TDMS Study 05075-02 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Battelle Columbus DATE: 09/09/94 EXP: 05075 DIPHENYLHYDANTOIN TIME: 16:10:05 TEST: 02 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: S. GRUMBEIN 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: 16:10:05 TEST: 02 CAGES FROM 0000 TO LAST CAGE TEST TYPE: CHRONIC ROUTE: DOSED FEED NTP C#: 55765 CONT: NO1-ES-82151 CAS: 57-41-0 PATHOLOGIST: S. GRUMBEIN S. EUSTIS DIPHENYLHYDANTOIN STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 734 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0 PPM 0-0 | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 11 CENSORED DEATHS 0 TERMINAL 39 | | | | UNCENSORED DEATHS | | 463 540 609 639 650 667 673 678 678 680 | | 683 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = O PPM 10-0 | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 13 CENSORED DEATHS 0 TERMINAL 37 | | | | UNCENSORED DEATHS | | 491 575 576 605 633 633 633 642 646 652 | | 696 716 720 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 30 PPM 1-1 | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 11 CENSORED DEATHS 0 TERMINAL 39 | | | | UNCENSORED DEATHS | | 495 506 546 548 574 584 586 602 669 705 | | 713 | | CENSORED DEATHS | | NONE | | | ================================================================================== DIPHENYLHYDANTOIN STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 734 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 100 PPM 10-3 | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 13 CENSORED DEATHS 1 TERMINAL 36 | | | | UNCENSORED DEATHS | | 585 585 617 632 632 633 660 660 674 678 | | 688 704 725 | | CENSORED DEATHS | | 429 | | | |--------------------------------------------------------------------------------| | DOSE = 100 PPM 3-3 | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 17 CENSORED DEATHS 0 TERMINAL 33 | | | | UNCENSORED DEATHS | | 223 481 535 564 566 573 632 643 645 649 | | 660 660 680 697 713 720 723 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 100 PPM 0-3 | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 9 CENSORED DEATHS 1 TERMINAL 40 | | | | UNCENSORED DEATHS | | 303 412 422 589 590 633 639 678 693 | | CENSORED DEATHS | | 429 | | | ================================================================================== DIPHENYLHYDANTOIN STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 734 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 300 PPM 10-10 | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 6 CENSORED DEATHS 0 TERMINAL 44 | | | | UNCENSORED DEATHS | | 564 641 678 680 710 718 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 300 PPM 0-10 | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 16 CENSORED DEATHS 0 TERMINAL 34 | | | | UNCENSORED DEATHS | | 31 31 31 31 31 31 99 244 408 612 | | 633 644 651 707 712 723 | | CENSORED DEATHS | | NONE | | | ================================================================================== DIPHENYLHYDANTOIN STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE 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) | | | |--------------------------------------------------------------------------------| | | | |0 PPM 0-0| 100.0 100.0 100.0 100.0 100.0 98.0 96.0 96.0 90.0 78.0 | | | | | | | |O | 100.0 100.0 100.0 100.0 100.0 100.0 98.0 92.0 80.0 74.0 | |PPM 10-0| | | | | |30 | 100.0 100.0 100.0 100.0 100.0 100.0 96.0 84.0 84.0 78.0 | |PPM 1-1 | | | | | |100 | 100.0 100.0 100.0 100.0 100.0 100.0 100.0 95.9 83.7 73.5 | |PPM 10-3 | | | | | |100 | 100.0 100.0 98.0 98.0 98.0 96.0 94.0 88.0 76.0 66.0 | |PPM 3-3 | | | | | |100 | 100.0 100.0 100.0 98.0 94.0 94.0 94.0 89.9 85.8 81.7 | |PPM 0-3 | | | | | |300 | 100.0 100.0 100.0 100.0 100.0 100.0 100.0 98.0 96.0 88.0 | |PPM 10-10 | | | | | |300 | 88.0 86.0 84.0 84.0 82.0 82.0 82.0 82.0 74.0 68.0 | |PPM 0-10 | | | | | ================================================================================== DIPHENYLHYDANTOIN STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 734 DAYS =============================================================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |-----------------------------------------------------------------------------------------------------------------------------| | DOSE | | | | 0 PPM 0-0 O 30 100 100 100 300 300 | | PPM 10-0 PPM 1-1 PPM 10-3 PPM 3-3 PPM 0-3 PPM 10-10 PPM 0-10| |-----------------------------------------------------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 78.0% 74.0% 78.0% 73.5% 66.0% 81.7% 88.0% 68.0% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.862N ----- P=1.000 P=0.764 P=0.245 P=0.897N P=0.251N P=0.282 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 632.7 632.2 593.5 651.8 609.6 551.0 665.2 351.2 | |NATURAL DEATHS (C) | (21.3) (17.3) (22.3) (11.9) (29.4) (45.8) (23.1) (76.7) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 711.7 707.5 703.1 706.5 691.7 695.0 725.7 611.5 | |(STANDARD ERROR) | ( 7.5) ( 7.7) ( 9.6) ( 8.2) (12.9) (13.8) ( 4.1) (35.0) | | | | =============================================================================================================================== (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 STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 736 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0 PPM 0-0 | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 14 CENSORED DEATHS 0 TERMINAL 36 | | | | UNCENSORED DEATHS | | 128 373 544 620 621 629 631 645 655 670 | | 670 670 712 726 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 0 PPM 10-0 | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 16 CENSORED DEATHS 0 TERMINAL 34 | | | | UNCENSORED DEATHS | | 364 486 491 528 530 579 580 607 607 617 | | 648 660 673 674 682 703 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 60 PPM 1-1 | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 15 CENSORED DEATHS 0 TERMINAL 35 | | | | UNCENSORED DEATHS | | 395 461 481 544 565 575 587 619 628 633 | | 636 638 682 690 721 | | CENSORED DEATHS | | NONE | | | ================================================================================== DIPHENYLHYDANTOIN STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 736 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 200 PPM 10-3 | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 13 CENSORED DEATHS 0 TERMINAL 37 | | | | UNCENSORED DEATHS | | 411 525 561 635 644 654 656 659 670 675 | | 690 725 735 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 200 PPM 3-3 | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 12 CENSORED DEATHS 0 TERMINAL 38 | | | | UNCENSORED DEATHS | | 185 574 619 625 643 653 660 675 687 702 | | 730 735 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 200 PPM 0-3 | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 12 CENSORED DEATHS 0 TERMINAL 38 | | | | UNCENSORED DEATHS | | 394 465 565 574 636 662 675 680 689 690 | | 717 730 | | CENSORED DEATHS | | NONE | | | ================================================================================== DIPHENYLHYDANTOIN STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 736 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 600 PPM 10-10 | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 10 CENSORED DEATHS 0 TERMINAL 40 | | | | UNCENSORED DEATHS | | 503 587 600 637 642 670 687 719 724 730 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 600 PPM 0-10 | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 13 CENSORED DEATHS 0 TERMINAL 37 | | | | UNCENSORED DEATHS | | 423 568 570 584 627 664 669 681 686 709 | | 716 726 729 | | CENSORED DEATHS | | NONE | | | ================================================================================== DIPHENYLHYDANTOIN STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 736 DAYS ================================================================================== | KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) | | | |--------------------------------------------------------------------------------| | DOSE TIME (DAYS) | | 90 180 270 365 425 485 545 605 665 736 (A) | | | |--------------------------------------------------------------------------------| | | | |0 | 100.0 98.0 98.0 98.0 96.0 96.0 94.0 94.0 82.0 72.0 | |PPM 0-0 | | | | | |0 | 100.0 100.0 100.0 98.0 98.0 98.0 90.0 86.0 76.0 68.0 | |PPM 10-0| | | | | |60 | 100.0 100.0 100.0 100.0 98.0 94.0 92.0 86.0 76.0 70.0 | |PPM 1-1 | | | | | |200 | 100.0 100.0 100.0 100.0 98.0 98.0 96.0 94.0 84.0 74.0 | |PPM 10-3 | | | | | |200 | 100.0 100.0 98.0 98.0 98.0 98.0 98.0 96.0 86.0 76.0 | |PPM 3-3 | | | | | |200 | 100.0 100.0 100.0 100.0 98.0 96.0 96.0 92.0 88.0 76.0 | |PPM 0-3 | | | | | |600 | 100.0 100.0 100.0 100.0 100.0 100.0 98.0 94.0 90.0 80.0 | |PPM 10-10 | | | | | |600 | 100.0 100.0 100.0 100.0 98.0 98.0 98.0 92.0 88.0 74.0 | |PPM 0-10 | | | | | ================================================================================== DIPHENYLHYDANTOIN STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 736 DAYS =============================================================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |-----------------------------------------------------------------------------------------------------------------------------| | DOSE | | | | 0 0 60 200 200 200 600 600 | | PPM 0-0 PPM 10-0 PPM 1-1 PPM 10-3 PPM 3-3 PPM 0-3 PPM 10-10 PPM 0-10| |-----------------------------------------------------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 72.0% 68.0% 70.0% 74.0% 76.0% 76.0% 80.0% 74.0% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.210N ----- P=0.893 P=0.919N P=0.746N P=0.743N P=0.430N P=0.910N | |(LIFE TABLE) | | | | | |MEAN DAY OF | 592.4 589.3 590.3 633.8 624.0 623.1 649.9 642.5 | |NATURAL DEATHS (C) | (42.4) (22.7) (23.3) (24.4) (42.1) (30.1) (22.8) (24.2) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 695.8 689.1 692.3 709.4 709.1 708.9 718.8 711.7 | |(STANDARD ERROR) | (14.8) (12.1) (11.7) ( 8.9) (11.9) ( 9.8) ( 6.6) ( 8.5) | | | | =============================================================================================================================== (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) DIPHENYLHYDANTOIN KAPLAN-MEIER SURVIVAL CURVES 0 PPM 0-0 = 1 O PPM 10-0 = 2 30 PPM 1-1 = 3 100 PPM 10-3 = 4 100 PPM 3-3 = 5 100 PPM 0-3 = 6 300 PPM 10-10 = 7 300 PPM 0-10 = 8 ------------------------------------------------------ SPECIES=MICE SEX=MALE ------------------------------------------------------- Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 8 5 6 1 2 7 4 | | 5 6 6 1 5 2 3 1 7 2 7 | 6 6 5 3 51 4 1 4 7 7 95 + | 6 533 5 2 6 1 4 41 77 P | 3 3 2 211 7 7 E | R 90 + 53 3 6 6 1 1 77 C | E | 8 8 5 46 411 7 7 N | 8 8 3 3 22 6 T 85 + | 8 8 3 22 434 6 S | 8 8 22 311 3 U | 6 6 R 80 + 8 8 52 5 4 4233 V | I | 88 142432 1 V | 88 5 5 A 75 + 4 4 L | 8 5 58 24 2 | 585 | 70 + 558 | | 55 8 | 5 5 65 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 25 obs hidden. DIPHENYLHYDANTOIN KAPLAN-MEIER SURVIVAL CURVES 0 PPM 0-0 = 1 0 PPM 10-0 = 2 60 PPM 1-1 = 3 200 PPM 10-3 = 4 200 PPM 3-3 = 5 200 PPM 0-3 = 6 600 PPM 10-10 = 7 600 PPM 0-10 = 8 ----------------------------------------------------- SPECIES=MICE SEX=FEMALE ------------------------------------------------------ Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 1 5 2 3 4 8 7 | | 1 5 2 1 3 4 8 36 2 7 4 5 7 | 96 + 1 36 322 4 1 45 7 7 5 | | 3 2 2 1 46 8 7 154 | P 92 + 3 36 8 544 E | R | 2 3 2 1164 4 67 C | E 88 + 33 11 5 576 7 N | T | 23 2 3 1 14 48567 7 | S 84 + 33 11 44565 77 U | R | 2 233 1 1485 58 7 7 V | I 80 + 2 2 4 4 586 57 V | A | 332 2 4 64 6 L | 76 + 3 2123 1 4 45 | | 33 1 1 44 | 72 + 223 31 1 | | 2 2 3 3 | 68 + 2 2 | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 47 obs hidden. --multipart-boundary Content-type: text/plain Range: bytes 41831-41831/41831 --multipart-boundary--