TDMS Study 05121-99 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
AB: BATTELLE COLUMBUS SCOPOLAMINE HYDROBROMIDE TRIHYDRATE DATE: 03/22/95
XPERIMENT: 05121 TEST: 99 TIME: 13:54:07
EST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
ONT: N01-ES-85227 ROUTE: GAVAGE NTP C#: 03098C
ATHOLOGIST: A. SINGER CAS: 6533-68-2
-----------------------------------------------------------------------------------------------------------------------------------
05121/07 - 05121/08 COMPARISON
REASONS FOR REMOVAL: 25022 Accidently Killed
25018 Dosing Accident
25019 Moribund Sacrifice
25020 Natural Death
25021 Terminal Sacrifice
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE 001 0 MG/KG
INCLUDE 002 0 MG/KG
INCLUDE 003 RTD 0 MG/KG
INCLUDE 005 RTD 0 MG/KG
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: BATTELLE COLUMBUS SCOPOLAMINE HYDROBROMIDE TRIHYDRATE DATE: 03/22/95
EXPERIMENT: 05121 TEST: 99 TIME: 13:54:87
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-85227 ROUTE: GAVAGE NTP C#: 03098C
PATHOLOGIST: A. SINGER CAS: 6533-68-2
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: BATTELLE COLUMBUS SCOPOLAMINE HYDROBROMIDE TRIHYDRATE DATE: 03/22/95
EXPERIMENT: 05121 TEST: 99 TIME: 13:54:87
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-85227 ROUTE: GAVAGE NTP C#: 03098C
PATHOLOGIST: A. SINGER CAS: 6533-68-2
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF THE STUDY OF SCOPOLAMINE HYDROBROMIDE TRIHYDRATE
====================================================================================================
MALE MICE
-------------
ORGAN MORPHOLOGY
------- ------------
Liver Hepatocellular Adenoma
Hepatocellular Carcinoma or Hepatocellular Adenoma
Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
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 Hepatocellular Adenoma
Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
All Organs Hemangiosarcoma
Hemangiosarcoma or Hemangioma
Malignant Lymphoma And Histiocytic Sarcoma
Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,
NOS, or Undifferentiated Cell Type
Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
====================================================================================================
DATE: 03/22/95 EXPERIMENT: 05121 TEST: 99 PAGE 1
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG RTD | 0 MG/KG RTD |
| | 0 MG/KG | 0 MG/KG |
|=================================================================================================================================|
| |
|Harderian Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 2/50 (4%) | 1/51 (2%) 3/50 (6%) |
|ADJUSTED (b) | 6.9% 4.1% | 3.0% 6.4% |
|TERMINAL (d) | 2/41 (5%) 2/49 (4%) | 1/33 (3%) 3/47 (6%) |
|FIRST INCIDENCE (DAYS) | 540 722 (T) | 723 (T) 723 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.434N | P=0.438 |
|INCIDENTAL TUMOR | P=0.496N | P=0.438 |
|LOGISTIC REGRESSION | P=0.556N | P=0.438 |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.500N | P=0.301 |
|=================================================================================================================================|
| |
|Harderian Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) | 2/51 (4%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 0.0% | 4.3% 0.0% |
|TERMINAL (d) | 0/41 (0%) 0/49 (0%) | 0/33 (0%) 0/47 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- | 511 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) | P=0.228N |
|INCIDENTAL TUMOR | (e) (e) | P=0.518N |
|LOGISTIC REGRESSION | (e) (e) | P=0.339N |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | (e) | P=0.252N |
|=================================================================================================================================|
DATE: 03/22/95 EXPERIMENT: 05121 TEST: 99 PAGE 2
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG RTD | 0 MG/KG RTD |
| | 0 MG/KG | 0 MG/KG |
|=================================================================================================================================|
| |
|Harderian Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 2/50 (4%) | 3/51 (6%) 3/50 (6%) |
|ADJUSTED (b) | 6.9% 4.1% | 7.2% 6.4% |
|TERMINAL (d) | 2/41 (5%) 2/49 (4%) | 1/33 (3%) 3/47 (6%) |
|FIRST INCIDENCE (DAYS) | 540 722 (T) | 511 723 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.434N | P=0.541N |
|INCIDENTAL TUMOR | P=0.496N | P=0.612 |
|LOGISTIC REGRESSION | P=0.556N | P=0.609 |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.500N | P=0.652 |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) | 0/51 (0%) 0/50 (0%) |
|ADJUSTED (b) | 6.9% 0.0% | 0.0% 0.0% |
|TERMINAL (d) | 2/41 (5%) 0/49 (0%) | 0/33 (0%) 0/47 (0%) |
|FIRST INCIDENCE (DAYS) | 647 --- | --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.101N | (e) (e) |
|INCIDENTAL TUMOR | P=0.200N | (e) (e) |
|LOGISTIC REGRESSION | P=0.126N | (e) (e) |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.121N | (e) |
|=================================================================================================================================|
DATE: 03/22/95 EXPERIMENT: 05121 TEST: 99 PAGE 3
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG RTD | 0 MG/KG RTD |
| | 0 MG/KG | 0 MG/KG |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) | 0/51 (0%) 0/50 (0%) |
|ADJUSTED (b) | 4.9% 0.0% | 0.0% 0.0% |
|TERMINAL (d) | 2/41 (5%) 0/49 (0%) | 0/33 (0%) 0/47 (0%) |
|FIRST INCIDENCE (DAYS) | 722 (T) --- | --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.200N | (e) (e) |
|INCIDENTAL TUMOR | P=0.200N | (e) (e) |
|LOGISTIC REGRESSION | P=0.200N | (e) (e) |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.247N | (e) |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 26/50 (52%) 3/50 (6%) | 15/51 (29%) 3/50 (6%) |
|ADJUSTED (b) | 59.0% 6.1% | 42.3% 6.4% |
|TERMINAL (d) | 23/41 (56%) 3/49 (6%) | 13/33 (39%) 3/47 (6%) |
|FIRST INCIDENCE (DAYS) | 680 722 (T) | 604 723 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001N** | P<0.001N** |
|INCIDENTAL TUMOR | P<0.001N** | P<0.001N** |
|LOGISTIC REGRESSION | P<0.001N** | P<0.001N** |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P<0.001N** | P=0.002N** |
|=================================================================================================================================|
DATE: 03/22/95 EXPERIMENT: 05121 TEST: 99 PAGE 4
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG RTD | 0 MG/KG RTD |
| | 0 MG/KG | 0 MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 2/50 (4%) | 8/51 (16%) 0/50 (0%) |
|ADJUSTED (b) | 14.0% 4.1% | 21.1% 0.0% |
|TERMINAL (d) | 4/41 (10%) 2/49 (4%) | 5/33 (15%) 0/47 (0%) |
|FIRST INCIDENCE (DAYS) | 700 722 (T) | 594 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.091N | P=0.002N** |
|INCIDENTAL TUMOR | P=0.259N | P=0.010N* |
|LOGISTIC REGRESSION | P=0.116N | P=0.005N** |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.134N | P=0.003N** |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 30/50 (60%) 5/50 (10%) | 22/51 (43%) 3/50 (6%) |
|ADJUSTED (b) | 65.2% 10.2% | 57.1% 6.4% |
|TERMINAL (d) | 25/41 (61%) 5/49 (10%) | 17/33 (52%) 3/47 (6%) |
|FIRST INCIDENCE (DAYS) | 680 722 (T) | 594 723 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001N** | P<0.001N** |
|INCIDENTAL TUMOR | P<0.001N** | P<0.001N** |
|LOGISTIC REGRESSION | P<0.001N** | P<0.001N** |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P<0.001N** | P<0.001N** |
|=================================================================================================================================|
DATE: 03/22/95 EXPERIMENT: 05121 TEST: 99 PAGE 5
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG RTD | 0 MG/KG RTD |
| | 0 MG/KG | 0 MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 30/50 (60%) 5/50 (10%) | 22/51 (43%) 3/50 (6%) |
|ADJUSTED (b) | 65.2% 10.2% | 57.1% 6.4% |
|TERMINAL (d) | 25/41 (61%) 5/49 (10%) | 17/33 (52%) 3/47 (6%) |
|FIRST INCIDENCE (DAYS) | 680 722 (T) | 594 723 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001N** | P<0.001N** |
|INCIDENTAL TUMOR | P<0.001N** | P<0.001N** |
|LOGISTIC REGRESSION | P<0.001N** | P<0.001N** |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P<0.001N** | P<0.001N** |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 12/50 (24%) 8/50 (16%) | 3/51 (6%) 3/50 (6%) |
|ADJUSTED (b) | 27.8% 16.3% | 8.0% 6.4% |
|TERMINAL (d) | 10/41 (24%) 8/49 (16%) | 1/33 (3%) 3/47 (6%) |
|FIRST INCIDENCE (DAYS) | 683 722 (T) | 618 723 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.123N | P=0.517N |
|INCIDENTAL TUMOR | P=0.247N | P=0.527 |
|LOGISTIC REGRESSION | P=0.179N | P=0.652N |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.227N | P=0.652 |
|=================================================================================================================================|
DATE: 03/22/95 EXPERIMENT: 05121 TEST: 99 PAGE 6
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG RTD | 0 MG/KG RTD |
| | 0 MG/KG | 0 MG/KG |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 2/50 (4%) | 1/51 (2%) 3/50 (6%) |
|ADJUSTED (b) | 6.8% 4.1% | 3.0% 6.3% |
|TERMINAL (d) | 1/41 (2%) 2/49 (4%) | 1/33 (3%) 2/47 (4%) |
|FIRST INCIDENCE (DAYS) | 680 722 (T) | 723 (T) 628 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.435N | P=0.422 |
|INCIDENTAL TUMOR | P=0.562 | P=0.292 |
|LOGISTIC REGRESSION | P=0.499N | P=0.305 |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.500N | P=0.301 |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 15/50 (30%) 10/50 (20%) | 4/51 (8%) 6/50 (12%) |
|ADJUSTED (b) | 33.2% 20.4% | 10.8% 12.5% |
|TERMINAL (d) | 11/41 (27%) 10/49 (20%) | 2/33 (6%) 5/47 (11%) |
|FIRST INCIDENCE (DAYS) | 680 722 (T) | 618 628 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.088N | P=0.567 |
|INCIDENTAL TUMOR | P=0.321N | P=0.245 |
|LOGISTIC REGRESSION | P=0.142N | P=0.381 |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.178N | P=0.358 |
|=================================================================================================================================|
DATE: 03/22/95 EXPERIMENT: 05121 TEST: 99 PAGE 7
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG RTD | 0 MG/KG RTD |
| | 0 MG/KG | 0 MG/KG |
|=================================================================================================================================|
| |
|Ovary |
| Cystadenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | | 3/51 (6%) 0/50 (0%) |
|ADJUSTED (b) | | 7.1% 0.0% |
|TERMINAL (d) | | 0/33 (0%) 0/47 (0%) |
|FIRST INCIDENCE (DAYS) | | 511 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.100N |
|INCIDENTAL TUMOR | | P=0.718N |
|LOGISTIC REGRESSION | | P=0.158N |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | | P=0.125N |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 0/48 (0%) | 4/50 (8%) 0/46 (0%) |
|ADJUSTED (b) | 0.0% 0.0% | 11.8% 0.0% |
|TERMINAL (d) | 0/40 (0%) 0/47 (0%) | 3/33 (9%) 0/44 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- | 720 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) | P=0.033N* |
|INCIDENTAL TUMOR | (e) (e) | P=0.076N |
|LOGISTIC REGRESSION | (e) (e) | P=0.041N* |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | (e) | P=0.069N |
|=================================================================================================================================|
DATE: 03/22/95 EXPERIMENT: 05121 TEST: 99 PAGE 8
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG RTD | 0 MG/KG RTD |
| | 0 MG/KG | 0 MG/KG |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) | |
|ADJUSTED (b) | 0.0% 4.1% | |
|TERMINAL (d) | 0/41 (0%) 2/49 (4%) | |
|FIRST INCIDENCE (DAYS) | --- 722 (T) | |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.279 | |
|INCIDENTAL TUMOR | P=0.279 | |
|LOGISTIC REGRESSION | P=0.279 | |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.247 | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) | 3/51 (6%) 1/50 (2%) |
|ADJUSTED (b) | 0.0% 0.0% | 9.1% 2.1% |
|TERMINAL (d) | 0/41 (0%) 0/49 (0%) | 3/33 (9%) 1/47 (2%) |
|FIRST INCIDENCE (DAYS) | --- --- | 723 (T) 723 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) | P=0.189N |
|INCIDENTAL TUMOR | (e) (e) | P=0.189N |
|LOGISTIC REGRESSION | (e) (e) | P=0.189N |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | (e) | P=0.316N |
|=================================================================================================================================|
DATE: 03/22/95 EXPERIMENT: 05121 TEST: 99 PAGE 9
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG RTD | 0 MG/KG RTD |
| | 0 MG/KG | 0 MG/KG |
|=================================================================================================================================|
| |
|Uterus |
| Sarcoma Stromal or Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # |
|----------- | | |
|OVERALL (a) | | 2/51 (4%) 0/50 (0%) |
|ADJUSTED (b) | | 6.1% 0.0% |
|TERMINAL (d) | | 2/33 (6%) 0/47 (0%) |
|FIRST INCIDENCE (DAYS) | | 723 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.165N |
|INCIDENTAL TUMOR | | P=0.165N |
|LOGISTIC REGRESSION | | P=0.165N |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | | P=0.252N |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) | 4/51 (8%) 0/50 (0%) |
|ADJUSTED (b) | 2.4% 2.0% | 11.3% 0.0% |
|TERMINAL (d) | 1/41 (2%) 1/49 (2%) | 2/33 (6%) 0/47 (0%) |
|FIRST INCIDENCE (DAYS) | 722 (T) 722 (T) | 709 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.721N | P=0.033N* |
|INCIDENTAL TUMOR | P=0.721N | P=0.165N |
|LOGISTIC REGRESSION | P=0.721N | P=0.042N* |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.753N | P=0.061N |
|=================================================================================================================================|
DATE: 03/22/95 EXPERIMENT: 05121 TEST: 99 PAGE 10
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG RTD | 0 MG/KG RTD |
| | 0 MG/KG | 0 MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma or Hemangioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) | 4/51 (8%) 0/50 (0%) |
|ADJUSTED (b) | 4.6% 2.0% | 11.3% 0.0% |
|TERMINAL (d) | 1/41 (2%) 1/49 (2%) | 2/33 (6%) 0/47 (0%) |
|FIRST INCIDENCE (DAYS) | 680 722 (T) | 709 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.452N | P=0.033N* |
|INCIDENTAL TUMOR | P=0.721N | P=0.165N |
|LOGISTIC REGRESSION | P=0.502N | P=0.042N* |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.500N | P=0.061N |
|=================================================================================================================================|
| |
|All Organs |
| Histiocytic Sarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) | 1/51 (2%) 2/50 (4%) |
|ADJUSTED (b) | 6.8% 0.0% | 2.0% 4.1% |
|TERMINAL (d) | 2/41 (5%) 0/49 (0%) | 0/33 (0%) 1/47 (2%) |
|FIRST INCIDENCE (DAYS) | 447 --- | 492 492 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.102N | P=0.545 |
|INCIDENTAL TUMOR | P=0.137N | P=0.278 |
|LOGISTIC REGRESSION | P=0.179N | P=0.323 |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.121N | P=0.492 |
|=================================================================================================================================|
DATE: 03/22/95 EXPERIMENT: 05121 TEST: 99 PAGE 11
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG RTD | 0 MG/KG RTD |
| | 0 MG/KG | 0 MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Lymphoma And Histiocytic Sarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 1/50 (2%) | 10/51 (20%) 4/50 (8%) |
|ADJUSTED (b) | 15.9% 2.0% | 24.6% 8.3% |
|TERMINAL (d) | 5/41 (12%) 0/49 (0%) | 5/33 (15%) 3/47 (6%) |
|FIRST INCIDENCE (DAYS) | 447 515 | 492 492 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.024N* | P=0.032N* |
|INCIDENTAL TUMOR | P=0.056N | P=0.189N |
|LOGISTIC REGRESSION | P=0.059N | P=0.117N |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.030N* | P=0.080N |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, |
| NOS, or Undifferentiated Cell Type |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 1/50 (2%) | 9/51 (18%) 2/50 (4%) |
|ADJUSTED (b) | 9.3% 2.0% | 23.0% 4.3% |
|TERMINAL (d) | 3/41 (7%) 0/49 (0%) | 5/33 (15%) 2/47 (4%) |
|FIRST INCIDENCE (DAYS) | 680 515 | 581 723 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.148N | P=0.010N** |
|INCIDENTAL TUMOR | P=0.316N | P=0.052N |
|LOGISTIC REGRESSION | P=0.229N | P=0.029N* |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.181N | P=0.028N* |
|=================================================================================================================================|
DATE: 03/22/95 EXPERIMENT: 05121 TEST: 99 PAGE 12
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG RTD | 0 MG/KG RTD |
| | 0 MG/KG | 0 MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 36/50 (72%) 14/50 (28%) | 24/51 (47%) 12/50 (24%) |
|ADJUSTED (b) | 78.2% 28.6% | 60.9% 25.5% |
|TERMINAL (d) | 31/41 (76%) 14/49 (29%) | 18/33 (55%) 12/47 (26%) |
|FIRST INCIDENCE (DAYS) | 540 722 (T) | 511 723 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001N** | P<0.001N** |
|INCIDENTAL TUMOR | P<0.001N** | P=0.005N** |
|LOGISTIC REGRESSION | P<0.001N** | P=0.005N** |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P<0.001N** | P=0.013N* |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 17/50 (34%) 6/50 (12%) | 26/51 (51%) 8/50 (16%) |
|ADJUSTED (b) | 36.8% 12.0% | 54.8% 16.0% |
|TERMINAL (d) | 12/41 (29%) 5/49 (10%) | 12/33 (36%) 5/47 (11%) |
|FIRST INCIDENCE (DAYS) | 447 515 | 492 492 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.004N** | P<0.001N** |
|INCIDENTAL TUMOR | P=0.037N* | P=0.018N* |
|LOGISTIC REGRESSION | P=0.013N* | P=0.003N** |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.008N** | P<0.001N** |
|=================================================================================================================================|
DATE: 03/22/95 EXPERIMENT: 05121 TEST: 99 PAGE 13
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG RTD | 0 MG/KG RTD |
| | 0 MG/KG | 0 MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 43/50 (86%) 19/50 (38%) | 40/51 (78%) 19/50 (38%) |
|ADJUSTED (b) | 87.8% 38.0% | 83.2% 38.0% |
|TERMINAL (d) | 35/41 (85%) 18/49 (37%) | 25/33 (76%) 16/47 (34%) |
|FIRST INCIDENCE (DAYS) | 447 515 | 492 492 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001N** | P<0.001N** |
|INCIDENTAL TUMOR | P<0.001N** | P<0.001N** |
|LOGISTIC REGRESSION | P<0.001N** | P<0.001N** |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | 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).