TDMS Study 89006-02 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst AZT/INTERFERON A/INTERFERON AD DATE: 08/21/96
EXPERIMENT: 89006 TEST: 02 TIME: 12:06:39
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-85225 ROUTE: GAVAGE NTP C#: C89006
PATHOLOGIST: JAMES E. HEATH CAS: 30516-871
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: Southern Research Inst AZT/INTERFERON A/INTERFERON AD DATE: 08/21/96
EXPERIMENT: 89006 TEST: 02 TIME: 12:06:39
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-85225 ROUTE: GAVAGE NTP C#: C89006
PATHOLOGIST: JAMES E. HEATH CAS: 30516-871
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF THE STUDY OF AZT/INTERFERON A/INTERFERON AD
====================================================================================================
MALE MICE
-------------
ORGAN MORPHOLOGY
------- ------------
Adrenal Cortex Adenoma
Liver Hepatocellular Carcinoma
Hepatocellular Carcinoma or Hepatoblastoma
Hepatocellular Carcinoma or Hepatocellular Adenoma
Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
Lung Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
Thyroid Gland: Follicular Cell
Adenoma
Carcinoma or Adenoma
All Organs Malignant and Benign Tumors
====================================================================================================
FEMALE MICE
-------------
ORGAN MORPHOLOGY
------- ------------
Liver Hemangiosarcoma
Hepatocellular Adenoma
Hepatocellular Carcinoma
Hepatocellular Carcinoma or Hepatoblastoma
Vagina Squamous Cell Carcinoma
All Organs Hemangiosarcoma
Histiocytic Sarcoma
Malignant Tumors
====================================================================================================
DATE: 08/21/96 EXPERIMENT: 89006 TEST: 02 PAGE 1
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- AZT/INTERFERON A/INTERFERON AD
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 30 MG/KG 60 MG/KG 120MG/KG | VEHICLE 30 MG/KG 60 MG/KG 120MG/KG |
| | CONTROL 500 U 500 U 500 U | CONTROL 500 U 500 U 500 U |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 3/50 (6%) | 1/49 (2%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 2.6% 8.3% | 3.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 1/38 (3%) 2/35 (6%) | 1/33 (3%) 0/32 (0%) 0/32 (0%) 0/24 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 731 (T) 727 | 729 (T) --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.027 * (e) P=0.511 P=0.120 | P=0.207N P=0.506N P=0.506N P=0.564N |
|INCIDENTAL TUMOR | P=0.025 * (e) P=0.511 P=0.127 | P=0.207N P=0.506N P=0.506N P=0.564N |
|LOGISTIC REGRESSION | P=0.024 * (e) P=0.511 P=0.113 | P=0.207N P=0.506N P=0.506N P=0.564N |
|COCHRAN-ARMITAGE | P=0.021 * | P=0.184N |
|FISHER EXACT | (e) P=0.500 P=0.121 | P=0.495N P=0.495N P=0.500N |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Malignant |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | 0/49 (0%) 0/49 (0%) 2/49 (4%) 0/48 (0%) |
|ADJUSTED (b) | 2.0% 0.0% 0.0% 0.0% | 0.0% 0.0% 6.3% 0.0% |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 0/38 (0%) 0/35 (0%) | 0/33 (0%) 0/31 (0%) 2/32 (6%) 0/24 (0%) |
|FIRST INCIDENCE (DAYS) | 374 --- --- --- | --- --- 729 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.186N P=0.513N P=0.508N P=0.496N | P=0.320 (e) P=0.231 (e) |
|INCIDENTAL TUMOR | P=0.284N P=0.500N (e) P=0.557N | P=0.320 (e) P=0.231 (e) |
|LOGISTIC REGRESSION | P=0.150N P=0.289N P=0.324N P=0.557N | P=0.320 (e) P=0.231 (e) |
|COCHRAN-ARMITAGE | P=0.185N | P=0.371 |
|FISHER EXACT | P=0.500N P=0.500N P=0.500N | (e) P=0.247 (e) |
|=================================================================================================================================|
DATE: 08/21/96 EXPERIMENT: 89006 TEST: 02 PAGE 2
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- AZT/INTERFERON A/INTERFERON AD
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 30 MG/KG 60 MG/KG 120MG/KG | VEHICLE 30 MG/KG 60 MG/KG 120MG/KG |
| | CONTROL 500 U 500 U 500 U | CONTROL 500 U 500 U 500 U |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | 0/49 (0%) 1/49 (2%) 2/49 (4%) 0/48 (0%) |
|ADJUSTED (b) | 2.0% 0.0% 0.0% 0.0% | 0.0% 3.2% 6.3% 0.0% |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 0/38 (0%) 0/35 (0%) | 0/33 (0%) 1/31 (3%) 2/32 (6%) 0/24 (0%) |
|FIRST INCIDENCE (DAYS) | 374 --- --- --- | --- 729 (T) 729 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.186N P=0.513N P=0.508N P=0.496N | P=0.431 P=0.488 P=0.231 (e) |
|INCIDENTAL TUMOR | P=0.284N P=0.500N (e) P=0.557N | P=0.431 P=0.488 P=0.231 (e) |
|LOGISTIC REGRESSION | P=0.150N P=0.289N P=0.324N P=0.557N | P=0.431 P=0.488 P=0.231 (e) |
|COCHRAN-ARMITAGE | P=0.185N | P=0.495 |
|FISHER EXACT | P=0.500N P=0.500N P=0.500N | P=0.500 P=0.247 (e) |
|=================================================================================================================================|
| |
|Harderian Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 3/50 (6%) 1/50 (2%) 2/50 (4%) | 0/50 (0%) 2/50 (4%) 1/50 (2%) 0/49 (0%) |
|ADJUSTED (b) | 7.2% 10.4% 2.1% 5.7% | 0.0% 6.3% 3.1% 0.0% |
|TERMINAL (d) | 1/36 (3%) 2/27 (7%) 0/38 (0%) 2/35 (6%) | 0/33 (0%) 2/32 (6%) 1/32 (3%) 0/24 (0%) |
|FIRST INCIDENCE (DAYS) | 618 708 563 731 (T) | --- 729 (T) 729 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.255N P=0.542 P=0.300N P=0.506N | P=0.571N P=0.231 P=0.494 (e) |
|INCIDENTAL TUMOR | P=0.233N P=0.615N P=0.187N P=0.435N | P=0.571N P=0.231 P=0.494 (e) |
|LOGISTIC REGRESSION | P=0.266N P=0.622 P=0.280N P=0.503N | P=0.571N P=0.231 P=0.494 (e) |
|COCHRAN-ARMITAGE | P=0.271N | P=0.505N |
|FISHER EXACT | P=0.661N P=0.309N P=0.500N | P=0.247 P=0.500 (e) |
|=================================================================================================================================|
DATE: 08/21/96 EXPERIMENT: 89006 TEST: 02 PAGE 3
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- AZT/INTERFERON A/INTERFERON AD
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 30 MG/KG 60 MG/KG 120MG/KG | VEHICLE 30 MG/KG 60 MG/KG 120MG/KG |
| | CONTROL 500 U 500 U 500 U | CONTROL 500 U 500 U 500 U |
|=================================================================================================================================|
| |
|Harderian Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 5.0% | 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 0/38 (0%) 1/35 (3%) | 0/33 (0%) 0/32 (0%) 0/32 (0%) 0/24 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- 632 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.066 (e) (e) P=0.242 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.060 (e) (e) P=0.310 | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.056 (e) (e) P=0.228 | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.056 | (e) |
|FISHER EXACT | (e) (e) P=0.247 | (e) (e) (e) |
|=================================================================================================================================|
| |
|Harderian Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 3/50 (6%) 1/50 (2%) 4/50 (8%) | 0/50 (0%) 2/50 (4%) 1/50 (2%) 0/49 (0%) |
|ADJUSTED (b) | 7.2% 10.4% 2.1% 10.6% | 0.0% 6.3% 3.1% 0.0% |
|TERMINAL (d) | 1/36 (3%) 2/27 (7%) 0/38 (0%) 3/35 (9%) | 0/33 (0%) 2/32 (6%) 1/32 (3%) 0/24 (0%) |
|FIRST INCIDENCE (DAYS) | 618 708 563 632 | --- 729 (T) 729 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.532 P=0.542 P=0.300N P=0.497 | P=0.571N P=0.231 P=0.494 (e) |
|INCIDENTAL TUMOR | P=0.551N P=0.615N P=0.187N P=0.607 | P=0.571N P=0.231 P=0.494 (e) |
|LOGISTIC REGRESSION | P=0.506 P=0.622 P=0.280N P=0.493 | P=0.571N P=0.231 P=0.494 (e) |
|COCHRAN-ARMITAGE | P=0.500 | P=0.505N |
|FISHER EXACT | P=0.661N P=0.309N P=0.500 | P=0.247 P=0.500 (e) |
|=================================================================================================================================|
DATE: 08/21/96 EXPERIMENT: 89006 TEST: 02 PAGE 4
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- AZT/INTERFERON A/INTERFERON AD
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 30 MG/KG 60 MG/KG 120MG/KG | VEHICLE 30 MG/KG 60 MG/KG 120MG/KG |
| | CONTROL 500 U 500 U 500 U | CONTROL 500 U 500 U 500 U |
|=================================================================================================================================|
| |
|Liver |
| Hemangiosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 5/50 (10%) 4/50 (8%) 4/50 (8%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/49 (4%) |
|ADJUSTED (b) | 7.5% 16.4% 10.1% 10.1% | 0.0% 0.0% 0.0% 6.6% |
|TERMINAL (d) | 1/36 (3%) 3/27 (11%) 3/38 (8%) 2/35 (6%) | 0/33 (0%) 0/32 (0%) 0/32 (0%) 1/24 (4%) |
|FIRST INCIDENCE (DAYS) | 675 663 685 638 | --- --- --- 597 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.491 P=0.231 P=0.520 P=0.487 | P=0.046 * (e) (e) P=0.198 |
|INCIDENTAL TUMOR | P=0.472 P=0.341 P=0.386 P=0.577 | P=0.070 (e) (e) P=0.308 |
|LOGISTIC REGRESSION | P=0.547N P=0.282 P=0.498 P=0.502 | P=0.053 (e) (e) P=0.227 |
|COCHRAN-ARMITAGE | P=0.454 | P=0.055 |
|FISHER EXACT | P=0.357 P=0.500 P=0.500 | (e) (e) P=0.242 |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 16/50 (32%) 16/50 (32%) 19/50 (38%) 18/50 (36%) | 11/50 (22%) 17/50 (34%) 14/50 (28%) 14/49 (29%) |
|ADJUSTED (b) | 40.5% 46.5% 47.3% 48.3% | 31.1% 51.5% 42.4% 49.0% |
|TERMINAL (d) | 13/36 (36%) 9/27 (33%) 17/38 (45%) 16/35 (46%) | 9/33 (27%) 16/32 (50%) 13/32 (41%) 10/24 (42%) |
|FIRST INCIDENCE (DAYS) | 477 518 563 638 | 649 667 713 617 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.394 P=0.261 P=0.406 P=0.380 | P=0.103 P=0.097 P=0.282 P=0.096 |
|INCIDENTAL TUMOR | P=0.340 P=0.400 P=0.287 P=0.414 | P=0.162 P=0.039 * P=0.257 P=0.168 |
|LOGISTIC REGRESSION | P=0.368 P=0.414 P=0.331 P=0.429 | P=0.173 P=0.052 P=0.239 P=0.161 |
|COCHRAN-ARMITAGE | P=0.297 | P=0.340 |
|FISHER EXACT | P=0.585N P=0.338 P=0.417 | P=0.133 P=0.322 P=0.301 |
|=================================================================================================================================|
DATE: 08/21/96 EXPERIMENT: 89006 TEST: 02 PAGE 5
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- AZT/INTERFERON A/INTERFERON AD
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 30 MG/KG 60 MG/KG 120MG/KG | VEHICLE 30 MG/KG 60 MG/KG 120MG/KG |
| | CONTROL 500 U 500 U 500 U | CONTROL 500 U 500 U 500 U |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 13/50 (26%) 20/50 (40%) 17/50 (34%) 14/50 (28%) | 13/50 (26%) 4/50 (8%) 5/50 (10%) 10/49 (20%) |
|ADJUSTED (b) | 31.9% 52.9% 40.1% 32.2% | 35.4% 11.8% 14.7% 32.5% |
|TERMINAL (d) | 9/36 (25%) 11/27 (41%) 13/38 (34%) 7/35 (20%) | 10/33 (30%) 3/32 (9%) 3/32 (9%) 5/24 (21%) |
|FIRST INCIDENCE (DAYS) | 477 376 598 527 | 649 628 707 589 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.435N P=0.029 * P=0.316 P=0.483 | P=0.473N P=0.025N* P=0.047N* P=0.573 |
|INCIDENTAL TUMOR | P=0.527 P=0.090 P=0.285 P=0.537 | P=0.299N P=0.041N* P=0.050N P=0.438N |
|LOGISTIC REGRESSION | P=0.511N P=0.087 P=0.245 P=0.481 | P=0.357N P=0.026N* P=0.041N* P=0.448N |
|COCHRAN-ARMITAGE | P=0.527 | P=0.287N |
|FISHER EXACT | P=0.101 P=0.257 P=0.500 | P=0.016N* P=0.033N* P=0.337N |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 13/50 (26%) 21/50 (42%) 17/50 (34%) 14/50 (28%) | 13/50 (26%) 4/50 (8%) 5/50 (10%) 10/49 (20%) |
|ADJUSTED (b) | 31.9% 54.5% 40.1% 32.2% | 35.4% 11.8% 14.7% 32.5% |
|TERMINAL (d) | 9/36 (25%) 11/27 (41%) 13/38 (34%) 7/35 (20%) | 10/33 (30%) 3/32 (9%) 3/32 (9%) 5/24 (21%) |
|FIRST INCIDENCE (DAYS) | 477 376 598 527 | 649 628 707 589 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.411N P=0.019 * P=0.316 P=0.483 | P=0.473N P=0.025N* P=0.047N* P=0.573 |
|INCIDENTAL TUMOR | P=0.503N P=0.065 P=0.285 P=0.537 | P=0.299N P=0.041N* P=0.050N P=0.438N |
|LOGISTIC REGRESSION | P=0.481N P=0.057 P=0.245 P=0.481 | P=0.357N P=0.026N* P=0.041N* P=0.448N |
|COCHRAN-ARMITAGE | P=0.500N | P=0.287N |
|FISHER EXACT | P=0.069 P=0.257 P=0.500 | P=0.016N* P=0.033N* P=0.337N |
|=================================================================================================================================|
DATE: 08/21/96 EXPERIMENT: 89006 TEST: 02 PAGE 6
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- AZT/INTERFERON A/INTERFERON AD
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 30 MG/KG 60 MG/KG 120MG/KG | VEHICLE 30 MG/KG 60 MG/KG 120MG/KG |
| | CONTROL 500 U 500 U 500 U | CONTROL 500 U 500 U 500 U |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 24/50 (48%) 31/50 (62%) 33/50 (66%) 29/50 (58%) | 20/50 (40%) 20/50 (40%) 18/50 (36%) 22/49 (45%) |
|ADJUSTED (b) | 56.8% 75.0% 74.9% 65.4% | 53.6% 58.7% 52.9% 65.9% |
|TERMINAL (d) | 18/36 (50%) 17/27 (63%) 27/38 (71%) 20/35 (57%) | 16/33 (48%) 18/32 (56%) 16/32 (50%) 13/24 (54%) |
|FIRST INCIDENCE (DAYS) | 477 376 563 527 | 649 628 707 589 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.307 P=0.016 * P=0.112 P=0.213 | P=0.099 P=0.499 P=0.478N P=0.092 |
|INCIDENTAL TUMOR | P=0.189 P=0.066 P=0.060 P=0.252 | P=0.220 P=0.294 P=0.521N P=0.218 |
|LOGISTIC REGRESSION | P=0.194 P=0.050 * P=0.043 * P=0.226 | P=0.198 P=0.360 P=0.533N P=0.191 |
|COCHRAN-ARMITAGE | P=0.152 | P=0.393 |
|FISHER EXACT | P=0.114 P=0.053 P=0.212 | P=0.581N P=0.418N P=0.386 |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 24/50 (48%) 32/50 (64%) 33/50 (66%) 29/50 (58%) | 20/50 (40%) 20/50 (40%) 18/50 (36%) 22/49 (45%) |
|ADJUSTED (b) | 56.8% 75.8% 74.9% 65.4% | 53.6% 58.7% 52.9% 65.9% |
|TERMINAL (d) | 18/36 (50%) 17/27 (63%) 27/38 (71%) 20/35 (57%) | 16/33 (48%) 18/32 (56%) 16/32 (50%) 13/24 (54%) |
|FIRST INCIDENCE (DAYS) | 477 376 563 527 | 649 628 707 589 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.328 P=0.011 * P=0.112 P=0.213 | P=0.099 P=0.499 P=0.478N P=0.092 |
|INCIDENTAL TUMOR | P=0.205 P=0.045 * P=0.060 P=0.252 | P=0.220 P=0.294 P=0.521N P=0.218 |
|LOGISTIC REGRESSION | P=0.213 P=0.030 * P=0.043 * P=0.226 | P=0.198 P=0.360 P=0.533N P=0.191 |
|COCHRAN-ARMITAGE | P=0.167 | P=0.393 |
|FISHER EXACT | P=0.079 P=0.053 P=0.212 | P=0.581N P=0.418N P=0.386 |
|=================================================================================================================================|
DATE: 08/21/96 EXPERIMENT: 89006 TEST: 02 PAGE 7
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- AZT/INTERFERON A/INTERFERON AD
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 30 MG/KG 60 MG/KG 120MG/KG | VEHICLE 30 MG/KG 60 MG/KG 120MG/KG |
| | CONTROL 500 U 500 U 500 U | CONTROL 500 U 500 U 500 U |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 10/49 (20%) 4/50 (8%) 9/50 (18%) 8/50 (16%) | 1/50 (2%) 3/50 (6%) 1/50 (2%) 1/49 (2%) |
|ADJUSTED (b) | 26.4% 14.8% 23.7% 22.0% | 3.0% 9.4% 3.1% 4.2% |
|TERMINAL (d) | 8/35 (23%) 4/27 (15%) 9/38 (24%) 7/35 (20%) | 1/33 (3%) 3/32 (9%) 1/32 (3%) 1/24 (4%) |
|FIRST INCIDENCE (DAYS) | 660 731 (T) 731 (T) 682 | 729 (T) 729 (T) 729 (T) 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.416N P=0.174N P=0.430N P=0.399N | P=0.526N P=0.293 P=0.755 P=0.689 |
|INCIDENTAL TUMOR | P=0.428N P=0.138N P=0.484N P=0.376N | P=0.526N P=0.293 P=0.755 P=0.689 |
|LOGISTIC REGRESSION | P=0.432N P=0.128N P=0.463N P=0.374N | P=0.526N P=0.293 P=0.755 P=0.689 |
|COCHRAN-ARMITAGE | P=0.484N | P=0.433N |
|FISHER EXACT | P=0.068N P=0.480N P=0.379N | P=0.309 P=0.753N P=0.747 |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 6/49 (12%) 2/50 (4%) 7/50 (14%) 6/50 (12%) | 0/50 (0%) 2/50 (4%) 1/50 (2%) 1/49 (2%) |
|ADJUSTED (b) | 15.6% 7.4% 17.8% 15.8% | 0.0% 6.3% 2.6% 3.1% |
|TERMINAL (d) | 4/35 (11%) 2/27 (7%) 6/38 (16%) 4/35 (11%) | 0/33 (0%) 2/32 (6%) 0/32 (0%) 0/24 (0%) |
|FIRST INCIDENCE (DAYS) | 542 731 (T) 699 672 | --- 729 (T) 647 673 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.399 P=0.224N P=0.552 P=0.612 | P=0.345 P=0.231 P=0.485 P=0.451 |
|INCIDENTAL TUMOR | P=0.357 P=0.194N P=0.363 P=0.613N | P=0.408 P=0.231 P=0.450 P=0.500 |
|LOGISTIC REGRESSION | P=0.389 P=0.165N P=0.513 P=0.599N | P=0.390 P=0.231 P=0.500 P=0.489 |
|COCHRAN-ARMITAGE | P=0.352 | P=0.405 |
|FISHER EXACT | P=0.128N P=0.516 P=0.606N | P=0.247 P=0.500 P=0.495 |
|=================================================================================================================================|
DATE: 08/21/96 EXPERIMENT: 89006 TEST: 02 PAGE 8
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- AZT/INTERFERON A/INTERFERON AD
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 30 MG/KG 60 MG/KG 120MG/KG | VEHICLE 30 MG/KG 60 MG/KG 120MG/KG |
| | CONTROL 500 U 500 U 500 U | CONTROL 500 U 500 U 500 U |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 16/49 (33%) 6/50 (12%) 14/50 (28%) 14/50 (28%) | 1/50 (2%) 4/50 (8%) 2/50 (4%) 2/49 (4%) |
|ADJUSTED (b) | 40.3% 22.2% 35.8% 36.4% | 3.0% 12.5% 5.6% 7.2% |
|TERMINAL (d) | 12/35 (34%) 6/27 (22%) 13/38 (34%) 11/35 (31%) | 1/33 (3%) 4/32 (13%) 1/32 (3%) 1/24 (4%) |
|FIRST INCIDENCE (DAYS) | 542 731 (T) 699 672 | 729 (T) 729 (T) 647 673 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.479N P=0.063N P=0.330N P=0.421N | P=0.385 P=0.169 P=0.484 P=0.398 |
|INCIDENTAL TUMOR | P=0.521N P=0.040N* P=0.506N P=0.391N | P=0.428 P=0.169 P=0.464 P=0.427 |
|LOGISTIC REGRESSION | P=0.494N P=0.031N* P=0.379N P=0.369N | P=0.445 P=0.169 P=0.495 P=0.451 |
|COCHRAN-ARMITAGE | P=0.493 | P=0.492 |
|FISHER EXACT | P=0.012N* P=0.388N P=0.388N | P=0.181 P=0.500 P=0.492 |
|=================================================================================================================================|
| |
|Ovary |
| Cystadenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | | 0/49 (0%) 4/49 (8%) 0/49 (0%) 2/49 (4%) |
|ADJUSTED (b) | | 0.0% 12.5% 0.0% 6.7% |
|TERMINAL (d) | | 0/33 (0%) 4/32 (13%) 0/31 (0%) 1/24 (4%) |
|FIRST INCIDENCE (DAYS) | | --- 729 (T) --- 604 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.336 P=0.058 (e) P=0.193 |
|INCIDENTAL TUMOR | | P=0.399 P=0.058 (e) P=0.308 |
|LOGISTIC REGRESSION | | P=0.395 P=0.058 (e) P=0.231 |
|COCHRAN-ARMITAGE | | P=0.426 |
|FISHER EXACT | | P=0.059 (e) P=0.247 |
|=================================================================================================================================|
DATE: 08/21/96 EXPERIMENT: 89006 TEST: 02 PAGE 9
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- AZT/INTERFERON A/INTERFERON AD
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 30 MG/KG 60 MG/KG 120MG/KG | VEHICLE 30 MG/KG 60 MG/KG 120MG/KG |
| | CONTROL 500 U 500 U 500 U | CONTROL 500 U 500 U 500 U |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 0/43 (0%) 0/48 (0%) 1/47 (2%) | 7/50 (14%) 3/47 (6%) 4/48 (8%) 5/47 (11%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 3.1% | 18.3% 9.4% 10.9% 17.9% |
|TERMINAL (d) | 0/35 (0%) 0/24 (0%) 0/38 (0%) 1/32 (3%) | 4/33 (12%) 3/32 (9%) 2/31 (6%) 3/24 (13%) |
|FIRST INCIDENCE (DAYS) | --- --- --- 731 (T) | 593 729 (T) 436 589 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.194 (e) (e) P=0.482 | P=0.480N P=0.190N P=0.299N P=0.562N |
|INCIDENTAL TUMOR | P=0.194 (e) (e) P=0.482 | P=0.339N P=0.173N P=0.233N P=0.344N |
|LOGISTIC REGRESSION | P=0.194 (e) (e) P=0.482 | P=0.385N P=0.196N P=0.285N P=0.456N |
|COCHRAN-ARMITAGE | P=0.188 | P=0.365N |
|FISHER EXACT | (e) (e) P=0.495 | P=0.185N P=0.286N P=0.424N |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 0/43 (0%) 0/48 (0%) 1/47 (2%) | 8/50 (16%) 3/47 (6%) 4/48 (8%) 5/47 (11%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 3.1% | 20.7% 9.4% 10.9% 17.9% |
|TERMINAL (d) | 0/35 (0%) 0/24 (0%) 0/38 (0%) 1/32 (3%) | 4/33 (12%) 3/32 (9%) 2/31 (6%) 3/24 (13%) |
|FIRST INCIDENCE (DAYS) | --- --- --- 731 (T) | 593 729 (T) 436 589 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.194 (e) (e) P=0.482 | P=0.364N P=0.129N P=0.214N P=0.457N |
|INCIDENTAL TUMOR | P=0.194 (e) (e) P=0.482 | P=0.231N P=0.149N P=0.171N P=0.244N |
|LOGISTIC REGRESSION | P=0.194 (e) (e) P=0.482 | P=0.276N P=0.130N P=0.198N P=0.350N |
|COCHRAN-ARMITAGE | P=0.188 | P=0.258N |
|FISHER EXACT | (e) (e) P=0.495 | P=0.120N P=0.199N P=0.318N |
|=================================================================================================================================|
DATE: 08/21/96 EXPERIMENT: 89006 TEST: 02 PAGE 10
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- AZT/INTERFERON A/INTERFERON AD
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 30 MG/KG 60 MG/KG 120MG/KG | VEHICLE 30 MG/KG 60 MG/KG 120MG/KG |
| | CONTROL 500 U 500 U 500 U | CONTROL 500 U 500 U 500 U |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Intermedia |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/48 (2%) 0/43 (0%) 0/48 (0%) 0/47 (0%) | 0/50 (0%) 0/47 (0%) 2/48 (4%) 1/47 (2%) |
|ADJUSTED (b) | 2.9% 0.0% 0.0% 0.0% | 0.0% 0.0% 4.5% 2.8% |
|TERMINAL (d) | 1/35 (3%) 0/24 (0%) 0/38 (0%) 0/32 (0%) | 0/33 (0%) 0/32 (0%) 0/31 (0%) 0/24 (0%) |
|FIRST INCIDENCE (DAYS) | 731 (T) --- --- --- | --- --- 597 617 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.185N P=0.575N P=0.484N P=0.518N | P=0.141 (e) P=0.242 P=0.469 |
|INCIDENTAL TUMOR | P=0.185N P=0.575N P=0.484N P=0.518N | P=0.301 (e) P=0.395 P=0.695 |
|LOGISTIC REGRESSION | P=0.185N P=0.575N P=0.484N P=0.518N | P=0.147 (e) P=0.226 P=0.492 |
|COCHRAN-ARMITAGE | P=0.186N | P=0.142 |
|FISHER EXACT | P=0.527N P=0.500N P=0.505N | (e) P=0.237 P=0.485 |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Intermedia |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/48 (2%) 1/43 (2%) 0/48 (0%) 0/47 (0%) | 0/50 (0%) 0/47 (0%) 2/48 (4%) 1/47 (2%) |
|ADJUSTED (b) | 2.9% 2.1% 0.0% 0.0% | 0.0% 0.0% 4.5% 2.8% |
|TERMINAL (d) | 1/35 (3%) 0/24 (0%) 0/38 (0%) 0/32 (0%) | 0/33 (0%) 0/32 (0%) 0/31 (0%) 0/24 (0%) |
|FIRST INCIDENCE (DAYS) | 731 (T) 296 --- --- | --- --- 597 617 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.171N P=0.712 P=0.484N P=0.518N | P=0.141 (e) P=0.242 P=0.469 |
|INCIDENTAL TUMOR | P=0.167N P=0.678N P=0.484N P=0.518N | P=0.301 (e) P=0.395 P=0.695 |
|LOGISTIC REGRESSION | P=0.161N P=0.700N P=0.484N P=0.518N | P=0.147 (e) P=0.226 P=0.492 |
|COCHRAN-ARMITAGE | P=0.170N | P=0.142 |
|FISHER EXACT | P=0.725 P=0.500N P=0.505N | (e) P=0.237 P=0.485 |
|=================================================================================================================================|
DATE: 08/21/96 EXPERIMENT: 89006 TEST: 02 PAGE 11
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- AZT/INTERFERON A/INTERFERON AD
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 30 MG/KG 60 MG/KG 120MG/KG | VEHICLE 30 MG/KG 60 MG/KG 120MG/KG |
| | CONTROL 500 U 500 U 500 U | CONTROL 500 U 500 U 500 U |
|=================================================================================================================================|
| |
|Skin |
| Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | 1/50 (2%) 4/50 (8%) 2/50 (4%) 1/49 (2%) |
|ADJUSTED (b) | 2.8% 2.3% 0.0% 2.9% | 2.5% 10.9% 5.7% 2.6% |
|TERMINAL (d) | 1/36 (3%) 0/27 (0%) 0/38 (0%) 1/35 (3%) | 0/33 (0%) 2/32 (6%) 1/32 (3%) 0/24 (0%) |
|FIRST INCIDENCE (DAYS) | 731 (T) 542 --- 731 (T) | 688 467 656 603 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.482N P=0.721 P=0.489N P=0.756 | P=0.517N P=0.158 P=0.472 P=0.721 |
|INCIDENTAL TUMOR | P=0.552N P=0.729 P=0.489N P=0.756 | P=0.365N P=0.191 P=0.437 P=0.647N |
|LOGISTIC REGRESSION | P=0.503N P=0.751N P=0.489N P=0.756 | P=0.446N P=0.179 P=0.498 P=0.759 |
|COCHRAN-ARMITAGE | P=0.500N | P=0.443N |
|FISHER EXACT | P=0.753N P=0.500N P=0.753N | P=0.181 P=0.500 P=0.747 |
|=================================================================================================================================|
| |
|Skin |
| Fibrosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | 1/50 (2%) 4/50 (8%) 2/50 (4%) 1/49 (2%) |
|ADJUSTED (b) | 0.0% 2.3% 0.0% 2.9% | 2.5% 10.9% 5.7% 2.6% |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 0/38 (0%) 1/35 (3%) | 0/33 (0%) 2/32 (6%) 1/32 (3%) 0/24 (0%) |
|FIRST INCIDENCE (DAYS) | --- 542 --- 731 (T) | 688 467 656 603 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.391 P=0.487 (e) P=0.494 | P=0.517N P=0.158 P=0.472 P=0.721 |
|INCIDENTAL TUMOR | P=0.316 P=0.500 (e) P=0.494 | P=0.365N P=0.191 P=0.437 P=0.647N |
|LOGISTIC REGRESSION | P=0.364 P=0.578 (e) P=0.494 | P=0.446N P=0.179 P=0.498 P=0.759 |
|COCHRAN-ARMITAGE | P=0.375 | P=0.443N |
|FISHER EXACT | P=0.500 (e) P=0.500 | P=0.181 P=0.500 P=0.747 |
|=================================================================================================================================|
DATE: 08/21/96 EXPERIMENT: 89006 TEST: 02 PAGE 12
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- AZT/INTERFERON A/INTERFERON AD
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 30 MG/KG 60 MG/KG 120MG/KG | VEHICLE 30 MG/KG 60 MG/KG 120MG/KG |
| | CONTROL 500 U 500 U 500 U | CONTROL 500 U 500 U 500 U |
|=================================================================================================================================|
| |
|Skin |
| Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | 1/50 (2%) 4/50 (8%) 2/50 (4%) 1/49 (2%) |
|ADJUSTED (b) | 2.8% 2.3% 0.0% 2.9% | 2.5% 10.9% 5.7% 2.6% |
|TERMINAL (d) | 1/36 (3%) 0/27 (0%) 0/38 (0%) 1/35 (3%) | 0/33 (0%) 2/32 (6%) 1/32 (3%) 0/24 (0%) |
|FIRST INCIDENCE (DAYS) | 731 (T) 542 --- 731 (T) | 688 467 656 603 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.482N P=0.721 P=0.489N P=0.756 | P=0.517N P=0.158 P=0.472 P=0.721 |
|INCIDENTAL TUMOR | P=0.552N P=0.729 P=0.489N P=0.756 | P=0.365N P=0.191 P=0.437 P=0.647N |
|LOGISTIC REGRESSION | P=0.503N P=0.751N P=0.489N P=0.756 | P=0.446N P=0.179 P=0.498 P=0.759 |
|COCHRAN-ARMITAGE | P=0.500N | P=0.443N |
|FISHER EXACT | P=0.753N P=0.500N P=0.753N | P=0.181 P=0.500 P=0.747 |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Squamous Cell Carcinoma or Papilloma Squamous |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | 1/50 (2%) 2/50 (4%) 1/50 (2%) 1/49 (2%) |
|ADJUSTED (b) | 2.8% 0.0% 0.0% 5.7% | 3.0% 6.3% 3.1% 3.0% |
|TERMINAL (d) | 1/36 (3%) 0/27 (0%) 0/38 (0%) 2/35 (6%) | 1/33 (3%) 2/32 (6%) 1/32 (3%) 0/24 (0%) |
|FIRST INCIDENCE (DAYS) | 731 (T) --- --- 731 (T) | 729 (T) 729 (T) 729 (T) 662 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.320 P=0.557N P=0.489N P=0.490 | P=0.578 P=0.489 P=0.755 P=0.700 |
|INCIDENTAL TUMOR | P=0.320 P=0.557N P=0.489N P=0.490 | P=0.557N P=0.489 P=0.755 P=0.725 |
|LOGISTIC REGRESSION | P=0.320 P=0.557N P=0.489N P=0.490 | P=0.544N P=0.489 P=0.755 P=0.743 |
|COCHRAN-ARMITAGE | P=0.301 | P=0.506N |
|FISHER EXACT | P=0.500N P=0.500N P=0.500 | P=0.500 P=0.753N P=0.747 |
|=================================================================================================================================|
DATE: 08/21/96 EXPERIMENT: 89006 TEST: 02 PAGE 13
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- AZT/INTERFERON A/INTERFERON AD
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 30 MG/KG 60 MG/KG 120MG/KG | VEHICLE 30 MG/KG 60 MG/KG 120MG/KG |
| | CONTROL 500 U 500 U 500 U | CONTROL 500 U 500 U 500 U |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Squamous Cell Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | 1/50 (2%) 1/50 (2%) 1/50 (2%) 1/49 (2%) |
|ADJUSTED (b) | 2.8% 0.0% 0.0% 5.7% | 3.0% 3.1% 3.1% 3.0% |
|TERMINAL (d) | 1/36 (3%) 0/27 (0%) 0/38 (0%) 2/35 (6%) | 1/33 (3%) 1/32 (3%) 1/32 (3%) 0/24 (0%) |
|FIRST INCIDENCE (DAYS) | 731 (T) --- --- 731 (T) | 729 (T) 729 (T) 729 (T) 662 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.320 P=0.557N P=0.489N P=0.490 | P=0.516 P=0.755 P=0.755 P=0.700 |
|INCIDENTAL TUMOR | P=0.320 P=0.557N P=0.489N P=0.490 | P=0.546 P=0.755 P=0.755 P=0.725 |
|LOGISTIC REGRESSION | P=0.320 P=0.557N P=0.489N P=0.490 | P=0.556 P=0.755 P=0.755 P=0.743 |
|COCHRAN-ARMITAGE | P=0.301 | P=0.584 |
|FISHER EXACT | P=0.500N P=0.500N P=0.500 | P=0.753N P=0.753N P=0.747 |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 2/50 (4%) 0/50 (0%) 1/49 (2%) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/49 (2%) |
|ADJUSTED (b) | 11.1% 7.4% 0.0% 2.9% | 3.0% 0.0% 0.0% 2.8% |
|TERMINAL (d) | 4/36 (11%) 2/27 (7%) 0/38 (0%) 1/35 (3%) | 1/33 (3%) 0/32 (0%) 0/32 (0%) 0/24 (0%) |
|FIRST INCIDENCE (DAYS) | 731 (T) 731 (T) --- 731 (T) | 729 (T) --- --- 617 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.038N* P=0.475N P=0.056N P=0.187N | P=0.586 P=0.506N P=0.506N P=0.707 |
|INCIDENTAL TUMOR | P=0.038N* P=0.475N P=0.056N P=0.187N | P=0.562N P=0.506N P=0.506N P=0.692N |
|LOGISTIC REGRESSION | P=0.038N* P=0.475N P=0.056N P=0.187N | P=0.617 P=0.506N P=0.506N P=0.752 |
|COCHRAN-ARMITAGE | P=0.044N* | P=0.621 |
|FISHER EXACT | P=0.339N P=0.059N P=0.187N | P=0.500N P=0.500N P=0.747 |
|=================================================================================================================================|
DATE: 08/21/96 EXPERIMENT: 89006 TEST: 02 PAGE 14
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- AZT/INTERFERON A/INTERFERON AD
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 30 MG/KG 60 MG/KG 120MG/KG | VEHICLE 30 MG/KG 60 MG/KG 120MG/KG |
| | CONTROL 500 U 500 U 500 U | CONTROL 500 U 500 U 500 U |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 2/50 (4%) 0/50 (0%) 1/49 (2%) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 2/49 (4%) |
|ADJUSTED (b) | 11.1% 7.4% 0.0% 2.9% | 3.0% 0.0% 0.0% 6.8% |
|TERMINAL (d) | 4/36 (11%) 2/27 (7%) 0/38 (0%) 1/35 (3%) | 1/33 (3%) 0/32 (0%) 0/32 (0%) 1/24 (4%) |
|FIRST INCIDENCE (DAYS) | 731 (T) 731 (T) --- 731 (T) | 729 (T) --- --- 617 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.038N* P=0.475N P=0.056N P=0.187N | P=0.251 P=0.506N P=0.506N P=0.409 |
|INCIDENTAL TUMOR | P=0.038N* P=0.475N P=0.056N P=0.187N | P=0.324 P=0.506N P=0.506N P=0.545 |
|LOGISTIC REGRESSION | P=0.038N* P=0.475N P=0.056N P=0.187N | P=0.286 P=0.506N P=0.506N P=0.470 |
|COCHRAN-ARMITAGE | P=0.044N* | P=0.297 |
|FISHER EXACT | P=0.339N P=0.059N P=0.187N | P=0.500N P=0.500N P=0.492 |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # # |
|----------- | | |
|OVERALL (a) | | 4/50 (8%) 0/50 (0%) 3/50 (6%) 2/49 (4%) |
|ADJUSTED (b) | | 10.7% 0.0% 8.7% 7.4% |
|TERMINAL (d) | | 2/33 (6%) 0/32 (0%) 2/32 (6%) 1/24 (4%) |
|FIRST INCIDENCE (DAYS) | | 593 --- 656 699 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.477N P=0.076N P=0.518N P=0.461N |
|INCIDENTAL TUMOR | | P=0.372N P=0.076N P=0.497N P=0.330N |
|LOGISTIC REGRESSION | | P=0.415N P=0.067N P=0.504N P=0.382N |
|COCHRAN-ARMITAGE | | P=0.388N |
|FISHER EXACT | | P=0.059N P=0.500N P=0.349N |
|=================================================================================================================================|
DATE: 08/21/96 EXPERIMENT: 89006 TEST: 02 PAGE 15
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- AZT/INTERFERON A/INTERFERON AD
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 30 MG/KG 60 MG/KG 120MG/KG | VEHICLE 30 MG/KG 60 MG/KG 120MG/KG |
| | CONTROL 500 U 500 U 500 U | CONTROL 500 U 500 U 500 U |
|=================================================================================================================================|
| |
|Uterus |
| Sarcoma Stromal or Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # # |
|----------- | | |
|OVERALL (a) | | 4/50 (8%) 0/50 (0%) 3/50 (6%) 3/49 (6%) |
|ADJUSTED (b) | | 10.7% 0.0% 8.7% 10.9% |
|TERMINAL (d) | | 2/33 (6%) 0/32 (0%) 2/32 (6%) 1/24 (4%) |
|FIRST INCIDENCE (DAYS) | | 593 --- 656 699 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.454 P=0.076N P=0.518N P=0.633N |
|INCIDENTAL TUMOR | | P=0.535N P=0.076N P=0.497N P=0.496N |
|LOGISTIC REGRESSION | | P=0.516 P=0.067N P=0.504N P=0.559N |
|COCHRAN-ARMITAGE | | P=0.549 |
|FISHER EXACT | | P=0.059N P=0.500N P=0.511N |
|=================================================================================================================================|
| |
|Vagina |
| Squamous Cell Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # # |
|----------- | | |
|OVERALL (a) | | 0/50 (0%) 0/50 (0%) 5/50 (10%) 6/49 (12%) |
|ADJUSTED (b) | | 0.0% 0.0% 15.6% 21.1% |
|TERMINAL (d) | | 0/33 (0%) 0/32 (0%) 5/32 (16%) 3/24 (13%) |
|FIRST INCIDENCE (DAYS) | | --- --- 729 (T) 631 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P<0.001 ** (e) P=0.030 * P=0.008 ** |
|INCIDENTAL TUMOR | | P<0.001 ** (e) P=0.030 * P=0.017 * |
|LOGISTIC REGRESSION | | P<0.001 ** (e) P=0.030 * P=0.011 * |
|COCHRAN-ARMITAGE | | P=0.001 ** |
|FISHER EXACT | | (e) P=0.028 * P=0.012 * |
|=================================================================================================================================|
DATE: 08/21/96 EXPERIMENT: 89006 TEST: 02 PAGE 16
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- AZT/INTERFERON A/INTERFERON AD
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 30 MG/KG 60 MG/KG 120MG/KG | VEHICLE 30 MG/KG 60 MG/KG 120MG/KG |
| | CONTROL 500 U 500 U 500 U | CONTROL 500 U 500 U 500 U |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 6/50 (12%) 5/50 (10%) 4/50 (8%) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 2/49 (4%) |
|ADJUSTED (b) | 7.5% 18.7% 12.7% 10.1% | 0.0% 0.0% 6.3% 6.6% |
|TERMINAL (d) | 1/36 (3%) 3/27 (11%) 4/38 (11%) 2/35 (6%) | 0/33 (0%) 0/32 (0%) 2/32 (6%) 1/24 (4%) |
|FIRST INCIDENCE (DAYS) | 675 624 685 638 | --- --- 729 (T) 597 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.497 P=0.145 P=0.381 P=0.487 | P=0.038 * (e) P=0.231 P=0.198 |
|INCIDENTAL TUMOR | P=0.489 P=0.285 P=0.262 P=0.577 | P=0.053 (e) P=0.231 P=0.308 |
|LOGISTIC REGRESSION | P=0.532N P=0.191 P=0.355 P=0.502 | P=0.050 * (e) P=0.231 P=0.227 |
|COCHRAN-ARMITAGE | P=0.456 | P=0.055 |
|FISHER EXACT | P=0.243 P=0.357 P=0.500 | (e) P=0.247 P=0.242 |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma or Hemangioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 6/50 (12%) 5/50 (10%) 4/50 (8%) | 1/50 (2%) 0/50 (0%) 2/50 (4%) 2/49 (4%) |
|ADJUSTED (b) | 7.5% 18.7% 12.7% 10.1% | 2.9% 0.0% 6.3% 6.6% |
|TERMINAL (d) | 1/36 (3%) 3/27 (11%) 4/38 (11%) 2/35 (6%) | 0/33 (0%) 0/32 (0%) 2/32 (6%) 1/24 (4%) |
|FIRST INCIDENCE (DAYS) | 675 624 685 638 | 710 --- 729 (T) 597 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.497 P=0.145 P=0.381 P=0.487 | P=0.160 P=0.518N P=0.486 P=0.430 |
|INCIDENTAL TUMOR | P=0.489 P=0.285 P=0.262 P=0.577 | P=0.226 P=0.795N P=0.464 P=0.582 |
|LOGISTIC REGRESSION | P=0.532N P=0.191 P=0.355 P=0.502 | P=0.189 P=0.518N P=0.477 P=0.478 |
|COCHRAN-ARMITAGE | P=0.456 | P=0.204 |
|FISHER EXACT | P=0.243 P=0.357 P=0.500 | P=0.500N P=0.500 P=0.492 |
|=================================================================================================================================|
DATE: 08/21/96 EXPERIMENT: 89006 TEST: 02 PAGE 17
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- AZT/INTERFERON A/INTERFERON AD
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 30 MG/KG 60 MG/KG 120MG/KG | VEHICLE 30 MG/KG 60 MG/KG 120MG/KG |
| | CONTROL 500 U 500 U 500 U | CONTROL 500 U 500 U 500 U |
|=================================================================================================================================|
| |
|All Organs |
| Histiocytic Sarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | 3/50 (6%) 3/50 (6%) 1/50 (2%) 0/49 (0%) |
|ADJUSTED (b) | 4.7% 4.6% 0.0% 0.0% | 7.8% 8.0% 2.5% 0.0% |
|TERMINAL (d) | 0/36 (0%) 0/27 (0%) 0/38 (0%) 0/35 (0%) | 1/33 (3%) 1/32 (3%) 0/32 (0%) 0/24 (0%) |
|FIRST INCIDENCE (DAYS) | 600 518 --- --- | 675 561 634 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.057N P=0.644 P=0.240N P=0.248N | P=0.064N P=0.606 P=0.339N P=0.179N |
|INCIDENTAL TUMOR | P=0.052N P=0.472N P=0.191N P=0.154N | P=0.018N* P=0.567 P=0.290N P=0.138N |
|LOGISTIC REGRESSION | P=0.055N P=0.626N P=0.224N P=0.261N | P=0.045N* P=0.658 P=0.216N P=0.137N |
|COCHRAN-ARMITAGE | P=0.057N | P=0.044N* |
|FISHER EXACT | P=0.691N P=0.247N P=0.247N | P=0.661N P=0.309N P=0.125N |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated |
| Cell Type |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 8/50 (16%) 5/50 (10%) 6/50 (12%) | 13/50 (26%) 8/50 (16%) 12/50 (24%) 11/49 (22%) |
|ADJUSTED (b) | 18.8% 25.2% 12.5% 15.6% | 34.6% 19.6% 32.5% 34.9% |
|TERMINAL (d) | 6/36 (17%) 5/27 (19%) 4/38 (11%) 4/35 (11%) | 9/33 (27%) 2/32 (6%) 8/32 (25%) 5/24 (21%) |
|FIRST INCIDENCE (DAYS) | 716 579 624 522 | 675 441 514 604 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.278N P=0.290 P=0.345N P=0.517N | P=0.365 P=0.232N P=0.547N P=0.477 |
|INCIDENTAL TUMOR | P=0.296N P=0.421 P=0.330N P=0.518N | P=0.446N P=0.214N P=0.544N P=0.472N |
|LOGISTIC REGRESSION | P=0.292N P=0.383 P=0.374N P=0.492N | P=0.528 P=0.177N P=0.525N P=0.551N |
|COCHRAN-ARMITAGE | P=0.319N | P=0.490N |
|FISHER EXACT | P=0.500 P=0.380N P=0.500N | P=0.163N P=0.500N P=0.430N |
|=================================================================================================================================|
DATE: 08/21/96 EXPERIMENT: 89006 TEST: 02 PAGE 18
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- AZT/INTERFERON A/INTERFERON AD
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 30 MG/KG 60 MG/KG 120MG/KG | VEHICLE 30 MG/KG 60 MG/KG 120MG/KG |
| | CONTROL 500 U 500 U 500 U | CONTROL 500 U 500 U 500 U |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 26/50 (52%) 20/50 (40%) 26/50 (52%) 30/50 (60%) | 23/50 (46%) 25/50 (50%) 23/50 (46%) 20/49 (41%) |
|ADJUSTED (b) | 63.0% 58.4% 64.8% 76.8% | 57.2% 75.7% 59.8% 61.1% |
|TERMINAL (d) | 21/36 (58%) 13/27 (48%) 24/38 (63%) 26/35 (74%) | 16/33 (48%) 24/32 (75%) 17/32 (53%) 12/24 (50%) |
|FIRST INCIDENCE (DAYS) | 477 518 563 638 | 593 667 436 589 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.243 P=0.569 P=0.478N P=0.230 | P=0.352 P=0.329 P=0.516 P=0.366 |
|INCIDENTAL TUMOR | P=0.187 P=0.354N P=0.583 P=0.281 | P=0.420N P=0.137 P=0.579N P=0.450N |
|LOGISTIC REGRESSION | P=0.207 P=0.341N P=0.582N P=0.283 | P=0.437N P=0.180 P=0.559 P=0.539N |
|COCHRAN-ARMITAGE | P=0.141 | P=0.291N |
|FISHER EXACT | P=0.158N P=0.579N P=0.273 | P=0.421 P=0.579N P=0.376N |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 30/50 (60%) 33/50 (66%) 29/50 (58%) 33/50 (66%) | 23/50 (46%) 23/50 (46%) 28/50 (56%) 28/49 (57%) |
|ADJUSTED (b) | 63.7% 74.2% 64.3% 67.3% | 57.2% 52.9% 64.9% 71.3% |
|TERMINAL (d) | 19/36 (53%) 16/27 (59%) 22/38 (58%) 19/35 (54%) | 16/33 (48%) 12/32 (38%) 17/32 (53%) 13/24 (54%) |
|FIRST INCIDENCE (DAYS) | 374 296 598 522 | 649 441 436 589 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.484N P=0.081 P=0.418N P=0.347 | P=0.025 * P=0.461 P=0.190 P=0.036 * |
|INCIDENTAL TUMOR | P=0.402 P=0.421 P=0.520 P=0.431 | P=0.130 P=0.474 P=0.131 P=0.151 |
|LOGISTIC REGRESSION | P=0.401 P=0.313 P=0.529N P=0.446 | P=0.081 P=0.521 P=0.190 P=0.135 |
|COCHRAN-ARMITAGE | P=0.397 | P=0.096 |
|FISHER EXACT | P=0.339 P=0.500N P=0.339 | P=0.579N P=0.212 P=0.182 |
|=================================================================================================================================|
DATE: 08/21/96 EXPERIMENT: 89006 TEST: 02 PAGE 19
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- AZT/INTERFERON A/INTERFERON AD
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | VEHICLE 30 MG/KG 60 MG/KG 120MG/KG | VEHICLE 30 MG/KG 60 MG/KG 120MG/KG |
| | CONTROL 500 U 500 U 500 U | CONTROL 500 U 500 U 500 U |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 40/50 (80%) 41/50 (82%) 42/50 (84%) 47/50 (94%) | 35/50 (70%) 39/50 (78%) 38/50 (76%) 36/49 (73%) |
|ADJUSTED (b) | 83.3% 89.1% 89.4% 95.9% | 81.3% 90.6% 84.4% 89.9% |
|TERMINAL (d) | 28/36 (78%) 22/27 (81%) 33/38 (87%) 33/35 (94%) | 25/33 (76%) 28/32 (88%) 25/32 (78%) 20/24 (83%) |
|FIRST INCIDENCE (DAYS) | 374 296 563 522 | 593 441 436 589 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.272 P=0.064 P=0.559 P=0.121 | P=0.059 P=0.178 P=0.280 P=0.052 |
|INCIDENTAL TUMOR | P=0.038 * P=0.426 P=0.238 P=0.060 | P=0.371 P=0.104 P=0.288 P=0.277 |
|LOGISTIC REGRESSION | P=0.044 * P=0.293 P=0.311 P=0.043 * | P=0.232 P=0.110 P=0.295 P=0.160 |
|COCHRAN-ARMITAGE | P=0.031 * | P=0.407 |
|FISHER EXACT | P=0.500 P=0.398 P=0.036 * | P=0.247 P=0.326 P=0.437 |
|=================================================================================================================================|
(a) Number of tumor-bearing animals / number of animals examined at site.
(b) Kaplan-Meier estimated lifetime tumor incidence after adjustment for
intercurrent mortality.
(d) Observed incidence at terminal kill.
(f) Beneath the control incidence are the P-values associated with the trend
test. Beneath the dosed group incidence are the P-values corresponding to
pairwise comparisons between the controls and that dosed group. The life
table analysis regards tumors in animals dying prior to terminal kill as
being (directly or indirectly) the cause of death. The incidental tumor
test regards these lesions as non-fatal. Logistic regression is an alternative
method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage
and Fisher's exact tests compare directly the overall incidence rates.
For all tests, a negative trend is indicated by "N".
(e) Value of Statistic cannot be computed.
(I) Interim sacrifice
(T) Terminal sacrifice
# Tumor rates based on number of animals necropsied.
* To the right of any statistical result, indicates significance at (P<=0.05).
** To the right of any statistical result, indicates significance at (P<=0.01).