TDMS Study 05188-05 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Battelle Columbus SODIUM XYLENESULFONATE DATE: 04/04/96 EXPERIMENT: 05188 TEST: 05 TIME: 04:41:48 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01-ES-05293 ROUTE: SKIN APPLICATION NTP C#: 55403D PATHOLOGIST: TOFT, J. CAS: 1300-72-7 ------------------------------------------------------------------------------------------------------------------------------------ REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Battelle Columbus SODIUM XYLENESULFONATE DATE: 04/04/96 EXPERIMENT: 05188 TEST: 05 TIME: 04:41:48 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-05293 ROUTE: SKIN APPLICATION NTP C#: 55403D PATHOLOGIST: TOFT, J. CAS: 1300-72-7 SODIUM XYLENESULFONATE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 735 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0 MG/KG | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 43 CENSORED DEATHS 0 TERMINAL 7 | | | | UNCENSORED DEATHS | | 441 447 492 499 527 534 546 547 554 557 | | 560 565 567 582 583 590 595 616 616 617 | | 618 636 639 645 648 650 652 658 672 681 | | 682 687 687 701 702 707 708 712 713 715 | | 724 728 728 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 60 MG/KG | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 33 CENSORED DEATHS 0 TERMINAL 17 | | | | UNCENSORED DEATHS | | 196 349 362 393 441 491 516 527 540 541 | | 547 565 601 603 603 609 609 619 623 631 | | 631 643 645 645 656 658 674 702 702 702 | | 710 726 732 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 120 MG/KG | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 41 CENSORED DEATHS 0 TERMINAL 9 | | | | UNCENSORED DEATHS | | 257 439 477 487 489 527 535 538 562 568 | | 571 573 579 594 596 606 609 612 621 622 | | 622 622 637 646 646 650 652 653 659 666 | | 672 672 673 695 700 704 708 708 715 718 | | 726 | | CENSORED DEATHS | | NONE | | | ================================================================================== SODIUM XYLENESULFONATE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 735 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 240 MG/KG | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 40 CENSORED DEATHS 0 TERMINAL 10 | | | | UNCENSORED DEATHS | | 382 428 433 480 520 524 525 527 530 541 | | 547 556 561 562 567 568 582 590 594 616 | | 629 631 638 642 652 658 667 669 679 687 | | 702 702 714 719 719 726 726 728 730 731 | | CENSORED DEATHS | | NONE | | | ================================================================================== SODIUM XYLENESULFONATE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 735 DAYS ================================================================================== | KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) | | | |--------------------------------------------------------------------------------| | DOSE TIME (DAYS) | | 90 180 270 365 425 485 545 605 665 735 (A) | | | |--------------------------------------------------------------------------------| | | | |0 MG/KG | 100.0 100.0 100.0 100.0 100.0 96.0 88.0 66.0 44.0 14.0 | | | | | | | |60 MG/KG | 100.0 100.0 98.0 94.0 92.0 90.0 80.0 70.0 48.0 34.0 | | | | | | | |120 | 100.0 100.0 98.0 98.0 98.0 94.0 84.0 70.0 42.0 18.0 | |MG/KG | | | | | |240 | 100.0 100.0 100.0 100.0 98.0 92.0 80.0 62.0 48.0 20.0 | |MG/KG | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | 0 MG/KG 60 MG/KG 120 240 | | MG/KG MG/KG | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 14.0% 34.0% 18.0% 20.0% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=1.000N P=0.115N P=0.927N P=0.580N | |(LIFE TABLE) | | | | | |MEAN DAY OF | 621.6 581.6 609.9 609.6 | |NATURAL DEATHS (C) | (11.9) (21.2) (14.3) (14.7) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 637.5 633.7 632.4 634.6 | |(STANDARD ERROR) | (11.7) (17.3) (13.5) (13.7) | | | | ================================================================================== (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) SODIUM XYLENESULFONATE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 736 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0 MG/KG | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 27 CENSORED DEATHS 1 TERMINAL 22 | | | | UNCENSORED DEATHS | | 303 393 408 420 420 480 485 488 490 490 | | 545 548 575 591 605 629 646 656 657 674 | | 682 692 693 708 718 719 732 | | CENSORED DEATHS | | 698 | | | |--------------------------------------------------------------------------------| | DOSE = 60 MG/KG | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 34 CENSORED DEATHS 0 TERMINAL 16 | | | | UNCENSORED DEATHS | | 201 277 301 367 386 446 447 486 497 525 | | 528 528 537 541 547 550 559 563 582 585 | | 590 622 626 630 643 644 645 645 666 694 | | 701 708 722 735 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 120 MG/KG | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 33 CENSORED DEATHS 0 TERMINAL 17 | | | | UNCENSORED DEATHS | | 441 444 445 462 492 501 510 517 527 532 | | 542 547 559 564 568 594 602 603 625 638 | | 643 645 646 648 660 666 673 697 706 708 | | 712 712 717 | | CENSORED DEATHS | | NONE | | | ================================================================================== SODIUM XYLENESULFONATE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 736 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 240 MG/KG | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 34 CENSORED DEATHS 0 TERMINAL 16 | | | | UNCENSORED DEATHS | | 289 324 338 379 391 396 412 441 507 515 | | 520 526 556 572 589 591 596 611 615 630 | | 633 634 640 646 651 653 674 677 695 696 | | 706 711 714 728 | | CENSORED DEATHS | | NONE | | | ================================================================================== SODIUM XYLENESULFONATE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 736 DAYS ================================================================================== | KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) | | | |--------------------------------------------------------------------------------| | DOSE TIME (DAYS) | | 90 180 270 365 425 485 545 605 665 736 (A) | | | |--------------------------------------------------------------------------------| | | | |0 MG/KG | 100.0 100.0 100.0 98.0 90.0 86.0 78.0 70.0 62.0 45.7 | | | | | | | |60 MG/KG | 100.0 100.0 98.0 94.0 90.0 86.0 72.0 58.0 44.0 32.0 | | | | | | | |120 | 100.0 100.0 100.0 100.0 100.0 92.0 78.0 64.0 50.0 34.0 | |MG/KG | | | | | |240 | 100.0 100.0 100.0 94.0 86.0 84.0 76.0 66.0 48.0 32.0 | |MG/KG | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | 0 MG/KG 60 MG/KG 120 240 | | MG/KG MG/KG | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 45.7% 32.0% 34.0% 32.0% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.309 P=0.156 P=0.329 P=0.193 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 572.1 550.7 592.3 566.4 | |NATURAL DEATHS (C) | (23.2) (22.2) (15.1) (21.6) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 646.7 610.0 641.2 620.6 | |(STANDARD ERROR) | (17.0) (19.4) (13.9) (18.5) | | | | ================================================================================== (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) SODIUM XYLENESULFONATE KAPLAN-MEIER SURVIVAL CURVES 0 MG/KG = 1 60 MG/KG = 2 120 MG/KG = 3 240 MG/KG = 4 ------------------------------------------------------ SPECIES=RATS SEX=MALE ------------------------------------------------------- Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 2 3 4 1 | 2 3 2 4 411 | 2 2 2 431 3311 | 2 2 4 1 41 90 + 2 32 11 | 2 2 311 | 2 4231113 | 4 4 33 80 + 22 | 211 P | 41331 322 E | 33 R 70 + 44 1 133 C | 4 4 E | 4 1 212 N | 4 11 2 T 60 + 4 4 | 1412 S | 3 111 U | 422 R 50 + V | 11 42 I | 1 312 2 V | 31414 A 40 + 4 22 L | 11 2 2 | 33 131442 2 | 30 + 33 44 | 11 | 334 4 | 11 20 + 11 4 | 3 3 | 1 1 | 10 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 58 obs hidden. SODIUM XYLENESULFONATE KAPLAN-MEIER SURVIVAL CURVES 0 MG/KG = 1 60 MG/KG = 2 120 MG/KG = 3 240 MG/KG = 4 ----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------ Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 104 + | | 1 2 4 1 3 | 2 2 4 1 4 1 33 96 + 2 2 4 4 1 1 | 2 4 2 4 11 3 3 | 2 42 3 3 | 24 1 2 1 33 88 + 4 4 11 33 | 4 42 2 33 P | 4 22 43 3 E | 2 44 2 R 80 + 1 4 22 1 C | 44 11 E | 22 13 1 N | 22 3341 1 T 72 + 22 33 1 1 | 3 3 1 1 S | 22 33 1 1 U | 22 334 11 R 64 + 2 2 3 3 V | 4 3 3 1 1 I | 2 2 44 11 V | 2 2 33 11 A 56 + 2244 L | 44 1 1 | 2 23 3 11 | 44 33 48 + 224 33 1 1 | 3 3 11 | 2 24 33 | 2 233 40 + 22 | 22 | 232 | 432 23 32 + 4 22 | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 29 obs hidden.