TDMS Study 92012-06 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Southern Research Inst 2-METHYLIMIDAZOLE DATE: 02/25/03 EXPERIMENT: 92012 TEST: 06 TIME: 07:42:42 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01-ES-85420 ROUTE: DOSED FEED NTP C#: 92012B PATHOLOGIST: HEATH, JAMES E. CAS: 693-98-1 ------------------------------------------------------------------------------------------------------------------------------------ FINAL#1/MICE REASONS FOR REMOVAL: 25019 Moribund Sacrifice 25020 Natural Death 25021 Terminal Sacrifice REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Southern Research Inst 2-METHYLIMIDAZOLE DATE: 02/25/03 EXPERIMENT: 92012 TEST: 06 TIME: 07:42:42 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-85420 ROUTE: DOSED FEED NTP C#: 92012B PATHOLOGIST: HEATH, JAMES E. CAS: 693-98-1 2-METHYLIMIDAZOLE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 7 CENSORED DEATHS 0 TERMINAL 43 | | | | UNCENSORED DEATHS | | 24 611 650 657 668 668 694 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 625 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 4 CENSORED DEATHS 0 TERMINAL 46 | | | | UNCENSORED DEATHS | | 40 657 696 726 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 1250 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 14 CENSORED DEATHS 0 TERMINAL 36 | | | | UNCENSORED DEATHS | | 7 7 7 21 22 400 512 531 611 623 | | 654 659 706 718 | | CENSORED DEATHS | | NONE | | | ================================================================================== 2-METHYLIMIDAZOLE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 2500 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 10 CENSORED DEATHS 0 TERMINAL 40 | | | | UNCENSORED DEATHS | | 7 7 7 21 531 654 656 693 695 701 | | CENSORED DEATHS | | NONE | | | ================================================================================== 2-METHYLIMIDAZOLE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 729 DAYS ================================================================================== | KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) | | | |--------------------------------------------------------------------------------| | DOSE TIME (DAYS) | | 90 180 270 365 425 485 545 605 665 729 (A) | | | |--------------------------------------------------------------------------------| | | | |0PPM | 98.0 98.0 98.0 98.0 98.0 98.0 98.0 98.0 92.0 86.0 | | | | | | | |625 PPM | 98.0 98.0 98.0 98.0 98.0 98.0 98.0 98.0 96.0 92.0 | | | | | | | |1250 PPM | 90.0 90.0 90.0 90.0 88.0 88.0 84.0 84.0 76.0 72.0 | | | | | | | |2500 PPM | 92.0 92.0 92.0 92.0 92.0 92.0 90.0 90.0 86.0 80.0 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | 0PPM 625 PPM 1250 PPM 2500 PPM | | | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 86.0% 92.0% 72.0% 80.0% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.197 P=0.497N P=0.111 P=0.557 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 567.4 529.8 391.3 397.2 | |NATURAL DEATHS (C) | (91.1) ( 164) (81.2) ( 106) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 706.4 713.1 634.4 662.6 | |(STANDARD ERROR) | (14.4) (13.8) (31.0) (27.8) | | | | ================================================================================== (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) 2-METHYLIMIDAZOLE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 4 CENSORED DEATHS 0 TERMINAL 46 | | | | UNCENSORED DEATHS | | 402 533 651 723 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 625 PPM | | --------------------- | | | | TOTAL 49 UNCENSORED DEATHS 6 CENSORED DEATHS 0 TERMINAL 43 | | | | UNCENSORED DEATHS | | 400 606 620 639 688 720 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 1250 PPM | | --------------------- | | | | TOTAL 49 UNCENSORED DEATHS 6 CENSORED DEATHS 0 TERMINAL 43 | | | | UNCENSORED DEATHS | | 128 555 623 658 693 720 | | CENSORED DEATHS | | NONE | | | ================================================================================== 2-METHYLIMIDAZOLE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 2500 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 5 CENSORED DEATHS 0 TERMINAL 45 | | | | UNCENSORED DEATHS | | 517 604 664 720 727 | | CENSORED DEATHS | | NONE | | | ================================================================================== 2-METHYLIMIDAZOLE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 729 DAYS ================================================================================== | KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) | | | |--------------------------------------------------------------------------------| | DOSE TIME (DAYS) | | 90 180 270 365 425 485 545 605 665 729 (A) | | | |--------------------------------------------------------------------------------| | | | |0PPM | 100.0 100.0 100.0 100.0 98.0 98.0 96.0 96.0 94.0 92.0 | | | | | | | |625 PPM | 100.0 100.0 100.0 100.0 98.0 98.0 98.0 98.0 91.8 87.8 | | | | | | | |1250 PPM | 100.0 98.0 98.0 98.0 98.0 98.0 98.0 95.9 91.8 87.8 | | | | | | | |2500 PPM | 100.0 100.0 100.0 100.0 100.0 100.0 98.0 96.0 94.0 90.0 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | 0PPM 625 PPM 1250 PPM 2500 PPM | | | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 92.0% 87.8% 87.8% 90.0% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.989 P=0.703 P=0.708 P=1.000 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 577.3 612.2 562.8 646.4 | |NATURAL DEATHS (C) | (70.3) (45.9) (90.1) (39.2) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 716.9 714.7 708.7 720.7 | |(STANDARD ERROR) | ( 7.7) ( 7.6) (12.9) ( 5.0) | | | | ================================================================================== (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) 2-METHYLIMIDAZOLE KAPLAN-MEIER SURVIVAL CURVES 0PPM = 1 625 PPM = 2 1250 PPM = 3 2500 PPM = 4 ------------------------------------------------------ SPECIES=MICE SEX=MALE ------------------------------------------------------- Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 13 1 2 | | 1 2 1 2 | 96 + 1 12 2 | P | 3 3 11 2 2 E | R 92 + 33 4 1 1 2 2 C | E | 3 3 4 4 N | T 88 + 3 3 1 1 | S | 3 3 4 41 1 U | R 84 + 3 3 44 V | I | 33 44 V | A 80 + 3 3 4 4 L | | 3 3 | 76 + 3 3 | | 3 3 | 72 + 3 3 | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 7 obs hidden. 2-METHYLIMIDAZOLE KAPLAN-MEIER SURVIVAL CURVES 0PPM = 1 625 PPM = 2 1250 PPM = 3 2500 PPM = 4 ----------------------------------------------------- SPECIES=MICE SEX=FEMALE ------------------------------------------------------ Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 3 1 4 | | | 98 + 3 1 4 1 3 2 | P | E | R 96 + 1 3 2 2 1 4 C | E | N | T 94 + 2 213 4 41 | S | U | R 92 + 2 3 2 41 1 V | I | V | A 90 + 2 24 4 L | | | 88 + 2 2 | | | 86 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 15 obs hidden.