TDMS Study 05121-07 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus SCOPOLAMINE HYDROBROMIDE TRIHYDRATE DATE: 04/03/96
EXPERIMENT: 05121 TEST: 07 TIME: 22:23:41
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-85227 ROUTE: GAVAGE NTP C#: 03098C
PATHOLOGIST: A. SINGER CAS: 6533-68-2
------------------------------------------------------------------------------------------------------------------------------------
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus SCOPOLAMINE HYDROBROMIDE TRIHYDRATE DATE: 04/03/96
EXPERIMENT: 05121 TEST: 07 TIME: 22:23:41
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: 04/03/96
EXPERIMENT: 05121 TEST: 07 TIME: 22:23:41
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
------- ------------
Harderian Gland Carcinoma
Liver Hemangiosarcoma
Hepatocellular Adenoma
Hepatocellular Carcinoma
Hepatocellular Carcinoma or Hepatoblastoma
Hepatocellular Carcinoma or Hepatocellular Adenoma
Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
All Organs Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
====================================================================================================
FEMALE MICE
-------------
ORGAN MORPHOLOGY
------- ------------
Liver Hepatocellular Adenoma
Hepatocellular Carcinoma or Hepatocellular Adenoma
Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
All Organs Malignant Tumors
====================================================================================================
DATE: 04/03/96 EXPERIMENT: 05121 TEST: 07 PAGE 1
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 1 MG/KG 5 MG/KG 25 MG/KG | 0 MG/KG 1 MG/KG 5 MG/KG 25 MG/KG |
| | FEED RTD | FEED RTD |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/119 (0%) 0/55 (0%) 0/60 (0%) 0/60 (0%) | 0/119 (0%) 2/59 (3%) 0/59 (0%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 0.0% 4.8% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/19 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/19 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/80 (0%) 0/34 (0%) 0/39 (0%) 0/39 (0%) | 0/69 (0%) 0/35 (0%) 0/36 (0%) 0/37 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- | --- 676 --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) (e) | P=0.485N P=0.109 (e) (e) |
|INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.539N P=0.087 (e) (e) |
|LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.487N P=0.103 (e) (e) |
|COCHRAN-ARMITAGE | (e) | P=0.486N |
|FISHER EXACT | (e) (e) (e) | P=0.109 (e) (e) |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/119 (0%) 0/55 (0%) 0/60 (0%) 0/60 (0%) | 1/119 (1%) 2/59 (3%) 0/59 (0%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 1.1% 4.8% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/19 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/19 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/80 (0%) 0/34 (0%) 0/39 (0%) 0/39 (0%) | 0/69 (0%) 0/35 (0%) 0/36 (0%) 0/37 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- | 610 676 --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) (e) | P=0.345N P=0.268 P=0.649N P=0.645N |
|INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.421N P=0.211 P=0.773N P=0.773N |
|LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.275N P=0.235 P=0.638N P=0.639N |
|COCHRAN-ARMITAGE | (e) | P=0.342N |
|FISHER EXACT | (e) (e) (e) | P=0.255 P=0.669N P=0.665N |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05121 TEST: 07 PAGE 2
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 1 MG/KG 5 MG/KG 25 MG/KG | 0 MG/KG 1 MG/KG 5 MG/KG 25 MG/KG |
| | FEED RTD | FEED RTD |
|=================================================================================================================================|
| |
|Harderian Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 4/120 (3%) 1/60 (2%) 1/60 (2%) 2/60 (3%) | 4/121 (3%) 3/60 (5%) 2/60 (3%) 1/61 (2%) |
|ADJUSTED (b) | 4.8% 2.6% 2.6% 4.2% | 5.5% 7.5% 5.1% 2.6% |
|INTERIM SACRIFICE 1 (c)| 0/19 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 3/81 (4%) 1/39 (3%) 1/39 (3%) 1/39 (3%) | 2/69 (3%) 2/36 (6%) 1/37 (3%) 1/38 (3%) |
|FIRST INCIDENCE (DAYS) | 540 726 (T) 726 (T) 405 | 707 482 676 726 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.546 P=0.443N P=0.448N P=0.663 | P=0.300N P=0.456 P=0.654N P=0.411N |
|INCIDENTAL TUMOR | P=0.616 P=0.424N P=0.424N P=0.571N | P=0.311N P=0.491 P=0.621 P=0.464N |
|LOGISTIC REGRESSION | P=0.555 P=0.421N P=0.438N P=0.670N | P=0.316N P=0.442 P=0.661 P=0.432N |
|COCHRAN-ARMITAGE | P=0.554 | P=0.315N |
|FISHER EXACT | P=0.459N P=0.459N P=0.682N | P=0.425 P=0.649 P=0.455N |
|=================================================================================================================================|
| |
|Harderian Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/120 (0%) 4/60 (7%) 1/60 (2%) 1/60 (2%) | 2/121 (2%) 1/60 (2%) 1/60 (2%) 0/61 (0%) |
|ADJUSTED (b) | 0.0% 9.7% 2.6% 2.6% | 2.1% 2.8% 2.6% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/19 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/81 (0%) 2/39 (5%) 1/39 (3%) 1/39 (3%) | 0/69 (0%) 1/36 (3%) 0/37 (0%) 0/38 (0%) |
|FIRST INCIDENCE (DAYS) | --- 705 726 (T) 726 (T) | 511 726 (T) 685 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.626N P=0.010 ** P=0.354 P=0.354 | P=0.320N P=0.727 P=0.717 P=0.408N |
|INCIDENTAL TUMOR | P=0.668 P=0.022 * P=0.354 P=0.354 | P=0.335N P=0.691N P=0.652 P=0.377N |
|LOGISTIC REGRESSION | P=0.628N P=0.011 * P=0.354 P=0.354 | P=0.363N P=0.725 P=0.668 P=0.412N |
|COCHRAN-ARMITAGE | P=0.615N | P=0.319N |
|FISHER EXACT | P=0.012 * P=0.333 P=0.333 | P=0.704 P=0.704 P=0.441N |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05121 TEST: 07 PAGE 3
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 1 MG/KG 5 MG/KG 25 MG/KG | 0 MG/KG 1 MG/KG 5 MG/KG 25 MG/KG |
| | FEED RTD | FEED RTD |
|=================================================================================================================================|
| |
|Harderian Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 4/120 (3%) 5/60 (8%) 2/60 (3%) 3/60 (5%) | 6/121 (5%) 4/60 (7%) 3/60 (5%) 1/61 (2%) |
|ADJUSTED (b) | 4.8% 12.1% 5.1% 6.7% | 7.5% 10.2% 7.5% 2.6% |
|INTERIM SACRIFICE 1 (c)| 0/19 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 3/81 (4%) 3/39 (8%) 2/39 (5%) 2/39 (5%) | 2/69 (3%) 3/36 (8%) 1/37 (3%) 1/38 (3%) |
|FIRST INCIDENCE (DAYS) | 540 705 726 (T) 405 | 511 482 676 726 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.564 P=0.135 P=0.658 P=0.437 | P=0.165N P=0.461 P=0.637N P=0.237N |
|INCIDENTAL TUMOR | P=0.587 P=0.193 P=0.662N P=0.541 | P=0.173N P=0.518 P=0.541 P=0.255N |
|LOGISTIC REGRESSION | P=0.575 P=0.152 P=0.668 P=0.450 | P=0.172N P=0.451 P=0.583 P=0.245N |
|COCHRAN-ARMITAGE | P=0.577 | P=0.171N |
|FISHER EXACT | P=0.139 P=0.682N P=0.429 | P=0.436 P=0.623 P=0.255N |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/120 (3%) 0/60 (0%) 1/60 (2%) 1/60 (2%) | 0/121 (0%) 1/60 (2%) 1/60 (2%) 0/61 (0%) |
|ADJUSTED (b) | 3.6% 0.0% 2.3% 2.6% | 0.0% 2.3% 2.7% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/19 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 2/81 (2%) 0/39 (0%) 0/39 (0%) 1/39 (3%) | 0/69 (0%) 0/36 (0%) 1/37 (3%) 0/38 (0%) |
|FIRST INCIDENCE (DAYS) | 647 --- 606 726 (T) | --- 594 726 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.675N P=0.273N P=0.587N P=0.587N | P=0.597N P=0.351 P=0.376 (e) |
|INCIDENTAL TUMOR | P=0.610N P=0.228N P=0.401N P=0.608N | P=0.658N P=0.282 P=0.376 (e) |
|LOGISTIC REGRESSION | P=0.666N P=0.259N P=0.571N P=0.574N | P=0.602N P=0.351 P=0.376 (e) |
|COCHRAN-ARMITAGE | P=0.664N | P=0.602N |
|FISHER EXACT | P=0.294N P=0.593N P=0.593N | P=0.331 P=0.331 (e) |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05121 TEST: 07 PAGE 4
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 1 MG/KG 5 MG/KG 25 MG/KG | 0 MG/KG 1 MG/KG 5 MG/KG 25 MG/KG |
| | FEED RTD | FEED RTD |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/120 (2%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | 0/121 (0%) 0/60 (0%) 0/60 (0%) 0/61 (0%) |
|ADJUSTED (b) | 2.5% 0.0% 0.0% 0.0% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/19 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 2/81 (2%) 0/39 (0%) 0/39 (0%) 0/39 (0%) | 0/69 (0%) 0/36 (0%) 0/37 (0%) 0/38 (0%) |
|FIRST INCIDENCE (DAYS) | 726 (T) --- --- --- | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.435N P=0.410N P=0.410N P=0.410N | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.435N P=0.410N P=0.410N P=0.410N | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.435N P=0.410N P=0.410N P=0.410N | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.429N | (e) |
|FISHER EXACT | P=0.443N P=0.443N P=0.443N | (e) (e) (e) |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/120 (2%) 0/60 (0%) 1/60 (2%) 0/60 (0%) | 0/121 (0%) 0/60 (0%) 0/60 (0%) 0/61 (0%) |
|ADJUSTED (b) | 2.5% 0.0% 2.6% 0.0% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/19 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 2/81 (2%) 0/39 (0%) 1/39 (3%) 0/39 (0%) | 0/69 (0%) 0/36 (0%) 0/37 (0%) 0/38 (0%) |
|FIRST INCIDENCE (DAYS) | 726 (T) --- 726 (T) --- | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.420N P=0.410N P=0.723 P=0.410N | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.420N P=0.410N P=0.723 P=0.410N | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.420N P=0.410N P=0.723 P=0.410N | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.414N | (e) |
|FISHER EXACT | P=0.443N P=0.742N P=0.443N | (e) (e) (e) |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05121 TEST: 07 PAGE 5
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 1 MG/KG 5 MG/KG 25 MG/KG | 0 MG/KG 1 MG/KG 5 MG/KG 25 MG/KG |
| | FEED RTD | FEED RTD |
|=================================================================================================================================|
| |
|Liver |
| Hemangiosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/120 (0%) 0/60 (0%) 4/60 (7%) 0/60 (0%) | 1/121 (1%) 1/60 (2%) 0/60 (0%) 0/61 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 9.0% 0.0% | 1.3% 2.2% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/19 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/81 (0%) 0/39 (0%) 1/39 (3%) 0/39 (0%) | 0/69 (0%) 0/36 (0%) 0/37 (0%) 0/38 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 560 --- | 709 562 --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.613N (e) P=0.010 * (e) | P=0.463N P=0.587 P=0.646N P=0.641N |
|INCIDENTAL TUMOR | P=0.311N (e) P=0.126 (e) | P=0.549N P=0.532 P=0.705N P=0.705N |
|LOGISTIC REGRESSION | P=0.463N (e) P=0.010 ** (e) | P=0.457N P=0.596 P=0.644N P=0.638N |
|COCHRAN-ARMITAGE | P=0.608N | P=0.456N |
|FISHER EXACT | (e) P=0.012 * (e) | P=0.554 P=0.669N P=0.665N |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 34/120 (28%) 26/60 (43%) 10/60 (17%) 8/60 (13%) | 23/121 (19%) 18/60 (30%) 9/60 (15%) 6/61 (10%) |
|ADJUSTED (b) | 37.7% 56.7% 22.7% 19.1% | 30.8% 47.1% 22.8% 15.4% |
|INTERIM SACRIFICE 1 (c)| 3/19 (16%) 4/10 (40%) 1/10 (10%) 0/10 (0%) | 1/20 (5%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 26/81 (32%) 20/39 (51%) 6/39 (15%) 6/39 (15%) | 19/69 (28%) 16/36 (44%) 7/37 (19%) 5/38 (13%) |
|FIRST INCIDENCE (DAYS) | 456 (I) 456 (I) 456 (I) 587 | 457 (I) 676 578 694 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.005N** P=0.027 * P=0.082N P=0.027N* | P=0.016N* P=0.086 P=0.261N P=0.056N |
|INCIDENTAL TUMOR | P=0.003N** P=0.048 * P=0.062N P=0.011N* | P=0.020N* P=0.071 P=0.320N P=0.071N |
|LOGISTIC REGRESSION | P=0.003N** P=0.046 * P=0.061N P=0.018N* | P=0.022N* P=0.060 P=0.341N P=0.080N |
|COCHRAN-ARMITAGE | P=0.003N** | P=0.026N* |
|FISHER EXACT | P=0.033 * P=0.060N P=0.018N* | P=0.072 P=0.328N P=0.081N |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05121 TEST: 07 PAGE 6
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 1 MG/KG 5 MG/KG 25 MG/KG | 0 MG/KG 1 MG/KG 5 MG/KG 25 MG/KG |
| | FEED RTD | FEED RTD |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 11/120 (9%) 15/60 (25%) 6/60 (10%) 8/60 (13%) | 10/121 (8%) 6/60 (10%) 8/60 (13%) 4/61 (7%) |
|ADJUSTED (b) | 13.0% 30.7% 14.9% 18.8% | 12.8% 16.0% 19.1% 10.3% |
|INTERIM SACRIFICE 1 (c)| 0/19 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 8/81 (10%) 6/39 (15%) 5/39 (13%) 6/39 (15%) | 6/69 (9%) 5/36 (14%) 4/37 (11%) 3/38 (8%) |
|FIRST INCIDENCE (DAYS) | 532 405 693 456 (I) | 594 680 617 694 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.563 P=0.006 ** P=0.505 P=0.255 | P=0.319N P=0.483 P=0.240 P=0.419N |
|INCIDENTAL TUMOR | P=0.545N P=0.018 * P=0.487 P=0.347 | P=0.413N P=0.427 P=0.122 P=0.528N |
|LOGISTIC REGRESSION | P=0.527N P=0.014 * P=0.520 P=0.275 | P=0.346N P=0.456 P=0.167 P=0.459N |
|COCHRAN-ARMITAGE | P=0.549N | P=0.349N |
|FISHER EXACT | P=0.005 ** P=0.526 P=0.270 | P=0.446 P=0.207 P=0.466N |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 11/120 (9%) 16/60 (27%) 6/60 (10%) 8/60 (13%) | 10/121 (8%) 6/60 (10%) 8/60 (13%) 4/61 (7%) |
|ADJUSTED (b) | 13.0% 32.8% 14.9% 18.8% | 12.8% 16.0% 19.1% 10.3% |
|INTERIM SACRIFICE 1 (c)| 0/19 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 8/81 (10%) 7/39 (18%) 5/39 (13%) 6/39 (15%) | 6/69 (9%) 5/36 (14%) 4/37 (11%) 3/38 (8%) |
|FIRST INCIDENCE (DAYS) | 532 405 693 456 (I) | 594 680 617 694 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.539N P=0.003 ** P=0.505 P=0.255 | P=0.319N P=0.483 P=0.240 P=0.419N |
|INCIDENTAL TUMOR | P=0.508N P=0.009 ** P=0.487 P=0.347 | P=0.413N P=0.427 P=0.122 P=0.528N |
|LOGISTIC REGRESSION | P=0.490N P=0.007 ** P=0.520 P=0.275 | P=0.346N P=0.456 P=0.167 P=0.459N |
|COCHRAN-ARMITAGE | P=0.513N | P=0.349N |
|FISHER EXACT | P=0.003 ** P=0.526 P=0.270 | P=0.446 P=0.207 P=0.466N |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05121 TEST: 07 PAGE 7
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 1 MG/KG 5 MG/KG 25 MG/KG | 0 MG/KG 1 MG/KG 5 MG/KG 25 MG/KG |
| | FEED RTD | FEED RTD |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 43/120 (36%) 37/60 (62%) 15/60 (25%) 16/60 (27%) | 32/121 (26%) 21/60 (35%) 16/60 (27%) 9/61 (15%) |
|ADJUSTED (b) | 46.4% 69.4% 33.7% 36.4% | 40.6% 55.0% 37.0% 23.1% |
|INTERIM SACRIFICE 1 (c)| 3/19 (16%) 4/10 (40%) 1/10 (10%) 1/10 (10%) | 1/20 (5%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 32/81 (40%) 23/39 (59%) 10/39 (26%) 12/39 (31%) | 24/69 (35%) 19/36 (53%) 10/37 (27%) 8/38 (21%) |
|FIRST INCIDENCE (DAYS) | 456 (I) 405 456 (I) 456 (I) | 457 (I) 676 578 694 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.032N* P=0.002 ** P=0.134N P=0.182N | P=0.012N* P=0.192 P=0.505N P=0.035N* |
|INCIDENTAL TUMOR | P=0.015N* P=0.004 ** P=0.103N P=0.079N | P=0.018N* P=0.146 P=0.471 P=0.054N |
|LOGISTIC REGRESSION | P=0.015N* P=0.002 ** P=0.094N P=0.100N | P=0.018N* P=0.138 P=0.478 P=0.052N |
|COCHRAN-ARMITAGE | P=0.019N* | P=0.020N* |
|FISHER EXACT | P<0.001 ** P=0.096N P=0.143N | P=0.155 P=0.555 P=0.053N |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 43/120 (36%) 37/60 (62%) 15/60 (25%) 16/60 (27%) | 32/121 (26%) 21/60 (35%) 16/60 (27%) 9/61 (15%) |
|ADJUSTED (b) | 46.4% 69.4% 33.7% 36.4% | 40.6% 55.0% 37.0% 23.1% |
|INTERIM SACRIFICE 1 (c)| 3/19 (16%) 4/10 (40%) 1/10 (10%) 1/10 (10%) | 1/20 (5%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 32/81 (40%) 23/39 (59%) 10/39 (26%) 12/39 (31%) | 24/69 (35%) 19/36 (53%) 10/37 (27%) 8/38 (21%) |
|FIRST INCIDENCE (DAYS) | 456 (I) 405 456 (I) 456 (I) | 457 (I) 676 578 694 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.032N* P=0.002 ** P=0.134N P=0.182N | P=0.012N* P=0.192 P=0.505N P=0.035N* |
|INCIDENTAL TUMOR | P=0.015N* P=0.004 ** P=0.103N P=0.079N | P=0.018N* P=0.146 P=0.471 P=0.054N |
|LOGISTIC REGRESSION | P=0.015N* P=0.002 ** P=0.094N P=0.100N | P=0.018N* P=0.138 P=0.478 P=0.052N |
|COCHRAN-ARMITAGE | P=0.019N* | P=0.020N* |
|FISHER EXACT | P<0.001 ** P=0.096N P=0.143N | P=0.155 P=0.555 P=0.053N |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05121 TEST: 07 PAGE 8
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 1 MG/KG 5 MG/KG 25 MG/KG | 0 MG/KG 1 MG/KG 5 MG/KG 25 MG/KG |
| | FEED RTD | FEED RTD |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 25/120 (21%) 7/60 (12%) 9/60 (15%) 7/60 (12%) | 5/121 (4%) 4/60 (7%) 1/60 (2%) 2/61 (3%) |
|ADJUSTED (b) | 28.4% 17.9% 21.7% 16.9% | 6.5% 11.1% 2.7% 5.3% |
|INTERIM SACRIFICE 1 (c)| 2/19 (11%) 0/10 (0%) 0/10 (0%) 1/10 (10%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 20/81 (25%) 7/39 (18%) 7/39 (18%) 6/39 (15%) | 2/69 (3%) 4/36 (11%) 1/37 (3%) 2/38 (5%) |
|FIRST INCIDENCE (DAYS) | 449 (I) 726 (T) 594 456 (I) | 618 726 (T) 726 (T) 726 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.198N P=0.131N P=0.302N P=0.132N | P=0.403N P=0.368 P=0.327N P=0.528N |
|INCIDENTAL TUMOR | P=0.193N P=0.109N P=0.254N P=0.140N | P=0.448N P=0.332 P=0.401N P=0.617N |
|LOGISTIC REGRESSION | P=0.164N P=0.075N P=0.232N P=0.090N | P=0.429N P=0.352 P=0.341N P=0.553N |
|COCHRAN-ARMITAGE | P=0.160N | P=0.428N |
|FISHER EXACT | P=0.093N P=0.232N P=0.093N | P=0.343 P=0.351N P=0.566N |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/120 (3%) 4/60 (7%) 1/60 (2%) 2/60 (3%) | 2/121 (2%) 3/60 (5%) 1/60 (2%) 1/61 (2%) |
|ADJUSTED (b) | 4.7% 9.7% 2.6% 5.1% | 2.9% 7.3% 2.6% 2.2% |
|INTERIM SACRIFICE 1 (c)| 0/19 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 2/81 (2%) 3/39 (8%) 1/39 (3%) 2/39 (5%) | 2/69 (3%) 1/36 (3%) 0/37 (0%) 0/38 (0%) |
|FIRST INCIDENCE (DAYS) | 680 618 726 (T) 726 (T) | 726 (T) 590 706 604 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.525N P=0.257 P=0.455N P=0.653 | P=0.484N P=0.220 P=0.721N P=0.713N |
|INCIDENTAL TUMOR | P=0.498N P=0.418 P=0.492N P=0.623 | P=0.575N P=0.185 P=0.717 P=0.700 |
|LOGISTIC REGRESSION | P=0.522N P=0.279 P=0.446N P=0.664 | P=0.490N P=0.208 P=0.727 P=0.730N |
|COCHRAN-ARMITAGE | P=0.510N | P=0.489N |
|FISHER EXACT | P=0.255 P=0.459N P=0.682N | P=0.204 P=0.704 P=0.740N |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05121 TEST: 07 PAGE 9
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 1 MG/KG 5 MG/KG 25 MG/KG | 0 MG/KG 1 MG/KG 5 MG/KG 25 MG/KG |
| | FEED RTD | FEED RTD |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 29/120 (24%) 11/60 (18%) 10/60 (17%) 9/60 (15%) | 7/121 (6%) 7/60 (12%) 2/60 (3%) 3/61 (5%) |
|ADJUSTED (b) | 32.3% 27.2% 24.2% 21.9% | 9.3% 17.9% 5.3% 7.4% |
|INTERIM SACRIFICE 1 (c)| 2/19 (11%) 0/10 (0%) 0/10 (0%) 1/10 (10%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 22/81 (27%) 10/39 (26%) 8/39 (21%) 8/39 (21%) | 4/69 (6%) 5/36 (14%) 1/37 (3%) 2/38 (5%) |
|FIRST INCIDENCE (DAYS) | 449 (I) 618 594 456 (I) | 618 590 706 604 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.183N P=0.312N P=0.234N P=0.155N | P=0.322N P=0.151 P=0.351N P=0.513N |
|INCIDENTAL TUMOR | P=0.168N P=0.205N P=0.199N P=0.169N | P=0.403N P=0.114 P=0.430N P=0.624N |
|LOGISTIC REGRESSION | P=0.150N P=0.198N P=0.170N P=0.104N | P=0.343N P=0.133 P=0.372N P=0.545N |
|COCHRAN-ARMITAGE | P=0.145N | P=0.341N |
|FISHER EXACT | P=0.245N P=0.169N P=0.108N | P=0.137 P=0.377N P=0.554N |
|=================================================================================================================================|
| |
|Nose |
| Mast Cell Tumor Malignant |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/120 (0%) 2/60 (3%) 0/60 (0%) 1/60 (2%) | 0/121 (0%) 0/60 (0%) 0/60 (0%) 0/61 (0%) |
|ADJUSTED (b) | 0.0% 4.9% 0.0% 2.3% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/19 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/81 (0%) 1/39 (3%) 0/39 (0%) 0/39 (0%) | 0/69 (0%) 0/36 (0%) 0/37 (0%) 0/38 (0%) |
|FIRST INCIDENCE (DAYS) | --- 707 --- 622 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.531 P=0.103 (e) P=0.360 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.614 P=0.150 (e) P=0.773 | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.538 P=0.108 (e) P=0.359 | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.539 | (e) |
|FISHER EXACT | P=0.110 (e) P=0.333 | (e) (e) (e) |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05121 TEST: 07 PAGE 10
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 1 MG/KG 5 MG/KG 25 MG/KG | 0 MG/KG 1 MG/KG 5 MG/KG 25 MG/KG |
| | FEED RTD | FEED RTD |
|=================================================================================================================================|
| |
|Ovary |
| Cystadenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | | 4/120 (3%) 0/59 (0%) 3/59 (5%) 1/61 (2%) |
|ADJUSTED (b) | | 4.3% 0.0% 8.3% 2.6% |
|INTERIM SACRIFICE 1 (c)| | 1/20 (5%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | | 0/69 (0%) 0/35 (0%) 3/36 (8%) 1/38 (3%) |
|FIRST INCIDENCE (DAYS) | | 457 (I) --- 726 (T) 726 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.484N P=0.192N P=0.448 P=0.429N |
|INCIDENTAL TUMOR | | P=0.486N P=0.159N P=0.409 P=0.418N |
|LOGISTIC REGRESSION | | P=0.496N P=0.198N P=0.437 P=0.434N |
|COCHRAN-ARMITAGE | | P=0.496N |
|FISHER EXACT | | P=0.199N P=0.421 P=0.452N |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/116 (0%) 0/56 (0%) 0/55 (0%) 1/53 (2%) | 5/118 (4%) 3/57 (5%) 3/57 (5%) 3/56 (5%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 2.2% | 6.9% 8.8% 7.5% 8.2% |
|INTERIM SACRIFICE 1 (c)| 0/19 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/79 (0%) 0/37 (0%) 0/36 (0%) 0/33 (0%) | 3/67 (4%) 3/34 (9%) 1/35 (3%) 2/33 (6%) |
|FIRST INCIDENCE (DAYS) | --- --- --- 594 | 617 726 (T) 604 670 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.177 (e) (e) P=0.362 | P=0.539 P=0.555 P=0.556 P=0.552 |
|INCIDENTAL TUMOR | P=0.357 (e) (e) P=0.773 | P=0.466 P=0.515 P=0.418 P=0.465 |
|LOGISTIC REGRESSION | P=0.164 (e) (e) P=0.337 | P=0.502 P=0.527 P=0.518 P=0.504 |
|COCHRAN-ARMITAGE | P=0.167 | P=0.519 |
|FISHER EXACT | (e) (e) P=0.314 | P=0.515 P=0.515 P=0.505 |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05121 TEST: 07 PAGE 11
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 1 MG/KG 5 MG/KG 25 MG/KG | 0 MG/KG 1 MG/KG 5 MG/KG 25 MG/KG |
| | FEED RTD | FEED RTD |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Intermedia |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/116 (2%) 0/56 (0%) 1/55 (2%) 0/53 (0%) | 0/118 (0%) 1/57 (2%) 0/57 (0%) 1/56 (2%) |
|ADJUSTED (b) | 2.4% 0.0% 2.1% 0.0% | 0.0% 2.9% 0.0% 3.0% |
|INTERIM SACRIFICE 1 (c)| 0/19 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/79 (1%) 0/37 (0%) 0/36 (0%) 0/33 (0%) | 0/67 (0%) 1/34 (3%) 0/35 (0%) 1/33 (3%) |
|FIRST INCIDENCE (DAYS) | 647 --- 520 --- | --- 726 (T) --- 726 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.434N P=0.405N P=0.720 P=0.430N | P=0.389 P=0.365 (e) P=0.359 |
|INCIDENTAL TUMOR | P=0.397N P=0.341N P=0.725N P=0.442N | P=0.389 P=0.365 (e) P=0.359 |
|LOGISTIC REGRESSION | P=0.346N P=0.400N P=0.546N P=0.425N | P=0.389 P=0.365 (e) P=0.359 |
|COCHRAN-ARMITAGE | P=0.433N | P=0.385 |
|FISHER EXACT | P=0.454N P=0.690 P=0.470N | P=0.326 (e) P=0.322 |
|=================================================================================================================================|
| |
|Spleen |
| Hemangiosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/120 (1%) 1/60 (2%) 1/60 (2%) 0/60 (0%) | 2/121 (2%) 0/60 (0%) 0/60 (0%) 0/61 (0%) |
|ADJUSTED (b) | 1.2% 2.3% 2.4% 0.0% | 2.8% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/19 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/81 (1%) 0/39 (0%) 0/39 (0%) 0/39 (0%) | 1/69 (1%) 0/36 (0%) 0/37 (0%) 0/38 (0%) |
|FIRST INCIDENCE (DAYS) | 726 (T) 705 693 --- | 721 --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.444N P=0.597 P=0.588 P=0.646N | P=0.415N P=0.394N P=0.388N P=0.381N |
|INCIDENTAL TUMOR | P=0.517N P=0.665 P=0.560 P=0.646N | P=0.449N P=0.414N P=0.431N P=0.428N |
|LOGISTIC REGRESSION | P=0.442N P=0.606 P=0.595 P=0.646N | P=0.426N P=0.402N P=0.404N P=0.397N |
|COCHRAN-ARMITAGE | P=0.437N | P=0.427N |
|FISHER EXACT | P=0.557 P=0.557 P=0.667N | P=0.446N P=0.446N P=0.441N |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05121 TEST: 07 PAGE 12
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 1 MG/KG 5 MG/KG 25 MG/KG | 0 MG/KG 1 MG/KG 5 MG/KG 25 MG/KG |
| | FEED RTD | FEED RTD |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Squamous Cell Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/120 (2%) 0/60 (0%) 1/60 (2%) 0/60 (0%) | 1/121 (1%) 0/60 (0%) 1/60 (2%) 2/61 (3%) |
|ADJUSTED (b) | 2.5% 0.0% 2.4% 0.0% | 1.4% 0.0% 2.7% 5.3% |
|INTERIM SACRIFICE 1 (c)| 0/19 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 2/81 (2%) 0/39 (0%) 0/39 (0%) 0/39 (0%) | 1/69 (1%) 0/36 (0%) 1/37 (3%) 2/38 (5%) |
|FIRST INCIDENCE (DAYS) | 726 (T) --- 693 --- | 726 (T) --- 726 (T) 726 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.420N P=0.410N P=0.721 P=0.410N | P=0.163 P=0.630N P=0.616 P=0.298 |
|INCIDENTAL TUMOR | P=0.454N P=0.410N P=0.702 P=0.410N | P=0.163 P=0.630N P=0.616 P=0.298 |
|LOGISTIC REGRESSION | P=0.420N P=0.410N P=0.726 P=0.410N | P=0.163 P=0.630N P=0.616 P=0.298 |
|COCHRAN-ARMITAGE | P=0.414N | P=0.147 |
|FISHER EXACT | P=0.443N P=0.742N P=0.443N | P=0.669N P=0.554 P=0.260 |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/120 (1%) 1/60 (2%) 0/60 (0%) 1/60 (2%) | 4/121 (3%) 0/59 (0%) 0/60 (0%) 3/61 (5%) |
|ADJUSTED (b) | 1.2% 2.6% 0.0% 2.6% | 5.8% 0.0% 0.0% 6.6% |
|INTERIM SACRIFICE 1 (c)| 0/19 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/9 (0%) 0/10 (0%) 1/10 (10%) |
|TERMINAL (d) | 1/81 (1%) 1/39 (3%) 0/39 (0%) 1/39 (3%) | 4/69 (6%) 0/36 (0%) 0/37 (0%) 1/38 (3%) |
|FIRST INCIDENCE (DAYS) | 726 (T) 726 (T) --- 726 (T) | 726 (T) --- --- 457 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.556 P=0.590 P=0.646N P=0.590 | P=0.218 P=0.176N P=0.170N P=0.483 |
|INCIDENTAL TUMOR | P=0.556 P=0.590 P=0.646N P=0.590 | P=0.203 P=0.176N P=0.170N P=0.459 |
|LOGISTIC REGRESSION | P=0.556 P=0.590 P=0.646N P=0.590 | P=0.198 P=0.176N P=0.170N P=0.449 |
|COCHRAN-ARMITAGE | P=0.563 | P=0.200 |
|FISHER EXACT | P=0.557 P=0.667N P=0.557 | P=0.201N P=0.196N P=0.434 |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05121 TEST: 07 PAGE 13
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 1 MG/KG 5 MG/KG 25 MG/KG | 0 MG/KG 1 MG/KG 5 MG/KG 25 MG/KG |
| | FEED RTD | FEED RTD |
|=================================================================================================================================|
| |
|Tooth |
| Odontoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/120 (1%) 1/60 (2%) 2/60 (3%) 1/60 (2%) | 0/121 (0%) 0/60 (0%) 0/60 (0%) 0/61 (0%) |
|ADJUSTED (b) | 1.2% 2.6% 5.1% 2.6% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/19 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/81 (1%) 1/39 (3%) 2/39 (5%) 1/39 (3%) | 0/69 (0%) 0/36 (0%) 0/37 (0%) 0/38 (0%) |
|FIRST INCIDENCE (DAYS) | 726 (T) 726 (T) 726 (T) 726 (T) | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.585 P=0.590 P=0.257 P=0.590 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.585 P=0.590 P=0.257 P=0.590 | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.585 P=0.590 P=0.257 P=0.590 | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.593 | (e) |
|FISHER EXACT | P=0.557 P=0.258 P=0.557 | (e) (e) (e) |
|=================================================================================================================================|
| |
|Uterus |
| Hemangiosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # # |
|----------- | | |
|OVERALL (a) | | 2/121 (2%) 0/60 (0%) 0/60 (0%) 0/61 (0%) |
|ADJUSTED (b) | | 2.9% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | | 2/69 (3%) 0/36 (0%) 0/37 (0%) 0/38 (0%) |
|FIRST INCIDENCE (DAYS) | | 726 (T) --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.413N P=0.391N P=0.384N P=0.377N |
|INCIDENTAL TUMOR | | P=0.413N P=0.391N P=0.384N P=0.377N |
|LOGISTIC REGRESSION | | P=0.413N P=0.391N P=0.384N P=0.377N |
|COCHRAN-ARMITAGE | | P=0.427N |
|FISHER EXACT | | P=0.446N P=0.446N P=0.441N |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05121 TEST: 07 PAGE 14
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 1 MG/KG 5 MG/KG 25 MG/KG | 0 MG/KG 1 MG/KG 5 MG/KG 25 MG/KG |
| | FEED RTD | FEED RTD |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # # |
|----------- | | |
|OVERALL (a) | | 2/121 (2%) 0/60 (0%) 0/60 (0%) 0/61 (0%) |
|ADJUSTED (b) | | 2.9% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | | 2/69 (3%) 0/36 (0%) 0/37 (0%) 0/38 (0%) |
|FIRST INCIDENCE (DAYS) | | 726 (T) --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.413N P=0.391N P=0.384N P=0.377N |
|INCIDENTAL TUMOR | | P=0.413N P=0.391N P=0.384N P=0.377N |
|LOGISTIC REGRESSION | | P=0.413N P=0.391N P=0.384N P=0.377N |
|COCHRAN-ARMITAGE | | P=0.427N |
|FISHER EXACT | | P=0.446N P=0.446N P=0.441N |
|=================================================================================================================================|
| |
|Uterus |
| Sarcoma Stromal or Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # # |
|----------- | | |
|OVERALL (a) | | 3/121 (2%) 1/60 (2%) 0/60 (0%) 0/61 (0%) |
|ADJUSTED (b) | | 4.3% 2.2% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | | 3/69 (4%) 0/36 (0%) 0/37 (0%) 0/38 (0%) |
|FIRST INCIDENCE (DAYS) | | 726 (T) 562 --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.225N P=0.561N P=0.252N P=0.246N |
|INCIDENTAL TUMOR | | P=0.248N P=0.595N P=0.252N P=0.246N |
|LOGISTIC REGRESSION | | P=0.233N P=0.573N P=0.252N P=0.246N |
|COCHRAN-ARMITAGE | | P=0.232N |
|FISHER EXACT | | P=0.596N P=0.296N P=0.291N |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05121 TEST: 07 PAGE 15
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 1 MG/KG 5 MG/KG 25 MG/KG | 0 MG/KG 1 MG/KG 5 MG/KG 25 MG/KG |
| | FEED RTD | FEED RTD |
|=================================================================================================================================|
| |
|All Organs |
| Hemangioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/120 (2%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | 0/121 (0%) 0/60 (0%) 1/60 (2%) 0/61 (0%) |
|ADJUSTED (b) | 2.4% 0.0% 0.0% 0.0% | 0.0% 0.0% 2.5% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/19 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/81 (1%) 0/39 (0%) 0/39 (0%) 0/39 (0%) | 0/69 (0%) 0/36 (0%) 0/37 (0%) 0/38 (0%) |
|FIRST INCIDENCE (DAYS) | 680 --- --- --- | --- --- 678 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.437N P=0.406N P=0.411N P=0.411N | P=0.820N (e) P=0.357 (e) |
|INCIDENTAL TUMOR | P=0.477N P=0.335N P=0.440N P=0.440N | P=0.861N (e) P=0.295 (e) |
|LOGISTIC REGRESSION | P=0.433N P=0.391N P=0.404N P=0.402N | P=0.819N (e) P=0.357 (e) |
|COCHRAN-ARMITAGE | P=0.429N | P=0.819N |
|FISHER EXACT | P=0.443N P=0.443N P=0.443N | (e) P=0.331 (e) |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 3/120 (3%) 2/60 (3%) 5/60 (8%) 0/60 (0%) | 7/121 (6%) 2/60 (3%) 1/60 (2%) 1/61 (2%) |
|ADJUSTED (b) | 3.7% 4.0% 11.2% 0.0% | 9.6% 4.5% 2.7% 2.6% |
|INTERIM SACRIFICE 1 (c)| 0/19 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 2/81 (2%) 0/39 (0%) 1/39 (3%) 0/39 (0%) | 4/69 (6%) 0/36 (0%) 1/37 (3%) 1/38 (3%) |
|FIRST INCIDENCE (DAYS) | 725 405 560 --- | 709 562 726 (T) 726 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.210N P=0.560 P=0.077 P=0.280N | P=0.187N P=0.355N P=0.173N P=0.165N |
|INCIDENTAL TUMOR | P=0.102N P=0.675 P=0.302 P=0.298N | P=0.233N P=0.405N P=0.207N P=0.201N |
|LOGISTIC REGRESSION | P=0.167N P=0.570 P=0.183 P=0.279N | P=0.198N P=0.362N P=0.188N P=0.179N |
|COCHRAN-ARMITAGE | P=0.201N | P=0.197N |
|FISHER EXACT | P=0.541 P=0.083 P=0.294N | P=0.377N P=0.192N P=0.186N |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05121 TEST: 07 PAGE 16
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 1 MG/KG 5 MG/KG 25 MG/KG | 0 MG/KG 1 MG/KG 5 MG/KG 25 MG/KG |
| | FEED RTD | FEED RTD |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma or Hemangioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 5/120 (4%) 2/60 (3%) 5/60 (8%) 0/60 (0%) | 7/121 (6%) 2/60 (3%) 2/60 (3%) 1/61 (2%) |
|ADJUSTED (b) | 6.0% 4.0% 11.2% 0.0% | 9.6% 4.5% 5.1% 2.6% |
|INTERIM SACRIFICE 1 (c)| 0/19 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 3/81 (4%) 0/39 (0%) 1/39 (3%) 0/39 (0%) | 4/69 (6%) 0/36 (0%) 1/37 (3%) 1/38 (3%) |
|FIRST INCIDENCE (DAYS) | 680 405 560 --- | 709 562 678 726 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.134N P=0.559N P=0.201 P=0.141N | P=0.187N P=0.355N P=0.341N P=0.165N |
|INCIDENTAL TUMOR | P=0.064N P=0.412N P=0.506 P=0.154N | P=0.238N P=0.405N P=0.411N P=0.201N |
|LOGISTIC REGRESSION | P=0.098N P=0.540N P=0.396 P=0.134N | P=0.197N P=0.362N P=0.369N P=0.179N |
|COCHRAN-ARMITAGE | P=0.125N | P=0.196N |
|FISHER EXACT | P=0.571N P=0.207 P=0.128N | P=0.377N P=0.377N P=0.186N |
|=================================================================================================================================|
| |
|All Organs |
| Histiocytic Sarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 3/120 (3%) 0/60 (0%) 0/60 (0%) 1/60 (2%) | 5/121 (4%) 2/60 (3%) 0/60 (0%) 1/61 (2%) |
|ADJUSTED (b) | 3.3% 0.0% 0.0% 2.5% | 5.6% 4.4% 0.0% 2.5% |
|INTERIM SACRIFICE 1 (c)| 0/19 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 2/81 (2%) 0/39 (0%) 0/39 (0%) 0/39 (0%) | 0/69 (0%) 0/36 (0%) 0/37 (0%) 0/38 (0%) |
|FIRST INCIDENCE (DAYS) | 447 --- --- 707 | 492 532 --- 691 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.689 P=0.272N P=0.275N P=0.583N | P=0.324N P=0.565N P=0.145N P=0.342N |
|INCIDENTAL TUMOR | P=0.689N P=0.252N P=0.252N P=0.533N | P=0.380N P=0.552N P=0.210N P=0.427N |
|LOGISTIC REGRESSION | P=0.697 P=0.271N P=0.269N P=0.569N | P=0.398N P=0.632N P=0.131N P=0.415N |
|COCHRAN-ARMITAGE | P=0.697 | P=0.315N |
|FISHER EXACT | P=0.294N P=0.294N P=0.593N | P=0.575N P=0.130N P=0.344N |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05121 TEST: 07 PAGE 17
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 1 MG/KG 5 MG/KG 25 MG/KG | 0 MG/KG 1 MG/KG 5 MG/KG 25 MG/KG |
| | FEED RTD | FEED RTD |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated |
| Cell Type |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 7/120 (6%) 2/60 (3%) 2/60 (3%) 3/60 (5%) | 15/121 (12%) 8/60 (13%) 9/60 (15%) 7/61 (11%) |
|ADJUSTED (b) | 8.5% 5.1% 5.0% 7.4% | 19.2% 21.6% 22.6% 16.2% |
|INTERIM SACRIFICE 1 (c)| 0/19 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 6/81 (7%) 2/39 (5%) 1/39 (3%) 2/39 (5%) | 10/69 (14%) 7/36 (19%) 7/37 (19%) 3/38 (8%) |
|FIRST INCIDENCE (DAYS) | 680 726 (T) 707 705 | 464 708 510 551 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.594 P=0.376N P=0.380N P=0.568N | P=0.416N P=0.552 P=0.448 P=0.480N |
|INCIDENTAL TUMOR | P=0.547 P=0.341N P=0.406N P=0.599N | P=0.491N P=0.534 P=0.356 P=0.581 |
|LOGISTIC REGRESSION | P=0.593 P=0.348N P=0.375N P=0.563N | P=0.502N P=0.524 P=0.382 P=0.597N |
|COCHRAN-ARMITAGE | P=0.610 | P=0.461N |
|FISHER EXACT | P=0.372N P=0.372N P=0.559N | P=0.515 P=0.393 P=0.532N |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 60/120 (50%) 32/60 (53%) 22/60 (37%) 19/60 (32%) | 39/121 (32%) 25/60 (42%) 21/60 (35%) 19/61 (31%) |
|ADJUSTED (b) | 63.4% 70.4% 47.6% 43.2% | 48.0% 62.0% 48.7% 44.7% |
|INTERIM SACRIFICE 1 (c)| 5/19 (26%) 4/10 (40%) 1/10 (10%) 1/10 (10%) | 1/20 (5%) 0/10 (0%) 0/10 (0%) 1/10 (10%) |
|TERMINAL (d) | 47/81 (58%) 26/39 (67%) 15/39 (38%) 15/39 (38%) | 28/69 (41%) 21/36 (58%) 15/37 (41%) 15/38 (39%) |
|FIRST INCIDENCE (DAYS) | 449 (I) 456 (I) 456 (I) 405 | 457 (I) 482 578 457 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.015N* P=0.297 P=0.113N P=0.028N* | P=0.250N P=0.184 P=0.512 P=0.394N |
|INCIDENTAL TUMOR | P=0.008N** P=0.429 P=0.060N P=0.010N* | P=0.338N P=0.151 P=0.335 P=0.513N |
|LOGISTIC REGRESSION | P=0.007N** P=0.511 P=0.055N P=0.010N* | P=0.335N P=0.122 P=0.372 P=0.523N |
|COCHRAN-ARMITAGE | P=0.008N** | P=0.334N |
|FISHER EXACT | P=0.396 P=0.062N P=0.014N* | P=0.139 P=0.417 P=0.511N |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05121 TEST: 07 PAGE 18
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE
TERMINAL SACRIFICE AT 104 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 1 MG/KG 5 MG/KG 25 MG/KG | 0 MG/KG 1 MG/KG 5 MG/KG 25 MG/KG |
| | FEED RTD | FEED RTD |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 28/120 (23%) 25/60 (42%) 16/60 (27%) 16/60 (27%) | 42/121 (35%) 22/60 (37%) 21/60 (35%) 14/61 (23%) |
|ADJUSTED (b) | 31.5% 49.8% 35.5% 35.6% | 45.7% 49.5% 47.7% 31.6% |
|INTERIM SACRIFICE 1 (c)| 0/19 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 21/81 (26%) 14/39 (36%) 10/39 (26%) 11/39 (28%) | 21/69 (30%) 14/36 (39%) 14/37 (38%) 8/38 (21%) |
|FIRST INCIDENCE (DAYS) | 447 405 560 405 | 464 532 510 551 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.480N P=0.011 * P=0.338 P=0.341 | P=0.049N* P=0.500 P=0.522N P=0.075N |
|INCIDENTAL TUMOR | P=0.375N P=0.037 * P=0.493 P=0.416 | P=0.074N P=0.413 P=0.317 P=0.136N |
|LOGISTIC REGRESSION | P=0.417N P=0.027 * P=0.504 P=0.381 | P=0.056N P=0.398 P=0.400 P=0.097N |
|COCHRAN-ARMITAGE | P=0.436N | P=0.048N* |
|FISHER EXACT | P=0.009 ** P=0.376 P=0.376 | P=0.460 P=0.548 P=0.072N |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 73/120 (61%) 45/60 (75%) 32/60 (53%) 31/60 (52%) | 69/121 (57%) 36/60 (60%) 35/60 (58%) 30/61 (49%) |
|ADJUSTED (b) | 74.2% 83.2% 66.6% 63.9% | 72.3% 78.0% 76.1% 65.0% |
|INTERIM SACRIFICE 1 (c)| 5/19 (26%) 4/10 (40%) 1/10 (10%) 2/10 (20%) | 1/20 (5%) 0/10 (0%) 0/10 (0%) 1/10 (10%) |
|TERMINAL (d) | 56/81 (69%) 30/39 (77%) 23/39 (59%) 22/39 (56%) | 43/69 (62%) 26/36 (72%) 26/37 (70%) 22/38 (58%) |
|FIRST INCIDENCE (DAYS) | 447 405 456 (I) 405 | 457 (I) 482 510 457 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.110N P=0.040 * P=0.332N P=0.257N | P=0.102N P=0.498 P=0.500N P=0.143N |
|INCIDENTAL TUMOR | P=0.022N* P=0.121 P=0.133N P=0.084N | P=0.175N P=0.388 P=0.252 P=0.294N |
|LOGISTIC REGRESSION | P=0.041N* P=0.080 P=0.107N P=0.119N | P=0.166N P=0.347 P=0.299 P=0.265N |
|COCHRAN-ARMITAGE | P=0.052N | P=0.139N |
|FISHER EXACT | P=0.041 * P=0.211N P=0.155N | P=0.413 P=0.498 P=0.199N |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05121 TEST: 07 PAGE 19
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SCOPOLAMINE HYDROBROMIDE TRIHYDRATE
TERMINAL SACRIFICE AT 104 WEEKS
(a) Number of tumor-bearing animals / number of animals examined at site.
(b) Kaplan-Meier estimated lifetime tumor incidence after adjustment for
intercurrent mortality.
(c) Observed incidence at interim kill.
Male interim sacrifices(days): 456
Female interim sacrifices(days): 457
(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).