TDMS Study 88070-03 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Battelle Northwest ISOBUTENE DATE: 06/11/97 EXPERIMENT: 88070 TEST: 03 TIME: 11:17:04 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01-ES-15313 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C88070 PATHOLOGIST: GRUMBEIN, S. 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: 06/11/97 EXPERIMENT: 88070 TEST: 03 TIME: 11:17:04 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-15313 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C88070 PATHOLOGIST: GRUMBEIN, S. CAS: 115-11-0007 ISOBUTENE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 733 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = CONTROL | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 43 CENSORED DEATHS 0 TERMINAL 7 | | | | UNCENSORED DEATHS | | 379 467 476 477 495 516 539 539 540 544 | | 552 560 574 576 580 580 590 614 616 621 | | 628 633 636 639 645 648 650 661 666 670 | | 678 681 683 683 684 691 692 705 706 706 | | 719 719 720 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 500 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 45 CENSORED DEATHS 0 TERMINAL 5 | | | | UNCENSORED DEATHS | | 244 389 460 469 482 507 514 523 526 526 | | 527 537 547 552 560 579 583 583 592 604 | | 607 614 624 625 626 627 632 641 642 660 | | 662 664 664 670 671 671 678 684 684 684 | | 692 692 702 706 716 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 2000 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 44 CENSORED DEATHS 0 TERMINAL 6 | | | | UNCENSORED DEATHS | | 352 453 480 496 497 500 512 516 520 520 | | 551 552 555 558 565 568 574 579 580 583 | | 585 590 607 614 614 614 620 627 628 628 | | 650 652 654 654 671 678 680 700 701 705 | | 706 706 714 714 | | CENSORED DEATHS | | NONE | | | ================================================================================== ISOBUTENE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 733 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 8000 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 42 CENSORED DEATHS 0 TERMINAL 8 | | | | UNCENSORED DEATHS | | 490 505 525 534 534 540 560 576 583 604 | | 604 607 608 610 611 618 631 636 636 647 | | 648 650 650 658 664 664 664 666 667 670 | | 678 688 688 688 689 690 692 700 701 701 | | 702 720 | | CENSORED DEATHS | | NONE | | | ================================================================================== ISOBUTENE 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 | 100.0 100.0 100.0 100.0 98.0 92.0 80.0 66.0 44.0 14.0 | | | | | | | |500 PPM | 100.0 100.0 98.0 98.0 96.0 90.0 76.0 60.0 34.0 10.0 | | | | | | | |2000 PPM | 100.0 100.0 100.0 98.0 98.0 94.0 80.0 56.0 32.0 12.0 | | | | | | | |8000 PPM | 100.0 100.0 100.0 100.0 100.0 100.0 88.0 78.0 46.0 16.0 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | CONTROL 500 PPM 2000 PPM 8000 PPM | | | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 14.0% 10.0% 12.0% 16.0% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.282N P=0.346 P=0.450 P=0.718N | |(LIFE TABLE) | | | | | |MEAN DAY OF | 613.4 596.5 596.0 633.3 | |NATURAL DEATHS (C) | (12.4) (14.0) (12.2) ( 9.2) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 630.2 610.1 612.4 649.2 | |(STANDARD ERROR) | (12.2) (13.9) (12.4) ( 9.3) | | | | ================================================================================== (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) ISOBUTENE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 733 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = CONTROL | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 27 CENSORED DEATHS 0 TERMINAL 23 | | | | UNCENSORED DEATHS | | 390 421 440 488 488 496 529 552 552 573 | | 581 608 642 642 648 663 664 678 691 705 | | 705 714 715 720 720 722 726 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 500 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 30 CENSORED DEATHS 1 TERMINAL 19 | | | | UNCENSORED DEATHS | | 216 420 440 455 479 494 496 534 534 548 | | 565 573 580 603 608 621 630 635 662 664 | | 688 688 692 701 708 714 716 718 719 722 | | CENSORED DEATHS | | 13 | | | |--------------------------------------------------------------------------------| | DOSE = 2000 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 17 CENSORED DEATHS 0 TERMINAL 33 | | | | UNCENSORED DEATHS | | 399 522 534 552 560 607 620 626 644 651 | | 680 684 686 701 705 706 720 | | CENSORED DEATHS | | NONE | | | ================================================================================== ISOBUTENE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 733 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 8000 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 28 CENSORED DEATHS 0 TERMINAL 22 | | | | UNCENSORED DEATHS | | 5 407 469 500 511 512 547 559 580 592 | | 597 628 630 642 650 657 663 664 668 671 | | 674 681 692 702 706 720 720 729 | | CENSORED DEATHS | | NONE | | | ================================================================================== ISOBUTENE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE 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 | 100.0 100.0 100.0 100.0 96.0 94.0 86.0 78.0 66.0 46.0 | | | | | | | |500 PPM | 100.0 100.0 98.0 98.0 95.9 89.8 81.6 71.4 59.2 38.8 | | | | | | | |2000 PPM | 100.0 100.0 100.0 100.0 98.0 98.0 94.0 90.0 80.0 66.0 | | | | | | | |8000 PPM | 98.0 98.0 98.0 98.0 96.0 94.0 88.0 78.0 64.0 44.0 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | CONTROL 500 PPM 2000 PPM 8000 PPM | | | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 46.0% 38.8% 66.0% 44.0% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.926 P=0.469 P=0.069N P=0.909 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 610.1 594.1 623.4 599.1 | |NATURAL DEATHS (C) | (20.0) (21.5) (20.9) (27.1) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 666.6 635.3 695.7 658.0 | |(STANDARD ERROR) | (13.8) (20.4) (10.2) (17.8) | | | | ================================================================================== (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) ISOBUTENE KAPLAN-MEIER SURVIVAL CURVES CONTROL = 1 500 PPM = 2 2000 PPM = 3 8000 PPM = 4 ------------------------------------------------------ SPECIES=RATS SEX=MALE ------------------------------------------------------- Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 112 + | | | 1 2 3 12 3 1 4 4 96 + 2 32111 3 4 4 4 | 2 1 1321 44 P | 321 2 14 4 4 E | 3 2211 44 4 R 80 + 322111 C | 2 21 11 44 E | 22332 44 N | 312 1 14 4 T 64 + 32 2 211 4 4 | 3 3 22111 S | 3 32 21144 U | 114 4 R 48 + 332221 14 V | 2 11 I | 3 33 1114 V | 22 A 32 + 3 3311 L | 222131 | 33 | 22 1 1 16 + 2 231 1 | 232 2 | | 0 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 65 obs hidden. ISOBUTENE KAPLAN-MEIER SURVIVAL CURVES CONTROL = 1 500 PPM = 2 2000 PPM = 3 8000 PPM = 4 ----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------ Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 14 2 13 | 4 2 13 421 3 | 421 1 2 4 1 4 3 3 3 | 2 2 44 33 90 + 211 44 3 3 | 1 4 1 4 3 3 P | 2 12 14 4 33 3 E | 2 1 14 4 33 R 80 + 2 211 44 3 3 C | 221 41 4 E | 22 1 4 1 3 3 N | 2 2 11 T 70 + 2 2 14 1 | 22 4 4 3 3 S | 22 141 1 3 3 U | 2 2 1 1 R 60 + 244 2 V | 44 11 I | 44 411 V | 2 2 A 50 + 2211 L | 22 | 41 1 | 40 + 22 2 | | | 30 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 25 obs hidden.