TDMS Study 96007-05 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Battelle Columbus TOXIC EQUIVALENCY FACTOR EVALUATION(PECDF) DATE: 09/30/03 EXPERIMENT: 96007 TEST: 05 TIME: 11:32:19 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: NO1-ES-75411 ROUTE: GAVAGE NTP C#: 96007F PATHOLOGIST: SELLS, DONALD CAS: 57117-31-4 ------------------------------------------------------------------------------------------------------------------------------------ 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(PECDF) DATE: 09/30/03 EXPERIMENT: 96007 TEST: 05 TIME: 11:32:19 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-75411 ROUTE: GAVAGE NTP C#: 96007F PATHOLOGIST: SELLS, DONALD CAS: 57117-31-4 TOXIC EQUIVALENCY FACTOR EVALUATION(PECDF) STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 728 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0 NG/KG | | --------------------- | | | | TOTAL 53 UNCENSORED DEATHS 28 CENSORED DEATHS 0 TERMINAL 25 | | | | UNCENSORED DEATHS | | 289 310 321 377 500 500 513 536 554 588 | | 603 610 619 619 651 651 652 659 675 678 | | 678 678 678 699 715 715 720 727 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 6 NG/KG | | --------------------- | | | | TOTAL 53 UNCENSORED DEATHS 30 CENSORED DEATHS 1 TERMINAL 22 | | | | UNCENSORED DEATHS | | 289 321 393 420 432 451 467 498 503 516 | | 526 530 547 587 600 624 635 645 647 651 | | 651 651 665 667 668 687 689 693 706 707 | | CENSORED DEATHS | | 296 | | | |--------------------------------------------------------------------------------| | DOSE = 20 NG/KG | | --------------------- | | | | TOTAL 53 UNCENSORED DEATHS 27 CENSORED DEATHS 2 TERMINAL 24 | | | | UNCENSORED DEATHS | | 116 196 219 246 297 393 420 451 497 517 | | 561 570 584 586 587 587 605 619 629 636 | | 638 668 675 675 677 689 701 | | CENSORED DEATHS | | 300 301 | | | ================================================================================== TOXIC EQUIVALENCY FACTOR EVALUATION(PECDF) STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 728 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 44 NG/KG | | --------------------- | | | | TOTAL 53 UNCENSORED DEATHS 27 CENSORED DEATHS 1 TERMINAL 25 | | | | UNCENSORED DEATHS | | 302 410 429 470 470 470 489 499 525 525 | | 525 548 561 570 570 573 589 599 603 616 | | 624 645 645 668 675 675 716 | | CENSORED DEATHS | | 472 | | | |--------------------------------------------------------------------------------| | DOSE = 92 NG/KG | | --------------------- | | | | TOTAL 53 UNCENSORED DEATHS 33 CENSORED DEATHS 0 TERMINAL 20 | | | | UNCENSORED DEATHS | | 113 241 267 315 321 337 348 353 382 420 | | 451 454 500 500 513 555 561 580 619 642 | | 651 662 667 668 675 675 675 681 707 717 | | 721 721 726 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 200 NG/KG | | ---------------------------- | | | | TOTAL 53 UNCENSORED DEATHS 30 CENSORED DEATHS 0 TERMINAL 23 | | | | UNCENSORED DEATHS | | 78 326 329 398 412 442 442 443 451 498 | | 498 498 513 513 549 570 570 577 586 597 | | 603 608 624 624 659 668 689 706 706 716 | | CENSORED DEATHS | | NONE | | | ================================================================================== TOXIC EQUIVALENCY FACTOR EVALUATION(PECDF) STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 728 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 200 NG/ KG STOP | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 35 CENSORED DEATHS 0 TERMINAL 15 | | | | UNCENSORED DEATHS | | 215 240 276 370 384 413 451 451 476 491 | | 495 500 500 503 512 525 547 605 610 610 | | 619 619 625 638 651 667 680 689 692 699 | | 701 715 715 716 716 | | CENSORED DEATHS | | NONE | | | ================================================================================== TOXIC EQUIVALENCY FACTOR EVALUATION(PECDF) 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 NG/KG | 100.0 100.0 100.0 94.3 92.5 92.5 84.9 79.2 66.0 47.2 | | | | | | | |6 NG/KG | 100.0 100.0 100.0 96.2 92.3 86.6 77.0 71.2 55.8 42.3 | | | | | | | |20 NG/KG | 100.0 98.1 92.5 90.6 86.6 84.7 80.7 66.9 59.1 47.3 | | | | | | | |44 NG/KG | 100.0 100.0 100.0 98.1 96.2 88.7 79.0 63.6 55.9 48.2 | | | | | | | |92 NG/KG | 100.0 98.1 94.3 84.9 81.1 77.4 71.7 66.0 58.5 37.7 | | | | | | | |200 | 98.1 98.1 98.1 94.3 90.6 83.0 73.6 60.4 52.8 43.4 | |NG/KG | | | | | |200 | 100.0 100.0 96.0 94.0 88.0 82.0 68.0 64.0 50.0 30.0 | |NG/ KG STOP| | | | | ================================================================================== TOXIC EQUIVALENCY FACTOR EVALUATION(PECDF) STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 728 DAYS =============================================================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |-----------------------------------------------------------------------------------------------------------------------------| | DOSE | | | | 0 NG/KG 6 NG/KG 20 NG/KG 44 NG/KG 92 NG/KG 200 200 | | NG/KG NG/ KG STOP | |-----------------------------------------------------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 47.2% 42.3% 47.3% 48.2% 37.7% 43.4% 30.0% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.089 P=0.531 P=0.765 P=0.823 P=0.272 P=0.470 P=0.057 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 589.8 568.9 520.0 555.2 527.8 529.8 551.9 | |NATURAL DEATHS (C) | (24.4) (21.5) (32.7) (18.1) (29.6) (25.2) (23.7) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 655.0 629.8 605.9 635.2 603.4 615.8 604.7 | |(STANDARD ERROR) | (15.9) (17.4) (23.3) (15.3) (22.7) (19.6) (20.2) | | | | =============================================================================================================================== (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) TOXIC EQUIVALENCY FACTOR EVALUATION(PECDF) KAPLAN-MEIER SURVIVAL CURVES 0 NG/KG = 1 6 NG/KG = 2 20 NG/KG = 3 44 NG/KG = 4 92 NG/KG = 5 200 NG/KG = 6 200 NG/ KG STOP = 7 ----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------ Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 6 3 7 1 4 | 6 3 3 7 5 1 4 126 4 | 3 3 53 57 116 71 2 42 4 4 | 3 3 55 71 7 6 62 2 1 90 + 3 5 5 7 3 6 2 6 2 | 555 3 73 2 24 4 1 1 1 P | 5 5 6 3 7 34 4 1 1 E | 5 5 6 7 32 2 1 1 R 80 + 5 5 2 42 4 33 1 11 C | 5 75 6 2 2 43 3 11 E | 2 44 2 N | 5 5 65 6 2 2 1 1 T 70 + 7 7 554 3 423 22 11 | 7 7 565 443 3 2 21 1 S | 7 56 44733 5 1 1 U | 644 3355 R 60 + 774334 53 V | 6 6 2 231 1 I | 76 74 224 1 1 V | 77 62 2 A 50 + 7 6353 3 11 L | 7 5 3 41 | 72 2 5 | 772 62 40 + 77 55 | 7 75 | | 30 + 77 | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 89 obs hidden.