TDMS Study 05075-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Battelle Columbus DATE: 09/09/94 EXP: 05075 DIPHENYLHYDANTOIN TIME: 09:36:21 TEST: 01 CAGES FROM 0000 TO LAST CAGE PAGE: 1 TEST TYPE: CHRONIC ROUTE: DOSED FEED NTP C#: 55765 CONT: NO1-ES-82151 CAS: 57-41-0 PATHOLOGIST: M. RYAN S. EUSTIS -------------------------------------------------------------------------------- REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Battelle Columbus DATE: 09/09/94 EXP: 05075 DIPHENYLHYDANTOIN TIME: 09:36:21 TEST: 01 CAGES FROM 0000 TO LAST CAGE TEST TYPE: CHRONIC ROUTE: DOSED FEED NTP C#: 55765 CONT: NO1-ES-82151 CAS: 57-41-0 PATHOLOGIST: M. RYAN S. EUSTIS DIPHENYLHYDANTOIN STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 732 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0 PPM 0-0 | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 24 CENSORED DEATHS 0 TERMINAL 26 | | | | UNCENSORED DEATHS | | 416 532 543 595 611 617 617 623 634 641 | | 645 655 658 659 659 661 667 673 683 688 | | 690 701 716 716 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 0 PPM 10-0 | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 26 CENSORED DEATHS 0 TERMINAL 24 | | | | UNCENSORED DEATHS | | 473 519 530 544 569 570 597 603 613 627 | | 632 646 651 659 662 662 666 666 679 687 | | 688 714 715 718 718 718 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 240 PPM 1-1 | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 17 CENSORED DEATHS 0 TERMINAL 33 | | | | UNCENSORED DEATHS | | 331 340 549 549 603 617 617 630 631 654 | | 654 673 675 683 709 717 723 | | CENSORED DEATHS | | NONE | | | ================================================================================== DIPHENYLHYDANTOIN STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 732 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 800 PPM 0-3 | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 24 CENSORED DEATHS 0 TERMINAL 26 | | | | UNCENSORED DEATHS | | 508 568 571 582 603 605 606 626 627 648 | | 672 676 690 690 704 708 708 709 709 715 | | 715 717 729 730 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 800 PPM 3-3 | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 28 CENSORED DEATHS 0 TERMINAL 22 | | | | UNCENSORED DEATHS | | 426 487 568 606 606 620 626 634 634 645 | | 652 660 661 661 661 664 667 672 673 687 | | 688 689 695 701 701 704 709 729 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 800 PPM 10-3 | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 27 CENSORED DEATHS 0 TERMINAL 23 | | | | UNCENSORED DEATHS | | 243 307 410 501 517 518 533 597 605 617 | | 623 630 643 648 650 652 659 662 680 680 | | 690 694 701 709 711 723 725 | | CENSORED DEATHS | | NONE | | | ================================================================================== DIPHENYLHYDANTOIN STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 732 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 2400 PPM 0-10 | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 28 CENSORED DEATHS 0 TERMINAL 22 | | | | UNCENSORED DEATHS | | 209 425 438 475 490 494 515 596 609 617 | | 629 631 642 647 662 666 667 680 683 687 | | 689 695 696 697 711 722 725 725 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 2400 PPM10-10 | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 19 CENSORED DEATHS 0 TERMINAL 31 | | | | UNCENSORED DEATHS | | 399 428 561 568 581 597 617 620 639 648 | | 655 657 657 665 674 709 715 723 725 | | CENSORED DEATHS | | NONE | | | ================================================================================== DIPHENYLHYDANTOIN STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 732 DAYS ================================================================================== | KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) | | | |--------------------------------------------------------------------------------| | DOSE TIME (DAYS) | | 90 180 270 365 425 485 545 605 665 732 (A) | | | |--------------------------------------------------------------------------------| | | | |0 PPM 0-0| 100.0 100.0 100.0 100.0 98.0 98.0 94.0 92.0 68.0 52.0 | | | | | | | |0 | 100.0 100.0 100.0 100.0 100.0 98.0 92.0 84.0 68.0 48.0 | |PPM 10-0 | | | | | |240 | 100.0 100.0 100.0 96.0 96.0 96.0 96.0 90.0 78.0 66.0 | |PPM 1-1 | | | | | |800 | 100.0 100.0 100.0 100.0 100.0 100.0 98.0 88.0 80.0 52.0 | |PPM 0-3 | | | | | |800 | 100.0 100.0 100.0 100.0 100.0 98.0 96.0 94.0 68.0 44.0 | |PPM 3-3 | | | | | |800 | 100.0 100.0 98.0 96.0 94.0 94.0 86.0 82.0 64.0 46.0 | |PPM 10-3 | | | | | |2400 | 100.0 100.0 98.0 98.0 96.0 92.0 86.0 84.0 70.0 44.0 | |PPM 0-10 | | | | | |2400 | 100.0 100.0 100.0 100.0 98.0 96.0 96.0 88.0 72.0 62.0 | |PPM10-10 | | | | | ================================================================================== DIPHENYLHYDANTOIN STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 732 DAYS =============================================================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |-----------------------------------------------------------------------------------------------------------------------------| | DOSE | | | | 0 PPM 0-0 0 240 800 800 800 2400 2400 | | PPM 10-0 PPM 1-1 PPM 0-3 PPM 3-3 PPM 10-3 PPM 0-10 PPM10-10 | |-----------------------------------------------------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 52.0% 48.0% 66.0% 52.0% 44.0% 46.0% 44.0% 62.0% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.979 ----- P=0.238N P=0.895N P=0.656 P=0.607 P=0.550 P=0.441N | |(LIFE TABLE) | | | | | |MEAN DAY OF | 637.5 635.6 609.1 659.0 647.4 604.7 611.5 623.1 | |NATURAL DEATHS (C) | (13.5) (13.3) (27.8) (12.7) (12.4) (23.6) (22.6) (20.4) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 686.6 681.9 690.2 697.0 684.6 663.3 664.5 690.6 | |(STANDARD ERROR) | ( 9.3) ( 9.7) (12.5) ( 8.0) ( 9.1) (15.5) (15.2) (10.7) | | | | =============================================================================================================================== (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) DIPHENYLHYDANTOIN STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0 PPM 0-0 | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 19 CENSORED DEATHS 0 TERMINAL 31 | | | | UNCENSORED DEATHS | | 116 388 421 470 484 513 586 593 595 602 | | 629 655 657 659 677 684 698 700 700 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 0 PPM 10-0 | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 21 CENSORED DEATHS 0 TERMINAL 29 | | | | UNCENSORED DEATHS | | 325 388 599 606 627 627 630 644 650 652 | | 659 661 683 685 692 698 699 707 707 711 | | 717 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 240 PPM 1-1 | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 23 CENSORED DEATHS 0 TERMINAL 27 | | | | UNCENSORED DEATHS | | 425 519 536 573 575 593 621 627 630 634 | | 634 634 634 673 681 684 690 690 692 698 | | 700 707 715 | | CENSORED DEATHS | | NONE | | | ================================================================================== DIPHENYLHYDANTOIN STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 800 PPM 0-3 | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 13 CENSORED DEATHS 0 TERMINAL 37 | | | | UNCENSORED DEATHS | | 248 255 470 509 586 602 609 611 624 654 | | 672 697 711 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 800 PPM 3-3 | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 21 CENSORED DEATHS 0 TERMINAL 29 | | | | UNCENSORED DEATHS | | 439 512 519 536 600 606 609 630 637 659 | | 662 671 676 676 690 690 699 699 702 707 | | 718 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 800 PPM 10-3 | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 17 CENSORED DEATHS 0 TERMINAL 33 | | | | UNCENSORED DEATHS | | 491 558 571 573 592 595 600 616 639 648 | | 659 685 686 698 704 704 707 | | CENSORED DEATHS | | NONE | | | ================================================================================== DIPHENYLHYDANTOIN STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 2400 PPM 0-10 | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 12 CENSORED DEATHS 0 TERMINAL 38 | | | | UNCENSORED DEATHS | | 499 575 620 622 623 643 671 683 693 699 | | 700 707 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 2400 PPM 10-10 | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 14 CENSORED DEATHS 5 TERMINAL 31 | | | | UNCENSORED DEATHS | | 395 540 544 582 587 593 593 630 643 671 | | 671 672 711 714 | | CENSORED DEATHS | | 128 128 128 128 128 | | | ================================================================================== DIPHENYLHYDANTOIN STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE 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 0-0| 100.0 98.0 98.0 98.0 94.0 90.0 88.0 80.0 72.0 62.0 | | | | | | | |0 | 100.0 100.0 100.0 98.0 96.0 96.0 96.0 94.0 76.0 58.0 | |PPM 10-0 | | | | | |240 | 100.0 100.0 100.0 100.0 98.0 98.0 94.0 88.0 74.0 54.0 | |PPM 1-1 | | | | | |800 | 100.0 100.0 96.0 96.0 96.0 94.0 92.0 88.0 80.0 74.0 | |PPM 0-3 | | | | | |800 | 100.0 100.0 100.0 100.0 100.0 98.0 92.0 90.0 78.0 58.0 | |PPM 3-3 | | | | | |800 | 100.0 100.0 100.0 100.0 100.0 100.0 98.0 86.0 78.0 66.0 | |PPM 10-3 | | | | | |2400 | 100.0 100.0 100.0 100.0 100.0 100.0 98.0 96.0 88.0 76.0 | |PPM 0-10 | | | | | |2400 | 100.0 100.0 100.0 100.0 97.8 97.8 93.3 84.4 80.0 68.9 | |PPM 10-10| | | | | ================================================================================== DIPHENYLHYDANTOIN STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 729 DAYS =============================================================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |-----------------------------------------------------------------------------------------------------------------------------| | DOSE | | | | 0 PPM 0-0 0 240 800 800 800 2400 2400 | | PPM 10-0 PPM 1-1 PPM 0-3 PPM 3-3 PPM 10-3 PPM 0-10 PPM 10-|0 |-----------------------------------------------------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 62.0% 58.0% 54.0% 74.0% 58.0% 66.0% 76.0% 68.9% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.038N ----- P=0.676 P=0.288N P=1.000 P=0.693N P=0.140N P=0.564N | |(LIFE TABLE) | | | | | |MEAN DAY OF | 569.8 636.5 633.3 557.5 635.1 630.9 644.6 610.4 | |NATURAL DEATHS (C) | (33.6) (21.8) (14.9) (42.0) (16.6) (15.3) (17.9) (22.4) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 668.5 690.2 685.0 684.4 689.6 695.7 708.7 635.7 | |(STANDARD ERROR) | (16.7) (11.1) ( 9.6) (15.1) ( 9.6) ( 8.4) ( 6.6) (26.0) | | | | =============================================================================================================================== (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) DIPHENYLHYDANTOIN KAPLAN-MEIER SURVIVAL CURVES 0 PPM 0-0 = 1 0 PPM 10-0 = 2 240 PPM 1-1 = 3 800 PPM 0-3 = 4 800 PPM 3-3 = 5 800 PPM 10-3 = 6 2400 PPM 0-10 = 7 2400 PPM10-10 = 8 ------------------------------------------------------ SPECIES=RATS SEX=MALE ------------------------------------------------------- Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 104 + | | 1 7 6 3 8 15 2 4 | 7 6 6 33 8 158 2 5 4 21 4 96 + 6 3 6 787 5 21 13 85 | 6 7 7 6 2 1 84 4 1 5 | 7 7 6 6 23 284 1 31 | 77 8 8311 P 88 + 7 6 6 2 2 55 E | 7 6 22 335 R | 6221318 C | 62621143 E 80 + 722115 4 N | 662 11 543 T | 676 4 4 | 621 1 33 S 72 + 7 7 834 43 U | 66 778 433 R | 6 11 833 V | 117 83 3 I 64 + 6211 V | 211 448 8 A | 66 L | 1612 56 + 55121 4 | 556 | 7 71 1 | 6 6 48 + 552 2 | 5 6 5 | 7 5 | 40 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 90 obs hidden. DIPHENYLHYDANTOIN KAPLAN-MEIER SURVIVAL CURVES 0 PPM 0-0 = 1 0 PPM 10-0 = 2 240 PPM 1-1 = 3 800 PPM 0-3 = 4 800 PPM 3-3 = 5 800 PPM 10-3 = 6 2400 PPM 0-10 = 7 2400 PPM 10-10 = 8 ----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------ Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 104 + | | 1 1 4 2 8 3 5 67 | 1 44 2 18 3 5 67 5 3 8 6 7 96 + 4 1 1 4 5 3 3 6 67 2 7 | 1 1 4 5 38 3 8 22 P | 1 1 4 5 334 652 2 E | 1 1 34 345 7 7 R 88 + 1 1 344 3 7 7 C | 1 164432 2 7 7 E | 8 4 4522 77 N | 11 33622 5 77 T 80 + 1 1 862 24 | 1 1 54 6 47 S | 2552 474 7 U | 3 1 1836 6 4 4 R 72 + 1 12266 V | 1122 I | 131 8 8 V | 22 6 A 64 + 55 L | 3122 1 | 522 | 33 2 2 56 + 3 3 | 3 3 | | 48 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 51 obs hidden.