TDMS Study 05132-05 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Battelle Northwest TETRAFLUOROETHYLENE DATE: 04/04/96 EXPERIMENT: 05132 TEST: 05 TIME: 00:43:33 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01ES85207 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 61596B PATHOLOGIST: S. GRUMBEIN CAS: 116-14-3 ------------------------------------------------------------------------------------------------------------------------------------ REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Battelle Northwest TETRAFLUOROETHYLENE DATE: 04/04/96 EXPERIMENT: 05132 TEST: 05 TIME: 00:43:33 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01ES85207 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 61596B PATHOLOGIST: S. GRUMBEIN CAS: 116-14-3 TETRAFLUOROETHYLENE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 733 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = CONTROL | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 33 CENSORED DEATHS 10 TERMINAL 17 | | | | UNCENSORED DEATHS | | 336 371 489 509 525 555 559 588 591 593 | | 594 624 632 635 649 659 664 674 677 679 | | 686 690 691 701 702 705 707 708 709 715 | | 716 721 727 | | CENSORED DEATHS | | 453 453 453 453 453 453 453 453 453 453 | | | |--------------------------------------------------------------------------------| | DOSE = 156 PPM | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 38 CENSORED DEATHS 10 TERMINAL 12 | | | | UNCENSORED DEATHS | | 351 450 470 494 509 529 533 555 555 581 | | 589 592 594 594 594 600 604 612 616 621 | | 627 652 653 659 664 664 681 686 691 698 | | 700 702 705 711 715 716 716 730 | | CENSORED DEATHS | | 453 453 453 453 453 453 453 453 453 453 | | | |--------------------------------------------------------------------------------| | DOSE = 312 PPM | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 33 CENSORED DEATHS 10 TERMINAL 17 | | | | UNCENSORED DEATHS | | 413 538 547 559 564 575 576 581 614 614 | | 616 617 617 621 627 631 632 632 635 638 | | 658 663 664 664 674 674 677 688 691 693 | | 723 726 729 | | CENSORED DEATHS | | 453 453 453 453 453 453 453 453 453 453 | | | ================================================================================== TETRAFLUOROETHYLENE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 733 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 625 PPM | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 49 CENSORED DEATHS 10 TERMINAL 1 | | | | UNCENSORED DEATHS | | 361 455 481 509 510 523 525 531 544 555 | | 559 571 572 572 583 586 590 593 594 603 | | 604 608 611 616 617 617 617 621 626 626 | | 630 632 632 639 639 639 652 663 663 668 | | 674 688 688 691 695 702 712 721 730 | | CENSORED DEATHS | | 453 453 453 453 453 453 453 453 453 453 | | | ================================================================================== TETRAFLUOROETHYLENE 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 98.3 96.7 96.7 90.6 78.5 66.5 34.2 | | | | | | | |156 PPM | 100.0 100.0 100.0 98.3 98.3 94.7 86.6 66.5 48.3 24.2 | | | | | | | |312 PPM | 100.0 100.0 100.0 100.0 98.3 98.3 96.3 84.3 52.2 34.1 | | | | | | | |625 PPM | 100.0 100.0 100.0 98.3 98.3 94.3 82.3 58.2 22.1 2.0 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | CONTROL 156 PPM 312 PPM 625 PPM | | | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 34.2% 24.2% 34.1% 2.0% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P<0.001 P=0.215 P=0.828 P<0.001 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 629.7 616.1 629.4 606.9 | |NATURAL DEATHS (C) | (16.9) (14.0) (11.1) (10.3) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 629.5 612.3 629.4 583.4 | |(STANDARD ERROR) | (15.0) (14.1) (13.3) (11.5) | | | | ================================================================================== (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) TETRAFLUOROETHYLENE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 734 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = CONTROL | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 22 CENSORED DEATHS 10 TERMINAL 28 | | | | UNCENSORED DEATHS | | 433 481 481 554 581 621 626 648 649 663 | | 677 685 692 693 698 699 702 707 707 714 | | 721 726 | | CENSORED DEATHS | | 454 454 454 454 454 454 454 454 454 454 | | | |--------------------------------------------------------------------------------| | DOSE = 312 PPM | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 34 CENSORED DEATHS 10 TERMINAL 16 | | | | UNCENSORED DEATHS | | 247 413 468 468 517 523 537 557 565 565 | | 574 574 581 583 588 594 597 600 617 618 | | 618 625 638 649 653 675 691 701 704 707 | | 722 723 730 730 | | CENSORED DEATHS | | 454 454 454 454 454 454 454 454 454 454 | | | |--------------------------------------------------------------------------------| | DOSE = 625 PPM | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 35 CENSORED DEATHS 10 TERMINAL 15 | | | | UNCENSORED DEATHS | | 363 387 469 477 478 504 534 536 544 581 | | 587 587 589 607 608 611 625 652 653 664 | | 668 668 672 674 677 685 698 698 699 702 | | 716 729 733 733 733 | | CENSORED DEATHS | | 454 454 454 454 454 454 454 454 454 454 | | | ================================================================================== TETRAFLUOROETHYLENE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 734 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 1250 PPM | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 31 CENSORED DEATHS 11 TERMINAL 18 | | | | UNCENSORED DEATHS | | 372 378 433 439 461 481 504 509 518 531 | | 538 572 576 579 583 594 603 608 610 621 | | 621 624 628 635 639 653 668 677 678 703 | | 727 | | CENSORED DEATHS | | 6 454 454 454 454 454 454 454 454 454 | | 454 | | | ================================================================================== TETRAFLUOROETHYLENE 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 | 100.0 100.0 100.0 100.0 100.0 94.3 94.3 90.3 80.3 56.2 | | | | | | | |312 PPM | 100.0 100.0 98.3 98.3 96.7 92.6 86.6 64.4 50.3 32.2 | | | | | | | |625 PPM | 100.0 100.0 100.0 98.3 96.7 90.6 82.6 74.5 60.4 30.2 | | | | | | | |1250 PPM | 100.0 100.0 100.0 100.0 96.6 89.1 78.7 66.3 47.6 37.3 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | CONTROL 312 PPM 625 PPM 1250 PPM | | | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 56.2% 32.2% 30.2% 37.3% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.034 P=0.008 P=0.007 P=0.014 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 643.5 598.6 615.5 573.0 | |NATURAL DEATHS (C) | (18.2) (17.3) (16.6) (16.5) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 654.2 610.6 618.2 592.0 | |(STANDARD ERROR) | (14.4) (15.3) (15.0) (18.1) | | | | ================================================================================== (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) TETRAFLUOROETHYLENE KAPLAN-MEIER SURVIVAL CURVES CONTROL = 1 156 PPM = 2 312 PPM = 3 625 PPM = 4 ------------------------------------------------------ SPECIES=RATS SEX=MALE ------------------------------------------------------- Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 112.38 + | | |1 1 241 3 2 3 96.33 + 1 2 2412 1 3 33 | 2 1 12 13 3 P | 422 1 1 E | 4 4 2 21 1 3 R 80.27 + 4 42 1 331 C | 11 E | 4 4 22 331 1 1 N | 4 4222 1 1 T 64.22 + 4 422 33 | 22 3 2 3 111 S | 44 2 2 1 1 U | 44 3 3 R 48.16 + 2 323 11 V | 44 222 11 I | 44 322 3 V | 44 2211 1 A 32.11 + 22 L | 4 4 4 2 2 | 44 2 | 44 4 16.05 + | 444 | 444 | 4 4 0.00 + | -+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+ 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 46 obs hidden. TETRAFLUOROETHYLENE KAPLAN-MEIER SURVIVAL CURVES CONTROL = 1 312 PPM = 2 625 PPM = 3 1250 PPM = 4 ----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------ Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 2 3 4 1 | 2 3 4 3 2 1 2 1 | 44 3 1 1 | 4 42 2 1 1 90 + 4 3 3 2 2 1 1 | 34 2 2 2 11 1 P | 44 33 22 E | 4 4 3 3 1 1 R 80 + 44 2233 1 1 C | 4 223 3 111 E | 22 3 3 N | 44 11 T 70 + 2 2 33 | 2243 3 3 11 S | 2442 U | 44 3 3 11 R 60 + 33 11 V | 22 2 11 I | 4422 33 1 1 V | 4422 A 50 + 4 2 23 L | 4 423232 | 44 | 4 33 40 + 2 32 | 32 2 | | 2 30 + 3 | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 36 obs hidden.