TDMS Study 92013-05 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Southern Research Inst 4-METHYLIMIDAZOLE DATE: 12/06/04 EXPERIMENT: 92013 TEST: 05 TIME: 08:46:17 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01-ES-85420 ROUTE: DOSED FEED NTP C#: 92013B PATHOLOGIST: FARNELL, DANIEL R. CAS: 822-36-6 ------------------------------------------------------------------------------------------------------------------------------------ FINAL #1 RATS REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Southern Research Inst 4-METHYLIMIDAZOLE DATE: 12/06/04 EXPERIMENT: 92013 TEST: 05 TIME: 08:46:17 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-85420 ROUTE: DOSED FEED NTP C#: 92013B PATHOLOGIST: FARNELL, DANIEL R. CAS: 822-36-6 4-METHYLIMIDAZOLE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 19 CENSORED DEATHS 0 TERMINAL 31 | | | | UNCENSORED DEATHS | | 464 547 582 589 597 642 653 667 667 685 | | 685 700 700 700 705 709 712 722 723 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 625 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 16 CENSORED DEATHS 0 TERMINAL 34 | | | | UNCENSORED DEATHS | | 275 275 477 516 547 567 577 593 621 637 | | 665 694 695 700 700 712 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 1250 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 17 CENSORED DEATHS 0 TERMINAL 33 | | | | UNCENSORED DEATHS | | 493 498 531 538 594 605 635 642 642 650 | | 653 694 700 700 706 712 717 | | CENSORED DEATHS | | NONE | | | ================================================================================== 4-METHYLIMIDAZOLE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 2500 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 18 CENSORED DEATHS 0 TERMINAL 32 | | | | UNCENSORED DEATHS | | 369 384 584 607 622 622 628 632 650 650 | | 651 653 663 666 670 689 693 704 | | CENSORED DEATHS | | NONE | | | ================================================================================== 4-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) | | | |--------------------------------------------------------------------------------| | | | |0 PPM | 100.0 100.0 100.0 100.0 100.0 98.0 98.0 90.0 86.0 62.0 | | | | | | | |625 PPM | 100.0 100.0 100.0 96.0 96.0 94.0 92.0 84.0 78.0 68.0 | | | | | | | |1250 PPM | 100.0 100.0 100.0 100.0 100.0 100.0 92.0 88.0 78.0 66.0 | | | | | | | |2500 PPM | 100.0 100.0 100.0 100.0 96.0 96.0 96.0 94.0 74.0 64.0 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | 0 PPM 625 PPM 1250 PPM 2500 PPM | | | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 62.0% 68.0% 66.0% 64.0% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.964 P=0.842N P=0.926N P=1.000 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 655.2 578.2 630.0 618.7 | |NATURAL DEATHS (C) | (16.0) (34.6) (18.3) (22.0) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 701.0 680.7 695.3 689.3 | |(STANDARD ERROR) | ( 7.9) (14.8) ( 9.1) (10.8) | | | | ================================================================================== (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) 4-METHYLIMIDAZOLE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 7 CENSORED DEATHS 0 TERMINAL 43 | | | | UNCENSORED DEATHS | | 16 302 498 624 667 694 700 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 1250 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 11 CENSORED DEATHS 0 TERMINAL 39 | | | | UNCENSORED DEATHS | | 421 434 463 536 636 653 657 677 700 705 | | 712 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 2500 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 16 CENSORED DEATHS 0 TERMINAL 34 | | | | UNCENSORED DEATHS | | 104 383 552 555 578 581 619 635 636 638 | | 653 672 693 700 700 728 | | CENSORED DEATHS | | NONE | | | ================================================================================== 4-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 15 CENSORED DEATHS 0 TERMINAL 35 | | | | UNCENSORED DEATHS | | 323 368 538 541 541 628 642 642 654 666 | | 686 688 705 712 717 | | CENSORED DEATHS | | NONE | | | ================================================================================== 4-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) | | | |--------------------------------------------------------------------------------| | | | |0 PPM | 98.0 98.0 98.0 96.0 96.0 96.0 94.0 94.0 92.0 86.0 | | | | | | | |1250 PPM | 100.0 100.0 100.0 100.0 98.0 94.0 92.0 92.0 86.0 78.0 | | | | | | | |2500 PPM | 100.0 98.0 98.0 98.0 96.0 96.0 96.0 88.0 78.0 68.0 | | | | | | | |5000 PPM | 100.0 100.0 100.0 98.0 96.0 96.0 90.0 90.0 82.0 70.0 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | 0 PPM 1250 PPM 2500 PPM 5000 PPM | | | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 86.0% 78.0% 68.0% 70.0% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.078 P=0.449 P=0.060 P=0.099 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 500.1 599.5 589.2 603.4 | |NATURAL DEATHS (C) | (96.9) (34.3) (38.4) (31.3) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 697.0 700.5 684.3 691.3 | |(STANDARD ERROR) | (17.0) (10.6) (15.2) (12.3) | | | | ================================================================================== (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) 4-METHYLIMIDAZOLE KAPLAN-MEIER SURVIVAL CURVES 0 PPM = 1 625 PPM = 2 1250 PPM = 3 2500 PPM = 4 ------------------------------------------------------ SPECIES=RATS SEX=MALE ------------------------------------------------------- Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | 100 + 1 2 4 1 3 | | 4 4 1 33 1 | 96 + 2 4 2 3 3 1 1 | | 2 2 33 1 1 4 | 92 + 2 3 2 114 4 | | 2 2 313 1 | P 88 + 2 2 3 4431 1 E | R | 2 2 433 1 1 C | E 84 + 2 2 4 4 N | T | 2 233 1 1 | S 80 + 2 33 2 U | R | 43 2 1 1 V | I 76 + 4 4 V | A | 44 L | 72 + 11 | | 4 4211 | 68 + 23 2 | | 4 4131 3 | 64 + 4 4 | | 1 1 | 60 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 16 obs hidden. 4-METHYLIMIDAZOLE KAPLAN-MEIER SURVIVAL CURVES 0 PPM = 1 1250 PPM = 2 2500 PPM = 3 5000 PPM = 4 ----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------ Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 1 3 4 2 | | 1 3 1 4 4 3 22 | 96 + 1 4 3 2 2 1 4 3 | | 2 1 2433 1 | P 92 + 2 3 3 12 1 E | R | 4 42 2 1 1 C | E 88 + 3 34 4 N | T | 3 3 2 2 1 1 | S 84 + 4 4 2 2 U | R | 33 4 4 22 V | I 80 + 3 3 4 4 22 V | A | 3 3 44 2 2 L | 76 + 3 3 4 | | 3344 | 72 + 44 | | 3 43 4 | 68 + 3 3 | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 5 obs hidden.