TR 393 Mouse Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Columbus SODIUM FLUORIDE DATE: 09/17/94 EXPERIMENT: 05131 TEST: 02 TIME: 08:50:39 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01-ES-55102 ROUTE: DOSED WATER NTP C#: 55221B PATHOLOGIST: J. TOFT S. EUSTIS CAS: 7681-49-4 ------------------------------------------------------------------------------------------------------------------------------------ REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Columbus SODIUM FLUORIDE DATE: 09/17/94 EXPERIMENT: 05131 TEST: 02 TIME: 08:50:39 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-55102 ROUTE: DOSED WATER NTP C#: 55221B PATHOLOGIST: J. TOFT S. EUSTIS CAS: 7681-49-4 MICE(B6C3F1) ---------------------------- FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED. IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED. ---------------- Adrenal Gland Bone Marrow Brain Clitoral Gland Epididymis Gallbladder Heart Islets, Pancreatic Kidney Liver Lung Nose Ovary Pancreas Parathyroid Gland Pituitary Gland Preputial Gland Prostate Salivary Glands Spleen Testes Thymus Thyroid Gland Urinary Bladder NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Columbus SODIUM FLUORIDE DATE: 09/17/94 EXPERIMENT: 05131 TEST: 02 TIME: 08:50:39 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-55102 ROUTE: DOSED WATER NTP C#: 55221B PATHOLOGIST: J. TOFT S. EUSTIS CAS: 7681-49-4 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF THE STUDY OF SODIUM FLUORIDE ==================================================================================================== MALE MICE ------------- ORGAN MORPHOLOGY ------- ------------ Harderian Gland Adenoma Carcinoma or Adenoma Liver Hepatoblastoma Hepatocellular Adenoma Hepatocellular Carcinoma Hepatocellular Carcinoma or Hepatoblastoma Hepatocellular Carcinoma or Hepatocellular Adenoma Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma Lung Alveolar/Bronchiolar Carcinoma Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma All Organs Benign Tumors Malignant Tumors Malignant and Benign Tumors ==================================================================================================== FEMALE MICE ------------- ORGAN MORPHOLOGY ------- ------------ Harderian Gland Adenoma Liver Hepatoblastoma Hepatocellular Adenoma Hepatocellular Carcinoma or Hepatocellular Adenoma Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma Pituitary Gland: Pars Distalis or Unspecified Site Adenoma All Organs Hemangiosarcoma or Hemangioma Malignant Lymphoma And Histiocytic Sarcoma Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated Cell Type Benign Tumors Malignant Tumors Malignant and Benign Tumors ==================================================================================================== DATE: 09/17/94 EXPERIMENT: 05131 TEST: 02 PAGE 1 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SODIUM FLUORIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | SPECIAL 25 PPM 100 PPM 175 PPM | SPECIAL 25 PPM 100 PPM 175 PPM | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Adrenal Cortex | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 10/131 (8%) 8/60 (13%) 6/62 (10%) 6/100 (6%) | 0/141 (0%) 0/62 (0%) 0/63 (0%) 0/99 (0%) | |ADJUSTED (b) | 16.3% 19.9% 16.2% 9.2% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/2 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | 0/10 (0%) 0/8 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 8/58 (14%) 7/39 (18%) 6/37 (16%) 6/65 (9%) | 0/53 (0%) 0/38 (0%) 0/34 (0%) 0/52 (0%) | |FIRST INCIDENCE (DAYS) | 669 707 729 (T) 729 (T) | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.083N P=0.436 P=0.571N P=0.157N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.126N P=0.335 P=0.561 P=0.227N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.115N P=0.357 P=0.564 P=0.214N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.255N | (e) | |FISHER EXACT | P=0.162 P=0.410 P=0.416N | (e) (e) (e) | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Benign | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/128 (0%) 1/60 (2%) 0/62 (0%) 1/99 (1%) | 0/138 (0%) 2/62 (3%) 1/63 (2%) 1/98 (1%) | |ADJUSTED (b) | 0.0% 2.6% 0.0% 1.5% | 0.0% 5.3% 2.9% 2.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/2 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | 0/10 (0%) 0/8 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 0/56 (0%) 1/39 (3%) 0/37 (0%) 1/65 (2%) | 0/51 (0%) 2/38 (5%) 1/34 (3%) 1/51 (2%) | |FIRST INCIDENCE (DAYS) | --- 729 (T) --- 729 (T) | --- 729 (T) 729 (T) 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.502 P=0.428 (e) P=0.530 | P=0.549 P=0.176 P=0.419 P=0.500 | |INCIDENTAL TUMOR | P=0.502 P=0.428 (e) P=0.530 | P=0.549 P=0.176 P=0.419 P=0.500 | |LOGISTIC REGRESSION | P=0.502 P=0.428 (e) P=0.530 | P=0.549 P=0.176 P=0.419 P=0.500 | |COCHRAN-ARMITAGE | P=0.427 | P=0.471 | |FISHER EXACT | P=0.319 (e) P=0.436 | P=0.095 P=0.313 P=0.415 | |=================================================================================================================================| DATE: 09/17/94 EXPERIMENT: 05131 TEST: 02 PAGE 2 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SODIUM FLUORIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | SPECIAL 25 PPM 100 PPM 175 PPM | SPECIAL 25 PPM 100 PPM 175 PPM | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma: Benign, Complex, Malignant, NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/128 (0%) 2/60 (3%) 0/62 (0%) 1/99 (1%) | 0/138 (0%) 2/62 (3%) 1/63 (2%) 1/98 (1%) | |ADJUSTED (b) | 0.0% 5.1% 0.0% 1.5% | 0.0% 5.3% 2.9% 2.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/2 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | 0/10 (0%) 0/8 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 0/56 (0%) 2/39 (5%) 0/37 (0%) 1/65 (2%) | 0/51 (0%) 2/38 (5%) 1/34 (3%) 1/51 (2%) | |FIRST INCIDENCE (DAYS) | --- 729 (T) --- 729 (T) | --- 729 (T) 729 (T) 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.556N P=0.163 (e) P=0.530 | P=0.549 P=0.176 P=0.419 P=0.500 | |INCIDENTAL TUMOR | P=0.556N P=0.163 (e) P=0.530 | P=0.549 P=0.176 P=0.419 P=0.500 | |LOGISTIC REGRESSION | P=0.556N P=0.163 (e) P=0.530 | P=0.549 P=0.176 P=0.419 P=0.500 | |COCHRAN-ARMITAGE | P=0.586 | P=0.471 | |FISHER EXACT | P=0.101 (e) P=0.436 | P=0.095 P=0.313 P=0.415 | |=================================================================================================================================| | | |Bone | | Osteosarcoma or Osteoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/131 (0%) 1/60 (2%) 0/62 (0%) 0/100 (0%) | 2/142 (1%) 0/62 (0%) 0/63 (0%) 0/99 (0%) | |ADJUSTED (b) | 0.0% 1.7% 0.0% 0.0% | 2.7% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/2 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 1/10 (10%) 0/9 (0%) 0/10 (0%) | 0/10 (0%) 0/8 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 0/58 (0%) 0/39 (0%) 0/37 (0%) 0/65 (0%) | 1/53 (2%) 0/38 (0%) 0/34 (0%) 0/52 (0%) | |FIRST INCIDENCE (DAYS) | --- 458 (I) --- --- | 420 --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.432N P=0.500 (e) (e) | P=0.149N P=0.357N P=0.374N P=0.282N | |INCIDENTAL TUMOR | P=0.432N P=0.500 (e) (e) | P=0.208N P=0.451N P=0.443N P=0.402N | |LOGISTIC REGRESSION | P=0.453N P=0.252 (e) (e) | P=0.167N P=0.444N P=0.435N P=0.322N | |COCHRAN-ARMITAGE | P=0.452N | P=0.167N | |FISHER EXACT | P=0.314 (e) (e) | P=0.483N P=0.479N P=0.346N | |=================================================================================================================================| DATE: 09/17/94 EXPERIMENT: 05131 TEST: 02 PAGE 3 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SODIUM FLUORIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | SPECIAL 25 PPM 100 PPM 175 PPM | SPECIAL 25 PPM 100 PPM 175 PPM | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Bone Marrow | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/131 (0%) 2/60 (3%) 1/62 (2%) 0/100 (0%) | 1/142 (1%) 1/62 (2%) 2/63 (3%) 0/99 (0%) | |ADJUSTED (b) | 0.0% 4.6% 2.2% 0.0% | 1.9% 2.6% 5.6% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/2 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | 0/10 (0%) 0/8 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 0/58 (0%) 1/39 (3%) 0/37 (0%) 0/65 (0%) | 1/53 (2%) 1/38 (3%) 1/34 (3%) 0/52 (0%) | |FIRST INCIDENCE (DAYS) | --- 619 579 --- | 729 (T) 729 (T) 724 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.376N P=0.143 P=0.368 (e) | P=0.386N P=0.686 P=0.355 P=0.504N | |INCIDENTAL TUMOR | P=0.551N P=0.069 P=0.331 (e) | P=0.452N P=0.686 P=0.264 P=0.504N | |LOGISTIC REGRESSION | P=0.414N P=0.108 P=0.344 (e) | P=0.398N P=0.686 P=0.329 P=0.504N | |COCHRAN-ARMITAGE | P=0.417N | P=0.465N | |FISHER EXACT | P=0.098 P=0.321 (e) | P=0.517 P=0.224 P=0.589N | |=================================================================================================================================| | | |Harderian Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 7/131 (5%) 2/60 (3%) 0/62 (0%) 2/100 (2%) | 5/142 (4%) 2/62 (3%) 7/63 (11%) 2/99 (2%) | |ADJUSTED (b) | 11.3% 5.1% 0.0% 2.7% | 7.0% 5.3% 18.4% 3.7% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/2 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 1/10 (10%) | 0/10 (0%) 0/8 (0%) 1/10 (10%) 0/9 (0%) | |TERMINAL (d) | 4/58 (7%) 2/39 (5%) 0/37 (0%) 1/65 (2%) | 2/53 (4%) 2/38 (5%) 5/34 (15%) 1/52 (2%) | |FIRST INCIDENCE (DAYS) | 698 729 (T) --- 458 (I) | 420 729 (T) 459 (I) 712 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.034N* P=0.224N P=0.043N* P=0.069N | P=0.428N P=0.431N P=0.123 P=0.286N | |INCIDENTAL TUMOR | P=0.073N P=0.335N P=0.088N P=0.161N | P=0.552 P=0.586N P=0.058 P=0.483N | |LOGISTIC REGRESSION | P=0.058N P=0.256N P=0.051N P=0.129N | P=0.532N P=0.561N P=0.049 * P=0.365N | |COCHRAN-ARMITAGE | P=0.074N | P=0.551N | |FISHER EXACT | P=0.422N P=0.063N P=0.170N | P=0.639N P=0.039 * P=0.395N | |=================================================================================================================================| DATE: 09/17/94 EXPERIMENT: 05131 TEST: 02 PAGE 4 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SODIUM FLUORIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | SPECIAL 25 PPM 100 PPM 175 PPM | SPECIAL 25 PPM 100 PPM 175 PPM | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Harderian Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 8/131 (6%) 3/60 (5%) 0/62 (0%) 3/100 (3%) | 6/142 (4%) 3/62 (5%) 7/63 (11%) 2/99 (2%) | |ADJUSTED (b) | 13.0% 7.1% 0.0% 4.2% | 8.8% 7.5% 18.4% 3.7% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/2 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 1/10 (10%) | 0/10 (0%) 0/8 (0%) 1/10 (10%) 0/9 (0%) | |TERMINAL (d) | 5/58 (9%) 2/39 (5%) 0/37 (0%) 2/65 (3%) | 3/53 (6%) 2/38 (5%) 5/34 (15%) 1/52 (2%) | |FIRST INCIDENCE (DAYS) | 698 540 --- 458 (I) | 420 648 459 (I) 712 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.041N* P=0.298N P=0.028N* P=0.083N | P=0.282N P=0.499N P=0.187 P=0.188N | |INCIDENTAL TUMOR | P=0.094N P=0.486N P=0.058N P=0.176N | P=0.414N P=0.603 P=0.102 P=0.338N | |LOGISTIC REGRESSION | P=0.073N P=0.382N P=0.034N* P=0.157N | P=0.379N P=0.640N P=0.085 P=0.259N | |COCHRAN-ARMITAGE | P=0.090N | P=0.402N | |FISHER EXACT | P=0.527N P=0.042N* P=0.218N | P=0.550 P=0.064 P=0.290N | |=================================================================================================================================| | | |Intestine Small: Duodenum | | Polyp Adenomatous | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/131 (0%) 0/60 (0%) 2/62 (3%) 1/100 (1%) | 0/142 (0%) 0/62 (0%) 0/63 (0%) 0/99 (0%) | |ADJUSTED (b) | 0.0% 0.0% 5.4% 1.5% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/2 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | 0/10 (0%) 0/8 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 0/58 (0%) 0/39 (0%) 2/37 (5%) 1/65 (2%) | 0/53 (0%) 0/38 (0%) 0/34 (0%) 0/52 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 729 (T) 729 (T) | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.227 (e) P=0.147 P=0.523 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.227 (e) P=0.147 P=0.523 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.227 (e) P=0.147 P=0.523 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.166 | (e) | |FISHER EXACT | (e) P=0.102 P=0.433 | (e) (e) (e) | |=================================================================================================================================| DATE: 09/17/94 EXPERIMENT: 05131 TEST: 02 PAGE 5 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SODIUM FLUORIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | SPECIAL 25 PPM 100 PPM 175 PPM | SPECIAL 25 PPM 100 PPM 175 PPM | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Islets, Pancreatic | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/130 (0%) 0/60 (0%) 0/62 (0%) 2/100 (2%) | 1/140 (1%) 1/62 (2%) 1/62 (2%) 1/99 (1%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 3.1% | 1.9% 2.2% 2.9% 1.9% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/2 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | 0/10 (0%) 0/8 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 0/58 (0%) 0/39 (0%) 0/37 (0%) 2/65 (3%) | 1/53 (2%) 0/38 (0%) 1/34 (3%) 1/52 (2%) | |FIRST INCIDENCE (DAYS) | --- --- --- 729 (T) | 729 (T) 617 729 (T) 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.074 (e) (e) P=0.264 | P=0.597 P=0.658 P=0.659 P=0.757 | |INCIDENTAL TUMOR | P=0.074 (e) (e) P=0.264 | P=0.568 P=0.583 P=0.659 P=0.757 | |LOGISTIC REGRESSION | P=0.074 (e) (e) P=0.264 | P=0.563 P=0.611 P=0.659 P=0.757 | |COCHRAN-ARMITAGE | P=0.052 | P=0.538 | |FISHER EXACT | (e) (e) P=0.188 | P=0.521 P=0.521 P=0.658 | |=================================================================================================================================| | | |Liver | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/131 (4%) 1/60 (2%) 2/62 (3%) 3/100 (3%) | 3/142 (2%) 0/62 (0%) 0/63 (0%) 1/99 (1%) | |ADJUSTED (b) | 5.8% 2.6% 5.4% 4.0% | 4.0% 0.0% 0.0% 1.9% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/2 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 2/10 (20%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | 0/10 (0%) 0/8 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 1/58 (2%) 1/39 (3%) 2/37 (5%) 1/65 (2%) | 1/53 (2%) 0/38 (0%) 0/34 (0%) 1/52 (2%) | |FIRST INCIDENCE (DAYS) | 458 (I) 729 (T) 729 (T) 386 | 518 --- --- 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.405N P=0.197N P=0.409N P=0.390N | P=0.297N P=0.234N P=0.256N P=0.369N | |INCIDENTAL TUMOR | P=0.543 P=0.292N P=0.530N P=0.639 | P=0.399N P=0.350N P=0.345N P=0.513N | |LOGISTIC REGRESSION | P=0.506N P=0.387N P=0.580N P=0.526N | P=0.331N P=0.295N P=0.291N P=0.432N | |COCHRAN-ARMITAGE | P=0.504N | P=0.334N | |FISHER EXACT | P=0.387N P=0.599N P=0.517N | P=0.335N P=0.330N P=0.456N | |=================================================================================================================================| DATE: 09/17/94 EXPERIMENT: 05131 TEST: 02 PAGE 6 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SODIUM FLUORIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | SPECIAL 25 PPM 100 PPM 175 PPM | SPECIAL 25 PPM 100 PPM 175 PPM | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Liver | | Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/131 (0%) 1/60 (2%) 1/62 (2%) 3/100 (3%) | 0/142 (0%) 1/62 (2%) 0/63 (0%) 2/99 (2%) | |ADJUSTED (b) | 0.0% 2.6% 2.7% 4.4% | 0.0% 2.6% 0.0% 3.2% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/2 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | 0/10 (0%) 0/8 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 0/58 (0%) 1/39 (3%) 1/37 (3%) 1/65 (2%) | 0/53 (0%) 1/38 (3%) 0/34 (0%) 0/52 (0%) | |FIRST INCIDENCE (DAYS) | --- 729 (T) 729 (T) 705 | --- 729 (T) --- 477 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.101 P=0.421 P=0.410 P=0.142 | P=0.174 P=0.434 (e) P=0.192 | |INCIDENTAL TUMOR | P=0.041 * P=0.421 P=0.410 P=0.030 * | P=0.072 P=0.434 (e) P=0.030 * | |LOGISTIC REGRESSION | P=0.082 P=0.421 P=0.410 P=0.109 | P=0.150 P=0.434 (e) P=0.164 | |COCHRAN-ARMITAGE | P=0.059 | P=0.150 | |FISHER EXACT | P=0.314 P=0.321 P=0.080 | P=0.304 (e) P=0.168 | |=================================================================================================================================| | | |Liver | | Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 69/131 (53%) 39/60 (65%) 32/62 (52%) 58/100 (58%)| 61/142 (43%) 32/62 (52%) 26/63 (41%) 36/99 (36%) | |ADJUSTED (b) | 81.1% 76.1% 75.7% 79.1% | 82.5% 70.4% 62.6% 61.6% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/2 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 4/10 (40%) 5/10 (50%) 2/9 (22%) 5/10 (50%) | 3/10 (30%) 4/8 (50%) 3/10 (30%) 2/9 (22%) | |TERMINAL (d) | 43/58 (74%) 27/39 (69%) 27/37 (73%) 50/65 (77%) | 41/53 (77%) 25/38 (66%) 19/34 (56%) 30/52 (58%) | |FIRST INCIDENCE (DAYS) | 420 458 (I) 459 (I) 458 (I) | 358 458 (I) 458 (I) 459 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.024N* P=0.148N P=0.031N* P=0.026N* | P=0.001N** P=0.044N* P=0.011N* P=0.001N** | |INCIDENTAL TUMOR | P=0.300N P=0.428 P=0.150N P=0.423N | P=0.009N** P=0.250N P=0.067N P=0.014N* | |LOGISTIC REGRESSION | P=0.476N P=0.294 P=0.292N P=0.472 | P=0.034N* P=0.562N P=0.181N P=0.050N* | |COCHRAN-ARMITAGE | P=0.412 | P=0.091N | |FISHER EXACT | P=0.075 P=0.506N P=0.251 | P=0.161 P=0.472N P=0.186N | |=================================================================================================================================| DATE: 09/17/94 EXPERIMENT: 05131 TEST: 02 PAGE 7 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SODIUM FLUORIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | SPECIAL 25 PPM 100 PPM 175 PPM | SPECIAL 25 PPM 100 PPM 175 PPM | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 32/131 (24%) 15/60 (25%) 14/62 (23%) 15/100 (15%)| 17/142 (12%) 11/62 (18%) 8/63 (13%) 13/99 (13%) | |ADJUSTED (b) | 41.1% 33.9% 31.2% 20.6% | 26.1% 27.5% 20.7% 23.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/2 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 1/9 (11%) 0/10 (0%) | 0/10 (0%) 0/8 (0%) 0/10 (0%) 1/9 (11%) | |TERMINAL (d) | 15/58 (26%) 10/39 (26%) 7/37 (19%) 8/65 (12%) | 9/53 (17%) 9/38 (24%) 5/34 (15%) 10/52 (19%) | |FIRST INCIDENCE (DAYS) | 519 624 459 (I) 529 | 602 678 527 459 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.006N** P=0.188N P=0.194N P=0.005N** | P=0.276N P=0.539N P=0.353N P=0.360N | |INCIDENTAL TUMOR | P=0.167N P=0.495 P=0.550 P=0.204N | P=0.504N P=0.319 P=0.554 P=0.553 | |LOGISTIC REGRESSION | P=0.100N P=0.545N P=0.477N P=0.135N | P=0.428N P=0.426 P=0.501N P=0.566N | |COCHRAN-ARMITAGE | P=0.041N* | P=0.514N | |FISHER EXACT | P=0.534 P=0.465N P=0.054N | P=0.188 P=0.525 P=0.469 | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 32/131 (24%) 16/60 (27%) 14/62 (23%) 17/100 (17%)| 17/142 (12%) 12/62 (19%) 8/63 (13%) 15/99 (15%) | |ADJUSTED (b) | 41.1% 36.1% 31.2% 23.2% | 26.1% 30.0% 20.7% 25.5% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/2 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 1/9 (11%) 0/10 (0%) | 0/10 (0%) 0/8 (0%) 0/10 (0%) 1/9 (11%) | |TERMINAL (d) | 15/58 (26%) 11/39 (28%) 7/37 (19%) 9/65 (14%) | 9/53 (17%) 10/38 (26%) 5/34 (15%) 10/52 (19%) | |FIRST INCIDENCE (DAYS) | 519 624 459 (I) 529 | 602 678 527 459 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.011N* P=0.245N P=0.194N P=0.012N* | P=0.398N P=0.530 P=0.353N P=0.528N | |INCIDENTAL TUMOR | P=0.265N P=0.403 P=0.550 P=0.359N | P=0.384 P=0.234 P=0.554 P=0.308 | |LOGISTIC REGRESSION | P=0.161N P=0.515 P=0.477N P=0.238N | P=0.486 P=0.323 P=0.501N P=0.398 | |COCHRAN-ARMITAGE | P=0.076N | P=0.411 | |FISHER EXACT | P=0.436 P=0.465N P=0.113N | P=0.122 P=0.525 P=0.299 | |=================================================================================================================================| DATE: 09/17/94 EXPERIMENT: 05131 TEST: 02 PAGE 8 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SODIUM FLUORIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | SPECIAL 25 PPM 100 PPM 175 PPM | SPECIAL 25 PPM 100 PPM 175 PPM | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 84/131 (64%) 44/60 (73%) 40/62 (65%) 66/100 (66%)| 68/142 (48%) 37/62 (60%) 29/63 (46%) 44/99 (44%) | |ADJUSTED (b) | 89.0% 84.4% 84.9% 83.4% | 86.4% 80.0% 66.7% 73.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/2 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 4/10 (40%) 5/10 (50%) 3/9 (33%) 5/10 (50%) | 3/10 (30%) 4/8 (50%) 3/10 (30%) 3/9 (33%) | |TERMINAL (d) | 48/58 (83%) 31/39 (79%) 30/37 (81%) 52/65 (80%) | 43/53 (81%) 29/38 (76%) 20/34 (59%) 36/52 (69%) | |FIRST INCIDENCE (DAYS) | 420 458 (I) 459 (I) 458 (I) | 358 458 (I) 458 (I) 459 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.006N** P=0.043N* P=0.031N* P=0.004N** | P=0.003N** P=0.057N P=0.009N** P=0.003N** | |INCIDENTAL TUMOR | P=0.379N P=0.555 P=0.329N P=0.472N | P=0.029N* P=0.417N P=0.085N P=0.048N* | |LOGISTIC REGRESSION | P=0.308N P=0.545 P=0.318N P=0.395N | P=0.071N P=0.452 P=0.157N P=0.128N | |COCHRAN-ARMITAGE | P=0.489N | P=0.166N | |FISHER EXACT | P=0.137 P=0.545 P=0.438 | P=0.081 P=0.463N P=0.346N | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 84/131 (64%) 44/60 (73%) 40/62 (65%) 66/100 (66%)| 68/142 (48%) 37/62 (60%) 29/63 (46%) 45/99 (45%) | |ADJUSTED (b) | 89.0% 84.4% 84.9% 83.4% | 86.4% 80.0% 66.7% 73.4% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/2 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 4/10 (40%) 5/10 (50%) 3/9 (33%) 5/10 (50%) | 3/10 (30%) 4/8 (50%) 3/10 (30%) 3/9 (33%) | |TERMINAL (d) | 48/58 (83%) 31/39 (79%) 30/37 (81%) 52/65 (80%) | 43/53 (81%) 29/38 (76%) 20/34 (59%) 36/52 (69%) | |FIRST INCIDENCE (DAYS) | 420 458 (I) 459 (I) 458 (I) | 358 458 (I) 458 (I) 459 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.006N** P=0.043N* P=0.031N* P=0.004N** | P=0.005N** P=0.057N P=0.009N** P=0.006N** | |INCIDENTAL TUMOR | P=0.379N P=0.555 P=0.329N P=0.472N | P=0.049N* P=0.417N P=0.085N P=0.083N | |LOGISTIC REGRESSION | P=0.308N P=0.545 P=0.318N P=0.395N | P=0.102N P=0.452 P=0.157N P=0.181N | |COCHRAN-ARMITAGE | P=0.489N | P=0.206N | |FISHER EXACT | P=0.137 P=0.545 P=0.438 | P=0.081 P=0.463N P=0.405N | |=================================================================================================================================| DATE: 09/17/94 EXPERIMENT: 05131 TEST: 02 PAGE 9 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SODIUM FLUORIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | SPECIAL 25 PPM 100 PPM 175 PPM | SPECIAL 25 PPM 100 PPM 175 PPM | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 13/131 (10%) 4/60 (7%) 13/62 (21%) 11/100 (11%)| 7/142 (5%) 4/62 (6%) 2/63 (3%) 4/99 (4%) | |ADJUSTED (b) | 20.8% 10.3% 32.4% 16.6% | 10.7% 9.6% 5.9% 7.7% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/2 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 1/10 (10%) 0/10 (0%) 1/9 (11%) 0/10 (0%) | 0/10 (0%) 0/8 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 11/58 (19%) 4/39 (10%) 11/37 (30%) 10/65 (15%) | 3/53 (6%) 2/38 (5%) 2/34 (6%) 4/52 (8%) | |FIRST INCIDENCE (DAYS) | 459 (I) 729 (T) 459 (I) 691 | 456 617 729 (T) 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.491 P=0.102N P=0.151 P=0.316N | P=0.216N P=0.550N P=0.269N P=0.319N | |INCIDENTAL TUMOR | P=0.412 P=0.114N P=0.109 P=0.395N | P=0.353N P=0.422 P=0.414N P=0.505N | |LOGISTIC REGRESSION | P=0.299 P=0.189N P=0.051 P=0.514N | P=0.290N P=0.564 P=0.354N P=0.436N | |COCHRAN-ARMITAGE | P=0.208 | P=0.328N | |FISHER EXACT | P=0.332N P=0.033 * P=0.478 | P=0.442 P=0.440N P=0.502N | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 16/131 (12%) 9/60 (15%) 1/62 (2%) 7/100 (7%) | 3/142 (2%) 2/62 (3%) 2/63 (3%) 3/99 (3%) | |ADJUSTED (b) | 23.1% 21.7% 2.7% 10.4% | 5.1% 5.3% 5.6% 5.8% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/2 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | 0/10 (0%) 0/8 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 10/58 (17%) 7/39 (18%) 1/37 (3%) 6/65 (9%) | 1/53 (2%) 2/38 (5%) 1/34 (3%) 3/52 (6%) | |FIRST INCIDENCE (DAYS) | 433 656 729 (T) 593 | 691 729 (T) 724 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.006N** P=0.453N P=0.006N** P=0.031N* | P=0.534 P=0.669N P=0.655 P=0.637 | |INCIDENTAL TUMOR | P=0.025N* P=0.467 P=0.011N* P=0.130N | P=0.411 P=0.549 P=0.469 P=0.505 | |LOGISTIC REGRESSION | P=0.016N* P=0.552 P=0.010N* P=0.088N | P=0.495 P=0.636 P=0.607 P=0.587 | |COCHRAN-ARMITAGE | P=0.028N* | P=0.414 | |FISHER EXACT | P=0.375 P=0.010N** P=0.138N | P=0.481 P=0.488 P=0.478 | |=================================================================================================================================| DATE: 09/17/94 EXPERIMENT: 05131 TEST: 02 PAGE 10 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SODIUM FLUORIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | SPECIAL 25 PPM 100 PPM 175 PPM | SPECIAL 25 PPM 100 PPM 175 PPM | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 29/131 (22%) 13/60 (22%) 14/62 (23%) 18/100 (18%)| 10/142 (7%) 6/62 (10%) 4/63 (6%) 7/99 (7%) | |ADJUSTED (b) | 42.1% 31.5% 35.0% 26.7% | 15.3% 14.7% 11.4% 13.5% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/2 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 1/10 (10%) 0/10 (0%) 1/9 (11%) 0/10 (0%) | 0/10 (0%) 0/8 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 21/58 (36%) 11/39 (28%) 12/37 (32%) 16/65 (25%) | 4/53 (8%) 4/38 (11%) 3/34 (9%) 7/52 (13%) | |FIRST INCIDENCE (DAYS) | 433 656 459 (I) 593 | 456 617 724 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.038N* P=0.125N P=0.225N P=0.026N* | P=0.280N P=0.537N P=0.324N P=0.364N | |INCIDENTAL TUMOR | P=0.119N P=0.270N P=0.358N P=0.109N | P=0.477N P=0.349 P=0.570N P=0.604 | |LOGISTIC REGRESSION | P=0.146N P=0.300N P=0.479N P=0.129N | P=0.382N P=0.515 P=0.438N P=0.509N | |COCHRAN-ARMITAGE | P=0.256N | P=0.452N | |FISHER EXACT | P=0.551N P=0.541 P=0.272N | P=0.349 P=0.560N P=0.592 | |=================================================================================================================================| | | |Ovary | | Cystadenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | | 3/139 (2%) 1/60 (2%) 0/63 (0%) 2/99 (2%) | |ADJUSTED (b) | | 5.7% 2.8% 0.0% 3.2% | |INTERIM SACRIFICE 1 (c)| | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| | 0/10 (0%) 0/8 (0%) 0/10 (0%) 1/9 (11%) | |TERMINAL (d) | | 3/53 (6%) 1/36 (3%) 0/34 (0%) 1/52 (2%) | |FIRST INCIDENCE (DAYS) | | 729 (T) 729 (T) --- 459 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.398N P=0.451N P=0.210N P=0.516N | |INCIDENTAL TUMOR | | P=0.398N P=0.451N P=0.210N P=0.516N | |LOGISTIC REGRESSION | | P=0.472N P=0.451N P=0.210N P=0.625N | |COCHRAN-ARMITAGE | | P=0.489N | |FISHER EXACT | | P=0.649N P=0.324N P=0.656N | |=================================================================================================================================| DATE: 09/17/94 EXPERIMENT: 05131 TEST: 02 PAGE 11 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SODIUM FLUORIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | SPECIAL 25 PPM 100 PPM 175 PPM | SPECIAL 25 PPM 100 PPM 175 PPM | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/123 (0%) 0/59 (0%) 0/59 (0%) 0/95 (0%) | 28/141 (20%) 7/61 (11%) 8/63 (13%) 13/98 (13%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 42.3% 17.4% 23.5% 24.3% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/2 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | 0/10 (0%) 0/8 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 0/53 (0%) 0/38 (0%) 0/36 (0%) 0/61 (0%) | 18/53 (34%) 5/37 (14%) 8/34 (24%) 12/52 (23%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 528 534 729 (T) 606 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.030N* P=0.008N** P=0.023N* P=0.014N* | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.080N P=0.038N* P=0.057N P=0.050N* | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.066N P=0.026N* P=0.051N P=0.045N* | |COCHRAN-ARMITAGE | (e) | P=0.131N | |FISHER EXACT | (e) (e) (e) | P=0.105N P=0.149N P=0.123N | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Fibrosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/131 (1%) 0/60 (0%) 0/62 (0%) 0/100 (0%) | 4/142 (3%) 2/62 (3%) 0/63 (0%) 5/99 (5%) | |ADJUSTED (b) | 1.0% 0.0% 0.0% 0.0% | 6.0% 4.3% 0.0% 9.3% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/2 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | 0/10 (0%) 0/8 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 0/58 (0%) 0/39 (0%) 0/37 (0%) 0/65 (0%) | 1/53 (2%) 1/38 (3%) 0/34 (0%) 4/52 (8%) | |FIRST INCIDENCE (DAYS) | 523 --- --- --- | 603 395 --- 705 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.320N P=0.636N P=0.640N P=0.546N | P=0.385 P=0.575N P=0.160N P=0.455 | |INCIDENTAL TUMOR | P=0.451N P=0.952N P=0.860N P=0.734N | P=0.219 P=0.528 P=0.268N P=0.260 | |LOGISTIC REGRESSION | P=0.326N P=0.709N P=0.665N P=0.564N | P=0.307 P=0.652 P=0.184N P=0.356 | |COCHRAN-ARMITAGE | P=0.323N | P=0.292 | |FISHER EXACT | P=0.686N P=0.679N P=0.567N | P=0.591 P=0.227N P=0.286 | |=================================================================================================================================| DATE: 09/17/94 EXPERIMENT: 05131 TEST: 02 PAGE 12 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SODIUM FLUORIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | SPECIAL 25 PPM 100 PPM 175 PPM | SPECIAL 25 PPM 100 PPM 175 PPM | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/131 (2%) 1/60 (2%) 0/62 (0%) 2/100 (2%) | 1/142 (1%) 0/62 (0%) 0/63 (0%) 0/99 (0%) | |ADJUSTED (b) | 2.1% 2.6% 0.0% 2.9% | 1.7% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/2 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | 0/10 (0%) 0/8 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 0/58 (0%) 1/39 (3%) 0/37 (0%) 1/65 (2%) | 0/53 (0%) 0/38 (0%) 0/34 (0%) 0/52 (0%) | |FIRST INCIDENCE (DAYS) | 496 729 (T) --- 684 | 713 --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.572N P=0.698N P=0.402N P=0.658 | P=0.308N P=0.591N P=0.602N P=0.525N | |INCIDENTAL TUMOR | P=0.406 P=0.588 P=0.547N P=0.361 | P=0.418N P=0.791N P=0.757N P=0.701N | |LOGISTIC REGRESSION | P=0.551 P=0.701 P=0.431N P=0.595 | P=0.317N P=0.610N P=0.622N P=0.540N | |COCHRAN-ARMITAGE | P=0.547 | P=0.335N | |FISHER EXACT | P=0.680 P=0.460N P=0.582 | P=0.696N P=0.693N P=0.589N | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Neurofibrosarcoma, Fibrosarcoma, Sarcoma, | | Neurofibroma, or Fibroma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/131 (1%) 0/60 (0%) 0/62 (0%) 0/100 (0%) | 4/142 (3%) 2/62 (3%) 0/63 (0%) 6/99 (6%) | |ADJUSTED (b) | 1.0% 0.0% 0.0% 0.0% | 6.0% 4.3% 0.0% 10.6% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/2 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | 0/10 (0%) 0/8 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 0/58 (0%) 0/39 (0%) 0/37 (0%) 0/65 (0%) | 1/53 (2%) 1/38 (3%) 0/34 (0%) 4/52 (8%) | |FIRST INCIDENCE (DAYS) | 523 --- --- --- | 603 395 --- 566 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.320N P=0.636N P=0.640N P=0.546N | P=0.242 P=0.575N P=0.160N P=0.318 | |INCIDENTAL TUMOR | P=0.451N P=0.952N P=0.860N P=0.734N | P=0.110 P=0.528 P=0.268N P=0.141 | |LOGISTIC REGRESSION | P=0.326N P=0.709N P=0.665N P=0.564N | P=0.178 P=0.652 P=0.184N P=0.219 | |COCHRAN-ARMITAGE | P=0.323N | P=0.171 | |FISHER EXACT | P=0.686N P=0.679N P=0.567N | P=0.591 P=0.227N P=0.180 | |=================================================================================================================================| DATE: 09/17/94 EXPERIMENT: 05131 TEST: 02 PAGE 13 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SODIUM FLUORIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | SPECIAL 25 PPM 100 PPM 175 PPM | SPECIAL 25 PPM 100 PPM 175 PPM | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Neurofibrosarcoma, Fibrosarcoma, or Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/131 (1%) 0/60 (0%) 0/62 (0%) 0/100 (0%) | 4/142 (3%) 2/62 (3%) 0/63 (0%) 6/99 (6%) | |ADJUSTED (b) | 1.0% 0.0% 0.0% 0.0% | 6.0% 4.3% 0.0% 10.6% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/2 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | 0/10 (0%) 0/8 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 0/58 (0%) 0/39 (0%) 0/37 (0%) 0/65 (0%) | 1/53 (2%) 1/38 (3%) 0/34 (0%) 4/52 (8%) | |FIRST INCIDENCE (DAYS) | 523 --- --- --- | 603 395 --- 566 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.320N P=0.636N P=0.640N P=0.546N | P=0.242 P=0.575N P=0.160N P=0.318 | |INCIDENTAL TUMOR | P=0.451N P=0.952N P=0.860N P=0.734N | P=0.110 P=0.528 P=0.268N P=0.141 | |LOGISTIC REGRESSION | P=0.326N P=0.709N P=0.665N P=0.564N | P=0.178 P=0.652 P=0.184N P=0.219 | |COCHRAN-ARMITAGE | P=0.323N | P=0.171 | |FISHER EXACT | P=0.686N P=0.679N P=0.567N | P=0.591 P=0.227N P=0.180 | |=================================================================================================================================| | | |Stomach, Forestomach | | Squamous Cell Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/131 (2%) 0/60 (0%) 0/62 (0%) 1/100 (1%) | 3/142 (2%) 4/62 (6%) 2/63 (3%) 4/99 (4%) | |ADJUSTED (b) | 2.2% 0.0% 0.0% 1.5% | 5.0% 10.5% 5.9% 6.6% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/2 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | 0/10 (0%) 0/8 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 0/58 (0%) 0/39 (0%) 0/37 (0%) 1/65 (2%) | 2/53 (4%) 4/38 (11%) 2/34 (6%) 2/52 (4%) | |FIRST INCIDENCE (DAYS) | 523 --- --- 729 (T) | 644 729 (T) 729 (T) 477 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.456N P=0.385N P=0.398N P=0.529N | P=0.510 P=0.309 P=0.649 P=0.427 | |INCIDENTAL TUMOR | P=0.617 P=0.708N P=0.547N P=0.719 | P=0.424 P=0.263 P=0.603 P=0.280 | |LOGISTIC REGRESSION | P=0.495N P=0.452N P=0.424N P=0.591N | P=0.425 P=0.232 P=0.597 P=0.334 | |COCHRAN-ARMITAGE | P=0.495N | P=0.396 | |FISHER EXACT | P=0.469N P=0.460N P=0.600N | P=0.127 P=0.488 P=0.309 | |=================================================================================================================================| DATE: 09/17/94 EXPERIMENT: 05131 TEST: 02 PAGE 14 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SODIUM FLUORIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | SPECIAL 25 PPM 100 PPM 175 PPM | SPECIAL 25 PPM 100 PPM 175 PPM | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/131 (2%) 1/60 (2%) 3/62 (5%) 2/100 (2%) | 6/142 (4%) 0/62 (0%) 0/63 (0%) 2/99 (2%) | |ADJUSTED (b) | 3.1% 2.6% 8.1% 3.1% | 8.5% 0.0% 0.0% 3.6% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/2 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | 0/10 (0%) 0/8 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 1/58 (2%) 1/39 (3%) 3/37 (8%) 2/65 (3%) | 2/53 (4%) 0/38 (0%) 0/34 (0%) 0/52 (0%) | |FIRST INCIDENCE (DAYS) | 684 729 (T) 729 (T) 729 (T) | 420 --- --- 707 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.509 P=0.650N P=0.290 P=0.663N | P=0.167N P=0.068N P=0.079N P=0.196N | |INCIDENTAL TUMOR | P=0.449 P=0.722N P=0.223 P=0.636 | P=0.362N P=0.150N P=0.145N P=0.488N | |LOGISTIC REGRESSION | P=0.462 P=0.688N P=0.245 P=0.672 | P=0.206N P=0.098N P=0.101N P=0.262N | |COCHRAN-ARMITAGE | P=0.374 | P=0.214N | |FISHER EXACT | P=0.680 P=0.190 P=0.582 | P=0.110N P=0.107N P=0.290N | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/131 (2%) 1/60 (2%) 3/62 (5%) 2/100 (2%) | 6/142 (4%) 1/62 (2%) 0/63 (0%) 2/99 (2%) | |ADJUSTED (b) | 3.1% 2.6% 8.1% 3.1% | 8.5% 1.9% 0.0% 3.6% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/2 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | 0/10 (0%) 1/8 (13%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 1/58 (2%) 1/39 (3%) 3/37 (8%) 2/65 (3%) | 2/53 (4%) 0/38 (0%) 0/34 (0%) 0/52 (0%) | |FIRST INCIDENCE (DAYS) | 684 729 (T) 729 (T) 729 (T) | 420 459 (I) --- 707 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.509 P=0.650N P=0.290 P=0.663N | P=0.126N P=0.173N P=0.079N P=0.196N | |INCIDENTAL TUMOR | P=0.449 P=0.722N P=0.223 P=0.636 | P=0.282N P=0.326N P=0.145N P=0.488N | |LOGISTIC REGRESSION | P=0.462 P=0.688N P=0.245 P=0.672 | P=0.168N P=0.284N P=0.101N P=0.262N | |COCHRAN-ARMITAGE | P=0.374 | P=0.171N | |FISHER EXACT | P=0.680 P=0.190 P=0.582 | P=0.317N P=0.107N P=0.290N | |=================================================================================================================================| DATE: 09/17/94 EXPERIMENT: 05131 TEST: 02 PAGE 15 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SODIUM FLUORIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | SPECIAL 25 PPM 100 PPM 175 PPM | SPECIAL 25 PPM 100 PPM 175 PPM | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Uterus | | Hemangioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 2/142 (1%) 0/62 (0%) 0/63 (0%) 0/99 (0%) | |ADJUSTED (b) | | 3.6% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| | 0/10 (0%) 0/8 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | | 1/53 (2%) 0/38 (0%) 0/34 (0%) 0/52 (0%) | |FIRST INCIDENCE (DAYS) | | 722 --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.134N P=0.322N P=0.341N P=0.250N | |INCIDENTAL TUMOR | | P=0.184N P=0.435N P=0.435N P=0.347N | |LOGISTIC REGRESSION | | P=0.140N P=0.344N P=0.360N P=0.262N | |COCHRAN-ARMITAGE | | P=0.167N | |FISHER EXACT | | P=0.483N P=0.479N P=0.346N | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 3/142 (2%) 1/62 (2%) 1/63 (2%) 1/99 (1%) | |ADJUSTED (b) | | 4.7% 2.6% 2.5% 1.2% | |INTERIM SACRIFICE 1 (c)| | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| | 1/10 (10%) 0/8 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | | 2/53 (4%) 1/38 (3%) 0/34 (0%) 0/52 (0%) | |FIRST INCIDENCE (DAYS) | | 459 (I) 729 (T) 653 349 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.274N P=0.420N P=0.443N P=0.356N | |INCIDENTAL TUMOR | | P=0.314N P=0.420N P=0.502N P=0.357N | |LOGISTIC REGRESSION | | P=0.336N P=0.571N P=0.590N P=0.443N | |COCHRAN-ARMITAGE | | P=0.336N | |FISHER EXACT | | P=0.645N P=0.639N P=0.456N | |=================================================================================================================================| DATE: 09/17/94 EXPERIMENT: 05131 TEST: 02 PAGE 16 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SODIUM FLUORIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | SPECIAL 25 PPM 100 PPM 175 PPM | SPECIAL 25 PPM 100 PPM 175 PPM | | | CONTROL | CONTROL | |=================================================================================================================================| | | |Uterus | | Sarcoma Stromal or Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 3/142 (2%) 1/62 (2%) 1/63 (2%) 2/99 (2%) | |ADJUSTED (b) | | 4.7% 2.6% 2.5% 3.1% | |INTERIM SACRIFICE 1 (c)| | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| | 1/10 (10%) 0/8 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | | 2/53 (4%) 1/38 (3%) 0/34 (0%) 1/52 (2%) | |FIRST INCIDENCE (DAYS) | | 459 (I) 729 (T) 653 349 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.486N P=0.420N P=0.443N P=0.550N | |INCIDENTAL TUMOR | | P=0.526N P=0.420N P=0.502N P=0.551N | |LOGISTIC REGRESSION | | P=0.563N P=0.571N P=0.590N P=0.657N | |COCHRAN-ARMITAGE | | P=0.564N | |FISHER EXACT | | P=0.645N P=0.639N P=0.665N | |=================================================================================================================================| | | |All Organs | | Hemangioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/131 (0%) 1/60 (2%) 0/62 (0%) 0/100 (0%) | 4/142 (3%) 2/62 (3%) 0/63 (0%) 2/99 (2%) | |ADJUSTED (b) | 0.0% 2.6% 0.0% 0.0% | 6.6% 5.3% 0.0% 3.7% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/2 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | 0/10 (0%) 0/8 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 0/58 (0%) 1/39 (3%) 0/37 (0%) 0/65 (0%) | 2/53 (4%) 2/38 (5%) 0/34 (0%) 1/52 (2%) | |FIRST INCIDENCE (DAYS) | --- 729 (T) --- --- | 592 729 (T) --- 709 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.403N P=0.421 (e) (e) | P=0.214N P=0.527N P=0.149N P=0.381N | |INCIDENTAL TUMOR | P=0.403N P=0.421 (e) (e) | P=0.303N P=0.651N P=0.216N P=0.555N | |LOGISTIC REGRESSION | P=0.403N P=0.421 (e) (e) | P=0.253N P=0.618N P=0.178N P=0.453N | |COCHRAN-ARMITAGE | P=0.452N | P=0.291N | |FISHER EXACT | P=0.314 (e) (e) | P=0.591 P=0.227N P=0.522N | |=================================================================================================================================| DATE: 09/17/94 EXPERIMENT: 05131 TEST: 02 PAGE 17 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SODIUM FLUORIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | SPECIAL 25 PPM 100 PPM 175 PPM | SPECIAL 25 PPM 100 PPM 175 PPM | | | CONTROL | CONTROL | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 7/131 (5%) 5/60 (8%) 4/62 (6%) 6/100 (6%) | 7/142 (5%) 3/62 (5%) 4/63 (6%) 1/99 (1%) | |ADJUSTED (b) | 7.7% 12.1% 10.1% 8.3% | 9.5% 7.7% 11.4% 1.9% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/2 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 2/10 (20%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | 1/10 (10%) 0/8 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 1/58 (2%) 4/39 (10%) 3/37 (8%) 3/65 (5%) | 2/53 (4%) 2/38 (5%) 3/34 (9%) 1/52 (2%) | |FIRST INCIDENCE (DAYS) | 458 (I) 619 579 386 | 458 (I) 698 724 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.401N P=0.560 P=0.578N P=0.539N | P=0.060N P=0.387N P=0.567N P=0.056N | |INCIDENTAL TUMOR | P=0.395 P=0.301 P=0.509 P=0.302 | P=0.133N P=0.632N P=0.501 P=0.130N | |LOGISTIC REGRESSION | P=0.543N P=0.317 P=0.507 P=0.522 | P=0.094N P=0.556N P=0.531 P=0.089N | |COCHRAN-ARMITAGE | P=0.539 | P=0.108N | |FISHER EXACT | P=0.310 P=0.494 P=0.524 | P=0.641N P=0.452 P=0.092N | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma or Hemangioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 7/131 (5%) 6/60 (10%) 4/62 (6%) 6/100 (6%) | 11/142 (8%) 5/62 (8%) 4/63 (6%) 3/99 (3%) | |ADJUSTED (b) | 7.7% 14.6% 10.1% 8.3% | 15.6% 12.8% 11.4% 5.6% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/2 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 2/10 (20%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | 1/10 (10%) 0/8 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 1/58 (2%) 5/39 (13%) 3/37 (8%) 3/65 (5%) | 4/53 (8%) 4/38 (11%) 3/34 (9%) 2/52 (4%) | |FIRST INCIDENCE (DAYS) | 458 (I) 619 579 386 | 458 (I) 698 724 709 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.342N P=0.420 P=0.578N P=0.539N | P=0.032N* P=0.327N P=0.251N P=0.047N* | |INCIDENTAL TUMOR | P=0.465 P=0.189 P=0.509 P=0.302 | P=0.090N P=0.591N P=0.451N P=0.145N | |LOGISTIC REGRESSION | P=0.486N P=0.197 P=0.507 P=0.522 | P=0.057N P=0.515N P=0.392N P=0.086N | |COCHRAN-ARMITAGE | P=0.495N | P=0.073N | |FISHER EXACT | P=0.188 P=0.494 P=0.524 | P=0.569 P=0.488N P=0.101N | |=================================================================================================================================| DATE: 09/17/94 EXPERIMENT: 05131 TEST: 02 PAGE 18 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SODIUM FLUORIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | SPECIAL 25 PPM 100 PPM 175 PPM | SPECIAL 25 PPM 100 PPM 175 PPM | | | CONTROL | CONTROL | |=================================================================================================================================| | | |All Organs | | Histiocytic Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/131 (2%) 0/60 (0%) 2/62 (3%) 2/100 (2%) | 5/142 (4%) 3/62 (5%) 2/63 (3%) 5/99 (5%) | |ADJUSTED (b) | 2.6% 0.0% 5.1% 2.9% | 7.4% 7.2% 4.9% 8.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/2 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | 0/10 (0%) 0/8 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 1/58 (2%) 0/39 (0%) 1/37 (3%) 1/65 (2%) | 2/53 (4%) 2/38 (5%) 0/34 (0%) 1/52 (2%) | |FIRST INCIDENCE (DAYS) | 359 --- 651 623 | 562 584 587 584 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.390 P=0.364N P=0.481 P=0.677 | P=0.466 P=0.617N P=0.497N P=0.512 | |INCIDENTAL TUMOR | P=0.215 P=0.456N P=0.380 P=0.455 | P=0.265 P=0.494 P=0.618 P=0.281 | |LOGISTIC REGRESSION | P=0.322 P=0.466N P=0.410 P=0.593 | P=0.190 P=0.564 P=0.568N P=0.195 | |COCHRAN-ARMITAGE | P=0.319 | P=0.386 | |FISHER EXACT | P=0.469N P=0.386 P=0.582 | P=0.459 P=0.631N P=0.393 | |=================================================================================================================================| | | |All Organs | | Malignant Lymphoma And Histiocytic Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 7/131 (5%) 1/60 (2%) 8/62 (13%) 3/100 (3%) | 17/142 (12%) 8/62 (13%) 13/63 (21%) 24/99 (24%) | |ADJUSTED (b) | 9.8% 2.6% 20.9% 4.4% | 26.8% 19.3% 33.2% 38.4% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/2 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | 0/10 (0%) 0/8 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 3/58 (5%) 1/39 (3%) 7/37 (19%) 2/65 (3%) | 10/53 (19%) 6/38 (16%) 9/34 (26%) 15/52 (29%) | |FIRST INCIDENCE (DAYS) | 359 729 (T) 651 623 | 562 584 379 241 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.363N P=0.126N P=0.152 P=0.167N | P=0.024 * P=0.261N P=0.322 P=0.092 | |INCIDENTAL TUMOR | P=0.517 P=0.236N P=0.069 P=0.454N | P=0.002 ** P=0.511N P=0.112 P=0.010 * | |LOGISTIC REGRESSION | P=0.495N P=0.186N P=0.082 P=0.268N | P=0.005 ** P=0.434N P=0.160 P=0.017 * | |COCHRAN-ARMITAGE | P=0.540N | P=0.004 ** | |FISHER EXACT | P=0.223N P=0.065 P=0.299N | P=0.509 P=0.082 P=0.011 * | |=================================================================================================================================| DATE: 09/17/94 EXPERIMENT: 05131 TEST: 02 PAGE 19 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SODIUM FLUORIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | SPECIAL 25 PPM 100 PPM 175 PPM | SPECIAL 25 PPM 100 PPM 175 PPM | | | CONTROL | CONTROL | |=================================================================================================================================| | | |All Organs | | Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, | | NOS, or Undifferentiated Cell Type | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 5/131 (4%) 1/60 (2%) 6/62 (10%) 1/100 (1%) | 12/142 (8%) 5/62 (8%) 11/63 (17%) 19/99 (19%) | |ADJUSTED (b) | 7.4% 2.6% 16.2% 1.5% | 20.3% 12.4% 29.7% 32.6% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/2 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) | 0/10 (0%) 0/8 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 2/58 (3%) 1/39 (3%) 6/37 (16%) 1/65 (2%) | 8/53 (15%) 4/38 (11%) 9/34 (26%) 14/52 (27%) | |FIRST INCIDENCE (DAYS) | 591 729 (T) 729 (T) 729 (T) | 652 587 379 241 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.224N P=0.244N P=0.200 P=0.101N | P=0.016 * P=0.237N P=0.223 P=0.088 | |INCIDENTAL TUMOR | P=0.335N P=0.382N P=0.119 P=0.247N | P=0.003 ** P=0.399N P=0.103 P=0.020 * | |LOGISTIC REGRESSION | P=0.295N P=0.299N P=0.134 P=0.147N | P=0.004 ** P=0.352N P=0.111 P=0.023 * | |COCHRAN-ARMITAGE | P=0.364N | P=0.003 ** | |FISHER EXACT | P=0.387N P=0.098 P=0.182N | P=0.584N P=0.053 P=0.013 * | |=================================================================================================================================| | | |All Organs | | Osteosarcoma or Osteoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/131 (0%) 1/60 (2%) 0/62 (0%) 0/100 (0%) | 2/142 (1%) 0/62 (0%) 0/63 (0%) 0/99 (0%) | |ADJUSTED (b) | 0.0% 1.7% 0.0% 0.0% | 2.7% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/2 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 0/10 (0%) 1/10 (10%) 0/9 (0%) 0/10 (0%) | 0/10 (0%) 0/8 (0%) 0/10 (0%) 0/9 (0%) | |TERMINAL (d) | 0/58 (0%) 0/39 (0%) 0/37 (0%) 0/65 (0%) | 1/53 (2%) 0/38 (0%) 0/34 (0%) 0/52 (0%) | |FIRST INCIDENCE (DAYS) | --- 458 (I) --- --- | 420 --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.432N P=0.500 (e) (e) | P=0.149N P=0.357N P=0.374N P=0.282N | |INCIDENTAL TUMOR | P=0.432N P=0.500 (e) (e) | P=0.208N P=0.451N P=0.443N P=0.402N | |LOGISTIC REGRESSION | P=0.453N P=0.252 (e) (e) | P=0.167N P=0.444N P=0.435N P=0.322N | |COCHRAN-ARMITAGE | P=0.452N | P=0.167N | |FISHER EXACT | P=0.314 (e) (e) | P=0.483N P=0.479N P=0.346N | |=================================================================================================================================| DATE: 09/17/94 EXPERIMENT: 05131 TEST: 02 PAGE 20 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SODIUM FLUORIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | SPECIAL 25 PPM 100 PPM 175 PPM | SPECIAL 25 PPM 100 PPM 175 PPM | | | CONTROL | CONTROL | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 79/131 (60%) 45/60 (75%) 38/62 (61%) 62/100 (62%)| 81/142 (57%) 38/62 (61%) 32/63 (51%) 48/99 (48%) | |ADJUSTED (b) | 88.2% 88.0% 86.0% 83.6% | 93.8% 78.7% 73.8% 74.5% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/2 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 5/10 (50%) 5/10 (50%) 3/9 (33%) 5/10 (50%) | 4/10 (40%) 4/8 (50%) 3/10 (30%) 3/9 (33%) | |TERMINAL (d) | 48/58 (83%) 33/39 (85%) 31/37 (84%) 53/65 (82%) | 48/53 (91%) 28/38 (74%) 23/34 (68%) 36/52 (69%) | |FIRST INCIDENCE (DAYS) | 420 458 (I) 459 (I) 458 (I) | 358 458 (I) 458 (I) 349 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.002N** P=0.117N P=0.026N* P=0.002N** | P<0.001N** P=0.004N** P<0.001N** P<0.001N** | |INCIDENTAL TUMOR | P=0.087N P=0.369 P=0.211N P=0.190N | P=0.012N* P=0.111N P=0.014N* P=0.015N* | |LOGISTIC REGRESSION | P=0.216N P=0.217 P=0.374N P=0.384N | P=0.020N* P=0.254N P=0.039N* P=0.030N* | |COCHRAN-ARMITAGE | P=0.395N | P=0.058N | |FISHER EXACT | P=0.034 * P=0.512 P=0.451 | P=0.341 P=0.249N P=0.119N | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 57/131 (44%) 32/60 (53%) 26/62 (42%) 33/100 (33%)| 44/142 (31%) 26/62 (42%) 25/63 (40%) 45/99 (45%) | |ADJUSTED (b) | 62.0% 65.1% 56.3% 42.8% | 55.7% 57.1% 59.0% 63.9% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/2 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 2/10 (20%) 1/10 (10%) 1/9 (11%) 0/10 (0%) | 1/10 (10%) 1/8 (13%) 0/10 (0%) 1/9 (11%) | |TERMINAL (d) | 25/58 (43%) 22/39 (56%) 17/37 (46%) 21/65 (32%) | 21/53 (40%) 19/38 (50%) 17/34 (50%) 27/52 (52%) | |FIRST INCIDENCE (DAYS) | 359 458 (I) 459 (I) 386 | 420 395 379 241 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001N** P=0.290N P=0.118N P=0.002N** | P=0.214 P=0.358N P=0.450N P=0.283 | |INCIDENTAL TUMOR | P=0.129N P=0.087 P=0.523 P=0.348N | P=0.006 ** P=0.190 P=0.160 P=0.005 ** | |LOGISTIC REGRESSION | P=0.043N* P=0.237 P=0.400N P=0.114N | P=0.024 * P=0.301 P=0.309 P=0.023 * | |COCHRAN-ARMITAGE | P=0.024N* | P=0.023 * | |FISHER EXACT | P=0.134 P=0.481N P=0.068N | P=0.088 P=0.146 P=0.016 * | |=================================================================================================================================| DATE: 09/17/94 EXPERIMENT: 05131 TEST: 02 PAGE 21 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- SODIUM FLUORIDE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | SPECIAL 25 PPM 100 PPM 175 PPM | SPECIAL 25 PPM 100 PPM 175 PPM | | | CONTROL | CONTROL | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) |101/131 (77%) 51/60 (85%) 47/62 (76%) 74/100 (74%)| 94/142 (66%) 45/62 (73%) 40/63 (63%) 65/99 (66%) | |ADJUSTED (b) | 94.3% 94.4% 93.9% 90.2% | 96.8% 88.0% 84.8% 86.5% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/0 0/2 (0%) 0/10 (0%) | 0/10 (0%) 0/2 (0%) 0/3 (0%) 0/10 (0%) | |INTERIM SACRIFICE 2 (c)| 6/10 (60%) 6/10 (60%) 4/9 (44%) 5/10 (50%) | 5/10 (50%) 4/8 (50%) 3/10 (30%) 4/9 (44%) | |TERMINAL (d) | 52/58 (90%) 36/39 (92%) 34/37 (92%) 57/65 (88%) | 50/53 (94%) 32/38 (84%) 27/34 (79%) 42/52 (81%) | |FIRST INCIDENCE (DAYS) | 359 458 (I) 459 (I) 386 | 358 395 379 241 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001N** P=0.012N* P=0.011N* P<0.001N** | P=0.015N* P=0.004N** P=0.002N** P=0.010N** | |INCIDENTAL TUMOR | P=0.166N P=0.537 P=0.294N P=0.335N | P=0.338N P=0.229N P=0.061N P=0.381N | |LOGISTIC REGRESSION | P=0.069N P=0.539N P=0.181N P=0.118N | P=0.302N P=0.321N P=0.076N P=0.400N | |COCHRAN-ARMITAGE | P=0.182N | P=0.355N | |FISHER EXACT | P=0.143 P=0.489N P=0.347N | P=0.232 P=0.412N P=0.519N | |=================================================================================================================================| (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): 165 458 Female interim sacrifices(days): 165 458 (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 157538-157538/157538 --multipart-boundary--