TDMS Study 05162-09 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Battelle Columbus DIETHANOLAMINE DATE: 04/08/96 EXPERIMENT: 05162 TEST: 09 TIME: 10:59:36 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01-ES-05293 ROUTE: SKIN APPLICATION NTP C#: 55174D PATHOLOGIST: RYAN, M. CAS: 111-42-2 ------------------------------------------------------------------------------------------------------------------------------------ CORE STUDY REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Battelle Columbus DIETHANOLAMINE DATE: 04/08/96 EXPERIMENT: 05162 TEST: 09 TIME: 10:59:36 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-05293 ROUTE: SKIN APPLICATION NTP C#: 55174D PATHOLOGIST: RYAN, M. CAS: 111-42-2 DIETHANOLAMINE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0 MG/KG | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 36 CENSORED DEATHS 0 TERMINAL 14 | | | | UNCENSORED DEATHS | | 101 302 394 479 507 560 561 561 582 595 | | 610 619 645 653 663 666 670 670 670 673 | | 674 680 683 687 687 687 689 694 696 702 | | 702 702 709 710 717 723 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 16 MG/KG | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 40 CENSORED DEATHS 0 TERMINAL 10 | | | | UNCENSORED DEATHS | | 463 509 538 541 542 554 560 562 572 576 | | 577 577 584 599 606 610 619 625 638 639 | | 640 642 648 661 662 663 666 670 670 673 | | 678 681 688 694 695 702 704 722 723 723 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 32 MG/KG | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 29 CENSORED DEATHS 0 TERMINAL 21 | | | | UNCENSORED DEATHS | | 471 499 504 527 533 542 556 568 599 618 | | 635 659 663 664 681 681 689 694 702 702 | | 702 702 709 710 710 715 715 722 723 | | CENSORED DEATHS | | NONE | | | ================================================================================== DIETHANOLAMINE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 64 MG/KG | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 28 CENSORED DEATHS 0 TERMINAL 22 | | | | UNCENSORED DEATHS | | 277 379 431 465 530 533 533 541 542 561 | | 577 587 621 632 640 641 642 643 653 656 | | 688 688 689 701 709 709 722 728 | | CENSORED DEATHS | | NONE | | | ================================================================================== DIETHANOLAMINE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 729 DAYS ================================================================================== | KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) | | | |--------------------------------------------------------------------------------| | DOSE TIME (DAYS) | | 90 180 270 365 425 485 545 605 665 729 (A) | | | |--------------------------------------------------------------------------------| | | | |0 MG/KG | 100.0 98.0 98.0 96.0 94.0 92.0 90.0 80.0 70.0 28.0 | | | | | | | |16 MG/KG | 100.0 100.0 100.0 100.0 100.0 98.0 90.0 72.0 48.0 20.0 | | | | | | | |32 MG/KG | 100.0 100.0 100.0 100.0 100.0 98.0 88.0 82.0 72.0 42.0 | | | | | | | |64 MG/KG | 100.0 100.0 100.0 98.0 96.0 92.0 82.0 76.0 60.0 44.0 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | 0 MG/KG 16 MG/KG 32 MG/KG 64 MG/KG | | | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 28.0% 20.0% 42.0% 44.0% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.066N P=0.204 P=0.125N P=0.279N | |(LIFE TABLE) | | | | | |MEAN DAY OF | 620.1 627.4 641.2 597.1 | |NATURAL DEATHS (C) | (21.4) (10.2) (14.9) (20.8) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 650.6 647.7 678.1 655.1 | |(STANDARD ERROR) | (16.9) (10.0) (10.6) (14.8) | | | | ================================================================================== (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) DIETHANOLAMINE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 730 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0 MG/KG | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 25 CENSORED DEATHS 0 TERMINAL 25 | | | | UNCENSORED DEATHS | | 438 460 489 506 522 531 579 589 597 600 | | 606 622 632 638 648 650 652 653 658 666 | | 671 678 697 701 729 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 8 MG/KG | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 21 CENSORED DEATHS 0 TERMINAL 29 | | | | UNCENSORED DEATHS | | 323 492 541 544 556 589 597 638 641 655 | | 666 681 689 699 702 703 703 703 704 722 | | 724 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 16 MG/KG | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 21 CENSORED DEATHS 0 TERMINAL 29 | | | | UNCENSORED DEATHS | | 351 365 434 490 561 579 591 606 619 634 | | 648 656 665 677 679 692 694 695 697 719 | | 727 | | CENSORED DEATHS | | NONE | | | ================================================================================== DIETHANOLAMINE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 730 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 32 MG/KG | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 26 CENSORED DEATHS 0 TERMINAL 24 | | | | UNCENSORED DEATHS | | 395 430 465 486 490 515 559 565 572 584 | | 589 609 621 629 642 646 656 668 669 675 | | 699 700 703 706 717 728 | | CENSORED DEATHS | | NONE | | | ================================================================================== DIETHANOLAMINE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 730 DAYS ================================================================================== | KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) | | | |--------------------------------------------------------------------------------| | DOSE TIME (DAYS) | | 90 180 270 365 425 485 545 605 665 730 (A) | | | |--------------------------------------------------------------------------------| | | | |0 MG/KG | 100.0 100.0 100.0 100.0 100.0 96.0 88.0 80.0 62.0 50.0 | | | | | | | |8 MG/KG | 100.0 100.0 100.0 98.0 98.0 98.0 92.0 86.0 80.0 58.0 | | | | | | | |16 MG/KG | 100.0 100.0 100.0 96.0 96.0 94.0 92.0 86.0 74.0 58.0 | | | | | | | |32 MG/KG | 100.0 100.0 100.0 100.0 98.0 94.0 88.0 78.0 66.0 48.0 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | 0 MG/KG 8 MG/KG 16 MG/KG 32 MG/KG | | | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 50.0% 58.0% 58.0% 48.0% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.709 P=0.337N P=0.448N P=0.982 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 608.5 632.0 608.5 604.5 | |NATURAL DEATHS (C) | (15.5) (21.5) (24.2) (18.4) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 669.2 688.8 679.0 664.8 | |(STANDARD ERROR) | (11.6) (11.3) (13.2) (13.0) | | | | ================================================================================== (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) DIETHANOLAMINE KAPLAN-MEIER SURVIVAL CURVES 0 MG/KG = 1 16 MG/KG = 2 32 MG/KG = 3 64 MG/KG = 4 ------------------------------------------------------ SPECIES=RATS SEX=MALE ------------------------------------------------------- Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 1 4 23 | 1 4 1 4 23 32 | 1 4 1 4 4 1 32 322 | 4 1 1 33 90 + 1 432 1 | 3 11 | 44 212 1 3 | 4 4221 13 3 P 80 + 4 4 1 13 3 E | 44 11 3 3 R | 22 2 1 4 11 C | 22 44 1 1 3 E 70 + 22 11 N | 22 33 T | 22 2 4 333 | 11 S 60 + 4 4 U | 11 R | 22 2 11 33 V | 44 I 50 + 33 V | 22 4 4 A | 11 33 4 L | 22 11 3 3 40 + | 22 | 22211 | 11 30 + 22 11 | 1 1 | 2 2 | 20 + 2 2 | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 30 obs hidden. DIETHANOLAMINE KAPLAN-MEIER SURVIVAL CURVES 0 MG/KG = 1 8 MG/KG = 2 16 MG/KG = 3 32 MG/KG = 4 ----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------ Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 104 + | | 1 2 3 4 1 | 2 3 3 4 41 1 2 96 + 3 3 14 12 2 | 3 4 1 1 P | 3 1 1 2 23 E | 4 4 11 23 3 2 R 88 + 4 1 4 1 22 C | 44 1 123 2 E | 44 113 3 N | 4 4 3 32 2 T 80 + 4 411 3 32 2 | 4 1 1 33 2 2 S | 4 1 1 3 3 22 U | 4411 3 3 22 R 72 + 4 11 22 V | 44 3 3 I | 11 33 V | 4 4 A 64 + L | 1 14 32 32 | 4 4 33 | 11 2 2 56 + 1 14 | 11 | 1 4 1 | 44 1 48 + 4 4 | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 19 obs hidden.