TDMS Study 05067-10 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Southern Research Inst THEOPHYLLINE DATE: 07/03/96 EXPERIMENT: 05067 TEST: 10 TIME: 12:27:37 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: NO1-ES-05297 ROUTE: GAVAGE NTP C#: 61609D PATHOLOGIST: ROGER THOMPSON 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: 07/03/96 EXPERIMENT: 05067 TEST: 10 TIME: 12:27:37 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-05297 ROUTE: GAVAGE NTP C#: 61609D PATHOLOGIST: ROGER THOMPSON CAS: 58-55-9 THEOPHYLLINE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 725 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = VEHICLE CONTROL | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 14 CENSORED DEATHS 0 TERMINAL 36 | | | | UNCENSORED DEATHS | | 438 485 605 627 627 635 635 676 700 700 | | 701 703 704 711 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 15 MG/KG | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 15 CENSORED DEATHS 0 TERMINAL 35 | | | | UNCENSORED DEATHS | | 421 464 511 521 522 554 562 569 627 627 | | 633 635 698 706 711 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 50 MG/KG | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 6 CENSORED DEATHS 0 TERMINAL 44 | | | | UNCENSORED DEATHS | | 556 577 620 668 672 700 | | CENSORED DEATHS | | NONE | | | ================================================================================== THEOPHYLLINE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 725 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 150 MG/KG | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 24 CENSORED DEATHS 0 TERMINAL 26 | | | | UNCENSORED DEATHS | | 16 32 95 121 184 211 212 282 331 332 | | 334 352 359 359 382 405 407 442 449 481 | | 598 636 636 703 | | CENSORED DEATHS | | NONE | | | ================================================================================== THEOPHYLLINE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 725 DAYS ================================================================================== | KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) | | | |--------------------------------------------------------------------------------| | DOSE TIME (DAYS) | | 90 180 270 365 425 485 545 605 665 725 (A) | | | |--------------------------------------------------------------------------------| | | | |VEHICLE | 100.0 100.0 100.0 100.0 100.0 96.0 96.0 94.0 86.0 72.0 | |CONTROL | | | | | |15 MG/KG | 100.0 100.0 100.0 100.0 98.0 96.0 90.0 84.0 76.0 70.0 | | | | | | | |50 MG/KG | 100.0 100.0 100.0 100.0 100.0 100.0 100.0 96.0 94.0 88.0 | | | | | | | |150 | 96.0 92.0 86.0 72.0 66.0 60.0 60.0 58.0 54.0 52.0 | |MG/KG | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | VEHICLE 15 MG/KG 50 MG/KG 150 | | CONTROL MG/KG | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 72.0% 70.0% 88.0% 52.0% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.001 P=0.838 P=0.090N P=0.014 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 639.1 584.1 632.2 348.3 | |NATURAL DEATHS (C) | (22.5) (22.7) (23.4) (37.9) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 700.9 682.7 713.9 544.2 | |(STANDARD ERROR) | ( 8.2) (11.4) ( 5.0) (32.4) | | | | ================================================================================== (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 MICE FIRST TERMINAL SACRIFICE AT 725 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = VEHICLE CONTROL | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 13 CENSORED DEATHS 0 TERMINAL 37 | | | | UNCENSORED DEATHS | | 501 555 561 583 605 624 627 642 643 643 | | 654 655 684 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 7.5 MG/KG | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 13 CENSORED DEATHS 0 TERMINAL 37 | | | | UNCENSORED DEATHS | | 494 584 591 603 604 611 633 637 644 652 | | 658 687 702 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 25 MG/KG | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 16 CENSORED DEATHS 0 TERMINAL 34 | | | | UNCENSORED DEATHS | | 542 593 612 629 655 661 667 668 669 688 | | 696 699 704 704 705 710 | | CENSORED DEATHS | | NONE | | | ================================================================================== THEOPHYLLINE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 725 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 75 MG/KG | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 17 CENSORED DEATHS 0 TERMINAL 33 | | | | UNCENSORED DEATHS | | 241 242 367 394 526 569 578 627 639 655 | | 658 687 687 702 704 705 719 | | CENSORED DEATHS | | NONE | | | ================================================================================== THEOPHYLLINE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 725 DAYS ================================================================================== | KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) | | | |--------------------------------------------------------------------------------| | DOSE TIME (DAYS) | | 90 180 270 365 425 485 545 605 665 725 (A) | | | |--------------------------------------------------------------------------------| | | | |VEHICLE | 100.0 100.0 100.0 100.0 100.0 100.0 98.0 90.0 76.0 74.0 | |CONTROL | | | | | |7.5 | 100.0 100.0 100.0 100.0 100.0 100.0 98.0 90.0 78.0 74.0 | |MG/KG | | | | | |25 MG/KG | 100.0 100.0 100.0 100.0 100.0 100.0 98.0 96.0 88.0 68.0 | | | | | | | |75 MG/KG | 100.0 100.0 96.0 96.0 92.0 92.0 90.0 86.0 78.0 66.0 | | | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | VEHICLE 7.5 25 MG/KG 75 MG/KG | | CONTROL MG/KG | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 74.0% 74.0% 68.0% 66.0% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.407 P=1.000N P=0.851 P=0.537 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 613.6 623.1 662.6 570.6 | |NATURAL DEATHS (C) | (14.1) (14.6) (11.9) (39.1) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 696.0 698.5 705.0 672.5 | |(STANDARD ERROR) | ( 7.8) ( 7.4) ( 5.6) (16.7) | | | | ================================================================================== (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) THEOPHYLLINE KAPLAN-MEIER SURVIVAL CURVES VEHICLE CONTROL = 1 15 MG/KG = 2 50 MG/KG = 3 150 MG/KG = 4 ------------------------------------------------------ SPECIES=MICE SEX=MALE ------------------------------------------------------- Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | 100 + 1 4 2 1 3 | | 4 4 2 1 2 1 3 3 | 4 4 2 1 2 3 1 3 95 + | 4 4 2 2 1 31 3 | 4 4 | 90 + 4 4 2 2 11 3 3 | | 22 3 3 | 4 4 22 1 1 P 85 + E | 4 4 2 2 1 1 R | C | E 80 + 22 11 N | T | 4 4 | 44 2 2 S 75 + U | 211 R | 4 4 21 1 V | I 70 + 4 4 2 2 V | A | 44 L | 4 4 65 + | 4 4 | 4 4 | 60 + 4 4 | | 4 4 | 55 + | 4 4 | 4 4 | 50 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 5 obs hidden. THEOPHYLLINE KAPLAN-MEIER SURVIVAL CURVES VEHICLE CONTROL = 1 7.5 MG/KG = 2 25 MG/KG = 3 75 MG/KG = 4 ----------------------------------------------------- SPECIES=MICE SEX=FEMALE ------------------------------------------------------ Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 4 21 3 | | 21 3 1 2 3 | 4 4 11 2 2 3 95 + | 4 4 1 1 2 23 3 P | 4 4 1 1 3 3 E | R 90 + 4 4 12 1 3 3 C | E | 44 2 2 33 N | 4 1 1 T 85 + | 422 S | 2 2 3 3 U | R 80 + 1 1 33 V | I | 2 2 V | 1 1232 A 75 + L | 14 2 1 | | 70 + 33 | | 4343 | 44 65 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 14 obs hidden.