TDMS Study 89006-06 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Southern Research Inst AZT DATE: 05/31/96 EXPERIMENT: 89006 TEST: 06 TIME: 13:43:08 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: NO1-ES-85225 ROUTE: GAVAGE NTP C#: C88072 PATHOLOGIST: R.B. THOMPSON CAS: 30516-87-1 ------------------------------------------------------------------------------------------------------------------------------------ TWO-YEAR CHRONIC REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Southern Research Inst AZT DATE: 05/31/96 EXPERIMENT: 89006 TEST: 06 TIME: 13:43:08 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-85225 ROUTE: GAVAGE NTP C#: C88072 PATHOLOGIST: R.B. THOMPSON CAS: 30516-87-1 AZT STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE 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 | | 325 425 458 565 570 576 590 596 606 632 | | 638 646 684 698 701 703 710 722 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 30 MG/KG | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 15 CENSORED DEATHS 0 TERMINAL 35 | | | | UNCENSORED DEATHS | | 257 348 350 458 484 568 582 624 634 652 | | 665 671 711 722 722 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 60 MG/KG | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 18 CENSORED DEATHS 3 TERMINAL 29 | | | | UNCENSORED DEATHS | | 310 422 473 501 505 547 564 584 596 638 | | 639 647 663 667 677 691 722 722 | | CENSORED DEATHS | | 4 256 382 | | | ================================================================================== AZT STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 120 MG/KG | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 8 CENSORED DEATHS 0 TERMINAL 42 | | | | UNCENSORED DEATHS | | 513 540 547 584 612 680 694 695 | | CENSORED DEATHS | | NONE | | | ================================================================================== AZT STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE 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 98.0 96.0 94.0 94.0 84.0 76.0 64.0 | |CONTROL | | | | | |30 MG/KG | 100.0 100.0 98.0 94.0 94.0 90.0 90.0 86.0 78.0 70.0 | | | | | | | |60 MG/KG | 100.0 100.0 100.0 97.9 95.8 93.7 89.4 80.9 72.4 61.7 | | | | | | | |120 | 100.0 100.0 100.0 100.0 100.0 100.0 96.0 92.0 90.0 84.0 | |MG/KG | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | VEHICLE 30 MG/KG 60 MG/KG 120 | | CONTROL MG/KG | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 64.0% 70.0% 61.7% 84.0% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.054N P=0.674N P=0.905 P=0.044N | |(LIFE TABLE) | | | | | |MEAN DAY OF | 602.5 563.2 587.1 608.1 | |NATURAL DEATHS (C) | (25.4) (38.7) (26.2) (26.1) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 683.5 679.3 647.0 709.7 | |(STANDARD ERROR) | (12.5) (15.7) (21.2) ( 7.5) | | | | ================================================================================== (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) AZT STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 731 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = VEHICLE CONTROL | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 16 CENSORED DEATHS 0 TERMINAL 34 | | | | UNCENSORED DEATHS | | 379 410 470 513 523 603 607 610 647 654 | | 665 683 691 706 723 723 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 30 MG/KG | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 11 CENSORED DEATHS 0 TERMINAL 39 | | | | UNCENSORED DEATHS | | 525 527 589 602 617 636 648 654 674 680 | | 690 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 60 MG/KG | | --------------------- | | | | TOTAL 50 UNCENSORED DEATHS 16 CENSORED DEATHS 3 TERMINAL 31 | | | | UNCENSORED DEATHS | | 219 296 493 523 556 582 612 620 620 662 | | 674 689 690 699 713 722 | | CENSORED DEATHS | | 3 87 288 | | | ================================================================================== AZT STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 731 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 120 MG/KG | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 18 CENSORED DEATHS 1 TERMINAL 31 | | | | UNCENSORED DEATHS | | 467 497 556 601 604 612 625 666 679 695 | | 695 703 709 710 710 714 721 722 | | CENSORED DEATHS | | 2 | | | ================================================================================== AZT STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 731 DAYS ================================================================================== | KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) | | | |--------------------------------------------------------------------------------| | DOSE TIME (DAYS) | | 90 180 270 365 425 485 545 605 665 731 (A) | | | |--------------------------------------------------------------------------------| | | | |VEHICLE | 100.0 100.0 100.0 100.0 96.0 94.0 90.0 88.0 78.0 68.0 | |CONTROL | | | | | |30 MG/KG | 100.0 100.0 100.0 100.0 100.0 100.0 96.0 92.0 84.0 78.0 | | | | | | | |60 MG/KG | 100.0 100.0 97.9 95.8 95.8 95.8 91.5 87.3 78.8 66.0 | | | | | | | |120 | 100.0 100.0 100.0 100.0 100.0 98.0 95.9 89.8 85.7 63.3 | |MG/KG | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | VEHICLE 30 MG/KG 60 MG/KG 120 | | CONTROL MG/KG | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 68.0% 78.0% 66.0% 63.3% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.499 P=0.360N P=0.971 P=0.874 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 600.4 622.0 585.6 649.2 | |NATURAL DEATHS (C) | (27.5) (17.2) (36.4) (18.5) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 689.2 707.0 648.2 687.0 | |(STANDARD ERROR) | (12.2) ( 7.4) (24.4) (16.4) | | | | ================================================================================== (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) AZT KAPLAN-MEIER SURVIVAL CURVES VEHICLE CONTROL = 1 30 MG/KG = 2 60 MG/KG = 3 120 MG/KG = 4 ------------------------------------------------------ SPECIES=MICE SEX=MALE ------------------------------------------------------- Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 2 3 1 4 | | 2 3 1 2 1 4 4 | 1 1 3 44 95 + | 2 1 3 3 4 1 4 | 2 2 11 4 4 | 33 P 90 + 2 3 3 11 4 4 E | R | 3 3212 1 4 4 C | 2 11 2 E 85 + 3 3 N | 11 22 4 4 T | 3 31 1 2 | 3 3 S 80 + 11 2 2 U | R | 11 22 V | 31 2 1 2 I 75 + 3 3 V | 1 1 2 2 A | 33 11 L | 70 + 33 2 2 | | 3 3 11 | 3 1 1 65 + | 1 1 | | 3 3 60 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 10 obs hidden. AZT KAPLAN-MEIER SURVIVAL CURVES VEHICLE CONTROL = 1 30 MG/KG = 2 60 MG/KG = 3 120 MG/KG = 4 ----------------------------------------------------- SPECIES=MICE SEX=FEMALE ------------------------------------------------------ Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 3 1 4 2 | | 3 3 1 1 4 4 22 | 3 1 1 3 2 4 2 95 + | 1 3 1 3 4 22 | 1 1 2 2 | 3 3 44 P 90 + 1 3 3 142 2 E | R | 3 3 42 2 C | 11 4 22 4 E 85 + 33 N | 1 12 42 T | 11 22 | 3 3 4 4 S 80 + 1 1 22 U | 3 3 R | 1 1244 2 V | 311 I 75 + 44 V | 1 1 A | 331 1 L | 70 + 3 3 | | 341 1 | 3 3 65 + 44 | 4 4 | | 60 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 11 obs hidden.