TDMS Study 05069-06 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Mason 1,2-DIHYDRO-2,2,4-TRIMETHYLQUINOLINE DATE: 10/14/93 EXPERIMENT: 05069 TEST: 06 TIME: 15:50:46 TEST TYPE: INIT/PROMOT CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01-ES-95256 ROUTE: DERMAL,SOLUTION NTP C#: 60902B PATHOLOGIST: M.E.P. GOAD CAS: 147-47-7 ------------------------------------------------------------------------------------------------------------------------------------ 52 WEEK INITATION PROMOTION REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE 007 TMQ/TPA INCLUDE 010 ACETONE/TPA NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Mason 1,2-DIHYDRO-2,2,4-TRIMETHYLQUINOLINE DATE: 10/14/93 EXPERIMENT: 05069 TEST: 06 TIME: 15:50:46 TEST TYPE: INIT/PROMOT CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-95256 ROUTE: DERMAL,SOLUTION NTP C#: 60902B PATHOLOGIST: M.E.P. GOAD CAS: 147-47-7 MICE(SENCAR) ---------------------------- 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. ---------------- Clitoral Gland Gallbladder Kidney Liver Lung Ovary Spleen Thymus DATE: 10/14/93 EXPERIMENT: 05069 TEST: 06 PAGE 1 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE MICE(SENCAR) -- 1,2-DIHYDRO-2,2,4-TRIMETHYLQUINOLINE TERMINAL SACRIFICE AT 54 WEEKS |==============================================================================| |DOSE | ACETONE/ TMQ/TPA | | | TPA | |==============================================================================| | | |Liver | | Hepatocellular Adenoma | | | |------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 1/30 (3%) 2/30 (7%) | |ADJUSTED (b) | 3.6% 8.0% | |TERMINAL (d) | 0/25 (0%) 2/25 (8%) | |FIRST INCIDENCE (DAYS) | 313 372 (T) | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.496 | |INCIDENTAL TUMOR | P=0.500 | |LOGISTIC REGRESSION | P=0.501 | |COCHRAN-ARMITAGE | | |FISHER EXACT | P=0.500 | |==============================================================================| | | |Skin | | Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma | | | |------------------------------------------------------------------------------| |TUMOR RATES | # # | |----------- | | |OVERALL (a) | 3/30 (10%) 5/30 (17%) | |ADJUSTED (b) | 11.3% 20.0% | |TERMINAL (d) | 2/25 (8%) 5/25 (20%) | |FIRST INCIDENCE (DAYS) | 313 372 (T) | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.352 | |INCIDENTAL TUMOR | P=0.354 | |LOGISTIC REGRESSION | P=0.339 | |COCHRAN-ARMITAGE | | |FISHER EXACT | P=0.353 | |==============================================================================| DATE: 10/14/93 EXPERIMENT: 05069 TEST: 06 PAGE 2 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE MICE(SENCAR) -- 1,2-DIHYDRO-2,2,4-TRIMETHYLQUINOLINE TERMINAL SACRIFICE AT 54 WEEKS |==============================================================================| |DOSE | ACETONE/ TMQ/TPA | | | TPA | |==============================================================================| | | |Skin | | Squamous Cell Papilloma | | | |------------------------------------------------------------------------------| |TUMOR RATES | # # | |----------- | | |OVERALL (a) | 3/30 (10%) 4/30 (13%) | |ADJUSTED (b) | 11.3% 16.0% | |TERMINAL (d) | 2/25 (8%) 4/25 (16%) | |FIRST INCIDENCE (DAYS) | 313 372 (T) | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.497 | |INCIDENTAL TUMOR | P=0.500 | |LOGISTIC REGRESSION | P=0.489 | |COCHRAN-ARMITAGE | | |FISHER EXACT | P=0.500 | |==============================================================================| | | |Skin | | Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma, | | Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma | | | |------------------------------------------------------------------------------| |TUMOR RATES | # # | |----------- | | |OVERALL (a) | 3/30 (10%) 5/30 (17%) | |ADJUSTED (b) | 11.3% 20.0% | |TERMINAL (d) | 2/25 (8%) 5/25 (20%) | |FIRST INCIDENCE (DAYS) | 313 372 (T) | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.352 | |INCIDENTAL TUMOR | P=0.354 | |LOGISTIC REGRESSION | P=0.339 | |COCHRAN-ARMITAGE | | |FISHER EXACT | P=0.353 | |==============================================================================| DATE: 10/14/93 EXPERIMENT: 05069 TEST: 06 PAGE 3 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE MICE(SENCAR) -- 1,2-DIHYDRO-2,2,4-TRIMETHYLQUINOLINE TERMINAL SACRIFICE AT 54 WEEKS |==============================================================================| |DOSE | ACETONE/ TMQ/TPA | | | TPA | |==============================================================================| | | |All Organs | | Benign Tumors | | | |------------------------------------------------------------------------------| |TUMOR RATES | # # | |----------- | | |OVERALL (a) | 3/30 (10%) 6/30 (20%) | |ADJUSTED (b) | 11.3% 24.0% | |TERMINAL (d) | 2/25 (8%) 6/25 (24%) | |FIRST INCIDENCE (DAYS) | 313 372 (T) | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.236 | |INCIDENTAL TUMOR | P=0.238 | |LOGISTIC REGRESSION | P=0.221 | |COCHRAN-ARMITAGE | | |FISHER EXACT | P=0.236 | |==============================================================================| | | |All Organs | | Malignant Tumors | | | |------------------------------------------------------------------------------| |TUMOR RATES | # # | |----------- | | |OVERALL (a) | 2/30 (7%) 4/30 (13%) | |ADJUSTED (b) | 7.3% 14.1% | |TERMINAL (d) | 0/25 (0%) 1/25 (4%) | |FIRST INCIDENCE (DAYS) | 313 213 | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.330 | |INCIDENTAL TUMOR | P=0.303 | |LOGISTIC REGRESSION | P=0.332 | |COCHRAN-ARMITAGE | | |FISHER EXACT | P=0.335 | |==============================================================================| DATE: 10/14/93 EXPERIMENT: 05069 TEST: 06 PAGE 4 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE MICE(SENCAR) -- 1,2-DIHYDRO-2,2,4-TRIMETHYLQUINOLINE TERMINAL SACRIFICE AT 54 WEEKS |==============================================================================| |DOSE | ACETONE/ TMQ/TPA | | | TPA | |==============================================================================| | | |All Organs | | Malignant and Benign Tumors | | | |------------------------------------------------------------------------------| |TUMOR RATES | # # | |----------- | | |OVERALL (a) | 4/30 (13%) 10/30 (33%) | |ADJUSTED (b) | 14.7% 35.5% | |TERMINAL (d) | 2/25 (8%) 7/25 (28%) | |FIRST INCIDENCE (DAYS) | 313 213 | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.076 | |INCIDENTAL TUMOR | P=0.060 | |LOGISTIC REGRESSION | P=0.065 | |COCHRAN-ARMITAGE | | |FISHER EXACT | P=0.063 | |==============================================================================| (a) Number of tumor-bearing animals / number of animals examined at site. (b) Kaplan-Meier estimated lifetime tumor incidence after adjustment for intercurrent mortality. (d) Observed incidence at terminal kill. (f) Beneath the control incidence are the P-values associated with the trend test. Beneath the dosed group incidence are the P-values corresponding to pairwise comparisons between the controls and that dosed group. The life table analysis regards tumors in animals dying prior to terminal kill as being (directly or indirectly) the cause of death. The incidental tumor test regards these lesions as non-fatal. Logistic regression is an alternative method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage and Fisher's exact tests compare directly the overall incidence rates. For all tests, a negative trend is indicated by "N". (e) Value of Statistic cannot be computed. (I) Interim sacrifice (T) Terminal sacrifice # Tumor rates based on number of animals necropsied. * To the right of any statistical result, indicates significance at (P<=0.05). ** To the right of any statistical result, indicates significance at (P<=0.01).