TDMS Study 05087-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Battelle Columbus DATE: 09/11/94 EXP: 05087 TRIAMTERENE TIME: 11:30:08 TEST: 01 CAGES FROM 0000 TO LAST CAGE PAGE: 1 TEST TYPE: CHRONIC ROUTE: DOSED FEED NTP C#: 56042B CONT: N01-ES-45041 CAS: 396-01-0 PATHOLOGIST: M. RYAN S. EUSTIS -------------------------------------------------------------------------------- REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Battelle Columbus DATE: 09/11/94 EXP: 05087 TRIAMTERENE TIME: 11:30:08 TEST: 01 CAGES FROM 0000 TO LAST CAGE TEST TYPE: CHRONIC ROUTE: DOSED FEED NTP C#: 56042B CONT: N01-ES-45041 CAS: 396-01-0 PATHOLOGIST: M. RYAN S. EUSTIS TRIAMTERENE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0 PPM | | --------------------- | | | | TOTAL 70 UNCENSORED DEATHS 22 CENSORED DEATHS 23 TERMINAL 25 | | | | UNCENSORED DEATHS | | 336 470 484 488 508 530 539 584 617 624 | | 645 653 655 659 675 681 702 709 714 719 | | 725 726 | | CENSORED DEATHS | | 83 83 83 93 93 94 94 94 95 95 | | 96 96 96 456 456 456 456 456 456 456 | | 456 456 456 | | | |--------------------------------------------------------------------------------| | DOSE = 150 PPM | | --------------------- | | | | TOTAL 70 UNCENSORED DEATHS 25 CENSORED DEATHS 20 TERMINAL 25 | | | | UNCENSORED DEATHS | | 324 366 539 542 610 610 611 611 617 619 | | 640 652 653 655 659 660 674 674 683 702 | | 702 710 713 715 722 | | CENSORED DEATHS | | 93 94 94 94 94 95 96 96 96 96 | | 456 456 456 456 456 456 456 456 456 456 | | | |--------------------------------------------------------------------------------| | DOSE = 300 PPM | | --------------------- | | | | TOTAL 70 UNCENSORED DEATHS 31 CENSORED DEATHS 20 TERMINAL 19 | | | | UNCENSORED DEATHS | | 531 539 541 552 572 592 617 626 626 635 | | 649 666 668 670 671 672 680 688 691 693 | | 693 694 698 701 702 702 705 713 718 719 | | 726 | | CENSORED DEATHS | | 93 93 94 94 94 95 96 96 96 96 | | 456 456 456 456 456 456 456 456 456 456 | | | ================================================================================== TRIAMTERENE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 600 PPM | | --------------------- | | | | TOTAL 70 UNCENSORED DEATHS 23 CENSORED DEATHS 20 TERMINAL 27 | | | | UNCENSORED DEATHS | | 368 508 519 522 542 558 589 592 616 634 | | 645 653 668 674 675 680 687 695 702 703 | | 709 712 715 | | CENSORED DEATHS | | 93 93 93 94 94 95 95 95 95 96 | | 456 456 456 456 456 456 456 456 456 456 | | | ================================================================================== TRIAMTERENE 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) | | | |--------------------------------------------------------------------------------| | | | |0 PPM | 100.0 100.0 100.0 98.2 98.2 94.0 85.4 83.3 70.5 53.4 | | | | | | | |150 PPM | 100.0 100.0 100.0 98.3 96.7 96.7 92.6 92.6 68.5 50.3 | | | | | | | |300 PPM | 100.0 100.0 100.0 100.0 100.0 100.0 94.0 88.0 78.0 38.0 | | | | | | | |600 PPM | 100.0 100.0 100.0 100.0 98.3 98.3 90.3 84.3 76.3 54.2 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | 0 PPM 150 PPM 300 PPM 600 PPM | | | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 53.4% 50.3% 38.0% 54.2% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=1.000N P=0.901 P=0.287 P=1.000N | |(LIFE TABLE) | | | | | |MEAN DAY OF | 611.0 626.5 656.5 624.6 | |NATURAL DEATHS (C) | (22.4) (19.6) (10.5) (18.3) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 534.6 562.8 567.3 565.0 | |(STANDARD ERROR) | (28.5) (26.2) (25.8) (26.2) | | | | ================================================================================== (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) TRIAMTERENE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0 PPM | | --------------------- | | | | TOTAL 70 UNCENSORED DEATHS 21 CENSORED DEATHS 20 TERMINAL 29 | | | | UNCENSORED DEATHS | | 451 534 554 571 573 596 660 671 673 676 | | 676 680 698 704 704 704 705 707 708 715 | | 725 | | CENSORED DEATHS | | 93 93 94 94 94 95 95 96 96 96 | | 456 456 456 456 456 456 456 456 456 456 | | | |--------------------------------------------------------------------------------| | DOSE = 150 PPM | | --------------------- | | | | TOTAL 70 UNCENSORED DEATHS 16 CENSORED DEATHS 20 TERMINAL 34 | | | | UNCENSORED DEATHS | | 476 522 592 600 611 643 662 666 676 700 | | 701 708 708 715 715 719 | | CENSORED DEATHS | | 93 93 93 93 94 95 95 95 95 95 | | 456 456 456 456 456 456 456 456 456 456 | | | |--------------------------------------------------------------------------------| | DOSE = 300 PPM | | --------------------- | | | | TOTAL 70 UNCENSORED DEATHS 16 CENSORED DEATHS 20 TERMINAL 34 | | | | UNCENSORED DEATHS | | 378 383 397 619 628 635 652 662 680 682 | | 689 689 696 704 707 723 | | CENSORED DEATHS | | 93 93 93 94 94 95 95 96 96 96 | | 456 456 456 456 456 456 456 456 456 456 | | | ================================================================================== TRIAMTERENE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 600 PPM | | --------------------- | | | | TOTAL 70 UNCENSORED DEATHS 21 CENSORED DEATHS 20 TERMINAL 29 | | | | UNCENSORED DEATHS | | 466 509 530 541 542 589 619 620 620 634 | | 647 648 648 685 695 698 698 707 707 709 | | 715 | | CENSORED DEATHS | | 93 93 93 94 94 95 95 95 96 96 | | 456 456 456 456 456 456 456 456 456 456 | | | ================================================================================== TRIAMTERENE 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 | 100.0 100.0 100.0 100.0 100.0 98.3 96.3 88.3 86.3 58.2 | | | | | | | |150 PPM | 100.0 100.0 100.0 100.0 100.0 98.0 96.0 92.0 86.0 68.0 | | | | | | | |300 PPM | 100.0 100.0 100.0 100.0 95.0 95.0 95.0 95.0 84.9 68.7 | | | | | | | |600 PPM | 100.0 100.0 100.0 100.0 100.0 98.0 90.0 88.0 74.0 58.0 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | 0 PPM 150 PPM 300 PPM 600 PPM | | | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 58.2% 68.0% 68.7% 58.0% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.722 P=0.383N P=0.455N P=0.985 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 651.7 650.9 620.3 629.9 | |NATURAL DEATHS (C) | (16.3) (18.3) (30.0) (16.3) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 576.2 581.4 574.5 569.6 | |(STANDARD ERROR) | (26.4) (26.6) (26.9) (26.2) | | | | ================================================================================== (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) TRIAMTERENE KAPLAN-MEIER SURVIVAL CURVES 0 PPM = 1 150 PPM = 2 300 PPM = 3 600 PPM = 4 ------------------------------------------------------ SPECIES=RATS SEX=MALE ------------------------------------------------------- Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 21 4 3 | 21 2 1 4 432 | 1 1 223 | 1 1 4 23 3 2 90 + 1 1 4 4 3 3 | 11 4 3 3 P | 1 1 4 223 E | 1 4133 R 80 + 11321 C | 211 3 E | 44 N | 1 1 T 70 + 1 14 | 23114 S | 213411 U | 2 2 R 60 + 411 V | 332211 I | 3322 4 V | 21 1 A 50 + 2 2 L | | 333 | 40 + 33 | 3 3 | | 30 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 44 obs hidden. TRIAMTERENE KAPLAN-MEIER SURVIVAL CURVES 0 PPM = 1 150 PPM = 2 300 PPM = 3 600 PPM = 4 ----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------ Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 3 1 42 | 3 3 1 1 | 42 4 2 | 3 3 4 241 1 2 95 + 3 3 | 4 4 1 1 22 | 2 233 | 33 90 + 4 1 41 2 2 | 1 3 3 1 P | 4 4 2 3 2 E | 11 R 85 + 3 3 C | 11 E | 4 4 2 2 N | 33 T 80 + 4 4 22 | 11 S | 22 U | 131 R 75 + 33 V | 4 4 1122 I | 4 4 V | 3 3 A 70 + L | 3 3 | 2 2 | 44 65 + | 11 | 411 | 60 + 411 | 1 1 | 4 4 | 55 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 11 obs hidden.