TDMS Study 93029-03 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: NCTR LEUKOMALACHITE GREEN DATE: 06/18/03 EXPERIMENT: 93029 TEST: 03 TIME: 15:14:50 TEST TYPE: CHRONIC PAGE: 1 CONT: 224-93-00001 ROUTE: DOSED FEED NTP C#: C93029 PATHOLOGIST: MISSING CAS: 129-73-7 ------------------------------------------------------------------------------------------------------------------------------------ REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: NCTR LEUKOMALACHITE GREEN DATE: 06/18/03 EXPERIMENT: 93029 TEST: 03 TIME: 15:14:50 TEST TYPE: CHRONIC CONT: 224-93-00001 ROUTE: DOSED FEED NTP C#: C93029 PATHOLOGIST: MISSING CAS: 129-73-7 LEUKOMALACHITE GREEN STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 733 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0 PPM | | --------------------- | | | | TOTAL 48 UNCENSORED DEATHS 24 CENSORED DEATHS 0 TERMINAL 24 | | | | UNCENSORED DEATHS | | 541 564 564 577 599 613 613 623 632 639 | | 653 659 662 662 666 690 698 701 706 717 | | 718 725 731 732 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 91 PPM | | --------------------- | | | | TOTAL 47 UNCENSORED DEATHS 17 CENSORED DEATHS 0 TERMINAL 30 | | | | UNCENSORED DEATHS | | 487 567 579 604 606 615 620 629 636 667 | | 671 697 709 724 729 729 732 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 272 PPM | | --------------------- | | | | TOTAL 48 UNCENSORED DEATHS 14 CENSORED DEATHS 0 TERMINAL 34 | | | | UNCENSORED DEATHS | | 435 439 477 543 599 629 652 662 668 698 | | 701 703 722 724 | | CENSORED DEATHS | | NONE | | | ================================================================================== LEUKOMALACHITE GREEN STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 733 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 543 PPM | | --------------------- | | | | TOTAL 47 UNCENSORED DEATHS 17 CENSORED DEATHS 0 TERMINAL 30 | | | | UNCENSORED DEATHS | | 475 505 601 645 645 658 660 661 661 676 | | 679 687 698 707 713 717 724 | | CENSORED DEATHS | | NONE | | | ================================================================================== LEUKOMALACHITE GREEN STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 733 DAYS ================================================================================== | KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) | | | |--------------------------------------------------------------------------------| | DOSE TIME (DAYS) | | 90 180 270 365 425 485 545 605 665 733 (A) | | | |--------------------------------------------------------------------------------| | | | |0 PPM | 100.0 100.0 100.0 100.0 100.0 100.0 97.9 89.6 70.8 50.0 | | | | | | | |91 PPM | 100.0 100.0 100.0 100.0 100.0 100.0 97.9 91.5 80.9 63.8 | | | | | | | |272 PPM | 100.0 100.0 100.0 100.0 100.0 93.8 91.7 89.6 83.3 70.8 | | | | | | | |543 PPM | 100.0 100.0 100.0 100.0 100.0 97.9 95.7 93.6 80.9 63.8 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | 0 PPM 91 PPM 272 PPM 543 PPM | | | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 50.0% 63.8% 70.8% 63.8% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.265N P=0.240N P=0.071N P=0.230N | |(LIFE TABLE) | | | | | |MEAN DAY OF | 653.5 647.1 618.0 653.6 | |NATURAL DEATHS (C) | (11.8) (16.7) (27.7) (16.8) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 693.3 701.9 699.5 704.3 | |(STANDARD ERROR) | ( 8.2) ( 8.5) (11.0) ( 8.2) | | | | ================================================================================== (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) LEUKOMALACHITE GREEN STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 734 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0 PPM | | --------------------- | | | | TOTAL 48 UNCENSORED DEATHS 15 CENSORED DEATHS 0 TERMINAL 33 | | | | UNCENSORED DEATHS | | 552 578 585 589 627 635 653 662 662 669 | | 673 714 718 719 719 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 91 PPM | | --------------------- | | | | TOTAL 48 UNCENSORED DEATHS 12 CENSORED DEATHS 0 TERMINAL 36 | | | | UNCENSORED DEATHS | | 60 561 605 625 657 683 690 709 714 716 | | 725 732 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 272 PPM | | --------------------- | | | | TOTAL 48 UNCENSORED DEATHS 13 CENSORED DEATHS 0 TERMINAL 35 | | | | UNCENSORED DEATHS | | 102 470 482 599 626 657 676 698 709 709 | | 709 719 724 | | CENSORED DEATHS | | NONE | | | ================================================================================== LEUKOMALACHITE GREEN STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 734 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 543 PPM | | --------------------- | | | | TOTAL 48 UNCENSORED DEATHS 14 CENSORED DEATHS 0 TERMINAL 34 | | | | UNCENSORED DEATHS | | 405 484 536 570 585 632 633 640 648 654 | | 669 676 719 733 | | CENSORED DEATHS | | NONE | | | ================================================================================== LEUKOMALACHITE GREEN STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS 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 | 100.0 100.0 100.0 100.0 100.0 100.0 100.0 91.7 81.2 68.7 | | | | | | | |91 PPM | 97.9 97.9 97.9 97.9 97.9 97.9 97.9 93.7 89.6 75.0 | | | | | | | |272 PPM | 100.0 97.9 97.9 97.9 97.9 93.7 93.7 91.7 87.5 72.9 | | | | | | | |543 PPM | 100.0 100.0 100.0 100.0 97.9 95.8 93.7 89.6 79.2 70.8 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | 0 PPM 91 PPM 272 PPM 543 PPM | | | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 68.7% 75.0% 72.9% 70.8% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.981 P=0.590N P=0.787N P=1.000N | |(LIFE TABLE) | | | | | |MEAN DAY OF | 650.3 623.1 606.2 613.1 | |NATURAL DEATHS (C) | (14.3) (53.4) (48.2) (24.1) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 707.9 706.3 699.4 698.8 | |(STANDARD ERROR) | ( 7.1) (14.7) (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) LEUKOMALACHITE GREEN KAPLAN-MEIER SURVIVAL CURVES 0 PPM = 1 91 PPM = 2 272 PPM = 3 543 PPM = 4 ------------------------------------------------------ SPECIES=RATS SEX=MALE ------------------------------------------------------- Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | 100 + 1 3 4 2 1 | | 4 2 4 1 1 | 3 3 4 2 2 4 95 + | 3 3 1 1 42 4 | | 3 1 1 90 + 1 1 3 | 22 44 | 223 3 4 | P 85 + 112 3 3 E | 1 1 33 R | 22 C | 11 424 3 E 80 + N | 1 1 33 T | 1 1 | 24 42 S 75 + 4232 3 U | R | 442 2 V | 11 3 3 I 70 + 44 2 2 V | 1 1 A | 44 L | 11 44 65 + 11 | 4 2 | | 60 + 1 1 | | | 11 55 + | 1 1 | | 50 + 1 | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 13 obs hidden. LEUKOMALACHITE GREEN KAPLAN-MEIER SURVIVAL CURVES 0 PPM = 1 91 PPM = 2 272 PPM = 3 543 PPM = 4 ----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------ Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100.00 +1 2 3 4 1 | | 2 3 4 3 4 1 2 1 | 95.83 + 334 4 2 11 2 | | 3 4 4 1 132 2 | P 91.67 + 4 4 13 1 2 E | R | 4 11 2 2 C | E 87.50 + 1 1 322 N | T | 44 1 1 3 23 2 | S 83.33 + 44 3 3 U | R | 44 11 22 V | I 79.17 + 4 11 22 V | A | 41 132 2 L | 75.00 + 4 113 2 | | 43 3 | 70.83 + 4 | | 1 1 | 66.67 + | -+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+ 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 15 obs hidden.