TDMS Study 05182-03 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: TSI Mason Research PHENOLPHTHALEIN DATE: 04/04/96 EXPERIMENT: 05182 TEST: 03 TIME: 03:26:11 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01-ES-05302 ROUTE: DOSED FEED NTP C#: 55798B PATHOLOGIST: VOELKER, FRANK KOVATCH, ROBERT CAS: 77-09-8 ------------------------------------------------------------------------------------------------------------------------------------ REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: TSI Mason Research PHENOLPHTHALEIN DATE: 04/04/96 EXPERIMENT: 05182 TEST: 03 TIME: 03:26:11 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-05302 ROUTE: DOSED FEED NTP C#: 55798B PATHOLOGIST: VOELKER, FRANK KOVATCH, ROBERT CAS: 77-09-8 PHENOLPHTHALEIN STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 29 CENSORED DEATHS 0 TERMINAL 21 | | | | UNCENSORED DEATHS | | 238 330 407 486 490 498 506 520 529 534 | | 553 561 571 577 598 601 608 614 615 617 | | 643 649 671 685 704 708 715 724 727 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 12000 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 35 CENSORED DEATHS 0 TERMINAL 15 | | | | UNCENSORED DEATHS | | 458 470 485 531 538 543 558 561 561 577 | | 591 592 594 610 614 618 624 626 632 633 | | 636 638 646 650 670 679 685 691 693 694 | | 701 710 715 723 728 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 25000 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 35 CENSORED DEATHS 0 TERMINAL 15 | | | | UNCENSORED DEATHS | | 372 383 416 444 482 584 591 601 622 623 | | 623 632 633 634 636 645 654 661 661 664 | | 666 670 671 671 681 681 692 697 698 701 | | 704 710 713 720 727 | | CENSORED DEATHS | | NONE | | | ================================================================================== PHENOLPHTHALEIN STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 50000 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 37 CENSORED DEATHS 0 TERMINAL 13 | | | | UNCENSORED DEATHS | | 485 524 528 541 542 563 570 585 591 594 | | 612 622 624 626 633 636 645 652 654 659 | | 664 664 665 668 671 673 673 685 693 696 | | 700 710 711 717 717 718 720 | | CENSORED DEATHS | | NONE | | | ================================================================================== PHENOLPHTHALEIN STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 729 DAYS ================================================================================== | KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) | | | |--------------------------------------------------------------------------------| | DOSE TIME (DAYS) | | 90 180 270 365 425 485 545 605 665 729 (A) | | | |--------------------------------------------------------------------------------| | | | |0 PPM | 100.0 100.0 98.0 96.0 94.0 94.0 80.0 68.0 56.0 42.0 | | | | | | | |12000 PPM| 100.0 100.0 100.0 100.0 100.0 94.0 88.0 74.0 52.0 30.0 | | | | | | | |25000 PPM| 100.0 100.0 100.0 100.0 94.0 90.0 90.0 84.0 60.0 30.0 | | | | | | | |50000 PPM| 100.0 100.0 100.0 100.0 100.0 98.0 90.0 80.0 54.0 26.0 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | 0 PPM 12000 PPM 25000 PPM 50000 P|M | | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 42.0% 30.0% 30.0% 26.0% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.463 P=0.492 P=0.626 P=0.405 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 575.1 619.3 627.5 638.7 | |NATURAL DEATHS (C) | (21.4) (12.2) (16.0) (10.3) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 639.8 652.2 658.0 662.2 | |(STANDARD ERROR) | (16.4) (11.1) (13.0) ( 9.5) | | | | ================================================================================== (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) PHENOLPHTHALEIN STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 735 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 20 CENSORED DEATHS 0 TERMINAL 30 | | | | UNCENSORED DEATHS | | 370 370 404 439 515 559 594 605 606 606 | | 648 650 659 683 687 700 702 709 723 724 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 12000 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 12 CENSORED DEATHS 0 TERMINAL 38 | | | | UNCENSORED DEATHS | | 435 549 571 628 673 674 675 679 679 705 | | 717 718 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 25000 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 18 CENSORED DEATHS 0 TERMINAL 32 | | | | UNCENSORED DEATHS | | 391 503 568 601 608 616 622 624 647 661 | | 689 690 697 711 717 726 729 730 | | CENSORED DEATHS | | NONE | | | ================================================================================== PHENOLPHTHALEIN STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 735 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 50000 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 12 CENSORED DEATHS 0 TERMINAL 38 | | | | UNCENSORED DEATHS | | 271 330 434 484 491 506 512 581 622 697 | | 712 724 | | CENSORED DEATHS | | NONE | | | ================================================================================== PHENOLPHTHALEIN STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS 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) | | | |--------------------------------------------------------------------------------| | | | |0 PPM | 100.0 100.0 100.0 100.0 94.0 92.0 90.0 84.0 74.0 60.0 | | | | | | | |12000 PPM| 100.0 100.0 100.0 100.0 100.0 98.0 98.0 94.0 92.0 76.0 | | | | | | | |25000 PPM| 100.0 100.0 100.0 100.0 98.0 98.0 96.0 92.0 80.0 64.0 | | | | | | | |50000 PPM| 100.0 100.0 100.0 96.0 96.0 92.0 86.0 84.0 82.0 76.0 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | 0 PPM 12000 PPM 25000 PPM 50000 P|M | | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 60.0% 76.0% 64.0% 76.0% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.278N P=0.108N P=0.679N P=0.166N | |(LIFE TABLE) | | | | | |MEAN DAY OF | 597.7 641.9 640.6 530.3 | |NATURAL DEATHS (C) | (26.4) (24.3) (20.8) (41.8) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 680.1 712.7 701.0 685.9 | |(STANDARD ERROR) | (14.2) ( 8.0) ( 9.8) (15.8) | | | | ================================================================================== (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) PHENOLPHTHALEIN KAPLAN-MEIER SURVIVAL CURVES 0 PPM = 1 12000 PPM = 2 25000 PPM = 3 50000 PPM = 4 ------------------------------------------------------ SPECIES=RATS SEX=MALE ------------------------------------------------------- Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 1 3 2 4 | 1 1 3 3 2 2 4 4 | 1 3 13 3 2 1 42 4 | 3 3 22 90 + 31 1 22 4 3 | 11 2 244 3 3 | 1 11 224 4 33 3 | 11 2 2 P 80 + 1 1 2 2 4 E | 1 1 43 3 R | 111 2 244 C | 1 1 44 E 70 + 22 3 3 N | 11 224 33 T | 11 22 43 3 | 11 4 4 S 60 + 1 1 33 U | 211 R | 21 41 1 V | 2 2 1 1 I 50 + 22 11 V | 223 11 A | 4223 11 L | 223 1 1 40 + 22 | 422 | 222 | 33 30 + 2 2 | | 4 4 | 20 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 45 obs hidden. PHENOLPHTHALEIN KAPLAN-MEIER SURVIVAL CURVES 0 PPM = 1 12000 PPM = 2 25000 PPM = 3 50000 PPM = 4 ----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------ Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 4 1 3 2 | | 4 4 3 2 3 2 | 4 1 1 4 3 2 2 95 + | 1 41 4 2 3 2 | 1 44 1 33 2 2 | P 90 + 4 41 1 33 E | R | 44 1 1 33 C | 4 4 1 1 33 E 85 + N | 4 43 3 T | 4 3 3 2 42 | S 80 + 1 1 3 34242 U | R | 4 4 V | 1 1 33 24 2 I 75 + V | 1 1 3 3 A | 11 33 L | 70 + 11 33 | | 11 3 3 | 11 65 + | 1 1 3 | | 60 + 1 1 | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 6 obs hidden.