TDMS Study 88070-04 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Battelle Northwest ISOBUTENE DATE: 06/20/97 EXPERIMENT: 88070 TEST: 04 TIME: 12:53:55 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01-ES-15313 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C88070 PATHOLOGIST: MILLER, R. CAS: 115-11-0007 ------------------------------------------------------------------------------------------------------------------------------------ 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 ISOBUTENE DATE: 06/20/97 EXPERIMENT: 88070 TEST: 04 TIME: 12:53:55 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-15313 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C88070 PATHOLOGIST: MILLER, R. CAS: 115-11-0007 ISOBUTENE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 733 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = CONTROL | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 22 CENSORED DEATHS 0 TERMINAL 28 | | | | UNCENSORED DEATHS | | 387 399 426 483 527 560 580 589 592 608 | | 610 611 653 653 664 681 695 695 708 709 | | 715 723 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 500 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 18 CENSORED DEATHS 0 TERMINAL 32 | | | | UNCENSORED DEATHS | | 405 512 522 546 562 583 596 601 639 649 | | 652 667 667 698 709 711 715 716 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 2000 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 23 CENSORED DEATHS 0 TERMINAL 27 | | | | UNCENSORED DEATHS | | 387 389 428 480 499 512 512 527 555 559 | | 583 584 628 631 636 639 645 653 681 686 | | 708 713 729 | | CENSORED DEATHS | | NONE | | | ================================================================================== ISOBUTENE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 733 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 8000 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 22 CENSORED DEATHS 0 TERMINAL 28 | | | | UNCENSORED DEATHS | | 251 330 341 386 457 499 508 512 547 547 | | 562 608 631 633 639 667 670 682 689 695 | | 706 727 | | CENSORED DEATHS | | NONE | | | ================================================================================== ISOBUTENE 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 96.0 92.0 90.0 82.0 70.0 56.0 | | | | | | | |500 PPM | 100.0 100.0 100.0 100.0 98.0 98.0 94.0 84.0 78.0 64.0 | | | | | | | |2000 PPM | 100.0 100.0 100.0 100.0 96.0 92.0 84.0 76.0 64.0 54.0 | | | | | | | |8000 PPM | 100.0 100.0 98.0 94.0 92.0 90.0 84.0 78.0 70.0 56.0 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | CONTROL 500 PPM 2000 PPM 8000 PPM | | | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 56.0% 64.0% 54.0% 56.0% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.642 P=0.488N P=0.835 P=0.977 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 603.1 619.4 581.0 558.5 | |NATURAL DEATHS (C) | (22.0) (20.3) (21.1) (29.0) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 675.8 692.1 663.1 656.2 | |(STANDARD ERROR) | (13.3) (10.6) (14.5) (17.6) | | | | ================================================================================== (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) ISOBUTENE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 735 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = CONTROL | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 18 CENSORED DEATHS 0 TERMINAL 32 | | | | UNCENSORED DEATHS | | 230 322 378 449 541 580 608 610 621 639 | | 653 667 667 681 709 709 723 723 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 500 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 19 CENSORED DEATHS 0 TERMINAL 31 | | | | UNCENSORED DEATHS | | 483 506 567 572 594 611 611 615 639 639 | | 639 649 653 653 691 695 695 727 731 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 2000 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 11 CENSORED DEATHS 0 TERMINAL 39 | | | | UNCENSORED DEATHS | | 477 509 543 600 618 620 628 675 686 692 | | 709 | | CENSORED DEATHS | | NONE | | | ================================================================================== ISOBUTENE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 735 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 8000 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 17 CENSORED DEATHS 0 TERMINAL 33 | | | | UNCENSORED DEATHS | | 527 565 583 596 617 645 653 672 687 701 | | 703 709 709 715 721 721 729 | | CENSORED DEATHS | | NONE | | | ================================================================================== ISOBUTENE 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 | 100.0 100.0 98.0 96.0 94.0 92.0 90.0 88.0 78.0 64.0 | | | | | | | |500 PPM | 100.0 100.0 100.0 100.0 100.0 98.0 96.0 90.0 72.0 62.0 | | | | | | | |2000 PPM | 100.0 100.0 100.0 100.0 100.0 98.0 94.0 92.0 86.0 78.0 | | | | | | | |8000 PPM | 100.0 100.0 100.0 100.0 100.0 100.0 98.0 92.0 86.0 66.0 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | CONTROL 500 PPM 2000 PPM 8000 PPM | | | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 64.0% 62.0% 78.0% 66.0% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.802N P=1.000 P=0.182N P=0.820N | |(LIFE TABLE) | | | | | |MEAN DAY OF | 583.9 630.0 614.3 661.9 | |NATURAL DEATHS (C) | (34.3) (15.3) (23.2) (15.2) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 680.6 695.1 708.4 710.2 | |(STANDARD ERROR) | (15.9) ( 9.3) ( 8.7) ( 7.1) | | | | ================================================================================== (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) ISOBUTENE KAPLAN-MEIER SURVIVAL CURVES CONTROL = 1 500 PPM = 2 2000 PPM = 3 8000 PPM = 4 ------------------------------------------------------ SPECIES=MICE SEX=MALE ------------------------------------------------------- Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 104 + | | 1 4 1 2 | 4 4 112 2 96 + 44 31 13 2 2 | 4 4 13 1 2 2 P | 4 4 1 3 1 2 2 E | 4 3 3 1 12 2 R 88 + 44 1 12 2 C | 43 3 1 1 E | 4 3 43 2 2 N | 1 1 22 T 80 + 434 3 11 22 | 4 4 2 2 S | 3 41 34 1 U | 33 2 2 R 72 + 44 1 1 2 2 V | 33 14 1 I | 33 1 1 22 V | 33 4 4 A 64 + 3 341 12 2 L | 44 | 3 4411 | 4 11 56 + 3 1 1 | 3 | | 48 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 15 obs hidden. ISOBUTENE KAPLAN-MEIER SURVIVAL CURVES CONTROL = 1 500 PPM = 2 2000 PPM = 3 8000 PPM = 4 ----------------------------------------------------- SPECIES=MICE SEX=FEMALE ------------------------------------------------------ Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | 100 + 1 1 2 4 | | 1 1 2 2 4 4 | 96 + 1 1 2 3 2 4 | | 1 1 3 22 4 3 | 92 + 1 1 2 23 3 | | 1 1 2 24 4 | P 88 + 1 1 33 44 E | R | 11 3 4 43 C | E 84 + 11 2 4334 N | T | 1 1 33 4 | S 80 + 1 1 3 3 U | R | 221 1 43 3 V | I 76 + 22 V | A | 1 1 44 L | 72 + 2 12 1 | | 22 | 68 + 141 4 | | 2 2 4 | 64 + 1 1 | | 2 | 60 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 16 obs hidden.