TDMS Study 05187-06 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Battelle Columbus METHYLEUGENOL DATE: 07/20/98 EXPERIMENT: 05187 TEST: 06 TIME: 10:26:52 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: NO1-ES-25337 ROUTE: GAVAGE NTP C#: 60991B PATHOLOGIST: TOFT, J. CAS: 93-15-2 ------------------------------------------------------------------------------------------------------------------------------------ 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 METHYLEUGENOL DATE: 07/20/98 EXPERIMENT: 05187 TEST: 06 TIME: 10:26:52 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-25337 ROUTE: GAVAGE NTP C#: 60991B PATHOLOGIST: TOFT, J. CAS: 93-15-2 METHYLEUGENOL STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 730 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0 MG/KG | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 11 CENSORED DEATHS 1 TERMINAL 38 | | | | UNCENSORED DEATHS | | 430 477 537 540 554 570 580 583 604 670 | | 693 | | CENSORED DEATHS | | 522 | | | |--------------------------------------------------------------------------------| | DOSE = 37 MG/KG | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 14 CENSORED DEATHS 0 TERMINAL 36 | | | | UNCENSORED DEATHS | | 488 546 593 593 614 636 655 670 673 687 | | 694 694 712 729 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 75 MG/KG | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 12 CENSORED DEATHS 1 TERMINAL 37 | | | | UNCENSORED DEATHS | | 326 486 522 522 572 575 589 614 630 639 | | 691 722 | | CENSORED DEATHS | | 37 | | | ================================================================================== METHYLEUGENOL STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 730 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 150 MG/KG | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 13 CENSORED DEATHS 2 TERMINAL 35 | | | | UNCENSORED DEATHS | | 459 512 543 554 561 569 579 583 604 660 | | 673 688 727 | | CENSORED DEATHS | | 339 705 | | | ================================================================================== METHYLEUGENOL STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 730 DAYS ================================================================================== | KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) | | | |--------------------------------------------------------------------------------| | DOSE TIME (DAYS) | | 90 180 270 365 425 485 545 605 665 730 (A) | | | |--------------------------------------------------------------------------------| | | | |0 MG/KG | 100.0 100.0 100.0 100.0 100.0 96.0 91.9 81.7 81.7 77.6 | | | | | | | |37 MG/KG | 100.0 100.0 100.0 100.0 100.0 100.0 98.0 92.0 86.0 72.0 | | | | | | | |75 MG/KG | 100.0 100.0 100.0 98.0 98.0 98.0 91.8 85.7 79.6 75.5 | | | | | | | |150 | 100.0 100.0 100.0 100.0 100.0 98.0 93.9 81.6 79.6 73.4 | |MG/KG | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | 0 MG/KG 37 MG/KG 75 MG/KG 150 | | MG/KG | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 77.6% 72.0% 75.5% 73.4% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.815 P=0.825 P=1.000 P=0.829 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 567.1 641.7 574.0 593.2 | |NATURAL DEATHS (C) | (22.8) (18.2) (30.1) (20.9) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 690.0 705.3 678.7 686.1 | |(STANDARD ERROR) | (11.3) ( 7.5) (17.6) (12.3) | | | | ================================================================================== (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) METHYLEUGENOL 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 19 CENSORED DEATHS 0 TERMINAL 31 | | | | UNCENSORED DEATHS | | 178 564 579 610 630 632 652 663 665 665 | | 670 673 673 695 702 706 717 718 728 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 37 MG/KG | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 31 CENSORED DEATHS 1 TERMINAL 18 | | | | UNCENSORED DEATHS | | 477 493 516 519 562 562 567 578 582 596 | | 604 605 605 617 620 627 629 632 633 649 | | 652 658 661 664 675 675 687 719 720 720 | | 726 | | CENSORED DEATHS | | 721 | | | |--------------------------------------------------------------------------------| | DOSE = 75 MG/KG | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 31 CENSORED DEATHS 1 TERMINAL 18 | | | | UNCENSORED DEATHS | | 465 484 489 520 521 545 582 590 597 611 | | 619 628 633 637 641 652 658 659 659 661 | | 690 694 694 698 704 714 717 720 722 727 | | 728 | | CENSORED DEATHS | | 371 | | | ================================================================================== METHYLEUGENOL STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 731 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 150 MG/KG | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 48 CENSORED DEATHS 0 TERMINAL 2 | | | | UNCENSORED DEATHS | | 379 450 477 505 505 518 537 548 577 588 | | 592 596 601 603 607 615 624 626 626 627 | | 634 652 652 654 659 662 666 676 676 676 | | 678 679 680 681 686 686 686 687 689 692 | | 705 711 712 717 717 718 723 730 | | CENSORED DEATHS | | NONE | | | ================================================================================== METHYLEUGENOL 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 98.0 98.0 98.0 98.0 98.0 98.0 94.0 80.0 62.0 | | | | | | | |37 MG/KG | 100.0 100.0 100.0 100.0 100.0 98.0 92.0 74.0 52.0 37.9 | | | | | | | |75 MG/KG | 100.0 100.0 100.0 100.0 100.0 95.9 87.8 81.6 59.2 36.7 | | | | | | | |150 | 100.0 100.0 100.0 100.0 98.0 94.0 86.0 72.0 48.0 4.0 | |MG/KG | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | 0 MG/KG 37 MG/KG 75 MG/KG 150 | | MG/KG | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 62.0% 37.9% 36.7% 4.0% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P<0.001 P=0.009 P=0.013 P<0.001 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 637.9 620.3 634.2 633.0 | |NATURAL DEATHS (C) | (27.6) (11.8) (13.9) (11.3) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 695.6 662.2 663.8 636.9 | |(STANDARD ERROR) | (12.2) (10.6) (12.4) (11.2) | | | | ================================================================================== (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) METHYLEUGENOL KAPLAN-MEIER SURVIVAL CURVES 0 MG/KG = 1 37 MG/KG = 2 75 MG/KG = 3 150 MG/KG = 4 ------------------------------------------------------ SPECIES=MICE SEX=MALE ------------------------------------------------------- Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 3 1 4 2 | | 3 1 4 12 4 2 | 13 4 3 12 2 P 95 + E | 11 4 R | 1 1 2 2 C | 3 443 E 90 + 1413 2 2 N | T | 11 3 2 2 | 11 3 3 2 2 S 85 + U | 1 13 3 22 R | 2 2 V | 1 3 3 41 I 80 + 3 414 12 V | A | 4 1 3 1 L | 2 2 75 + 4 3 3 | 2 4 2 | 2 | 70 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 22 obs hidden. METHYLEUGENOL KAPLAN-MEIER SURVIVAL CURVES 0 MG/KG = 1 37 MG/KG = 2 75 MG/KG = 3 150 MG/KG = 4 ----------------------------------------------------- SPECIES=MICE SEX=FEMALE ------------------------------------------------------ Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | 100 + 1 1 4 3 2 | 1 4 4 3 232 1 | 4 432 42 2 1 1 1 | 2 2 1 1 90 + 44 3 3 11 | 4 43 3 1 1 | 4 4 2 22 3 1 1 | 42 32 3 80 + 4 42233 11 | 44 33 11 | 42 233 1 1 | 33 11 P 70 + 4422 3 3 E | 4 4 1 1 R | 22 3 3 11 C | 2 2 1 1 E 60 + 44 22 3 3 N | 4 4 33 T | 2 2 | 4 2 2 S 50 + 333 U | 442 2 33 R | 44 2 2 V | 33 I 40 + 22 V | 2 2 A | 44 L | 30 + | | 44 | 20 + 4 4 | 44 | 44 | 10 + | 44 | 4 4 | 0 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 20 obs hidden.