TDMS Study 88034-03 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Battelle Northwest DATE: 05/08/95 EXP: 88034 OZONE TIME: 20:11:15 TEST: 03 CAGES FROM 0000 TO LAST CAGE PAGE: 1 TEST TYPE: CHRONIC ROUTE: RESPIRATORY EXPOSURE WHOLE NTP C#: C88034 CONT: N01-ES-95239 CAS: 10028-15-6 PATHOLOGIST: S. GRUMBEIN -------------------------------------------------------------------------------- REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Battelle Northwest DATE: 05/08/95 EXP: 88034 OZONE TIME: 20:11:15 TEST: 03 CAGES FROM 0000 TO LAST CAGE TEST TYPE: CHRONIC ROUTE: RESPIRATORY EXPOSURE WHOLE NTP C#: C88034 CONT: N01-ES-95239 CAS: 10028-15-6 PATHOLOGIST: S. GRUMBEIN OZONE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 733 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = CONTROL | | --------------------- | | | | TOTAL 56 UNCENSORED DEATHS 41 CENSORED DEATHS 7 TERMINAL 8 | | | | UNCENSORED DEATHS | | 247 359 462 481 498 514 516 517 537 543 | | 546 562 565 575 578 583 594 600 601 606 | | 624 632 639 639 643 644 648 648 651 670 | | 670 674 676 681 681 687 695 697 709 715 | | 720 | | CENSORED DEATHS | | 602 602 602 602 602 602 617 | | | |--------------------------------------------------------------------------------| | DOSE = 0.12 PPM | | --------------------- | | | | TOTAL 56 UNCENSORED DEATHS 45 CENSORED DEATHS 6 TERMINAL 5 | | | | UNCENSORED DEATHS | | 175 441 441 466 468 480 489 503 533 537 | | 540 574 591 603 603 605 608 611 616 619 | | 622 625 639 639 642 653 653 663 667 667 | | 676 678 681 681 691 693 695 695 698 701 | | 709 709 716 723 723 | | CENSORED DEATHS | | 602 602 602 602 602 602 | | | |--------------------------------------------------------------------------------| | DOSE = 0.5 PPM | | --------------------- | | | | TOTAL 56 UNCENSORED DEATHS 43 CENSORED DEATHS 6 TERMINAL 7 | | | | UNCENSORED DEATHS | | 264 387 433 442 454 470 498 499 520 524 | | 527 539 546 575 583 583 592 604 608 611 | | 621 625 625 625 639 649 654 663 669 671 | | 678 681 681 687 695 697 698 701 715 720 | | 722 723 723 | | CENSORED DEATHS | | 602 602 602 602 602 602 | | | ================================================================================== OZONE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 733 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 1.0 PPM | | --------------------- | | | | TOTAL 56 UNCENSORED DEATHS 43 CENSORED DEATHS 6 TERMINAL 7 | | | | UNCENSORED DEATHS | | 372 422 458 502 526 540 552 559 562 568 | | 574 583 583 590 596 600 611 615 616 616 | | 619 621 623 623 635 640 644 651 653 654 | | 658 658 659 665 667 667 667 681 695 709 | | 715 723 723 | | CENSORED DEATHS | | 602 602 602 602 602 602 | | | ================================================================================== OZONE 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 98.2 96.4 96.4 92.9 82.1 66.1 44.1 17.6 | | | | | | | |0.12 PPM | 100.0 98.2 98.2 98.2 98.2 89.3 80.4 70.6 45.7 10.4 | | | | | | | |0.5 PPM | 100.0 100.0 98.2 98.2 96.4 89.3 78.6 67.5 46.4 14.8 | | | | | | | |1.0 PPM | 100.0 100.0 100.0 100.0 96.4 94.6 89.3 71.4 33.6 14.7 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | CONTROL 0.12 PPM 0.5 PPM 1.0 PPM | | | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 17.6% 10.4% 14.8% 14.7% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.936 P=0.876 P=1.000N P=0.870 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 598.2 609.8 600.5 611.5 | |NATURAL DEATHS (C) | (15.2) (15.6) (15.9) (11.5) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 618.2 620.0 617.2 625.7 | |(STANDARD ERROR) | (12.7) (13.4) (13.5) (10.4) | | | | ================================================================================== (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) OZONE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 733 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = CONTROL | | --------------------- | | | | TOTAL 56 UNCENSORED DEATHS 22 CENSORED DEATHS 6 TERMINAL 28 | | | | UNCENSORED DEATHS | | 362 443 446 502 527 537 553 566 571 603 | | 608 630 665 667 681 687 688 695 709 709 | | 709 723 | | CENSORED DEATHS | | 602 602 602 602 602 602 | | | |--------------------------------------------------------------------------------| | DOSE = 0.12 PPM | | --------------------- | | | | TOTAL 56 UNCENSORED DEATHS 26 CENSORED DEATHS 6 TERMINAL 24 | | | | UNCENSORED DEATHS | | 275 413 469 470 541 568 579 583 596 596 | | 600 611 622 628 637 664 667 667 677 681 | | 701 702 708 709 714 727 | | CENSORED DEATHS | | 602 602 602 602 602 602 | | | |--------------------------------------------------------------------------------| | DOSE = 0.5 PPM | | --------------------- | | | | TOTAL 56 UNCENSORED DEATHS 20 CENSORED DEATHS 6 TERMINAL 30 | | | | UNCENSORED DEATHS | | 120 378 536 553 555 591 613 638 653 657 | | 659 660 665 697 698 702 709 709 723 730 | | CENSORED DEATHS | | 602 602 602 602 602 602 | | | ================================================================================== OZONE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 733 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 1.0 PPM | | --------------------- | | | | TOTAL 56 UNCENSORED DEATHS 23 CENSORED DEATHS 6 TERMINAL 27 | | | | UNCENSORED DEATHS | | 50 183 275 434 463 512 526 571 583 616 | | 627 636 641 648 651 654 665 668 681 683 | | 685 715 719 | | CENSORED DEATHS | | 602 602 602 602 602 602 | | | ================================================================================== OZONE 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 98.2 98.2 94.6 89.3 81.9 75.7 57.3 | | | | | | | |0.12 PPM | 100.0 100.0 100.0 98.2 96.4 92.9 91.1 80.4 70.1 49.5 | | | | | | | |0.5 PPM | 100.0 98.2 98.2 98.2 96.4 96.4 94.6 89.3 75.1 60.9 | | | | | | | |1.0 PPM | 98.2 98.2 96.4 94.6 94.6 91.1 87.5 83.9 67.6 55.3 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | CONTROL 0.12 PPM 0.5 PPM 1.0 PPM | | | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 57.3% 49.5% 60.9% 55.3% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.931N P=0.535 P=0.729N P=0.866 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 603.7 607.9 612.3 560.3 | |NATURAL DEATHS (C) | (21.8) (20.8) (32.0) (36.5) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 668.2 660.9 675.9 648.0 | |(STANDARD ERROR) | (12.1) (12.7) (14.0) (18.6) | | | | ================================================================================== (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) OZONE KAPLAN-MEIER SURVIVAL CURVES CONTROL = 1 0.12 PPM = 2 0.5 PPM = 3 1.0 PPM = 4 ------------------------------------------------------ SPECIES=RATS SEX=MALE ------------------------------------------------------- Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 2 1 3 4 | 2 1 3 1 4 3 432 1 | 323 12 1 4 | 3 3 1 1 4 90 + 3 2322 1 1 4 44 | 2 2 44 | 2 1 3 11 444 | 3322 80 + 331 12 4 | 33 1214 2 2 P | 33 44 E | 11 14 4 R 70 + 113 C | 22 E | 11221 N | 3311 T 60 + 2211 | 2 2 S | 4343 U | 4232 R 50 + 113 V | 442 23 I | 14 21 V | 22 A 40 + 113 L | 4 4 22 | 1133 | 44 22 30 + 112 | 4 4113 | 4 1313 | 2211 20 + 2233 | 21 1 | 22 3 | 10 + 2 2 | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 60 obs hidden. OZONE KAPLAN-MEIER SURVIVAL CURVES CONTROL = 1 0.12 PPM = 2 0.5 PPM = 3 1.0 PPM = 4 ----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------ Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | 100 + 1 4 3 2 1 | 4 3 4 2 1 3 2 1 | | 4 4 3 2 2 3 95 + 4 4 1 22 1 3 3 | | 4 42 1 1 233 | 4 4 112 3 2 3 90 + | 4 41 1 22 3 3 | 4 1 1422 3 3 | 11 2 2 P 85 + 3 3 E | 1 4 14 R | 4 4 C | 3 3 E 80 + 212 14 N | 22 T | 144 1 | 22 44 11 S 75 + 3 3 U | 22 1 1 R | 2 2 V | 44 1133 I 70 + 4 22 V | 33 A | 44 11 L | 22 65 + 4 4 1 1 3 | 22 | 3 3 | 2 2 3 60 + | 4 141 | 22 1 1 | 55 + 4 4 | | | 2 2 50 + 2 2 | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 8 obs hidden.