TDMS Study 05079-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: LITRI DATE: 09/10/94 EXP: 05079 TALC TIME: 15:25:36 TEST: 01 CAGES FROM 0000 TO LAST CAGE PAGE: 1 TEST TYPE: CHRONIC ROUTE: RESPIRATORY EXPOSURE WHOLE NTP C#: 06008 CONT: CAS: 14807966 PATHOLOGIST: B. JONES F. HAHN -------------------------------------------------------------------------------- REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: LITRI DATE: 09/10/94 EXP: 05079 TALC TIME: 15:25:36 TEST: 01 CAGES FROM 0000 TO LAST CAGE TEST TYPE: CHRONIC ROUTE: RESPIRATORY EXPOSURE WHOLE NTP C#: 06008 CONT: CAS: 14807966 PATHOLOGIST: B. JONES F. HAHN TALC STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 799 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = CONTROL | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 41 CENSORED DEATHS 0 TERMINAL 9 | | | | UNCENSORED DEATHS | | 334 360 429 499 551 568 586 590 593 622 | | 628 631 635 650 656 670 682 682 698 700 | | 700 704 709 724 739 740 741 745 746 747 | | 759 761 764 766 782 784 785 786 787 790 | | 795 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = CONTROL LUNG TOX | | ---------------------------- | | | | TOTAL 22 UNCENSORED DEATHS 11 CENSORED DEATHS 11 TERMINAL 0 | | | | UNCENSORED DEATHS | | 173 320 331 555 584 593 601 660 730 730 | | 731 | | CENSORED DEATHS | | 192 192 194 333 333 556 556 556 738 738 | | 738 | | | |--------------------------------------------------------------------------------| | DOSE = 6 MG/M3 | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 36 CENSORED DEATHS 0 TERMINAL 14 | | | | UNCENSORED DEATHS | | 186 527 529 544 558 573 593 593 604 611 | | 633 648 650 657 663 673 677 690 715 722 | | 728 734 739 740 741 746 747 757 759 761 | | 762 780 781 783 787 791 | | CENSORED DEATHS | | NONE | | | ================================================================================== TALC STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 799 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 6 MG/M3 LUNG TOX | | ---------------------------- | | | | TOTAL 22 UNCENSORED DEATHS 7 CENSORED DEATHS 15 TERMINAL 0 | | | | UNCENSORED DEATHS | | 566 573 616 652 670 706 725 | | CENSORED DEATHS | | 192 193 194 333 333 333 556 556 556 738 | | 738 738 738 738 738 | | | |--------------------------------------------------------------------------------| | DOSE = 18 MG/M3 | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 34 CENSORED DEATHS 0 TERMINAL 16 | | | | UNCENSORED DEATHS | | 248 492 500 594 607 609 614 615 615 617 | | 628 634 645 651 651 653 676 683 697 698 | | 701 705 719 722 737 743 778 783 788 791 | | 791 793 794 798 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 18 MG/M3LUNG TOX | | ---------------------------- | | | | TOTAL 22 UNCENSORED DEATHS 12 CENSORED DEATHS 10 TERMINAL 0 | | | | UNCENSORED DEATHS | | 510 557 568 627 629 651 651 704 718 724 | | 730 731 | | CENSORED DEATHS | | 192 193 194 333 333 333 556 556 738 738 | | | ================================================================================== TALC STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 799 DAYS ================================================================================== | KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) | | | |--------------------------------------------------------------------------------| | DOSE TIME (DAYS) | | 90 180 270 365 425 485 545 605 665 799 (A) | | | |--------------------------------------------------------------------------------| | | | |CONTROL | 100.0 100.0 100.0 96.0 96.0 94.0 92.0 82.0 70.0 18.0 | | | | | | | |CONTROL | 100.0 95.5 95.5 84.8 84.8 84.8 84.8 55.2 47.3 0.0 | |LUNG TOX | | | | | |6 MG/M3 | 100.0 100.0 98.0 98.0 98.0 98.0 92.0 82.0 70.0 28.0 | | | | | | | |6 | 100.0 100.0 100.0 100.0 100.0 100.0 100.0 84.6 69.2 0.0 | |MG/M3 LUNG |OX | | | | |18 MG/M3 | 100.0 100.0 98.0 98.0 98.0 98.0 94.0 92.0 68.0 32.0 | | | | | | | |18 | 100.0 100.0 100.0 100.0 100.0 100.0 93.8 79.3 50.5 0.0 | |MG/M3LUNG T|X | | | | ================================================================================== TALC STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 799 DAYS =============================================================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |-----------------------------------------------------------------------------------------------------------------------------| | DOSE | | | | CONTROL CONTROL 6 MG/M3 6 18 MG/M3 18 | | LUNG TOX MG/M3 LUNG TOX MG/M3LUNG TOX| |-----------------------------------------------------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 18.0% 0.0% 28.0% 0.0% 32.0% 0.0% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.342N ----- P=0.422N P=1.000 P=0.192N P=0.061 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 673.6 546.2 671.7 644.0 669.7 650.0 | |NATURAL DEATHS (C) | (17.8) (57.1) (19.3) (23.4) (18.9) (21.7) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 696.2 506.1 707.4 553.7 711.1 543.9 | |(STANDARD ERROR) | (16.1) (44.1) (16.1) (42.1) (15.4) (41.0) | | | | =============================================================================================================================== (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) TALC STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 862 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = CONTROL | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 39 CENSORED DEATHS 0 TERMINAL 11 | | | | UNCENSORED DEATHS | | 370 390 398 558 568 584 586 599 626 634 | | 647 677 678 688 696 716 719 727 731 762 | | 766 767 768 772 779 786 789 800 805 808 | | 813 816 817 824 827 835 841 846 859 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = CONTROL LUNG TOX | | ---------------------------- | | | | TOTAL 22 UNCENSORED DEATHS 7 CENSORED DEATHS 14 TERMINAL 1 | | | | UNCENSORED DEATHS | | 180 450 622 673 716 718 728 | | CENSORED DEATHS | | 192 193 194 333 333 333 556 556 556 739 | | 739 739 739 739 | | | |--------------------------------------------------------------------------------| | DOSE = 6 MG/M3 | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 36 CENSORED DEATHS 1 TERMINAL 13 | | | | UNCENSORED DEATHS | | 482 508 526 557 561 566 566 647 651 668 | | 678 690 697 705 720 724 729 738 740 747 | | 755 760 762 766 768 786 798 798 799 800 | | 812 815 818 819 841 849 | | CENSORED DEATHS | | 820 | | | ================================================================================== TALC STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 862 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 6 MG/M3 LUNG TOX | | ---------------------------- | | | | TOTAL 22 UNCENSORED DEATHS 4 CENSORED DEATHS 18 TERMINAL 0 | | | | UNCENSORED DEATHS | | 510 625 716 734 | | CENSORED DEATHS | | 192 193 194 333 333 333 556 556 556 739 | | 739 739 739 739 739 739 739 739 | | | |--------------------------------------------------------------------------------| | DOSE = 18 MG/M3 | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 41 CENSORED DEATHS 0 TERMINAL 9 | | | | UNCENSORED DEATHS | | 536 558 586 594 615 633 646 660 661 675 | | 676 678 684 693 697 706 710 716 717 724 | | 739 740 746 747 773 784 786 796 803 822 | | 823 828 829 835 841 841 842 848 850 854 | | 857 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 18 MG/M3LUNG TOX | | ---------------------------- | | | | TOTAL 22 UNCENSORED DEATHS 10 CENSORED DEATHS 12 TERMINAL 0 | | | | UNCENSORED DEATHS | | 376 558 594 621 621 648 650 677 698 726 | | CENSORED DEATHS | | 192 193 194 333 333 333 556 556 556 739 | | 739 739 | | | ================================================================================== TALC STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 862 DAYS ================================================================================== | KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) | | | |--------------------------------------------------------------------------------| | DOSE TIME (DAYS) | | 90 180 270 365 425 485 545 605 665 862 (A) | | | |--------------------------------------------------------------------------------| | | | |CONTROL | 100.0 100.0 100.0 100.0 94.0 94.0 94.0 84.0 78.0 22.0 | | | | | | | |CONTROL | 100.0 95.5 95.5 95.5 95.5 89.1 89.1 89.1 81.0 48.6 | |LUNG TOX | | | | | |6 MG/M3 | 100.0 100.0 100.0 100.0 100.0 98.0 94.0 86.0 82.0 27.7 | | | | | | | |6 | 100.0 100.0 100.0 100.0 100.0 100.0 93.8 93.8 85.9 0.0 | |MG/M3 LUNG |OX | | | | |18 MG/M3 | 100.0 100.0 100.0 100.0 100.0 100.0 98.0 92.0 82.0 18.0 | | | | | | | |18 | 100.0 100.0 100.0 100.0 93.8 93.8 93.8 78.1 46.9 0.0 | |MG/M3LUNG T|X | | | | ================================================================================== TALC STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 862 DAYS =============================================================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |-----------------------------------------------------------------------------------------------------------------------------| | DOSE | | | | CONTROL CONTROL 6 MG/M3 6 18 MG/M3 18 | | LUNG TOX MG/M3 LUNG TOX MG/M3LUNG TOX| |-----------------------------------------------------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 22.0% 48.6% 27.7% 0.0% 18.0% 0.0% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.390 ----- P=0.805N P=0.716N P=0.977 P=0.017 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 709.5 583.9 712.4 646.3 735.3 616.9 | |NATURAL DEATHS (C) | (20.4) (76.6) (16.9) (51.3) (14.0) (31.0) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 743.1 540.5 753.4 567.4 758.1 528.7 | |(STANDARD ERROR) | (18.2) (47.7) (15.4) (44.3) (13.4) (40.3) | | | | =============================================================================================================================== (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) TALC KAPLAN-MEIER SURVIVAL CURVES CONTROL = 1 CONTROL LUNG TOX = 2 6 MG/M3 = 3 6 MG/M3 LUNG TOX = 4 18 MG/M3 = 5 18 MG/M3LUNG TOX = 6 ------------------------------------------------------ SPECIES=RATS SEX=MALE ------------------------------------------------------- Plot of SURVIVAL*WEEK. Symbol is value of DOSE. 100 + 1 2 3 5 1 6 4 | 3 5 1 1 5 3 | 2 2 1 1 516 3 3 6 5 | 1 31344 5 5 90 + 2 2 13 1 | 6 1 13 55 | 2 2 4 11 34 | 1 331 80 + 2 6 2 3113 | 4 11 34 | 1 13 | 113 P 70 + 22 51313 E | 5 151 R | 6 6 3131 3 C | 22 4 4 33 E 60 + 55 N | 11 33 T | 2 2 115133 | 1 1 S 50 + 6 6 33 U | 2 2 5 5 R | 4 11 3 55 V | 6 6 I 40 + 1 1 V | 3 355 A | 66 11 L | 1 1355 30 + 66 | 11 3 | | 22 20 + 11 | 11 | 66 | 10 + | | | 0 + 2 ---+---------+---------+---------+---------+---------+---------+---------+---------+---------+---------+---------+---------+-- 0 10 20 30 40 50 60 70 80 90 100 110 120 WEEK NOTE: 48 obs hidden. TALC KAPLAN-MEIER SURVIVAL CURVES CONTROL = 1 CONTROL LUNG TOX = 2 6 MG/M3 = 3 6 MG/M3 LUNG TOX = 4 18 MG/M3 = 5 18 MG/M3LUNG TOX = 6 ----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------ Plot of SURVIVAL*WEEK. Symbol is value of DOSE. 100 + 1 2 16 3 4 5 | 1 1 3 3 5 5 | 2 611 2 3 3 1 55 4 | 131 5 5 90 + 2 11 525 | 5 5 | 63 161 1 35 4 | 1 3535 80 + 21 1 32 | 6 6 1 13 4 4 | 1133 | 21132 P 70 + 151344 E | 5533 R | 1113 C | 6 6 5513 1 E 60 + 5 3311 N | 22 33 T | 5 31 | 5 11 S 50 + 311 U | 6 6 2 533 2 R | 11 V | 11 5 I 40 + 6 6 311 V | 335 A | 115 L | 6 6 3153 30 + 1133 | 1133 | 11 | 6 6 11 20 + 5 | 55 | | 10 + | | | 0 + 4 ---+--------------+--------------+--------------+--------------+--------------+--------------+--------------+-- 0 20 40 60 80 100 120 140 WEEK NOTE: 60 obs hidden.