TDMS Study 05163-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: HLA, VA DATE: 09/17/94 EXP: 05163 C. I. ACID RED 114 TIME: 22:06:13 TEST: 01 CAGES FROM 0000 TO LAST CAGE PAGE: 1 TEST TYPE: CHRONIC ROUTE: DOSED WATER NTP C#: 61096 CONT: NO1ES9565503 CAS: 6459-94-5 PATHOLOGIST: G. PARKER S. EUSTIS -------------------------------------------------------------------------------- REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: HLA, VA DATE: 09/17/94 EXP: 05163 C. I. ACID RED 114 TIME: 22:06:13 TEST: 01 CAGES FROM 0000 TO LAST CAGE TEST TYPE: CHRONIC ROUTE: DOSED WATER NTP C#: 61096 CONT: NO1ES9565503 CAS: 6459-94-5 PATHOLOGIST: G. PARKER S. EUSTIS C. I. ACID RED 114 STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 732 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = CONTROL | | --------------------- | | | | TOTAL 70 UNCENSORED DEATHS 26 CENSORED DEATHS 20 TERMINAL 24 | | | | UNCENSORED DEATHS | | 131 355 454 458 475 529 564 569 590 607 | | 607 636 641 650 651 671 680 682 687 696 | | 701 706 711 715 715 729 | | CENSORED DEATHS | | 277 277 277 277 277 277 277 277 277 277 | | 459 459 459 459 459 459 459 459 459 459 | | | |--------------------------------------------------------------------------------| | DOSE = 0.007 | | --------------------- | | | | TOTAL 45 UNCENSORED DEATHS 20 CENSORED DEATHS 10 TERMINAL 15 | | | | UNCENSORED DEATHS | | 352 447 465 524 530 530 545 631 641 649 | | 651 652 658 666 694 694 694 701 705 724 | | CENSORED DEATHS | | 459 459 459 459 459 459 459 459 459 459 | | | |--------------------------------------------------------------------------------| | DOSE = 0.015 | | --------------------- | | | | TOTAL 75 UNCENSORED DEATHS 39 CENSORED DEATHS 10 TERMINAL 26 | | | | UNCENSORED DEATHS | | 325 403 455 499 530 565 567 593 594 599 | | 614 638 641 641 641 641 641 654 654 657 | | 663 666 669 672 673 677 681 687 691 691 | | 693 693 694 694 694 705 711 714 715 | | CENSORED DEATHS | | 459 459 459 459 459 459 459 459 459 459 | | | ================================================================================== C. I. ACID RED 114 STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 732 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0.03 | | --------------------- | | | | TOTAL 70 UNCENSORED DEATHS 49 CENSORED DEATHS 20 TERMINAL 1 | | | | UNCENSORED DEATHS | | 298 377 383 412 456 470 473 501 511 512 | | 524 524 530 530 530 531 531 531 538 545 | | 556 581 582 614 617 622 625 634 638 638 | | 649 651 658 661 663 663 663 663 677 693 | | 693 694 694 694 704 711 711 723 724 | | CENSORED DEATHS | | 277 277 277 277 277 277 277 277 277 277 | | 459 459 459 459 459 459 459 459 459 459 | | | ================================================================================== C. I. ACID RED 114 STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 732 DAYS ================================================================================== | KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) | | | |--------------------------------------------------------------------------------| | DOSE TIME (DAYS) | | 90 180 270 365 425 485 545 605 665 732 (A) | | | |--------------------------------------------------------------------------------| | | | |CONTROL | 100.0 98.6 98.6 96.9 96.9 91.5 89.5 83.4 71.2 48.8 | | | | | | | |0.007 | 100.0 100.0 100.0 97.8 97.8 92.7 81.1 81.1 63.7 43.4 | | | | | | | |0.015 | 100.0 100.0 100.0 98.7 97.3 96.0 92.9 85.2 68.1 40.3 | | | | | | | |0.03 | 100.0 100.0 100.0 98.3 93.3 87.6 61.1 55.0 24.4 2.0 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | CONTROL 0.007 0.015 0.03 | | | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 48.8% 43.4% 40.3% 2.0% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P<0.001 P=0.730 P=0.507 P<0.001 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 600.4 607.7 631.7 587.8 | |NATURAL DEATHS (C) | (26.7) (23.0) (13.9) (14.5) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 579.1 616.1 643.4 527.1 | |(STANDARD ERROR) | (20.8) (18.1) (12.3) (17.0) | | | | ================================================================================== (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) C. I. ACID RED 114 STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 733 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = CONTROL | | --------------------- | | | | TOTAL 70 UNCENSORED DEATHS 14 CENSORED DEATHS 20 TERMINAL 36 | | | | UNCENSORED DEATHS | | 431 505 524 533 547 562 587 589 641 663 | | 683 711 715 715 | | CENSORED DEATHS | | 277 277 277 277 277 277 277 277 277 277 | | 460 460 460 460 460 460 460 460 460 460 | | | |--------------------------------------------------------------------------------| | DOSE = 0.015 | | --------------------- | | | | TOTAL 45 UNCENSORED DEATHS 22 CENSORED DEATHS 10 TERMINAL 13 | | | | UNCENSORED DEATHS | | 411 411 462 500 523 538 567 582 607 614 | | 638 638 641 658 658 662 663 665 677 708 | | 715 726 | | CENSORED DEATHS | | 460 460 460 460 460 460 460 460 460 460 | | | |--------------------------------------------------------------------------------| | DOSE = 0.03 | | --------------------- | | | | TOTAL 75 UNCENSORED DEATHS 58 CENSORED DEATHS 11 TERMINAL 6 | | | | UNCENSORED DEATHS | | 87 285 344 400 403 448 454 477 487 491 | | 494 496 515 517 521 523 530 531 532 538 | | 545 545 554 567 575 579 581 582 587 588 | | 592 592 592 592 599 609 614 617 631 637 | | 638 641 641 648 649 656 658 676 677 680 | | 693 693 694 709 715 715 715 715 | | CENSORED DEATHS | | 53 460 460 460 460 460 460 460 460 460 | | 460 | | | ================================================================================== C. I. ACID RED 114 STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 733 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0.06 | | --------------------- | | | | TOTAL 70 UNCENSORED DEATHS 50 CENSORED DEATHS 20 TERMINAL 0 | | | | UNCENSORED DEATHS | | 186 229 258 276 339 344 349 351 355 355 | | 372 379 383 384 384 392 400 403 403 411 | | 411 411 411 412 413 413 413 421 433 433 | | 433 454 456 458 473 475 477 486 488 501 | | 501 501 545 551 551 578 582 599 603 614 | | CENSORED DEATHS | | 277 277 277 277 277 277 277 277 277 277 | | 460 460 460 460 460 460 460 460 460 460 | | | ================================================================================== C. I. ACID RED 114 STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 733 DAYS ================================================================================== | KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) | | | |--------------------------------------------------------------------------------| | DOSE TIME (DAYS) | | 90 180 270 365 425 485 545 605 665 733 (A) | | | |--------------------------------------------------------------------------------| | | | |CONTROL | 100.0 100.0 100.0 100.0 100.0 98.3 92.3 84.3 80.3 72.2 | | | | | | | |0.015 | 100.0 100.0 100.0 100.0 95.6 92.7 84.0 78.2 49.2 37.6 | | | | | | | |0.03 | 98.6 98.6 98.6 95.9 93.2 89.0 66.7 46.1 27.0 9.5 | | | | | | | |0.06 | 100.0 100.0 95.7 84.2 53.9 35.6 19.2 2.7 0.0 0.0 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | CONTROL 0.015 0.03 0.06 | | | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 72.2% 37.6% 9.5% 0.0% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P<0.001 P=0.002 P<0.001 P<0.001 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 600.4 602.9 570.1 429.0 | |NATURAL DEATHS (C) | (23.9) (19.8) (15.0) (13.1) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 602.3 608.7 561.5 411.7 | |(STANDARD ERROR) | (20.2) (17.5) (15.2) (11.5) | | | | ================================================================================== (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) C. I. ACID RED 114 KAPLAN-MEIER SURVIVAL CURVES CONTROL = 1 0.007 = 2 0.015 = 3 0.03 = 4 ------------------------------------------------------ SPECIES=RATS SEX=MALE ------------------------------------------------------- Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | 100 + 1 1 4 3 2 | 1 4 3 1 4 4 3 2 1 | 4 4 2 112 3 3 | 4 121 21 3 90 + 21 1 3 | 4 4 11 33 | 44 2 2 1 13 3 | 44 4 1 13 3 80 + 2 1 1 | 44 11 | 113 | P 70 + 12 31 1 E | 33 R | 44 11 C | 44 2 23 11 E 60 + 4 4 4 233311 N | 44 11 T | 4 4 11 | 44 22 S 50 + 44 33 1 1 U | 44 32 2 R | 44 33 V | 332 2 I 40 + 44 3 3 V | 44 A | 4 4 L | 30 + | | 4 4 | 4 4 20 + | 44 | | 44 10 + 44 | | 4 4 | 4 4 0 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 33 obs hidden. C. I. ACID RED 114 KAPLAN-MEIER SURVIVAL CURVES CONTROL = 1 0.015 = 2 0.03 = 3 0.06 = 4 ----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------ Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | 100 + 1 3 4 2 1 | 3 4 4 4 3 3 1 1 1 | 4 4 43 32 2 1 1 | 44 3 3 32 2 1 1 90 + 44 3 33 2 2 1 1 | 33 2 2 1 1 1 | 4 4 2 2 1 1 | 4 4 3 3 1 1 80 + 3 3 2 2 1 1 | 2 2 1 11 | 44 4 33 22 | 33 2 2 1 1 P 70 + 44 33 E | 3 3 R | 33 C | 3 3 2 2 E 60 + 33 N | 2 2 T | 4 44 3 3 | S 50 + 4 4 2 2 U | 44 33 2 2 R | 4 4 333 V | 33 3 22 I 40 + 22 V | 44 33 2 2 A | 44 L | 33 30 + 4 4 33 | 3 3 | 33 | 4 4 33 20 + 44 33 | 3 3 | 33 | 4 4 10 + 44 3 3 | 4 4 | 44 | 44 0 + 4 | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 15 obs hidden.