TDMS Study 05084-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Mason TURMERIC OLEORESIN DATE: 09/10/94 EXPERIMENT: 05084 TEST: 01 TIME: 21:56:16 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01ES9561902 ROUTE: DOSED FEED NTP C#: 60015 PATHOLOGIST: R. FLEISCHMAN CAS: 458-37-7 ------------------------------------------------------------------------------------------------------------------------------------ REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Mason TURMERIC OLEORESIN DATE: 09/10/94 EXPERIMENT: 05084 TEST: 01 TIME: 21:56:16 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01ES9561902 ROUTE: DOSED FEED NTP C#: 60015 PATHOLOGIST: R. FLEISCHMAN CAS: 458-37-7 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: Mason TURMERIC OLEORESIN DATE: 09/10/94 EXPERIMENT: 05084 TEST: 01 TIME: 21:56:16 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01ES9561902 ROUTE: DOSED FEED NTP C#: 60015 PATHOLOGIST: R. FLEISCHMAN CAS: 458-37-7 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF THE STUDY OF TURMERIC OLEORESIN ==================================================================================================== MALE RATS ------------- ORGAN MORPHOLOGY ------- ------------ Adrenal Medulla Pheochromocytoma Benign Pheochromocytoma: Benign, Complex, Malignant, NOS Pituitary Gland: Pars Distalis or Unspecified Site Adenoma Carcinoma or Adenoma Skin Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma Squamous Cell Papilloma Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma, Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma Testes Adenoma All Organs Malignant Tumors Malignant and Benign Tumors ==================================================================================================== FEMALE RATS ------------- ORGAN MORPHOLOGY ------- ------------ Clitoral/Preputial Gland Adenoma Carcinoma or Adenoma Mammary Gland Fibroadenoma Fibroma, Fibroadenoma or Adenoma Fibroma, Fibroadenoma, Carcinoma, or Adenoma ==================================================================================================== DATE: 09/11/94 EXPERIMENT: 05084 TEST: 01 PAGE 1 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TURMERIC OLEORESIN MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 2,000PPM 10,000 50,000 | 0 PPM 2,000PPM 10,000 50,000 | | | MALE MALE PPM MALE PPM MALE | FEMALE FEMALE PPM FEM PPM FEM | |=================================================================================================================================| | | |Adrenal Cortex | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/60 (2%) 0/60 (0%) 1/59 (2%) 0/60 (0%) | 0/60 (0%) 0/60 (0%) 3/60 (5%) 1/60 (2%) | |ADJUSTED (b) | 3.1% 0.0% 5.0% 0.0% | 0.0% 0.0% 9.0% 2.9% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 0/18 (0%) 0/17 (0%) 0/15 (0%) 0/17 (0%) | 0/33 (0%) 0/27 (0%) 1/28 (4%) 1/34 (3%) | |FIRST INCIDENCE (DAYS) | 644 --- 707 --- | --- --- 591 727 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.546N P=0.461N P=0.760 P=0.541N | P=0.549 (e) P=0.104 P=0.506 | |INCIDENTAL TUMOR | P=0.591N P=0.500N P=0.735N P=0.557N | P=0.460 (e) P=0.117 P=0.506 | |LOGISTIC REGRESSION | P=0.525N P=0.494N P=0.757 P=0.518N | P=0.524 (e) P=0.113 P=0.506 | |COCHRAN-ARMITAGE | P=0.485N | P=0.520 | |FISHER EXACT | P=0.500N P=0.748 P=0.500N | (e) P=0.122 P=0.500 | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Benign | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 14/57 (25%) 20/60 (33%) 18/60 (30%) 9/59 (15%) | 3/60 (5%) 0/59 (0%) 2/60 (3%) 2/60 (3%) | |ADJUSTED (b) | 49.6% 61.9% 62.9% 41.9% | 9.1% 0.0% 6.4% 5.9% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 6/18 (33%) 6/17 (35%) 6/15 (40%) 5/16 (31%) | 3/33 (9%) 0/26 (0%) 1/28 (4%) 2/34 (6%) | |FIRST INCIDENCE (DAYS) | 609 588 634 615 | 727 (T) --- 680 727 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.112N P=0.259 P=0.210 P=0.299N | P=0.617 P=0.165N P=0.570N P=0.486N | |INCIDENTAL TUMOR | P=0.214N P=0.520 P=0.515 P=0.320N | P=0.600 P=0.165N P=0.537N P=0.486N | |LOGISTIC REGRESSION | P=0.140N P=0.458 P=0.545 P=0.258N | P=0.600 P=0.165N P=0.552N P=0.486N | |COCHRAN-ARMITAGE | P=0.029N* | P=0.567 | |FISHER EXACT | P=0.200 P=0.326 P=0.153N | P=0.125N P=0.500N P=0.500N | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05084 TEST: 01 PAGE 2 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TURMERIC OLEORESIN MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 2,000PPM 10,000 50,000 | 0 PPM 2,000PPM 10,000 50,000 | | | MALE MALE PPM MALE PPM MALE | FEMALE FEMALE PPM FEM PPM FEM | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Malignant | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/57 (0%) 1/60 (2%) 2/60 (3%) 1/59 (2%) | 0/60 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 5.9% 11.6% 6.3% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 0/18 (0%) 1/17 (6%) 1/15 (7%) 1/16 (6%) | 0/33 (0%) 0/26 (0%) 0/28 (0%) 0/34 (0%) | |FIRST INCIDENCE (DAYS) | --- 729 (T) 715 729 (T) | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.568 P=0.489 P=0.214 P=0.477 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.539 P=0.489 P=0.272 P=0.477 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.534 P=0.489 P=0.224 P=0.477 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.600 | (e) | |FISHER EXACT | P=0.513 P=0.261 P=0.509 | (e) (e) (e) | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma: Benign, Complex, Malignant, NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 14/57 (25%) 21/60 (35%) 19/60 (32%) 9/59 (15%) | 3/60 (5%) 0/59 (0%) 2/60 (3%) 2/60 (3%) | |ADJUSTED (b) | 49.6% 65.3% 67.1% 41.9% | 9.1% 0.0% 6.4% 5.9% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 6/18 (33%) 7/17 (41%) 7/15 (47%) 5/16 (31%) | 3/33 (9%) 0/26 (0%) 1/28 (4%) 2/34 (6%) | |FIRST INCIDENCE (DAYS) | 609 588 634 615 | 727 (T) --- 680 727 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.091N P=0.203 P=0.157 P=0.299N | P=0.617 P=0.165N P=0.570N P=0.486N | |INCIDENTAL TUMOR | P=0.172N P=0.427 P=0.414 P=0.320N | P=0.600 P=0.165N P=0.537N P=0.486N | |LOGISTIC REGRESSION | P=0.114N P=0.375 P=0.440 P=0.258N | P=0.600 P=0.165N P=0.552N P=0.486N | |COCHRAN-ARMITAGE | P=0.022N* | P=0.567 | |FISHER EXACT | P=0.151 P=0.259 P=0.153N | P=0.125N P=0.500N P=0.500N | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05084 TEST: 01 PAGE 3 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TURMERIC OLEORESIN MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 2,000PPM 10,000 50,000 | 0 PPM 2,000PPM 10,000 50,000 | | | MALE MALE PPM MALE PPM MALE | FEMALE FEMALE PPM FEM PPM FEM | |=================================================================================================================================| | | |Brain | | Oligodendroglioma, Glioma, or Astrocytoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/60 (0%) 2/60 (3%) 1/60 (2%) 0/60 (0%) | 0/60 (0%) 0/60 (0%) 1/60 (2%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 3.9% 6.7% 0.0% | 0.0% 0.0% 3.6% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 0/18 (0%) 0/17 (0%) 1/15 (7%) 0/17 (0%) | 0/33 (0%) 0/27 (0%) 1/28 (4%) 0/34 (0%) | |FIRST INCIDENCE (DAYS) | --- 337 729 (T) --- | --- --- 727 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.384N P=0.262 P=0.464 (e) | P=0.737N (e) P=0.467 (e) | |INCIDENTAL TUMOR | P=0.367N P=0.500 P=0.464 (e) | P=0.737N (e) P=0.467 (e) | |LOGISTIC REGRESSION | P=0.318N P=0.209 P=0.464 (e) | P=0.737N (e) P=0.467 (e) | |COCHRAN-ARMITAGE | P=0.360N | P=0.763N | |FISHER EXACT | P=0.248 P=0.500 (e) | (e) P=0.500 (e) | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/58 (5%) 5/58 (9%) 2/59 (3%) 3/60 (5%) | 7/60 (12%) 13/58 (22%) 16/57 (28%) 17/58 (29%) | |ADJUSTED (b) | 14.8% 14.6% 13.3% 10.5% | 17.6% 40.4% 47.3% 47.8% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/9 (0%) | 2/10 (20%) 1/10 (10%) 1/10 (10%) 1/9 (11%) | |TERMINAL (d) | 2/17 (12%) 1/17 (6%) 2/15 (13%) 1/17 (6%) | 4/33 (12%) 9/26 (35%) 11/28 (39%) 15/33 (45%) | |FIRST INCIDENCE (DAYS) | 671 459 (I) 729 (T) 374 | 455 (I) 457 (I) 455 (I) 457 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.549N P=0.413 P=0.550N P=0.635 | P=0.121 P=0.054 P=0.015 * P=0.017 * | |INCIDENTAL TUMOR | P=0.520N P=0.464 P=0.500N P=0.655 | P=0.067 P=0.076 P=0.014 * P=0.016 * | |LOGISTIC REGRESSION | P=0.525N P=0.390 P=0.490N P=0.649 | P=0.066 P=0.092 P=0.015 * P=0.015 * | |COCHRAN-ARMITAGE | P=0.472N | P=0.061 | |FISHER EXACT | P=0.358 P=0.492N P=0.644N | P=0.095 P=0.022 * P=0.015 * | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05084 TEST: 01 PAGE 4 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TURMERIC OLEORESIN MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 2,000PPM 10,000 50,000 | 0 PPM 2,000PPM 10,000 50,000 | | | MALE MALE PPM MALE PPM MALE | FEMALE FEMALE PPM FEM PPM FEM | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/58 (3%) 2/58 (3%) 1/59 (2%) 1/60 (2%) | 1/60 (2%) 4/58 (7%) 0/57 (0%) 0/58 (0%) | |ADJUSTED (b) | 8.1% 5.7% 2.2% 5.9% | 3.0% 13.8% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 1/17 (6%) 0/17 (0%) 0/15 (0%) 1/17 (6%) | 1/33 (3%) 3/26 (12%) 0/28 (0%) 0/33 (0%) | |FIRST INCIDENCE (DAYS) | 529 459 (I) 467 729 (T) | 727 (T) 654 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.473N P=0.667N P=0.514N P=0.531N | P=0.121N P=0.128 P=0.533N P=0.500N | |INCIDENTAL TUMOR | P=0.298N P=0.623 P=0.738N P=0.443N | P=0.131N P=0.157 P=0.533N P=0.500N | |LOGISTIC REGRESSION | P=0.406N P=0.681 P=0.486N P=0.523N | P=0.130N P=0.155 P=0.533N P=0.500N | |COCHRAN-ARMITAGE | P=0.415N | P=0.137N | |FISHER EXACT | P=0.691N P=0.494N P=0.487N | P=0.172 P=0.513N P=0.508N | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/58 (9%) 7/58 (12%) 3/59 (5%) 4/60 (7%) | 8/60 (13%) 17/58 (29%) 16/57 (28%) 17/58 (29%) | |ADJUSTED (b) | 22.3% 19.5% 15.2% 16.0% | 20.5% 52.2% 47.3% 47.8% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 2/10 (20%) 0/10 (0%) 0/9 (0%) | 2/10 (20%) 1/10 (10%) 1/10 (10%) 1/9 (11%) | |TERMINAL (d) | 3/17 (18%) 1/17 (6%) 2/15 (13%) 2/17 (12%) | 5/33 (15%) 12/26 (46%) 11/28 (39%) 15/33 (45%) | |FIRST INCIDENCE (DAYS) | 529 459 (I) 467 374 | 455 (I) 457 (I) 455 (I) 457 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.431N P=0.445 P=0.402N P=0.541N | P=0.278 P=0.012 * P=0.026 * P=0.030 * | |INCIDENTAL TUMOR | P=0.303N P=0.418 P=0.499N P=0.473N | P=0.181 P=0.020 * P=0.026 * P=0.029 * | |LOGISTIC REGRESSION | P=0.373N P=0.397 P=0.337N P=0.528N | P=0.176 P=0.026 * P=0.027 * P=0.027 * | |COCHRAN-ARMITAGE | P=0.338N | P=0.163 | |FISHER EXACT | P=0.381 P=0.349N P=0.478N | P=0.028 * P=0.040 * P=0.028 * | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05084 TEST: 01 PAGE 5 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TURMERIC OLEORESIN MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 2,000PPM 10,000 50,000 | 0 PPM 2,000PPM 10,000 50,000 | | | MALE MALE PPM MALE PPM MALE | FEMALE FEMALE PPM FEM PPM FEM | |=================================================================================================================================| | | |Islets, Pancreatic | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/57 (4%) 1/60 (2%) 1/58 (2%) 3/58 (5%) | 2/59 (3%) 0/60 (0%) 0/60 (0%) 1/59 (2%) | |ADJUSTED (b) | 9.0% 3.2% 2.4% 9.5% | 6.1% 0.0% 0.0% 2.9% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 1/17 (6%) 0/17 (0%) 0/15 (0%) 0/17 (0%) | 2/33 (6%) 0/27 (0%) 0/28 (0%) 1/34 (3%) | |FIRST INCIDENCE (DAYS) | 662 696 568 522 | 727 (T) --- --- 727 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.190 P=0.456N P=0.499N P=0.448 | P=0.710N P=0.283N P=0.275N P=0.490N | |INCIDENTAL TUMOR | P=0.210 P=0.380N P=0.481N P=0.459 | P=0.710N P=0.283N P=0.275N P=0.490N | |LOGISTIC REGRESSION | P=0.169 P=0.439N P=0.494N P=0.480 | P=0.710N P=0.283N P=0.275N P=0.490N | |COCHRAN-ARMITAGE | P=0.260 | P=0.680 | |FISHER EXACT | P=0.481N P=0.493N P=0.508 | P=0.244N P=0.244N P=0.500N | |=================================================================================================================================| | | |Islets, Pancreatic | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/57 (4%) 1/60 (2%) 2/58 (3%) 3/58 (5%) | 3/59 (5%) 0/60 (0%) 0/60 (0%) 2/59 (3%) | |ADJUSTED (b) | 9.0% 3.2% 8.9% 9.5% | 9.1% 0.0% 0.0% 5.9% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 1/17 (6%) 0/17 (0%) 1/15 (7%) 0/17 (0%) | 3/33 (9%) 0/27 (0%) 0/28 (0%) 2/34 (6%) | |FIRST INCIDENCE (DAYS) | 662 696 568 522 | 727 (T) --- --- 727 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.238 P=0.456N P=0.682 P=0.448 | P=0.529 P=0.158N P=0.151N P=0.486N | |INCIDENTAL TUMOR | P=0.261 P=0.380N P=0.691N P=0.459 | P=0.529 P=0.158N P=0.151N P=0.486N | |LOGISTIC REGRESSION | P=0.269 P=0.439N P=0.687N P=0.480 | P=0.529 P=0.158N P=0.151N P=0.486N | |COCHRAN-ARMITAGE | P=0.307 | P=0.474 | |FISHER EXACT | P=0.481N P=0.684N P=0.508 | P=0.119N P=0.119N P=0.500N | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05084 TEST: 01 PAGE 6 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TURMERIC OLEORESIN MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 2,000PPM 10,000 50,000 | 0 PPM 2,000PPM 10,000 50,000 | | | MALE MALE PPM MALE PPM MALE | FEMALE FEMALE PPM FEM PPM FEM | |=================================================================================================================================| | | |Liver | | Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/60 (0%) 1/60 (2%) 4/60 (7%) 3/60 (5%) | 1/60 (2%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 2.9% 15.8% 9.3% | 3.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 1/10 (10%) 1/9 (11%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 0/18 (0%) 0/17 (0%) 0/15 (0%) 1/17 (6%) | 1/33 (3%) 0/27 (0%) 0/28 (0%) 0/34 (0%) | |FIRST INCIDENCE (DAYS) | --- 660 459 (I) 374 | 727 (T) --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.149 P=0.531 P=0.058 P=0.111 | P=0.563N P=0.540N P=0.533N P=0.494N | |INCIDENTAL TUMOR | P=0.137 P=0.605 P=0.109 P=0.142 | P=0.563N P=0.540N P=0.533N P=0.494N | |LOGISTIC REGRESSION | P=0.208 P=0.513 P=0.062 P=0.157 | P=0.563N P=0.540N P=0.533N P=0.494N | |COCHRAN-ARMITAGE | P=0.197 | P=0.588N | |FISHER EXACT | P=0.500 P=0.059 P=0.122 | P=0.500N P=0.500N P=0.500N | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/60 (2%) 1/60 (2%) 5/60 (8%) 4/60 (7%) | 1/60 (2%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 5.6% 2.9% 19.4% 15.0% | 3.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 1/10 (10%) 1/9 (11%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 1/18 (6%) 0/17 (0%) 0/15 (0%) 2/17 (12%) | 1/33 (3%) 0/27 (0%) 0/28 (0%) 0/34 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) 660 459 (I) 374 | 727 (T) --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.129 P=0.750N P=0.089 P=0.161 | P=0.563N P=0.540N P=0.533N P=0.494N | |INCIDENTAL TUMOR | P=0.109 P=0.711N P=0.168 P=0.192 | P=0.563N P=0.540N P=0.533N P=0.494N | |LOGISTIC REGRESSION | P=0.150 P=0.733N P=0.102 P=0.175 | P=0.563N P=0.540N P=0.533N P=0.494N | |COCHRAN-ARMITAGE | P=0.174 | P=0.588N | |FISHER EXACT | P=0.752N P=0.103 P=0.182 | P=0.500N P=0.500N P=0.500N | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05084 TEST: 01 PAGE 7 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TURMERIC OLEORESIN MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 2,000PPM 10,000 50,000 | 0 PPM 2,000PPM 10,000 50,000 | | | MALE MALE PPM MALE PPM MALE | FEMALE FEMALE PPM FEM PPM FEM | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/60 (2%) 1/60 (2%) 5/60 (8%) 4/60 (7%) | 1/60 (2%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 5.6% 2.9% 19.4% 15.0% | 3.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 1/10 (10%) 1/9 (11%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 1/18 (6%) 0/17 (0%) 0/15 (0%) 2/17 (12%) | 1/33 (3%) 0/27 (0%) 0/28 (0%) 0/34 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) 660 459 (I) 374 | 727 (T) --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.129 P=0.750N P=0.089 P=0.161 | P=0.563N P=0.540N P=0.533N P=0.494N | |INCIDENTAL TUMOR | P=0.109 P=0.711N P=0.168 P=0.192 | P=0.563N P=0.540N P=0.533N P=0.494N | |LOGISTIC REGRESSION | P=0.150 P=0.733N P=0.102 P=0.175 | P=0.563N P=0.540N P=0.533N P=0.494N | |COCHRAN-ARMITAGE | P=0.174 | P=0.588N | |FISHER EXACT | P=0.752N P=0.103 P=0.182 | P=0.500N P=0.500N P=0.500N | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/59 (3%) 2/60 (3%) 5/60 (8%) 2/60 (3%) | 1/60 (2%) 0/60 (0%) 2/60 (3%) 1/60 (2%) | |ADJUSTED (b) | 8.2% 6.3% 18.6% 11.8% | 3.0% 0.0% 6.8% 2.9% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 1/17 (6%) 0/17 (0%) 2/15 (13%) 2/17 (12%) | 1/33 (3%) 0/27 (0%) 1/28 (4%) 1/34 (3%) | |FIRST INCIDENCE (DAYS) | 543 611 456 (I) 729 (T) | 727 (T) --- 708 727 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.579N P=0.651N P=0.205 P=0.673 | P=0.658 P=0.540N P=0.448 P=0.755N | |INCIDENTAL TUMOR | P=0.369N P=0.619 P=0.089 P=0.652N | P=0.625 P=0.540N P=0.491 P=0.755N | |LOGISTIC REGRESSION | P=0.552N P=0.673N P=0.227 P=0.656 | P=0.642 P=0.540N P=0.457 P=0.755N | |COCHRAN-ARMITAGE | P=0.517N | P=0.617 | |FISHER EXACT | P=0.684N P=0.226 P=0.684N | P=0.500N P=0.500 P=0.752N | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05084 TEST: 01 PAGE 8 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TURMERIC OLEORESIN MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 2,000PPM 10,000 50,000 | 0 PPM 2,000PPM 10,000 50,000 | | | MALE MALE PPM MALE PPM MALE | FEMALE FEMALE PPM FEM PPM FEM | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/59 (5%) 3/60 (5%) 5/60 (8%) 2/60 (3%) | 1/60 (2%) 1/60 (2%) 2/60 (3%) 1/60 (2%) | |ADJUSTED (b) | 13.9% 11.9% 18.6% 11.8% | 3.0% 3.7% 6.8% 2.9% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 2/17 (12%) 1/17 (6%) 2/15 (13%) 2/17 (12%) | 1/33 (3%) 1/27 (4%) 1/28 (4%) 1/34 (3%) | |FIRST INCIDENCE (DAYS) | 543 611 456 (I) 729 (T) | 727 (T) 727 (T) 708 727 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.407N P=0.626N P=0.330 P=0.523N | P=0.571N P=0.717 P=0.448 P=0.755N | |INCIDENTAL TUMOR | P=0.238N P=0.597 P=0.182 P=0.455N | P=0.607N P=0.717 P=0.491 P=0.755N | |LOGISTIC REGRESSION | P=0.411N P=0.606N P=0.366 P=0.554N | P=0.592N P=0.717 P=0.457 P=0.755N | |COCHRAN-ARMITAGE | P=0.356N | P=0.627N | |FISHER EXACT | P=0.652N P=0.368 P=0.492N | P=0.752N P=0.500 P=0.752N | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 1/60 (2%) 0/60 (0%) | 2/60 (3%) 1/60 (2%) 2/60 (3%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 0.0% 1.7% 0.0% | 6.1% 3.7% 6.8% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 0/18 (0%) 0/17 (0%) 0/15 (0%) 0/17 (0%) | 2/33 (6%) 1/27 (4%) 1/28 (4%) 0/34 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 337 --- | 727 (T) 727 (T) 708 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.764N (e) P=0.493 (e) | P=0.186N P=0.570N P=0.637 P=0.232N | |INCIDENTAL TUMOR | P=0.787N (e) (e) (e) | P=0.204N P=0.570N P=0.673 P=0.232N | |LOGISTIC REGRESSION | P=0.727N (e) P=0.732 (e) | P=0.194N P=0.570N P=0.650 P=0.232N | |COCHRAN-ARMITAGE | P=0.763N | P=0.214N | |FISHER EXACT | (e) P=0.500 (e) | P=0.500N P=0.691N P=0.248N | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05084 TEST: 01 PAGE 9 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TURMERIC OLEORESIN MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 2,000PPM 10,000 50,000 | 0 PPM 2,000PPM 10,000 50,000 | | | MALE MALE PPM MALE PPM MALE | FEMALE FEMALE PPM FEM PPM FEM | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/60 (2%) 0/60 (0%) 1/60 (2%) 0/60 (0%) | 3/60 (5%) 1/60 (2%) 2/60 (3%) 0/60 (0%) | |ADJUSTED (b) | 3.6% 0.0% 1.7% 0.0% | 9.1% 3.7% 6.8% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 0/18 (0%) 0/17 (0%) 0/15 (0%) 0/17 (0%) | 3/33 (9%) 1/27 (4%) 1/28 (4%) 0/34 (0%) | |FIRST INCIDENCE (DAYS) | 676 --- 337 --- | 727 (T) 727 (T) 708 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.514N P=0.461N P=0.752 P=0.531N | P=0.126N P=0.378N P=0.571N P=0.115N | |INCIDENTAL TUMOR | P=0.546N P=0.395N P=0.414N P=0.573N | P=0.138N P=0.378N P=0.537N P=0.115N | |LOGISTIC REGRESSION | P=0.423N P=0.480N P=0.729N P=0.527N | P=0.131N P=0.378N P=0.560N P=0.115N | |COCHRAN-ARMITAGE | P=0.486N | P=0.149N | |FISHER EXACT | P=0.500N P=0.752N P=0.500N | P=0.309N P=0.500N P=0.122N | |=================================================================================================================================| | | |Mammary Gland | | Fibroadenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 1/60 (2%) 1/60 (2%) | 13/60 (22%) 22/60 (37%) 19/60 (32%) 16/60 (27%) | |ADJUSTED (b) | 0.0% 0.0% 3.3% 5.9% | 36.5% 61.4% 52.1% 42.8% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 0/18 (0%) 0/17 (0%) 0/15 (0%) 1/17 (6%) | 11/33 (33%) 14/27 (52%) 11/28 (39%) 13/34 (38%) | |FIRST INCIDENCE (DAYS) | --- --- 662 729 (T) | 517 552 489 598 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.353 (e) P=0.500 P=0.489 | P=0.252N P=0.016 * P=0.071 P=0.361 | |INCIDENTAL TUMOR | P=0.300 (e) P=0.586 P=0.489 | P=0.407N P=0.035 * P=0.121 P=0.339 | |LOGISTIC REGRESSION | P=0.324 (e) P=0.499 P=0.489 | P=0.364N P=0.036 * P=0.084 P=0.334 | |COCHRAN-ARMITAGE | P=0.376 | P=0.414N | |FISHER EXACT | (e) P=0.500 P=0.500 | P=0.054 P=0.151 P=0.335 | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05084 TEST: 01 PAGE 10 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TURMERIC OLEORESIN MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 2,000PPM 10,000 50,000 | 0 PPM 2,000PPM 10,000 50,000 | | | MALE MALE PPM MALE PPM MALE | FEMALE FEMALE PPM FEM PPM FEM | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/60 (2%) 0/60 (0%) 1/60 (2%) 1/60 (2%) | 13/60 (22%) 22/60 (37%) 19/60 (32%) 16/60 (27%) | |ADJUSTED (b) | 3.6% 0.0% 3.3% 5.9% | 36.5% 61.4% 52.1% 42.8% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 0/18 (0%) 0/17 (0%) 0/15 (0%) 1/17 (6%) | 11/33 (33%) 14/27 (52%) 11/28 (39%) 13/34 (38%) | |FIRST INCIDENCE (DAYS) | 676 --- 662 729 (T) | 517 552 489 598 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.534 P=0.461N P=0.756 P=0.737 | P=0.252N P=0.016 * P=0.071 P=0.361 | |INCIDENTAL TUMOR | P=0.463 P=0.395N P=0.664N P=0.713 | P=0.407N P=0.035 * P=0.121 P=0.339 | |LOGISTIC REGRESSION | P=0.520 P=0.480N P=0.761 P=0.729 | P=0.364N P=0.036 * P=0.084 P=0.334 | |COCHRAN-ARMITAGE | P=0.574 | P=0.414N | |FISHER EXACT | P=0.500N P=0.752N P=0.752N | P=0.054 P=0.151 P=0.335 | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma, Carcinoma, or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/60 (2%) 0/60 (0%) 2/60 (3%) 1/60 (2%) | 14/60 (23%) 23/60 (38%) 20/60 (33%) 16/60 (27%) | |ADJUSTED (b) | 3.6% 0.0% 5.0% 5.9% | 39.4% 64.4% 54.9% 42.8% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 0/18 (0%) 0/17 (0%) 0/15 (0%) 1/17 (6%) | 12/33 (36%) 15/27 (56%) 12/28 (43%) 13/34 (38%) | |FIRST INCIDENCE (DAYS) | 676 --- 337 729 (T) | 517 552 489 598 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.583 P=0.461N P=0.492 P=0.737 | P=0.179N P=0.015 * P=0.068 P=0.448 | |INCIDENTAL TUMOR | P=0.540 P=0.395N P=0.664N P=0.713 | P=0.302N P=0.033 * P=0.117 P=0.425 | |LOGISTIC REGRESSION | P=0.627 P=0.480N P=0.521 P=0.729 | P=0.271N P=0.036 * P=0.082 P=0.421 | |COCHRAN-ARMITAGE | P=0.617 | P=0.325N | |FISHER EXACT | P=0.500N P=0.500 P=0.752N | P=0.057 P=0.156 P=0.417 | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05084 TEST: 01 PAGE 11 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TURMERIC OLEORESIN MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 2,000PPM 10,000 50,000 | 0 PPM 2,000PPM 10,000 50,000 | | | MALE MALE PPM MALE PPM MALE | FEMALE FEMALE PPM FEM PPM FEM | |=================================================================================================================================| | | |Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip) | | Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 1/60 (2%) | 1/60 (2%) 0/60 (0%) 0/60 (0%) 2/60 (3%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 5.9% | 2.1% 0.0% 0.0% 5.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 0/18 (0%) 0/17 (0%) 0/15 (0%) 1/17 (6%) | 0/33 (0%) 0/27 (0%) 0/28 (0%) 0/34 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- 729 (T) | 517 --- --- 661 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.238 (e) (e) P=0.489 | P=0.176 P=0.500N P=0.513N P=0.498 | |INCIDENTAL TUMOR | P=0.238 (e) (e) P=0.489 | P=0.131 P=0.638N P=0.362N P=0.526 | |LOGISTIC REGRESSION | P=0.238 (e) (e) P=0.489 | P=0.097 P=0.504N P=0.467N P=0.426 | |COCHRAN-ARMITAGE | P=0.237 | P=0.168 | |FISHER EXACT | (e) (e) P=0.500 | P=0.500N P=0.500N P=0.500 | |=================================================================================================================================| | | |Ovary | | Granulosa Cell Tumor Benign | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | | 2/60 (3%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | | 5.7% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | | 1/33 (3%) 0/27 (0%) 0/28 (0%) 0/34 (0%) | |FIRST INCIDENCE (DAYS) | | 692 --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.335N P=0.262N P=0.271N P=0.233N | |INCIDENTAL TUMOR | | P=0.366N P=0.192N P=0.229N P=0.236N | |LOGISTIC REGRESSION | | P=0.343N P=0.246N P=0.259N P=0.236N | |COCHRAN-ARMITAGE | | P=0.350N | |FISHER EXACT | | P=0.248N P=0.248N P=0.248N | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05084 TEST: 01 PAGE 12 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TURMERIC OLEORESIN MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 2,000PPM 10,000 50,000 | 0 PPM 2,000PPM 10,000 50,000 | | | MALE MALE PPM MALE PPM MALE | FEMALE FEMALE PPM FEM PPM FEM | |=================================================================================================================================| | | |Ovary | | Granulosa Cell Tumor, Benign, Malignant, NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | | 2/60 (3%) 0/60 (0%) 1/60 (2%) 0/60 (0%) | |ADJUSTED (b) | | 5.7% 0.0% 3.6% 0.0% | |INTERIM SACRIFICE 1 (c)| | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | | 1/33 (3%) 0/27 (0%) 1/28 (4%) 0/34 (0%) | |FIRST INCIDENCE (DAYS) | | 692 --- 727 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.297N P=0.262N P=0.552N P=0.233N | |INCIDENTAL TUMOR | | P=0.321N P=0.192N P=0.509N P=0.236N | |LOGISTIC REGRESSION | | P=0.307N P=0.246N P=0.538N P=0.236N | |COCHRAN-ARMITAGE | | P=0.318N | |FISHER EXACT | | P=0.248N P=0.500N P=0.248N | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 26/60 (43%) 18/60 (30%) 17/59 (29%) 14/58 (24%) | 28/60 (47%) 27/58 (47%) 25/60 (42%) 25/60 (42%) | |ADJUSTED (b) | 60.8% 59.5% 61.1% 49.4% | 64.2% 64.9% 59.8% 60.1% | |INTERIM SACRIFICE 1 (c)| 3/10 (30%) 1/10 (10%) 1/10 (10%) 1/9 (11%) | 2/10 (20%) 1/10 (10%) 1/10 (10%) 1/9 (11%) | |TERMINAL (d) | 5/18 (28%) 7/17 (41%) 6/14 (43%) 5/17 (29%) | 18/33 (55%) 13/26 (50%) 12/28 (43%) 18/34 (53%) | |FIRST INCIDENCE (DAYS) | 435 459 (I) 456 (I) 456 (I) | 455 (I) 444 455 367 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.183N P=0.082N P=0.150N P=0.088N | P=0.210N P=0.376 P=0.538 P=0.334N | |INCIDENTAL TUMOR | P=0.086N P=0.119N P=0.113N P=0.045N* | P=0.393N P=0.551N P=0.365N P=0.404N | |LOGISTIC REGRESSION | P=0.163N P=0.074N P=0.077N P=0.052N | P=0.324N P=0.559 P=0.433N P=0.365N | |COCHRAN-ARMITAGE | P=0.067N | P=0.337N | |FISHER EXACT | P=0.092N P=0.072N P=0.022N* | P=0.568N P=0.357N P=0.357N | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05084 TEST: 01 PAGE 13 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TURMERIC OLEORESIN MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 2,000PPM 10,000 50,000 | 0 PPM 2,000PPM 10,000 50,000 | | | MALE MALE PPM MALE PPM MALE | FEMALE FEMALE PPM FEM PPM FEM | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/59 (0%) 0/58 (0%) | 2/60 (3%) 0/58 (0%) 1/60 (2%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 5.5% 0.0% 2.3% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 0/18 (0%) 0/17 (0%) 0/14 (0%) 0/17 (0%) | 1/33 (3%) 0/26 (0%) 0/28 (0%) 0/34 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 676 --- 526 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.313N P=0.272N P=0.536N P=0.242N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.304N P=0.204N P=0.412N P=0.236N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.315N P=0.254N P=0.502N P=0.237N | |COCHRAN-ARMITAGE | (e) | P=0.315N | |FISHER EXACT | (e) (e) (e) | P=0.256N P=0.500N P=0.248N | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 26/60 (43%) 18/60 (30%) 17/59 (29%) 14/58 (24%) | 30/60 (50%) 27/58 (47%) 26/60 (43%) 25/60 (42%) | |ADJUSTED (b) | 60.8% 59.5% 61.1% 49.4% | 67.4% 64.9% 60.8% 60.1% | |INTERIM SACRIFICE 1 (c)| 3/10 (30%) 1/10 (10%) 1/10 (10%) 1/9 (11%) | 2/10 (20%) 1/10 (10%) 1/10 (10%) 1/9 (11%) | |TERMINAL (d) | 5/18 (28%) 7/17 (41%) 6/14 (43%) 5/17 (29%) | 19/33 (58%) 13/26 (50%) 12/28 (43%) 18/34 (53%) | |FIRST INCIDENCE (DAYS) | 435 459 (I) 456 (I) 456 (I) | 455 (I) 444 455 367 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.183N P=0.082N P=0.150N P=0.088N | P=0.158N P=0.493 P=0.536N P=0.223N | |INCIDENTAL TUMOR | P=0.086N P=0.119N P=0.113N P=0.045N* | P=0.298N P=0.387N P=0.271N P=0.263N | |LOGISTIC REGRESSION | P=0.163N P=0.074N P=0.077N P=0.052N | P=0.242N P=0.445N P=0.360N P=0.232N | |COCHRAN-ARMITAGE | P=0.067N | P=0.256N | |FISHER EXACT | P=0.092N P=0.072N P=0.022N* | P=0.425N P=0.292N P=0.232N | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05084 TEST: 01 PAGE 14 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TURMERIC OLEORESIN MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 2,000PPM 10,000 50,000 | 0 PPM 2,000PPM 10,000 50,000 | | | MALE MALE PPM MALE PPM MALE | FEMALE FEMALE PPM FEM PPM FEM | |=================================================================================================================================| | | |Skin | | Keratoacanthoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 3/60 (5%) 0/60 (0%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 0.0% 10.7% 0.0% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 0/18 (0%) 0/17 (0%) 0/15 (0%) 0/17 (0%) | 0/33 (0%) 0/27 (0%) 0/28 (0%) 0/34 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 634 --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.613N (e) P=0.127 (e) | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.692N (e) P=0.165 (e) | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.585N (e) P=0.119 (e) | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.540N | (e) | |FISHER EXACT | (e) P=0.122 (e) | (e) (e) (e) | |=================================================================================================================================| | | |Skin | | Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 5/60 (8%) 0/60 (0%) 2/60 (3%) 1/60 (2%) | 1/60 (2%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 19.3% 0.0% 10.0% 3.6% | 3.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 2/18 (11%) 0/17 (0%) 1/15 (7%) 0/17 (0%) | 1/33 (3%) 0/27 (0%) 0/28 (0%) 0/34 (0%) | |FIRST INCIDENCE (DAYS) | 589 --- 674 633 | 727 (T) --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.334N P=0.029N* P=0.254N P=0.145N | P=0.563N P=0.540N P=0.533N P=0.494N | |INCIDENTAL TUMOR | P=0.367N P=0.027N* P=0.214N P=0.158N | P=0.563N P=0.540N P=0.533N P=0.494N | |LOGISTIC REGRESSION | P=0.333N P=0.026N* P=0.218N P=0.131N | P=0.563N P=0.540N P=0.533N P=0.494N | |COCHRAN-ARMITAGE | P=0.273N | P=0.588N | |FISHER EXACT | P=0.029N* P=0.219N P=0.103N | P=0.500N P=0.500N P=0.500N | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05084 TEST: 01 PAGE 15 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TURMERIC OLEORESIN MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 2,000PPM 10,000 50,000 | 0 PPM 2,000PPM 10,000 50,000 | | | MALE MALE PPM MALE PPM MALE | FEMALE FEMALE PPM FEM PPM FEM | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 4/60 (7%) 0/60 (0%) 2/60 (3%) 1/60 (2%) | 1/60 (2%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 17.0% 0.0% 10.0% 3.6% | 3.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 2/18 (11%) 0/17 (0%) 1/15 (7%) 0/17 (0%) | 1/33 (3%) 0/27 (0%) 0/28 (0%) 0/34 (0%) | |FIRST INCIDENCE (DAYS) | 609 --- 674 633 | 727 (T) --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.422N P=0.058N P=0.386N P=0.227N | P=0.563N P=0.540N P=0.533N P=0.494N | |INCIDENTAL TUMOR | P=0.463N P=0.052N P=0.324N P=0.248N | P=0.563N P=0.540N P=0.533N P=0.494N | |LOGISTIC REGRESSION | P=0.440N P=0.047N* P=0.339N P=0.221N | P=0.563N P=0.540N P=0.533N P=0.494N | |COCHRAN-ARMITAGE | P=0.363N | P=0.588N | |FISHER EXACT | P=0.059N P=0.340N P=0.182N | P=0.500N P=0.500N P=0.500N | |=================================================================================================================================| | | |Skin | | Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma, | | Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 5/60 (8%) 0/60 (0%) 5/60 (8%) 2/60 (3%) | 1/60 (2%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 19.3% 0.0% 19.6% 9.2% | 3.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 2/18 (11%) 0/17 (0%) 1/15 (7%) 1/17 (6%) | 1/33 (3%) 0/27 (0%) 0/28 (0%) 0/34 (0%) | |FIRST INCIDENCE (DAYS) | 589 --- 634 633 | 727 (T) --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.503N P=0.029N* P=0.594 P=0.277N | P=0.563N P=0.540N P=0.533N P=0.494N | |INCIDENTAL TUMOR | P=0.574N P=0.027N* P=0.583N P=0.301N | P=0.563N P=0.540N P=0.533N P=0.494N | |LOGISTIC REGRESSION | P=0.506N P=0.026N* P=0.628 P=0.270N | P=0.563N P=0.540N P=0.533N P=0.494N | |COCHRAN-ARMITAGE | P=0.408N | P=0.588N | |FISHER EXACT | P=0.029N* P=0.628N P=0.219N | P=0.500N P=0.500N P=0.500N | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05084 TEST: 01 PAGE 16 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TURMERIC OLEORESIN MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 2,000PPM 10,000 50,000 | 0 PPM 2,000PPM 10,000 50,000 | | | MALE MALE PPM MALE PPM MALE | FEMALE FEMALE PPM FEM PPM FEM | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Fibroma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/60 (5%) 1/60 (2%) 1/60 (2%) 3/60 (5%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 12.7% 2.4% 3.7% 14.5% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 1/18 (6%) 0/17 (0%) 0/15 (0%) 2/17 (12%) | 0/33 (0%) 0/27 (0%) 0/28 (0%) 0/34 (0%) | |FIRST INCIDENCE (DAYS) | 676 611 676 569 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.302 P=0.259N P=0.338N P=0.608 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.241 P=0.223N P=0.210N P=0.568 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.293 P=0.269N P=0.306N P=0.595 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.375 | (e) | |FISHER EXACT | P=0.309N P=0.309N P=0.660N | (e) (e) (e) | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Neurofibrosarcoma, Fibrosarcoma, Sarcoma, | | Neurofibroma, or Fibroma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 5/60 (8%) 2/60 (3%) 1/60 (2%) 4/60 (7%) | 1/60 (2%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 19.1% 5.6% 3.7% 20.2% | 2.3% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 1/18 (6%) 0/17 (0%) 0/15 (0%) 3/17 (18%) | 0/33 (0%) 0/27 (0%) 0/28 (0%) 0/34 (0%) | |FIRST INCIDENCE (DAYS) | 563 611 676 569 | 603 --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.354 P=0.163N P=0.124N P=0.572N | P=0.582N P=0.505N P=0.525N P=0.500N | |INCIDENTAL TUMOR | P=0.270 P=0.115N P=0.057N P=0.630N | P=0.733N P=0.443N P=0.536N P=0.638N | |LOGISTIC REGRESSION | P=0.351 P=0.184N P=0.104N P=0.588N | P=0.585N P=0.500N P=0.490N P=0.494N | |COCHRAN-ARMITAGE | P=0.453 | P=0.588N | |FISHER EXACT | P=0.219N P=0.103N P=0.500N | P=0.500N P=0.500N P=0.500N | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05084 TEST: 01 PAGE 17 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TURMERIC OLEORESIN MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 2,000PPM 10,000 50,000 | 0 PPM 2,000PPM 10,000 50,000 | | | MALE MALE PPM MALE PPM MALE | FEMALE FEMALE PPM FEM PPM FEM | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Neurofibrosarcoma, Fibrosarcoma, or Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/60 (3%) 1/60 (2%) 0/60 (0%) 1/60 (2%) | 1/60 (2%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 7.3% 3.2% 0.0% 5.9% | 2.3% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 0/18 (0%) 0/17 (0%) 0/15 (0%) 1/17 (6%) | 0/33 (0%) 0/27 (0%) 0/28 (0%) 0/34 (0%) | |FIRST INCIDENCE (DAYS) | 563 696 --- 729 (T) | 603 --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.664N P=0.433N P=0.242N P=0.544N | P=0.582N P=0.505N P=0.525N P=0.500N | |INCIDENTAL TUMOR | P=0.695 P=0.380N P=0.206N P=0.582N | P=0.733N P=0.443N P=0.536N P=0.638N | |LOGISTIC REGRESSION | P=0.657N P=0.479N P=0.239N P=0.544N | P=0.585N P=0.500N P=0.490N P=0.494N | |COCHRAN-ARMITAGE | P=0.598N | P=0.588N | |FISHER EXACT | P=0.500N P=0.248N P=0.500N | P=0.500N P=0.500N P=0.500N | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Schwannoma Malignant | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/60 (2%) 0/60 (0%) 1/60 (2%) 0/60 (0%) | 0/60 (0%) 2/60 (3%) 0/60 (0%) 1/60 (2%) | |ADJUSTED (b) | 2.4% 0.0% 6.7% 0.0% | 0.0% 6.1% 0.0% 2.4% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 0/18 (0%) 0/17 (0%) 1/15 (7%) 0/17 (0%) | 0/33 (0%) 1/27 (4%) 0/28 (0%) 0/34 (0%) | |FIRST INCIDENCE (DAYS) | 543 --- 729 (T) --- | --- 622 --- 659 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.522N P=0.473N P=0.743 P=0.549N | P=0.659 P=0.215 (e) P=0.510 | |INCIDENTAL TUMOR | P=0.352N P=0.831N P=0.653 P=0.402N | P=0.566 P=0.248 (e) P=0.500 | |LOGISTIC REGRESSION | P=0.502N P=0.526N P=0.761 P=0.469N | P=0.640 P=0.236 (e) P=0.499 | |COCHRAN-ARMITAGE | P=0.486N | P=0.640 | |FISHER EXACT | P=0.500N P=0.752N P=0.500N | P=0.248 (e) P=0.500 | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05084 TEST: 01 PAGE 18 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TURMERIC OLEORESIN MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 2,000PPM 10,000 50,000 | 0 PPM 2,000PPM 10,000 50,000 | | | MALE MALE PPM MALE PPM MALE | FEMALE FEMALE PPM FEM PPM FEM | |=================================================================================================================================| | | |Testes | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 40/60 (67%) 47/60 (78%) 44/60 (73%) 43/60 (72%) | | |ADJUSTED (b) | 100.0% 95.8% 100.0% 100.0% | | |INTERIM SACRIFICE 1 (c)| 3/10 (30%) 3/10 (30%) 4/10 (40%) 3/9 (33%) | | |TERMINAL (d) | 18/18 (100%) 15/17 (88%) 15/15 (100%) 17/17 (100%)| | |FIRST INCIDENCE (DAYS) | 456 (I) 459 (I) 456 (I) 456 | | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.203 P=0.348 P=0.188 P=0.155 | | |INCIDENTAL TUMOR | P=0.065 P=0.320 P=0.266 P=0.069 | | |LOGISTIC REGRESSION | P=0.037 * P=0.272 P=0.218 P=0.023 * | | |COCHRAN-ARMITAGE | P=0.520N | | |FISHER EXACT | P=0.110 P=0.275 P=0.346 | | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/60 (7%) 8/60 (13%) 5/60 (8%) 6/60 (10%) | 6/60 (10%) 2/60 (3%) 3/60 (5%) 3/60 (5%) | |ADJUSTED (b) | 14.2% 24.9% 19.0% 23.3% | 18.2% 6.5% 10.7% 8.8% | |INTERIM SACRIFICE 1 (c)| 2/10 (20%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 2/18 (11%) 1/17 (6%) 1/15 (7%) 2/17 (12%) | 6/33 (18%) 1/27 (4%) 3/28 (11%) 3/34 (9%) | |FIRST INCIDENCE (DAYS) | 456 (I) 602 467 538 | 727 (T) 700 727 (T) 727 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.412 P=0.246 P=0.458 P=0.310 | P=0.350N P=0.196N P=0.325N P=0.224N | |INCIDENTAL TUMOR | P=0.408 P=0.317 P=0.460 P=0.317 | P=0.365N P=0.165N P=0.325N P=0.224N | |LOGISTIC REGRESSION | P=0.461 P=0.203 P=0.499 P=0.334 | P=0.361N P=0.170N P=0.325N P=0.224N | |COCHRAN-ARMITAGE | P=0.545 | P=0.430N | |FISHER EXACT | P=0.181 P=0.500 P=0.372 | P=0.136N P=0.245N P=0.245N | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05084 TEST: 01 PAGE 19 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TURMERIC OLEORESIN MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 2,000PPM 10,000 50,000 | 0 PPM 2,000PPM 10,000 50,000 | | | MALE MALE PPM MALE PPM MALE | FEMALE FEMALE PPM FEM PPM FEM | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/60 (3%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | 2/60 (3%) 0/60 (0%) 1/60 (2%) 0/60 (0%) | |ADJUSTED (b) | 8.3% 0.0% 0.0% 0.0% | 5.8% 0.0% 2.6% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 1/18 (6%) 0/17 (0%) 0/15 (0%) 0/17 (0%) | 1/33 (3%) 0/27 (0%) 0/28 (0%) 0/34 (0%) | |FIRST INCIDENCE (DAYS) | 633 --- --- --- | 707 --- 591 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.376N P=0.231N P=0.253N P=0.268N | P=0.298N P=0.292N P=0.548N P=0.233N | |INCIDENTAL TUMOR | P=0.377N P=0.246N P=0.275N P=0.278N | P=0.386N P=0.192N P=0.511N P=0.236N | |LOGISTIC REGRESSION | P=0.384N P=0.213N P=0.238N P=0.268N | P=0.317N P=0.251N P=0.517N P=0.234N | |COCHRAN-ARMITAGE | P=0.350N | P=0.318N | |FISHER EXACT | P=0.248N P=0.248N P=0.248N | P=0.248N P=0.500N P=0.248N | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 6/60 (10%) 8/60 (13%) 5/60 (8%) 6/60 (10%) | 8/60 (13%) 2/60 (3%) 4/60 (7%) 3/60 (5%) | |ADJUSTED (b) | 22.0% 24.9% 19.0% 23.3% | 23.5% 6.5% 13.0% 8.8% | |INTERIM SACRIFICE 1 (c)| 2/10 (20%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 3/18 (17%) 1/17 (6%) 1/15 (7%) 2/17 (12%) | 7/33 (21%) 1/27 (4%) 3/28 (11%) 3/34 (9%) | |FIRST INCIDENCE (DAYS) | 456 (I) 602 467 538 | 707 700 591 727 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.535 P=0.468 P=0.546N P=0.541 | P=0.205N P=0.087N P=0.262N P=0.090N | |INCIDENTAL TUMOR | P=0.537 P=0.549 P=0.556N P=0.547 | P=0.247N P=0.052N P=0.246N P=0.091N | |LOGISTIC REGRESSION | P=0.581 P=0.432 P=0.504N P=0.568 | P=0.237N P=0.062N P=0.229N P=0.087N | |COCHRAN-ARMITAGE | P=0.494N | P=0.269N | |FISHER EXACT | P=0.389 P=0.500N P=0.619N | P=0.047N* P=0.181N P=0.102N | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05084 TEST: 01 PAGE 20 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TURMERIC OLEORESIN MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 2,000PPM 10,000 50,000 | 0 PPM 2,000PPM 10,000 50,000 | | | MALE MALE PPM MALE PPM MALE | FEMALE FEMALE PPM FEM PPM FEM | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/60 (2%) 2/60 (3%) 0/60 (0%) 1/60 (2%) | 0/60 (0%) 0/60 (0%) 1/60 (2%) 0/60 (0%) | |ADJUSTED (b) | 2.6% 11.8% 0.0% 5.9% | 0.0% 0.0% 3.6% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 0/18 (0%) 2/17 (12%) 0/15 (0%) 1/17 (6%) | 0/33 (0%) 0/27 (0%) 1/28 (4%) 0/34 (0%) | |FIRST INCIDENCE (DAYS) | 553 729 (T) --- 729 (T) | --- --- 727 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.642N P=0.506 P=0.485N P=0.732 | P=0.737N (e) P=0.467 (e) | |INCIDENTAL TUMOR | P=0.641N P=0.487 P=0.527N P=0.722 | P=0.737N (e) P=0.467 (e) | |LOGISTIC REGRESSION | P=0.683N P=0.530 P=0.486N P=0.745 | P=0.737N (e) P=0.467 (e) | |COCHRAN-ARMITAGE | P=0.617N | P=0.763N | |FISHER EXACT | P=0.500 P=0.500N P=0.752N | (e) P=0.500 (e) | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/60 (2%) 3/60 (5%) 0/60 (0%) 1/60 (2%) | 0/60 (0%) 1/60 (2%) 1/60 (2%) 0/60 (0%) | |ADJUSTED (b) | 2.6% 13.7% 0.0% 5.9% | 0.0% 2.9% 3.6% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 0/18 (0%) 2/17 (12%) 0/15 (0%) 1/17 (6%) | 0/33 (0%) 0/27 (0%) 1/28 (4%) 0/34 (0%) | |FIRST INCIDENCE (DAYS) | 553 582 --- 729 (T) | --- 700 727 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.530N P=0.333 P=0.485N P=0.732 | P=0.489N P=0.500 P=0.467 (e) | |INCIDENTAL TUMOR | P=0.528N P=0.294 P=0.527N P=0.722 | P=0.534N P=0.623 P=0.467 (e) | |LOGISTIC REGRESSION | P=0.541N P=0.319 P=0.486N P=0.745 | P=0.502N P=0.494 P=0.467 (e) | |COCHRAN-ARMITAGE | P=0.487N | P=0.514N | |FISHER EXACT | P=0.309 P=0.500N P=0.752N | P=0.500 P=0.500 (e) | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05084 TEST: 01 PAGE 21 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TURMERIC OLEORESIN MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 2,000PPM 10,000 50,000 | 0 PPM 2,000PPM 10,000 50,000 | | | MALE MALE PPM MALE PPM MALE | FEMALE FEMALE PPM FEM PPM FEM | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 10/60 (17%) 10/60 (17%) 11/60 (18%) 9/60 (15%) | |ADJUSTED (b) | | 24.2% 31.3% 33.3% 22.2% | |INTERIM SACRIFICE 1 (c)| | 1/10 (10%) 0/10 (0%) 0/10 (0%) 1/9 (11%) | |TERMINAL (d) | | 5/33 (15%) 7/27 (26%) 8/28 (29%) 5/34 (15%) | |FIRST INCIDENCE (DAYS) | | 457 (I) 552 462 457 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.340N P=0.475 P=0.378 P=0.495N | |INCIDENTAL TUMOR | | P=0.414N P=0.531 P=0.521 P=0.529N | |LOGISTIC REGRESSION | | P=0.431N P=0.593 P=0.482 P=0.500N | |COCHRAN-ARMITAGE | | P=0.432N | |FISHER EXACT | | P=0.596N P=0.500 P=0.500N | |=================================================================================================================================| | | |Zymbal's Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 1/60 (2%) | 2/60 (3%) 0/60 (0%) 1/60 (2%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 4.8% | 5.2% 0.0% 2.4% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 0/18 (0%) 0/17 (0%) 0/15 (0%) 0/17 (0%) | 1/33 (3%) 0/27 (0%) 0/28 (0%) 0/34 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- 695 | 574 --- 576 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.192 (e) (e) P=0.457 | P=0.309N P=0.259N P=0.533N P=0.236N | |INCIDENTAL TUMOR | P=0.120 (e) (e) P=0.427 | P=0.419N P=0.229N P=0.563N P=0.310N | |LOGISTIC REGRESSION | P=0.200 (e) (e) P=0.470 | P=0.317N P=0.238N P=0.494N P=0.238N | |COCHRAN-ARMITAGE | P=0.237 | P=0.318N | |FISHER EXACT | (e) (e) P=0.500 | P=0.248N P=0.500N P=0.248N | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05084 TEST: 01 PAGE 22 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TURMERIC OLEORESIN MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 2,000PPM 10,000 50,000 | 0 PPM 2,000PPM 10,000 50,000 | | | MALE MALE PPM MALE PPM MALE | FEMALE FEMALE PPM FEM PPM FEM | |=================================================================================================================================| | | |All Organs | | Leukemia: Lymphocytic, Monocytic, Mononuclear, | | or Undifferentiated | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 27/60 (45%) 29/60 (48%) 35/60 (58%) 23/60 (38%) | 15/60 (25%) 19/60 (32%) 18/60 (30%) 21/60 (35%) | |ADJUSTED (b) | 76.8% 71.0% 83.0% 65.8% | 38.7% 47.2% 44.4% 49.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 11/18 (61%) 7/17 (41%) 8/15 (53%) 6/17 (35%) | 10/33 (30%) 8/27 (30%) 8/28 (29%) 13/34 (38%) | |FIRST INCIDENCE (DAYS) | 465 456 (I) 464 400 | 553 444 414 367 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.440N P=0.524N P=0.103 P=0.524N | P=0.350 P=0.178 P=0.217 P=0.193 | |INCIDENTAL TUMOR | P=0.269N P=0.542 P=0.076 P=0.444N | P=0.119 P=0.380 P=0.348 P=0.102 | |LOGISTIC REGRESSION | P=0.475N P=0.550N P=0.083 P=0.581N | P=0.154 P=0.330 P=0.292 P=0.147 | |COCHRAN-ARMITAGE | P=0.114N | P=0.210 | |FISHER EXACT | P=0.427 P=0.100 P=0.289N | P=0.272 P=0.342 P=0.160 | |=================================================================================================================================| | | |All Organs | | Mesothelioma Benign, Malignant, NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 2/60 (3%) 1/60 (2%) 1/60 (2%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 7.4% 4.3% 5.9% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 0/18 (0%) 0/17 (0%) 0/15 (0%) 1/17 (6%) | 0/33 (0%) 0/27 (0%) 0/28 (0%) 0/34 (0%) | |FIRST INCIDENCE (DAYS) | --- 612 695 729 (T) | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.628 P=0.263 P=0.476 P=0.489 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.571 P=0.297 P=0.586 P=0.489 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.619 P=0.254 P=0.498 P=0.489 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.673 | (e) | |FISHER EXACT | P=0.248 P=0.500 P=0.500 | (e) (e) (e) | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05084 TEST: 01 PAGE 23 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TURMERIC OLEORESIN MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 2,000PPM 10,000 50,000 | 0 PPM 2,000PPM 10,000 50,000 | | | MALE MALE PPM MALE PPM MALE | FEMALE FEMALE PPM FEM PPM FEM | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 54/60 (90%) 53/60 (88%) 53/60 (88%) 48/60 (80%) | 46/60 (77%) 47/60 (78%) 44/60 (73%) 44/60 (73%) | |ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | 91.7% 97.8% 95.5% 97.7% | |INTERIM SACRIFICE 1 (c)| 7/10 (70%) 4/10 (40%) 7/10 (70%) 5/9 (56%) | 5/10 (50%) 2/10 (20%) 2/10 (20%) 3/9 (33%) | |TERMINAL (d) | 18/18 (100%) 17/17 (100%) 15/15 (100%) 17/17 (100%)| 29/33 (88%) 26/27 (96%) 26/28 (93%) 33/34 (97%) | |FIRST INCIDENCE (DAYS) | 435 459 (I) 456 (I) 374 | 455 (I) 444 455 367 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.427 P=0.311N P=0.441 P=0.534 | P=0.133N P=0.181 P=0.331 P=0.385N | |INCIDENTAL TUMOR | P=0.266N P=0.337N P=0.574 P=0.278N | P=0.375N P=0.408 P=0.526N P=0.494N | |LOGISTIC REGRESSION | P=0.496 P=0.289N P=0.554 P=0.588N | P=0.377N P=0.504 P=0.565N P=0.468N | |COCHRAN-ARMITAGE | P=0.058N | P=0.352N | |FISHER EXACT | P=0.500N P=0.500N P=0.100N | P=0.500 P=0.417N P=0.417N | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 34/60 (57%) 36/60 (60%) 40/60 (67%) 26/60 (43%) | 25/60 (42%) 25/60 (42%) 24/60 (40%) 24/60 (40%) | |ADJUSTED (b) | 85.8% 79.0% 88.6% 73.2% | 56.2% 58.8% 55.2% 53.9% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 3/10 (30%) 0/10 (0%) 0/9 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 13/18 (72%) 9/17 (53%) 10/15 (67%) 8/17 (47%) | 14/33 (42%) 11/27 (41%) 10/28 (36%) 14/34 (41%) | |FIRST INCIDENCE (DAYS) | 465 337 337 400 | 517 444 414 367 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.257N P=0.497N P=0.168 P=0.335N | P=0.333N P=0.390 P=0.432 P=0.472N | |INCIDENTAL TUMOR | P=0.051N P=0.522 P=0.116 P=0.173N | P=0.413 P=0.405N P=0.462N P=0.507 | |LOGISTIC REGRESSION | P=0.151N P=0.551 P=0.131 P=0.314N | P=0.481 P=0.426N P=0.523N P=0.575 | |COCHRAN-ARMITAGE | P=0.021N* | P=0.477N | |FISHER EXACT | P=0.427 P=0.174 P=0.101N | P=0.573N P=0.500N P=0.500N | |=================================================================================================================================| DATE: 09/11/94 EXPERIMENT: 05084 TEST: 01 PAGE 24 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- TURMERIC OLEORESIN MALE TERMINAL SACRIFICE AT 105 WEEKS FEMALE TERMINAL SACRIFICE AT 104 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0 PPM 2,000PPM 10,000 50,000 | 0 PPM 2,000PPM 10,000 50,000 | | | MALE MALE PPM MALE PPM MALE | FEMALE FEMALE PPM FEM PPM FEM | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 56/60 (93%) 55/60 (92%) 55/60 (92%) 49/60 (82%) | 53/60 (88%) 50/60 (83%) 49/60 (82%) 49/60 (82%) | |ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | 96.3% 98.0% 96.0% 98.0% | |INTERIM SACRIFICE 1 (c)| 7/10 (70%) 5/10 (50%) 7/10 (70%) 5/9 (56%) | 5/10 (50%) 2/10 (20%) 2/10 (20%) 3/9 (33%) | |TERMINAL (d) | 18/18 (100%) 17/17 (100%) 15/15 (100%) 17/17 (100%)| 31/33 (94%) 26/27 (96%) 26/28 (93%) 33/34 (97%) | |FIRST INCIDENCE (DAYS) | 435 337 337 374 | 455 (I) 444 414 367 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.480 P=0.313N P=0.439 P=0.528N | P=0.145N P=0.379 P=0.426 P=0.282N | |INCIDENTAL TUMOR | P=0.057N P=0.385N P=0.565 P=0.120N | P=0.487N P=0.231N P=0.165N P=0.335N | |LOGISTIC REGRESSION | P=0.317N P=0.365N P=0.509 P=0.394N | P=0.395N P=0.248N P=0.321N P=0.277N | |COCHRAN-ARMITAGE | P=0.017N* | P=0.316N | |FISHER EXACT | P=0.500N P=0.500N P=0.048N* | P=0.301N P=0.222N P=0.222N | |=================================================================================================================================| (a) Number of tumor-bearing animals / number of animals examined at site. (b) Kaplan-Meier estimated lifetime tumor incidence after adjustment for intercurrent mortality. (c) Observed incidence at interim kill. Male interim sacrifices(days): 456 Female interim sacrifices(days): 455 (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).