Pathology Tables for Peer Review
The National Toxicology Program
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Battelle Columbus OXYMETHOLONE DATE: 11/24/97 EXPERIMENT: 88032 TEST: 05 TIME: 11:36:10 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: NO1-ES-05295 ROUTE: GAVAGE NTP C#: 88032B PATHOLOGIST: YARRINGTON, J. CAS: 434-07-01 ------------------------------------------------------------------------------------------------------------------------------------ CORE STUDY REASONS FOR REMOVAL: 25018 Dosing Accident 25019 Moribund Sacrifice 25020 Natural Death 25026 Other 25021 Terminal Sacrifice REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Battelle Columbus OXYMETHOLONE DATE: 11/24/97 EXPERIMENT: 88032 TEST: 05 TIME: 11:36:10 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-05295 ROUTE: GAVAGE NTP C#: 88032B PATHOLOGIST: YARRINGTON, J. CAS: 434-07-01 OXYMETHOLONE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 728 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0 MG/KG | | --------------------- | | | | TOTAL 51 UNCENSORED DEATHS 36 CENSORED DEATHS 0 TERMINAL 15 | | | | UNCENSORED DEATHS | | 316 366 384 429 464 471 479 486 486 519 | | 524 549 549 553 589 591 596 600 605 611 | | 611 633 646 646 654 654 657 660 666 692 | | 702 706 707 714 716 720 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 3 MG/KG | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 34 CENSORED DEATHS 1 TERMINAL 15 | | | | UNCENSORED DEATHS | | 202 321 408 424 479 485 485 499 561 563 | | 588 597 598 600 618 622 629 659 675 675 | | 679 692 692 693 703 703 706 706 707 709 | | 709 714 718 720 | | CENSORED DEATHS | | 146 | | | |--------------------------------------------------------------------------------| | DOSE = 30 MG/KG | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 36 CENSORED DEATHS 0 TERMINAL 14 | | | | UNCENSORED DEATHS | | 281 353 437 517 527 538 564 577 597 601 | | 605 609 622 629 640 644 644 653 666 666 | | 669 680 681 692 693 696 700 703 703 705 | | 706 707 716 719 720 727 | | CENSORED DEATHS | | NONE | | | ================================================================================== OXYMETHOLONE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 728 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 150 MG/KG | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 27 CENSORED DEATHS 3 TERMINAL 20 | | | | UNCENSORED DEATHS | | 34 114 115 434 551 561 563 563 577 611 | | 629 636 639 641 644 646 659 660 666 675 | | 675 688 703 708 712 715 724 | | CENSORED DEATHS | | 80 116 145 | | | ================================================================================== OXYMETHOLONE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS 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) | | | |--------------------------------------------------------------------------------| | | | |0 MG/KG | 100.0 100.0 100.0 98.0 94.1 86.3 78.4 62.7 45.1 29.4 | | | | | | | |3 MG/KG | 100.0 100.0 98.0 95.9 91.8 85.7 83.7 71.4 63.3 30.6 | | | | | | | |30 MG/KG | 100.0 100.0 100.0 96.0 96.0 94.0 88.0 78.0 64.0 28.0 | | | | | | | |150 | 98.0 93.9 93.9 93.9 93.9 91.8 91.8 81.1 61.9 42.7 | |MG/KG | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | 0 MG/KG 3 MG/KG 30 MG/KG 150 | | MG/KG | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 29.4% 30.6% 28.0% 42.7% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.150N P=0.631N P=0.670N P=0.141N | |(LIFE TABLE) | | | | | |MEAN DAY OF | 582.0 604.1 627.4 575.7 | |NATURAL DEATHS (C) | (17.8) (21.7) (17.0) (36.1) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 624.9 632.1 655.6 608.9 | |(STANDARD ERROR) | (15.7) (19.5) (13.8) (28.3) | | | | ================================================================================== (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) OXYMETHOLONE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 728 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0 MG/KG | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 24 CENSORED DEATHS 1 TERMINAL 25 | | | | UNCENSORED DEATHS | | 478 478 506 533 540 543 548 549 561 562 | | 566 573 574 589 621 625 678 684 693 705 | | 706 707 707 708 | | CENSORED DEATHS | | 573 | | | |--------------------------------------------------------------------------------| | DOSE = 3 MG/KG | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 21 CENSORED DEATHS 0 TERMINAL 29 | | | | UNCENSORED DEATHS | | 299 501 523 537 556 562 576 579 582 590 | | 639 646 652 652 665 670 691 702 705 711 | | 725 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 30 MG/KG | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 19 CENSORED DEATHS 1 TERMINAL 30 | | | | UNCENSORED DEATHS | | 229 441 478 478 497 560 561 638 653 659 | | 665 670 671 674 693 693 698 708 713 | | CENSORED DEATHS | | 118 | | | ================================================================================== OXYMETHOLONE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 728 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 100 MG/KG | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 18 CENSORED DEATHS 1 TERMINAL 31 | | | | UNCENSORED DEATHS | | 387 394 490 510 511 539 562 625 659 659 | | 659 663 674 680 695 704 713 725 | | CENSORED DEATHS | | 177 | | | ================================================================================== OXYMETHOLONE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS 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) | | | |--------------------------------------------------------------------------------| | | | |0 MG/KG | 100.0 100.0 100.0 100.0 100.0 96.0 88.0 71.9 67.8 51.4 | | | | | | | |3 MG/KG | 100.0 100.0 100.0 98.0 98.0 98.0 92.0 80.0 70.0 58.0 | | | | | | | |30 MG/KG | 100.0 100.0 98.0 98.0 98.0 91.8 89.8 85.7 77.6 61.2 | | | | | | | |100 | 100.0 100.0 100.0 100.0 95.9 95.9 87.8 85.7 75.5 63.3 | |MG/KG | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | 0 MG/KG 3 MG/KG 30 MG/KG 100 | | MG/KG | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 51.4% 58.0% 61.2% 63.3% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.365N P=0.545N P=0.392N P=0.296N | |(LIFE TABLE) | | | | | |MEAN DAY OF | 601.4 607.8 598.9 602.7 | |NATURAL DEATHS (C) | (16.0) (21.3) (28.9) (25.3) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 664.1 677.5 666.7 671.9 | |(STANDARD ERROR) | (11.9) (12.2) (17.9) (16.0) | | | | ================================================================================== (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) OXYMETHOLONE KAPLAN-MEIER SURVIVAL CURVES 0 MG/KG = 1 3 MG/KG = 2 30 MG/KG = 3 150 MG/KG = 4 ------------------------------------------------------ SPECIES=RATS SEX=MALE ------------------------------------------------------- Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 4 2 3 1 | 4 4 2 3 1 3 1 | 4 2 3 1 1 2 213 3 | 21 1 2 3 3 4 90 + 1122 33 4 4 | 111 3 3 | 2 2 3 3 3 | 1 2 1 2 4 P 80 + 2 42 334 4 E | 1 1 2 2 44 R | 3 3344 C | 1 12 23 3 E 70 + N | 11 22 44 T | 11 2 343 23 | 11 242 S 60 + 1 1 44 U | 1 1 3232 R | 433 V | 11 4 4 I 50 + 2324 V | 1 1 44 A | 11 33 44 L | 1 1 4 40 + 1 12 | | 112 | 11 30 + 11 | 3 | | 20 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 28 obs hidden. OXYMETHOLONE KAPLAN-MEIER SURVIVAL CURVES 0 MG/KG = 1 3 MG/KG = 2 30 MG/KG = 3 100 MG/KG = 4 ----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------ Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | 100 + 1 3 2 4 1 | | 3 2 44 3 2 | 4 3 14 21 2 95 + | 4 1 2 1 | 11 2 | 3 3 90 + 3 4 4 22 | | 41132 2 | 3 4 3 P 85 + E | 1 1 22 4 3 3 4 R | 2 2 C | 3 3 E 80 + 2 2 N | T | 11 22 33 | 22 S 75 + 4 4 U | 1 1 334 R | 1 1 2 2 V | 3434 I 70 + 11 22 44 V | A | 1 21 2344 L | 112 2 65 + 3 3 4 | 11 4 | 22 | 1 13 3 60 + 2 2 | | 2 | 55 + | 11 | | 1 1 50 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 14 obs hidden.
Web page last updated on November 11, 2004