TDMS Study 05057-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Mason DATE: 09/08/94 EXP: 05057 HC YELLOW 4 TIME: 04:42:19 TEST: 01 CAGES FROM 0000 TO LAST CAGE PAGE: 1 TEST TYPE: CHRONIC ROUTE: DOSED FEED NTP C#: 56019 CONT: N01ES9561901 CAS: 5982043-8 PATHOLOGIST: K. MURTHY S. EUSTIS -------------------------------------------------------------------------------- REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Mason DATE: 09/08/94 EXP: 05057 HC YELLOW 4 TIME: 04:42:19 TEST: 01 CAGES FROM 0000 TO LAST CAGE TEST TYPE: CHRONIC ROUTE: DOSED FEED NTP C#: 56019 CONT: N01ES9561901 CAS: 5982043-8 PATHOLOGIST: K. MURTHY S. EUSTIS HC YELLOW 4 STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = UNTREATED 61 UM | | ---------------------------- | | | | TOTAL 70 UNCENSORED DEATHS 30 CENSORED DEATHS 19 TERMINAL 21 | | | | UNCENSORED DEATHS | | 288 470 485 508 587 598 605 610 619 625 | | 637 637 639 651 655 658 662 665 666 673 | | 689 694 707 710 710 713 721 722 724 725 | | CENSORED DEATHS | | 175 175 175 175 175 175 176 176 176 176 | | 470 470 470 470 470 470 470 470 470 | | | |--------------------------------------------------------------------------------| | DOSE = 0.25% 61 | | --------------------- | | | | TOTAL 70 UNCENSORED DEATHS 21 CENSORED DEATHS 20 TERMINAL 29 | | | | UNCENSORED DEATHS | | 367 396 467 481 588 619 620 623 626 626 | | 646 653 658 668 672 673 718 723 723 728 | | 728 | | CENSORED DEATHS | | 175 175 175 176 176 176 176 176 176 176 | | 470 470 470 470 470 470 470 470 470 470 | | | |--------------------------------------------------------------------------------| | DOSE = 0.5% 61 | | --------------------- | | | | TOTAL 69 UNCENSORED DEATHS 21 CENSORED DEATHS 20 TERMINAL 28 | | | | UNCENSORED DEATHS | | 367 430 436 553 557 570 588 605 654 658 | | 668 676 680 694 694 694 696 702 704 714 | | 715 | | CENSORED DEATHS | | 175 175 175 175 175 175 176 176 176 176 | | 470 470 470 470 470 470 470 470 470 470 | | | ================================================================================== HC YELLOW 4 STATISTICAL ANALYSIS OF SURVIVAL DATA MALE 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) | | | |--------------------------------------------------------------------------------| | | | |UNTREATED | 100.0 100.0 100.0 98.3 98.3 94.7 92.7 86.8 65.1 41.4 | |61 UM | | | | | |0.25% 61| 100.0 100.0 100.0 100.0 96.7 93.0 93.0 91.0 74.8 58.6 | | | | | | | |0.5% 61 | 100.0 100.0 100.0 100.0 98.3 94.9 94.9 84.6 80.5 57.8 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | UNTREATED 0.25% 61 0.5% 61 | | 61 UM | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 41.4% 58.6% 57.8% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.141N P=0.139N P=0.174N | |(LIFE TABLE) | | | | | |MEAN DAY OF | 635.1 619.2 621.7 | |NATURAL DEATHS (C) | (17.2) (23.1) (22.4) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 576.4 580.0 578.6 | |(STANDARD ERROR) | (23.0) (23.4) (23.7) | | | | ================================================================================== (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) HC YELLOW 4 STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = UNTREATED 61UF | | ---------------------------- | | | | TOTAL 70 UNCENSORED DEATHS 23 CENSORED DEATHS 20 TERMINAL 27 | | | | UNCENSORED DEATHS | | 409 422 447 531 582 600 612 625 645 647 | | 650 658 658 658 692 699 700 701 702 710 | | 710 723 728 | | CENSORED DEATHS | | 182 182 182 183 183 183 183 183 183 183 | | 464 464 464 464 464 464 464 464 464 464 | | | |--------------------------------------------------------------------------------| | DOSE = 0.5% 61 | | --------------------- | | | | TOTAL 70 UNCENSORED DEATHS 19 CENSORED DEATHS 20 TERMINAL 31 | | | | UNCENSORED DEATHS | | 478 544 545 611 612 619 628 664 666 668 | | 672 685 686 710 710 710 710 713 713 | | CENSORED DEATHS | | 182 182 182 182 183 183 183 183 183 183 | | 464 464 464 464 464 464 464 464 464 464 | | | |--------------------------------------------------------------------------------| | DOSE = 1.0% 61 | | --------------------- | | | | TOTAL 70 UNCENSORED DEATHS 16 CENSORED DEATHS 20 TERMINAL 34 | | | | UNCENSORED DEATHS | | 497 531 545 557 632 632 643 650 651 672 | | 686 692 710 715 716 722 | | CENSORED DEATHS | | 182 182 182 182 182 182 182 182 183 183 | | 464 464 464 464 464 464 464 464 464 464 | | | ================================================================================== HC YELLOW 4 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) | | | |--------------------------------------------------------------------------------| | | | |UNTREATED | 100.0 100.0 100.0 100.0 96.7 95.0 93.0 88.9 72.8 54.6 | |61UF | | | | | |0.5% 61 | 100.0 100.0 100.0 100.0 100.0 98.0 94.0 94.0 84.0 62.0 | | | | | | | |1.0% 61 | 100.0 100.0 100.0 100.0 100.0 100.0 94.0 92.0 82.0 68.0 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | UNTREATED 0.5% 61 1.0% 61 | | 61UF | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 54.6% 62.0% 68.0% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.168N P=0.453N P=0.210N | |(LIFE TABLE) | | | | | |MEAN DAY OF | 630.8 649.7 640.7 | |NATURAL DEATHS (C) | (19.7) (15.5) (18.0) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 580.8 591.6 592.8 | |(STANDARD ERROR) | (23.1) (23.1) (23.2) | | | | ================================================================================== (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) HC YELLOW 4 KAPLAN-MEIER SURVIVAL CURVES UNTREATED 61 UM = 1 0.25% 61 = 2 0.5% 61 = 3 ------------------------------------------------------ SPECIES=RATS SEX=MALE ------------------------------------------------------- Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 1 2 | 1 2 2 33 21 1 | 3 2 21 1 3 | 2 1 33 1 P 90 + 3 3 1 11 2 E | 3 3 11 R | 3112 3 C | 11 E 80 + 11 22 3 N | 11 333 T | 112 2 3 3 | 11 S 70 + 1 122 U | 2 22 R | 11 33 V | 11 33 I 60 + 1 11 33 V | 11 32 2 A | 11 L | 50 + 11 | 11 | | 1 1 40 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 20 obs hidden. HC YELLOW 4 KAPLAN-MEIER SURVIVAL CURVES UNTREATED 61UF = 1 0.5% 61 = 2 1.0% 61 = 3 ----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------ Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 1 2 3 | 1 1 | 2 3 3 2 | 1 1 3 3 95 + 1 1 | 2 3 2 | 1 3 1 3 | 1 1 90 + 22 | 1 1 P | 12133 E | 2 33 2 R 85 + 1 1 C | 22 E | 3 3 N | T 80 + 3 3 | 11 S | 2 23 U | 3 3 R 75 + V | 2 23 I | 1 1 V | 11 A 70 + 33 L | | 3 3 | 11 65 + | | 11 2 | 60 + | 1 1 | | 55 + 1 1 | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 7 obs hidden.