TR 358 Rat Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Columbus OCHRATOXIN A DATE: 09/05/94 EXPERIMENT: 05036 TEST: 01 TIME: 02:39:22 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01-CP-95653 ROUTE: GAVAGE NTP C#: 56586 PATHOLOGIST: R. PERSING S. EUSTIS CAS: 303-47-9 ------------------------------------------------------------------------------------------------------------------------------------ REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Columbus OCHRATOXIN A DATE: 09/05/94 EXPERIMENT: 05036 TEST: 01 TIME: 02:39:22 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-CP-95653 ROUTE: GAVAGE NTP C#: 56586 PATHOLOGIST: R. PERSING S. EUSTIS CAS: 303-47-9 RATS(FISCHER344) ---------------------------- FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED. IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED. ---------------- Adrenal Gland Bone Marrow Brain Clitoral Gland Epididymis Heart Islets, Pancreatic Kidney Liver Lung Nose Ovary Pancreas Parathyroid Gland Pituitary Gland Preputial Gland Prostate Salivary Glands Spleen Testes Thymus Thyroid Gland Urinary Bladder NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Columbus OCHRATOXIN A DATE: 09/05/94 EXPERIMENT: 05036 TEST: 01 TIME: 02:39:22 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-CP-95653 ROUTE: GAVAGE NTP C#: 56586 PATHOLOGIST: R. PERSING S. EUSTIS CAS: 303-47-9 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF THE STUDY OF OCHRATOXIN A ==================================================================================================== MALE RATS ------------- ORGAN MORPHOLOGY ------- ------------ Adrenal Medulla Pheochromocytoma Malignant Pheochromocytoma: Benign, Complex, Malignant, NOS Islets, Pancreatic Adenoma Carcinoma or Adenoma Kidney: Renal Tubule Adenoma Carcinoma Carcinoma or Adenoma Lung Alveolar/Bronchiolar Adenoma Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma Pancreas Adenoma Pituitary Gland: Pars Distalis or Unspecified Site Adenoma Carcinoma Carcinoma or Adenoma Skin: Subcutaneous Tissue Neurofibrosarcoma, Fibrosarcoma, Sarcoma, Neurofibroma, or Fibroma Testes Adenoma Thyroid Gland: C-Cell Adenoma Carcinoma or Adenoma All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated Benign Tumors Malignant Tumors Malignant and Benign Tumors ==================================================================================================== NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Columbus OCHRATOXIN A DATE: 09/05/94 EXPERIMENT: 05036 TEST: 01 TIME: 02:39:22 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-CP-95653 ROUTE: GAVAGE NTP C#: 56586 PATHOLOGIST: R. PERSING S. EUSTIS CAS: 303-47-9 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF THE STUDY OF OCHRATOXIN A ==================================================================================================== FEMALE RATS ------------- ORGAN MORPHOLOGY ------- ------------ Kidney: Renal Tubule Adenoma Carcinoma Carcinoma or Adenoma Mammary Gland Fibroadenoma Fibroma, Fibroadenoma or Adenoma Fibroma, Fibroadenoma, Carcinoma, or Adenoma Pituitary Gland: Pars Distalis or Unspecified Site Adenoma Carcinoma or Adenoma Thyroid Gland: C-Cell Adenoma Carcinoma or Adenoma Thyroid Gland: Follicular Cell Carcinoma or Adenoma Uterus Polyp Stromal Sarcoma Stromal or Polyp Stromal All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated Benign Tumors Malignant and Benign Tumors ==================================================================================================== DATE: 09/05/94 EXPERIMENT: 05036 TEST: 01 PAGE 1 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OCHRATOXIN A MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 UG/KG 21 UG/KG 70 UG/KG 210 UG/ | 0 UG/KG 21 UG/KG 70 UG/KG 210 UG/ | | | KG | KG | |=================================================================================================================================| | | |Adrenal Cortex | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/25 (0%) 0/25 (0%) 0/50 (0%) | 2/50 (4%) 0/29 (0%) 0/15 (0%) 0/50 (0%) | |ADJUSTED (b) | 5.1% 0.0% 0.0% 0.0% | 6.3% 0.0% 0.0% 0.0% | |TERMINAL (d) | 2/39 (5%) 0/1 (0%) 0/1 (0%) 0/23 (0%) | 2/32 (6%) 0/1 (0%) 0/0 0/35 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) --- --- --- | 728 (T) --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.275N P=0.981N P=0.981N P=0.361N | P=0.159N P=0.967N (e) P=0.219N | |INCIDENTAL TUMOR | P=0.275N P=0.981N P=0.981N P=0.361N | P=0.159N P=0.967N (e) P=0.219N | |LOGISTIC REGRESSION | P=0.275N P=0.981N P=0.981N P=0.361N | P=0.159N P=0.967N (e) P=0.219N | |COCHRAN-ARMITAGE | P=0.218N | P=0.227N | |FISHER EXACT | P=0.441N P=0.441N P=0.247N | P=0.398N P=0.589N P=0.247N | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Benign | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 17/50 (34%) 4/25 (16%) 5/26 (19%) 11/50 (22%) | 3/50 (6%) 1/27 (4%) 2/16 (13%) 4/50 (8%) | |ADJUSTED (b) | 42.3% 11.5% 54.6% 37.6% | 8.9% 4.0% 100.0% 10.2% | |TERMINAL (d) | 16/39 (41%) 0/1 (0%) 2/4 (50%) 6/23 (26%) | 2/32 (6%) 0/1 (0%) 1/1 (100%) 2/35 (6%) | |FIRST INCIDENCE (DAYS) | 495 627 669 408 | 675 718 697 415 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.523 P=0.248 P=0.234 P=0.547 | P=0.512 P=0.719 P=0.309 P=0.537 | |INCIDENTAL TUMOR | P=0.324N P=0.637N P=0.499 P=0.305N | P=0.362 P=0.680N P=0.201 P=0.439 | |LOGISTIC REGRESSION | P=0.360N P=0.393N P=0.568N P=0.279N | P=0.451 P=0.658 P=0.094 P=0.500 | |COCHRAN-ARMITAGE | P=0.246N | P=0.390 | |FISHER EXACT | P=0.084N P=0.140N P=0.133N | P=0.561N P=0.351 P=0.500 | |=================================================================================================================================| DATE: 09/05/94 EXPERIMENT: 05036 TEST: 01 PAGE 2 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OCHRATOXIN A MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 UG/KG 21 UG/KG 70 UG/KG 210 UG/ | 0 UG/KG 21 UG/KG 70 UG/KG 210 UG/ | | | KG | KG | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Malignant | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/25 (0%) 2/26 (8%) 1/50 (2%) | 0/50 (0%) 0/27 (0%) 0/16 (0%) 0/50 (0%) | |ADJUSTED (b) | 0.0% 0.0% 50.0% 4.3% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/39 (0%) 0/1 (0%) 2/4 (50%) 1/23 (4%) | 0/32 (0%) 0/1 (0%) 0/1 (0%) 0/35 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 729 (T) 729 (T) | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.382 (e) P<0.001 ** P=0.395 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.382 (e) P<0.001 ** P=0.395 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.382 (e) P<0.001 ** P=0.395 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.436 | (e) | |FISHER EXACT | (e) P=0.114 P=0.500 | (e) (e) (e) | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma: Benign, Complex, Malignant, NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 18/50 (36%) 4/25 (16%) 8/26 (31%) 13/50 (26%) | 3/50 (6%) 2/27 (7%) 2/16 (13%) 4/50 (8%) | |ADJUSTED (b) | 44.8% 11.5% 100.0% 44.9% | 8.9% 100.0% 100.0% 10.2% | |TERMINAL (d) | 17/39 (44%) 0/1 (0%) 4/4 (100%) 8/23 (35%) | 2/32 (6%) 1/1 (100%) 1/1 (100%) 2/35 (6%) | |FIRST INCIDENCE (DAYS) | 495 627 459 408 | 675 718 697 415 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.384 P=0.255 P=0.014 * P=0.390 | P=0.556N P=0.238 P=0.309 P=0.537 | |INCIDENTAL TUMOR | P=0.439N P=0.627N P=0.056 P=0.467N | P=0.487 P=0.339 P=0.201 P=0.439 | |LOGISTIC REGRESSION | P=0.471N P=0.347N P=0.334 P=0.414N | P=0.553 P=0.201 P=0.094 P=0.500 | |COCHRAN-ARMITAGE | P=0.338N | P=0.481 | |FISHER EXACT | P=0.061N P=0.424N P=0.194N | P=0.578 P=0.351 P=0.500 | |=================================================================================================================================| DATE: 09/05/94 EXPERIMENT: 05036 TEST: 01 PAGE 3 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OCHRATOXIN A MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 UG/KG 21 UG/KG 70 UG/KG 210 UG/ | 0 UG/KG 21 UG/KG 70 UG/KG 210 UG/ | | | KG | KG | |=================================================================================================================================| | | |Brain | | Astrocytoma Malignant | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/25 (0%) 1/25 (4%) 0/50 (0%) | 0/50 (0%) 2/28 (7%) 0/15 (0%) 0/50 (0%) | |ADJUSTED (b) | 2.6% 0.0% 0.0% 0.0% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/39 (3%) 0/1 (0%) 0/0 0/23 (0%) | 0/32 (0%) 0/0 0/0 0/35 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) --- 297 --- | --- 538 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.459N P=0.999N P=0.508 P=0.605N | P=0.346N P=0.209 (e) (e) | |INCIDENTAL TUMOR | P=0.629N P=0.999N P=0.500 P=0.605N | P=0.442N P=0.293 (e) (e) | |LOGISTIC REGRESSION | P=0.441N P=0.999N P=0.642 P=0.605N | P=0.333N P=0.116 (e) (e) | |COCHRAN-ARMITAGE | P=0.408N | P=0.326N | |FISHER EXACT | P=0.667N P=0.559 P=0.500N | P=0.126 (e) (e) | |=================================================================================================================================| | | |Brain | | Oligodendroglioma, Glioma, or Astrocytoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/25 (0%) 1/25 (4%) 0/50 (0%) | 0/50 (0%) 2/28 (7%) 1/15 (7%) 0/50 (0%) | |ADJUSTED (b) | 2.6% 0.0% 0.0% 0.0% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/39 (3%) 0/1 (0%) 0/0 0/23 (0%) | 0/32 (0%) 0/0 0/0 0/35 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) --- 297 --- | --- 538 564 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.459N P=0.999N P=0.508 P=0.605N | P=0.361N P=0.209 P=0.504 (e) | |INCIDENTAL TUMOR | P=0.629N P=0.999N P=0.500 P=0.605N | P=0.460N P=0.293 P=0.557 (e) | |LOGISTIC REGRESSION | P=0.441N P=0.999N P=0.642 P=0.605N | P=0.342N P=0.116 P=0.340 (e) | |COCHRAN-ARMITAGE | P=0.408N | P=0.323N | |FISHER EXACT | P=0.667N P=0.559 P=0.500N | P=0.126 P=0.231 (e) | |=================================================================================================================================| DATE: 09/05/94 EXPERIMENT: 05036 TEST: 01 PAGE 4 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OCHRATOXIN A MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 UG/KG 21 UG/KG 70 UG/KG 210 UG/ | 0 UG/KG 21 UG/KG 70 UG/KG 210 UG/ | | | KG | KG | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 6/50 (12%) 3/28 (11%) 1/25 (4%) 3/48 (6%) | 7/49 (14%) 4/29 (14%) 3/17 (18%) 3/47 (6%) | |ADJUSTED (b) | 14.6% 75.0% 0.0% 12.5% | 18.3% 54.4% 60.0% 9.1% | |TERMINAL (d) | 4/39 (10%) 3/4 (75%) 0/0 2/23 (9%) | 3/31 (10%) 1/2 (50%) 3/5 (60%) 3/33 (9%) | |FIRST INCIDENCE (DAYS) | 691 729 (T) 516 723 | 497 622 728 (T) 728 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.376N P=0.159 P=0.551N P=0.541N | P=0.058N P=0.505 P=0.610 P=0.150N | |INCIDENTAL TUMOR | P=0.272N P=0.367 P=0.194N P=0.247N | P=0.105N P=0.573N P=0.446 P=0.208N | |LOGISTIC REGRESSION | P=0.298N P=0.281 P=0.359N P=0.456N | P=0.098N P=0.578 P=0.451 P=0.175N | |COCHRAN-ARMITAGE | P=0.224N | P=0.130N | |FISHER EXACT | P=0.589N P=0.250N P=0.264N | P=0.616N P=0.505 P=0.176N | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 6/50 (12%) 3/28 (11%) 1/25 (4%) 3/48 (6%) | 7/49 (14%) 4/29 (14%) 4/17 (24%) 4/47 (9%) | |ADJUSTED (b) | 14.6% 75.0% 0.0% 12.5% | 18.3% 54.4% 80.0% 11.5% | |TERMINAL (d) | 4/39 (10%) 3/4 (75%) 0/0 2/23 (9%) | 3/31 (10%) 1/2 (50%) 4/5 (80%) 3/33 (9%) | |FIRST INCIDENCE (DAYS) | 691 729 (T) 516 723 | 497 622 728 (T) 699 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.376N P=0.159 P=0.551N P=0.541N | P=0.105N P=0.505 P=0.348 P=0.242N | |INCIDENTAL TUMOR | P=0.272N P=0.367 P=0.194N P=0.247N | P=0.196N P=0.573N P=0.203 P=0.368N | |LOGISTIC REGRESSION | P=0.298N P=0.281 P=0.359N P=0.456N | P=0.167N P=0.578 P=0.214 P=0.285N | |COCHRAN-ARMITAGE | P=0.224N | P=0.222N | |FISHER EXACT | P=0.589N P=0.250N P=0.264N | P=0.616N P=0.297 P=0.287N | |=================================================================================================================================| DATE: 09/05/94 EXPERIMENT: 05036 TEST: 01 PAGE 5 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OCHRATOXIN A MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 UG/KG 21 UG/KG 70 UG/KG 210 UG/ | 0 UG/KG 21 UG/KG 70 UG/KG 210 UG/ | | | KG | KG | |=================================================================================================================================| | | |Islets, Pancreatic | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/50 (10%) 2/26 (8%) 3/26 (12%) 1/50 (2%) | 0/50 (0%) 0/28 (0%) 1/14 (7%) 0/50 (0%) | |ADJUSTED (b) | 12.8% 6.1% 100.0% 3.4% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 5/39 (13%) 0/1 (0%) 2/2 (100%) 0/23 (0%) | 0/32 (0%) 0/0 0/0 0/35 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) 633 544 649 | --- --- 637 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.176N P=0.268 P=0.011 * P=0.254N | P=0.785N (e) P=0.505 (e) | |INCIDENTAL TUMOR | P=0.104N P=0.769 P=0.014 * P=0.164N | P=0.809 (e) P=0.557 (e) | |LOGISTIC REGRESSION | P=0.110N P=0.488 P=0.300 P=0.176N | P=0.729N (e) P=0.261 (e) | |COCHRAN-ARMITAGE | P=0.085N | P=0.721N | |FISHER EXACT | P=0.550N P=0.560 P=0.102N | (e) P=0.219 (e) | |=================================================================================================================================| | | |Islets, Pancreatic | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 6/50 (12%) 2/26 (8%) 3/26 (12%) 2/50 (4%) | 1/50 (2%) 0/28 (0%) 1/14 (7%) 0/50 (0%) | |ADJUSTED (b) | 15.4% 6.1% 100.0% 7.6% | 3.1% 0.0% 0.0% 0.0% | |TERMINAL (d) | 6/39 (15%) 0/1 (0%) 2/2 (100%) 1/23 (4%) | 1/32 (3%) 0/0 0/0 0/35 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) 633 544 649 | 728 (T) --- 637 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.247N P=0.282 P=0.016 * P=0.350N | P=0.367N (e) P=0.505 P=0.482N | |INCIDENTAL TUMOR | P=0.161N P=0.776 P=0.019 * P=0.256N | P=0.388N (e) P=0.557 P=0.482N | |LOGISTIC REGRESSION | P=0.169N P=0.551 P=0.367 P=0.257N | P=0.389N (e) P=0.388 P=0.482N | |COCHRAN-ARMITAGE | P=0.127N | P=0.412N | |FISHER EXACT | P=0.440N P=0.633N P=0.134N | P=0.641N P=0.392 P=0.500N | |=================================================================================================================================| DATE: 09/05/94 EXPERIMENT: 05036 TEST: 01 PAGE 6 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OCHRATOXIN A MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 UG/KG 21 UG/KG 70 UG/KG 210 UG/ | 0 UG/KG 21 UG/KG 70 UG/KG 210 UG/ | | | KG | KG | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/51 (2%) 6/51 (12%) 10/50 (20%) | 0/50 (0%) 0/51 (0%) 1/50 (2%) 5/50 (10%) | |ADJUSTED (b) | 2.6% 3.8% 19.7% 33.1% | 0.0% 0.0% 2.4% 14.3% | |TERMINAL (d) | 1/39 (3%) 1/26 (4%) 4/26 (15%) 5/23 (22%) | 0/32 (0%) 0/23 (0%) 0/35 (0%) 5/35 (14%) | |FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 524 513 | --- --- 637 728 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.669 P=0.023 * P<0.001 ** | P=0.003 ** (e) P=0.505 P=0.041 * | |INCIDENTAL TUMOR | P<0.001 ** P=0.669 P=0.042 * P=0.007 ** | P=0.002 ** (e) P=0.557 P=0.041 * | |LOGISTIC REGRESSION | P<0.001 ** P=0.669 P=0.053 P=0.004 ** | P=0.002 ** (e) P=0.493 P=0.041 * | |COCHRAN-ARMITAGE | P<0.001 ** | P=0.001 ** | |FISHER EXACT | P=0.748N P=0.059 P=0.004 ** | (e) P=0.500 P=0.028 * | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/51 (0%) 16/51 (31%) 30/50 (60%) | 0/50 (0%) 0/51 (0%) 1/50 (2%) 3/50 (6%) | |ADJUSTED (b) | 0.0% 0.0% 43.4% 77.2% | 0.0% 0.0% 2.0% 8.6% | |TERMINAL (d) | 0/39 (0%) 0/26 (0%) 7/26 (27%) 15/23 (65%) | 0/32 (0%) 0/23 (0%) 0/35 (0%) 3/35 (9%) | |FIRST INCIDENCE (DAYS) | --- --- 507 390 | --- --- 319 728 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** (e) P<0.001 ** P<0.001 ** | P=0.031 * (e) P=0.504 P=0.137 | |INCIDENTAL TUMOR | P<0.001 ** (e) P<0.001 ** P<0.001 ** | P=0.025 * (e) P=0.500 P=0.137 | |LOGISTIC REGRESSION | P<0.001 ** (e) P<0.001 ** P<0.001 ** | P=0.017 * (e) P=0.357 P=0.137 | |COCHRAN-ARMITAGE | P<0.001 ** | P=0.021 * | |FISHER EXACT | (e) P<0.001 ** P<0.001 ** | (e) P=0.500 P=0.121 | |=================================================================================================================================| DATE: 09/05/94 EXPERIMENT: 05036 TEST: 01 PAGE 7 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OCHRATOXIN A MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 UG/KG 21 UG/KG 70 UG/KG 210 UG/ | 0 UG/KG 21 UG/KG 70 UG/KG 210 UG/ | | | KG | KG | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/51 (2%) 20/51 (39%) 36/50 (72%) | 0/50 (0%) 0/51 (0%) 2/50 (4%) 8/50 (16%) | |ADJUSTED (b) | 2.6% 3.8% 53.4% 87.2% | 0.0% 0.0% 4.3% 22.9% | |TERMINAL (d) | 1/39 (3%) 1/26 (4%) 10/26 (38%) 18/23 (78%) | 0/32 (0%) 0/23 (0%) 0/35 (0%) 8/35 (23%) | |FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 507 390 | --- --- 319 728 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.669 P<0.001 ** P<0.001 ** | P<0.001 ** (e) P=0.245 P=0.006 ** | |INCIDENTAL TUMOR | P<0.001 ** P=0.669 P<0.001 ** P<0.001 ** | P<0.001 ** (e) P=0.271 P=0.006 ** | |LOGISTIC REGRESSION | P<0.001 ** P=0.669 P<0.001 ** P<0.001 ** | P<0.001 ** (e) P=0.180 P=0.006 ** | |COCHRAN-ARMITAGE | P<0.001 ** | P<0.001 ** | |FISHER EXACT | P=0.748N P<0.001 ** P<0.001 ** | (e) P=0.247 P=0.003 ** | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/26 (0%) 0/26 (0%) 2/50 (4%) | 0/50 (0%) 0/29 (0%) 0/19 (0%) 0/50 (0%) | |ADJUSTED (b) | 2.6% 0.0% 0.0% 7.2% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/39 (3%) 0/1 (0%) 0/1 (0%) 1/23 (4%) | 0/32 (0%) 0/1 (0%) 0/4 (0%) 0/35 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) --- --- 589 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.215 P=0.999N P=0.999N P=0.356 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.252 P=0.999N P=0.999N P=0.639 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.256 P=0.999N P=0.999N P=0.471 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.268 | (e) | |FISHER EXACT | P=0.658N P=0.658N P=0.500 | (e) (e) (e) | |=================================================================================================================================| DATE: 09/05/94 EXPERIMENT: 05036 TEST: 01 PAGE 8 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OCHRATOXIN A MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 UG/KG 21 UG/KG 70 UG/KG 210 UG/ | 0 UG/KG 21 UG/KG 70 UG/KG 210 UG/ | | | KG | KG | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/26 (0%) 0/26 (0%) 2/50 (4%) | 0/50 (0%) 0/29 (0%) 0/19 (0%) 0/50 (0%) | |ADJUSTED (b) | 2.6% 0.0% 0.0% 7.2% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/39 (3%) 0/1 (0%) 0/1 (0%) 1/23 (4%) | 0/32 (0%) 0/1 (0%) 0/4 (0%) 0/35 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) --- --- 589 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.215 P=0.999N P=0.999N P=0.356 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.252 P=0.999N P=0.999N P=0.639 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.256 P=0.999N P=0.999N P=0.471 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.268 | (e) | |FISHER EXACT | P=0.658N P=0.658N P=0.500 | (e) (e) (e) | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 3/30 (10%) 0/27 (0%) 0/50 (0%) | 0/50 (0%) 1/32 (3%) 0/18 (0%) 1/50 (2%) | |ADJUSTED (b) | 0.0% 24.8% 0.0% 0.0% | 0.0% 2.7% 0.0% 2.9% | |TERMINAL (d) | 0/39 (0%) 1/5 (20%) 0/2 (0%) 0/23 (0%) | 0/32 (0%) 0/4 (0%) 0/3 (0%) 1/35 (3%) | |FIRST INCIDENCE (DAYS) | --- 633 --- --- | --- 637 --- 728 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.305N P=0.027 * (e) (e) | P=0.557 P=0.480 (e) P=0.518 | |INCIDENTAL TUMOR | P=0.212N P=0.121 (e) (e) | P=0.533 P=0.695 (e) P=0.518 | |LOGISTIC REGRESSION | P=0.246N P=0.019 * (e) (e) | P=0.536 P=0.413 (e) P=0.518 | |COCHRAN-ARMITAGE | P=0.222N | P=0.516 | |FISHER EXACT | P=0.049 * (e) (e) | P=0.390 (e) P=0.500 | |=================================================================================================================================| DATE: 09/05/94 EXPERIMENT: 05036 TEST: 01 PAGE 9 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OCHRATOXIN A MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 UG/KG 21 UG/KG 70 UG/KG 210 UG/ | 0 UG/KG 21 UG/KG 70 UG/KG 210 UG/ | | | KG | KG | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 4/30 (13%) 0/27 (0%) 0/50 (0%) | 0/50 (0%) 1/32 (3%) 0/18 (0%) 1/50 (2%) | |ADJUSTED (b) | 0.0% 43.6% 0.0% 0.0% | 0.0% 2.7% 0.0% 2.9% | |TERMINAL (d) | 0/39 (0%) 2/5 (40%) 0/2 (0%) 0/23 (0%) | 0/32 (0%) 0/4 (0%) 0/3 (0%) 1/35 (3%) | |FIRST INCIDENCE (DAYS) | --- 633 --- --- | --- 637 --- 728 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.232N P=0.002 ** (e) (e) | P=0.557 P=0.480 (e) P=0.518 | |INCIDENTAL TUMOR | P=0.165N P=0.007 ** (e) (e) | P=0.533 P=0.695 (e) P=0.518 | |LOGISTIC REGRESSION | P=0.185N P=0.003 ** (e) (e) | P=0.536 P=0.413 (e) P=0.518 | |COCHRAN-ARMITAGE | P=0.155N | P=0.516 | |FISHER EXACT | P=0.017 * (e) (e) | P=0.390 (e) P=0.500 | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/51 (0%) 0/51 (0%) 0/50 (0%) | 1/50 (2%) 2/51 (4%) 2/50 (4%) 2/50 (4%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 3.1% 7.9% 5.2% 5.2% | |TERMINAL (d) | 0/39 (0%) 0/26 (0%) 0/26 (0%) 0/23 (0%) | 1/32 (3%) 1/23 (4%) 1/35 (3%) 1/35 (3%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 728 (T) 716 659 626 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.561 P=0.401 P=0.530 P=0.524 | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.448 P=0.457 P=0.474 P=0.554 | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.508 P=0.427 P=0.508 P=0.503 | |COCHRAN-ARMITAGE | (e) | P=0.487 | |FISHER EXACT | (e) (e) (e) | P=0.508 P=0.500 P=0.500 | |=================================================================================================================================| DATE: 09/05/94 EXPERIMENT: 05036 TEST: 01 PAGE 10 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OCHRATOXIN A MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 UG/KG 21 UG/KG 70 UG/KG 210 UG/ | 0 UG/KG 21 UG/KG 70 UG/KG 210 UG/ | | | KG | KG | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/51 (0%) 1/51 (2%) 0/50 (0%) | 1/50 (2%) 2/51 (4%) 3/50 (6%) 2/50 (4%) | |ADJUSTED (b) | 0.0% 0.0% 3.6% 0.0% | 3.1% 7.9% 8.0% 5.2% | |TERMINAL (d) | 0/39 (0%) 0/26 (0%) 0/26 (0%) 0/23 (0%) | 1/32 (3%) 1/23 (4%) 2/35 (6%) 1/35 (3%) | |FIRST INCIDENCE (DAYS) | --- --- 717 --- | 728 (T) 716 659 626 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.791 (e) P=0.434 (e) | P=0.578 P=0.401 P=0.338 P=0.524 | |INCIDENTAL TUMOR | P=0.750N (e) P=0.757 (e) | P=0.473 P=0.457 P=0.294 P=0.554 | |LOGISTIC REGRESSION | P=0.805 (e) P=0.474 (e) | P=0.522 P=0.427 P=0.315 P=0.503 | |COCHRAN-ARMITAGE | P=0.789N | P=0.496 | |FISHER EXACT | (e) P=0.505 (e) | P=0.508 P=0.309 P=0.500 | |=================================================================================================================================| | | |Mammary Gland | | Fibroadenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 2/51 (4%) 1/51 (2%) 3/50 (6%) | 17/50 (34%) 23/51 (45%) 22/50 (44%) 28/50 (56%) | |ADJUSTED (b) | 7.2% 7.7% 3.8% 10.8% | 46.6% 70.5% 56.3% 69.9% | |TERMINAL (d) | 2/39 (5%) 2/26 (8%) 1/26 (4%) 2/23 (9%) | 13/32 (41%) 14/23 (61%) 18/35 (51%) 23/35 (66%) | |FIRST INCIDENCE (DAYS) | 516 729 (T) 729 (T) 513 | 525 436 659 630 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.361 P=0.650N P=0.416N P=0.483 | P=0.205 P=0.021 * P=0.313 P=0.052 | |INCIDENTAL TUMOR | P=0.472 P=0.645N P=0.390N P=0.633 | P=0.037 * P=0.058 P=0.188 P=0.015 * | |LOGISTIC REGRESSION | P=0.473 P=0.512N P=0.301N P=0.661 | P=0.046 * P=0.096 P=0.234 P=0.020 * | |COCHRAN-ARMITAGE | P=0.504 | P=0.030 * | |FISHER EXACT | P=0.491N P=0.301N P=0.661N | P=0.174 P=0.206 P=0.022 * | |=================================================================================================================================| DATE: 09/05/94 EXPERIMENT: 05036 TEST: 01 PAGE 11 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OCHRATOXIN A MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 UG/KG 21 UG/KG 70 UG/KG 210 UG/ | 0 UG/KG 21 UG/KG 70 UG/KG 210 UG/ | | | KG | KG | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 2/51 (4%) 2/51 (4%) 3/50 (6%) | 17/50 (34%) 23/51 (45%) 22/50 (44%) 28/50 (56%) | |ADJUSTED (b) | 7.2% 7.7% 7.3% 10.8% | 46.6% 70.5% 56.3% 69.9% | |TERMINAL (d) | 2/39 (5%) 2/26 (8%) 1/26 (4%) 2/23 (9%) | 13/32 (41%) 14/23 (61%) 18/35 (51%) 23/35 (66%) | |FIRST INCIDENCE (DAYS) | 516 729 (T) 717 513 | 525 436 659 630 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.358 P=0.650N P=0.635N P=0.483 | P=0.205 P=0.021 * P=0.313 P=0.052 | |INCIDENTAL TUMOR | P=0.500 P=0.645N P=0.478N P=0.633 | P=0.037 * P=0.058 P=0.188 P=0.015 * | |LOGISTIC REGRESSION | P=0.473 P=0.512N P=0.502N P=0.661 | P=0.046 * P=0.096 P=0.234 P=0.020 * | |COCHRAN-ARMITAGE | P=0.511 | P=0.030 * | |FISHER EXACT | P=0.491N P=0.491N P=0.661N | P=0.174 P=0.206 P=0.022 * | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma, Carcinoma, or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 2/51 (4%) 2/51 (4%) 3/50 (6%) | 17/50 (34%) 24/51 (47%) 22/50 (44%) 30/50 (60%) | |ADJUSTED (b) | 7.2% 7.7% 7.3% 10.8% | 46.6% 73.8% 56.3% 73.1% | |TERMINAL (d) | 2/39 (5%) 2/26 (8%) 1/26 (4%) 2/23 (9%) | 13/32 (41%) 15/23 (65%) 18/35 (51%) 24/35 (69%) | |FIRST INCIDENCE (DAYS) | 516 729 (T) 717 513 | 525 436 659 626 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.358 P=0.650N P=0.635N P=0.483 | P=0.127 P=0.012 * P=0.313 P=0.024 * | |INCIDENTAL TUMOR | P=0.500 P=0.645N P=0.478N P=0.633 | P=0.015 * P=0.034 * P=0.188 P=0.006 ** | |LOGISTIC REGRESSION | P=0.473 P=0.512N P=0.502N P=0.661 | P=0.019 * P=0.063 P=0.234 P=0.007 ** | |COCHRAN-ARMITAGE | P=0.511 | P=0.012 * | |FISHER EXACT | P=0.491N P=0.491N P=0.661N | P=0.128 P=0.206 P=0.008 ** | |=================================================================================================================================| DATE: 09/05/94 EXPERIMENT: 05036 TEST: 01 PAGE 12 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OCHRATOXIN A MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 UG/KG 21 UG/KG 70 UG/KG 210 UG/ | 0 UG/KG 21 UG/KG 70 UG/KG 210 UG/ | | | KG | KG | |=================================================================================================================================| | | |Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip) | | Papilloma Squamous or Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/51 (4%) 2/51 (4%) 0/50 (0%) | 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 2.6% 7.7% 6.0% 0.0% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/39 (3%) 2/26 (8%) 0/26 (0%) 0/23 (0%) | 0/32 (0%) 0/23 (0%) 0/35 (0%) 0/35 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 589 --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.343N P=0.360 P=0.408 P=0.605N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.258N P=0.360 P=0.689N P=0.605N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.279N P=0.360 P=0.502 P=0.605N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.247N | (e) | |FISHER EXACT | P=0.508 P=0.508 P=0.500N | (e) (e) (e) | |=================================================================================================================================| | | |Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip) | | Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/51 (4%) 2/51 (4%) 0/50 (0%) | 1/50 (2%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 2.6% 7.7% 6.0% 0.0% | 2.5% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/39 (3%) 2/26 (8%) 0/26 (0%) 0/23 (0%) | 0/32 (0%) 0/23 (0%) 0/35 (0%) 0/35 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 589 --- | 654 --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.343N P=0.360 P=0.408 P=0.605N | P=0.468N P=0.538N P=0.495N P=0.505N | |INCIDENTAL TUMOR | P=0.258N P=0.360 P=0.689N P=0.605N | P=0.592N P=0.443N P=0.581N P=0.617N | |LOGISTIC REGRESSION | P=0.279N P=0.360 P=0.502 P=0.605N | P=0.480N P=0.494N P=0.504N P=0.501N | |COCHRAN-ARMITAGE | P=0.247N | P=0.477N | |FISHER EXACT | P=0.508 P=0.508 P=0.500N | P=0.495N P=0.500N P=0.500N | |=================================================================================================================================| DATE: 09/05/94 EXPERIMENT: 05036 TEST: 01 PAGE 13 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OCHRATOXIN A MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 UG/KG 21 UG/KG 70 UG/KG 210 UG/ | 0 UG/KG 21 UG/KG 70 UG/KG 210 UG/ | | | KG | KG | |=================================================================================================================================| | | |Pancreas | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 3/26 (12%) 0/24 (0%) 3/50 (6%) | 0/50 (0%) 0/29 (0%) 0/14 (0%) 1/50 (2%) | |ADJUSTED (b) | 10.3% 100.0% 0.0% 13.0% | 0.0% 0.0% 0.0% 2.9% | |TERMINAL (d) | 4/39 (10%) 1/1 (100%) 0/0 3/23 (13%) | 0/32 (0%) 0/1 (0%) 0/0 1/35 (3%) | |FIRST INCIDENCE (DAYS) | 729 (T) 627 --- 729 (T) | --- --- --- 728 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.516N P=0.031 * (e) P=0.532 | P=0.381 (e) (e) P=0.518 | |INCIDENTAL TUMOR | P=0.457N P=0.129 (e) P=0.532 | P=0.381 (e) (e) P=0.518 | |LOGISTIC REGRESSION | P=0.471N P=0.180 (e) P=0.532 | P=0.381 (e) (e) P=0.518 | |COCHRAN-ARMITAGE | P=0.378N | P=0.277 | |FISHER EXACT | P=0.450 P=0.200N P=0.500N | (e) (e) P=0.500 | |=================================================================================================================================| | | |Parathyroid Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/41 (5%) 0/21 (0%) 0/21 (0%) 0/47 (0%) | 0/39 (0%) 0/17 (0%) 0/13 (0%) 1/42 (2%) | |ADJUSTED (b) | 5.7% 0.0% 0.0% 0.0% | 0.0% 0.0% 0.0% 3.2% | |TERMINAL (d) | 2/35 (6%) 0/1 (0%) 0/0 0/22 (0%) | 0/26 (0%) 0/0 0/0 1/31 (3%) | |FIRST INCIDENCE (DAYS) | 729 (T) --- --- --- | --- --- --- 728 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.264N P=0.974N (e) P=0.345N | P=0.403 (e) (e) P=0.535 | |INCIDENTAL TUMOR | P=0.264N P=0.974N (e) P=0.345N | P=0.403 (e) (e) P=0.535 | |LOGISTIC REGRESSION | P=0.264N P=0.974N (e) P=0.345N | P=0.403 (e) (e) P=0.535 | |COCHRAN-ARMITAGE | P=0.197N | P=0.302 | |FISHER EXACT | P=0.434N P=0.434N P=0.214N | (e) (e) P=0.519 | |=================================================================================================================================| DATE: 09/05/94 EXPERIMENT: 05036 TEST: 01 PAGE 14 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OCHRATOXIN A MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 UG/KG 21 UG/KG 70 UG/KG 210 UG/ | 0 UG/KG 21 UG/KG 70 UG/KG 210 UG/ | | | KG | KG | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 14/50 (28%) 16/33 (48%) 7/27 (26%) 11/49 (22%) | 16/49 (33%) 19/41 (46%) 15/35 (43%) 22/49 (45%) | |ADJUSTED (b) | 34.1% 90.2% 77.9% 40.4% | 40.0% 73.1% 66.7% 53.4% | |TERMINAL (d) | 12/39 (31%) 7/8 (88%) 3/4 (75%) 8/23 (35%) | 9/32 (28%) 8/13 (62%) 13/20 (65%) 16/35 (46%) | |FIRST INCIDENCE (DAYS) | 704 409 540 540 | 466 585 589 520 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.387N P<0.001 ** P=0.056 P=0.318 | P=0.466N P=0.020 * P=0.263 P=0.246 | |INCIDENTAL TUMOR | P=0.133N P=0.013 * P=0.311 P=0.540N | P=0.252 P=0.100 P=0.177 P=0.107 | |LOGISTIC REGRESSION | P=0.150N P=0.007 ** P=0.241 P=0.560 | P=0.359 P=0.046 * P=0.173 P=0.149 | |COCHRAN-ARMITAGE | P=0.092N | P=0.255 | |FISHER EXACT | P=0.048 * P=0.534N P=0.343N | P=0.134 P=0.234 P=0.150 | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/33 (6%) 2/27 (7%) 0/49 (0%) | 1/49 (2%) 2/41 (5%) 1/35 (3%) 0/49 (0%) | |ADJUSTED (b) | 0.0% 15.6% 27.6% 0.0% | 3.1% 6.9% 2.6% 0.0% | |TERMINAL (d) | 0/39 (0%) 1/8 (13%) 1/4 (25%) 0/23 (0%) | 1/32 (3%) 0/13 (0%) 0/20 (0%) 0/35 (0%) | |FIRST INCIDENCE (DAYS) | --- 722 716 --- | 728 (T) 658 667 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.457N P=0.071 P=0.044 * (e) | P=0.193N P=0.353 P=0.716 P=0.482N | |INCIDENTAL TUMOR | P=0.367N P=0.160 P=0.108 (e) | P=0.320N P=0.467 P=0.660 P=0.482N | |LOGISTIC REGRESSION | P=0.427N P=0.039 * P=0.025 * (e) | P=0.208N P=0.360 P=0.675 P=0.482N | |COCHRAN-ARMITAGE | P=0.340N | P=0.220N | |FISHER EXACT | P=0.155 P=0.120 (e) | P=0.433 P=0.663 P=0.500N | |=================================================================================================================================| DATE: 09/05/94 EXPERIMENT: 05036 TEST: 01 PAGE 15 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OCHRATOXIN A MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 UG/KG 21 UG/KG 70 UG/KG 210 UG/ | 0 UG/KG 21 UG/KG 70 UG/KG 210 UG/ | | | KG | KG | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 14/50 (28%) 18/33 (55%) 9/27 (33%) 11/49 (22%) | 17/49 (35%) 20/41 (49%) 16/35 (46%) 22/49 (45%) | |ADJUSTED (b) | 34.1% 100.0% 100.0% 40.4% | 42.6% 73.9% 67.6% 53.4% | |TERMINAL (d) | 12/39 (31%) 8/8 (100%) 4/4 (100%) 8/23 (35%) | 10/32 (31%) 8/13 (62%) 13/20 (65%) 16/35 (46%) | |FIRST INCIDENCE (DAYS) | 704 409 540 540 | 466 585 589 520 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.328N P<0.001 ** P=0.008 ** P=0.318 | P=0.370N P=0.017 * P=0.254 P=0.312 | |INCIDENTAL TUMOR | P=0.089N P=0.002 ** P=0.091 P=0.540N | P=0.320 P=0.088 P=0.154 P=0.154 | |LOGISTIC REGRESSION | P=0.106N P<0.001 ** P=0.050 * P=0.560 | P=0.463 P=0.040 * P=0.153 P=0.204 | |COCHRAN-ARMITAGE | P=0.058N | P=0.345 | |FISHER EXACT | P=0.014 * P=0.406 P=0.343N | P=0.128 P=0.214 P=0.205 | |=================================================================================================================================| | | |Pituitary Gland: Pars Intermedia | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/33 (0%) 0/27 (0%) 0/49 (0%) | 0/49 (0%) 0/41 (0%) 2/35 (6%) 0/49 (0%) | |ADJUSTED (b) | 2.6% 0.0% 0.0% 0.0% | 0.0% 0.0% 7.3% 0.0% | |TERMINAL (d) | 1/39 (3%) 0/8 (0%) 0/4 (0%) 0/23 (0%) | 0/32 (0%) 0/13 (0%) 1/20 (5%) 0/35 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) --- --- --- | --- --- 637 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.495N P=0.810N P=0.919N P=0.605N | P=0.641N (e) P=0.191 (e) | |INCIDENTAL TUMOR | P=0.495N P=0.810N P=0.919N P=0.605N | P=0.699N (e) P=0.217 (e) | |LOGISTIC REGRESSION | P=0.495N P=0.810N P=0.919N P=0.605N | P=0.664N (e) P=0.162 (e) | |COCHRAN-ARMITAGE | P=0.452N | P=0.672N | |FISHER EXACT | P=0.602N P=0.649N P=0.505N | (e) P=0.171 (e) | |=================================================================================================================================| DATE: 09/05/94 EXPERIMENT: 05036 TEST: 01 PAGE 16 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OCHRATOXIN A MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 UG/KG 21 UG/KG 70 UG/KG 210 UG/ | 0 UG/KG 21 UG/KG 70 UG/KG 210 UG/ | | | KG | KG | |=================================================================================================================================| | | |Skin | | Keratoacanthoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/51 (2%) 4/51 (8%) 2/50 (4%) | 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 2.6% 3.8% 13.2% 7.3% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/39 (3%) 1/26 (4%) 2/26 (8%) 1/23 (4%) | 0/32 (0%) 0/23 (0%) 0/35 (0%) 0/35 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 589 647 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.268 P=0.669 P=0.100 P=0.349 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.369 P=0.669 P=0.290 P=0.496 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.345 P=0.669 P=0.165 P=0.433 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.409 | (e) | |FISHER EXACT | P=0.748N P=0.187 P=0.500 | (e) (e) (e) | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/51 (2%) 4/51 (8%) 1/50 (2%) | 0/50 (0%) 2/51 (4%) 0/50 (0%) 1/50 (2%) | |ADJUSTED (b) | 5.1% 3.8% 11.2% 4.3% | 0.0% 8.7% 0.0% 2.9% | |TERMINAL (d) | 2/39 (5%) 1/26 (4%) 1/26 (4%) 1/23 (4%) | 0/32 (0%) 2/23 (9%) 0/35 (0%) 1/35 (3%) | |FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 459 729 (T) | --- 728 (T) --- 728 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.608N P=0.640N P=0.233 P=0.681N | P=0.677 P=0.168 (e) P=0.518 | |INCIDENTAL TUMOR | P=0.471N P=0.640N P=0.522 P=0.681N | P=0.677 P=0.168 (e) P=0.518 | |LOGISTIC REGRESSION | P=0.489N P=0.640N P=0.348 P=0.681N | P=0.677 P=0.168 (e) P=0.518 | |COCHRAN-ARMITAGE | P=0.469N | P=0.623 | |FISHER EXACT | P=0.492N P=0.348 P=0.500N | P=0.252 (e) P=0.500 | |=================================================================================================================================| DATE: 09/05/94 EXPERIMENT: 05036 TEST: 01 PAGE 17 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OCHRATOXIN A MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 UG/KG 21 UG/KG 70 UG/KG 210 UG/ | 0 UG/KG 21 UG/KG 70 UG/KG 210 UG/ | | | KG | KG | |=================================================================================================================================| | | |Skin | | Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma, | | Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 4/50 (8%) 2/51 (4%) 7/51 (14%) 3/50 (6%) | 0/50 (0%) 2/51 (4%) 0/50 (0%) 1/50 (2%) | |ADJUSTED (b) | 10.3% 7.7% 21.1% 11.5% | 0.0% 8.7% 0.0% 2.9% | |TERMINAL (d) | 4/39 (10%) 2/26 (8%) 3/26 (12%) 2/23 (9%) | 0/32 (0%) 2/23 (9%) 0/35 (0%) 1/35 (3%) | |FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 459 647 | --- 728 (T) --- 728 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.419 P=0.535N P=0.122 P=0.551 | P=0.677 P=0.168 (e) P=0.518 | |INCIDENTAL TUMOR | P=0.574 P=0.535N P=0.350 P=0.652 | P=0.677 P=0.168 (e) P=0.518 | |LOGISTIC REGRESSION | P=0.557 P=0.535N P=0.252 P=0.646 | P=0.677 P=0.168 (e) P=0.518 | |COCHRAN-ARMITAGE | P=0.544N | P=0.623 | |FISHER EXACT | P=0.329N P=0.274 P=0.500N | P=0.252 (e) P=0.500 | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Fibroma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 4/50 (8%) 4/51 (8%) 1/51 (2%) 2/50 (4%) | 0/50 (0%) 1/51 (2%) 1/50 (2%) 0/50 (0%) | |ADJUSTED (b) | 9.7% 14.2% 3.8% 6.1% | 0.0% 2.5% 2.3% 0.0% | |TERMINAL (d) | 2/39 (5%) 2/26 (8%) 1/26 (4%) 0/23 (0%) | 0/32 (0%) 0/23 (0%) 0/35 (0%) 0/35 (0%) | |FIRST INCIDENCE (DAYS) | 540 717 729 (T) 425 | --- 624 622 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.387N P=0.459 P=0.278N P=0.507N | P=0.528N P=0.495 P=0.510 (e) | |INCIDENTAL TUMOR | P=0.185N P=0.529N P=0.158N P=0.148N | P=0.594N P=0.695 P=0.557 (e) | |LOGISTIC REGRESSION | P=0.265N P=0.607 P=0.181N P=0.328N | P=0.551N P=0.518 P=0.491 (e) | |COCHRAN-ARMITAGE | P=0.245N | P=0.536N | |FISHER EXACT | P=0.631N P=0.175N P=0.339N | P=0.505 P=0.500 (e) | |=================================================================================================================================| DATE: 09/05/94 EXPERIMENT: 05036 TEST: 01 PAGE 18 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OCHRATOXIN A MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 UG/KG 21 UG/KG 70 UG/KG 210 UG/ | 0 UG/KG 21 UG/KG 70 UG/KG 210 UG/ | | | KG | KG | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Fibrosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/51 (0%) 2/51 (4%) 0/50 (0%) | 1/50 (2%) 2/51 (4%) 0/50 (0%) 2/50 (4%) | |ADJUSTED (b) | 2.6% 0.0% 5.7% 0.0% | 3.1% 6.5% 0.0% 5.3% | |TERMINAL (d) | 1/39 (3%) 0/26 (0%) 1/26 (4%) 0/23 (0%) | 1/32 (3%) 1/23 (4%) 0/35 (0%) 1/35 (3%) | |FIRST INCIDENCE (DAYS) | 729 (T) --- 290 --- | 728 (T) 525 --- 645 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.523N P=0.581N P=0.414 P=0.605N | P=0.514 P=0.424 P=0.482N P=0.518 | |INCIDENTAL TUMOR | P=0.688N P=0.581N P=0.407 P=0.605N | P=0.461 P=0.445 P=0.482N P=0.454 | |LOGISTIC REGRESSION | P=0.460N P=0.581N P=0.494 P=0.605N | P=0.464 P=0.507 P=0.482N P=0.504 | |COCHRAN-ARMITAGE | P=0.460N | P=0.464 | |FISHER EXACT | P=0.495N P=0.508 P=0.500N | P=0.508 P=0.500N P=0.500 | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Neurofibrosarcoma, Fibrosarcoma, Sarcoma, | | Neurofibroma, or Fibroma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 6/50 (12%) 4/51 (8%) 4/51 (8%) 2/50 (4%) | 1/50 (2%) 3/51 (6%) 1/50 (2%) 2/50 (4%) | |ADJUSTED (b) | 14.1% 14.2% 11.8% 6.1% | 3.1% 8.8% 2.3% 5.3% | |TERMINAL (d) | 3/39 (8%) 2/26 (8%) 2/26 (8%) 0/23 (0%) | 1/32 (3%) 1/23 (4%) 0/35 (0%) 1/35 (3%) | |FIRST INCIDENCE (DAYS) | 526 717 290 425 | 728 (T) 525 622 645 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.251N P=0.566N P=0.514N P=0.273N | P=0.623 P=0.249 P=0.745N P=0.518 | |INCIDENTAL TUMOR | P=0.111N P=0.285N P=0.255N P=0.039N* | P=0.551 P=0.342 P=0.718N P=0.454 | |LOGISTIC REGRESSION | P=0.132N P=0.385N P=0.354N P=0.127N | P=0.574 P=0.317 P=0.762 P=0.504 | |COCHRAN-ARMITAGE | P=0.135N | P=0.580 | |FISHER EXACT | P=0.358N P=0.358N P=0.134N | P=0.316 P=0.753N P=0.500 | |=================================================================================================================================| DATE: 09/05/94 EXPERIMENT: 05036 TEST: 01 PAGE 19 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OCHRATOXIN A MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 UG/KG 21 UG/KG 70 UG/KG 210 UG/ | 0 UG/KG 21 UG/KG 70 UG/KG 210 UG/ | | | KG | KG | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Neurofibrosarcoma, Fibrosarcoma, or Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/51 (0%) 3/51 (6%) 0/50 (0%) | 1/50 (2%) 2/51 (4%) 0/50 (0%) 2/50 (4%) | |ADJUSTED (b) | 4.8% 0.0% 8.1% 0.0% | 3.1% 6.5% 0.0% 5.3% | |TERMINAL (d) | 1/39 (3%) 0/26 (0%) 1/26 (4%) 0/23 (0%) | 1/32 (3%) 1/23 (4%) 0/35 (0%) 1/35 (3%) | |FIRST INCIDENCE (DAYS) | 526 --- 290 --- | 728 (T) 525 --- 645 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.356N P=0.289N P=0.429 P=0.306N | P=0.514 P=0.424 P=0.482N P=0.518 | |INCIDENTAL TUMOR | P=0.337N P=0.284N P=0.647 P=0.196N | P=0.461 P=0.445 P=0.482N P=0.454 | |LOGISTIC REGRESSION | P=0.306N P=0.229N P=0.487 P=0.232N | P=0.464 P=0.507 P=0.482N P=0.504 | |COCHRAN-ARMITAGE | P=0.302N | P=0.464 | |FISHER EXACT | P=0.243N P=0.509 P=0.247N | P=0.508 P=0.500N P=0.500 | |=================================================================================================================================| | | |Testes | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 44/50 (88%) 39/50 (78%) 42/48 (88%) 40/50 (80%) | | |ADJUSTED (b) | 97.8% 100.0% 100.0% 97.5% | | |TERMINAL (d) | 38/39 (97%) 25/25 (100%) 23/23 (100%) 22/23 (96%) | | |FIRST INCIDENCE (DAYS) | 516 428 507 425 | | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.011 * P=0.018 * P=0.002 ** P=0.004 ** | | |INCIDENTAL TUMOR | P=0.568N P=0.476N P=0.470 P=0.588N | | |LOGISTIC REGRESSION | P=0.547 P=0.376N P=0.459 P=0.573N | | |COCHRAN-ARMITAGE | P=0.327N | | |FISHER EXACT | P=0.143N P=0.591N P=0.207N | | |=================================================================================================================================| DATE: 09/05/94 EXPERIMENT: 05036 TEST: 01 PAGE 20 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OCHRATOXIN A MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 UG/KG 21 UG/KG 70 UG/KG 210 UG/ | 0 UG/KG 21 UG/KG 70 UG/KG 210 UG/ | | | KG | KG | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 9/50 (18%) 5/29 (17%) 6/26 (23%) 5/50 (10%) | 7/50 (14%) 7/32 (22%) 5/18 (28%) 3/50 (6%) | |ADJUSTED (b) | 22.5% 62.4% 100.0% 19.3% | 18.9% 100.0% 100.0% 8.0% | |TERMINAL (d) | 8/39 (21%) 3/5 (60%) 2/2 (100%) 4/23 (17%) | 4/32 (13%) 4/4 (100%) 3/3 (100%) 1/35 (3%) | |FIRST INCIDENCE (DAYS) | 704 675 516 513 | 568 637 669 659 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.363N P=0.062 P=0.017 * P=0.546N | P=0.024N* P=0.028 * P=0.150 P=0.144N | |INCIDENTAL TUMOR | P=0.191N P=0.204 P=0.082 P=0.403N | P=0.050N P=0.113 P=0.100 P=0.184N | |LOGISTIC REGRESSION | P=0.208N P=0.209 P=0.144 P=0.358N | P=0.034N* P=0.112 P=0.053 P=0.157N | |COCHRAN-ARMITAGE | P=0.144N | P=0.058N | |FISHER EXACT | P=0.594N P=0.404 P=0.194N | P=0.264 P=0.169 P=0.159N | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 9/50 (18%) 6/29 (21%) 7/26 (27%) 6/50 (12%) | 8/50 (16%) 7/32 (22%) 5/18 (28%) 3/50 (6%) | |ADJUSTED (b) | 22.5% 81.2% 100.0% 22.4% | 21.8% 100.0% 100.0% 8.0% | |TERMINAL (d) | 8/39 (21%) 4/5 (80%) 2/2 (100%) 4/23 (17%) | 5/32 (16%) 4/4 (100%) 3/3 (100%) 1/35 (3%) | |FIRST INCIDENCE (DAYS) | 704 675 516 513 | 568 637 669 659 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.459N P=0.014 * P=0.008 ** P=0.544 | P=0.014N* P=0.035 * P=0.169 P=0.090N | |INCIDENTAL TUMOR | P=0.235N P=0.057 P=0.061 P=0.464N | P=0.031N* P=0.134 P=0.117 P=0.115N | |LOGISTIC REGRESSION | P=0.268N P=0.084 P=0.057 P=0.481N | P=0.022N* P=0.152 P=0.072 P=0.098N | |COCHRAN-ARMITAGE | P=0.184N | P=0.041N* | |FISHER EXACT | P=0.495 P=0.268 P=0.288N | P=0.349 P=0.225 P=0.100N | |=================================================================================================================================| DATE: 09/05/94 EXPERIMENT: 05036 TEST: 01 PAGE 21 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OCHRATOXIN A MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 UG/KG 21 UG/KG 70 UG/KG 210 UG/ | 0 UG/KG 21 UG/KG 70 UG/KG 210 UG/ | | | KG | KG | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/29 (3%) 0/26 (0%) 0/50 (0%) | 0/50 (0%) 1/32 (3%) 1/18 (6%) 0/50 (0%) | |ADJUSTED (b) | 5.1% 20.0% 0.0% 0.0% | 0.0% 25.0% 2.5% 0.0% | |TERMINAL (d) | 2/39 (5%) 1/5 (20%) 0/2 (0%) 0/23 (0%) | 0/32 (0%) 1/4 (25%) 0/3 (0%) 0/35 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) --- --- | --- 728 (T) 665 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.216N P=0.383 P=0.910N P=0.361N | P=0.435N P=0.108 P=0.516 (e) | |INCIDENTAL TUMOR | P=0.216N P=0.383 P=0.910N P=0.361N | P=0.511N P=0.108 P=0.419 (e) | |LOGISTIC REGRESSION | P=0.216N P=0.383 P=0.910N P=0.361N | P=0.452N P=0.108 P=0.274 (e) | |COCHRAN-ARMITAGE | P=0.152N | P=0.484N | |FISHER EXACT | P=0.697N P=0.430N P=0.247N | P=0.390 P=0.265 (e) | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 1/29 (3%) 1/26 (4%) 1/50 (2%) | 0/50 (0%) 2/32 (6%) 1/18 (6%) 0/50 (0%) | |ADJUSTED (b) | 7.7% 20.0% 3.0% 4.3% | 0.0% 28.0% 2.5% 0.0% | |TERMINAL (d) | 3/39 (8%) 1/5 (20%) 0/2 (0%) 1/23 (4%) | 0/32 (0%) 1/4 (25%) 0/3 (0%) 0/35 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 706 729 (T) | --- 718 665 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.395N P=0.470 P=0.563 P=0.507N | P=0.298N P=0.051 P=0.516 (e) | |INCIDENTAL TUMOR | P=0.354N P=0.470 P=0.772 P=0.507N | P=0.416N P=0.082 P=0.419 (e) | |LOGISTIC REGRESSION | P=0.380N P=0.470 P=0.610 P=0.507N | P=0.294N P=0.020 * P=0.274 (e) | |COCHRAN-ARMITAGE | P=0.276N | P=0.334N | |FISHER EXACT | P=0.532N P=0.577N P=0.309N | P=0.149 P=0.265 (e) | |=================================================================================================================================| DATE: 09/05/94 EXPERIMENT: 05036 TEST: 01 PAGE 22 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OCHRATOXIN A MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 UG/KG 21 UG/KG 70 UG/KG 210 UG/ | 0 UG/KG 21 UG/KG 70 UG/KG 210 UG/ | | | KG | KG | |=================================================================================================================================| | | |Tongue | | Squamous Cell Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/51 (4%) 2/51 (4%) 0/50 (0%) | 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 0.0% 7.7% 6.0% 0.0% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/39 (0%) 2/26 (8%) 0/26 (0%) 0/23 (0%) | 0/32 (0%) 0/23 (0%) 0/35 (0%) 0/35 (0%) | |FIRST INCIDENCE (DAYS) | --- 729 (T) 589 --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.481N P=0.154 P=0.197 (e) | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.373N P=0.154 P=0.757 (e) | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.409N P=0.154 P=0.243 (e) | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.381N | (e) | |FISHER EXACT | P=0.252 P=0.252 (e) | (e) (e) (e) | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 2/50 (4%) 7/51 (14%) 2/50 (4%) 7/50 (14%) | |ADJUSTED (b) | | 5.7% 23.6% 5.4% 17.8% | |TERMINAL (d) | | 1/32 (3%) 4/23 (17%) 1/35 (3%) 4/35 (11%) | |FIRST INCIDENCE (DAYS) | | 673 624 669 305 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.247 P=0.043 * P=0.674N P=0.105 | |INCIDENTAL TUMOR | | P=0.122 P=0.112 P=0.639 P=0.051 | |LOGISTIC REGRESSION | | P=0.160 P=0.071 P=0.689N P=0.080 | |COCHRAN-ARMITAGE | | P=0.156 | |FISHER EXACT | | P=0.085 P=0.691N P=0.080 | |=================================================================================================================================| DATE: 09/05/94 EXPERIMENT: 05036 TEST: 01 PAGE 23 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OCHRATOXIN A MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 UG/KG 21 UG/KG 70 UG/KG 210 UG/ | 0 UG/KG 21 UG/KG 70 UG/KG 210 UG/ | | | KG | KG | |=================================================================================================================================| | | |Uterus | | Sarcoma Stromal or Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 2/50 (4%) 7/51 (14%) 3/50 (6%) 7/50 (14%) | |ADJUSTED (b) | | 5.7% 23.6% 7.4% 17.8% | |TERMINAL (d) | | 1/32 (3%) 4/23 (17%) 1/35 (3%) 4/35 (11%) | |FIRST INCIDENCE (DAYS) | | 673 624 506 305 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.258 P=0.043 * P=0.522 P=0.105 | |INCIDENTAL TUMOR | | P=0.131 P=0.112 P=0.423 P=0.051 | |LOGISTIC REGRESSION | | P=0.164 P=0.071 P=0.494 P=0.080 | |COCHRAN-ARMITAGE | | P=0.165 | |FISHER EXACT | | P=0.085 P=0.500 P=0.080 | |=================================================================================================================================| | | |Zymbal's Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/51 (4%) 0/51 (0%) 3/50 (6%) | 0/50 (0%) 1/51 (2%) 2/50 (4%) 0/50 (0%) | |ADJUSTED (b) | 0.0% 4.4% 0.0% 8.2% | 0.0% 2.3% 4.2% 0.0% | |TERMINAL (d) | 0/39 (0%) 0/26 (0%) 0/26 (0%) 0/23 (0%) | 0/32 (0%) 0/23 (0%) 0/35 (0%) 0/35 (0%) | |FIRST INCIDENCE (DAYS) | --- 409 --- 540 | --- 577 466 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.088 P=0.242 (e) P=0.097 | P=0.516N P=0.500 P=0.245 (e) | |INCIDENTAL TUMOR | P=0.287 P=0.500 (e) P=0.324 | P=0.551N P=0.695 P=0.176 (e) | |LOGISTIC REGRESSION | P=0.092 P=0.215 (e) P=0.120 | P=0.585N P=0.537 P=0.183 (e) | |COCHRAN-ARMITAGE | P=0.105 | P=0.516N | |FISHER EXACT | P=0.252 (e) P=0.121 | P=0.505 P=0.247 (e) | |=================================================================================================================================| DATE: 09/05/94 EXPERIMENT: 05036 TEST: 01 PAGE 24 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OCHRATOXIN A MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 UG/KG 21 UG/KG 70 UG/KG 210 UG/ | 0 UG/KG 21 UG/KG 70 UG/KG 210 UG/ | | | KG | KG | |=================================================================================================================================| | | |All Organs | | Leukemia: Lymphocytic, Monocytic, Mononuclear, | | or Undifferentiated | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 12/50 (24%) 7/51 (14%) 7/51 (14%) 7/50 (14%) | 10/50 (20%) 8/51 (16%) 2/50 (4%) 3/50 (6%) | |ADJUSTED (b) | 29.8% 18.7% 19.3% 22.5% | 23.8% 21.0% 5.1% 7.9% | |TERMINAL (d) | 11/39 (28%) 1/26 (4%) 2/26 (8%) 3/23 (13%) | 3/32 (9%) 0/23 (0%) 0/35 (0%) 2/35 (6%) | |FIRST INCIDENCE (DAYS) | 516 418 544 408 | 495 585 667 568 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.503N P=0.392N P=0.387N P=0.504N | P=0.022N* P=0.531N P=0.018N* P=0.039N* | |INCIDENTAL TUMOR | P=0.168N P=0.128N P=0.092N P=0.244N | P=0.062N P=0.099N P=0.023N* P=0.039N* | |LOGISTIC REGRESSION | P=0.251N P=0.151N P=0.042N* P=0.198N | P=0.057N P=0.160N P=0.017N* P=0.053N | |COCHRAN-ARMITAGE | P=0.246N | P=0.026N* | |FISHER EXACT | P=0.143N P=0.143N P=0.154N | P=0.380N P=0.014N* P=0.036N* | |=================================================================================================================================| | | |All Organs | | Mesothelioma Benign, Malignant, NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 4/51 (8%) 0/51 (0%) 0/50 (0%) | 0/50 (0%) 0/51 (0%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 2.6% 11.4% 0.0% 0.0% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/39 (3%) 1/26 (4%) 0/26 (0%) 0/23 (0%) | 0/32 (0%) 0/23 (0%) 0/35 (0%) 0/35 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) 487 --- --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.155N P=0.118 P=0.581N P=0.605N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.078N P=0.259 P=0.581N P=0.605N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.108N P=0.184 P=0.581N P=0.605N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.108N | (e) | |FISHER EXACT | P=0.187 P=0.495N P=0.500N | (e) (e) (e) | |=================================================================================================================================| DATE: 09/05/94 EXPERIMENT: 05036 TEST: 01 PAGE 25 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OCHRATOXIN A MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 UG/KG 21 UG/KG 70 UG/KG 210 UG/ | 0 UG/KG 21 UG/KG 70 UG/KG 210 UG/ | | | KG | KG | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 47/50 (94%) 46/51 (90%) 48/51 (94%) 44/50 (88%) | 34/50 (68%) 38/51 (75%) 34/50 (68%) 42/50 (84%) | |ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | 75.3% 90.2% 79.0% 93.3% | |TERMINAL (d) | 39/39 (100%) 26/26 (100%) 26/26 (100%) 23/23 (100%)| 21/32 (66%) 19/23 (83%) 26/35 (74%) 32/35 (91%) | |FIRST INCIDENCE (DAYS) | 377 409 459 408 | 466 436 589 305 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.015 * P=0.006 ** P=0.004 ** P=0.002 ** | P=0.516 P=0.037 * P=0.402N P=0.225 | |INCIDENTAL TUMOR | P=0.153N P=0.500N P=0.702 P=0.378N | P=0.041 * P=0.283 P=0.579 P=0.033 * | |LOGISTIC REGRESSION | P=0.134N P=0.746N P=0.809 P=0.345N | P=0.066 P=0.187 P=0.547N P=0.048 * | |COCHRAN-ARMITAGE | P=0.238N | P=0.052 | |FISHER EXACT | P=0.369N P=0.652 P=0.243N | P=0.308 P=0.585N P=0.050 | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 22/50 (44%) 18/51 (35%) 28/51 (55%) 39/50 (78%) | 14/50 (28%) 19/51 (37%) 13/50 (26%) 10/50 (20%) | |ADJUSTED (b) | 52.1% 43.5% 65.0% 82.3% | 33.4% 47.7% 27.6% 24.0% | |TERMINAL (d) | 19/39 (49%) 5/26 (19%) 12/26 (46%) 15/23 (65%) | 6/32 (19%) 4/23 (17%) 3/35 (9%) 5/35 (14%) | |FIRST INCIDENCE (DAYS) | 495 409 290 390 | 495 525 319 305 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.444 P=0.021 * P<0.001 ** | P=0.060N P=0.103 P=0.445N P=0.224N | |INCIDENTAL TUMOR | P<0.001 ** P=0.163N P=0.314 P=0.007 ** | P=0.225N P=0.465 P=0.578 P=0.287N | |LOGISTIC REGRESSION | P<0.001 ** P=0.256N P=0.181 P<0.001 ** | P=0.143N P=0.348 P=0.593N P=0.245N | |COCHRAN-ARMITAGE | P<0.001 ** | P=0.082N | |FISHER EXACT | P=0.245N P=0.185 P<0.001 ** | P=0.218 P=0.500N P=0.241N | |=================================================================================================================================| DATE: 09/05/94 EXPERIMENT: 05036 TEST: 01 PAGE 26 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- OCHRATOXIN A MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 UG/KG 21 UG/KG 70 UG/KG 210 UG/ | 0 UG/KG 21 UG/KG 70 UG/KG 210 UG/ | | | KG | KG | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 47/50 (94%) 47/51 (92%) 50/51 (98%) 50/50 (100%)| 39/50 (78%) 44/51 (86%) 40/50 (80%) 45/50 (90%) | |ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | 81.2% 93.6% 81.6% 95.7% | |TERMINAL (d) | 39/39 (100%) 26/26 (100%) 26/26 (100%) 23/23 (100%)| 23/32 (72%) 20/23 (87%) 26/35 (74%) 33/35 (94%) | |FIRST INCIDENCE (DAYS) | 377 409 290 390 | 466 436 319 305 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.001 ** P=0.004 ** P=0.002 ** P<0.001 ** | P=0.365N P=0.027 * P=0.457N P=0.356 | |INCIDENTAL TUMOR | P=0.059 P=0.771 P=0.234 P=0.331 | P=0.067 P=0.250 P=0.442 P=0.064 | |LOGISTIC REGRESSION | P=0.098 P=0.696 P=0.479 P=0.290 | P=0.094 P=0.111 P=0.442 P=0.084 | |COCHRAN-ARMITAGE | P=0.048 * | P=0.120 | |FISHER EXACT | P=0.511N P=0.301 P=0.121 | P=0.205 P=0.500 P=0.086 | |=================================================================================================================================| (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). --multipart-boundary Content-type: text/plain Range: bytes 183829-183829/183829 --multipart-boundary--