TDMS Study 92012-05 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Southern Research Inst 2-METHYLIMIDAZOLE DATE: 02/24/03 EXPERIMENT: 92012 TEST: 05 TIME: 14:36:23 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01-ES-85420 ROUTE: DOSED FEED NTP C#: 92012B PATHOLOGIST: FARNELL, DANIEL R. CAS: 693-98-1 ------------------------------------------------------------------------------------------------------------------------------------ FINAL #1/RATS 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: 02/24/03 EXPERIMENT: 92012 TEST: 05 TIME: 14:36:23 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-85420 ROUTE: DOSED FEED NTP C#: 92012B PATHOLOGIST: FARNELL, DANIEL R. CAS: 693-98-1 2-METHYLIMIDAZOLE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 15 CENSORED DEATHS 0 TERMINAL 35 | | | | UNCENSORED DEATHS | | 315 572 603 638 643 651 668 680 689 694 | | 694 696 716 722 726 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 300 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 10 CENSORED DEATHS 0 TERMINAL 40 | | | | UNCENSORED DEATHS | | 507 521 548 572 605 608 660 668 675 693 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 1000 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 14 CENSORED DEATHS 0 TERMINAL 36 | | | | UNCENSORED DEATHS | | 392 439 471 538 548 583 641 644 668 673 | | 694 696 703 717 | | CENSORED DEATHS | | NONE | | | ================================================================================== 2-METHYLIMIDAZOLE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 3000 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 15 CENSORED DEATHS 0 TERMINAL 35 | | | | UNCENSORED DEATHS | | 249 395 491 562 574 598 598 605 618 687 | | 689 689 689 702 706 | | CENSORED DEATHS | | NONE | | | ================================================================================== 2-METHYLIMIDAZOLE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS 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 98.0 98.0 98.0 98.0 94.0 88.0 70.0 | | | | | | | |300 PPM | 100.0 100.0 100.0 100.0 100.0 100.0 96.0 90.0 86.0 80.0 | | | | | | | |1000 PPM | 100.0 100.0 100.0 100.0 98.0 94.0 92.0 88.0 84.0 72.0 | | | | | | | |3000 PPM | 100.0 100.0 98.0 98.0 96.0 96.0 94.0 84.0 82.0 70.0 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | 0PPM 300 PPM 1000 PPM 3000 PPM | | | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 70.0% 80.0% 72.0% 70.0% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.606 P=0.438N P=1.000N P=1.000 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 647.1 605.7 600.5 590.1 | |NATURAL DEATHS (C) | (26.2) (21.2) (28.6) (33.2) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 704.4 704.3 693.0 687.3 | |(STANDARD ERROR) | ( 9.4) ( 8.1) (11.3) (13.3) | | | | ================================================================================== (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 RATS FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 10 CENSORED DEATHS 0 TERMINAL 40 | | | | UNCENSORED DEATHS | | 328 583 588 602 605 616 653 658 671 703 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 1000 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 11 CENSORED DEATHS 0 TERMINAL 39 | | | | UNCENSORED DEATHS | | 425 483 483 538 538 598 638 638 680 680 | | 702 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 2500 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 22 CENSORED DEATHS 0 TERMINAL 28 | | | | UNCENSORED DEATHS | | 244 332 496 526 532 548 548 548 580 598 | | 605 638 638 641 646 665 668 680 701 702 | | 702 710 | | CENSORED DEATHS | | NONE | | | ================================================================================== 2-METHYLIMIDAZOLE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 5000 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 8 CENSORED DEATHS 0 TERMINAL 42 | | | | UNCENSORED DEATHS | | 434 638 644 675 689 696 722 722 | | CENSORED DEATHS | | NONE | | | ================================================================================== 2-METHYLIMIDAZOLE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS 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 98.0 98.0 98.0 98.0 90.0 84.0 80.0 | | | | | | | |1000 PPM | 100.0 100.0 100.0 100.0 98.0 94.0 90.0 88.0 84.0 78.0 | | | | | | | |2500 PPM | 100.0 100.0 98.0 96.0 96.0 96.0 90.0 78.0 68.0 56.0 | | | | | | | |5000 PPM | 100.0 100.0 100.0 100.0 100.0 98.0 98.0 98.0 94.0 84.0 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | 0PPM 1000 PPM 2500 PPM 5000 PPM | | | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 80.0% 78.0% 56.0% 84.0% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.821N P=0.958 P=0.016 P=0.697N | |(LIFE TABLE) | | | | | |MEAN DAY OF | 600.7 582.1 588.5 652.5 | |NATURAL DEATHS (C) | (32.7) (28.3) (25.1) (33.1) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 703.3 696.7 667.2 716.8 | |(STANDARD ERROR) | ( 9.7) (10.6) (14.8) ( 6.4) | | | | ================================================================================== (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 = 1 300 PPM = 2 1000 PPM = 3 3000 PPM = 4 ------------------------------------------------------ SPECIES=RATS SEX=MALE ------------------------------------------------------- Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 4 1 3 2 | | 4 1 34 3 2 2 1 | 4 3 3 4 2 2 1 1 P 95 + E | 3 4 3 2 42 1 1 R | 3 3 42 2 C | E 90 + 3 4 3 4 11 N | T | 3 2 31 21 | 44 21 1 S 85 + U | 4 4 3 2211 R | 4 32 11 V | I 80 + 3 23 2 V | A | L | 13 1 75 + | 4 3 11 | 3 3 | 70 + 4 1 1 | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 13 obs hidden. 2-METHYLIMIDAZOLE KAPLAN-MEIER SURVIVAL CURVES 0PPM = 1 1000 PPM = 2 2500 PPM = 3 5000 PPM = 4 ----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------ Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 3 1 24 | | 3 13 24 2 1 4 | 3 3 95 + | 2 3 32 1 1 4 4 | 11 4 4 | 90 + 32 3 211 44 | P | 2 1 2 1 4 4 E | R 85 + C | 3 3 2 1 1 2 4 4 E | 3 3 1 1 N | T 80 + 33 2 1 1 | S | 3 3 2 2 U | R 75 + V | I | 33 V | A 70 + 3 3 L | | 33 | 3 3 65 + | 3 3 | | 60 + | | 33 | 3 3 55 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 4 obs hidden.