TDMS Study 05212-05 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Battelle Columbus OXAZEPAM DATE: 07/19/96 EXPERIMENT: 05212 TEST: 05 TIME: 17:01:29 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: NO1-ES-15322 ROUTE: DOSED FEED NTP C#: 62453B PATHOLOGIST: RYAN, M. CAS: 604-75-1 ------------------------------------------------------------------------------------------------------------------------------------ CORE STUDY REASONS FOR REMOVAL: 25022 Accidently Killed 25019 Moribund Sacrifice 25020 Natural Death 25021 Terminal Sacrifice REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE 001 0 PPM INCLUDE 002 0 PPM INCLUDE 003 625 PPM INCLUDE 004 625 PPM INCLUDE 007 2500 PPM INCLUDE 008 2500 PPM INCLUDE 009 5000 PPM INCLUDE 010 5000 PPM INCLUDE 011 10,000 PPM STOP INCLUDE 012 10,000 PPM STOP NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Battelle Columbus OXAZEPAM DATE: 07/19/96 EXPERIMENT: 05212 TEST: 05 TIME: 17:01:29 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-15322 ROUTE: DOSED FEED NTP C#: 62453B PATHOLOGIST: RYAN, M. CAS: 604-75-1 OXAZEPAM STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 730 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 33 CENSORED DEATHS 0 TERMINAL 17 | | | | UNCENSORED DEATHS | | 471 480 491 498 517 519 537 541 554 571 | | 585 592 601 608 621 681 682 682 682 684 | | 688 690 690 694 695 695 696 698 698 698 | | 711 716 723 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 625 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 39 CENSORED DEATHS 0 TERMINAL 11 | | | | UNCENSORED DEATHS | | 386 426 448 452 466 473 481 501 523 524 | | 536 536 550 557 571 572 578 585 585 586 | | 586 589 604 614 620 625 628 634 642 651 | | 652 667 682 698 702 709 712 714 722 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 2500 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 44 CENSORED DEATHS 0 TERMINAL 6 | | | | UNCENSORED DEATHS | | 381 400 415 424 440 479 507 526 554 558 | | 568 570 571 576 596 599 600 605 613 613 | | 620 626 633 641 641 653 655 659 659 662 | | 663 663 673 676 680 681 684 687 689 695 | | 701 702 705 716 | | CENSORED DEATHS | | NONE | | | ================================================================================== OXAZEPAM STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 730 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 5000 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 50 CENSORED DEATHS 0 TERMINAL 0 | | | | UNCENSORED DEATHS | | 223 224 237 422 432 439 439 442 451 451 | | 452 467 498 498 507 512 516 519 521 526 | | 528 529 529 529 530 530 541 541 543 550 | | 562 562 562 575 576 577 585 605 605 610 | | 618 620 628 631 634 647 688 705 710 712 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 10,000 PPM STOP | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 50 CENSORED DEATHS 0 TERMINAL 0 | | | | UNCENSORED DEATHS | | 317 480 484 490 498 542 558 564 567 572 | | 584 585 587 590 590 596 596 605 613 613 | | 613 614 614 616 618 620 627 631 634 638 | | 641 641 641 645 647 653 659 670 681 687 | | 690 691 692 694 696 697 702 719 719 722 | | CENSORED DEATHS | | NONE | | | ================================================================================== OXAZEPAM STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 730 DAYS ================================================================================== | KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) | | | |--------------------------------------------------------------------------------| | DOSE TIME (DAYS) | | 90 180 270 365 425 485 545 605 665 730 (A) | | | |--------------------------------------------------------------------------------| | | | |0 PPM | 100.0 100.0 100.0 100.0 100.0 96.0 84.0 74.0 70.0 34.0 | | | | | | | |625 PPM | 100.0 100.0 100.0 100.0 98.0 86.0 76.0 54.0 38.0 22.0 | | | | | | | |2500 PPM | 100.0 100.0 100.0 100.0 92.0 88.0 84.0 64.0 36.0 12.0 | | | | | | | |5000 PPM | 100.0 100.0 94.0 94.0 92.0 76.0 42.0 22.0 8.0 0.0 | | | | | | | |10,000 | 100.0 100.0 100.0 98.0 98.0 94.0 88.0 64.0 26.0 0.0 | |PPM STOP | | | | | ================================================================================== OXAZEPAM STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 730 DAYS =============================================================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |-----------------------------------------------------------------------------------------------------------------------------| | DOSE | | | | 0 PPM 625 PPM 2500 PPM 5000 PPM 10,000 | | PPM STOP | |-----------------------------------------------------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 34.0% 22.0% 12.0% 0.0% 0.0% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P<0.001 P=0.070 P=0.002 P<0.001 P<0.001 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 626.9 584.3 605.9 530.8 616.9 | |NATURAL DEATHS (C) | (14.4) (14.0) (13.5) (15.1) (10.5) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 662.0 616.3 620.8 530.8 616.9 | |(STANDARD ERROR) | (11.7) (13.9) (13.2) (15.1) (10.5) | | | | =============================================================================================================================== (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) OXAZEPAM STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 17 CENSORED DEATHS 1 TERMINAL 32 | | | | UNCENSORED DEATHS | | 223 228 522 529 550 569 571 583 613 641 | | 647 690 696 697 700 701 708 | | CENSORED DEATHS | | 597 | | | |--------------------------------------------------------------------------------| | DOSE = 625 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 24 CENSORED DEATHS 0 TERMINAL 26 | | | | UNCENSORED DEATHS | | 288 400 475 478 550 590 606 612 631 633 | | 634 647 654 666 669 697 708 715 717 718 | | 718 718 718 728 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 2500 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 30 CENSORED DEATHS 0 TERMINAL 20 | | | | UNCENSORED DEATHS | | 414 432 453 506 539 540 550 556 565 578 | | 583 585 589 597 597 611 632 633 634 646 | | 652 669 692 697 700 700 701 703 703 728 | | CENSORED DEATHS | | NONE | | | ================================================================================== OXAZEPAM STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 5000 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 19 CENSORED DEATHS 0 TERMINAL 31 | | | | UNCENSORED DEATHS | | 17 413 550 613 624 631 634 638 641 646 | | 669 675 679 683 700 711 715 715 721 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 10,000 PPM STOP | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 25 CENSORED DEATHS 0 TERMINAL 25 | | | | UNCENSORED DEATHS | | 478 506 562 562 562 570 585 599 604 609 | | 609 646 662 669 669 697 699 703 714 715 | | 716 718 719 725 725 | | CENSORED DEATHS | | NONE | | | ================================================================================== OXAZEPAM 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 | 100.0 100.0 96.0 96.0 96.0 96.0 92.0 84.0 77.9 65.6 | | | | | | | |625 PPM | 100.0 100.0 100.0 98.0 96.0 92.0 92.0 88.0 74.0 52.0 | | | | | | | |2500 PPM | 100.0 100.0 100.0 100.0 98.0 94.0 88.0 70.0 58.0 40.0 | | | | | | | |5000 PPM | 98.0 98.0 98.0 98.0 96.0 96.0 96.0 94.0 80.0 62.0 | | | | | | | |10,000 | 100.0 100.0 100.0 100.0 100.0 98.0 96.0 82.0 74.0 50.0 | |PPM STOP | | | | | ================================================================================== OXAZEPAM STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 729 DAYS =============================================================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |-----------------------------------------------------------------------------------------------------------------------------| | DOSE | | | | 0 PPM 625 PPM 2500 PPM 5000 PPM 10,000 | | PPM STOP | |-----------------------------------------------------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 65.6% 52.0% 40.0% 62.0% 50.0% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.767 P=0.339 P=0.019 P=0.967 P=0.257 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 580.5 623.8 606.2 614.5 640.9 | |NATURAL DEATHS (C) | (36.0) (23.1) (15.3) (37.0) (14.8) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 675.9 678.5 655.3 685.5 685.0 | |(STANDARD ERROR) | (15.7) (13.3) (12.6) (15.9) ( 9.7) | | | | =============================================================================================================================== (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) OXAZEPAM KAPLAN-MEIER SURVIVAL CURVES 0 PPM = 1 625 PPM = 2 2500 PPM = 3 5000 PPM = 4 10,000 PPM STOP = 5 ------------------------------------------------------ SPECIES=RATS SEX=MALE ------------------------------------------------------- Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 112 + | | | 1 4 5 32 3 2 11 96 + 4 4 3 32 2 2 1511 | 343 2 2235 1 1 1 5 P | 44 22 23 1311 55 E | 4 4 2 23 1 151 R 80 + 4 4 2 2 3 1 1 1 C | 4 4 2 22 335 111 E | 444 2 23 531 1 1 N | 4 4 222 33 T 64 + 44 33 | 2 2 333 11 S | 2 22 333 11 U | 222 3 3 R 48 + 4 4 522 3 3 V | 44 222 I | 4 4 22 2 1 11 V | 4 4 55 3232 2 11 1 A 32 + 55 33 222 L | 44 4 5 55 33 | 44 5 533 2 2 2 | 44 33 16 + 444 553 3 | 4 4 3 3 | 4 454 5 | 4455 0 + 4 5 | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 74 obs hidden. OXAZEPAM KAPLAN-MEIER SURVIVAL CURVES 0 PPM = 1 625 PPM = 2 2500 PPM = 3 5000 PPM = 4 10,000 PPM STOP = 5 ----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------ Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 4 1 2 3 5 | 4 11 2 243 3 5 5 | 1 24 3 3 22 3 11 4 5 4 | 2 3 13 1 4 4 P 90 + 331 51 2 44 E | 33 5 5 2 2 R | 3331 1 521 24 C | 3 3 1 14 E 80 + 33 11 4 N | 5 2 1 44 1 T | 3 33 22 524411 | 4 4 S 70 + 3 3 2 114 U | 3 3 2114 R | 5512 1 V | 3 3 54 4 I 60 + 33 V | 3 3 A | 3 33 22 L | 2 2 50 + 5 5 | 33 | | 3 3 40 + 3 3 | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 42 obs hidden.