TDMS Study 05214-02 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Mason TRANS-DELTA-9-TETRAHYDROCANNABINOL DATE: 05/20/95
EXPERIMENT: 05214 TEST: 02 TIME: 13:11:33
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-85212 ROUTE: GAVAGE NTP C#: 56371B
PATHOLOGIST: F. VOELKER M. GOAD 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: 02 TIME: 13:11:33
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-85212 ROUTE: GAVAGE NTP C#: 56371B
PATHOLOGIST: F. VOELKER M. GOAD CAS: 1972-08-3
MICE(B6C3F1)
----------------------------
FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED.
IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED.
----------------
Adrenal Cortex
Adrenal Medulla
Bone Marrow
Brain
Clitoral Gland
Epididymis
Gallbladder
Heart
Islets, Pancreatic
Kidney
Liver
Lung
Nose
Ovary
Pancreas
Parathyroid Gland
Pituitary Gland
Preputial Gland
Prostate
Salivary Glands
Spleen
Testes
Thymus
Thyroid Gland
Urinary Bladder
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Mason TRANS-DELTA-9-TETRAHYDROCANNABINOL DATE: 05/20/95
EXPERIMENT: 05214 TEST: 02 TIME: 13:11:33
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-85212 ROUTE: GAVAGE NTP C#: 56371B
PATHOLOGIST: F. VOELKER M. GOAD CAS: 1972-08-3
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF THE STUDY OF TRANS-DELTA-9-TETRAHYDROCANNABINOL
====================================================================================================
MALE MICE
-------------
ORGAN MORPHOLOGY
------- ------------
Liver Hepatocellular Adenoma
Hepatocellular Carcinoma
Hepatocellular Carcinoma or Hepatoblastoma
Hepatocellular Carcinoma or Hepatocellular Adenoma
Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
Thyroid Gland: Follicular Cell
Adenoma
Carcinoma or Adenoma
All Organs Malignant Lymphoma And Histiocytic Sarcoma
Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
====================================================================================================
FEMALE MICE
-------------
ORGAN MORPHOLOGY
------- ------------
Liver Hepatocellular Adenoma
Hepatocellular Carcinoma
Hepatocellular Carcinoma or Hepatoblastoma
Hepatocellular Carcinoma or Hepatocellular Adenoma
Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
Carcinoma or Adenoma
Thyroid Gland: Follicular Cell
Adenoma
Carcinoma or Adenoma
All Organs Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
====================================================================================================
DATE: 05/20/95 EXPERIMENT: 05214 TEST: 02 PAGE 1
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRANS-DELTA-9-TETRAHYDROCANNABINOL
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 125 250 500 | 0 125 250 500 |
| | MG/KG MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Harderian Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/80 (3%) 3/60 (5%) 5/70 (7%) 0/70 (0%) | 3/60 (5%) 1/60 (2%) 1/60 (2%) 1/60 (2%) |
|ADJUSTED (b) | 3.7% 5.7% 11.1% 0.0% | 6.4% 2.0% 2.0% 2.4% |
|INTERIM SACRIFICE 1 (c)| 0/18 (0%) 0/0 0/9 (0%) 0/10 (0%) | |
|TERMINAL (d) | 1/50 (2%) 3/53 (6%) 5/45 (11%) 0/34 (0%) | 3/47 (6%) 1/50 (2%) 0/44 (0%) 1/41 (2%) |
|FIRST INCIDENCE (DAYS) | 672 730 (T) 730 (T) --- | 737 (T) 737 (T) 651 737 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.383N P=0.518 P=0.175 P=0.343N | P=0.290N P=0.284N P=0.333N P=0.355N |
|INCIDENTAL TUMOR | P=0.456N P=0.419 P=0.143 P=0.577N | P=0.296N P=0.284N P=0.351N P=0.355N |
|LOGISTIC REGRESSION | P=0.391N P=0.481 P=0.163 P=0.324N | P=0.280N P=0.284N P=0.320N P=0.355N |
|COCHRAN-ARMITAGE | P=0.251N | P=0.242N |
|FISHER EXACT | P=0.366 P=0.170 P=0.283N | P=0.309N P=0.309N P=0.309N |
|=================================================================================================================================|
| |
|Liver |
| Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/62 (3%) 0/60 (0%) 0/61 (0%) 0/57 (0%) | 0/60 (0%) 0/60 (0%) 0/59 (0%) 0/60 (0%) |
|ADJUSTED (b) | 3.7% 0.0% 0.0% 0.0% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/0 | |
|TERMINAL (d) | 1/50 (2%) 0/53 (0%) 0/45 (0%) 0/34 (0%) | 0/47 (0%) 0/50 (0%) 0/44 (0%) 0/41 (0%) |
|FIRST INCIDENCE (DAYS) | 672 --- --- --- | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.152N P=0.237N P=0.273N P=0.343N | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.230N P=0.358N P=0.343N P=0.577N | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.130N P=0.250N P=0.252N P=0.304N | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.121N | (e) |
|FISHER EXACT | P=0.256N P=0.252N P=0.269N | (e) (e) (e) |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05214 TEST: 02 PAGE 2
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRANS-DELTA-9-TETRAHYDROCANNABINOL
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 125 250 500 | 0 125 250 500 |
| | MG/KG MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 25/62 (40%) 11/60 (18%) 6/61 (10%) 2/57 (4%) | 17/60 (28%) 9/60 (15%) 7/59 (12%) 3/60 (5%) |
|ADJUSTED (b) | 45.3% 19.8% 12.8% 5.6% | 34.4% 17.6% 15.5% 7.3% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/0 | |
|TERMINAL (d) | 20/50 (40%) 9/53 (17%) 4/45 (9%) 1/34 (3%) | 15/47 (32%) 8/50 (16%) 6/44 (14%) 3/41 (7%) |
|FIRST INCIDENCE (DAYS) | 672 566 716 611 | 659 714 694 737 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001N** P=0.004N** P<0.001N** P<0.001N** | P=0.001N** P=0.044N* P=0.032N* P=0.002N** |
|INCIDENTAL TUMOR | P<0.001N** P=0.010N** P<0.001N** P<0.001N** | P=0.002N** P=0.048N* P=0.039N* P=0.002N** |
|LOGISTIC REGRESSION | P<0.001N** P=0.010N* P<0.001N** P<0.001N** | P=0.001N** P=0.047N* P=0.032N* P=0.002N** |
|COCHRAN-ARMITAGE | P<0.001N** | P<0.001N** |
|FISHER EXACT | P=0.007N** P<0.001N** P<0.001N** | P=0.060N P=0.021N* P<0.001N** |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 10/62 (16%) 3/60 (5%) 5/61 (8%) 1/57 (2%) | 6/60 (10%) 5/60 (8%) 4/59 (7%) 1/60 (2%) |
|ADJUSTED (b) | 18.2% 5.4% 10.5% 2.9% | 12.2% 9.6% 8.8% 2.2% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/0 | |
|TERMINAL (d) | 6/50 (12%) 2/53 (4%) 3/45 (7%) 1/34 (3%) | 4/47 (9%) 4/50 (8%) 3/44 (7%) 0/41 (0%) |
|FIRST INCIDENCE (DAYS) | 554 563 574 730 (T) | 706 661 674 701 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.031N* P=0.038N* P=0.205N P=0.033N* | P=0.066N P=0.461N P=0.418N P=0.088N |
|INCIDENTAL TUMOR | P=0.037N* P=0.060N P=0.289N P=0.060N | P=0.072N P=0.494N P=0.490N P=0.095N |
|LOGISTIC REGRESSION | P=0.014N* P=0.052N P=0.166N P=0.020N* | P=0.059N P=0.482N P=0.420N P=0.082N |
|COCHRAN-ARMITAGE | P=0.009N** | P=0.041N* |
|FISHER EXACT | P=0.043N* P=0.143N P=0.006N** | P=0.500N P=0.382N P=0.057N |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05214 TEST: 02 PAGE 3
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRANS-DELTA-9-TETRAHYDROCANNABINOL
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 125 250 500 | 0 125 250 500 |
| | MG/KG MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 12/62 (19%) 3/60 (5%) 5/61 (8%) 1/57 (2%) | 6/60 (10%) 5/60 (8%) 4/59 (7%) 1/60 (2%) |
|ADJUSTED (b) | 21.5% 5.4% 10.5% 2.9% | 12.2% 9.6% 8.8% 2.2% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/0 | |
|TERMINAL (d) | 7/50 (14%) 2/53 (4%) 3/45 (7%) 1/34 (3%) | 4/47 (9%) 4/50 (8%) 3/44 (7%) 0/41 (0%) |
|FIRST INCIDENCE (DAYS) | 554 563 574 730 (T) | 706 661 674 701 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.012N* P=0.014N* P=0.108N P=0.016N* | P=0.066N P=0.461N P=0.418N P=0.088N |
|INCIDENTAL TUMOR | P=0.017N* P=0.028N* P=0.167N P=0.039N* | P=0.072N P=0.494N P=0.490N P=0.095N |
|LOGISTIC REGRESSION | P=0.004N** P=0.019N* P=0.076N P=0.007N** | P=0.059N P=0.482N P=0.420N P=0.082N |
|COCHRAN-ARMITAGE | P=0.003N** | P=0.041N* |
|FISHER EXACT | P=0.015N* P=0.062N P=0.002N** | P=0.500N P=0.382N P=0.057N |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 31/62 (50%) 13/60 (22%) 9/61 (15%) 3/57 (5%) | 22/60 (37%) 14/60 (23%) 11/59 (19%) 4/60 (7%) |
|ADJUSTED (b) | 54.3% 23.0% 18.7% 8.4% | 43.0% 26.8% 23.8% 9.4% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/0 | |
|TERMINAL (d) | 24/50 (48%) 10/53 (19%) 6/45 (13%) 2/34 (6%) | 18/47 (38%) 12/50 (24%) 9/44 (20%) 3/41 (7%) |
|FIRST INCIDENCE (DAYS) | 554 563 574 611 | 659 661 674 701 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001N** P<0.001N** P<0.001N** P<0.001N** | P<0.001N** P=0.060N P=0.039N* P<0.001N** |
|INCIDENTAL TUMOR | P<0.001N** P=0.001N** P<0.001N** P<0.001N** | P<0.001N** P=0.065N P=0.052N P<0.001N** |
|LOGISTIC REGRESSION | P<0.001N** P=0.001N** P<0.001N** P<0.001N** | P<0.001N** P=0.063N P=0.035N* P<0.001N** |
|COCHRAN-ARMITAGE | P<0.001N** | P<0.001N** |
|FISHER EXACT | P<0.001N** P<0.001N** P<0.001N** | P=0.081N P=0.023N* P<0.001N** |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05214 TEST: 02 PAGE 4
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRANS-DELTA-9-TETRAHYDROCANNABINOL
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 125 250 500 | 0 125 250 500 |
| | 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) | 31/62 (50%) 13/60 (22%) 9/61 (15%) 3/57 (5%) | 22/60 (37%) 14/60 (23%) 11/59 (19%) 4/60 (7%) |
|ADJUSTED (b) | 54.3% 23.0% 18.7% 8.4% | 43.0% 26.8% 23.8% 9.4% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/0 | |
|TERMINAL (d) | 24/50 (48%) 10/53 (19%) 6/45 (13%) 2/34 (6%) | 18/47 (38%) 12/50 (24%) 9/44 (20%) 3/41 (7%) |
|FIRST INCIDENCE (DAYS) | 554 563 574 611 | 659 661 674 701 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001N** P<0.001N** P<0.001N** P<0.001N** | P<0.001N** P=0.060N P=0.039N* P<0.001N** |
|INCIDENTAL TUMOR | P<0.001N** P=0.001N** P<0.001N** P<0.001N** | P<0.001N** P=0.065N P=0.052N P<0.001N** |
|LOGISTIC REGRESSION | P<0.001N** P=0.001N** P<0.001N** P<0.001N** | P<0.001N** P=0.063N P=0.035N* P<0.001N** |
|COCHRAN-ARMITAGE | P<0.001N** | P<0.001N** |
|FISHER EXACT | P<0.001N** P<0.001N** P<0.001N** | P=0.081N P=0.023N* P<0.001N** |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 11/62 (18%) 11/60 (18%) 7/61 (11%) 7/59 (12%) | 1/59 (2%) 1/60 (2%) 3/60 (5%) 2/60 (3%) |
|ADJUSTED (b) | 20.9% 20.4% 14.5% 18.0% | 2.1% 2.0% 6.5% 4.7% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/0 | |
|TERMINAL (d) | 9/50 (18%) 10/53 (19%) 4/45 (9%) 5/34 (15%) | 1/47 (2%) 1/50 (2%) 2/44 (5%) 1/41 (2%) |
|FIRST INCIDENCE (DAYS) | 585 725 574 256 | 737 (T) 737 (T) 651 722 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.433N P=0.536N P=0.309N P=0.535N | P=0.267 P=0.748N P=0.281 P=0.458 |
|INCIDENTAL TUMOR | P=0.381N P=0.565 P=0.386N P=0.352N | P=0.264 P=0.748N P=0.276 P=0.451 |
|LOGISTIC REGRESSION | P=0.299N P=0.589 P=0.298N P=0.371N | P=0.277 P=0.748N P=0.296 P=0.457 |
|COCHRAN-ARMITAGE | P=0.158N | P=0.330 |
|FISHER EXACT | P=0.559 P=0.234N P=0.258N | P=0.748N P=0.316 P=0.506 |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05214 TEST: 02 PAGE 5
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRANS-DELTA-9-TETRAHYDROCANNABINOL
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 125 250 500 | 0 125 250 500 |
| | MG/KG MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/62 (6%) 3/60 (5%) 1/61 (2%) 1/59 (2%) | 2/59 (3%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 7.8% 5.7% 2.2% 2.9% | 4.3% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/0 | |
|TERMINAL (d) | 3/50 (6%) 3/53 (6%) 1/45 (2%) 1/34 (3%) | 2/47 (4%) 0/50 (0%) 0/44 (0%) 0/41 (0%) |
|FIRST INCIDENCE (DAYS) | 705 730 (T) 730 (T) 730 (T) | 737 (T) --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.178N P=0.470N P=0.216N P=0.318N | P=0.128N P=0.225N P=0.253N P=0.269N |
|INCIDENTAL TUMOR | P=0.228N P=0.560N P=0.261N P=0.451N | P=0.128N P=0.225N P=0.253N P=0.269N |
|LOGISTIC REGRESSION | P=0.186N P=0.494N P=0.223N P=0.329N | P=0.128N P=0.225N P=0.253N P=0.269N |
|COCHRAN-ARMITAGE | P=0.101N | P=0.113N |
|FISHER EXACT | P=0.518N P=0.187N P=0.198N | P=0.244N P=0.244N P=0.244N |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 14/62 (23%) 14/60 (23%) 7/61 (11%) 8/59 (14%) | 2/59 (3%) 1/60 (2%) 3/60 (5%) 2/60 (3%) |
|ADJUSTED (b) | 26.2% 25.9% 14.5% 20.8% | 4.3% 2.0% 6.5% 4.7% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/0 | |
|TERMINAL (d) | 11/50 (22%) 13/53 (25%) 4/45 (9%) 6/34 (18%) | 2/47 (4%) 1/50 (2%) 2/44 (5%) 1/41 (2%) |
|FIRST INCIDENCE (DAYS) | 585 725 574 256 | 737 (T) 737 (T) 651 722 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.275N P=0.519N P=0.131N P=0.419N | P=0.431 P=0.478N P=0.468 P=0.648 |
|INCIDENTAL TUMOR | P=0.260N P=0.525 P=0.188N P=0.320N | P=0.428 P=0.478N P=0.462 P=0.642 |
|LOGISTIC REGRESSION | P=0.175N P=0.583 P=0.120N P=0.273N | P=0.444 P=0.478N P=0.484 P=0.650 |
|COCHRAN-ARMITAGE | P=0.065N | P=0.506 |
|FISHER EXACT | P=0.546 P=0.081N P=0.147N | P=0.494N P=0.508 P=0.684N |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05214 TEST: 02 PAGE 6
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRANS-DELTA-9-TETRAHYDROCANNABINOL
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 125 250 500 | 0 125 250 500 |
| | MG/KG MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Ovary |
| Cystadenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | | 1/59 (2%) 3/59 (5%) 2/60 (3%) 1/59 (2%) |
|ADJUSTED (b) | | 2.1% 6.0% 4.5% 2.5% |
|INTERIM SACRIFICE 1 (c)| | |
|TERMINAL (d) | | 1/47 (2%) 3/50 (6%) 2/44 (5%) 1/40 (3%) |
|FIRST INCIDENCE (DAYS) | | 737 (T) 737 (T) 737 (T) 737 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.550N P=0.328 P=0.477 P=0.725 |
|INCIDENTAL TUMOR | | P=0.550N P=0.328 P=0.477 P=0.725 |
|LOGISTIC REGRESSION | | P=0.550N P=0.328 P=0.477 P=0.725 |
|COCHRAN-ARMITAGE | | P=0.473N |
|FISHER EXACT | | P=0.309 P=0.506 P=0.752N |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/59 (2%) 0/57 (0%) 0/59 (0%) 0/53 (0%) | 9/55 (16%) 5/58 (9%) 2/58 (3%) 4/57 (7%) |
|ADJUSTED (b) | 2.1% 0.0% 0.0% 0.0% | 19.6% 9.9% 4.8% 9.4% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/0 | |
|TERMINAL (d) | 1/48 (2%) 0/51 (0%) 0/43 (0%) 0/30 (0%) | 9/46 (20%) 4/48 (8%) 2/42 (5%) 3/41 (7%) |
|FIRST INCIDENCE (DAYS) | 730 (T) --- --- --- | 737 (T) 661 737 (T) 722 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.358N P=0.488N P=0.522N P=0.594N | P=0.116N P=0.173N P=0.039N* P=0.167N |
|INCIDENTAL TUMOR | P=0.358N P=0.488N P=0.522N P=0.594N | P=0.113N P=0.170N P=0.039N* P=0.164N |
|LOGISTIC REGRESSION | P=0.358N P=0.488N P=0.522N P=0.594N | P=0.106N P=0.169N P=0.039N* P=0.154N |
|COCHRAN-ARMITAGE | P=0.316N | P=0.070N |
|FISHER EXACT | P=0.509N P=0.500N P=0.527N | P=0.168N P=0.021N* P=0.106N |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05214 TEST: 02 PAGE 7
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRANS-DELTA-9-TETRAHYDROCANNABINOL
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 125 250 500 | 0 125 250 500 |
| | 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) | 1/59 (2%) 0/57 (0%) 0/59 (0%) 0/53 (0%) | 9/55 (16%) 6/58 (10%) 2/58 (3%) 4/57 (7%) |
|ADJUSTED (b) | 2.1% 0.0% 0.0% 0.0% | 19.6% 11.6% 4.8% 9.4% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/0 | |
|TERMINAL (d) | 1/48 (2%) 0/51 (0%) 0/43 (0%) 0/30 (0%) | 9/46 (20%) 4/48 (8%) 2/42 (5%) 3/41 (7%) |
|FIRST INCIDENCE (DAYS) | 730 (T) --- --- --- | 737 (T) 661 737 (T) 722 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.358N P=0.488N P=0.522N P=0.594N | P=0.102N P=0.261N P=0.039N* P=0.167N |
|INCIDENTAL TUMOR | P=0.358N P=0.488N P=0.522N P=0.594N | P=0.097N P=0.251N P=0.039N* P=0.164N |
|LOGISTIC REGRESSION | P=0.358N P=0.488N P=0.522N P=0.594N | P=0.091N P=0.255N P=0.039N* P=0.154N |
|COCHRAN-ARMITAGE | P=0.316N | P=0.059N |
|FISHER EXACT | P=0.509N P=0.500N P=0.527N | P=0.253N P=0.021N* P=0.106N |
|=================================================================================================================================|
| |
|Skin |
| Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/80 (0%) 0/60 (0%) 1/70 (1%) 0/70 (0%) | 2/60 (3%) 2/60 (3%) 2/60 (3%) 1/60 (2%) |
|ADJUSTED (b) | 0.0% 0.0% 2.2% 0.0% | 3.9% 3.5% 4.4% 2.2% |
|INTERIM SACRIFICE 1 (c)| 0/18 (0%) 0/0 0/9 (0%) 0/10 (0%) | |
|TERMINAL (d) | 0/50 (0%) 0/53 (0%) 1/45 (2%) 0/34 (0%) | 1/47 (2%) 0/50 (0%) 1/44 (2%) 0/41 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 730 (T) --- | 623 590 694 701 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.650 (e) P=0.479 (e) | P=0.435N P=0.675N P=0.666 P=0.546N |
|INCIDENTAL TUMOR | P=0.650 (e) P=0.479 (e) | P=0.352N P=0.753 P=0.644N P=0.471N |
|LOGISTIC REGRESSION | P=0.650 (e) P=0.479 (e) | P=0.434N P=0.640 P=0.691 P=0.516N |
|COCHRAN-ARMITAGE | P=0.682 | P=0.373N |
|FISHER EXACT | (e) P=0.467 (e) | P=0.691N P=0.691N P=0.500N |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05214 TEST: 02 PAGE 8
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRANS-DELTA-9-TETRAHYDROCANNABINOL
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 125 250 500 | 0 125 250 500 |
| | MG/KG MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/80 (0%) 0/60 (0%) 1/70 (1%) 0/70 (0%) | 2/60 (3%) 2/60 (3%) 2/60 (3%) 1/60 (2%) |
|ADJUSTED (b) | 0.0% 0.0% 2.2% 0.0% | 3.9% 3.5% 4.4% 2.2% |
|INTERIM SACRIFICE 1 (c)| 0/18 (0%) 0/0 0/9 (0%) 0/10 (0%) | |
|TERMINAL (d) | 0/50 (0%) 0/53 (0%) 1/45 (2%) 0/34 (0%) | 1/47 (2%) 0/50 (0%) 1/44 (2%) 0/41 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 730 (T) --- | 623 590 694 701 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.650 (e) P=0.479 (e) | P=0.435N P=0.675N P=0.666 P=0.546N |
|INCIDENTAL TUMOR | P=0.650 (e) P=0.479 (e) | P=0.352N P=0.753 P=0.644N P=0.471N |
|LOGISTIC REGRESSION | P=0.650 (e) P=0.479 (e) | P=0.434N P=0.640 P=0.691 P=0.516N |
|COCHRAN-ARMITAGE | P=0.682 | P=0.373N |
|FISHER EXACT | (e) P=0.467 (e) | P=0.691N P=0.691N P=0.500N |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Squamous Cell Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 3/80 (4%) 2/60 (3%) 0/70 (0%) 2/70 (3%) | 3/60 (5%) 0/60 (0%) 0/60 (0%) 2/60 (3%) |
|ADJUSTED (b) | 6.0% 3.8% 0.0% 5.9% | 6.2% 0.0% 0.0% 4.9% |
|INTERIM SACRIFICE 1 (c)| 0/18 (0%) 0/0 0/9 (0%) 0/10 (0%) | |
|TERMINAL (d) | 3/50 (6%) 2/53 (4%) 0/45 (0%) 2/34 (6%) | 2/47 (4%) 0/50 (0%) 0/44 (0%) 2/41 (5%) |
|FIRST INCIDENCE (DAYS) | 730 (T) 730 (T) --- 730 (T) | 710 --- --- 737 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.530N P=0.473N P=0.141N P=0.672N | P=0.584N P=0.114N P=0.136N P=0.559N |
|INCIDENTAL TUMOR | P=0.530N P=0.474N P=0.141N P=0.672N | P=0.594N P=0.124N P=0.149N P=0.575N |
|LOGISTIC REGRESSION | P=0.530N P=0.474N P=0.141N P=0.672N | P=0.584N P=0.116N P=0.133N P=0.561N |
|COCHRAN-ARMITAGE | P=0.400N | P=0.530N |
|FISHER EXACT | P=0.634N P=0.149N P=0.563N | P=0.122N P=0.122N P=0.500N |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05214 TEST: 02 PAGE 9
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRANS-DELTA-9-TETRAHYDROCANNABINOL
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 125 250 500 | 0 125 250 500 |
| | 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) | 0/62 (0%) 6/60 (10%) 3/61 (5%) 1/57 (2%) | 4/60 (7%) 9/60 (15%) 3/60 (5%) 1/60 (2%) |
|ADJUSTED (b) | 0.0% 11.1% 6.7% 3.0% | 8.5% 18.0% 6.8% 2.4% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/0 | |
|TERMINAL (d) | 0/50 (0%) 5/53 (9%) 3/45 (7%) 1/33 (3%) | 4/47 (9%) 9/50 (18%) 3/44 (7%) 1/41 (2%) |
|FIRST INCIDENCE (DAYS) | --- 725 730 (T) 730 (T) | 737 (T) 737 (T) 737 (T) 737 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.519 P=0.023 * P=0.104 P=0.417 | P=0.075N P=0.143 P=0.536N P=0.223N |
|INCIDENTAL TUMOR | P=0.437 P=0.010 * P=0.104 P=0.417 | P=0.075N P=0.143 P=0.536N P=0.223N |
|LOGISTIC REGRESSION | P=0.504 P=0.020 * P=0.104 P=0.417 | P=0.075N P=0.143 P=0.536N P=0.223N |
|COCHRAN-ARMITAGE | P=0.493N | P=0.049N* |
|FISHER EXACT | P=0.012 * P=0.119 P=0.479 | P=0.120 P=0.500N P=0.182N |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/62 (2%) 6/60 (10%) 3/61 (5%) 1/57 (2%) | 4/60 (7%) 10/60 (17%) 3/60 (5%) 1/60 (2%) |
|ADJUSTED (b) | 1.8% 11.1% 6.7% 3.0% | 8.5% 20.0% 6.8% 2.4% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/0 | |
|TERMINAL (d) | 0/50 (0%) 5/53 (9%) 3/45 (7%) 1/33 (3%) | 4/47 (9%) 10/50 (20%) 3/44 (7%) 1/41 (2%) |
|FIRST INCIDENCE (DAYS) | 678 725 730 (T) 730 (T) | 737 (T) 737 (T) 737 (T) 737 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.527N P=0.072 P=0.266 P=0.657 | P=0.065N P=0.095 P=0.536N P=0.223N |
|INCIDENTAL TUMOR | P=0.501 P=0.021 * P=0.211 P=0.417 | P=0.065N P=0.095 P=0.536N P=0.223N |
|LOGISTIC REGRESSION | P=0.537N P=0.059 P=0.262 P=0.690 | P=0.065N P=0.095 P=0.536N P=0.223N |
|COCHRAN-ARMITAGE | P=0.353N | P=0.041N* |
|FISHER EXACT | P=0.052 P=0.303 P=0.731 | P=0.077 P=0.500N P=0.182N |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05214 TEST: 02 PAGE 10
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRANS-DELTA-9-TETRAHYDROCANNABINOL
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 125 250 500 | 0 125 250 500 |
| | MG/KG MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma or Hemangioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/80 (1%) 1/60 (2%) 0/70 (0%) 2/70 (3%) | 1/60 (2%) 1/60 (2%) 1/60 (2%) 0/60 (0%) |
|ADJUSTED (b) | 2.0% 1.7% 0.0% 5.9% | 2.0% 2.0% 2.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/18 (0%) 0/0 0/9 (0%) 0/10 (0%) | |
|TERMINAL (d) | 1/50 (2%) 0/53 (0%) 0/45 (0%) 2/34 (6%) | 0/47 (0%) 1/50 (2%) 0/44 (0%) 0/41 (0%) |
|FIRST INCIDENCE (DAYS) | 730 (T) 566 --- 730 (T) | 710 737 (T) 644 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.250 P=0.754N P=0.521N P=0.367 | P=0.347N P=0.749N P=0.742 P=0.521N |
|INCIDENTAL TUMOR | P=0.357 P=0.698N P=0.521N P=0.367 | P=0.286N P=0.753 P=0.688N P=0.557N |
|LOGISTIC REGRESSION | P=0.284 P=0.663 P=0.521N P=0.367 | P=0.321N P=0.758N P=0.759N P=0.520N |
|COCHRAN-ARMITAGE | P=0.351 | P=0.312N |
|FISHER EXACT | P=0.675 P=0.533N P=0.450 | P=0.752N P=0.752N P=0.500N |
|=================================================================================================================================|
| |
|All Organs |
| Histiocytic Sarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/80 (3%) 0/60 (0%) 0/70 (0%) 0/70 (0%) | 1/60 (2%) 0/60 (0%) 1/60 (2%) 0/60 (0%) |
|ADJUSTED (b) | 3.7% 0.0% 0.0% 0.0% | 1.9% 0.0% 2.3% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/18 (0%) 0/0 0/9 (0%) 0/10 (0%) | |
|TERMINAL (d) | 1/50 (2%) 0/53 (0%) 0/45 (0%) 0/34 (0%) | 0/47 (0%) 0/50 (0%) 1/44 (2%) 0/41 (0%) |
|FIRST INCIDENCE (DAYS) | 591 --- --- --- | 677 --- 737 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.148N P=0.233N P=0.270N P=0.329N | P=0.441N P=0.493N P=0.738 P=0.532N |
|INCIDENTAL TUMOR | P=0.086N P=0.179N P=0.251N P=0.159N | P=0.451N P=0.527N P=0.721 P=0.557N |
|LOGISTIC REGRESSION | P=0.127N P=0.320N P=0.271N P=0.297N | P=0.422N P=0.510N P=0.757 P=0.504N |
|COCHRAN-ARMITAGE | P=0.127N | P=0.405N |
|FISHER EXACT | P=0.325N P=0.283N P=0.283N | P=0.500N P=0.752N P=0.500N |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05214 TEST: 02 PAGE 11
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRANS-DELTA-9-TETRAHYDROCANNABINOL
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 125 250 500 | 0 125 250 500 |
| | MG/KG MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Lymphoma And Histiocytic Sarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 8/80 (10%) 1/60 (2%) 4/70 (6%) 2/70 (3%) | 12/60 (20%) 6/60 (10%) 6/60 (10%) 5/60 (8%) |
|ADJUSTED (b) | 14.1% 1.9% 8.9% 5.9% | 24.1% 11.6% 12.6% 11.4% |
|INTERIM SACRIFICE 1 (c)| 0/18 (0%) 0/0 0/9 (0%) 0/10 (0%) | |
|TERMINAL (d) | 5/50 (10%) 1/53 (2%) 4/45 (9%) 2/34 (6%) | 10/47 (21%) 5/50 (10%) 4/44 (9%) 3/41 (7%) |
|FIRST INCIDENCE (DAYS) | 146 730 (T) 730 (T) 730 (T) | 518 694 632 682 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.165N P=0.020N* P=0.249N P=0.147N | P=0.110N P=0.082N P=0.136N P=0.107N |
|INCIDENTAL TUMOR | P=0.058N P=0.018N* P=0.167N P=0.026N* | P=0.085N P=0.102N P=0.074N P=0.110N |
|LOGISTIC REGRESSION | P=0.115N P=0.085N P=0.261N P=0.096N | P=0.089N P=0.094N P=0.113N P=0.091N |
|COCHRAN-ARMITAGE | P=0.087N | P=0.058N |
|FISHER EXACT | P=0.045N* P=0.255N P=0.075N | P=0.100N P=0.100N P=0.057N |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated |
| Cell Type |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 6/80 (8%) 1/60 (2%) 4/70 (6%) 2/70 (3%) | 11/60 (18%) 6/60 (10%) 5/60 (8%) 5/60 (8%) |
|ADJUSTED (b) | 10.7% 1.9% 8.9% 5.9% | 22.7% 11.6% 10.4% 11.4% |
|INTERIM SACRIFICE 1 (c)| 0/18 (0%) 0/0 0/9 (0%) 0/10 (0%) | |
|TERMINAL (d) | 4/50 (8%) 1/53 (2%) 4/45 (9%) 2/34 (6%) | 10/47 (21%) 5/50 (10%) 3/44 (7%) 3/41 (7%) |
|FIRST INCIDENCE (DAYS) | 146 730 (T) 730 (T) 730 (T) | 518 694 632 682 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.336N P=0.063N P=0.447N P=0.282N | P=0.138N P=0.120N P=0.117N P=0.148N |
|INCIDENTAL TUMOR | P=0.184N P=0.078N P=0.347N P=0.107N | P=0.108N P=0.144N P=0.056N P=0.153N |
|LOGISTIC REGRESSION | P=0.264N P=0.197N P=0.465N P=0.210N | P=0.116N P=0.138N P=0.101N P=0.135N |
|COCHRAN-ARMITAGE | P=0.210N | P=0.078N |
|FISHER EXACT | P=0.118N P=0.459N P=0.186N | P=0.148N P=0.089N P=0.089N |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05214 TEST: 02 PAGE 12
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRANS-DELTA-9-TETRAHYDROCANNABINOL
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 125 250 500 | 0 125 250 500 |
| | MG/KG MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 36/80 (45%) 29/60 (48%) 20/70 (29%) 14/70 (20%) | 30/60 (50%) 22/60 (37%) 18/60 (30%) 11/60 (18%) |
|ADJUSTED (b) | 63.1% 51.7% 41.6% 36.7% | 59.9% 42.2% 38.0% 26.1% |
|INTERIM SACRIFICE 1 (c)| 0/18 (0%) 0/0 0/9 (0%) 0/10 (0%) | |
|TERMINAL (d) | 29/50 (58%) 26/53 (49%) 17/45 (38%) 11/34 (32%) | 27/47 (57%) 20/50 (40%) 15/44 (34%) 10/41 (24%) |
|FIRST INCIDENCE (DAYS) | 585 566 574 256 | 659 661 644 722 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.009N** P=0.101N P=0.021N* P=0.019N* | P=0.001N** P=0.057N P=0.041N* P=0.001N** |
|INCIDENTAL TUMOR | P=0.007N** P=0.204N P=0.036N* P=0.018N* | P=0.001N** P=0.062N P=0.035N* P=0.001N** |
|LOGISTIC REGRESSION | P=0.006N** P=0.183N P=0.021N* P=0.013N* | P=0.001N** P=0.064N P=0.036N* P=0.001N** |
|COCHRAN-ARMITAGE | P<0.001N** | P<0.001N** |
|FISHER EXACT | P=0.413 P=0.028N* P<0.001N** | P=0.099N P=0.020N* P<0.001N** |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 25/80 (31%) 7/60 (12%) 12/70 (17%) 5/70 (7%) | 23/60 (38%) 14/60 (23%) 12/60 (20%) 6/60 (10%) |
|ADJUSTED (b) | 41.3% 12.8% 25.4% 14.7% | 42.3% 25.6% 24.6% 13.4% |
|INTERIM SACRIFICE 1 (c)| 0/18 (0%) 0/0 0/9 (0%) 0/10 (0%) | |
|TERMINAL (d) | 15/50 (30%) 6/53 (11%) 10/45 (22%) 5/34 (15%) | 16/47 (34%) 10/50 (20%) 8/44 (18%) 3/41 (7%) |
|FIRST INCIDENCE (DAYS) | 146 563 574 730 (T) | 456 590 632 682 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.005N** P<0.001N** P=0.038N* P=0.004N** | P=0.002N** P=0.051N P=0.051N P=0.002N** |
|INCIDENTAL TUMOR | P=0.003N** P<0.001N** P=0.038N* P=0.003N** | P<0.001N** P=0.059N P=0.018N* P=0.001N** |
|LOGISTIC REGRESSION | P=0.002N** P=0.003N** P=0.040N* P=0.001N** | P<0.001N** P=0.071N P=0.027N* P<0.001N** |
|COCHRAN-ARMITAGE | P<0.001N** | P<0.001N** |
|FISHER EXACT | P=0.005N** P=0.034N* P<0.001N** | P=0.057N P=0.022N* P<0.001N** |
|=================================================================================================================================|
DATE: 05/20/95 EXPERIMENT: 05214 TEST: 02 PAGE 13
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- TRANS-DELTA-9-TETRAHYDROCANNABINOL
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 125 250 500 | 0 125 250 500 |
| | 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) | 45/80 (56%) 33/60 (55%) 27/70 (39%) 18/70 (26%) | 46/60 (77%) 31/60 (52%) 26/60 (43%) 16/60 (27%) |
|ADJUSTED (b) | 73.7% 57.8% 56.2% 47.7% | 82.1% 56.2% 52.8% 35.4% |
|INTERIM SACRIFICE 1 (c)| 0/18 (0%) 0/0 0/9 (0%) 0/10 (0%) | |
|TERMINAL (d) | 34/50 (68%) 29/53 (55%) 24/45 (53%) 15/34 (44%) | 37/47 (79%) 26/50 (52%) 21/44 (48%) 12/41 (29%) |
|FIRST INCIDENCE (DAYS) | 146 563 574 256 | 456 590 632 682 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.006N** P=0.021N* P=0.016N* P=0.008N** | P<0.001N** P=0.004N** P=0.003N** P<0.001N** |
|INCIDENTAL TUMOR | P=0.001N** P=0.043N* P=0.016N* P=0.002N** | P<0.001N** P=0.002N** P<0.001N** P<0.001N** |
|LOGISTIC REGRESSION | P=0.002N** P=0.093N P=0.013N* P=0.002N** | P<0.001N** P=0.002N** P<0.001N** P<0.001N** |
|COCHRAN-ARMITAGE | P<0.001N** | P<0.001N** |
|FISHER EXACT | P=0.509N P=0.023N* P<0.001N** | P=0.004N** P<0.001N** P<0.001N** |
|=================================================================================================================================|
(a) Number of tumor-bearing animals / number of animals examined at site.
(b) Kaplan-Meier estimated lifetime tumor incidence after adjustment for
intercurrent mortality.
(d) Observed incidence at terminal kill.
(f) Beneath the control incidence are the P-values associated with the trend
test. Beneath the dosed group incidence are the P-values corresponding to
pairwise comparisons between the controls and that dosed group. The life
table analysis regards tumors in animals dying prior to terminal kill as
being (directly or indirectly) the cause of death. The incidental tumor
test regards these lesions as non-fatal. Logistic regression is an alternative
method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage
and Fisher's exact tests compare directly the overall incidence rates.
For all tests, a negative trend is indicated by "N".
(e) Value of Statistic cannot be computed.
(I) Interim sacrifice
(T) Terminal sacrifice
# Tumor rates based on number of animals necropsied.
* To the right of any statistical result, indicates significance at (P<=0.05).
** To the right of any statistical result, indicates significance at (P<=0.01).