TDMS Study 05103-05 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Southern Research Inst 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 TIME: 20:09:59 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01-ES-85234 ROUTE: DOSED FEED NTP C#: 55516C PATHOLOGIST: DR. D. FARNELL CAS: 3296-90-0 ------------------------------------------------------------------------------------------------------------------------------------ REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Southern Research Inst 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL DATE: 05/19/95 EXPERIMENT: 05103 TEST: 05 TIME: 20:09:59 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-85234 ROUTE: DOSED FEED NTP C#: 55516C PATHOLOGIST: DR. D. FARNELL CAS: 3296-90-0 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 736 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = UNTREATD CONTROL | | ---------------------------- | | | | TOTAL 70 UNCENSORED DEATHS 25 CENSORED DEATHS 19 TERMINAL 26 | | | | UNCENSORED DEATHS | | 334 467 481 519 608 619 619 628 629 631 | | 659 660 663 675 675 675 682 696 697 703 | | 716 721 722 725 726 | | CENSORED DEATHS | | 92 92 92 92 92 92 92 92 92 92 | | 456 456 456 456 456 456 456 456 456 | | | |--------------------------------------------------------------------------------| | DOSE = 0.25% | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 33 CENSORED DEATHS 7 TERMINAL 20 | | | | UNCENSORED DEATHS | | 235 450 451 467 480 512 512 537 543 548 | | 555 568 576 586 586 610 620 645 648 659 | | 660 662 675 675 681 681 695 696 711 716 | | 723 725 726 | | CENSORED DEATHS | | 456 456 456 456 456 456 456 | | | |--------------------------------------------------------------------------------| | DOSE = 0.50% | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 38 CENSORED DEATHS 9 TERMINAL 13 | | | | UNCENSORED DEATHS | | 451 536 536 564 576 592 605 608 608 620 | | 621 621 627 633 641 641 641 645 654 656 | | 662 666 666 673 681 684 684 689 694 695 | | 696 696 697 697 703 722 726 731 | | CENSORED DEATHS | | 456 456 456 456 456 456 456 456 456 | | | ================================================================================== 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 736 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 1.00% | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 54 CENSORED DEATHS 5 TERMINAL 1 | | | | UNCENSORED DEATHS | | 149 381 393 432 451 471 495 509 513 516 | | 523 541 542 544 549 556 567 567 567 568 | | 570 570 574 576 576 577 585 586 598 604 | | 608 610 619 619 619 620 620 643 647 654 | | 658 662 662 670 681 682 687 690 695 697 | | 709 711 723 733 | | CENSORED DEATHS | | 456 456 456 456 456 | | | |--------------------------------------------------------------------------------| | DOSE = 2.00% | | --------------------- | | | | TOTAL 70 UNCENSORED DEATHS 60 CENSORED DEATHS 10 TERMINAL 0 | | | | UNCENSORED DEATHS | | 222 365 366 388 396 402 410 424 425 432 | | 432 439 451 471 471 490 507 507 511 513 | | 513 516 516 519 520 521 522 522 527 530 | | 537 572 575 576 579 585 586 591 592 592 | | 605 610 619 619 619 620 621 625 647 653 | | 654 659 659 660 663 677 703 704 704 726 | | CENSORED DEATHS | | 92 92 92 92 92 92 92 92 92 92 | | | ================================================================================== 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS 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) | | | |--------------------------------------------------------------------------------| | | | |UNTREATD | 100.0 100.0 100.0 98.3 98.3 94.4 92.4 92.4 74.7 51.1 | |CONTROL | | | | | |0.25% | 100.0 100.0 98.3 98.3 98.3 91.2 83.6 72.2 58.9 38.0 | | | | | | | |0.50% | 100.0 100.0 100.0 100.0 100.0 98.3 94.4 86.5 59.0 25.6 | | | | | | | |1.00% | 100.0 98.3 98.3 98.3 95.0 89.8 75.2 45.8 22.0 1.8 | | | | | | | |2.00% | 100.0 100.0 98.3 96.7 85.0 75.0 48.3 31.7 8.3 0.0 | | | | | | | ================================================================================== 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 736 DAYS =============================================================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |-----------------------------------------------------------------------------------------------------------------------------| | DOSE | | | | UNTREATD 0.25% 0.50% 1.00% 2.00% | | CONTROL | |-----------------------------------------------------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 51.1% 38.0% 25.6% 1.8% 0.0% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P<0.001 P=0.124 P=0.010 P<0.001 P<0.001 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 637.2 600.4 645.7 584.6 544.3 | |NATURAL DEATHS (C) | (19.0) (18.7) ( 9.6) (13.8) (13.3) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 572.7 628.8 636.8 576.4 479.7 | |(STANDARD ERROR) | (26.7) (15.4) (12.5) (13.5) (22.2) | | | | =============================================================================================================================== (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) 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 738 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = UNTREATD CONTROL | | ---------------------------- | | | | TOTAL 60 UNCENSORED DEATHS 14 CENSORED DEATHS 10 TERMINAL 36 | | | | UNCENSORED DEATHS | | 460 481 516 624 633 654 689 690 694 696 | | 696 708 716 722 | | CENSORED DEATHS | | 456 456 456 456 456 456 456 456 456 456 | | | |--------------------------------------------------------------------------------| | DOSE = 0.25% | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 24 CENSORED DEATHS 9 TERMINAL 27 | | | | UNCENSORED DEATHS | | 404 460 509 609 619 645 656 676 680 683 | | 684 684 695 695 697 701 704 709 719 722 | | 723 723 725 725 | | CENSORED DEATHS | | 456 456 456 456 456 456 456 456 456 | | | |--------------------------------------------------------------------------------| | DOSE = 0.50% | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 30 CENSORED DEATHS 7 TERMINAL 23 | | | | UNCENSORED DEATHS | | 388 409 432 481 508 565 576 585 610 627 | | 631 632 633 660 662 670 670 673 682 683 | | 694 695 695 696 697 697 704 719 726 728 | | CENSORED DEATHS | | 456 456 456 456 456 456 456 | | | ================================================================================== 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 738 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 1.00% | | --------------------- | | | | TOTAL 60 UNCENSORED DEATHS 47 CENSORED DEATHS 8 TERMINAL 5 | | | | UNCENSORED DEATHS | | 369 432 460 474 509 516 523 540 551 574 | | 577 585 585 592 592 594 598 610 610 619 | | 625 625 627 630 631 631 634 645 659 660 | | 660 670 680 682 682 683 683 684 684 689 | | 694 694 709 722 725 725 726 | | CENSORED DEATHS | | 456 456 456 456 456 456 456 456 | | | ================================================================================== 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 738 DAYS ================================================================================== | KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) | | | |--------------------------------------------------------------------------------| | DOSE TIME (DAYS) | | 90 180 270 365 425 485 545 605 665 738 (A) | | | |--------------------------------------------------------------------------------| | | | |UNTREATD | 100.0 100.0 100.0 100.0 100.0 96.0 94.0 94.0 88.0 72.0 | |CONTROL | | | | | |0.25% | 100.0 100.0 100.0 100.0 98.3 96.4 94.4 94.4 86.5 53.1 | | | | | | | |0.50% | 100.0 100.0 100.0 100.0 96.7 93.1 91.2 85.5 72.2 43.7 | | | | | | | |1.00% | 100.0 100.0 100.0 100.0 98.3 92.8 85.1 67.7 40.6 9.7 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | UNTREATD 0.25% 0.50% 1.00% | | CONTROL | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 72.0% 53.1% 43.7% 9.7% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P<0.001 P=0.095 P=0.004 P<0.001 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 641.4 660.3 627.6 618.5 | |NATURAL DEATHS (C) | (24.0) (17.5) (17.4) (11.8) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 668.5 664.6 649.9 606.8 | |(STANDARD ERROR) | (14.5) (14.1) (14.3) (12.8) | | | | ================================================================================== (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) 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL KAPLAN-MEIER SURVIVAL CURVES UNTREATD CONTROL = 1 0.25% = 2 0.50% = 3 1.00% = 4 2.00% = 5 ------------------------------------------------------ SPECIES=RATS SEX=MALE ------------------------------------------------------- Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | 100 + 1 4 5 2 1 3 | 4 5 2 1 5 4 4 2 1 1 3 | 5 54 4 2 2 1 1 3 3 | 555 4 4 242 1 3 3 1 90 + 55 42 4 2 3 3 1 1 | 5 5 4 42 2 3 3 11 | 55 44 22 | 55 4 4 222 3 311 80 + 5 5 4 4 2 2 1 1 | 5 5 22 33 | 5 5 44 22 33 1 1 | 5 5 444 2 2 33 P 70 + 22 11 E | 55 2 32 1 1 R | 44 23 2 C | 5 5 11 E 60 + 3 232 1 1 N | 44 11 T | 322 | 55 44 32 2 S 50 + 55 4 4 1 1 U | 5 55 44 332 2 R | 44 33 22 V | 55 44 22 I 40 + V | 5 5 2 2 A | L | 5 554 4 33 3 30 + 55 444 | 3 3 | 4 4 33 | 55 44 20 + 5 5 4 4 | 55 44 | 5 5 | 44 10 + 4 4 | 5 5 5 | 4 4 | 5 4 44 0 + 5 --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 24 obs hidden. 2,2-BIS(BROMOMETHYL)-1,3-PROPANEDIOL KAPLAN-MEIER SURVIVAL CURVES UNTREATD CONTROL = 1 0.25% = 2 0.50% = 3 1.00% = 4 ----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------ Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 4 3 2 1 | 4 3 23 3 1 1 2 | 3 4 41 21 2 1 | 43 3 2 211 90 + 34 4 3 3 2 1 21 | 4 4 33 21 2 1 | 44 3 3 2211 | 4 4 3 33 80 + 444 | 2 1 1 P | 4 4 3 3 111 E | 33 1 1 R 70 + 44 22 C | 4 4 333 22 E | 44 22 N | 44 3 3 22 T 60 + | S | 44 U | 33 2 2 R 50 + 3 3 V | 4 4 4 33 I | V | 3 3 A 40 + 44 L | 4 4 | | 30 + | | 44 | 44 20 + 4 4 | 4 4 | | 10 + 4 4 | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 23 obs hidden.