TDMS Study 05162-10 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Battelle Columbus DIETHANOLAMINE DATE: 06/11/96 EXPERIMENT: 05162 TEST: 10 TIME: 13:02:59 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01-ES-05293 ROUTE: SKIN APPLICATION NTP C#: 55174D PATHOLOGIST: PERSING, R. CAS: 111-42-2 ------------------------------------------------------------------------------------------------------------------------------------ CORE STUDY REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Battelle Columbus DIETHANOLAMINE DATE: 06/11/96 EXPERIMENT: 05162 TEST: 10 TIME: 13:02:59 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-05293 ROUTE: SKIN APPLICATION NTP C#: 55174D PATHOLOGIST: PERSING, R. CAS: 111-42-2 DIETHANOLAMINE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0 MG/KG | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 10 CENSORED DEATHS 0 TERMINAL 40 | | | | UNCENSORED DEATHS | | 411 473 485 593 596 611 649 674 678 716 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 40 MG/KG | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 7 CENSORED DEATHS 0 TERMINAL 43 | | | | UNCENSORED DEATHS | | 499 576 641 670 692 706 723 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 80 MG/KG | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 16 CENSORED DEATHS 0 TERMINAL 34 | | | | UNCENSORED DEATHS | | 445 556 558 583 599 631 633 641 654 667 | | 681 685 699 701 715 724 | | CENSORED DEATHS | | NONE | | | ================================================================================== DIETHANOLAMINE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 160 MG/KG | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 19 CENSORED DEATHS 1 TERMINAL 30 | | | | UNCENSORED DEATHS | | 386 446 540 598 605 606 634 660 674 684 | | 696 700 706 716 717 719 719 719 723 | | CENSORED DEATHS | | 230 | | | ================================================================================== DIETHANOLAMINE 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) | | | |--------------------------------------------------------------------------------| | | | |0 MG/KG | 100.0 100.0 100.0 100.0 98.0 94.0 94.0 90.0 86.0 80.0 | | | | | | | |40 MG/KG | 100.0 100.0 100.0 100.0 100.0 100.0 98.0 96.0 94.0 86.0 | | | | | | | |80 MG/KG | 100.0 100.0 100.0 100.0 100.0 98.0 98.0 90.0 82.0 68.0 | | | | | | | |160 | 100.0 100.0 100.0 100.0 98.0 95.9 93.9 89.8 83.7 61.2 | |MG/KG | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | 0 MG/KG 40 MG/KG 80 MG/KG 160 | | MG/KG | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 80.0% 86.0% 68.0% 61.2% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.015 P=0.539N P=0.289 P=0.097 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 588.6 643.9 635.8 644.6 | |NATURAL DEATHS (C) | (31.9) (30.4) (18.4) (22.2) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 700.9 717.1 699.2 687.0 | |(STANDARD ERROR) | (10.1) ( 5.8) ( 8.5) (13.8) | | | | ================================================================================== (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) DIETHANOLAMINE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 731 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0 MG/KG | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 6 CENSORED DEATHS 0 TERMINAL 44 | | | | UNCENSORED DEATHS | | 508 576 659 674 692 729 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 40 MG/KG | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 17 CENSORED DEATHS 0 TERMINAL 33 | | | | UNCENSORED DEATHS | | 418 421 423 424 458 491 514 526 527 534 | | 599 610 649 655 689 691 696 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 80 MG/KG | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 17 CENSORED DEATHS 0 TERMINAL 33 | | | | UNCENSORED DEATHS | | 474 539 540 556 568 600 614 614 626 633 | | 638 684 684 696 712 725 730 | | CENSORED DEATHS | | NONE | | | ================================================================================== DIETHANOLAMINE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 731 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 160 MG/KG | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 27 CENSORED DEATHS 0 TERMINAL 23 | | | | UNCENSORED DEATHS | | 522 585 593 594 599 606 606 607 607 611 | | 631 641 658 674 681 694 696 701 701 709 | | 714 716 716 717 721 724 726 | | CENSORED DEATHS | | NONE | | | ================================================================================== DIETHANOLAMINE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE 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) | | | |--------------------------------------------------------------------------------| | | | |0 MG/KG | 100.0 100.0 100.0 100.0 100.0 100.0 98.0 96.0 94.0 88.0 | | | | | | | |40 MG/KG | 100.0 100.0 100.0 100.0 92.0 90.0 80.0 78.0 72.0 66.0 | | | | | | | |80 MG/KG | 100.0 100.0 100.0 100.0 100.0 98.0 94.0 88.0 78.0 66.0 | | | | | | | |160 | 100.0 100.0 100.0 100.0 100.0 100.0 98.0 90.0 74.0 46.0 | |MG/KG | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | 0 MG/KG 40 MG/KG 80 MG/KG 160 | | MG/KG | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 88.0% 66.0% 66.0% 46.0% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P<0.001 P=0.012 P=0.016 P<0.001 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 639.7 548.5 625.5 657.4 | |NATURAL DEATHS (C) | (33.5) (24.9) (17.9) (11.0) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 720.0 669.0 695.1 691.3 | |(STANDARD ERROR) | ( 5.6) (14.9) ( 9.3) ( 7.9) | | | | ================================================================================== (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) DIETHANOLAMINE KAPLAN-MEIER SURVIVAL CURVES 0 MG/KG = 1 40 MG/KG = 2 80 MG/KG = 3 160 MG/KG = 4 ------------------------------------------------------ SPECIES=MICE SEX=MALE ------------------------------------------------------- Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 4 1 3 2 | | 4 1 3 1 2 3 2 | 4 1 1 4 2 2 95 + | 1 4 3 3 14 2 2 | 3 11 2 2 | 44 P 90 + 1 1 3 2 2 E | R | 41 4 1 2 2 C | 331 4 1 2 2 E 85 + N | 3 3 4 4 T | 3 31 1 | 44 S 80 + 3 3 4 1 1 U | R | V | 3 3 I 75 + 44 V | 33 4 A | 3 3 L | 70 + 33 | | 3 3 | 65 + | 44 | | 4 4 60 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 9 obs hidden. DIETHANOLAMINE KAPLAN-MEIER SURVIVAL CURVES 0 MG/KG = 1 40 MG/KG = 2 80 MG/KG = 3 160 MG/KG = 4 ----------------------------------------------------- SPECIES=MICE SEX=FEMALE ------------------------------------------------------ Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 2 3 1 4 | 22 3 1 4 3 14 | 33 3 14 4 1 1 | 2 2 3 3 44 1 1 P 90 + 2 2 3 34 1 1 E | 2 2 3 3 1 R | 2 2 3 3 C | 22 44 33 E 80 + 2 2 4 33 N | 2 2 43 3 T | 2 422 43 3 | 2 4423 3 S 70 + 4 4 3 3 U | 22 3 3 R | 24 2 V | 44 I 60 + V | 44 A | L | 50 + 44 | | 4 4 | 40 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 13 obs hidden.