TDMS Study 05132-06 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Battelle Northwest TETRAFLUOROETHYLENE DATE: 04/04/96 EXPERIMENT: 05132 TEST: 06 TIME: 01:31:44 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01ES85207 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 61596B PATHOLOGIST: P. MELLICK 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: 06 TIME: 01:31:44 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01ES85207 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 61596B PATHOLOGIST: P. MELLICK CAS: 116-14-3 TETRAFLUOROETHYLENE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 666 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = CONTROL | | --------------------- | | | | TOTAL 58 UNCENSORED DEATHS 10 CENSORED DEATHS 10 TERMINAL 38 | | | | UNCENSORED DEATHS | | 452 475 538 541 597 597 611 639 650 650 | | CENSORED DEATHS | | 456 456 456 456 456 456 456 456 456 456 | | | |--------------------------------------------------------------------------------| | DOSE = 312 PPM | | --------------------- | | | | TOTAL 58 UNCENSORED DEATHS 37 CENSORED DEATHS 10 TERMINAL 11 | | | | UNCENSORED DEATHS | | 44 75 77 462 463 495 508 509 513 522 | | 537 537 537 541 541 541 551 552 566 569 | | 573 586 590 593 593 599 600 614 614 616 | | 625 631 637 646 646 649 660 | | CENSORED DEATHS | | 456 456 456 456 456 456 456 456 456 456 | | | |--------------------------------------------------------------------------------| | DOSE = 625 PPM | | --------------------- | | | | TOTAL 58 UNCENSORED DEATHS 46 CENSORED DEATHS 10 TERMINAL 2 | | | | UNCENSORED DEATHS | | 363 368 415 420 433 446 447 484 485 497 | | 509 516 517 518 518 531 539 541 541 541 | | 547 548 548 551 554 569 573 586 589 589 | | 593 597 600 607 608 608 615 616 618 631 | | 632 639 646 649 653 657 | | CENSORED DEATHS | | 456 456 456 456 456 456 456 456 456 456 | | | ================================================================================== TETRAFLUOROETHYLENE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 666 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 1250 PPM | | --------------------- | | | | TOTAL 58 UNCENSORED DEATHS 47 CENSORED DEATHS 10 TERMINAL 1 | | | | UNCENSORED DEATHS | | 5 259 315 356 401 465 483 518 527 527 | | 536 541 541 541 543 544 548 548 551 559 | | 563 565 574 575 578 583 585 586 586 589 | | 599 600 600 606 608 608 608 610 613 613 | | 623 629 630 631 643 646 654 | | CENSORED DEATHS | | 456 456 456 456 456 456 456 456 456 456 | | | ================================================================================== TETRAFLUOROETHYLENE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 666 DAYS ================================================================================== | KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) | | | |--------------------------------------------------------------------------------| | DOSE TIME (DAYS) | | 90 180 270 365 425 485 545 605 665 666 (A) | | | |--------------------------------------------------------------------------------| | | | |CONTROL | 100.0 100.0 100.0 100.0 100.0 96.2 92.0 87.8 79.5 79.5 | | | | | | | |312 PPM | 94.8 94.8 94.8 94.8 94.8 90.6 67.4 44.3 23.2 23.2 | | | | | | | |625 PPM | 100.0 100.0 100.0 98.3 93.1 83.6 60.1 32.2 4.3 4.3 | | | | | | | |1250 PPM | 98.3 98.3 96.6 93.1 91.4 87.1 68.0 31.9 2.1 2.1 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | CONTROL 312 PPM 625 PPM 1250 PPM | | | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 79.5% 23.2% 4.3% 2.1% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P<0.001 P<0.001 P<0.001 P<0.001 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 575.0 530.1 549.0 545.0 | |NATURAL DEATHS (C) | (22.4) (24.5) (11.1) (16.7) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 614.1 543.1 537.0 531.7 | |(STANDARD ERROR) | (11.2) (17.8) (10.4) (14.4) | | | | ================================================================================== (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) TETRAFLUOROETHYLENE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 667 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = CONTROL | | --------------------- | | | | TOTAL 58 UNCENSORED DEATHS 12 CENSORED DEATHS 10 TERMINAL 36 | | | | UNCENSORED DEATHS | | 400 488 531 541 573 595 597 603 617 621 | | 626 660 | | CENSORED DEATHS | | 457 457 457 457 457 457 457 457 457 457 | | | |--------------------------------------------------------------------------------| | DOSE = 312 PPM | | --------------------- | | | | TOTAL 58 UNCENSORED DEATHS 44 CENSORED DEATHS 10 TERMINAL 4 | | | | UNCENSORED DEATHS | | 429 429 454 455 493 530 530 539 541 541 | | 541 541 566 585 588 596 600 600 603 607 | | 609 614 614 614 614 614 615 618 631 636 | | 636 638 639 639 643 644 645 646 646 646 | | 649 651 657 659 | | CENSORED DEATHS | | 457 457 457 457 457 457 457 457 457 457 | | | |--------------------------------------------------------------------------------| | DOSE = 625 PPM | | --------------------- | | | | TOTAL 58 UNCENSORED DEATHS 41 CENSORED DEATHS 11 TERMINAL 6 | | | | UNCENSORED DEATHS | | 457 476 478 481 484 489 492 510 535 541 | | 541 541 541 552 555 556 566 569 569 569 | | 569 580 589 595 597 608 614 615 619 629 | | 630 630 631 636 642 650 652 653 653 653 | | 661 | | CENSORED DEATHS | | 457 457 457 457 457 457 457 457 457 457 | | 580 | | | ================================================================================== TETRAFLUOROETHYLENE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 667 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 1250 PPM | | --------------------- | | | | TOTAL 58 UNCENSORED DEATHS 44 CENSORED DEATHS 10 TERMINAL 4 | | | | UNCENSORED DEATHS | | 135 144 366 468 484 484 507 509 513 518 | | 536 541 541 548 552 552 555 563 565 569 | | 580 585 586 586 586 587 588 588 589 597 | | 597 600 606 608 608 608 619 623 626 629 | | 639 642 646 646 | | CENSORED DEATHS | | 457 457 457 457 457 457 457 457 457 457 | | | ================================================================================== TETRAFLUOROETHYLENE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 667 DAYS ================================================================================== | KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) | | | |--------------------------------------------------------------------------------| | DOSE TIME (DAYS) | | 90 180 270 365 425 485 545 605 665 667 (A) | | | |--------------------------------------------------------------------------------| | | | |CONTROL | 100.0 100.0 100.0 100.0 98.3 98.3 92.0 83.6 75.3 75.3 | | | | | | | |312 PPM | 100.0 100.0 100.0 100.0 100.0 93.1 76.2 61.4 8.5 8.5 | | | | | | | |625 PPM | 100.0 100.0 100.0 100.0 100.0 89.9 73.2 47.8 13.0 13.0 | | | | | | | |1250 PPM | 100.0 96.6 96.6 96.6 94.8 88.5 73.8 33.7 8.4 8.4 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | CONTROL 312 PPM 625 PPM 1250 PPM | | | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 75.3% 8.5% 13.0% 8.4% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P<0.001 P<0.001 P<0.001 P<0.001 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 571.0 590.6 575.8 550.4 | |NATURAL DEATHS (C) | (20.7) ( 9.5) ( 9.3) (16.0) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 610.9 572.8 564.8 542.4 | |(STANDARD ERROR) | (11.3) (10.4) ( 9.9) (13.7) | | | | ================================================================================== (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 = 1 312 PPM = 2 625 PPM = 3 1250 PPM = 4 ------------------------------------------------------ SPECIES=MICE SEX=MALE ------------------------------------------------------- Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | 100 + 14 2 3 1 | 4 2 2 4 4 3 3 3 1 1 | 2 4 4 2 1 1 1 | 4 4 3 3 3 22 1 1 90 + 2 4 2 | 3 432 24 1 1 | 22 4 1 1 | 33 322 1 1 80 + 33242 1 1 | 4 4 | 2 2 | P 70 + 3 3 E | 33 22 R | C | 242 E 60 + 33422 N | 2 2 T | 44 22 | 33 4 4 S 50 + 3 3 44 U | 22 R | 3 3 2 2 V | 33 I 40 + 44 V | 33 2 2 A | 22 L | 33 2 2 30 + | | 3 3 2 2 | 4 33 22 20 + 3 3 | 44 | 4433 | 3 3 10 + 44 | 44 33 | 43 3 | 4 4 0 + | ---+-----------+-----------+-----------+-----------+-----------+-----------+-----------+-----------+-----------+-----------+-- 0 10 20 30 40 50 60 70 80 90 100 WEEK NOTE: 27 obs hidden. TETRAFLUOROETHYLENE KAPLAN-MEIER SURVIVAL CURVES CONTROL = 1 312 PPM = 2 625 PPM = 3 1250 PPM = 4 ----------------------------------------------------- SPECIES=MICE SEX=FEMALE ------------------------------------------------------ Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | 100 + 1 4 1 2 3 | 44 4 1 2 23 3 1 | 4 4 331 1 1 | 2 4 332 1 1 90 + 2 2 1 1 | 33 4 22 11 | 3 34 2 2 11 | 3 3 3 1 1 80 + 4 4 11 | 4 4 1 1 | 24 2 2 11 | 33 P 70 + 33 2 2 E | 433 R | 433 C | 22 E 60 + 44 4 N | 3 34 2 2 T | 3 3 | S 50 + 33 U | 33 R | 3 22 V | 44 32 2 I 40 + 44 33 V | A | 22 L | 44 33 30 + | 33 | 4 4 2 23 | 20 + 44 | 4 4 | 33 | 4 2233 10 + 22 | 4 22 | | 0 + | ---+-----------+-----------+-----------+-----------+-----------+-----------+-----------+-----------+-----------+-----------+-- 0 10 20 30 40 50 60 70 80 90 100 WEEK NOTE: 22 obs hidden.