TDMS Study 88035-06 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Battelle Columbus PRIMACLONE DATE: 12/30/96 EXPERIMENT: 88035 TEST: 06 TIME: 17:03:36 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01-ES-05295 ROUTE: DOSED FEED NTP C#: C88035 PATHOLOGIST: PERSING, R. CAS: 0000125-33-7 ------------------------------------------------------------------------------------------------------------------------------------ REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: MERGE 001 001 0 PPM MERGE 002 002 0 PPM MERGE 003 003 300 PPM MERGE 004 004 300 PPM MERGE 005 005 600 PPM MERGE 006 006 600 PPM MERGE 007 007 1300 PPM MERGE 008 008 1300 PPM NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Battelle Columbus PRIMACLONE DATE: 12/30/96 EXPERIMENT: 88035 TEST: 06 TIME: 17:03:36 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-05295 ROUTE: DOSED FEED NTP C#: C88035 PATHOLOGIST: PERSING, R. CAS: 0000125-33-7 PRIMACLONE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 726 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 15 CENSORED DEATHS 0 TERMINAL 35 | | | | UNCENSORED DEATHS | | 432 511 526 551 552 573 576 578 583 635 | | 642 649 698 701 701 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 300 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 16 CENSORED DEATHS 0 TERMINAL 34 | | | | UNCENSORED DEATHS | | 603 603 614 617 617 617 636 639 642 643 | | 646 672 673 695 710 712 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 600 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 19 CENSORED DEATHS 0 TERMINAL 31 | | | | UNCENSORED DEATHS | | 422 566 575 578 602 614 619 621 625 643 | | 645 646 652 658 667 681 687 692 701 | | CENSORED DEATHS | | NONE | | | ================================================================================== PRIMACLONE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 726 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 1300 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 31 CENSORED DEATHS 0 TERMINAL 19 | | | | UNCENSORED DEATHS | | 22 368 470 492 516 551 559 562 565 606 | | 617 625 625 625 632 637 638 646 656 658 | | 674 674 674 697 698 699 702 706 712 716 | | 720 | | CENSORED DEATHS | | NONE | | | ================================================================================== PRIMACLONE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 726 DAYS ================================================================================== | KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) | | | |--------------------------------------------------------------------------------| | DOSE TIME (DAYS) | | 90 180 270 365 425 485 545 605 665 726 (A) | | | |--------------------------------------------------------------------------------| | | | |0 PPM | 100.0 100.0 100.0 100.0 100.0 98.0 94.0 82.0 76.0 70.0 | | | | | | | |300 PPM | 100.0 100.0 100.0 100.0 100.0 100.0 100.0 96.0 78.0 68.0 | | | | | | | |600 PPM | 100.0 100.0 100.0 100.0 98.0 98.0 98.0 90.0 72.0 62.0 | | | | | | | |1300 PPM | 98.0 98.0 98.0 98.0 96.0 94.0 90.0 82.0 60.0 38.0 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | 0 PPM 300 PPM 600 PPM 1300 PPM | | | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 70.0% 68.0% 62.0% 38.0% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P<0.001 P=1.000N P=0.611 P=0.005 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 593.9 646.2 626.0 604.6 | |NATURAL DEATHS (C) | (19.9) ( 9.1) (14.5) (24.4) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 686.4 700.5 688.0 650.7 | |(STANDARD ERROR) | (10.4) ( 6.0) ( 8.8) (17.2) | | | | ================================================================================== (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) PRIMACLONE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 727 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 9 CENSORED DEATHS 0 TERMINAL 41 | | | | UNCENSORED DEATHS | | 420 519 595 596 621 621 645 673 694 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 300 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 8 CENSORED DEATHS 0 TERMINAL 42 | | | | UNCENSORED DEATHS | | 613 673 690 701 718 720 724 726 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 600 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 5 CENSORED DEATHS 1 TERMINAL 44 | | | | UNCENSORED DEATHS | | 498 677 680 694 699 | | CENSORED DEATHS | | 561 | | | ================================================================================== PRIMACLONE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 727 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 1300 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 11 CENSORED DEATHS 0 TERMINAL 39 | | | | UNCENSORED DEATHS | | 583 597 631 638 673 673 673 673 677 693 | | 721 | | CENSORED DEATHS | | NONE | | | ================================================================================== PRIMACLONE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 727 DAYS ================================================================================== | KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) | | | |--------------------------------------------------------------------------------| | DOSE TIME (DAYS) | | 90 180 270 365 425 485 545 605 665 727 (A) | | | |--------------------------------------------------------------------------------| | | | |0 PPM | 100.0 100.0 100.0 100.0 98.0 98.0 96.0 92.0 86.0 82.0 | | | | | | | |300 PPM | 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 98.0 84.0 | | | | | | | |600 PPM | 100.0 100.0 100.0 100.0 100.0 100.0 98.0 98.0 98.0 89.8 | | | | | | | |1300 PPM | 100.0 100.0 100.0 100.0 100.0 100.0 100.0 96.0 92.0 78.0 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | 0 PPM 300 PPM 600 PPM 1300 PPM | | | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 82.0% 84.0% 89.8% 78.0% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.642 P=0.864N P=0.359N P=0.884 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 598.2 695.6 649.6 657.5 | |NATURAL DEATHS (C) | (27.9) (13.5) (38.1) (12.4) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 703.8 722.0 715.9 711.7 | |(STANDARD ERROR) | ( 8.5) ( 2.6) ( 5.7) ( 4.9) | | | | ================================================================================== (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) PRIMACLONE KAPLAN-MEIER SURVIVAL CURVES 0 PPM = 1 300 PPM = 2 600 PPM = 3 1300 PPM = 4 ------------------------------------------------------ SPECIES=MICE SEX=MALE ------------------------------------------------------- Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 4 31 2 | 4 4 31 1 3 | 4 4 4 1 1 1 3 3 222 | 4 4 3 3 90 + 4 1 1 3 3 | 44 11 32 2 P | 44 11 3322 E | 4 1 4 313 R 80 + 4 4 112 C | 44 11 2 E | 13 22 11 N | 44 3 3 2 2 T 70 + 3 3 1 1 | 44 33 2 2 S | 444 3 3 U | 3 3 R 60 + 4 4 V | I | 4 4 V | A 50 + L | 44 | 44 | 44 40 + | 44 | | 30 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 17 obs hidden. PRIMACLONE KAPLAN-MEIER SURVIVAL CURVES 0 PPM = 1 300 PPM = 2 600 PPM = 3 1300 PPM = 4 ----------------------------------------------------- SPECIES=MICE SEX=FEMALE ------------------------------------------------------ Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 1 3 4 2 | | 1 3 1 4 4 2 2 | P 96 + 1 14 4 232 E | R | 11 44 3232 C | E 92 + 1 1 4 4 2 2 N | T | 3 3 | S 88 + 1 1 22 U | R | 1 1 V | I 84 + 1 1 2 V | A | 4 41 1 L | 80 + 4 4 | | 44 | 76 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 5 obs hidden.