TDMS Study 56111-04 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Battelle Columbus TRANS-CINNAMALDEHYDE DATE: 12/11/02 EXPERIMENT: 56111 TEST: 04 TIME: 10:49:47 TEST TYPE: CHRONIC PAGE: 1 CONT: N01-ES-55384 ROUTE: DOSED FEED NTP C#: 56111B PATHOLOGIST: MARIT, GARY 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: 04 TIME: 10:49:47 TEST TYPE: CHRONIC CONT: N01-ES-55384 ROUTE: DOSED FEED NTP C#: 56111B PATHOLOGIST: MARIT, GARY CAS: 14371-10-9 TRANS-CINNAMALDEHYDE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 728 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = VEHICLE CONTROL | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 3 CENSORED DEATHS 0 TERMINAL 47 | | | | UNCENSORED DEATHS | | 100 572 708 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = .312% | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 4 CENSORED DEATHS 0 TERMINAL 46 | | | | UNCENSORED DEATHS | | 50 594 644 701 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = .625% | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 11 CENSORED DEATHS 0 TERMINAL 39 | | | | UNCENSORED DEATHS | | 365 498 533 533 561 566 588 652 652 699 | | 702 | | CENSORED DEATHS | | NONE | | | ================================================================================== TRANS-CINNAMALDEHYDE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 728 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 1.25% | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 1 CENSORED DEATHS 0 TERMINAL 49 | | | | UNCENSORED DEATHS | | 596 | | CENSORED DEATHS | | NONE | | | ================================================================================== TRANS-CINNAMALDEHYDE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 728 DAYS ================================================================================== | KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) | | | |--------------------------------------------------------------------------------| | DOSE TIME (DAYS) | | 90 180 270 365 425 485 545 605 665 728 (A) | | | |--------------------------------------------------------------------------------| | | | |VEHICLE | 100.0 98.0 98.0 98.0 98.0 98.0 98.0 96.0 96.0 94.0 | |CONTROL | | | | | |.312% | 98.0 98.0 98.0 98.0 98.0 98.0 98.0 96.0 94.0 92.0 | | | | | | | |.625% | 100.0 100.0 100.0 98.0 98.0 98.0 92.0 86.0 82.0 78.0 | | | | | | | |1.25% | 100.0 100.0 100.0 100.0 100.0 100.0 100.0 98.0 98.0 98.0 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | VEHICLE .312% .625% 1.25% | | CONTROL | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 94.0% 92.0% 78.0% 98.0% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.712N P=0.990 P=0.043 P=0.603N | |(LIFE TABLE) | | | | | |MEAN DAY OF | 460.0 497.3 577.2 596.0 | |NATURAL DEATHS (C) | ( 184) ( 151) (29.7) ( . ) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 711.9 709.5 694.8 725.4 | |(STANDARD ERROR) | (12.9) (13.8) (10.9) ( 2.6) | | | | ================================================================================== (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 MICE FIRST TERMINAL SACRIFICE AT 733 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = VEHICLE CONTROL | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 9 CENSORED DEATHS 0 TERMINAL 41 | | | | UNCENSORED DEATHS | | 456 463 463 570 609 614 693 698 726 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = .312% | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 13 CENSORED DEATHS 0 TERMINAL 37 | | | | UNCENSORED DEATHS | | 325 551 558 575 596 628 652 663 668 673 | | 708 723 728 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = .625% | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 6 CENSORED DEATHS 0 TERMINAL 44 | | | | UNCENSORED DEATHS | | 425 568 638 642 691 726 | | CENSORED DEATHS | | NONE | | | ================================================================================== TRANS-CINNAMALDEHYDE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 733 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 1.25% | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 7 CENSORED DEATHS 0 TERMINAL 43 | | | | UNCENSORED DEATHS | | 226 379 568 587 627 680 726 | | CENSORED DEATHS | | NONE | | | ================================================================================== TRANS-CINNAMALDEHYDE 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) | | | |--------------------------------------------------------------------------------| | | | |VEHICLE | 100.0 100.0 100.0 100.0 100.0 94.0 94.0 92.0 88.0 82.0 | |CONTROL | | | | | |.312% | 100.0 100.0 100.0 98.0 98.0 98.0 98.0 90.0 84.0 74.0 | | | | | | | |.625% | 100.0 100.0 100.0 100.0 98.0 98.0 98.0 96.0 92.0 88.0 | | | | | | | |1.25% | 100.0 100.0 98.0 98.0 96.0 96.0 96.0 92.0 90.0 86.0 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | VEHICLE .312% .625% 1.25% | | CONTROL | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 82.0% 74.0% 88.0% 86.0% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.371N P=0.485 P=0.556N P=0.788N | |(LIFE TABLE) | | | | | |MEAN DAY OF | 588.0 619.1 615.0 541.9 | |NATURAL DEATHS (C) | (35.8) (29.6) (43.8) (67.1) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 706.9 703.4 718.8 706.2 | |(STANDARD ERROR) | (10.0) (10.3) ( 7.3) (12.9) | | | | ================================================================================== (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=MICE SEX=MALE ------------------------------------------------------- Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100.0 +1 2 1 3 4 | | | 2 1 3 3 1 24 4 97.5 + | | 3 3 1 2 2 1 | 95.0 + | P | 2 21 1 E | R 92.5 + C | 3 3 2 2 E | N | T 90.0 + | S | U | 3 3 R 87.5 + V | I | 3 3 V | A 85.0 + L | | | 82.5 + | 3 3 | | 80.0 + 33 | | | 3 3 77.5 + | -+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 3 obs hidden. TRANS-CINNAMALDEHYDE KAPLAN-MEIER SURVIVAL CURVES VEHICLE CONTROL = 1 .312% = 2 .625% = 3 1.25% = 4 ----------------------------------------------------- SPECIES=MICE SEX=FEMALE ------------------------------------------------------ Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 4 2 3 1 | | 4 2 4 3 11 2 3 | 4 22 3 3 P 95 + E | 1 2 124 R | 124 21 4 3 3 C | E 90 + 211 2 43 3 N | T | 1 2 2 41 3 3 | 2 2 11 4 4 S 85 + U | 22 1 1 R | 22 1 1 V | I 80 + 2 2 V | A | 2 2 L | 75 + | 2 2 | | 70 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 7 obs hidden.