TDMS Study 05187-09 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Battelle Columbus METHYLEUGENOL DATE: 07/20/98 EXPERIMENT: 05187 TEST: 09 TIME: 09:16:03 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: NO1-ES-25337 ROUTE: GAVAGE NTP C#: 60991B PATHOLOGIST: MISSING CAS: 93-15-2 ------------------------------------------------------------------------------------------------------------------------------------ CORE STUDY REASONS FOR REMOVAL: 25022 Accidently Killed 25018 Dosing Accident 25019 Moribund Sacrifice 25020 Natural Death 25021 Terminal Sacrifice REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE 001 0 MG/KG INCLUDE 002 0 MG/KG INCLUDE 003 37 MG/KG INCLUDE 004 37 MG/KG INCLUDE 005 75 MG/KG INCLUDE 006 75 MG/KG INCLUDE 007 150 MG/KG INCLUDE 008 150 MG/KG NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Battelle Columbus METHYLEUGENOL DATE: 07/20/98 EXPERIMENT: 05187 TEST: 09 TIME: 09:16:03 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-25337 ROUTE: GAVAGE NTP C#: 60991B PATHOLOGIST: MISSING CAS: 93-15-2 METHYLEUGENOL STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 730 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0 MG/KG | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 30 CENSORED DEATHS 0 TERMINAL 20 | | | | UNCENSORED DEATHS | | 344 521 529 553 564 588 603 610 610 614 | | 617 626 639 642 652 661 662 668 704 704 | | 707 707 712 714 715 718 721 722 722 729 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 37 MG/KG | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 33 CENSORED DEATHS 1 TERMINAL 16 | | | | UNCENSORED DEATHS | | 403 406 431 535 542 572 575 579 579 589 | | 596 602 606 625 638 639 650 660 661 664 | | 673 674 680 695 703 704 704 704 712 718 | | 718 718 725 | | CENSORED DEATHS | | 591 | | | |--------------------------------------------------------------------------------| | DOSE = 75 MG/KG | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 32 CENSORED DEATHS 3 TERMINAL 15 | | | | UNCENSORED DEATHS | | 438 467 502 521 568 572 582 595 596 601 | | 610 619 630 638 639 642 642 651 659 661 | | 664 673 674 692 695 695 695 696 696 706 | | 709 712 | | CENSORED DEATHS | | 15 522 658 | | | ================================================================================== METHYLEUGENOL STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 730 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 150 MG/KG | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 49 CENSORED DEATHS 1 TERMINAL 0 | | | | UNCENSORED DEATHS | | 337 409 457 467 495 502 523 546 547 568 | | 575 583 584 598 598 600 602 607 610 614 | | 621 625 633 638 642 642 642 646 648 650 | | 654 658 659 660 660 660 660 661 669 670 | | 680 680 683 684 688 688 700 704 712 | | CENSORED DEATHS | | 699 | | | ================================================================================== METHYLEUGENOL STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS 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 98.0 98.0 98.0 94.0 86.0 66.0 40.0 | | | | | | | |37 MG/KG | 100.0 100.0 100.0 100.0 96.0 94.0 90.0 75.9 59.5 32.8 | | | | | | | |75 MG/KG | 100.0 100.0 100.0 100.0 100.0 95.9 91.8 79.3 56.1 32.4 | | | | | | | |150 | 100.0 100.0 100.0 98.0 96.0 92.0 86.0 66.0 24.0 0.0 | |MG/KG | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | 0 MG/KG 37 MG/KG 75 MG/KG 150 | | MG/KG | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 40.0% 32.8% 32.4% 0.0% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P<0.001 P=0.389 P=0.294 P<0.001 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 642.6 626.7 629.4 613.0 | |NATURAL DEATHS (C) | (15.3) (15.3) (12.6) (11.3) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 677.6 659.0 645.7 614.8 | |(STANDARD ERROR) | (11.0) (12.3) (16.7) (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 STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 730 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0 MG/KG | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 28 CENSORED DEATHS 0 TERMINAL 22 | | | | UNCENSORED DEATHS | | 241 407 448 459 459 549 555 569 597 598 | | 598 609 616 619 641 641 641 644 653 679 | | 683 698 700 703 711 717 719 724 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 37 MG/KG | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 25 CENSORED DEATHS 0 TERMINAL 25 | | | | UNCENSORED DEATHS | | 347 443 450 520 564 569 588 606 609 611 | | 611 618 620 637 646 650 665 673 683 683 | | 694 703 717 718 724 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 75 MG/KG | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 27 CENSORED DEATHS 1 TERMINAL 22 | | | | UNCENSORED DEATHS | | 297 515 527 541 557 595 609 613 625 627 | | 629 637 676 676 676 683 683 690 690 702 | | 703 712 714 717 717 721 724 | | CENSORED DEATHS | | 444 | | | ================================================================================== METHYLEUGENOL STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 730 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 150 MG/KG | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 38 CENSORED DEATHS 1 TERMINAL 11 | | | | UNCENSORED DEATHS | | 483 483 508 527 534 541 548 553 572 576 | | 589 591 600 605 609 609 611 620 620 620 | | 632 641 647 652 660 667 676 679 679 694 | | 702 703 711 711 717 723 724 724 | | CENSORED DEATHS | | 590 | | | ================================================================================== METHYLEUGENOL STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS 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 98.0 98.0 96.0 90.0 90.0 78.0 62.0 44.0 | | | | | | | |37 MG/KG | 100.0 100.0 100.0 98.0 98.0 94.0 92.0 86.0 66.0 50.0 | | | | | | | |75 MG/KG | 100.0 100.0 100.0 98.0 98.0 98.0 91.9 87.8 75.5 44.9 | | | | | | | |150 | 100.0 100.0 100.0 100.0 100.0 96.0 88.0 71.8 49.3 22.6 | |MG/KG | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | 0 MG/KG 37 MG/KG 75 MG/KG 150 | | MG/KG | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 44.0% 50.0% 44.9% 22.6% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.015 P=0.640N P=0.807N P=0.053 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 602.8 614.0 639.1 624.8 | |NATURAL DEATHS (C) | (21.3) (18.6) (17.8) (11.4) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 658.8 672.0 675.2 647.2 | |(STANDARD ERROR) | (14.9) (12.4) (12.4) (10.7) | | | | ================================================================================== (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=RATS SEX=MALE ------------------------------------------------------- Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | 100 + 1 41 2 3 | 41 4 3 3 1 | 24 2 43 3 112 1 | 4 4 3 221 13 90 + 44 2 12 1 | 4 4 221 1 | 4 44 3 3 11 | 4 42 23 80 + 44 22 11 | 44 311 | 4 22 31 1 | 2 1 1 P 70 + 1 1 E | 22 R | 444 32 11 1 C | 3 3 E 60 + 44 2 2 N | 44 T | 444 3 22 11 | 3232211 S 50 + 33 U | R | 44 11 V | 22 1 1 I 40 + 44 3322 1 V | 33 A | 4 4 22 L | 3 2 2 30 + | | 44 | 20 + 4 4 | | | 44 10 + | 44 | 44 | 44 0 + 4 | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 31 obs hidden. METHYLEUGENOL KAPLAN-MEIER SURVIVAL CURVES 0 MG/KG = 1 37 MG/KG = 2 75 MG/KG = 3 150 MG/KG = 4 ----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------ Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 1 3 2 4 | 1 3 2 1 2 3 | 1 1 21 4 43 23 3 | 2443 32 90 + 1 441322 3 | 411 2 2 3 3 | 41 1 2 123 | 44 22 3 P 80 + 4 4 E | 112233 R | 44111 2 3 C | 1 212 E 70 + 33 N | 44 2 2 T | 44 1 1 2 223 | 1 1 3 3 S 60 + 4 4 11 2 U | 44 1 123 R | 44 11 2 V | 44 4 1122 I 50 + 44 112 2 V | 44 33 A | 11 1 L | 40 + 4 44 | | 44 | 30 + 44 | 44 | | 4 4 20 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 32 obs hidden.