TDMS Study 56111-03 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Battelle Columbus TRANS-CINNAMALDEHYDE DATE: 12/11/02 EXPERIMENT: 56111 TEST: 03 TIME: 10:48:25 TEST TYPE: CHRONIC PAGE: 1 CONT: N01-ES-55384 ROUTE: DOSED FEED NTP C#: 56111B PATHOLOGIST: TOFT, JOHN CAS: 14371-10-9 ------------------------------------------------------------------------------------------------------------------------------------ REASONS FOR REMOVAL: 25022 Accidently Killed 25018 Dosing Accident 25019 Moribund Sacrifice 25020 Natural Death 25020 Natural Death 25017 Scheduled Sacrifice 25021 Terminal Sacrifice 25007 Wrong Sex REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE 003 VEHICLE CONTROL INCLUDE 004 VEHICLE CONTROL INCLUDE 005 .312% INCLUDE 006 .312% INCLUDE 007 .625% INCLUDE 008 .625% INCLUDE 009 1.25% INCLUDE 010 1.25% NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Battelle Columbus TRANS-CINNAMALDEHYDE DATE: 12/11/02 EXPERIMENT: 56111 TEST: 03 TIME: 10:48:25 TEST TYPE: CHRONIC CONT: N01-ES-55384 ROUTE: DOSED FEED NTP C#: 56111B PATHOLOGIST: TOFT, JOHN CAS: 14371-10-9 TRANS-CINNAMALDEHYDE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 731 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = VEHICLE CONTROL | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 19 CENSORED DEATHS 0 TERMINAL 31 | | | | UNCENSORED DEATHS | | 429 499 505 508 554 577 577 577 598 606 | | 606 606 624 637 647 653 655 707 724 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = .312% | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 14 CENSORED DEATHS 0 TERMINAL 36 | | | | UNCENSORED DEATHS | | 170 404 591 593 619 643 648 672 680 682 | | 682 690 710 725 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = .625% | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 23 CENSORED DEATHS 0 TERMINAL 27 | | | | UNCENSORED DEATHS | | 123 178 488 506 535 535 560 577 583 593 | | 609 614 621 624 624 627 645 655 676 677 | | 682 695 713 | | CENSORED DEATHS | | NONE | | | ================================================================================== TRANS-CINNAMALDEHYDE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 731 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 1.25% | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 9 CENSORED DEATHS 0 TERMINAL 41 | | | | UNCENSORED DEATHS | | 499 633 666 672 675 691 698 709 715 | | CENSORED DEATHS | | NONE | | | ================================================================================== TRANS-CINNAMALDEHYDE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 731 DAYS ================================================================================== | KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) | | | |--------------------------------------------------------------------------------| | DOSE TIME (DAYS) | | 90 180 270 365 425 485 545 605 665 731 (A) | | | |--------------------------------------------------------------------------------| | | | |VEHICLE | 100.0 100.0 100.0 100.0 100.0 98.0 92.0 82.0 66.0 62.0 | |CONTROL | | | | | |.312% | 100.0 98.0 98.0 98.0 96.0 96.0 96.0 92.0 86.0 72.0 | | | | | | | |.625% | 100.0 96.0 96.0 96.0 96.0 96.0 88.0 80.0 64.0 54.0 | | | | | | | |1.25% | 100.0 100.0 100.0 100.0 100.0 100.0 98.0 98.0 96.0 82.0 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | VEHICLE .312% .625% 1.25% | | CONTROL | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 62.0% 72.0% 54.0% 82.0% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.064N P=0.284N P=0.548 P=0.025N | |(LIFE TABLE) | | | | | |MEAN DAY OF | 594.2 607.8 571.3 662.0 | |NATURAL DEATHS (C) | (16.8) (39.8) (30.4) (22.0) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 679.0 696.5 657.5 718.6 | |(STANDARD ERROR) | (11.4) (13.4) (17.9) ( 5.3) | | | | ================================================================================== (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) TRANS-CINNAMALDEHYDE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 735 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = VEHICLE CONTROL | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 14 CENSORED DEATHS 0 TERMINAL 36 | | | | UNCENSORED DEATHS | | 523 526 597 620 632 652 670 679 683 690 | | 690 695 702 734 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = .312% | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 17 CENSORED DEATHS 0 TERMINAL 33 | | | | UNCENSORED DEATHS | | 85 561 597 618 620 626 652 652 671 675 | | 675 681 697 697 701 718 718 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = .625% | | --------------------- | | | | TOTAL 49 UNCENSORED DEATHS 14 CENSORED DEATHS 0 TERMINAL 35 | | | | UNCENSORED DEATHS | | 177 459 470 498 543 610 613 632 652 652 | | 681 702 709 734 | | CENSORED DEATHS | | NONE | | | ================================================================================== TRANS-CINNAMALDEHYDE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 735 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 1.25% | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 17 CENSORED DEATHS 0 TERMINAL 33 | | | | UNCENSORED DEATHS | | 172 536 564 568 590 597 634 635 643 665 | | 669 681 694 697 718 723 726 | | CENSORED DEATHS | | NONE | | | ================================================================================== TRANS-CINNAMALDEHYDE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 735 DAYS ================================================================================== | KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) | | | |--------------------------------------------------------------------------------| | DOSE TIME (DAYS) | | 90 180 270 365 425 485 545 605 665 735 (A) | | | |--------------------------------------------------------------------------------| | | | |VEHICLE | 100.0 100.0 100.0 100.0 100.0 100.0 96.0 94.0 88.0 72.0 | |CONTROL | | | | | |.312% | 98.0 98.0 98.0 98.0 98.0 98.0 98.0 94.0 84.0 66.0 | | | | | | | |.625% | 100.0 98.0 98.0 98.0 98.0 93.9 89.8 89.8 79.6 71.4 | | | | | | | |1.25% | 100.0 98.0 98.0 98.0 98.0 98.0 96.0 88.0 80.0 66.0 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | VEHICLE .312% .625% 1.25% | | CONTROL | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 72.0% 66.0% 71.4% 66.0% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.652 P=0.642 P=1.000 P=0.609 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 649.5 626.1 580.9 618.4 | |NATURAL DEATHS (C) | (17.0) (35.4) (39.1) (31.3) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 711.1 698.0 691.0 695.3 | |(STANDARD ERROR) | ( 7.2) (13.9) (14.8) (13.1) | | | | ================================================================================== (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) TRANS-CINNAMALDEHYDE KAPLAN-MEIER SURVIVAL CURVES VEHICLE CONTROL = 1 .312% = 2 .625% = 3 1.25% = 4 ------------------------------------------------------ SPECIES=RATS SEX=MALE ------------------------------------------------------- Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 104 + | | 1 3 2 1 4 | 3 23 2 1 1 4 96 + 3 2 3 11 2 4 4 | 3 3 P | 1 3 1 2 2 44 E | 1 1 2 2 4 4 R 88 + 3 3 22 44 C | 3 3 2 2 4 4 E | 13 1 2 2 44 N | 3 311 4 4 T 80 + 3 3 | 33 22 S | 1331 2 2 U | 311 2 2 R 72 + 1 1 2 2 V | 11 I | 3 3 V | 31 1 A 64 + 3 3 1 1 L | 1 1 | 33 | 3 3 56 + 3 3 | 3 3 | | 48 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 8 obs hidden. TRANS-CINNAMALDEHYDE KAPLAN-MEIER SURVIVAL CURVES VEHICLE CONTROL = 1 .312% = 2 .625% = 3 1.25% = 4 ----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------ Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 2 43 1 | | 2 43 3 114 2 | 3 3 14 2 1 95 + | 3 3 44 1 1 P | 4 4 1 1 E | 3 3 R 90 + 3 44 3221 1 C | E | 4 24 1 1 N | 3 3 11 T 85 + | 34 2 211 S | 4 42211 U | R 80 + 3 44 3 V | I | 422113 V | 2 11 A 75 + 33 L | 13 1 | 22 4 1 | 3 70 + 2 24 | | | 24 2 65 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 19 obs hidden.