TDMS Study 60968-02 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Battelle Northwest ISOBUTYRALDEHYDE DATE: 09/23/96 EXPERIMENT: 60968 TEST: 02 TIME: 16:35:24 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01-ES-95241 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 60968B PATHOLOGIST: S. GRUMBEIN GRUMBEIN, SONDRA 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: 09/23/96 EXPERIMENT: 60968 TEST: 02 TIME: 16:35:24 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-95241 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 60968B PATHOLOGIST: S. GRUMBEIN GRUMBEIN, SONDRA CAS: 0078-84-2 ISOBUTYRALDEHYDE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 733 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = CONTROL | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 10 CENSORED DEATHS 0 TERMINAL 40 | | | | UNCENSORED DEATHS | | 455 520 639 639 639 659 664 676 682 685 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 500 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 13 CENSORED DEATHS 0 TERMINAL 37 | | | | UNCENSORED DEATHS | | 415 573 580 605 611 623 632 649 670 680 | | 709 712 723 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 1000 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 15 CENSORED DEATHS 0 TERMINAL 35 | | | | UNCENSORED DEATHS | | 43 322 359 410 421 448 529 535 560 630 | | 632 649 672 711 728 | | CENSORED DEATHS | | NONE | | | ================================================================================== ISOBUTYRALDEHYDE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 733 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 2000 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 20 CENSORED DEATHS 0 TERMINAL 30 | | | | UNCENSORED DEATHS | | 415 499 547 571 588 597 616 639 649 653 | | 653 658 665 670 679 690 691 709 723 723 | | CENSORED DEATHS | | NONE | | | ================================================================================== ISOBUTYRALDEHYDE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE 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 | 100.0 100.0 100.0 100.0 100.0 98.0 96.0 96.0 86.0 80.0 | | | | | | | |500 PPM | 100.0 100.0 100.0 100.0 98.0 98.0 98.0 92.0 84.0 74.0 | | | | | | | |1000 PPM | 98.0 98.0 98.0 94.0 90.0 88.0 84.0 82.0 76.0 70.0 | | | | | | | |2000 PPM | 100.0 100.0 100.0 100.0 98.0 98.0 96.0 88.0 74.0 60.0 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | CONTROL 500 PPM 1000 PPM 2000 PPM | | | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 80.0% 74.0% 70.0% 60.0% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.034 P=0.605 P=0.270 P=0.051 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 625.8 629.4 509.9 631.8 | |NATURAL DEATHS (C) | (24.2) (22.5) (47.0) (17.4) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 711.6 706.1 666.1 692.5 | |(STANDARD ERROR) | ( 7.7) ( 8.6) (20.1) ( 9.9) | | | | ================================================================================== (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) ISOBUTYRALDEHYDE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 735 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = CONTROL | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 21 CENSORED DEATHS 1 TERMINAL 28 | | | | UNCENSORED DEATHS | | 76 344 533 543 583 596 611 623 637 639 | | 646 646 657 686 691 695 700 701 701 712 | | 723 | | CENSORED DEATHS | | 69 | | | |--------------------------------------------------------------------------------| | DOSE = 500 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 17 CENSORED DEATHS 1 TERMINAL 32 | | | | UNCENSORED DEATHS | | 93 527 546 595 611 611 621 623 636 663 | | 681 686 691 695 702 712 731 | | CENSORED DEATHS | | 603 | | | |--------------------------------------------------------------------------------| | DOSE = 1000 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 14 CENSORED DEATHS 0 TERMINAL 36 | | | | UNCENSORED DEATHS | | 537 547 554 577 581 609 611 631 633 645 | | 653 665 674 713 | | CENSORED DEATHS | | NONE | | | ================================================================================== ISOBUTYRALDEHYDE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 735 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 2000 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 13 CENSORED DEATHS 0 TERMINAL 37 | | | | UNCENSORED DEATHS | | 415 415 483 611 652 653 653 653 653 665 | | 681 682 702 | | CENSORED DEATHS | | NONE | | | ================================================================================== ISOBUTYRALDEHYDE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 735 DAYS ================================================================================== | KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) | | | |--------------------------------------------------------------------------------| | DOSE TIME (DAYS) | | 90 180 270 365 425 485 545 605 665 735 (A) | | | |--------------------------------------------------------------------------------| | | | |CONTROL | 98.0 98.0 98.0 95.9 95.9 95.9 91.8 87.8 73.5 57.1 | | | | | | | |500 PPM | 100.0 98.0 98.0 98.0 98.0 98.0 96.0 92.0 79.7 65.4 | | | | | | | |1000 PPM | 100.0 100.0 100.0 100.0 100.0 100.0 98.0 90.0 76.0 72.0 | | | | | | | |2000 PPM | 100.0 100.0 100.0 100.0 96.0 94.0 94.0 94.0 80.0 74.0 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | CONTROL 500 PPM 1000 PPM 2000 PPM | | | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 57.1% 65.4% 72.0% 74.0% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.103N P=0.508N P=0.225N P=0.120N | |(LIFE TABLE) | | | | | |MEAN DAY OF | 606.8 613.2 616.4 609.1 | |NATURAL DEATHS (C) | (32.4) (35.4) (14.0) (28.1) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 667.8 690.9 701.8 702.3 | |(STANDARD ERROR) | (20.2) (14.5) ( 8.5) (10.6) | | | | ================================================================================== (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=MICE SEX=MALE ------------------------------------------------------- Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 3 2 1 | | 3 3 2 1 4 1 2 | 3 3 4 1 4 22 1 95 + | 3 3 4 42 2 | 3 3 4 4 22 | P 90 + 3 3 4 4 22 1 1 E | R | 3 3 4 42 2 C | 33 4 242 1 1 E 85 + N | 3 3 42 211 T | 3 3 44 2 2 | S 80 + 33 1 2 1 U | R | 3 3 V | 34 43 2 2 I 75 + V | 43 3 2 2 A | 44 3 3 L | 70 + 4 4 3 3 | | | 4 4 65 + | 4 4 | | 60 + 4 4 | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 8 obs hidden. ISOBUTYRALDEHYDE KAPLAN-MEIER SURVIVAL CURVES CONTROL = 1 500 PPM = 2 1000 PPM = 3 2000 PPM = 4 ----------------------------------------------------- SPECIES=MICE SEX=FEMALE ------------------------------------------------------ Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 1 2 4 3 | | 1 2 1 23 3 | 1 4 4 21233 95 + | 4 11 3 3 2 4 | 2 2 4 | 1 1 90 + 31 13 | P | 1312 E | 11 3 R 85 + C | 1 1 E | 3 34 4 N | 11 2 T 80 + 113 2 2 | S | 3 3 U | 3 322 4 R 75 + 11 V | 1 312243 4 I | 3 3 V | 1122 A 70 + 1122 L | | 2 2 | 65 + 11 2 | | | 11 60 + | 1 1 | 1 1 | 55 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 15 obs hidden.