TDMS Study 05035-02 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Mason 4-HYDROXYACETANILIDE DATE: 09/04/94
EXPERIMENT: 05035 TEST: 02 TIME: 22:38:30
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01CP9561902 ROUTE: DOSED FEED NTP C#: 55801
PATHOLOGIST: A. RUSSFIELD S. EUSTIS CAS: 103-90-2
------------------------------------------------------------------------------------------------------------------------------------
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Mason 4-HYDROXYACETANILIDE DATE: 09/04/94
EXPERIMENT: 05035 TEST: 02 TIME: 22:38:30
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01CP9561902 ROUTE: DOSED FEED NTP C#: 55801
PATHOLOGIST: A. RUSSFIELD S. EUSTIS CAS: 103-90-2
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 Gland
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 4-HYDROXYACETANILIDE DATE: 09/04/94
EXPERIMENT: 05035 TEST: 02 TIME: 22:38:30
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01CP9561902 ROUTE: DOSED FEED NTP C#: 55801
PATHOLOGIST: A. RUSSFIELD S. EUSTIS CAS: 103-90-2
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF THE STUDY OF 4-HYDROXYACETANILIDE
====================================================================================================
MALE MICE
-------------
ORGAN MORPHOLOGY
------- ------------
Adrenal Medulla Pheochromocytoma: Benign, Complex, Malignant, NOS
Liver Hepatocellular Adenoma
Hepatocellular Carcinoma
Hepatocellular Carcinoma or Hepatocellular Adenoma
Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
All Organs Malignant Lymphoma And Histiocytic Sarcoma
Malignant Tumors
Malignant and Benign Tumors
====================================================================================================
FEMALE MICE
-------------
ORGAN MORPHOLOGY
------- ------------
Skin: Subcutaneous Tissue Fibrosarcoma
Neurofibrosarcoma, Fibrosarcoma, Sarcoma,
Neurofibroma, or Fibroma
====================================================================================================
DATE: 09/05/94 EXPERIMENT: 05035 TEST: 02 PAGE 1
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4-HYDROXYACETANILIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 0.06% LM 0.3% MM 0.6% HM | CONTROL 0.06% LF 0.3% MF 0.6% HF |
| | UM | UF |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/47 (0%) 4/48 (8%) 1/48 (2%) 1/48 (2%) | 0/46 (0%) 0/46 (0%) 0/45 (0%) 0/48 (0%) |
|ADJUSTED (b) | 0.0% 9.9% 2.5% 3.4% | 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/31 (0%) 3/39 (8%) 0/30 (0%) 1/29 (3%) | 0/0 0/0 0/0 0/1 (0%) |
|FIRST INCIDENCE (DAYS) | --- 671 657 729 (T) | 0/24 (0%) 0/32 (0%) 0/22 (0%) 0/37 (0%) |
|-----------------------| | --- --- --- --- |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.455N P=0.095 P=0.521 P=0.487 | |
|INCIDENTAL TUMOR | P=0.365N P=0.054 P=0.674 P=0.487 | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.404N P=0.073 P=0.492 P=0.487 | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.391N | (e) (e) (e) (e) |
|FISHER EXACT | P=0.061 P=0.505 P=0.505 | (e) |
(e) (e) (e)
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/47 (0%) 5/48 (10%) 1/48 (2%) 1/48 (2%) | 1/46 (2%) 0/46 (0%) 0/45 (0%) 0/48 (0%) |
|ADJUSTED (b) | 0.0% 12.4% 2.5% 3.4% | 4.2% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/31 (0%) 4/39 (10%) 0/30 (0%) 1/29 (3%) | 0/0 0/0 0/0 0/1 (0%) |
|FIRST INCIDENCE (DAYS) | --- 671 657 729 (T) | 1/24 (4%) 0/32 (0%) 0/22 (0%) 0/37 (0%) |
|-----------------------| | 730 (T) --- --- --- |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.354N P=0.056 P=0.521 P=0.487 | |
|INCIDENTAL TUMOR | P=0.275N P=0.032 * P=0.674 P=0.487 | P=0.320N P=0.443N P=0.517N P=0.414N |
|LOGISTIC REGRESSION | P=0.303N P=0.041 * P=0.492 P=0.487 | P=0.320N P=0.443N P=0.517N P=0.414N |
|COCHRAN-ARMITAGE | P=0.290N | P=0.320N P=0.443N P=0.517N P=0.414N |
|FISHER EXACT | P=0.030 * P=0.505 P=0.505 | P=0.347N |
P=0.500N P=0.505N P=0.489N
|=================================================================================================================================|
DATE: 09/05/94 EXPERIMENT: 05035 TEST: 02 PAGE 2
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4-HYDROXYACETANILIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 0.06% LM 0.3% MM 0.6% HM | CONTROL 0.06% LF 0.3% MF 0.6% HF |
| | UM | UF |
|=================================================================================================================================|
| |
|Harderian Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 2/50 (4%) 3/50 (6%) 3/50 (6%) | 4/50 (8%) 2/50 (4%) 1/50 (2%) 2/51 (4%) |
|ADJUSTED (b) | 12.0% 5.0% 9.1% 8.6% | 12.2% 6.3% 4.0% 5.3% |
|TERMINAL (d) | 3/32 (9%) 2/40 (5%) 1/31 (3%) 2/31 (6%) | 0/0 0/0 0/0 0/1 (0%) |
|FIRST INCIDENCE (DAYS) | 703 729 (T) 709 523 | 1/27 (4%) 2/32 (6%) 1/25 (4%) 2/38 (5%) |
|-----------------------| | 635 730 (T) 730 (T) 730 (T) |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.539 P=0.246N P=0.514N P=0.514N | |
|INCIDENTAL TUMOR | P=0.561N P=0.311N P=0.369N P=0.524N | P=0.218N P=0.295N P=0.215N P=0.235N |
|LOGISTIC REGRESSION | P=0.564N P=0.275N P=0.440N P=0.511N | P=0.317N P=0.355N P=0.219N P=0.512N |
|COCHRAN-ARMITAGE | P=0.545N | P=0.260N P=0.325N P=0.212N P=0.301N |
|FISHER EXACT | P=0.339N P=0.500N P=0.500N | P=0.279N |
P=0.339N P=0.181N P=0.329N
|=================================================================================================================================|
| |
|Harderian Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 2/50 (4%) 3/50 (6%) 3/50 (6%) | 5/50 (10%) 2/50 (4%) 2/50 (4%) 2/51 (4%) |
|ADJUSTED (b) | 12.0% 5.0% 9.1% 8.6% | 14.3% 6.3% 7.1% 5.3% |
|TERMINAL (d) | 3/32 (9%) 2/40 (5%) 1/31 (3%) 2/31 (6%) | 0/0 0/0 0/0 0/1 (0%) |
|FIRST INCIDENCE (DAYS) | 703 729 (T) 709 523 | 1/27 (4%) 2/32 (6%) 1/25 (4%) 2/38 (5%) |
|-----------------------| | 611 730 (T) 684 730 (T) |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.539 P=0.246N P=0.514N P=0.514N | |
|INCIDENTAL TUMOR | P=0.561N P=0.311N P=0.369N P=0.524N | P=0.173N P=0.188N P=0.270N P=0.144N |
|LOGISTIC REGRESSION | P=0.564N P=0.275N P=0.440N P=0.511N | P=0.294N P=0.215N P=0.265N P=0.331N |
|COCHRAN-ARMITAGE | P=0.545N | P=0.214N P=0.211N P=0.252N P=0.200N |
|FISHER EXACT | P=0.339N P=0.500N P=0.500N | P=0.220N |
P=0.218N P=0.218N P=0.210N
|=================================================================================================================================|
DATE: 09/05/94 EXPERIMENT: 05035 TEST: 02 PAGE 3
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4-HYDROXYACETANILIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 0.06% LM 0.3% MM 0.6% HM | CONTROL 0.06% LF 0.3% MF 0.6% HF |
| | UM | UF |
|=================================================================================================================================|
| |
|Intestine Small |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 2/50 (4%) 0/50 (0%) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/51 (0%) |
|ADJUSTED (b) | 3.1% 2.5% 6.5% 0.0% | 3.7% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/32 (3%) 1/40 (3%) 2/31 (6%) 0/31 (0%) | 0/0 0/0 0/0 0/1 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 729 (T) --- | 1/27 (4%) 0/32 (0%) 0/25 (0%) 0/38 (0%) |
|-----------------------| | 730 (T) --- --- --- |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.419N P=0.711N P=0.489 P=0.506N | |
|INCIDENTAL TUMOR | P=0.419N P=0.711N P=0.489 P=0.506N | P=0.323N P=0.466N P=0.515N P=0.432N |
|LOGISTIC REGRESSION | P=0.419N P=0.711N P=0.489 P=0.506N | P=0.323N P=0.466N P=0.515N P=0.432N |
|COCHRAN-ARMITAGE | P=0.374N | P=0.323N P=0.466N P=0.515N P=0.432N |
|FISHER EXACT | P=0.753N P=0.500 P=0.500N | P=0.349N |
P=0.500N P=0.500N P=0.495N
|=================================================================================================================================|
| |
|Intestine Small: Jejunum |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 2/50 (4%) 0/50 (0%) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/51 (0%) |
|ADJUSTED (b) | 0.0% 2.5% 6.5% 0.0% | 3.7% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/32 (0%) 1/40 (3%) 2/31 (6%) 0/31 (0%) | 0/0 0/0 0/0 0/1 (0%) |
|FIRST INCIDENCE (DAYS) | --- 729 (T) 729 (T) --- | 1/27 (4%) 0/32 (0%) 0/25 (0%) 0/38 (0%) |
|-----------------------| | 730 (T) --- --- --- |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.629N P=0.545 P=0.231 (e) | |
|INCIDENTAL TUMOR | P=0.629N P=0.545 P=0.231 (e) | P=0.323N P=0.466N P=0.515N P=0.432N |
|LOGISTIC REGRESSION | P=0.629N P=0.545 P=0.231 (e) | P=0.323N P=0.466N P=0.515N P=0.432N |
|COCHRAN-ARMITAGE | P=0.588N | P=0.323N P=0.466N P=0.515N P=0.432N |
|FISHER EXACT | P=0.500 P=0.247 (e) | P=0.349N |
P=0.500N P=0.500N P=0.495N
|=================================================================================================================================|
DATE: 09/05/94 EXPERIMENT: 05035 TEST: 02 PAGE 4
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4-HYDROXYACETANILIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 0.06% LM 0.3% MM 0.6% HM | CONTROL 0.06% LF 0.3% MF 0.6% HF |
| | UM | UF |
|=================================================================================================================================|
| |
|Liver |
| Hemangiosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 2/50 (4%) 1/50 (2%) | 0/49 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|ADJUSTED (b) | 5.3% 2.5% 5.0% 2.4% | 0.0% 0.0% 3.8% 0.0% |
|TERMINAL (d) | 1/32 (3%) 1/40 (3%) 0/31 (0%) 0/31 (0%) | 0/0 0/0 0/0 0/1 (0%) |
|FIRST INCIDENCE (DAYS) | 541 729 (T) 650 570 | 0/27 (0%) 0/32 (0%) 0/25 (0%) 0/38 (0%) |
|-----------------------| | --- --- 726 --- |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.511N P=0.451N P=0.677N P=0.509N | |
|INCIDENTAL TUMOR | P=0.399N P=0.482N P=0.614N P=0.478N | P=0.675 (e) P=0.485 (e) |
|LOGISTIC REGRESSION | P=0.476N P=0.500N P=0.668 P=0.487N | P=0.475 (e) P=0.477 (e) |
|COCHRAN-ARMITAGE | P=0.479N | P=0.666 (e) P=0.483 (e) |
|FISHER EXACT | P=0.500N P=0.691N P=0.500N | P=0.651 |
(e) P=0.505 (e)
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 11/50 (22%) 8/50 (16%) 5/50 (10%) 4/50 (8%) | 3/49 (6%) 4/50 (8%) 7/50 (14%) 2/50 (4%) |
|ADJUSTED (b) | 29.4% 19.4% 14.7% 11.7% | 11.1% 11.9% 22.3% 5.3% |
|TERMINAL (d) | 7/32 (22%) 7/40 (18%) 4/31 (13%) 3/31 (10%) | 0/0 0/0 0/0 0/1 (0%) |
|FIRST INCIDENCE (DAYS) | 479 502 512 512 | 3/27 (11%) 3/32 (9%) 3/25 (12%) 2/38 (5%) |
|-----------------------| | 730 (T) 667 549 730 (T) |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.052N P=0.180N P=0.092N P=0.059N | |
|INCIDENTAL TUMOR | P=0.035N* P=0.349N P=0.087N P=0.054N | P=0.318N P=0.584 P=0.132 P=0.346N |
|LOGISTIC REGRESSION | P=0.030N* P=0.297N P=0.079N P=0.049N* | P=0.493N P=0.549 P=0.128 P=0.346N |
|COCHRAN-ARMITAGE | P=0.029N* | P=0.396N P=0.535 P=0.127 P=0.346N |
|FISHER EXACT | P=0.306N P=0.086N P=0.045N* | P=0.426N |
P=0.511 P=0.167 P=0.490N
|=================================================================================================================================|
DATE: 09/05/94 EXPERIMENT: 05035 TEST: 02 PAGE 5
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4-HYDROXYACETANILIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 0.06% LM 0.3% MM 0.6% HM | CONTROL 0.06% LF 0.3% MF 0.6% HF |
| | UM | UF |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 1/50 (2%) 6/50 (12%) 3/50 (6%) | 0/49 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|ADJUSTED (b) | 17.6% 2.5% 15.6% 8.7% | 0.0% 0.0% 0.0% 2.2% |
|TERMINAL (d) | 2/32 (6%) 1/40 (3%) 2/31 (6%) 1/31 (3%) | 0/0 0/0 0/0 0/1 (0%) |
|FIRST INCIDENCE (DAYS) | 563 729 (T) 647 637 | 0/27 (0%) 0/32 (0%) 0/25 (0%) 0/38 (0%) |
|-----------------------| | --- --- --- 596 |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.452N P=0.024N* P=0.465N P=0.182N | |
|INCIDENTAL TUMOR | P=0.210N P=0.232N P=0.338N P=0.129N | P=0.195 (e) (e) P=0.514 |
|LOGISTIC REGRESSION | P=0.231N P=0.153N P=0.264N P=0.145N | P=0.189 (e) (e) P=0.527 |
|COCHRAN-ARMITAGE | P=0.386N | P=0.176 (e) (e) P=0.436 |
|FISHER EXACT | P=0.030N* P=0.500N P=0.159N | P=0.188 |
(e) (e) P=0.505
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 16/50 (32%) 9/50 (18%) 10/50 (20%) 7/50 (14%) | 3/49 (6%) 4/50 (8%) 7/50 (14%) 3/50 (6%) |
|ADJUSTED (b) | 39.8% 21.8% 25.9% 19.7% | 11.1% 11.9% 22.3% 7.4% |
|TERMINAL (d) | 9/32 (28%) 8/40 (20%) 5/31 (16%) 4/31 (13%) | 0/0 0/0 0/0 0/1 (0%) |
|FIRST INCIDENCE (DAYS) | 479 502 512 512 | 3/27 (11%) 3/32 (9%) 3/25 (12%) 2/38 (5%) |
|-----------------------| | 730 (T) 667 549 596 |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.108N P=0.038N* P=0.136N P=0.046N* | |
|INCIDENTAL TUMOR | P=0.036N* P=0.202N P=0.079N P=0.030N* | P=0.461N P=0.584 P=0.132 P=0.520N |
|LOGISTIC REGRESSION | P=0.031N* P=0.080N P=0.057N P=0.031N* | P=0.480 P=0.549 P=0.128 P=0.515N |
|COCHRAN-ARMITAGE | P=0.054N | P=0.558N P=0.535 P=0.127 P=0.620N |
|FISHER EXACT | P=0.083N P=0.127N P=0.028N* | P=0.547 |
P=0.511 P=0.167 P=0.651N
|=================================================================================================================================|
DATE: 09/05/94 EXPERIMENT: 05035 TEST: 02 PAGE 6
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4-HYDROXYACETANILIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 0.06% LM 0.3% MM 0.6% HM | CONTROL 0.06% LF 0.3% MF 0.6% HF |
| | UM | UF |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 16/50 (32%) 9/50 (18%) 10/50 (20%) 7/50 (14%) | 3/49 (6%) 4/50 (8%) 7/50 (14%) 3/50 (6%) |
|ADJUSTED (b) | 39.8% 21.8% 25.9% 19.7% | 11.1% 11.9% 22.3% 7.4% |
|TERMINAL (d) | 9/32 (28%) 8/40 (20%) 5/31 (16%) 4/31 (13%) | 0/0 0/0 0/0 0/1 (0%) |
|FIRST INCIDENCE (DAYS) | 479 502 512 512 | 3/27 (11%) 3/32 (9%) 3/25 (12%) 2/38 (5%) |
|-----------------------| | 730 (T) 667 549 596 |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.108N P=0.038N* P=0.136N P=0.046N* | |
|INCIDENTAL TUMOR | P=0.036N* P=0.202N P=0.079N P=0.030N* | P=0.461N P=0.584 P=0.132 P=0.520N |
|LOGISTIC REGRESSION | P=0.031N* P=0.080N P=0.057N P=0.031N* | P=0.480 P=0.549 P=0.128 P=0.515N |
|COCHRAN-ARMITAGE | P=0.054N | P=0.558N P=0.535 P=0.127 P=0.620N |
|FISHER EXACT | P=0.083N P=0.127N P=0.028N* | P=0.547 |
P=0.511 P=0.167 P=0.651N
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 6/50 (12%) 5/50 (10%) 10/50 (20%) | 1/50 (2%) 4/50 (8%) 4/50 (8%) 4/51 (8%) |
|ADJUSTED (b) | 24.2% 15.0% 15.0% 29.8% | 3.7% 10.9% 14.7% 10.5% |
|TERMINAL (d) | 7/32 (22%) 6/40 (15%) 3/31 (10%) 8/31 (26%) | 0/0 0/0 0/0 0/1 (0%) |
|FIRST INCIDENCE (DAYS) | 718 729 (T) 687 563 | 1/27 (4%) 2/32 (6%) 3/25 (12%) 4/38 (11%) |
|-----------------------| | 730 (T) 638 659 730 (T) |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.166 P=0.228N P=0.299N P=0.368 | |
|INCIDENTAL TUMOR | P=0.215 P=0.273N P=0.204N P=0.368 | P=0.353 P=0.217 P=0.158 P=0.294 |
|LOGISTIC REGRESSION | P=0.208 P=0.248N P=0.256N P=0.378 | P=0.303 P=0.245 P=0.149 P=0.294 |
|COCHRAN-ARMITAGE | P=0.262 | P=0.277 P=0.182 P=0.145 P=0.294 |
|FISHER EXACT | P=0.387N P=0.277N P=0.398 | P=0.254 |
P=0.181 P=0.181 P=0.187
|=================================================================================================================================|
DATE: 09/05/94 EXPERIMENT: 05035 TEST: 02 PAGE 7
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4-HYDROXYACETANILIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 0.06% LM 0.3% MM 0.6% HM | CONTROL 0.06% LF 0.3% MF 0.6% HF |
| | UM | UF |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) |
|ADJUSTED (b) | 0.0% 2.4% 0.0% 5.3% | 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/32 (0%) 0/40 (0%) 0/31 (0%) 0/31 (0%) | 0/0 0/0 0/0 0/1 (0%) |
|FIRST INCIDENCE (DAYS) | --- 671 --- 632 | 0/27 (0%) 0/32 (0%) 0/25 (0%) 0/38 (0%) |
|-----------------------| | --- --- --- --- |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.156 P=0.531 (e) P=0.240 | |
|INCIDENTAL TUMOR | P=0.257 P=0.331 (e) P=0.246 | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.169 P=0.500 (e) P=0.237 | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.168 | (e) (e) (e) (e) |
|FISHER EXACT | P=0.500 (e) P=0.247 | (e) |
(e) (e) (e)
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 7/50 (14%) 5/50 (10%) 12/50 (24%) | 1/50 (2%) 4/50 (8%) 4/50 (8%) 4/51 (8%) |
|ADJUSTED (b) | 24.2% 17.0% 15.0% 33.6% | 3.7% 10.9% 14.7% 10.5% |
|TERMINAL (d) | 7/32 (22%) 6/40 (15%) 3/31 (10%) 8/31 (26%) | 0/0 0/0 0/0 0/1 (0%) |
|FIRST INCIDENCE (DAYS) | 718 671 687 563 | 1/27 (4%) 2/32 (6%) 3/25 (12%) 4/38 (11%) |
|-----------------------| | 730 (T) 638 659 730 (T) |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.085 P=0.325N P=0.299N P=0.210 | |
|INCIDENTAL TUMOR | P=0.137 P=0.427N P=0.204N P=0.207 | P=0.353 P=0.217 P=0.158 P=0.294 |
|LOGISTIC REGRESSION | P=0.115 P=0.391N P=0.256N P=0.206 | P=0.303 P=0.245 P=0.149 P=0.294 |
|COCHRAN-ARMITAGE | P=0.146 | P=0.277 P=0.182 P=0.145 P=0.294 |
|FISHER EXACT | P=0.500N P=0.277N P=0.227 | P=0.254 |
P=0.181 P=0.181 P=0.187
|=================================================================================================================================|
DATE: 09/05/94 EXPERIMENT: 05035 TEST: 02 PAGE 8
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4-HYDROXYACETANILIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 0.06% LM 0.3% MM 0.6% HM | CONTROL 0.06% LF 0.3% MF 0.6% HF |
| | UM | UF |
|=================================================================================================================================|
| |
|Ovary |
| Cystadenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | | 0/47 (0%) 2/49 (4%) 1/49 (2%) 0/51 (0%) |
|ADJUSTED (b) | | 0.0% 6.3% 3.8% 0.0% |
|TERMINAL (d) | | 0/0 0/0 0/0 0/1 (0%) |
|FIRST INCIDENCE (DAYS) | | 0/25 (0%) 2/32 (6%) 0/24 (0%) 0/38 (0%) |
|-----------------------| | --- 730 (T) 726 --- |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | |
|INCIDENTAL TUMOR | | P=0.297N P=0.294 P=0.485 (e) |
|LOGISTIC REGRESSION | | P=0.392N P=0.294 P=0.477 (e) |
|COCHRAN-ARMITAGE | | P=0.305N P=0.294 P=0.489 (e) |
|FISHER EXACT | | P=0.340N |
P=0.258 P=0.510 (e)
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 0/39 (0%) 0/39 (0%) 0/46 (0%) | 14/46 (30%) 16/43 (37%) 7/42 (17%) 14/46 (30%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 42.7% 48.8% 27.7% 39.3% |
|TERMINAL (d) | 0/31 (0%) 0/34 (0%) 0/24 (0%) 0/27 (0%) | 0/0 0/0 0/0 0/1 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- | 8/25 (32%) 12/28 (43%) 4/19 (21%) 12/33 (36%) |
|-----------------------| | 536 634 534 596 |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) (e) | |
|INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.183N P=0.531 P=0.181N P=0.317N |
|LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.348N P=0.351 P=0.172N P=0.554N |
|COCHRAN-ARMITAGE | (e) | P=0.301N P=0.342 P=0.179N P=0.553N |
|FISHER EXACT | (e) (e) (e) | P=0.310N |
P=0.326 P=0.103N P=0.589N
|=================================================================================================================================|
DATE: 09/05/94 EXPERIMENT: 05035 TEST: 02 PAGE 9
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4-HYDROXYACETANILIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 0.06% LM 0.3% MM 0.6% HM | CONTROL 0.06% LF 0.3% MF 0.6% HF |
| | UM | UF |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 0/39 (0%) 0/39 (0%) 0/46 (0%) | 15/46 (33%) 17/43 (40%) 8/42 (19%) 14/46 (30%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 46.1% 49.9% 30.0% 39.3% |
|TERMINAL (d) | 0/31 (0%) 0/34 (0%) 0/24 (0%) 0/27 (0%) | 0/0 0/0 0/0 0/1 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- | 9/25 (36%) 12/28 (43%) 4/19 (21%) 12/33 (36%) |
|-----------------------| | 536 549 534 596 |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) (e) | |
|INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.131N P=0.537 P=0.202N P=0.236N |
|LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.279N P=0.365 P=0.200N P=0.447N |
|COCHRAN-ARMITAGE | (e) | P=0.226N P=0.337 P=0.202N P=0.458N |
|FISHER EXACT | (e) (e) (e) | P=0.231N |
P=0.323 P=0.114N P=0.500N
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 2/50 (4%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) |
|ADJUSTED (b) | 3.1% 0.0% 6.5% 0.0% | 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/32 (3%) 0/40 (0%) 2/31 (6%) 0/31 (0%) | 0/0 0/0 0/0 0/1 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) --- 729 (T) --- | 0/27 (0%) 0/32 (0%) 0/25 (0%) 0/38 (0%) |
|-----------------------| | --- --- --- --- |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.571N P=0.455N P=0.489 P=0.506N | |
|INCIDENTAL TUMOR | P=0.571N P=0.455N P=0.489 P=0.506N | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.571N P=0.455N P=0.489 P=0.506N | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.529N | (e) (e) (e) (e) |
|FISHER EXACT | P=0.500N P=0.500 P=0.500N | (e) |
(e) (e) (e)
|=================================================================================================================================|
DATE: 09/05/94 EXPERIMENT: 05035 TEST: 02 PAGE 10
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4-HYDROXYACETANILIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 0.06% LM 0.3% MM 0.6% HM | CONTROL 0.06% LF 0.3% MF 0.6% HF |
| | UM | UF |
|=================================================================================================================================|
| |
|Skin |
| Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma, |
| Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 2/50 (4%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) |
|ADJUSTED (b) | 5.5% 2.5% 6.5% 0.0% | 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/32 (3%) 1/40 (3%) 2/31 (6%) 0/31 (0%) | 0/0 0/0 0/0 0/1 (0%) |
|FIRST INCIDENCE (DAYS) | 578 729 (T) 729 (T) --- | 0/27 (0%) 0/32 (0%) 0/25 (0%) 0/38 (0%) |
|-----------------------| | --- --- --- --- |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.259N P=0.443N P=0.692N P=0.246N | |
|INCIDENTAL TUMOR | P=0.213N P=0.711N P=0.659 P=0.219N | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.231N P=0.499N P=0.682N P=0.238N | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.227N | (e) (e) (e) (e) |
|FISHER EXACT | P=0.500N P=0.691N P=0.247N | (e) |
(e) (e) (e)
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Fibrosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 5/50 (10%) 3/50 (6%) 6/50 (12%) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 1/51 (2%) |
|ADJUSTED (b) | 13.0% 12.1% 7.9% 15.8% | 0.0% 0.0% 6.1% 2.6% |
|TERMINAL (d) | 2/32 (6%) 4/40 (10%) 1/31 (3%) 1/31 (3%) | 0/0 0/0 0/0 0/1 (0%) |
|FIRST INCIDENCE (DAYS) | 463 671 654 523 | 0/27 (0%) 0/32 (0%) 0/25 (0%) 0/38 (0%) |
|-----------------------| | --- --- 642 661 |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.396 P=0.527N P=0.346N P=0.485 | |
|INCIDENTAL TUMOR | P=0.535 P=0.578 P=0.277N P=0.468 | P=0.229 (e) P=0.215 P=0.527 |
|LOGISTIC REGRESSION | P=0.462 P=0.631N P=0.417N P=0.506 | P=0.049 * (e) P=0.215 P=0.077 |
|COCHRAN-ARMITAGE | P=0.463 | P=0.212 (e) P=0.227 P=0.501 |
|FISHER EXACT | P=0.630N P=0.357N P=0.500 | P=0.213 |
(e) P=0.247 P=0.505
|=================================================================================================================================|
DATE: 09/05/94 EXPERIMENT: 05035 TEST: 02 PAGE 11
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4-HYDROXYACETANILIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 0.06% LM 0.3% MM 0.6% HM | CONTROL 0.06% LF 0.3% MF 0.6% HF |
| | UM | UF |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Neurofibrosarcoma, Fibrosarcoma, Sarcoma, |
| Neurofibroma, or Fibroma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 5/50 (10%) 3/50 (6%) 6/50 (12%) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 1/51 (2%) |
|ADJUSTED (b) | 13.0% 12.1% 7.9% 15.8% | 0.0% 0.0% 6.1% 2.6% |
|TERMINAL (d) | 2/32 (6%) 4/40 (10%) 1/31 (3%) 1/31 (3%) | 0/0 0/0 0/0 0/1 (0%) |
|FIRST INCIDENCE (DAYS) | 463 671 654 523 | 0/27 (0%) 0/32 (0%) 0/25 (0%) 0/38 (0%) |
|-----------------------| | --- --- 642 661 |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.396 P=0.527N P=0.346N P=0.485 | |
|INCIDENTAL TUMOR | P=0.535 P=0.578 P=0.277N P=0.468 | P=0.229 (e) P=0.215 P=0.527 |
|LOGISTIC REGRESSION | P=0.462 P=0.631N P=0.417N P=0.506 | P=0.049 * (e) P=0.215 P=0.077 |
|COCHRAN-ARMITAGE | P=0.463 | P=0.212 (e) P=0.227 P=0.501 |
|FISHER EXACT | P=0.630N P=0.357N P=0.500 | P=0.213 |
(e) P=0.247 P=0.505
|=================================================================================================================================|
| |
|Spleen |
| Hemangiosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/49 (0%) 0/48 (0%) | 0/49 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 6.3% 0.0% 0.0% 0.0% | 0.0% 3.0% 0.0% 0.0% |
|TERMINAL (d) | 2/32 (6%) 0/40 (0%) 0/30 (0%) 0/31 (0%) | 0/0 0/0 0/0 0/1 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) --- --- --- | 0/27 (0%) 0/32 (0%) 0/25 (0%) 0/38 (0%) |
|-----------------------| | --- 691 --- --- |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.180N P=0.191N P=0.252N P=0.245N | |
|INCIDENTAL TUMOR | P=0.180N P=0.191N P=0.252N P=0.245N | P=0.432N P=0.500 (e) (e) |
|LOGISTIC REGRESSION | P=0.180N P=0.191N P=0.251N P=0.245N | P=0.667N P=0.419 (e) (e) |
|COCHRAN-ARMITAGE | P=0.165N | P=0.445N P=0.506 (e) (e) |
|FISHER EXACT | P=0.247N P=0.253N P=0.258N | P=0.447N |
P=0.505 (e) (e)
|=================================================================================================================================|
DATE: 09/05/94 EXPERIMENT: 05035 TEST: 02 PAGE 12
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4-HYDROXYACETANILIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 0.06% LM 0.3% MM 0.6% HM | CONTROL 0.06% LF 0.3% MF 0.6% HF |
| | UM | UF |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Squamous Cell Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 3/50 (6%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/51 (0%) |
|ADJUSTED (b) | 3.1% 0.0% 8.7% 6.5% | 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/32 (3%) 0/40 (0%) 2/31 (6%) 2/31 (6%) | 0/0 0/0 0/0 0/1 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) --- 654 729 (T) | 0/27 (0%) 0/32 (0%) 0/25 (0%) 0/38 (0%) |
|-----------------------| | --- --- --- --- |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.148 P=0.455N P=0.307 P=0.489 | |
|INCIDENTAL TUMOR | P=0.159 P=0.455N P=0.351 P=0.489 | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.168 P=0.455N P=0.327 P=0.489 | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.185 | (e) (e) (e) (e) |
|FISHER EXACT | P=0.500N P=0.309 P=0.500 | (e) |
(e) (e) (e)
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 1/49 (2%) 2/50 (4%) 1/50 (2%) | 0/48 (0%) 1/50 (2%) 1/50 (2%) 2/50 (4%) |
|ADJUSTED (b) | 6.3% 2.5% 6.5% 3.2% | 0.0% 3.1% 4.0% 5.4% |
|TERMINAL (d) | 2/32 (6%) 1/40 (3%) 2/31 (6%) 1/31 (3%) | 0/0 0/0 0/0 0/1 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 729 (T) 729 (T) | 0/27 (0%) 1/32 (3%) 1/25 (4%) 2/37 (5%) |
|-----------------------| | --- 730 (T) 730 (T) 730 (T) |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.538N P=0.422N P=0.684 P=0.511N | |
|INCIDENTAL TUMOR | P=0.538N P=0.422N P=0.684 P=0.511N | P=0.228 P=0.534 P=0.485 P=0.310 |
|LOGISTIC REGRESSION | P=0.538N P=0.422N P=0.684 P=0.511N | P=0.228 P=0.534 P=0.485 P=0.310 |
|COCHRAN-ARMITAGE | P=0.470N | P=0.228 P=0.534 P=0.485 P=0.310 |
|FISHER EXACT | P=0.500N P=0.684N P=0.492N | P=0.173 |
P=0.510 P=0.510 P=0.258
|=================================================================================================================================|
DATE: 09/05/94 EXPERIMENT: 05035 TEST: 02 PAGE 13
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4-HYDROXYACETANILIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 0.06% LM 0.3% MM 0.6% HM | CONTROL 0.06% LF 0.3% MF 0.6% HF |
| | UM | UF |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/49 (6%) 1/49 (2%) 3/50 (6%) 1/50 (2%) | 0/48 (0%) 1/50 (2%) 2/50 (4%) 2/50 (4%) |
|ADJUSTED (b) | 9.4% 2.5% 9.0% 3.2% | 0.0% 3.1% 8.0% 5.4% |
|TERMINAL (d) | 3/32 (9%) 1/40 (3%) 2/31 (6%) 1/31 (3%) | 0/0 0/0 0/0 0/1 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 666 729 (T) | 0/27 (0%) 1/32 (3%) 2/25 (8%) 2/37 (5%) |
|-----------------------| | --- 730 (T) 730 (T) 730 (T) |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.436N P=0.229N P=0.653 P=0.316N | |
|INCIDENTAL TUMOR | P=0.415N P=0.229N P=0.629N P=0.316N | P=0.229 P=0.534 P=0.221 P=0.310 |
|LOGISTIC REGRESSION | P=0.401N P=0.229N P=0.641N P=0.316N | P=0.229 P=0.534 P=0.221 P=0.310 |
|COCHRAN-ARMITAGE | P=0.364N | P=0.229 P=0.534 P=0.221 P=0.310 |
|FISHER EXACT | P=0.309N P=0.651N P=0.301N | P=0.170 |
P=0.510 P=0.258 P=0.258
|=================================================================================================================================|
| |
|All Organs |
| Hemangioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 1/51 (2%) |
|ADJUSTED (b) | 0.0% 2.5% 2.9% 0.0% | 0.0% 6.3% 0.0% 2.6% |
|TERMINAL (d) | 0/32 (0%) 1/40 (3%) 0/31 (0%) 0/31 (0%) | 0/0 0/0 0/0 0/1 (0%) |
|FIRST INCIDENCE (DAYS) | --- 729 (T) 687 --- | 0/27 (0%) 2/32 (6%) 0/25 (0%) 1/38 (3%) |
|-----------------------| | --- 730 (T) --- 730 (T) |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.563N P=0.545 P=0.500 (e) | |
|INCIDENTAL TUMOR | P=0.524N P=0.545 P=0.623 (e) | P=0.572N P=0.276 (e) P=0.568 |
|LOGISTIC REGRESSION | P=0.544N P=0.545 P=0.506 (e) | P=0.572N P=0.276 (e) P=0.568 |
|COCHRAN-ARMITAGE | P=0.536N | P=0.573N P=0.276 (e) P=0.568 |
|FISHER EXACT | P=0.500 P=0.500 (e) | P=0.639N |
P=0.247 (e) P=0.505
|=================================================================================================================================|
DATE: 09/05/94 EXPERIMENT: 05035 TEST: 02 PAGE 14
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4-HYDROXYACETANILIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 0.06% LM 0.3% MM 0.6% HM | CONTROL 0.06% LF 0.3% MF 0.6% HF |
| | UM | UF |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 2/50 (4%) 2/50 (4%) 1/50 (2%) | 2/50 (4%) 3/50 (6%) 1/50 (2%) 0/51 (0%) |
|ADJUSTED (b) | 11.4% 5.0% 5.0% 2.4% | 4.9% 9.1% 3.8% 0.0% |
|TERMINAL (d) | 3/32 (9%) 2/40 (5%) 0/31 (0%) 0/31 (0%) | 0/0 0/0 0/0 0/1 (0%) |
|FIRST INCIDENCE (DAYS) | 541 729 (T) 650 570 | 0/27 (0%) 2/32 (6%) 0/25 (0%) 0/38 (0%) |
|-----------------------| | 536 691 726 --- |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.192N P=0.258N P=0.333N P=0.192N | |
|INCIDENTAL TUMOR | P=0.134N P=0.276N P=0.276N P=0.175N | P=0.067N P=0.537 P=0.532N P=0.227N |
|LOGISTIC REGRESSION | P=0.161N P=0.327N P=0.335N P=0.181N | P=0.156N P=0.378 P=0.552N P=0.620N |
|COCHRAN-ARMITAGE | P=0.160N | P=0.077N P=0.494 P=0.489N P=0.219N |
|FISHER EXACT | P=0.339N P=0.339N P=0.181N | P=0.076N |
P=0.500 P=0.500N P=0.243N
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma or Hemangioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 2/50 (4%) 3/50 (6%) 1/50 (2%) | 2/50 (4%) 4/50 (8%) 1/50 (2%) 1/51 (2%) |
|ADJUSTED (b) | 11.4% 5.0% 7.8% 2.4% | 4.9% 12.1% 3.8% 2.6% |
|TERMINAL (d) | 3/32 (9%) 2/40 (5%) 0/31 (0%) 0/31 (0%) | 0/0 0/0 0/0 0/1 (0%) |
|FIRST INCIDENCE (DAYS) | 541 729 (T) 650 570 | 0/27 (0%) 3/32 (9%) 0/25 (0%) 1/38 (3%) |
|-----------------------| | 536 691 726 730 (T) |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.232N P=0.258N P=0.493N P=0.192N | |
|INCIDENTAL TUMOR | P=0.155N P=0.276N P=0.389N P=0.175N | P=0.134N P=0.385 P=0.532N P=0.447N |
|LOGISTIC REGRESSION | P=0.195N P=0.327N P=0.498N P=0.181N | P=0.274N P=0.251 P=0.552N P=0.724 |
|COCHRAN-ARMITAGE | P=0.193N | P=0.164N P=0.335 P=0.489N P=0.497N |
|FISHER EXACT | P=0.339N P=0.500N P=0.181N | P=0.163N |
P=0.339 P=0.500N P=0.492N
|=================================================================================================================================|
DATE: 09/05/94 EXPERIMENT: 05035 TEST: 02 PAGE 15
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4-HYDROXYACETANILIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 0.06% LM 0.3% MM 0.6% HM | CONTROL 0.06% LF 0.3% MF 0.6% HF |
| | UM | UF |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Lymphoma And Histiocytic Sarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 4/50 (8%) 4/50 (8%) 2/50 (4%) | 11/50 (22%) 11/50 (22%) 8/50 (16%) 17/51 (33%) |
|ADJUSTED (b) | 22.8% 9.7% 12.0% 6.5% | 30.1% 27.9% 28.5% 37.1% |
|TERMINAL (d) | 6/32 (19%) 3/40 (8%) 2/31 (6%) 2/31 (6%) | 0/0 0/0 0/0 1/1 (100%) |
|FIRST INCIDENCE (DAYS) | 267 651 687 729 (T) | 5/27 (19%) 6/32 (19%) 5/25 (20%) 10/38 (26%) |
|-----------------------| | 506 516 701 457 (I) |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.085N P=0.106N P=0.197N P=0.055N | |
|INCIDENTAL TUMOR | P=0.061N P=0.150N P=0.185N P=0.050N | P=0.320 P=0.495N P=0.397N P=0.417 |
|LOGISTIC REGRESSION | P=0.056N P=0.175N P=0.165N P=0.050N | P=0.097 P=0.577 P=0.394N P=0.116 |
|COCHRAN-ARMITAGE | P=0.055N | P=0.110 P=0.580 P=0.379N P=0.131 |
|FISHER EXACT | P=0.178N P=0.178N P=0.046N* | P=0.110 |
P=0.595N P=0.306N P=0.147
|=================================================================================================================================|
| |
|All Organs |
| Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, |
| NOS, or Undifferentiated Cell Type |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 4/50 (8%) 3/50 (6%) 2/50 (4%) | 10/50 (20%) 10/50 (20%) 7/50 (14%) 16/51 (31%) |
|ADJUSTED (b) | 19.9% 9.7% 9.4% 6.5% | 26.9% 25.1% 24.9% 35.8% |
|TERMINAL (d) | 5/32 (16%) 3/40 (8%) 2/31 (6%) 2/31 (6%) | 0/0 0/0 0/0 1/1 (100%) |
|FIRST INCIDENCE (DAYS) | 267 651 715 729 (T) | 4/27 (15%) 5/32 (16%) 4/25 (16%) 10/38 (26%) |
|-----------------------| | 506 516 701 457 (I) |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.101N P=0.173N P=0.175N P=0.092N | |
|INCIDENTAL TUMOR | P=0.079N P=0.236N P=0.190N P=0.085N | P=0.296 P=0.510N P=0.386N P=0.397 |
|LOGISTIC REGRESSION | P=0.070N P=0.259N P=0.152N P=0.084N | P=0.087 P=0.564 P=0.382N P=0.126 |
|COCHRAN-ARMITAGE | P=0.068N | P=0.102 P=0.579 P=0.358N P=0.128 |
|FISHER EXACT | P=0.262N P=0.159N P=0.080N | P=0.102 |
P=0.598N P=0.298N P=0.140
|=================================================================================================================================|
DATE: 09/05/94 EXPERIMENT: 05035 TEST: 02 PAGE 16
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4-HYDROXYACETANILIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 0.06% LM 0.3% MM 0.6% HM | CONTROL 0.06% LF 0.3% MF 0.6% HF |
| | UM | UF |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 23/50 (46%) 22/50 (44%) 21/50 (42%) 20/50 (40%) | 22/50 (44%) 22/50 (44%) 17/50 (34%) 22/51 (43%) |
|ADJUSTED (b) | 60.1% 52.3% 54.4% 56.3% | 61.6% 57.5% 51.7% 54.8% |
|TERMINAL (d) | 17/32 (53%) 20/40 (50%) 14/31 (45%) 16/31 (52%) | 0/0 0/0 0/0 0/1 (0%) |
|FIRST INCIDENCE (DAYS) | 479 502 512 512 | 14/27 (52%) 16/32 (50%) 10/25 (40%) 20/38 (53%) |
|-----------------------| | 536 634 534 596 |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.532 P=0.188N P=0.441N P=0.396N | |
|INCIDENTAL TUMOR | P=0.374N P=0.430N P=0.295N P=0.392N | P=0.167N P=0.370N P=0.335N P=0.151N |
|LOGISTIC REGRESSION | P=0.339N P=0.430N P=0.302N P=0.374N | P=0.418N P=0.483N P=0.324N P=0.388N |
|COCHRAN-ARMITAGE | P=0.299N | P=0.375N P=0.543N P=0.336N P=0.437N |
|FISHER EXACT | P=0.500N P=0.420N P=0.343N | P=0.428N |
P=0.580N P=0.206N P=0.545N
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 25/50 (50%) 14/50 (28%) 17/50 (34%) 13/50 (26%) | 20/50 (40%) 15/50 (30%) 14/50 (28%) 19/51 (37%) |
|ADJUSTED (b) | 56.3% 32.6% 40.6% 31.8% | 50.0% 38.1% 42.0% 39.9% |
|TERMINAL (d) | 13/32 (41%) 11/40 (28%) 7/31 (23%) 4/31 (13%) | 0/0 0/0 0/0 1/1 (100%) |
|FIRST INCIDENCE (DAYS) | 267 651 647 523 | 9/27 (33%) 9/32 (28%) 6/25 (24%) 10/38 (26%) |
|-----------------------| | 506 516 642 251 |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.136N P=0.009N** P=0.112N P=0.035N* | |
|INCIDENTAL TUMOR | P=0.011N* P=0.086N P=0.022N* P=0.008N** | P=0.289N P=0.146N P=0.269N P=0.193N |
|LOGISTIC REGRESSION | P=0.024N* P=0.020N* P=0.085N P=0.012N* | P=0.377 P=0.227N P=0.244N P=0.525N |
|COCHRAN-ARMITAGE | P=0.046N* | P=0.522 P=0.207N P=0.250N P=0.537N |
|FISHER EXACT | P=0.020N* P=0.078N P=0.011N* | P=0.523 |
P=0.201N P=0.146N P=0.469N
|=================================================================================================================================|
DATE: 09/05/94 EXPERIMENT: 05035 TEST: 02 PAGE 17
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- 4-HYDROXYACETANILIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | CONTROL 0.06% LM 0.3% MM 0.6% HM | CONTROL 0.06% LF 0.3% MF 0.6% HF |
| | UM | UF |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 35/50 (70%) 29/50 (58%) 31/50 (62%) 28/50 (56%) | 35/50 (70%) 28/50 (56%) 24/50 (48%) 35/51 (69%) |
|ADJUSTED (b) | 77.6% 65.9% 70.1% 66.3% | 81.0% 67.7% 66.2% 72.8% |
|TERMINAL (d) | 22/32 (69%) 25/40 (63%) 18/31 (58%) 17/31 (55%) | 0/0 0/0 0/0 1/1 (100%) |
|FIRST INCIDENCE (DAYS) | 267 502 512 512 | 19/27 (70%) 19/32 (59%) 13/25 (52%) 25/38 (66%) |
|-----------------------| | 506 516 534 251 |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.466N P=0.030N* P=0.314N P=0.207N | |
|INCIDENTAL TUMOR | P=0.121N P=0.238N P=0.124N P=0.113N | P=0.210N P=0.061N P=0.123N P=0.085N |
|LOGISTIC REGRESSION | P=0.143N P=0.136N P=0.195N P=0.133N | P=0.385 P=0.093N P=0.064N P=0.517N |
|COCHRAN-ARMITAGE | P=0.173N | P=0.440 P=0.093N P=0.060N P=0.520N |
|FISHER EXACT | P=0.149N P=0.263N P=0.107N | P=0.444 |
P=0.107N P=0.021N* P=0.526N
|=================================================================================================================================|
(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):
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).
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