TDMS Study 05087-02 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Battelle Columbus DATE: 09/11/94 EXP: 05087 TRIAMTERENE TIME: 13:47:47 TEST: 02 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: L. MEZZA 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: 13:47:47 TEST: 02 CAGES FROM 0000 TO LAST CAGE TEST TYPE: CHRONIC ROUTE: DOSED FEED NTP C#: 56042B CONT: N01-ES-45041 CAS: 396-01-0 PATHOLOGIST: L. MEZZA S. EUSTIS TRIAMTERENE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0PPM | | --------------------- | | | | TOTAL 70 UNCENSORED DEATHS 3 CENSORED DEATHS 20 TERMINAL 47 | | | | UNCENSORED DEATHS | | 585 623 690 | | CENSORED DEATHS | | 93 93 93 94 94 95 95 95 96 96 | | 456 456 456 456 456 456 457 457 457 457 | | | |--------------------------------------------------------------------------------| | DOSE = 100PPM | | --------------------- | | | | TOTAL 70 UNCENSORED DEATHS 5 CENSORED DEATHS 20 TERMINAL 45 | | | | UNCENSORED DEATHS | | 522 557 599 601 681 | | CENSORED DEATHS | | 93 93 94 94 94 95 95 96 96 96 | | 456 456 456 456 456 457 457 457 457 457 | | | |--------------------------------------------------------------------------------| | DOSE = 200PPM | | --------------------- | | | | TOTAL 70 UNCENSORED DEATHS 4 CENSORED DEATHS 20 TERMINAL 46 | | | | UNCENSORED DEATHS | | 617 641 682 706 | | CENSORED DEATHS | | 93 94 94 94 94 95 96 96 96 96 | | 456 456 456 456 456 456 457 457 457 457 | | | ================================================================================== TRIAMTERENE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 400PPM | | --------------------- | | | | TOTAL 70 UNCENSORED DEATHS 14 CENSORED DEATHS 10 TERMINAL 46 | | | | UNCENSORED DEATHS | | 283 284 284 284 284 285 285 285 286 286 | | 286 288 620 711 | | CENSORED DEATHS | | 93 93 93 93 94 95 95 95 95 96 | | | ================================================================================== TRIAMTERENE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE 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) | | | |--------------------------------------------------------------------------------| | | | |0PPM | 100.0 100.0 100.0 100.0 100.0 100.0 100.0 98.0 96.0 94.0 | | | | | | | |100PPM | 100.0 100.0 100.0 100.0 100.0 100.0 98.0 92.0 92.0 90.0 | | | | | | | |200PPM | 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 96.0 92.0 | | | | | | | |400PPM | 100.0 100.0 100.0 80.0 80.0 80.0 80.0 80.0 78.3 76.7 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | 0PPM 100PPM 200PPM 400PPM | | | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 94.0% 90.0% 92.0% 76.7% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.002 P=0.685 P=1.000 P=0.010 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 632.7 592.0 661.5 339.4 | |NATURAL DEATHS (C) | (30.7) (26.6) (20.0) (37.2) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 595.3 589.7 595.6 560.4 | |(STANDARD ERROR) | (27.1) (27.0) (27.1) (30.2) | | | | ================================================================================== (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 MICE FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0PPM | | --------------------- | | | | TOTAL 70 UNCENSORED DEATHS 12 CENSORED DEATHS 20 TERMINAL 38 | | | | UNCENSORED DEATHS | | 23 114 362 431 494 509 530 589 696 711 | | 723 725 | | CENSORED DEATHS | | 93 93 93 94 94 95 96 96 96 96 | | 456 456 456 456 456 456 457 457 457 457 | | | |--------------------------------------------------------------------------------| | DOSE = 100PPM | | --------------------- | | | | TOTAL 70 UNCENSORED DEATHS 7 CENSORED DEATHS 20 TERMINAL 43 | | | | UNCENSORED DEATHS | | 250 579 629 639 664 670 683 | | CENSORED DEATHS | | 93 93 93 93 94 95 95 96 96 96 | | 456 456 457 457 457 457 457 457 457 457 | | | |--------------------------------------------------------------------------------| | DOSE = 200PPM | | --------------------- | | | | TOTAL 70 UNCENSORED DEATHS 7 CENSORED DEATHS 20 TERMINAL 43 | | | | UNCENSORED DEATHS | | 490 528 560 586 660 677 712 | | CENSORED DEATHS | | 93 94 94 94 94 95 95 95 96 96 | | 456 456 456 456 457 457 457 457 457 457 | | | ================================================================================== TRIAMTERENE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 400PPM | | --------------------- | | | | TOTAL 70 UNCENSORED DEATHS 17 CENSORED DEATHS 10 TERMINAL 43 | | | | UNCENSORED DEATHS | | 280 283 284 285 522 579 585 600 613 623 | | 629 645 690 703 704 705 712 | | CENSORED DEATHS | | 93 93 94 94 94 95 95 95 95 96 | | | ================================================================================== TRIAMTERENE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE 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) | | | |--------------------------------------------------------------------------------| | | | |0PPM | 98.6 96.9 96.9 95.2 95.2 93.6 87.5 85.4 85.4 77.3 | | | | | | | |100PPM | 100.0 100.0 98.3 98.3 98.3 98.3 98.3 96.3 90.3 86.3 | | | | | | | |200PPM | 100.0 100.0 100.0 100.0 100.0 100.0 96.0 92.0 90.0 86.0 | | | | | | | |400PPM | 100.0 100.0 100.0 93.3 93.3 93.3 91.7 86.7 80.0 71.7 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | 0PPM 100PPM 200PPM 400PPM | | | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 77.3% 86.3% 86.0% 71.7% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.308 P=0.286N P=0.284N P=0.672 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 492.3 587.7 601.9 555.4 | |NATURAL DEATHS (C) | (67.0) (57.8) (31.3) (39.8) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 558.8 585.3 586.7 596.2 | |(STANDARD ERROR) | (28.8) (27.3) (26.9) (27.8) | | | | ================================================================================== (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 0PPM = 1 100PPM = 2 200PPM = 3 400PPM = 4 ------------------------------------------------------ SPECIES=MICE SEX=MALE ------------------------------------------------------- Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | 100.0 +1 4 2 1 3 | | | 2 2 1 1 3 97.5 + | | 2 2 1 3 31 | 95.0 + | | 31 3 1 | P 92.5 + E | 2 2 3 3 R | C | E 90.0 + 2 2 N | T | | S 87.5 + U | R | V | I 85.0 + V | A | L | 82.5 + | 44 | | 80.0 + 4 4 | | | 4 4 77.5 + | 4 4 | | 75.0 + | -+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 4 obs hidden. TRIAMTERENE KAPLAN-MEIER SURVIVAL CURVES 0PPM = 1 100PPM = 2 200PPM = 3 400PPM = 4 ----------------------------------------------------- SPECIES=MICE SEX=FEMALE ------------------------------------------------------ Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 1 2 4 3 | 1 1 2 44 2 | 1 1 3 3 | 3 3 2 2 P 95 + 1 1 E | 4 1 1 4 3 3 2 2 R | 3 2 2 C | 1 1 4 4 E 90 + 1 1 44 223 N | 4 4 2 2 T | 1 1 3 3 | 4 4 2 3 2 S 85 + 1 44 1 U | 44 1 1 R | V | 4 4 1 1 I 80 + 4 4 V | 4 4 A | 1 1 L | 75 + | 44 | | 4 4 70 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 6 obs hidden.