TDMS Study 05091-02 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: American Biogenics DATE: 09/12/94 EXP: 05091 DIHYDROCOUMARIN TIME: 13:18:28 TEST: 02 CAGES FROM 0000 TO LAST CAGE PAGE: 1 TEST TYPE: CHRONIC ROUTE: GAVAGE NTP C#: 55890B CONT: NO1-ES-45039 CAS: 119-84-6 PATHOLOGIST: R. DAHLGREN S. EUSTIS -------------------------------------------------------------------------------- REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: American Biogenics DATE: 09/12/94 EXP: 05091 DIHYDROCOUMARIN TIME: 13:18:28 TEST: 02 CAGES FROM 0000 TO LAST CAGE TEST TYPE: CHRONIC ROUTE: GAVAGE NTP C#: 55890B CONT: NO1-ES-45039 CAS: 119-84-6 PATHOLOGIST: R. DAHLGREN S. EUSTIS DIHYDROCOUMARIN STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = VEHICLE CONTROL | | ---------------------------- | | | | TOTAL 70 UNCENSORED DEATHS 7 CENSORED DEATHS 21 TERMINAL 42 | | | | UNCENSORED DEATHS | | 449 456 528 591 658 690 696 | | CENSORED DEATHS | | 11 455 455 455 455 456 456 456 456 456 | | 456 458 458 458 458 458 458 458 458 458 | | 458 | | | |--------------------------------------------------------------------------------| | DOSE = 200MG/KG | | --------------------- | | | | TOTAL 70 UNCENSORED DEATHS 11 CENSORED DEATHS 20 TERMINAL 39 | | | | UNCENSORED DEATHS | | 423 438 449 553 558 568 643 666 673 718 | | 723 | | CENSORED DEATHS | | 107 455 455 455 455 455 455 456 456 456 | | 458 458 458 458 458 458 458 458 458 458 | | | |--------------------------------------------------------------------------------| | DOSE = 400MG/KG | | --------------------- | | | | TOTAL 70 UNCENSORED DEATHS 16 CENSORED DEATHS 20 TERMINAL 34 | | | | UNCENSORED DEATHS | | 393 410 555 583 599 618 639 640 655 659 | | 675 679 715 718 718 722 | | CENSORED DEATHS | | 14 455 455 455 455 455 456 456 456 456 | | 458 458 458 458 458 458 458 458 458 458 | | | ================================================================================== DIHYDROCOUMARIN STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 800MG/KG | | --------------------- | | | | TOTAL 70 UNCENSORED DEATHS 12 CENSORED DEATHS 20 TERMINAL 38 | | | | UNCENSORED DEATHS | | 417 438 477 489 527 561 613 634 645 652 | | 716 722 | | CENSORED DEATHS | | 455 455 455 455 455 456 456 456 456 456 | | 458 458 458 458 458 458 458 458 458 458 | | | ================================================================================== DIHYDROCOUMARIN 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) | | | |--------------------------------------------------------------------------------| | | | |VEHICLE | 100.0 100.0 100.0 100.0 100.0 97.0 94.9 92.9 90.8 86.7 | |CONTROL | | | | | |200MG/KG | 100.0 100.0 100.0 100.0 98.6 95.7 95.7 89.5 87.5 79.4 | | | | | | | |400MG/KG | 100.0 100.0 100.0 100.0 97.1 97.1 97.1 91.0 80.9 68.8 | | | | | | | |800MG/KG | 100.0 100.0 100.0 100.0 98.6 95.1 91.1 89.0 81.0 76.9 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | VEHICLE 200MG/KG 400MG/KG 800MG/KG | | CONTROL | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 86.7% 79.4% 68.8% 76.9% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.287 P=0.443 P=0.071 P=0.315 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 581.1 582.9 623.6 574.3 | |NATURAL DEATHS (C) | (39.9) (33.4) (25.0) (30.2) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 626.2 623.3 620.8 624.7 | |(STANDARD ERROR) | (17.5) (16.8) (17.2) (15.3) | | | | ================================================================================== (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) DIHYDROCOUMARIN STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = VEHICLE CONTROL | | ---------------------------- | | | | TOTAL 70 UNCENSORED DEATHS 13 CENSORED DEATHS 21 TERMINAL 36 | | | | UNCENSORED DEATHS | | 117 545 587 597 605 639 643 668 674 674 | | 680 704 707 | | CENSORED DEATHS | | 15 24 455 455 455 455 456 456 456 456 | | 456 458 458 458 458 458 458 458 458 458 | | 458 | | | |--------------------------------------------------------------------------------| | DOSE = 200MG/KG | | --------------------- | | | | TOTAL 70 UNCENSORED DEATHS 11 CENSORED DEATHS 20 TERMINAL 39 | | | | UNCENSORED DEATHS | | 437 590 594 615 632 671 685 703 717 720 | | 721 | | CENSORED DEATHS | | 455 455 456 456 456 456 456 456 456 456 | | 458 458 458 458 458 458 458 458 458 458 | | | |--------------------------------------------------------------------------------| | DOSE = 400MG/KG | | --------------------- | | | | TOTAL 70 UNCENSORED DEATHS 9 CENSORED DEATHS 20 TERMINAL 41 | | | | UNCENSORED DEATHS | | 444 515 538 665 687 694 694 700 717 | | CENSORED DEATHS | | 455 455 456 456 456 456 456 456 456 458 | | 458 458 458 458 458 458 458 458 458 521 | | | ================================================================================== DIHYDROCOUMARIN STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 800MG/KG | | --------------------- | | | | TOTAL 70 UNCENSORED DEATHS 23 CENSORED DEATHS 18 TERMINAL 29 | | | | UNCENSORED DEATHS | | 9 419 420 422 462 504 526 529 540 545 | | 554 583 592 595 637 646 654 689 692 701 | | 703 703 704 | | CENSORED DEATHS | | 455 455 456 456 456 456 456 456 456 458 | | 458 458 458 458 458 458 458 458 | | | ================================================================================== DIHYDROCOUMARIN 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) | | | |--------------------------------------------------------------------------------| | | | |VEHICLE | 100.0 98.5 98.5 98.5 98.5 98.5 96.5 90.3 86.2 73.9 | |CONTROL | | | | | |200MG/KG | 100.0 100.0 100.0 100.0 100.0 98.6 98.6 94.5 90.5 78.5 | | | | | | | |400MG/KG | 100.0 100.0 100.0 100.0 100.0 98.6 94.6 94.6 92.6 82.5 | | | | | | | |800MG/KG | 98.6 98.6 98.6 98.6 94.3 92.3 82.5 74.6 68.8 57.0 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | VEHICLE 200MG/KG 400MG/KG 800MG/KG | | CONTROL | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 73.9% 78.5% 82.5% 57.0% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.014 P=0.698N P=0.396N P=0.063 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 603.1 644.1 628.2 557.8 | |NATURAL DEATHS (C) | (42.7) (25.6) (33.6) (32.0) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 611.5 637.9 639.2 602.8 | |(STANDARD ERROR) | (20.0) (14.8) (14.8) (17.1) | | | | ================================================================================== (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) DIHYDROCOUMARIN KAPLAN-MEIER SURVIVAL CURVES VEHICLE CONTROL = 1 200MG/KG = 2 400MG/KG = 3 800MG/KG = 4 ------------------------------------------------------ SPECIES=MICE SEX=MALE ------------------------------------------------------- Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 3 42 1 | 3 342 2 11 | 3 2 21 4 1 3 | 2 2 95 + 44 1 3 3 1 | 22 P | 4 4 3 13 1 E | 4 242 3 3 1 1 R 90 + 2 2 C | 4 43 3 11 E | 4 42 2 N | 1 1 T 85 + 4343 22 | 2 2 S | 43 3 U | 4 3 3 22 R 80 + V | 42 2 I | 4 4 V | 3 3 A 75 + L | | | 33 70 + | 3 3 | | 65 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 8 obs hidden. DIHYDROCOUMARIN KAPLAN-MEIER SURVIVAL CURVES VEHICLE CONTROL = 1 200MG/KG = 2 400MG/KG = 3 800MG/KG = 4 ----------------------------------------------------- SPECIES=MICE SEX=FEMALE ------------------------------------------------------ Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 4 1 23 | 4 1 4 23 3 1 2 | | 44 3 31 1 95 + 3 1 21 2 3 | 4 4 | 4 4 112 2 3 3 | 90 + 4 4 1 21 2 33 | 2 2 P | E | 4 4 1 1 2 2 R 85 + 32 2 C | 11 E | 4 4 3 3 N | T 80 + 4 4 11 | 4 4 2 2 S | 1 1 U | R 75 + 4 4 V | 1 1 I | 4 4 V | 44 A 70 + L | 4 4 | | 65 + 4 4 | | | 60 + | | 4 4 | 55 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 4 obs hidden.