TDMS Study 56348-04 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Battelle Columbus CITRAL DATE: 07/05/01 EXPERIMENT: 56348 TEST: 04 TIME: 13:35:48 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01-ES-55384 ROUTE: DOSED FEED NTP C#: C56348 PATHOLOGIST: DR. M. RYAN CAS: 5392-40-5 ------------------------------------------------------------------------------------------------------------------------------------ REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Battelle Columbus CITRAL DATE: 07/05/01 EXPERIMENT: 56348 TEST: 04 TIME: 13:35:48 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-55384 ROUTE: DOSED FEED NTP C#: C56348 PATHOLOGIST: DR. M. RYAN CAS: 5392-40-5 CITRAL STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 727 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = UNTREAT CONTROL | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 2 CENSORED DEATHS 0 TERMINAL 48 | | | | UNCENSORED DEATHS | | 397 626 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = VEHICLE CONTROL | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 7 CENSORED DEATHS 0 TERMINAL 43 | | | | UNCENSORED DEATHS | | 121 310 530 530 626 682 682 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 500 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 10 CENSORED DEATHS 0 TERMINAL 40 | | | | UNCENSORED DEATHS | | 418 419 491 511 576 601 626 629 680 711 | | CENSORED DEATHS | | NONE | | | ================================================================================== CITRAL STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 727 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 1000 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 8 CENSORED DEATHS 0 TERMINAL 42 | | | | UNCENSORED DEATHS | | 427 616 650 682 689 697 710 720 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 2000 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 10 CENSORED DEATHS 0 TERMINAL 40 | | | | UNCENSORED DEATHS | | 447 456 500 608 626 633 652 661 681 682 | | CENSORED DEATHS | | NONE | | | ================================================================================== CITRAL STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 727 DAYS ================================================================================== | KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) | | | |--------------------------------------------------------------------------------| | DOSE TIME (DAYS) | | 90 180 270 365 425 485 545 605 665 727 (A) | | | |--------------------------------------------------------------------------------| | | | |UNTREAT | 100.0 100.0 100.0 100.0 98.0 98.0 98.0 98.0 96.0 96.0 | |CONTROL | | | | | |VEHICLE | 100.0 98.0 98.0 96.0 96.0 96.0 92.0 92.0 90.0 86.0 | |CONTROL | | | | | |500 PPM | 100.0 100.0 100.0 100.0 96.0 96.0 92.0 88.0 84.0 80.0 | | | | | | | |1000 PPM | 100.0 100.0 100.0 100.0 100.0 98.0 98.0 98.0 94.0 84.0 | | | | | | | |2000 PPM | 100.0 100.0 100.0 100.0 100.0 96.0 94.0 94.0 84.0 80.0 | | | | | | | ================================================================================== CITRAL STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 727 DAYS =============================================================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |-----------------------------------------------------------------------------------------------------------------------------| | DOSE | | | | UNTREAT VEHICLE 500 PPM 1000 PPM 2000 PPM | | CONTROL CONTROL | |-----------------------------------------------------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 96.0% 86.0% 80.0% 84.0% 80.0% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.126 ----- P=0.032 P=0.102 P=0.033 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 511.5 497.3 566.2 648.9 594.6 | |NATURAL DEATHS (C) | ( 115) (79.2) (32.5) (33.8) (28.9) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 718.4 694.8 694.8 714.5 700.5 | |(STANDARD ERROR) | ( 6.9) (15.4) (11.1) ( 6.6) ( 9.4) | | | | =============================================================================================================================== (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) CITRAL STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 733 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = UNTREAT CONTROL | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 9 CENSORED DEATHS 1 TERMINAL 40 | | | | UNCENSORED DEATHS | | 242 242 243 544 545 557 660 709 722 | | CENSORED DEATHS | | 9 | | | |--------------------------------------------------------------------------------| | DOSE = VEHICLE CONTROL | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 8 CENSORED DEATHS 1 TERMINAL 41 | | | | UNCENSORED DEATHS | | 441 470 625 633 680 688 709 719 | | CENSORED DEATHS | | 114 | | | |--------------------------------------------------------------------------------| | DOSE = 500 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 5 CENSORED DEATHS 0 TERMINAL 45 | | | | UNCENSORED DEATHS | | 413 600 615 653 698 | | CENSORED DEATHS | | NONE | | | ================================================================================== CITRAL STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 733 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 1000 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 7 CENSORED DEATHS 0 TERMINAL 43 | | | | UNCENSORED DEATHS | | 469 575 618 625 645 709 717 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 2000 PPM | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 10 CENSORED DEATHS 0 TERMINAL 40 | | | | UNCENSORED DEATHS | | 264 491 523 557 576 597 628 656 700 706 | | CENSORED DEATHS | | NONE | | | ================================================================================== CITRAL STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE 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) | | | |--------------------------------------------------------------------------------| | | | |UNTREAT | 100.0 100.0 93.9 93.9 93.9 93.9 89.8 87.8 85.7 81.6 | |CONTROL | | | | | |VEHICLE | 100.0 100.0 100.0 100.0 100.0 95.9 95.9 95.9 91.8 83.7 | |CONTROL | | | | | |500 PPM | 100.0 100.0 100.0 100.0 98.0 98.0 98.0 96.0 92.0 90.0 | | | | | | | |1000 PPM | 100.0 100.0 100.0 100.0 100.0 98.0 98.0 96.0 90.0 86.0 | | | | | | | |2000 PPM | 100.0 100.0 98.0 98.0 98.0 98.0 94.0 88.0 84.0 80.0 | | | | | | | ================================================================================== CITRAL STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 733 DAYS =============================================================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |-----------------------------------------------------------------------------------------------------------------------------| | DOSE | | | | UNTREAT VEHICLE 500 PPM 1000 PPM 2000 PPM | | CONTROL CONTROL | |-----------------------------------------------------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 81.6% 83.7% 90.0% 86.0% 80.0% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.710 ----- P=0.343N P=0.694N P=1.000 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 496.0 620.6 595.8 622.6 569.8 | |NATURAL DEATHS (C) | (67.2) (38.0) (48.7) (31.9) (40.7) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 675.9 702.6 719.3 717.5 700.4 | |(STANDARD ERROR) | (22.1) (14.6) ( 7.3) ( 6.9) (12.2) | | | | =============================================================================================================================== (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) CITRAL KAPLAN-MEIER SURVIVAL CURVES UNTREAT CONTROL = 1 VEHICLE CONTROL = 2 500 PPM = 3 1000 PPM = 4 2000 PPM = 5 ------------------------------------------------------ SPECIES=MICE SEX=MALE ------------------------------------------------------- Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | 100 + 1 2 1 34 5 | | | 98 + 2 2 1 4 5 5 4 1 | | | 96 + 2 3 5 35 2 4 1 4 1 | | | P 94 + 353 5 4 4 E | R | C | E 92 + 3 2 3 5 2 44 N | T | | S 90 + 3 3 25 244 U | R | V | I 88 + 3 35 5 4 4 V | A | L | 86 + 5 5 2 442 | | | 84 + 3 5 3 44 | | | 82 + 3 3 | | | 80 + 5 3 3 --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 8 obs hidden. CITRAL KAPLAN-MEIER SURVIVAL CURVES UNTREAT CONTROL = 1 VEHICLE CONTROL = 2 500 PPM = 3 1000 PPM = 4 2000 PPM = 5 ----------------------------------------------------- SPECIES=MICE SEX=FEMALE ------------------------------------------------------ Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | 100 + 1 1 5 3 2 4 | | | 98 + 5 3 2 42 5 4 3 | | | 96 + 2 5 5 4 3 342 | | | P 94 + 1 5 1 5 3422 3 E | R | C | E 92 + 5 5 42 43 2 3 N | T | | S 90 + 1 1 5 5 4 223 4 3 U | R | V | I 88 + 1 5 5 1 2 24 V | A | L | 86 + 5 5 4 4 | 1 12 | | 84 + 5 5 | 121 2 | | 82 + 55 | 1 1 | | 80 + 5 5 --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 7 obs hidden.