TDMS Study 88031-05 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Battelle Columbus DIPROPYLENE GLYCOL DATE: 02/04/02 EXPERIMENT: 88031 TEST: 05 TIME: 10:32:00 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01-ES-55388 ROUTE: DOSED WATER NTP C#: C88031 PATHOLOGIST: MISSING CAS: 25265-71-8 ------------------------------------------------------------------------------------------------------------------------------------ FINAL#3 REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Battelle Columbus DIPROPYLENE GLYCOL DATE: 02/04/02 EXPERIMENT: 88031 TEST: 05 TIME: 10:32:00 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-55388 ROUTE: DOSED WATER NTP C#: C88031 PATHOLOGIST: MISSING CAS: 25265-71-8 DIPROPYLENE GLYCOL STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0.0% | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 27 CENSORED DEATHS 0 TERMINAL 23 | | | | UNCENSORED DEATHS | | 261 323 376 511 564 564 565 568 569 582 | | 584 636 645 653 653 654 667 673 676 679 | | 687 697 697 698 698 717 718 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 0.25% | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 23 CENSORED DEATHS 0 TERMINAL 27 | | | | UNCENSORED DEATHS | | 417 456 505 528 550 554 558 564 586 614 | | 649 649 661 680 684 698 709 711 716 717 | | 721 726 728 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 1.0% | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 23 CENSORED DEATHS 0 TERMINAL 27 | | | | UNCENSORED DEATHS | | 340 543 562 564 583 584 586 598 617 619 | | 623 627 627 647 649 649 674 682 698 712 | | 718 725 726 | | CENSORED DEATHS | | NONE | | | ================================================================================== DIPROPYLENE GLYCOL STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 4.0% | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 50 CENSORED DEATHS 0 TERMINAL 0 | | | | UNCENSORED DEATHS | | 398 408 431 438 449 483 484 484 484 502 | | 507 525 529 532 543 554 561 564 564 564 | | 565 574 578 584 586 589 596 598 598 610 | | 610 613 613 614 614 617 619 624 627 627 | | 627 629 631 640 645 647 653 673 682 690 | | CENSORED DEATHS | | NONE | | | ================================================================================== DIPROPYLENE GLYCOL 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) | | | |--------------------------------------------------------------------------------| | | | |0.0% | 100.0 100.0 98.0 96.0 94.0 94.0 92.0 78.0 68.0 46.0 | | | | | | | |0.25% | 100.0 100.0 100.0 100.0 98.0 96.0 92.0 82.0 74.0 54.0 | | | | | | | |1.0% | 100.0 100.0 100.0 98.0 98.0 98.0 96.0 84.0 68.0 54.0 | | | | | | | |4.0% | 100.0 100.0 100.0 100.0 96.0 82.0 70.0 42.0 6.0 0.0 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | 0.0% 0.25% 1.0% 4.0% | | | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 46.0% 54.0% 54.0% 0.0% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P<0.001 P=0.437N P=0.507N P<0.001 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 604.3 625.3 624.0 571.5 | |NATURAL DEATHS (C) | (22.7) (19.5) (17.2) (10.1) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 661.6 681.3 680.7 571.5 | |(STANDARD ERROR) | (15.1) (11.5) (10.8) (10.1) | | | | ================================================================================== (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) DIPROPYLENE GLYCOL STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0.0% | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 20 CENSORED DEATHS 0 TERMINAL 30 | | | | UNCENSORED DEATHS | | 247 413 527 540 542 543 596 624 626 626 | | 659 696 697 697 697 697 702 709 724 728 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 0.25% | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 19 CENSORED DEATHS 0 TERMINAL 31 | | | | UNCENSORED DEATHS | | 417 425 435 542 585 585 585 622 624 626 | | 634 641 668 680 683 717 717 721 725 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 1.0% | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 12 CENSORED DEATHS 0 TERMINAL 38 | | | | UNCENSORED DEATHS | | 295 597 598 600 604 627 638 665 667 681 | | 717 725 | | CENSORED DEATHS | | NONE | | | ================================================================================== DIPROPYLENE GLYCOL STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 4.0% | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 18 CENSORED DEATHS 1 TERMINAL 31 | | | | UNCENSORED DEATHS | | 533 542 564 577 582 597 597 626 626 652 | | 659 668 681 694 694 711 718 725 | | CENSORED DEATHS | | 536 | | | ================================================================================== DIPROPYLENE GLYCOL STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE 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) | | | |--------------------------------------------------------------------------------| | | | |0.0% | 100.0 100.0 98.0 98.0 96.0 96.0 88.0 86.0 78.0 60.0 | | | | | | | |0.25% | 100.0 100.0 100.0 100.0 96.0 94.0 92.0 86.0 76.0 62.0 | | | | | | | |1.0% | 100.0 100.0 100.0 98.0 98.0 98.0 98.0 90.0 84.0 76.0 | | | | | | | |4.0% | 100.0 100.0 100.0 100.0 100.0 100.0 96.0 85.7 77.6 63.3 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | 0.0% 0.25% 1.0% 4.0% | | | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 60.0% 62.0% 76.0% 63.3% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=1.000N P=1.000N P=0.134N P=0.889N | |(LIFE TABLE) | | | | | |MEAN DAY OF | 614.5 612.2 617.8 635.9 | |NATURAL DEATHS (C) | (27.0) (22.5) (32.1) (14.6) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 683.2 684.6 702.3 691.6 | |(STANDARD ERROR) | (13.3) (11.7) (10.1) ( 8.8) | | | | ================================================================================== (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) DIPROPYLENE GLYCOL KAPLAN-MEIER SURVIVAL CURVES 0.0% = 1 0.25% = 2 1.0% = 3 4.0% = 4 ------------------------------------------------------ SPECIES=RATS SEX=MALE ------------------------------------------------------- Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 112 + | | | 1 1 1 3 4 42 2 3 96 + 1 1 4 44 2 1 2 3 3 | 4 4 4 1 2 221 3 P | 44 211 3 3 E | 4 4 21 1 3 23 R 80 + 44 4 1 2331 2 C | 44 31 11 2 2 E | 4 4 4 2 2 N | 44 31 113 2 2 T 64 + 3 3 22 | 44 1 11 322 S | 444 2 2 U | 4 4 1 1 R 48 + 44 1 1 V | 4 4 I | V | A 32 + 44 L | 44 | | 16 + 444 | 44 | 44 4 | 444 0 + 4 | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 38 obs hidden. DIPROPYLENE GLYCOL KAPLAN-MEIER SURVIVAL CURVES 0.0% = 1 0.25% = 2 1.0% = 3 4.0% = 4 ----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------ Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 1 3 2 4 | | 1 3 122 44 3 | 1 2 2 1 4 4 95 + | 2 1 1 4 4 | 2 42 33 | P 90 + 4 43 3 E | R | 1 1 3 3 C | 2 1 21 3 3 E 85 + N | 22 33 T | 3 3 | 4 4 S 80 + 12 4 1 3 3 U | R | 22 14 1 33 V | 2 2 3 3 I 75 + 4 4 V | 2 2 4 A | L | 70 + 2 4 42 | | 1144 | 11 65 + 44 | 121 4 | 2 2 | 60 + 1 1 | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 13 obs hidden.