TDMS Study 60968-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Battelle Northwest ISOBUTYRALDEHYDE DATE: 08/06/96 EXPERIMENT: 60968 TEST: 01 TIME: 17:18:06 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01-ES-95241 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 60968B PATHOLOGIST: R. RENNE RENNE, R. CAS: 0078-84-2 ------------------------------------------------------------------------------------------------------------------------------------ CORE STUDY REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Battelle Northwest ISOBUTYRALDEHYDE DATE: 08/06/96 EXPERIMENT: 60968 TEST: 01 TIME: 17:18:06 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-95241 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 60968B PATHOLOGIST: R. RENNE RENNE, R. CAS: 0078-84-2 ISOBUTYRALDEHYDE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 733 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = CONTROL | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 38 CENSORED DEATHS 0 TERMINAL 12 | | | | UNCENSORED DEATHS | | 259 421 433 465 482 523 547 549 556 566 | | 574 579 580 604 608 608 614 618 636 642 | | 651 663 663 664 678 678 678 681 685 687 | | 692 695 698 705 706 706 720 729 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 500 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 35 CENSORED DEATHS 0 TERMINAL 15 | | | | UNCENSORED DEATHS | | 184 384 403 540 554 575 579 580 594 601 | | 605 608 614 614 616 616 618 635 636 644 | | 663 664 667 667 674 678 679 679 687 687 | | 692 706 715 716 728 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 1000 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 39 CENSORED DEATHS 0 TERMINAL 11 | | | | UNCENSORED DEATHS | | 419 440 468 468 479 486 489 502 520 523 | | 538 539 541 552 568 576 578 580 586 590 | | 601 607 616 617 625 636 636 650 664 666 | | 679 686 692 700 701 706 715 720 720 | | CENSORED DEATHS | | NONE | | | ================================================================================== ISOBUTYRALDEHYDE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 733 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 2000 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 40 CENSORED DEATHS 0 TERMINAL 10 | | | | UNCENSORED DEATHS | | 441 443 463 465 468 491 494 496 520 545 | | 552 576 579 580 581 582 590 607 615 624 | | 632 636 636 636 637 638 638 645 650 652 | | 652 658 660 664 678 679 680 684 720 723 | | CENSORED DEATHS | | NONE | | | ================================================================================== ISOBUTYRALDEHYDE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 733 DAYS ================================================================================== | KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) | | | |--------------------------------------------------------------------------------| | DOSE TIME (DAYS) | | 90 180 270 365 425 485 545 605 665 733 (A) | | | |--------------------------------------------------------------------------------| | | | |CONTROL | 100.0 100.0 98.0 98.0 96.0 90.0 88.0 72.0 52.0 24.0 | | | | | | | |500 PPM | 100.0 100.0 98.0 98.0 94.0 94.0 92.0 78.0 56.0 30.0 | | | | | | | |1000 PPM | 100.0 100.0 100.0 100.0 98.0 90.0 74.0 58.0 42.0 22.0 | | | | | | | |2000 PPM | 100.0 100.0 100.0 100.0 100.0 90.0 80.0 66.0 32.0 20.0 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | CONTROL 500 PPM 1000 PPM 2000 PPM | | | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 24.0% 30.0% 22.0% 20.0% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.171 P=0.618N P=0.561 P=0.323 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 611.7 614.3 591.8 597.8 | |NATURAL DEATHS (C) | (16.2) (17.9) (13.7) (12.4) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 640.8 649.9 622.8 624.8 | |(STANDARD ERROR) | (14.3) (14.7) (13.6) (12.5) | | | | ================================================================================== (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) ISOBUTYRALDEHYDE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 734 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = CONTROL | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 23 CENSORED DEATHS 0 TERMINAL 27 | | | | UNCENSORED DEATHS | | 56 400 428 447 448 496 547 547 561 580 | | 580 616 617 623 625 678 679 687 690 692 | | 695 720 725 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 500 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 25 CENSORED DEATHS 1 TERMINAL 24 | | | | UNCENSORED DEATHS | | 511 524 544 551 552 575 591 608 624 636 | | 636 640 642 663 678 678 681 687 692 695 | | 701 701 705 706 712 | | CENSORED DEATHS | | 71 | | | |--------------------------------------------------------------------------------| | DOSE = 1000 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 26 CENSORED DEATHS 0 TERMINAL 24 | | | | UNCENSORED DEATHS | | 487 489 508 580 608 614 636 637 656 664 | | 664 677 681 685 687 687 692 692 696 701 | | 706 706 706 706 720 727 | | CENSORED DEATHS | | NONE | | | ================================================================================== ISOBUTYRALDEHYDE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 734 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 2000 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 18 CENSORED DEATHS 0 TERMINAL 32 | | | | UNCENSORED DEATHS | | 441 471 511 541 549 586 624 624 632 642 | | 646 646 646 664 664 673 681 706 | | CENSORED DEATHS | | NONE | | | ================================================================================== ISOBUTYRALDEHYDE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 734 DAYS ================================================================================== | KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) | | | |--------------------------------------------------------------------------------| | DOSE TIME (DAYS) | | 90 180 270 365 425 485 545 605 665 734 (A) | | | |--------------------------------------------------------------------------------| | | | |CONTROL | 98.0 98.0 98.0 98.0 96.0 90.0 88.0 78.0 70.0 54.0 | | | | | | | |500 PPM | 100.0 100.0 100.0 100.0 100.0 100.0 93.9 85.7 71.4 49.0 | | | | | | | |1000 PPM | 100.0 100.0 100.0 100.0 100.0 100.0 94.0 92.0 78.0 48.0 | | | | | | | |2000 PPM | 100.0 100.0 100.0 100.0 100.0 96.0 92.0 88.0 70.0 64.0 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | CONTROL 500 PPM 1000 PPM 2000 PPM | | | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 54.0% 49.0% 48.0% 64.0% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.265N P=0.954 P=1.000 P=0.367N | |(LIFE TABLE) | | | | | |MEAN DAY OF | 571.2 637.3 654.3 608.2 | |NATURAL DEATHS (C) | (31.1) (12.7) (13.5) (17.8) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 659.1 672.4 692.6 688.7 | |(STANDARD ERROR) | (18.3) (15.4) ( 9.0) (10.7) | | | | ================================================================================== (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) ISOBUTYRALDEHYDE KAPLAN-MEIER SURVIVAL CURVES CONTROL = 1 500 PPM = 2 1000 PPM = 3 2000 PPM = 4 ------------------------------------------------------ SPECIES=RATS SEX=MALE ------------------------------------------------------- Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | 100 + 1 2 1 3 4 | 2 1 2 31 34 | 2 2 1134 3 | 2 1 1 2 92 + 1 1 2 2 | 4 134 1 2 2 | 1 1 | 3 3 84 + 43 3 11 2 2 | 4 4 11 22 | 3 344 11 22 | 4 11 P 76 + 33 22 E | 33 1 1 R | 3 3 C | 334 E 68 + 4 4 112 N | 4 411 2 T | 33 441 1 | 3 3 4 411 S 60 + 33 4411 2 U | 33 1 1 R | 33 22 V | 33 I 52 + 33 121 V | 334 A | L | 343 11 44 + 3 3 2 2 | 44 33 11 | 33 | 33112 36 + 4 4 33 2 2 | 311 | 4 4 33 22 | 2 2 28 + 44 1 1 | 1 1 | 4 4 1 | 34 3 20 + 4 4 | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 24 obs hidden. ISOBUTYRALDEHYDE KAPLAN-MEIER SURVIVAL CURVES CONTROL = 1 500 PPM = 2 1000 PPM = 3 2000 PPM = 4 ----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------ Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 1 4 3 2 | 1 1 4 4 2 2 | 1 1 1 4 3 3 2 22 3 | 44 3 3 P 90 + 1 1 2 24 33 E | 1 1 24 2 3 43 R | 1 1 2 2 43 3 C | 1 1 2 224 3 3 E 80 + 44 N | 1 1 22 3 3 T | 11 4 4 33 | 11 2 2 233 S 70 + 1 4 1 U | 22 R | 12134 4 V | 33 I 60 + 112 V | 1 1 A | 11 1 L | 3 3 50 + 2233 2 | 3 3 | | 40 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 26 obs hidden.