0/40 (0%) 0/33 (0%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- 725 (T) | 725 (T) --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.051 (e) (e) P=0.316 | P=0.279N P=0.390N P=0.428N P=0.434N |
|INCIDENTAL TUMOR | P=0.051 (e) (e) P=0.316 | P=0.279N P=0.390N P=0.428N P=0.434N |
|LOGISTIC REGRESSION | P=0.051 (e) (e) P=0.316 | P=0.279N P=0.390N P=0.428N P=0.434N |
|COCHRAN-ARMITAGE | P=0.046 * | P=0.306N |
|FISHER EXACT | (e) (e) P=0.244 | P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
| |
|Skin |
| Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor (M or B), Basal |
| Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepithelioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 4/62 (6%) 1/60 (2%) 3/61 (5%) 3/61 (5%) | 1/60 (2%) 2/60 (3%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 16.6% 2.9% 9.1% 8.8% | 4.3% 5.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) | 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) |
|TERMINAL (d) | 3/22 (14%) 1/35 (3%) 3/33 (9%) 2/31 (6%) | 1/23 (4%) 2/40 (5%) 0/33 (0%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | 683 725 (T) 725 (T) 659 | 725 (T) 725 (T) --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.465N P=0.078N P=0.300N P=0.337N | P=0.153N P=0.689 P=0.428N P=0.434N |
|INCIDENTAL TUMOR | P=0.497N P=0.106N P=0.336N P=0.412N | P=0.153N P=0.689 P=0.428N P=0.434N |
|LOGISTIC REGRESSION | P=0.513N P=0.108N P=0.369N P=0.418N | P=0.153N P=0.689 P=0.428N P=0.434N |
|COCHRAN-ARMITAGE | P=0.566N | P=0.188N |
|FISHER EXACT | P=0.193N P=0.509N P=0.509N | P=0.500 P=0.500N P=0.500N |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05214 TEST: 01 PAGE 12
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRANS-DELTA-9-TETRAHYDROCANNABINOL
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 12.5 25 50 | 0 12.5 25 50 |
| | MG/KG MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/62 (2%) 1/60 (2%) 0/61 (0%) 2/61 (3%) | 1/60 (2%) 2/60 (3%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 3.8% 2.5% 0.0% 4.4% | 2.5% 4.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 1/9 (11%) | 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/22 (0%) 0/35 (0%) 0/33 (0%) 0/31 (0%) | 0/23 (0%) 0/40 (0%) 0/33 (0%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | 715 675 --- 448 (I) | 590 276 --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.392 P=0.694N P=0.452N P=0.544 | P=0.179N P=0.565 P=0.468N P=0.486N |
|INCIDENTAL TUMOR | P=0.325 P=0.640 P=0.557N P=0.421 | P=0.178N P=0.349 P=0.590N P=0.621N |
|LOGISTIC REGRESSION | P=0.365 P=0.733N P=0.458N P=0.492 | P=0.145N P=0.408 P=0.513N P=0.499N |
|COCHRAN-ARMITAGE | P=0.365 | P=0.188N |
|FISHER EXACT | P=0.744 P=0.504N P=0.494 | P=0.500 P=0.500N P=0.500N |
|=================================================================================================================================|
| |
|Skin |
| Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/62 (2%) 0/60 (0%) 0/61 (0%) 1/61 (2%) | 1/60 (2%) 2/60 (3%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 3.8% 0.0% 0.0% 2.7% | 2.5% 4.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) | 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/22 (0%) 0/35 (0%) 0/33 (0%) 0/31 (0%) | 0/23 (0%) 0/40 (0%) 0/33 (0%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | 715 --- --- 684 | 590 276 --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.629 P=0.441N P=0.452N P=0.705N | P=0.179N P=0.565 P=0.468N P=0.486N |
|INCIDENTAL TUMOR | P=0.555 P=0.607N P=0.557N P=0.700 | P=0.178N P=0.349 P=0.590N P=0.621N |
|LOGISTIC REGRESSION | P=0.608 P=0.451N P=0.458N P=0.739N | P=0.145N P=0.408 P=0.513N P=0.499N |
|COCHRAN-ARMITAGE | P=0.593 | P=0.188N |
|FISHER EXACT | P=0.508N P=0.504N P=0.748 | P=0.500 P=0.500N P=0.500N |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05214 TEST: 01 PAGE 13
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRANS-DELTA-9-TETRAHYDROCANNABINOL
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 12.5 25 50 | 0 12.5 25 50 |
| | MG/KG MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 3/62 (5%) 1/60 (2%) 3/61 (5%) 1/61 (2%) | 0/60 (0%) 1/60 (2%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 13.6% 2.9% 9.1% 2.5% | 0.0% 2.5% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) | 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) |
|TERMINAL (d) | 3/22 (14%) 1/35 (3%) 3/33 (9%) 0/31 (0%) | 0/23 (0%) 1/40 (3%) 0/33 (0%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | 725 (T) 725 (T) 725 (T) 659 | --- 725 (T) --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.236N P=0.156N P=0.465N P=0.205N | P=0.548N P=0.610 (e) (e) |
|INCIDENTAL TUMOR | P=0.251N P=0.156N P=0.465N P=0.241N | P=0.548N P=0.610 (e) (e) |
|LOGISTIC REGRESSION | P=0.268N P=0.156N P=0.465N P=0.253N | P=0.548N P=0.610 (e) (e) |
|COCHRAN-ARMITAGE | P=0.317N | P=0.567N |
|FISHER EXACT | P=0.322N P=0.652 P=0.316N | P=0.500 (e) (e) |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, Squamous Cell Carcinoma or Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 4/62 (6%) 1/60 (2%) 3/61 (5%) 1/61 (2%) | 0/60 (0%) 2/60 (3%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 16.6% 2.9% 9.1% 2.5% | 0.0% 5.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) | 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) |
|TERMINAL (d) | 3/22 (14%) 1/35 (3%) 3/33 (9%) 0/31 (0%) | 0/23 (0%) 2/40 (5%) 0/33 (0%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | 683 725 (T) 725 (T) 659 | --- 725 (T) --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.133N P=0.078N P=0.300N P=0.106N | P=0.371N P=0.367 (e) (e) |
|INCIDENTAL TUMOR | P=0.155N P=0.106N P=0.336N P=0.152N | P=0.371N P=0.367 (e) (e) |
|LOGISTIC REGRESSION | P=0.160N P=0.108N P=0.369N P=0.142N | P=0.371N P=0.367 (e) (e) |
|COCHRAN-ARMITAGE | P=0.197N | P=0.405N |
|FISHER EXACT | P=0.193N P=0.509N P=0.187N | P=0.248 (e) (e) |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05214 TEST: 01 PAGE 14
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRANS-DELTA-9-TETRAHYDROCANNABINOL
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 12.5 25 50 | 0 12.5 25 50 |
| | MG/KG MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Squamous Cell Carcinoma or Papilloma Squamous |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/62 (0%) 1/60 (2%) 0/61 (0%) 2/61 (3%) | 1/60 (2%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 2.9% 0.0% 6.2% | 3.4% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) | 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/22 (0%) 1/35 (3%) 0/33 (0%) 1/31 (3%) | 0/23 (0%) 0/40 (0%) 0/33 (0%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | --- 725 (T) --- 697 | 647 --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.160 P=0.593 (e) P=0.301 | P=0.280N P=0.417N P=0.431N P=0.446N |
|INCIDENTAL TUMOR | P=0.148 P=0.593 (e) P=0.243 | P=0.303N P=0.612N P=0.473N P=0.531N |
|LOGISTIC REGRESSION | P=0.149 P=0.593 (e) P=0.271 | P=0.305N P=0.494N P=0.493N P=0.495N |
|COCHRAN-ARMITAGE | P=0.140 | P=0.306N |
|FISHER EXACT | P=0.492 (e) P=0.244 | P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 55/62 (89%) 41/60 (68%) 36/61 (59%) 43/61 (70%) | |
|ADJUSTED (b) | 98.1% 93.0% 92.2% 95.5% | |
|INTERIM SACRIFICE 1 (c)| 9/10 (90%) 1/9 (11%) 0/9 (0%) 0/9 (0%) | |
|TERMINAL (d) | 21/22 (95%) 32/35 (91%) 30/33 (91%) 29/31 (94%) | |
|FIRST INCIDENCE (DAYS) | 438 448 (I) 592 563 | |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.002N** P<0.001N** P<0.001N** P<0.001N** | |
|INCIDENTAL TUMOR | P=0.005N** P<0.001N** P<0.001N** P=0.001N** | |
|LOGISTIC REGRESSION | P=0.114N P=0.020N* P=0.001N** P=0.079N | |
|COCHRAN-ARMITAGE | P=0.031N* | |
|FISHER EXACT | P=0.005N** P<0.001N** P=0.011N* | |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05214 TEST: 01 PAGE 15
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRANS-DELTA-9-TETRAHYDROCANNABINOL
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 12.5 25 50 | 0 12.5 25 50 |
| | MG/KG MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/62 (5%) 7/59 (12%) 2/60 (3%) 4/59 (7%) | 3/60 (5%) 0/60 (0%) 2/60 (3%) 1/60 (2%) |
|ADJUSTED (b) | 11.4% 18.6% 4.8% 12.9% | 8.1% 0.0% 5.1% 3.1% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 1/9 (11%) 1/9 (11%) 0/9 (0%) | 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) |
|TERMINAL (d) | 2/22 (9%) 6/35 (17%) 1/33 (3%) 4/31 (13%) | 0/23 (0%) 0/40 (0%) 1/33 (3%) 1/32 (3%) |
|FIRST INCIDENCE (DAYS) | 600 448 (I) 448 (I) 725 (T) | 620 --- 562 725 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.404N P=0.348 P=0.395N P=0.649N | P=0.304N P=0.091N P=0.395N P=0.249N |
|INCIDENTAL TUMOR | P=0.421N P=0.302 P=0.491N P=0.629 | P=0.433N P=0.279N P=0.637N P=0.439N |
|LOGISTIC REGRESSION | P=0.495N P=0.199 P=0.507N P=0.569 | P=0.415N P=0.123N P=0.668N P=0.295N |
|COCHRAN-ARMITAGE | P=0.523N | P=0.337N |
|FISHER EXACT | P=0.142 P=0.516N P=0.472 | P=0.122N P=0.500N P=0.309N |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/62 (5%) 7/59 (12%) 2/60 (3%) 4/59 (7%) | 4/60 (7%) 0/60 (0%) 2/60 (3%) 1/60 (2%) |
|ADJUSTED (b) | 11.4% 18.6% 4.8% 12.9% | 12.1% 0.0% 5.1% 3.1% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 1/9 (11%) 1/9 (11%) 0/9 (0%) | 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) |
|TERMINAL (d) | 2/22 (9%) 6/35 (17%) 1/33 (3%) 4/31 (13%) | 1/23 (4%) 0/40 (0%) 1/33 (3%) 1/32 (3%) |
|FIRST INCIDENCE (DAYS) | 600 448 (I) 448 (I) 725 (T) | 620 --- 562 725 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.404N P=0.348 P=0.395N P=0.649N | P=0.168N P=0.035N* P=0.232N P=0.128N |
|INCIDENTAL TUMOR | P=0.421N P=0.302 P=0.491N P=0.629 | P=0.259N P=0.114N P=0.417N P=0.243N |
|LOGISTIC REGRESSION | P=0.495N P=0.199 P=0.507N P=0.569 | P=0.196N P=0.055N P=0.318N P=0.163N |
|COCHRAN-ARMITAGE | P=0.523N | P=0.200N |
|FISHER EXACT | P=0.142 P=0.516N P=0.472 | P=0.059N P=0.340N P=0.182N |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05214 TEST: 01 PAGE 16
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRANS-DELTA-9-TETRAHYDROCANNABINOL
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 12.5 25 50 | 0 12.5 25 50 |
| | MG/KG MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/62 (2%) 0/59 (0%) 1/60 (2%) 2/59 (3%) | 1/60 (2%) 1/60 (2%) 0/60 (0%) 1/60 (2%) |
|ADJUSTED (b) | 4.5% 0.0% 3.0% 5.4% | 2.2% 2.4% 0.0% 3.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) | 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/22 (5%) 0/35 (0%) 1/33 (3%) 1/31 (3%) | 0/23 (0%) 0/40 (0%) 0/33 (0%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | 725 (T) --- 725 (T) 589 | 524 701 --- 717 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.282 P=0.407N P=0.669N P=0.590 | P=0.599N P=0.689N P=0.487N P=0.728N |
|INCIDENTAL TUMOR | P=0.258 P=0.407N P=0.669N P=0.533 | P=0.623 P=0.474 P=0.795N P=0.654 |
|LOGISTIC REGRESSION | P=0.250 P=0.407N P=0.669N P=0.514 | P=0.617N P=0.749 P=0.510N P=0.762N |
|COCHRAN-ARMITAGE | P=0.239 | P=0.616N |
|FISHER EXACT | P=0.512N P=0.744 P=0.481 | P=0.752N P=0.500N P=0.752N |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/62 (3%) 0/59 (0%) 1/60 (2%) 2/59 (3%) | 1/60 (2%) 1/60 (2%) 0/60 (0%) 1/60 (2%) |
|ADJUSTED (b) | 8.2% 0.0% 3.0% 5.4% | 2.2% 2.4% 0.0% 3.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) | 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/22 (5%) 0/35 (0%) 1/33 (3%) 1/31 (3%) | 0/23 (0%) 0/40 (0%) 0/33 (0%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | 715 --- 725 (T) 589 | 524 701 --- 717 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.520 P=0.161N P=0.380N P=0.605N | P=0.599N P=0.689N P=0.487N P=0.728N |
|INCIDENTAL TUMOR | P=0.462 P=0.241N P=0.440N P=0.685 | P=0.623 P=0.474 P=0.795N P=0.654 |
|LOGISTIC REGRESSION | P=0.480 P=0.176N P=0.406N P=0.673N | P=0.617N P=0.749 P=0.510N P=0.762N |
|COCHRAN-ARMITAGE | P=0.457 | P=0.616N |
|FISHER EXACT | P=0.260N P=0.512N P=0.672 | P=0.752N P=0.500N P=0.752N |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05214 TEST: 01 PAGE 17
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRANS-DELTA-9-TETRAHYDROCANNABINOL
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 12.5 25 50 | 0 12.5 25 50 |
| | MG/KG MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # # |
|----------- | | |
|OVERALL (a) | | 9/60 (15%) 5/60 (8%) 3/60 (5%) 3/60 (5%) |
|ADJUSTED (b) | | 26.9% 12.1% 7.7% 8.0% |
|INTERIM SACRIFICE 1 (c)| | 1/9 (11%) 0/9 (0%) 1/9 (11%) 1/10 (10%) |
|TERMINAL (d) | | 3/23 (13%) 4/40 (10%) 2/33 (6%) 2/32 (6%) |
|FIRST INCIDENCE (DAYS) | | 454 (I) 659 454 (I) 454 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.024N* P=0.051N P=0.026N* P=0.030N* |
|INCIDENTAL TUMOR | | P=0.039N* P=0.224N P=0.064N P=0.072N |
|LOGISTIC REGRESSION | | P=0.040N* P=0.144N P=0.060N P=0.061N |
|COCHRAN-ARMITAGE | | P=0.041N* |
|FISHER EXACT | | P=0.197N P=0.063N P=0.063N |
|=================================================================================================================================|
| |
|Uterus |
| Sarcoma Stromal or Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # # |
|----------- | | |
|OVERALL (a) | | 9/60 (15%) 5/60 (8%) 3/60 (5%) 3/60 (5%) |
|ADJUSTED (b) | | 26.9% 12.1% 7.7% 8.0% |
|INTERIM SACRIFICE 1 (c)| | 1/9 (11%) 0/9 (0%) 1/9 (11%) 1/10 (10%) |
|TERMINAL (d) | | 3/23 (13%) 4/40 (10%) 2/33 (6%) 2/32 (6%) |
|FIRST INCIDENCE (DAYS) | | 454 (I) 659 454 (I) 454 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.024N* P=0.051N P=0.026N* P=0.030N* |
|INCIDENTAL TUMOR | | P=0.039N* P=0.224N P=0.064N P=0.072N |
|LOGISTIC REGRESSION | | P=0.040N* P=0.144N P=0.060N P=0.061N |
|COCHRAN-ARMITAGE | | P=0.041N* |
|FISHER EXACT | | P=0.197N P=0.063N P=0.063N |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05214 TEST: 01 PAGE 18
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRANS-DELTA-9-TETRAHYDROCANNABINOL
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 12.5 25 50 | 0 12.5 25 50 |
| | MG/KG MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 14/62 (23%) 9/60 (15%) 10/61 (16%) 8/61 (13%) | 9/60 (15%) 17/60 (28%) 20/60 (33%) 13/60 (22%) |
|ADJUSTED (b) | 35.3% 20.6% 26.5% 21.1% | 32.3% 38.1% 47.6% 32.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) | 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) |
|TERMINAL (d) | 2/22 (9%) 2/35 (6%) 6/33 (18%) 4/31 (13%) | 6/23 (26%) 13/40 (33%) 12/33 (36%) 6/32 (19%) |
|FIRST INCIDENCE (DAYS) | 505 456 651 531 | 524 534 509 454 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.085N P=0.079N P=0.114N P=0.066N | P=0.460 P=0.407 P=0.130 P=0.481 |
|INCIDENTAL TUMOR | P=0.235N P=0.605 P=0.584N P=0.255N | P=0.275 P=0.106 P=0.026 * P=0.225 |
|LOGISTIC REGRESSION | P=0.210N P=0.495N P=0.515N P=0.224N | P=0.277 P=0.152 P=0.043 * P=0.296 |
|COCHRAN-ARMITAGE | P=0.134N | P=0.315 |
|FISHER EXACT | P=0.201N P=0.262N P=0.128N | P=0.060 P=0.016 * P=0.240 |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma: Benign, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/62 (3%) 2/60 (3%) 2/61 (3%) 0/61 (0%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 4.9% 4.9% 5.7% 0.0% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) | 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/22 (0%) 1/35 (3%) 1/33 (3%) 0/31 (0%) | 0/23 (0%) 0/40 (0%) 0/33 (0%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | 508 527 674 --- | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.139N P=0.620N P=0.622N P=0.223N | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.242N P=0.507 P=0.491 P=0.366N | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.166N P=0.661 P=0.691 P=0.249N | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.166N | (e) |
|FISHER EXACT | P=0.678 P=0.684 P=0.252N | (e) (e) (e) |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05214 TEST: 01 PAGE 19
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRANS-DELTA-9-TETRAHYDROCANNABINOL
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 12.5 25 50 | 0 12.5 25 50 |
| | MG/KG MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 60/62 (97%) 50/60 (83%) 49/61 (80%) 48/61 (79%) | 43/60 (72%) 38/60 (63%) 37/60 (62%) 27/60 (45%) |
|ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | 89.3% 79.1% 78.1% 66.7% |
|INTERIM SACRIFICE 1 (c)| 10/10 (100%) 4/9 (44%) 4/9 (44%) 1/9 (11%) | 3/9 (33%) 1/9 (11%) 1/9 (11%) 1/10 (10%) |
|TERMINAL (d) | 22/22 (100%) 35/35 (100%) 33/33 (100%) 31/31 (100%)| 18/23 (78%) 30/40 (75%) 23/33 (70%) 19/32 (59%) |
|FIRST INCIDENCE (DAYS) | 438 448 (I) 448 (I) 448 (I) | 374 454 (I) 426 449 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.002N** P<0.001N** P<0.001N** P<0.001N** | P<0.001N** P<0.001N** P=0.009N** P<0.001N** |
|INCIDENTAL TUMOR | P<0.001N** P<0.001N** P=0.001N** P<0.001N** | P=0.001N** P=0.135N P=0.150N P=0.002N** |
|LOGISTIC REGRESSION | P=0.178N P=0.095N P=0.463N P=0.173N | P=0.001N** P=0.045N* P=0.114N P=0.001N** |
|COCHRAN-ARMITAGE | P=0.007N** | P=0.002N** |
|FISHER EXACT | P=0.013N* P=0.004N** P=0.002N** | P=0.218N P=0.166N P=0.003N** |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 22/62 (35%) 17/60 (28%) 17/61 (28%) 14/61 (23%) | 18/60 (30%) 23/60 (38%) 20/60 (33%) 15/60 (25%) |
|ADJUSTED (b) | 53.0% 37.3% 40.1% 35.7% | 51.8% 47.3% 47.6% 37.2% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) | 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) |
|TERMINAL (d) | 5/22 (23%) 7/35 (20%) 9/33 (27%) 7/31 (23%) | 8/23 (35%) 15/40 (38%) 12/33 (36%) 8/32 (25%) |
|FIRST INCIDENCE (DAYS) | 505 456 324 531 | 524 276 509 454 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.045N* P=0.059N P=0.075N P=0.031N* | P=0.112N P=0.326N P=0.309N P=0.130N |
|INCIDENTAL TUMOR | P=0.143N P=0.543 P=0.558N P=0.168N | P=0.231N P=0.135 P=0.435 P=0.413N |
|LOGISTIC REGRESSION | P=0.138N P=0.515N P=0.468N P=0.128N | P=0.217N P=0.346 P=0.487 P=0.401N |
|COCHRAN-ARMITAGE | P=0.087N | P=0.199N |
|FISHER EXACT | P=0.257N P=0.238N P=0.092N | P=0.221 P=0.422 P=0.342N |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05214 TEST: 01 PAGE 20
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TRANS-DELTA-9-TETRAHYDROCANNABINOL
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 12.5 25 50 | 0 12.5 25 50 |
| | MG/KG MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 61/62 (98%) 53/60 (88%) 52/61 (85%) 48/61 (79%) | 47/60 (78%) 43/60 (72%) 45/60 (75%) 36/60 (60%) |
|ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | 92.1% 82.6% 88.2% 79.6% |
|INTERIM SACRIFICE 1 (c)| 10/10 (100%) 4/9 (44%) 4/9 (44%) 1/9 (11%) | 3/9 (33%) 1/9 (11%) 1/9 (11%) 1/10 (10%) |
|TERMINAL (d) | 22/22 (100%) 35/35 (100%) 33/33 (100%) 31/31 (100%)| 19/23 (83%) 31/40 (78%) 27/33 (82%) 23/32 (72%) |
|FIRST INCIDENCE (DAYS) | 438 448 (I) 211 448 (I) | 374 276 426 449 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.001N** P<0.001N** P=0.001N** P<0.001N** | P=0.010N* P=0.001N** P=0.025N* P=0.003N** |
|INCIDENTAL TUMOR | P<0.001N** P=0.004N** P=0.013N* P<0.001N** | P=0.020N* P=0.388N P=0.445N P=0.027N* |
|LOGISTIC REGRESSION | P=0.091N P=0.660N P=0.629 P=0.105N | P=0.013N* P=0.113N P=0.316N P=0.014N* |
|COCHRAN-ARMITAGE | P<0.001N** | P=0.020N* |
|FISHER EXACT | P=0.028N* P=0.008N** P<0.001N** | P=0.264N P=0.415N P=0.024N* |
|=================================================================================================================================|
(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): 448
Female interim sacrifices(days): 454
(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).