TDMS Study 05067-09 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Southern Research Inst THEOPHYLLINE DATE: 07/11/96 EXPERIMENT: 05067 TEST: 09 TIME: 17:51:19 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: NO1-ES-05297 ROUTE: GAVAGE NTP C#: 61609D PATHOLOGIST: DANIEL FARNELL FARNELL, DANIEL R. CAS: 58-55-9 ------------------------------------------------------------------------------------------------------------------------------------ CORE STUDY REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Southern Research Inst THEOPHYLLINE DATE: 07/11/96 EXPERIMENT: 05067 TEST: 09 TIME: 17:51:19 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-05297 ROUTE: GAVAGE NTP C#: 61609D PATHOLOGIST: DANIEL FARNELL FARNELL, DANIEL R. CAS: 58-55-9 THEOPHYLLINE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = VEHICLE CONTROL | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 26 CENSORED DEATHS 1 TERMINAL 23 | | | | UNCENSORED DEATHS | | 529 533 545 546 572 598 607 614 616 617 | | 617 638 638 642 649 649 658 670 670 671 | | 671 700 719 726 727 728 | | CENSORED DEATHS | | 388 | | | |--------------------------------------------------------------------------------| | DOSE = 7.5 MG/KG | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 16 CENSORED DEATHS 1 TERMINAL 33 | | | | UNCENSORED DEATHS | | 372 497 500 547 558 566 616 616 624 644 | | 666 667 706 713 719 723 | | CENSORED DEATHS | | 234 | | | |--------------------------------------------------------------------------------| | DOSE = 25 MG/KG | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 20 CENSORED DEATHS 1 TERMINAL 29 | | | | UNCENSORED DEATHS | | 233 422 425 498 498 520 558 558 560 572 | | 590 616 617 622 639 647 666 670 680 706 | | CENSORED DEATHS | | 526 | | | ================================================================================== THEOPHYLLINE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE RATS FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 75 MG/KG | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 26 CENSORED DEATHS 0 TERMINAL 24 | | | | UNCENSORED DEATHS | | 211 241 306 387 387 441 456 457 457 457 | | 457 457 462 497 498 552 566 572 576 595 | | 642 643 649 671 706 706 | | CENSORED DEATHS | | NONE | | | ================================================================================== THEOPHYLLINE 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) | | | |--------------------------------------------------------------------------------| | | | |VEHICLE | 100.0 100.0 100.0 100.0 100.0 100.0 93.9 87.8 65.3 46.9 | |CONTROL | | | | | |7.5 | 100.0 100.0 100.0 100.0 98.0 98.0 93.9 87.8 79.6 67.3 | |MG/KG | | | | | |25 MG/KG | 100.0 100.0 98.0 98.0 94.0 94.0 88.0 77.8 67.5 59.3 | | | | | | | |75 MG/KG | 100.0 100.0 96.0 94.0 90.0 74.0 70.0 60.0 54.0 48.0 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | VEHICLE 7.5 25 MG/KG 75 MG/KG | | CONTROL MG/KG | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 46.9% 67.3% 59.3% 48.0% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.118 P=0.084N P=0.526N P=0.586 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 636.5 608.4 564.9 501.9 | |NATURAL DEATHS (C) | (11.6) (24.4) (25.0) (25.8) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 674.1 680.5 659.3 610.9 | |(STANDARD ERROR) | (10.6) (14.3) (15.3) (21.0) | | | | ================================================================================== (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) THEOPHYLLINE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = VEHICLE CONTROL | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 18 CENSORED DEATHS 0 TERMINAL 32 | | | | UNCENSORED DEATHS | | 399 441 498 498 524 533 545 576 580 630 | | 667 667 670 670 678 691 719 720 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 7.5 MG/KG | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 19 CENSORED DEATHS 1 TERMINAL 30 | | | | UNCENSORED DEATHS | | 5 404 478 504 579 595 598 600 600 614 | | 614 614 646 651 670 691 692 694 700 | | CENSORED DEATHS | | 293 | | | |--------------------------------------------------------------------------------| | DOSE = 25 MG/KG | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 17 CENSORED DEATHS 0 TERMINAL 33 | | | | UNCENSORED DEATHS | | 497 498 520 531 541 551 601 617 642 649 | | 661 663 670 671 674 719 723 | | CENSORED DEATHS | | NONE | | | ================================================================================== THEOPHYLLINE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE RATS FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 75 MG/KG | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 14 CENSORED DEATHS 3 TERMINAL 33 | | | | UNCENSORED DEATHS | | 393 421 586 614 614 614 642 648 660 671 | | 691 695 695 706 | | CENSORED DEATHS | | 244 244 336 | | | ================================================================================== THEOPHYLLINE 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) | | | |--------------------------------------------------------------------------------| | | | |VEHICLE | 100.0 100.0 100.0 100.0 98.0 96.0 86.0 82.0 80.0 64.0 | |CONTROL | | | | | |7.5 | 98.0 98.0 98.0 98.0 96.0 93.9 91.9 81.7 71.5 61.3 | |MG/KG | | | | | |25 MG/KG | 100.0 100.0 100.0 100.0 100.0 100.0 90.0 86.0 76.0 66.0 | | | | | | | |75 MG/KG | 100.0 100.0 100.0 100.0 95.7 95.7 95.7 93.6 80.9 70.2 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | VEHICLE 7.5 25 MG/KG 75 MG/KG | | CONTROL MG/KG | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 64.0% 61.3% 66.0% 70.2% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.389N P=0.916 P=0.955N P=0.584N | |(LIFE TABLE) | | | | | |MEAN DAY OF | 594.8 576.3 613.4 617.9 | |NATURAL DEATHS (C) | (23.1) (36.4) (18.4) (25.8) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 680.7 662.2 689.7 670.6 | |(STANDARD ERROR) | (12.3) (18.8) ( 9.9) (17.5) | | | | ================================================================================== (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) THEOPHYLLINE KAPLAN-MEIER SURVIVAL CURVES VEHICLE CONTROL = 1 7.5 MG/KG = 2 25 MG/KG = 3 75 MG/KG = 4 ------------------------------------------------------ SPECIES=RATS SEX=MALE ------------------------------------------------------- Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 4 3 2 1 | 4 3 4 2 3 2 11 | 4 4 4 3 22 112 | 122 1 P 90 + 4 4 3 3 221 1 E | 4 4 3 32 112 R | 11 C | 3 3 112 2 E 80 + 3 3 2 2 N | 3 31 1 T | 4 4 33 2 2 | 44 3 11 222 S 70 + 4 4 33 22 U | 4 4 11 3 2 2 R | 444 1 1 V | 4 4 3 3 3 I 60 + 4 4 3 3 V | 1 1 A | 44 4 1 1 L | 4 4 11 50 + | 4 1 1 | | 40 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 15 obs hidden. THEOPHYLLINE KAPLAN-MEIER SURVIVAL CURVES VEHICLE CONTROL = 1 7.5 MG/KG = 2 25 MG/KG = 3 75 MG/KG = 4 ----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------ Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 12 1 3 | | 2 12 4 1 33 | 2 4 1 2 1 3 4 95 + | 2 2 33 4 4 | 1 13 3 2 | P 90 + 1 133 2 2 E | R | 113 22 4 4 C | 1 1 3 3 E 85 + 44 N | 3 3 T | 1 1 33 4 | 2 2 44 S 80 + 1 3 31 U | 4 4 R | V | 33 44 I 75 + 2 2 V | A | 11 44 L | 2 2 70 + 21 1 4 3 4 | | 1 13 | 3 3 65 + 22 | 1 1 | | 2 2 60 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 14 obs hidden.