TDMS Study 96007-03 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Battelle Columbus TOXIC EQUIVALENCY FACTOR EVALUATION (TCDD) DATE: 09/30/03 EXPERIMENT: 96007 TEST: 03 TIME: 08:48:54 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: NO1-ES-75411 ROUTE: GAVAGE NTP C#: 96007G PATHOLOGIST: SELLS, DONALD CAS: 1746-01-6 ------------------------------------------------------------------------------------------------------------------------------------ FINAL # 3 RATS REASONS FOR REMOVAL: 25018 Dosing Accident 25019 Moribund Sacrifice 25020 Natural Death 25021 Terminal Sacrifice REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Battelle Columbus TOXIC EQUIVALENCY FACTOR EVALUATION (TCDD) DATE: 09/30/03 EXPERIMENT: 96007 TEST: 03 TIME: 08:48:54 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-75411 ROUTE: GAVAGE NTP C#: 96007G PATHOLOGIST: SELLS, DONALD CAS: 1746-01-6 TOXIC EQUIVALENCY FACTOR EVALUATION (TCDD) STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 731 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0 NG/KG | | --------------------- | | | | TOTAL 53 UNCENSORED DEATHS 28 CENSORED DEATHS 0 TERMINAL 25 | | | | UNCENSORED DEATHS | | 169 185 351 361 366 469 474 487 492 512 | | 526 533 548 610 631 645 646 646 647 648 | | 666 668 675 694 697 701 717 722 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 3 NG/KG | | --------------------- | | | | TOTAL 54 UNCENSORED DEATHS 33 CENSORED DEATHS 0 TERMINAL 21 | | | | UNCENSORED DEATHS | | 200 241 264 264 341 361 394 448 449 462 | | 485 490 492 526 548 556 556 556 556 557 | | 557 578 578 604 604 607 613 620 647 648 | | 681 718 729 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 10 NG/KG | | --------------------- | | | | TOTAL 53 UNCENSORED DEATHS 25 CENSORED DEATHS 5 TERMINAL 23 | | | | UNCENSORED DEATHS | | 240 344 348 429 550 578 578 578 578 578 | | 604 613 614 626 635 645 650 659 659 676 | | 697 717 718 720 728 | | CENSORED DEATHS | | 47 54 177 236 724 | | | ================================================================================== TOXIC EQUIVALENCY FACTOR EVALUATION (TCDD) STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 731 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 22 NG/KG | | --------------------- | | | | TOTAL 53 UNCENSORED DEATHS 34 CENSORED DEATHS 0 TERMINAL 19 | | | | UNCENSORED DEATHS | | 53 197 338 373 380 389 406 416 417 453 | | 462 485 522 533 545 557 561 578 578 578 | | 592 601 607 615 626 626 626 641 645 675 | | 680 690 708 708 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 46 NG/KG | | --------------------- | | | | TOTAL 53 UNCENSORED DEATHS 31 CENSORED DEATHS 0 TERMINAL 22 | | | | UNCENSORED DEATHS | | 141 185 317 341 396 444 474 486 486 518 | | 557 578 589 590 599 621 642 645 657 659 | | 672 673 673 675 677 683 694 701 701 708 | | 720 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 100 NG/KG | | ---------------------------- | | | | TOTAL 53 UNCENSORED DEATHS 32 CENSORED DEATHS 0 TERMINAL 21 | | | | UNCENSORED DEATHS | | 396 474 546 561 581 598 599 604 610 610 | | 612 614 638 638 641 641 642 647 648 652 | | 655 667 668 673 680 693 701 716 717 721 | | 722 723 | | CENSORED DEATHS | | NONE | | | ================================================================================== TOXIC EQUIVALENCY FACTOR EVALUATION (TCDD) STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 731 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 100 NG/ KG/STOP | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 29 CENSORED DEATHS 0 TERMINAL 21 | | | | UNCENSORED DEATHS | | 215 345 394 410 474 484 520 537 578 578 | | 578 584 604 614 629 641 643 645 645 653 | | 656 673 702 702 718 724 726 726 729 | | CENSORED DEATHS | | NONE | | | ================================================================================== TOXIC EQUIVALENCY FACTOR EVALUATION (TCDD) STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS 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 NG/KG | 100.0 98.1 96.2 92.5 90.6 86.8 77.4 75.5 62.3 47.2 | | | | | | | |3 NG/KG | 100.0 100.0 92.6 88.9 87.0 79.6 74.1 53.7 44.4 38.9 | | | | | | | |10 NG/KG | 100.0 100.0 98.0 93.9 93.9 91.8 91.8 77.6 61.2 48.9 | | | | | | | |22 NG/KG | 98.1 98.1 96.2 94.3 83.0 77.4 71.7 58.5 45.3 35.8 | | | | | | | |46 NG/KG | 100.0 98.1 96.2 92.5 90.6 86.8 81.1 71.7 62.3 41.5 | | | | | | | |100 | 100.0 100.0 100.0 100.0 98.1 96.2 96.2 84.9 60.4 39.6 | |NG/KG | | | | | |100 | 100.0 100.0 98.0 96.0 92.0 88.0 84.0 74.0 58.0 42.0 | |NG/ KG/STOP| | | | | ================================================================================== TOXIC EQUIVALENCY FACTOR EVALUATION (TCDD) STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 731 DAYS =============================================================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |-----------------------------------------------------------------------------------------------------------------------------| | DOSE | | | | 0 NG/KG 3 NG/KG 10 NG/KG 22 NG/KG 46 NG/KG 100 100 | | NG/KG NG/ KG/STOP | |-----------------------------------------------------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 47.2% 38.9% 48.9% 35.8% 41.5% 39.6% 42.0% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.736N P=0.289 P=0.840N P=0.184 P=0.728 P=0.807 P=0.860 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 553.1 513.0 590.5 525.3 564.6 634.0 590.6 | |NATURAL DEATHS (C) | (28.9) (23.8) (25.1) (25.2) (27.6) (12.5) (23.5) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 637.0 597.8 619.1 599.1 633.7 672.4 649.6 | |(STANDARD ERROR) | (19.5) (20.5) (24.7) (21.1) (19.7) (10.0) (16.8) | | | | =============================================================================================================================== (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) TOXIC EQUIVALENCY FACTOR EVALUATION (TCDD) KAPLAN-MEIER SURVIVAL CURVES 0 NG/KG = 1 3 NG/KG = 2 10 NG/KG = 3 22 NG/KG = 4 46 NG/KG = 5 100 NG/KG = 6 100 NG/ KG/STOP = 7 ----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------ Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 4 5 1 2 7 3 6 | 4 5 1 1 2 7 2 2 3 6 6 | 1 4 5 4311 4 7 7 3 6 6 6 | 2 2 114 4 5 7 3 7 3 6 6 90 + 2 21 442 5 17 7 3 3 6 | 424 4 2 11 1 7 66 P | 2 2 11 7 7 7 66 E | 4 22 21 1 R 80 + 44 4 1 11 5 3 3 C | 22 4 1 1 57 5 33 6 E | 2 424 1 7 71 N | 4422 55 1531 1 T 70 + 44 57353 | 4 4 55 S | 735 3 U | 4 4 17 51 R 60 + 2 2 44 6 353 3 V | 2 424 7 11 1 3 I | 4 4 66 7 V | 22 55611 7 A 50 + 224 4 5651 11 3 L | 2 42 1 1 | 2 42 55 7 7 | 424 526 5 40 + 4 426 2 | | 4 4 | 30 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 101 obs hidden.