TDMS Study 99036-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Battelle Columbus TRANSGENIC MODEL EVALUATION II (PHENOLPHTHALEIN) DATE: 04/21/04 EXPERIMENT: 99036 TEST: 01 TIME: 08:36:58 TEST TYPE: SUBCHRON 26-WEEK CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01-ES-65406 ROUTE: DOSED FEED NTP C#: C99036 PATHOLOGIST: MISSING CAS: 77-09-08 ------------------------------------------------------------------------------------------------------------------------------------ FINAL #1 MICE REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Battelle Columbus TRANSGENIC MODEL EVALUATION II (PHENOLPHTHALEIN) DATE: 04/21/04 EXPERIMENT: 99036 TEST: 01 TIME: 08:36:58 TEST TYPE: SUBCHRON 26-WEEK CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-65406 ROUTE: DOSED FEED NTP C#: C99036 PATHOLOGIST: MISSING CAS: 77-09-08 TRANSGENIC MODEL EVALUATION II (PHENOLPHTHALEIN) STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 183 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0 PPM | | --------------------- | | | | TOTAL 15 UNCENSORED DEATHS 2 CENSORED DEATHS 0 TERMINAL 13 | | | | UNCENSORED DEATHS | | 18 76 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 200 PPM | | --------------------- | | | | TOTAL 15 UNCENSORED DEATHS 0 CENSORED DEATHS 0 TERMINAL 15 | | | | UNCENSORED DEATHS | | NONE | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 375 PPM | | --------------------- | | | | TOTAL 15 UNCENSORED DEATHS 0 CENSORED DEATHS 0 TERMINAL 15 | | | | UNCENSORED DEATHS | | NONE | | CENSORED DEATHS | | NONE | | | ================================================================================== TRANSGENIC MODEL EVALUATION II (PHENOLPHTHALEIN) STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 183 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 750 PPM | | --------------------- | | | | TOTAL 15 UNCENSORED DEATHS 2 CENSORED DEATHS 0 TERMINAL 13 | | | | UNCENSORED DEATHS | | 18 43 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 3000 PPM | | --------------------- | | | | TOTAL 15 UNCENSORED DEATHS 0 CENSORED DEATHS 0 TERMINAL 15 | | | | UNCENSORED DEATHS | | NONE | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 12,000 PPM | | --------------------- | | | | TOTAL 15 UNCENSORED DEATHS 1 CENSORED DEATHS 0 TERMINAL 14 | | | | UNCENSORED DEATHS | | 30 | | CENSORED DEATHS | | NONE | | | ================================================================================== TRANSGENIC MODEL EVALUATION II (PHENOLPHTHALEIN) STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 183 DAYS ================================================================================== | KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) | | | |--------------------------------------------------------------------------------| | DOSE TIME (DAYS) | | 19 38 57 76 95 114 133 152 171 183 (A) | | | |--------------------------------------------------------------------------------| | | | |0 PPM | 93.3 93.3 93.3 93.3 86.7 86.7 86.7 86.7 86.7 86.7 | | | | | | | |200 PPM | 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 | | | | | | | |375 PPM | 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 | | | | | | | |750 PPM | 93.3 93.3 86.7 86.7 86.7 86.7 86.7 86.7 86.7 86.7 | | | | | | | |3000 PPM | 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 | | | | | | | |12,000 PPM| 100.0 93.3 93.3 93.3 93.3 93.3 93.3 93.3 93.3 93.3 | | | | | | | ================================================================================== TRANSGENIC MODEL EVALUATION II (PHENOLPHTHALEIN) STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 183 DAYS =============================================================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |-----------------------------------------------------------------------------------------------------------------------------| | DOSE | | | | 0 PPM 200 PPM 375 PPM 750 PPM 3000 PPM 12,000 PPM | | | |-----------------------------------------------------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 86.7% 100.0% 100.0% 86.7% 100.0% 93.3% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=1.000N P=0.464N P=0.464N P=1.000 P=0.464N P=0.984N | |(LIFE TABLE) | | | | | |MEAN DAY OF | 47.0 . . 30.5 . 30.0 | |NATURAL DEATHS (C) | (29.0) ( . ) ( . ) (12.5) ( . ) ( . ) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 164.9 183.0 183.0 162.7 183.0 172.8 | |(STANDARD ERROR) | (12.7) ( 0.0) ( 0.0) (13.9) ( 0.0) (10.2) | | | | =============================================================================================================================== (A) FIRST TERMINAL SACRIFICE (B) THE FIRST ENTRY IS THE TREND TEST (TARONE, 1975) RESULT. SUBSEQUENT ENTRIES ARE THE RESULTS OF PAIRWISE TESTS (COX,1972). NEGATIVE TRENDS ARE INDICATED BY "N". (C) MEAN OF ALL UNCENSORED DEATHS PRIOR TO TERMINAL SACRIFICE (D) MEAN OF ALL DEATHS (UNCENSORED, CENSORED, TERMINAL SACRIFICE) TRANSGENIC MODEL EVALUATION II (PHENOLPHTHALEIN) STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 184 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0 PPM | | --------------------- | | | | TOTAL 15 UNCENSORED DEATHS 0 CENSORED DEATHS 0 TERMINAL 15 | | | | UNCENSORED DEATHS | | NONE | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 200 PPM | | --------------------- | | | | TOTAL 15 UNCENSORED DEATHS 2 CENSORED DEATHS 0 TERMINAL 13 | | | | UNCENSORED DEATHS | | 13 21 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 375 PPM | | --------------------- | | | | TOTAL 15 UNCENSORED DEATHS 1 CENSORED DEATHS 0 TERMINAL 14 | | | | UNCENSORED DEATHS | | 15 | | CENSORED DEATHS | | NONE | | | ================================================================================== TRANSGENIC MODEL EVALUATION II (PHENOLPHTHALEIN) STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 184 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 750 PPM | | --------------------- | | | | TOTAL 15 UNCENSORED DEATHS 0 CENSORED DEATHS 0 TERMINAL 15 | | | | UNCENSORED DEATHS | | NONE | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 3000 PPM | | --------------------- | | | | TOTAL 15 UNCENSORED DEATHS 1 CENSORED DEATHS 0 TERMINAL 14 | | | | UNCENSORED DEATHS | | 26 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 12,000 PPM | | --------------------- | | | | TOTAL 15 UNCENSORED DEATHS 0 CENSORED DEATHS 0 TERMINAL 15 | | | | UNCENSORED DEATHS | | NONE | | CENSORED DEATHS | | NONE | | | ================================================================================== TRANSGENIC MODEL EVALUATION II (PHENOLPHTHALEIN) STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 184 DAYS ================================================================================== | KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) | | | |--------------------------------------------------------------------------------| | DOSE TIME (DAYS) | | 19 38 57 76 95 114 133 152 171 184 (A) | | | |--------------------------------------------------------------------------------| | | | |0 PPM | 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 | | | | | | | |200 PPM | 93.3 86.7 86.7 86.7 86.7 86.7 86.7 86.7 86.7 86.7 | | | | | | | |375 PPM | 93.3 93.3 93.3 93.3 93.3 93.3 93.3 93.3 93.3 93.3 | | | | | | | |750 PPM | 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 | | | | | | | |3000 PPM | 100.0 93.3 93.3 93.3 93.3 93.3 93.3 93.3 93.3 93.3 | | | | | | | |12,000 PPM| 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 | | | | | | | ================================================================================== TRANSGENIC MODEL EVALUATION II (PHENOLPHTHALEIN) STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 184 DAYS =============================================================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |-----------------------------------------------------------------------------------------------------------------------------| | DOSE | | | | 0 PPM 200 PPM 375 PPM 750 PPM 3000 PPM 12,000 PPM | | | |-----------------------------------------------------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 100.0% 86.7% 93.3% 100.0% 93.3% 100.0% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.746N P=0.464 P=1.000 ----- P=1.000 ----- | |(LIFE TABLE) | | | | | |MEAN DAY OF | . 17.0 15.0 . 26.0 . | |NATURAL DEATHS (C) | ( . ) ( 4.0) ( . ) ( . ) ( . ) ( . ) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 184.0 161.7 172.7 184.0 173.5 184.0 | |(STANDARD ERROR) | ( 0.0) (15.2) (11.3) ( 0.0) (10.5) ( 0.0) | | | | =============================================================================================================================== (A) FIRST TERMINAL SACRIFICE (B) THE FIRST ENTRY IS THE TREND TEST (TARONE, 1975) RESULT. SUBSEQUENT ENTRIES ARE THE RESULTS OF PAIRWISE TESTS (COX,1972). NEGATIVE TRENDS ARE INDICATED BY "N". (C) MEAN OF ALL UNCENSORED DEATHS PRIOR TO TERMINAL SACRIFICE (D) MEAN OF ALL DEATHS (UNCENSORED, CENSORED, TERMINAL SACRIFICE) TRANSGENIC MODEL EVALUATION II (PHENOLPHTHALEIN) KAPLAN-MEIER SURVIVAL CURVES 0 PPM = 1 200 PPM = 2 375 PPM = 3 750 PPM = 4 3000 PPM = 5 12,000 PPM = 6 ------------------------------------------------------ SPECIES=MICE SEX=MALE ------------------------------------------------------- Plot of SURVIVAL*WEEK. Symbol is value of DOSE. (NOTE: 10 obs hidden.) P | E | R 100.00 +1 1 6 2 C | E | N | T 93.33 + 1 6 4 1 6 | S | U | R 86.67 + 4 1 1 V | I -+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+ V 0.0 2.5 5.0 7.5 10.0 12.5 15.0 17.5 20.0 22.5 25.0 27.5 A WEEK TRANSGENIC MODEL EVALUATION II (PHENOLPHTHALEIN) KAPLAN-MEIER SURVIVAL CURVES 0 PPM = 1 200 PPM = 2 375 PPM = 3 750 PPM = 4 3000 PPM = 5 12,000 PPM = 6 ----------------------------------------------------- SPECIES=MICE SEX=FEMALE ------------------------------------------------------ Plot of SURVIVAL*WEEK. Symbol is value of DOSE. (NOTE: 9 obs hidden.) P | E | R 100.00 + 1 2 3 5 1 C | E | N | T 93.33 + 2 2 5 3 | S | U | R 86.67 + 2 2 V | I ---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+-- V 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 A WEEK