TDMS Study 89006-04 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst AZT/INTERFERON A/INTERFERON AD DATE: 07/12/96
EXPERIMENT: 89006 TEST: 04 TIME: 15:47:36
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: NO1-ES-85225 ROUTE: GAVAGE NTP C#: C89006
PATHOLOGIST: R.B. THOMPSON CAS: 30516-871
------------------------------------------------------------------------------------------------------------------------------------
CORE STUDY
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst AZT/INTERFERON A/INTERFERON AD DATE: 07/12/96
EXPERIMENT: 89006 TEST: 04 TIME: 15:47:36
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-85225 ROUTE: GAVAGE NTP C#: C89006
PATHOLOGIST: R.B. THOMPSON 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: 07/12/96
EXPERIMENT: 89006 TEST: 04 TIME: 15:47:36
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-85225 ROUTE: GAVAGE NTP C#: C89006
PATHOLOGIST: R.B. THOMPSON 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
------- ------------
Harderian Gland Adenoma
Carcinoma or Adenoma
All Organs Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated
Cell Type
Malignant Tumors
====================================================================================================
FEMALE MICE
-------------
ORGAN MORPHOLOGY
------- ------------
Liver Hepatocellular Adenoma
Lung Alveolar/Bronchiolar Adenoma
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
Skin Hemangiosarcoma
Vagina Squamous Cell Carcinoma
All Organs Hemangiosarcoma or Hemangioma
Benign Tumors
====================================================================================================
DATE: 07/12/96 EXPERIMENT: 89006 TEST: 04 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 5000 U 5000 U 5000 U | CONTROL 5000 U 5000 U 5000 U |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 6/50 (12%) 3/50 (6%) 4/50 (8%) | 0/50 (0%) 0/49 (0%) 1/50 (2%) 1/49 (2%) |
|ADJUSTED (b) | 6.2% 16.2% 8.6% 10.7% | 0.0% 0.0% 2.8% 3.1% |
|TERMINAL (d) | 1/31 (3%) 5/35 (14%) 3/35 (9%) 2/34 (6%) | 0/37 (0%) 0/38 (0%) 1/36 (3%) 1/32 (3%) |
|FIRST INCIDENCE (DAYS) | 724 554 729 (T) 632 | --- --- 730 (T) 730 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.472 P=0.169 P=0.552 P=0.361 | P=0.206 (e) P=0.495 P=0.471 |
|INCIDENTAL TUMOR | P=0.458 P=0.136 P=0.476 P=0.254 | P=0.206 (e) P=0.495 P=0.471 |
|LOGISTIC REGRESSION | P=0.438 P=0.134 P=0.527 P=0.333 | P=0.206 (e) P=0.495 P=0.471 |
|COCHRAN-ARMITAGE | P=0.455 | P=0.233 |
|FISHER EXACT | P=0.141 P=0.510 P=0.349 | (e) P=0.500 P=0.495 |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/48 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | 2/50 (4%) 1/49 (2%) 0/50 (0%) 1/49 (2%) |
|ADJUSTED (b) | 3.2% 5.7% 0.0% 0.0% | 5.2% 2.2% 0.0% 3.1% |
|TERMINAL (d) | 1/31 (3%) 2/35 (6%) 0/35 (0%) 0/34 (0%) | 1/37 (3%) 0/38 (0%) 0/36 (0%) 1/32 (3%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) --- --- | 701 638 --- 730 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.174N P=0.543 P=0.476N P=0.482N | P=0.403N P=0.489N P=0.243N P=0.549N |
|INCIDENTAL TUMOR | P=0.174N P=0.543 P=0.476N P=0.482N | P=0.358N P=0.525N P=0.263N P=0.500N |
|LOGISTIC REGRESSION | P=0.174N P=0.543 P=0.476N P=0.481N | P=0.376N P=0.516N P=0.248N P=0.531N |
|COCHRAN-ARMITAGE | P=0.182N | P=0.370N |
|FISHER EXACT | P=0.515 P=0.490N P=0.490N | P=0.508N P=0.247N P=0.508N |
|=================================================================================================================================|
DATE: 07/12/96 EXPERIMENT: 89006 TEST: 04 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 5000 U 5000 U 5000 U | CONTROL 5000 U 5000 U 5000 U |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/48 (2%) 2/50 (4%) 1/50 (2%) 1/50 (2%) | 3/50 (6%) 1/49 (2%) 0/50 (0%) 1/49 (2%) |
|ADJUSTED (b) | 3.2% 5.7% 2.9% 2.9% | 7.3% 2.2% 0.0% 3.1% |
|TERMINAL (d) | 1/31 (3%) 2/35 (6%) 1/35 (3%) 1/34 (3%) | 1/37 (3%) 0/38 (0%) 0/36 (0%) 1/32 (3%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 729 (T) 729 (T) | 618 638 --- 730 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.509N P=0.543 P=0.735N P=0.741N | P=0.226N P=0.300N P=0.130N P=0.348N |
|INCIDENTAL TUMOR | P=0.509N P=0.543 P=0.735N P=0.741N | P=0.197N P=0.309N P=0.179N P=0.294N |
|LOGISTIC REGRESSION | P=0.509N P=0.543 P=0.735N P=0.741N | P=0.197N P=0.332N P=0.116N P=0.312N |
|COCHRAN-ARMITAGE | P=0.520N | P=0.203N |
|FISHER EXACT | P=0.515 P=0.742N P=0.742N | P=0.316N P=0.121N P=0.316N |
|=================================================================================================================================|
| |
|Bone Marrow |
| Hemangiosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/50 (2%) 1/50 (2%) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/48 (0%) |
|ADJUSTED (b) | 0.0% 5.7% 2.3% 2.9% | 2.7% 0.0% 2.4% 0.0% |
|TERMINAL (d) | 0/31 (0%) 2/35 (6%) 0/35 (0%) 1/34 (3%) | 1/37 (3%) 0/38 (0%) 0/36 (0%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | --- 729 (T) 581 729 (T) | 730 (T) --- 648 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.510 P=0.265 P=0.491 P=0.518 | P=0.426N P=0.495N P=0.752 P=0.529N |
|INCIDENTAL TUMOR | P=0.569 P=0.265 P=0.500 P=0.518 | P=0.386N P=0.495N P=0.737 P=0.529N |
|LOGISTIC REGRESSION | P=0.497 P=0.265 P=0.563 P=0.518 | P=0.412N P=0.495N P=0.763 P=0.529N |
|COCHRAN-ARMITAGE | P=0.500 | P=0.413N |
|FISHER EXACT | P=0.247 P=0.500 P=0.500 | P=0.500N P=0.753N P=0.510N |
|=================================================================================================================================|
DATE: 07/12/96 EXPERIMENT: 89006 TEST: 04 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 5000 U 5000 U 5000 U | CONTROL 5000 U 5000 U 5000 U |
|=================================================================================================================================|
| |
|Harderian Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 9/50 (18%) 3/50 (6%) 4/50 (8%) | 3/50 (6%) 2/50 (4%) 1/50 (2%) 1/50 (2%) |
|ADJUSTED (b) | 7.9% 22.9% 8.6% 11.8% | 8.1% 5.3% 2.8% 3.1% |
|TERMINAL (d) | 1/31 (3%) 6/35 (17%) 3/35 (9%) 4/34 (12%) | 3/37 (8%) 2/38 (5%) 1/36 (3%) 1/32 (3%) |
|FIRST INCIDENCE (DAYS) | 613 528 729 (T) 729 (T) | 730 (T) 730 (T) 730 (T) 730 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.396N P=0.082 P=0.633N P=0.527 | P=0.239N P=0.488N P=0.315N P=0.358N |
|INCIDENTAL TUMOR | P=0.388N P=0.050 * P=0.637 P=0.501 | P=0.239N P=0.488N P=0.315N P=0.358N |
|LOGISTIC REGRESSION | P=0.432N P=0.064 P=0.644 P=0.484 | P=0.239N P=0.488N P=0.315N P=0.358N |
|COCHRAN-ARMITAGE | P=0.419N | P=0.199N |
|FISHER EXACT | P=0.061 P=0.661N P=0.500 | P=0.500N P=0.309N P=0.309N |
|=================================================================================================================================|
| |
|Harderian Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 9/50 (18%) 4/50 (8%) 4/50 (8%) | 4/50 (8%) 2/50 (4%) 2/50 (4%) 1/50 (2%) |
|ADJUSTED (b) | 7.9% 22.9% 11.0% 11.8% | 10.8% 5.3% 5.6% 3.1% |
|TERMINAL (d) | 1/31 (3%) 6/35 (17%) 3/35 (9%) 4/34 (12%) | 4/37 (11%) 2/38 (5%) 2/36 (6%) 1/32 (3%) |
|FIRST INCIDENCE (DAYS) | 613 528 665 729 (T) | 730 (T) 730 (T) 730 (T) 730 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.418N P=0.082 P=0.519 P=0.527 | P=0.172N P=0.324N P=0.349N P=0.225N |
|INCIDENTAL TUMOR | P=0.441N P=0.050 * P=0.409 P=0.501 | P=0.172N P=0.324N P=0.349N P=0.225N |
|LOGISTIC REGRESSION | P=0.448N P=0.064 P=0.481 P=0.484 | P=0.172N P=0.324N P=0.349N P=0.225N |
|COCHRAN-ARMITAGE | P=0.437N | P=0.137N |
|FISHER EXACT | P=0.061 P=0.500 P=0.500 | P=0.339N P=0.339N P=0.181N |
|=================================================================================================================================|
DATE: 07/12/96 EXPERIMENT: 89006 TEST: 04 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 5000 U 5000 U 5000 U | CONTROL 5000 U 5000 U 5000 U |
|=================================================================================================================================|
| |
|Liver |
| Hemangiosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 4/50 (8%) 4/50 (8%) 5/50 (10%) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 6.3% 10.3% 10.4% 12.5% | 2.7% 2.6% 0.0% 0.0% |
|TERMINAL (d) | 1/31 (3%) 2/35 (6%) 2/35 (6%) 1/34 (3%) | 1/37 (3%) 1/38 (3%) 0/36 (0%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | 727 661 581 565 | 730 (T) 730 (T) --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.202 P=0.373 P=0.380 P=0.227 | P=0.257N P=0.756N P=0.505N P=0.529N |
|INCIDENTAL TUMOR | P=0.143 P=0.244 P=0.241 P=0.188 | P=0.257N P=0.756N P=0.505N P=0.529N |
|LOGISTIC REGRESSION | P=0.154 P=0.327 P=0.319 P=0.224 | P=0.257N P=0.756N P=0.505N P=0.529N |
|COCHRAN-ARMITAGE | P=0.194 | P=0.236N |
|FISHER EXACT | P=0.339 P=0.339 P=0.218 | P=0.753N P=0.500N P=0.500N |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 19/50 (38%) 17/50 (34%) 15/50 (30%) 17/50 (34%) | 19/50 (38%) 10/50 (20%) 14/50 (28%) 15/50 (30%) |
|ADJUSTED (b) | 57.0% 47.0% 40.1% 43.9% | 46.0% 24.6% 36.8% 45.1% |
|TERMINAL (d) | 17/31 (55%) 16/35 (46%) 13/35 (37%) 13/34 (38%) | 15/37 (41%) 8/38 (21%) 12/36 (33%) 14/32 (44%) |
|FIRST INCIDENCE (DAYS) | 613 661 488 498 | 589 638 722 630 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.304N P=0.254N P=0.151N P=0.311N | P=0.495 P=0.038N* P=0.229N P=0.437N |
|INCIDENTAL TUMOR | P=0.310N P=0.298N P=0.187N P=0.296N | P=0.494N P=0.038N* P=0.268N P=0.360N |
|LOGISTIC REGRESSION | P=0.433N P=0.428N P=0.322N P=0.467N | P=0.487N P=0.035N* P=0.234N P=0.329N |
|COCHRAN-ARMITAGE | P=0.381N | P=0.396N |
|FISHER EXACT | P=0.418N P=0.263N P=0.418N | P=0.038N* P=0.198N P=0.263N |
|=================================================================================================================================|
DATE: 07/12/96 EXPERIMENT: 89006 TEST: 04 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 5000 U 5000 U 5000 U | CONTROL 5000 U 5000 U 5000 U |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 19/50 (38%) 24/50 (48%) 18/50 (36%) 16/50 (32%) | 14/50 (28%) 15/50 (30%) 14/50 (28%) 12/50 (24%) |
|ADJUSTED (b) | 41.7% 58.0% 45.3% 38.0% | 35.7% 36.5% 34.6% 32.4% |
|TERMINAL (d) | 6/31 (19%) 18/35 (51%) 14/35 (40%) 9/34 (26%) | 12/37 (32%) 12/38 (32%) 10/36 (28%) 8/32 (25%) |
|FIRST INCIDENCE (DAYS) | 462 528 386 526 | 651 656 488 630 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.171N P=0.321 P=0.434N P=0.331N | P=0.496N P=0.535 P=0.553 P=0.555N |
|INCIDENTAL TUMOR | P=0.121N P=0.104 P=0.529 P=0.398N | P=0.338N P=0.488 P=0.530 P=0.442N |
|LOGISTIC REGRESSION | P=0.139N P=0.134 P=0.561 P=0.274N | P=0.386N P=0.532 P=0.524 P=0.465N |
|COCHRAN-ARMITAGE | P=0.169N | P=0.325N |
|FISHER EXACT | P=0.210 P=0.500N P=0.338N | P=0.500 P=0.588N P=0.410N |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 20/50 (40%) 24/50 (48%) 18/50 (36%) 16/50 (32%) | 14/50 (28%) 15/50 (30%) 14/50 (28%) 12/50 (24%) |
|ADJUSTED (b) | 43.2% 58.0% 45.3% 38.0% | 35.7% 36.5% 34.6% 32.4% |
|TERMINAL (d) | 6/31 (19%) 18/35 (51%) 14/35 (40%) 9/34 (26%) | 12/37 (32%) 12/38 (32%) 10/36 (28%) 8/32 (25%) |
|FIRST INCIDENCE (DAYS) | 462 528 386 526 | 651 656 488 630 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.137N P=0.384 P=0.369N P=0.273N | P=0.496N P=0.535 P=0.553 P=0.555N |
|INCIDENTAL TUMOR | P=0.099N P=0.134 P=0.580 P=0.354N | P=0.338N P=0.488 P=0.530 P=0.442N |
|LOGISTIC REGRESSION | P=0.104N P=0.180 P=0.533N P=0.209N | P=0.386N P=0.532 P=0.524 P=0.465N |
|COCHRAN-ARMITAGE | P=0.130N | P=0.325N |
|FISHER EXACT | P=0.273 P=0.418N P=0.266N | P=0.500 P=0.588N P=0.410N |
|=================================================================================================================================|
DATE: 07/12/96 EXPERIMENT: 89006 TEST: 04 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 5000 U 5000 U 5000 U | CONTROL 5000 U 5000 U 5000 U |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 35/50 (70%) 33/50 (66%) 28/50 (56%) 29/50 (58%) | 24/50 (48%) 23/50 (46%) 23/50 (46%) 23/50 (46%) |
|ADJUSTED (b) | 77.3% 78.3% 67.8% 65.5% | 58.3% 54.6% 55.9% 63.4% |
|TERMINAL (d) | 21/31 (68%) 26/35 (74%) 22/35 (63%) 19/34 (56%) | 20/37 (54%) 19/38 (50%) 18/36 (50%) 19/32 (59%) |
|FIRST INCIDENCE (DAYS) | 462 528 386 498 | 589 638 488 630 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.104N P=0.268N P=0.082N P=0.145N | P=0.334 P=0.450N P=0.547N P=0.415 |
|INCIDENTAL TUMOR | P=0.067N P=0.515N P=0.145N P=0.154N | P=0.504 P=0.489N P=0.549 P=0.544 |
|LOGISTIC REGRESSION | P=0.097N P=0.460N P=0.138N P=0.150N | P=0.489 P=0.460N P=0.555 P=0.561 |
|COCHRAN-ARMITAGE | P=0.104N | P=0.471N |
|FISHER EXACT | P=0.415N P=0.107N P=0.149N | P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 36/50 (72%) 33/50 (66%) 28/50 (56%) 29/50 (58%) | 24/50 (48%) 23/50 (46%) 23/50 (46%) 23/50 (46%) |
|ADJUSTED (b) | 77.9% 78.3% 67.8% 65.5% | 58.3% 54.6% 55.9% 63.4% |
|TERMINAL (d) | 21/31 (68%) 26/35 (74%) 22/35 (63%) 19/34 (56%) | 20/37 (54%) 19/38 (50%) 18/36 (50%) 19/32 (59%) |
|FIRST INCIDENCE (DAYS) | 462 528 386 498 | 589 638 488 630 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.082N P=0.220N P=0.063N P=0.115N | P=0.334 P=0.450N P=0.547N P=0.415 |
|INCIDENTAL TUMOR | P=0.052N P=0.450N P=0.118N P=0.128N | P=0.504 P=0.489N P=0.549 P=0.544 |
|LOGISTIC REGRESSION | P=0.068N P=0.375N P=0.096N P=0.105N | P=0.489 P=0.460N P=0.555 P=0.561 |
|COCHRAN-ARMITAGE | P=0.076N | P=0.471N |
|FISHER EXACT | P=0.333N P=0.072N P=0.104N | P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
DATE: 07/12/96 EXPERIMENT: 89006 TEST: 04 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 5000 U 5000 U 5000 U | CONTROL 5000 U 5000 U 5000 U |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 8/50 (16%) 7/50 (14%) 6/50 (12%) | 4/50 (8%) 4/50 (8%) 0/50 (0%) 2/50 (4%) |
|ADJUSTED (b) | 16.2% 22.9% 20.0% 16.1% | 9.4% 9.9% 0.0% 5.1% |
|TERMINAL (d) | 3/31 (10%) 8/35 (23%) 7/35 (20%) 4/34 (12%) | 2/37 (5%) 3/38 (8%) 0/36 (0%) 1/32 (3%) |
|FIRST INCIDENCE (DAYS) | 474 729 (T) 729 (T) 600 | 575 592 --- 557 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.448N P=0.458 P=0.567 P=0.592N | P=0.197N P=0.631N P=0.074N P=0.382N |
|INCIDENTAL TUMOR | P=0.442N P=0.402 P=0.474 P=0.608N | P=0.183N P=0.603N P=0.110N P=0.331N |
|LOGISTIC REGRESSION | P=0.511N P=0.371 P=0.467 P=0.615N | P=0.144N P=0.617 P=0.048N* P=0.284N |
|COCHRAN-ARMITAGE | P=0.486N | P=0.162N |
|FISHER EXACT | P=0.387 P=0.500 P=0.620N | P=0.643N P=0.059N P=0.339N |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 4/50 (8%) 3/50 (6%) 0/50 (0%) | 2/50 (4%) 1/50 (2%) 3/50 (6%) 1/50 (2%) |
|ADJUSTED (b) | 6.5% 10.6% 7.9% 0.0% | 5.4% 2.2% 7.6% 3.1% |
|TERMINAL (d) | 2/31 (6%) 2/35 (6%) 2/35 (6%) 0/34 (0%) | 2/37 (5%) 0/38 (0%) 2/36 (6%) 1/32 (3%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 683 562 --- | 730 (T) 598 344 730 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.127N P=0.386 P=0.540 P=0.218N | P=0.521N P=0.491N P=0.484 P=0.551N |
|INCIDENTAL TUMOR | P=0.163N P=0.293 P=0.544 P=0.218N | P=0.445N P=0.476N P=0.685 P=0.551N |
|LOGISTIC REGRESSION | P=0.143N P=0.328 P=0.487 P=0.218N | P=0.439N P=0.512N P=0.546 P=0.551N |
|COCHRAN-ARMITAGE | P=0.137N | P=0.474N |
|FISHER EXACT | P=0.339 P=0.500 P=0.247N | P=0.500N P=0.500 P=0.500N |
|=================================================================================================================================|
DATE: 07/12/96 EXPERIMENT: 89006 TEST: 04 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 5000 U 5000 U 5000 U | CONTROL 5000 U 5000 U 5000 U |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 12/50 (24%) 10/50 (20%) 6/50 (12%) | 6/50 (12%) 5/50 (10%) 3/50 (6%) 3/50 (6%) |
|ADJUSTED (b) | 22.2% 32.2% 27.4% 16.1% | 14.5% 11.8% 7.6% 8.2% |
|TERMINAL (d) | 5/31 (16%) 10/35 (29%) 9/35 (26%) 4/34 (12%) | 4/37 (11%) 3/38 (8%) 2/36 (6%) 2/32 (6%) |
|FIRST INCIDENCE (DAYS) | 474 683 562 600 | 575 592 344 557 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.198N P=0.307 P=0.479 P=0.357N | P=0.212N P=0.487N P=0.269N P=0.302N |
|INCIDENTAL TUMOR | P=0.216N P=0.215 P=0.400 P=0.363N | P=0.161N P=0.448N P=0.200N P=0.263N |
|LOGISTIC REGRESSION | P=0.248N P=0.208 P=0.361 P=0.388N | P=0.134N P=0.532N P=0.193N P=0.221N |
|COCHRAN-ARMITAGE | P=0.228N | P=0.162N |
|FISHER EXACT | P=0.227 P=0.398 P=0.387N | P=0.500N P=0.243N P=0.243N |
|=================================================================================================================================|
| |
|Ovary |
| Cystadenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | | 3/50 (6%) 0/49 (0%) 2/49 (4%) 1/50 (2%) |
|ADJUSTED (b) | | 8.1% 0.0% 5.6% 2.6% |
|TERMINAL (d) | | 3/37 (8%) 0/37 (0%) 2/36 (6%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | | 730 (T) --- 730 (T) 676 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.381N P=0.121N P=0.513N P=0.351N |
|INCIDENTAL TUMOR | | P=0.350N P=0.121N P=0.513N P=0.308N |
|LOGISTIC REGRESSION | | P=0.360N P=0.121N P=0.513N P=0.324N |
|COCHRAN-ARMITAGE | | P=0.336N |
|FISHER EXACT | | P=0.125N P=0.510N P=0.309N |
|=================================================================================================================================|
DATE: 07/12/96 EXPERIMENT: 89006 TEST: 04 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 5000 U 5000 U 5000 U | CONTROL 5000 U 5000 U 5000 U |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/47 (0%) 0/43 (0%) 0/48 (0%) 0/43 (0%) | 8/49 (16%) 7/44 (16%) 6/48 (13%) 2/44 (5%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 19.9% 20.6% 16.6% 5.6% |
|TERMINAL (d) | 0/29 (0%) 0/33 (0%) 0/34 (0%) 0/32 (0%) | 5/36 (14%) 7/34 (21%) 5/35 (14%) 1/31 (3%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- | 618 730 (T) 729 658 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) (e) | P=0.053N P=0.536N P=0.411N P=0.075N |
|INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.049N* P=0.582N P=0.490N P=0.068N |
|LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.050N* P=0.572N P=0.436N P=0.070N |
|COCHRAN-ARMITAGE | (e) | P=0.044N* |
|FISHER EXACT | (e) (e) (e) | P=0.591N P=0.403N P=0.065N |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Intermedia |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/47 (0%) 0/43 (0%) 0/48 (0%) 1/43 (2%) | 2/49 (4%) 0/44 (0%) 1/48 (2%) 0/44 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 3.1% | 5.6% 0.0% 2.4% 0.0% |
|TERMINAL (d) | 0/29 (0%) 0/33 (0%) 0/34 (0%) 1/32 (3%) | 2/36 (6%) 0/34 (0%) 0/35 (0%) 0/31 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- 729 (T) | 730 (T) --- 620 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.203 (e) (e) P=0.520 | P=0.204N P=0.251N P=0.512N P=0.272N |
|INCIDENTAL TUMOR | P=0.203 (e) (e) P=0.520 | P=0.227N P=0.251N P=0.626N P=0.272N |
|LOGISTIC REGRESSION | P=0.203 (e) (e) P=0.520 | P=0.200N P=0.251N P=0.513N P=0.272N |
|COCHRAN-ARMITAGE | P=0.190 | P=0.200N |
|FISHER EXACT | (e) (e) P=0.478 | P=0.275N P=0.508N P=0.275N |
|=================================================================================================================================|
DATE: 07/12/96 EXPERIMENT: 89006 TEST: 04 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 5000 U 5000 U 5000 U | CONTROL 5000 U 5000 U 5000 U |
|=================================================================================================================================|
| |
|Skin |
| Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | 2/50 (4%) 1/50 (2%) 2/50 (4%) 1/50 (2%) |
|ADJUSTED (b) | 0.0% 4.3% 0.0% 0.0% | 4.9% 2.6% 5.1% 2.0% |
|TERMINAL (d) | 0/31 (0%) 0/35 (0%) 0/35 (0%) 0/34 (0%) | 1/37 (3%) 1/38 (3%) 1/36 (3%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | --- 439 --- --- | 625 730 (T) 648 501 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.410N P=0.233 (e) (e) | P=0.478N P=0.491N P=0.677 P=0.517N |
|INCIDENTAL TUMOR | P=0.291N P=0.208 (e) (e) | P=0.411N P=0.476N P=0.610 P=0.499N |
|LOGISTIC REGRESSION | P=0.367N P=0.337 (e) (e) | P=0.416N P=0.506N P=0.695N P=0.426N |
|COCHRAN-ARMITAGE | P=0.405N | P=0.444N |
|FISHER EXACT | P=0.247 (e) (e) | P=0.500N P=0.691N P=0.500N |
|=================================================================================================================================|
| |
|Skin |
| Fibrosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | 1/50 (2%) 1/50 (2%) 2/50 (4%) 1/50 (2%) |
|ADJUSTED (b) | 0.0% 4.3% 0.0% 0.0% | 2.3% 2.6% 5.1% 2.0% |
|TERMINAL (d) | 0/31 (0%) 0/35 (0%) 0/35 (0%) 0/34 (0%) | 0/37 (0%) 1/38 (3%) 1/36 (3%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | --- 439 --- --- | 625 730 (T) 648 501 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.410N P=0.233 (e) (e) | P=0.564 P=0.755N P=0.483 P=0.760 |
|INCIDENTAL TUMOR | P=0.291N P=0.208 (e) (e) | P=0.600N P=0.740N P=0.398 P=0.743N |
|LOGISTIC REGRESSION | P=0.367N P=0.337 (e) (e) | P=0.617N P=0.752 P=0.519 P=0.693N |
|COCHRAN-ARMITAGE | P=0.405N | P=0.591 |
|FISHER EXACT | P=0.247 (e) (e) | P=0.753N P=0.500 P=0.753N |
|=================================================================================================================================|
DATE: 07/12/96 EXPERIMENT: 89006 TEST: 04 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 5000 U 5000 U 5000 U | CONTROL 5000 U 5000 U 5000 U |
|=================================================================================================================================|
| |
|Skin |
| Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | 2/50 (4%) 1/50 (2%) 2/50 (4%) 1/50 (2%) |
|ADJUSTED (b) | 0.0% 4.3% 0.0% 0.0% | 4.9% 2.6% 5.1% 2.0% |
|TERMINAL (d) | 0/31 (0%) 0/35 (0%) 0/35 (0%) 0/34 (0%) | 1/37 (3%) 1/38 (3%) 1/36 (3%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | --- 439 --- --- | 625 730 (T) 648 501 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.410N P=0.233 (e) (e) | P=0.478N P=0.491N P=0.677 P=0.517N |
|INCIDENTAL TUMOR | P=0.291N P=0.208 (e) (e) | P=0.411N P=0.476N P=0.610 P=0.499N |
|LOGISTIC REGRESSION | P=0.367N P=0.337 (e) (e) | P=0.416N P=0.506N P=0.695N P=0.426N |
|COCHRAN-ARMITAGE | P=0.405N | P=0.444N |
|FISHER EXACT | P=0.247 (e) (e) | P=0.500N P=0.691N P=0.500N |
|=================================================================================================================================|
| |
|Skin |
| Hemangiosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | 3/50 (6%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 3.2% 0.0% 0.0% 0.0% | 8.1% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/31 (3%) 0/35 (0%) 0/35 (0%) 0/34 (0%) | 3/37 (8%) 0/38 (0%) 0/36 (0%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) --- --- --- | 730 (T) --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.296N P=0.476N P=0.476N P=0.482N | P=0.054N P=0.116N P=0.126N P=0.147N |
|INCIDENTAL TUMOR | P=0.296N P=0.476N P=0.476N P=0.482N | P=0.054N P=0.116N P=0.126N P=0.147N |
|LOGISTIC REGRESSION | P=0.296N P=0.476N P=0.476N P=0.482N | P=0.054N P=0.116N P=0.126N P=0.147N |
|COCHRAN-ARMITAGE | P=0.306N | P=0.047N* |
|FISHER EXACT | P=0.500N P=0.500N P=0.500N | P=0.121N P=0.121N P=0.121N |
|=================================================================================================================================|
DATE: 07/12/96 EXPERIMENT: 89006 TEST: 04 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 5000 U 5000 U 5000 U | CONTROL 5000 U 5000 U 5000 U |
|=================================================================================================================================|
| |
|Spleen |
| Hemangiosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/48 (2%) 2/50 (4%) 4/50 (8%) 4/49 (8%) | 3/49 (6%) 0/49 (0%) 1/49 (2%) 1/49 (2%) |
|ADJUSTED (b) | 3.2% 5.2% 10.4% 9.9% | 8.1% 0.0% 2.4% 3.2% |
|TERMINAL (d) | 1/31 (3%) 1/35 (3%) 2/35 (6%) 1/34 (3%) | 3/37 (8%) 0/38 (0%) 0/36 (0%) 1/31 (3%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 661 581 565 | 730 (T) --- 648 730 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.117 P=0.525 P=0.210 P=0.179 | P=0.341N P=0.116N P=0.318N P=0.370N |
|INCIDENTAL TUMOR | P=0.152 P=0.487 P=0.163 P=0.297 | P=0.304N P=0.116N P=0.330N P=0.370N |
|LOGISTIC REGRESSION | P=0.114 P=0.507 P=0.181 P=0.188 | P=0.312N P=0.116N P=0.321N P=0.370N |
|COCHRAN-ARMITAGE | P=0.115 | P=0.296N |
|FISHER EXACT | P=0.515 P=0.194 P=0.187 | P=0.121N P=0.309N P=0.309N |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 2/50 (4%) 1/50 (2%) 5/49 (10%) | 2/49 (4%) 4/50 (8%) 6/50 (12%) 2/50 (4%) |
|ADJUSTED (b) | 17.2% 5.7% 2.9% 14.7% | 5.6% 10.5% 16.7% 6.3% |
|TERMINAL (d) | 4/31 (13%) 2/35 (6%) 1/35 (3%) 5/34 (15%) | 2/36 (6%) 4/38 (11%) 6/36 (17%) 2/32 (6%) |
|FIRST INCIDENCE (DAYS) | 677 729 (T) 729 (T) 729 (T) | 730 (T) 730 (T) 730 (T) 730 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.510N P=0.112N P=0.051N P=0.454N | P=0.536 P=0.361 P=0.132 P=0.652 |
|INCIDENTAL TUMOR | P=0.559 P=0.146N P=0.082N P=0.576N | P=0.536 P=0.361 P=0.132 P=0.652 |
|LOGISTIC REGRESSION | P=0.563N P=0.139N P=0.065N P=0.533N | P=0.536 P=0.361 P=0.132 P=0.652 |
|COCHRAN-ARMITAGE | P=0.549N | P=0.528N |
|FISHER EXACT | P=0.134N P=0.056N P=0.514N | P=0.349 P=0.141 P=0.684N |
|=================================================================================================================================|
DATE: 07/12/96 EXPERIMENT: 89006 TEST: 04 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 5000 U 5000 U 5000 U | CONTROL 5000 U 5000 U 5000 U |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 3/50 (6%) 1/50 (2%) 5/49 (10%) | 2/49 (4%) 4/50 (8%) 6/50 (12%) 2/50 (4%) |
|ADJUSTED (b) | 17.2% 8.6% 2.9% 14.7% | 5.6% 10.5% 16.7% 6.3% |
|TERMINAL (d) | 4/31 (13%) 3/35 (9%) 1/35 (3%) 5/34 (15%) | 2/36 (6%) 4/38 (11%) 6/36 (17%) 2/32 (6%) |
|FIRST INCIDENCE (DAYS) | 677 729 (T) 729 (T) 729 (T) | 730 (T) 730 (T) 730 (T) 730 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.453N P=0.203N P=0.051N P=0.454N | P=0.536 P=0.361 P=0.132 P=0.652 |
|INCIDENTAL TUMOR | P=0.532N P=0.252N P=0.082N P=0.576N | P=0.536 P=0.361 P=0.132 P=0.652 |
|LOGISTIC REGRESSION | P=0.508N P=0.249N P=0.065N P=0.533N | P=0.536 P=0.361 P=0.132 P=0.652 |
|COCHRAN-ARMITAGE | P=0.494N | P=0.528N |
|FISHER EXACT | P=0.243N P=0.056N P=0.514N | P=0.349 P=0.141 P=0.684N |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # # |
|----------- | | |
|OVERALL (a) | | 0/50 (0%) 3/50 (6%) 0/50 (0%) 1/50 (2%) |
|ADJUSTED (b) | | 0.0% 7.3% 0.0% 3.1% |
|TERMINAL (d) | | 0/37 (0%) 2/38 (5%) 0/36 (0%) 1/32 (3%) |
|FIRST INCIDENCE (DAYS) | | --- 598 --- 730 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.600 P=0.128 (e) P=0.471 |
|INCIDENTAL TUMOR | | P=0.604 P=0.135 (e) P=0.471 |
|LOGISTIC REGRESSION | | P=0.630 P=0.114 (e) P=0.471 |
|COCHRAN-ARMITAGE | | P=0.634 |
|FISHER EXACT | | P=0.121 (e) P=0.500 |
|=================================================================================================================================|
DATE: 07/12/96 EXPERIMENT: 89006 TEST: 04 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 5000 U 5000 U 5000 U | CONTROL 5000 U 5000 U 5000 U |
|=================================================================================================================================|
| |
|Vagina |
| Squamous Cell Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # # |
|----------- | | |
|OVERALL (a) | | 0/50 (0%) 0/50 (0%) 5/50 (10%) 4/50 (8%) |
|ADJUSTED (b) | | 0.0% 0.0% 13.9% 12.5% |
|TERMINAL (d) | | 0/37 (0%) 0/38 (0%) 5/36 (14%) 4/32 (13%) |
|FIRST INCIDENCE (DAYS) | | --- --- 730 (T) 730 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.009 ** (e) P=0.031 * P=0.046 * |
|INCIDENTAL TUMOR | | P=0.009 ** (e) P=0.031 * P=0.046 * |
|LOGISTIC REGRESSION | | P=0.009 ** (e) P=0.031 * P=0.046 * |
|COCHRAN-ARMITAGE | | P=0.016 * |
|FISHER EXACT | | (e) P=0.028 * P=0.059 |
|=================================================================================================================================|
| |
|All Organs |
| Hemangioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 2.9% | 5.1% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/31 (0%) 0/35 (0%) 0/35 (0%) 1/34 (3%) | 1/37 (3%) 0/38 (0%) 0/36 (0%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- 729 (T) | 682 --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.203 (e) (e) P=0.518 | P=0.125N P=0.234N P=0.243N P=0.268N |
|INCIDENTAL TUMOR | P=0.203 (e) (e) P=0.518 | P=0.106N P=0.257N P=0.263N P=0.210N |
|LOGISTIC REGRESSION | P=0.203 (e) (e) P=0.518 | P=0.118N P=0.237N P=0.247N P=0.243N |
|COCHRAN-ARMITAGE | P=0.198 | P=0.115N |
|FISHER EXACT | (e) (e) P=0.500 | P=0.247N P=0.247N P=0.247N |
|=================================================================================================================================|
DATE: 07/12/96 EXPERIMENT: 89006 TEST: 04 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 5000 U 5000 U 5000 U | CONTROL 5000 U 5000 U 5000 U |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 5/50 (10%) 4/50 (8%) 6/50 (12%) | 5/50 (10%) 2/50 (4%) 1/50 (2%) 1/50 (2%) |
|ADJUSTED (b) | 15.6% 13.0% 10.4% 15.2% | 13.5% 5.3% 2.4% 3.1% |
|TERMINAL (d) | 4/31 (13%) 3/35 (9%) 2/35 (6%) 2/34 (6%) | 5/37 (14%) 2/38 (5%) 0/36 (0%) 1/32 (3%) |
|FIRST INCIDENCE (DAYS) | 727 661 581 565 | 730 (T) 730 (T) 648 730 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.452 P=0.571N P=0.440N P=0.526 | P=0.078N P=0.205N P=0.112N P=0.138N |
|INCIDENTAL TUMOR | P=0.385 P=0.585 P=0.564N P=0.513 | P=0.069N P=0.205N P=0.117N P=0.138N |
|LOGISTIC REGRESSION | P=0.426 P=0.619 P=0.530N P=0.493 | P=0.068N P=0.205N P=0.114N P=0.138N |
|COCHRAN-ARMITAGE | P=0.437 | P=0.060N |
|FISHER EXACT | P=0.630N P=0.500N P=0.500 | P=0.218N P=0.102N P=0.102N |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma or Hemangioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 5/50 (10%) 4/50 (8%) 7/50 (14%) | 7/50 (14%) 2/50 (4%) 1/50 (2%) 1/50 (2%) |
|ADJUSTED (b) | 15.6% 13.0% 10.4% 17.8% | 18.3% 5.3% 2.4% 3.1% |
|TERMINAL (d) | 4/31 (13%) 3/35 (9%) 2/35 (6%) 3/34 (9%) | 6/37 (16%) 2/38 (5%) 0/36 (0%) 1/32 (3%) |
|FIRST INCIDENCE (DAYS) | 727 661 581 565 | 682 730 (T) 648 730 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.324 P=0.571N P=0.440N P=0.413 | P=0.023N* P=0.076N P=0.038N* P=0.051N |
|INCIDENTAL TUMOR | P=0.263 P=0.585 P=0.564N P=0.393 | P=0.017N* P=0.081N P=0.041N* P=0.041N* |
|LOGISTIC REGRESSION | P=0.296 P=0.619 P=0.530N P=0.368 | P=0.019N* P=0.073N P=0.038N* P=0.041N* |
|COCHRAN-ARMITAGE | P=0.306 | P=0.016N* |
|FISHER EXACT | P=0.630N P=0.500N P=0.380 | P=0.080N P=0.030N* P=0.030N* |
|=================================================================================================================================|
DATE: 07/12/96 EXPERIMENT: 89006 TEST: 04 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 5000 U 5000 U 5000 U | CONTROL 5000 U 5000 U 5000 U |
|=================================================================================================================================|
| |
|All Organs |
| Histiocytic Sarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | 2/50 (4%) 1/50 (2%) 1/50 (2%) 1/50 (2%) |
|ADJUSTED (b) | 3.2% 0.0% 2.4% 0.0% | 5.4% 2.3% 2.1% 2.9% |
|TERMINAL (d) | 1/31 (3%) 0/35 (0%) 0/35 (0%) 0/34 (0%) | 2/37 (5%) 0/38 (0%) 0/36 (0%) 0/32 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) --- 605 --- | 730 (T) 640 318 713 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.409N P=0.476N P=0.755N P=0.482N | P=0.441N P=0.491N P=0.511N P=0.543N |
|INCIDENTAL TUMOR | P=0.331N P=0.476N P=0.747N P=0.482N | P=0.311N P=0.476N P=0.244N P=0.487N |
|LOGISTIC REGRESSION | P=0.402N P=0.476N P=0.758N P=0.482N | P=0.352N P=0.503N P=0.391N P=0.530N |
|COCHRAN-ARMITAGE | P=0.405N | P=0.409N |
|FISHER EXACT | P=0.500N P=0.753N P=0.500N | P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated |
| Cell Type |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) 6/50 (12%) 3/50 (6%) | 8/50 (16%) 12/50 (24%) 8/50 (16%) 6/50 (12%) |
|ADJUSTED (b) | 4.7% 7.7% 14.9% 7.8% | 18.7% 28.3% 21.3% 15.6% |
|TERMINAL (d) | 0/31 (0%) 2/35 (6%) 2/35 (6%) 1/34 (3%) | 4/37 (11%) 8/38 (21%) 7/36 (19%) 2/32 (6%) |
|FIRST INCIDENCE (DAYS) | 670 473 605 586 | 589 592 604 557 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.384 P=0.516 P=0.140 P=0.487 | P=0.301N P=0.260 P=0.574 P=0.462N |
|INCIDENTAL TUMOR | P=0.310 P=0.426 P=0.037 * P=0.274 | P=0.182N P=0.220 P=0.464 P=0.298N |
|LOGISTIC REGRESSION | P=0.395 P=0.526 P=0.054 P=0.309 | P=0.215N P=0.217 P=0.585 P=0.358N |
|COCHRAN-ARMITAGE | P=0.389 | P=0.204N |
|FISHER EXACT | P=0.500 P=0.134 P=0.500 | P=0.227 P=0.607N P=0.387N |
|=================================================================================================================================|
DATE: 07/12/96 EXPERIMENT: 89006 TEST: 04 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 5000 U 5000 U 5000 U | CONTROL 5000 U 5000 U 5000 U |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 28/50 (56%) 30/50 (60%) 26/50 (52%) 31/50 (62%) | 36/50 (72%) 24/50 (48%) 24/50 (48%) 22/50 (44%) |
|ADJUSTED (b) | 71.1% 74.6% 68.1% 73.5% | 78.1% 56.7% 61.5% 60.3% |
|TERMINAL (d) | 20/31 (65%) 25/35 (71%) 23/35 (66%) 23/34 (68%) | 27/37 (73%) 20/38 (53%) 21/36 (58%) 18/32 (56%) |
|FIRST INCIDENCE (DAYS) | 474 528 488 498 | 575 592 620 557 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.464 P=0.534N P=0.254N P=0.484 | P=0.063N P=0.017N* P=0.029N* P=0.040N* |
|INCIDENTAL TUMOR | P=0.427 P=0.433 P=0.439N P=0.345 | P=0.022N* P=0.009N** P=0.042N* P=0.008N** |
|LOGISTIC REGRESSION | P=0.292 P=0.358 P=0.536N P=0.282 | P=0.016N* P=0.011N* P=0.024N* P=0.006N** |
|COCHRAN-ARMITAGE | P=0.358 | P=0.009N** |
|FISHER EXACT | P=0.420 P=0.421N P=0.342 | P=0.012N* P=0.012N* P=0.004N** |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 28/50 (56%) 34/50 (68%) 29/50 (58%) 26/50 (52%) | 32/50 (64%) 28/50 (56%) 33/50 (66%) 28/50 (56%) |
|ADJUSTED (b) | 58.1% 72.3% 64.4% 55.3% | 69.4% 60.8% 74.7% 61.6% |
|TERMINAL (d) | 11/31 (35%) 22/35 (63%) 19/35 (54%) 13/34 (38%) | 23/37 (62%) 20/38 (53%) 25/36 (69%) 15/32 (47%) |
|FIRST INCIDENCE (DAYS) | 462 439 386 517 | 589 592 318 501 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.251N P=0.323 P=0.538N P=0.399N | P=0.448 P=0.262N P=0.431 P=0.517N |
|INCIDENTAL TUMOR | P=0.323N P=0.026 * P=0.138 P=0.557 | P=0.286N P=0.252N P=0.411 P=0.246N |
|LOGISTIC REGRESSION | P=0.182N P=0.064 P=0.273 P=0.451N | P=0.357N P=0.299N P=0.419 P=0.283N |
|COCHRAN-ARMITAGE | P=0.226N | P=0.321N |
|FISHER EXACT | P=0.151 P=0.500 P=0.421N | P=0.270N P=0.500 P=0.270N |
|=================================================================================================================================|
DATE: 07/12/96 EXPERIMENT: 89006 TEST: 04 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 5000 U 5000 U 5000 U | CONTROL 5000 U 5000 U 5000 U |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 41/50 (82%) 44/50 (88%) 40/50 (80%) 43/50 (86%) | 44/50 (88%) 40/50 (80%) 41/50 (82%) 39/50 (78%) |
|ADJUSTED (b) | 83.7% 91.7% 87.0% 89.6% | 91.7% 85.1% 91.0% 86.5% |
|TERMINAL (d) | 23/31 (74%) 31/35 (89%) 29/35 (83%) 29/34 (85%) | 33/37 (89%) 31/38 (82%) 32/36 (89%) 26/32 (81%) |
|FIRST INCIDENCE (DAYS) | 462 439 386 498 | 575 592 318 501 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.497N P=0.554N P=0.337N P=0.560N | P=0.432 P=0.225N P=0.445N P=0.562N |
|INCIDENTAL TUMOR | P=0.369 P=0.076 P=0.302 P=0.254 | P=0.212N P=0.158N P=0.476N P=0.203N |
|LOGISTIC REGRESSION | P=0.483 P=0.247 P=0.390 P=0.370 | P=0.247N P=0.169N P=0.515N P=0.200N |
|COCHRAN-ARMITAGE | P=0.448 | P=0.160N |
|FISHER EXACT | P=0.288 P=0.500N P=0.393 | P=0.207N P=0.288N P=0.143N |
|=================================================================================================================================|
(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).