TDMS Study 89006-02 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Southern Research Inst AZT/INTERFERON A/INTERFERON AD DATE: 08/21/96 EXPERIMENT: 89006 TEST: 02 TIME: 11:12:21 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: NO1-ES-85225 ROUTE: GAVAGE NTP C#: C89006 PATHOLOGIST: JAMES E. HEATH CAS: 30516-871 ------------------------------------------------------------------------------------------------------------------------------------ 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/INTERFERON A/INTERFERON AD DATE: 08/21/96 EXPERIMENT: 89006 TEST: 02 TIME: 11:12:21 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-85225 ROUTE: GAVAGE NTP C#: C89006 PATHOLOGIST: JAMES E. HEATH CAS: 30516-871 AZT/INTERFERON A/INTERFERON AD STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 731 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = VEHICLE CONTROL | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 14 CENSORED DEATHS 0 TERMINAL 36 | | | | UNCENSORED DEATHS | | 358 374 477 531 542 600 618 660 675 690 | | 703 716 716 726 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 30 MG/KG 500 U | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 21 CENSORED DEATHS 2 TERMINAL 27 | | | | UNCENSORED DEATHS | | 131 296 376 501 518 542 554 556 570 579 | | 604 624 656 658 663 674 705 708 717 720 | | 723 | | CENSORED DEATHS | | 3 15 | | | |--------------------------------------------------------------------------------| | DOSE = 60 MG/KG 500 U | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 9 CENSORED DEATHS 3 TERMINAL 38 | | | | UNCENSORED DEATHS | | 303 563 598 624 631 636 685 699 722 | | CENSORED DEATHS | | 15 15 722 | | | ================================================================================== AZT/INTERFERON A/INTERFERON AD STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 731 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 120MG/KG 500 U | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 15 CENSORED DEATHS 0 TERMINAL 35 | | | | UNCENSORED DEATHS | | 522 527 546 562 575 632 638 663 672 682 | | 682 696 699 703 727 | | CENSORED DEATHS | | NONE | | | ================================================================================== AZT/INTERFERON A/INTERFERON AD STATISTICAL ANALYSIS OF SURVIVAL DATA MALE 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 98.0 96.0 94.0 90.0 88.0 84.0 72.0 | |CONTROL | | | | | |30 | 100.0 97.9 97.9 95.8 93.8 93.8 87.5 77.1 68.8 56.3 | |MG/KG 500 U| | | | | |60 | 100.0 100.0 100.0 97.9 97.9 97.9 97.9 93.8 87.5 81.3 | |MG/KG 500 U| | | | | |120MG/KG | 100.0 100.0 100.0 100.0 100.0 100.0 96.0 90.0 84.0 70.0 | |500 U | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | VEHICLE 30 60 120MG/KG | | CONTROL MG/KG 500 U MG/KG 500 U 500 U | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 72.0% 56.3% 81.3% 70.0% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.816 P=0.136 P=0.393N P=0.998 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 599.0 575.0 606.8 635.1 | |NATURAL DEATHS (C) | (33.5) (33.0) (41.5) (18.1) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 694.0 636.6 679.8 702.2 | |(STANDARD ERROR) | (12.4) (25.3) (21.7) ( 8.2) | | | | ================================================================================== (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/INTERFERON A/INTERFERON AD STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = VEHICLE CONTROL | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 14 CENSORED DEATHS 3 TERMINAL 33 | | | | UNCENSORED DEATHS | | 467 530 568 593 610 649 675 688 690 705 | | 705 707 710 715 | | CENSORED DEATHS | | 3 17 26 | | | |--------------------------------------------------------------------------------| | DOSE = 30 MG/KG 500 U | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 14 CENSORED DEATHS 4 TERMINAL 32 | | | | UNCENSORED DEATHS | | 441 467 480 526 527 534 561 603 610 628 | | 631 638 667 702 | | CENSORED DEATHS | | 2 24 57 541 | | | |--------------------------------------------------------------------------------| | DOSE = 60 MG/KG 500 U | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 16 CENSORED DEATHS 2 TERMINAL 32 | | | | UNCENSORED DEATHS | | 436 445 514 594 597 598 614 614 634 647 | | 656 660 682 689 707 713 | | CENSORED DEATHS | | 14 20 | | | ================================================================================== AZT/INTERFERON A/INTERFERON AD STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 729 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 120MG/KG 500 U | | ---------------------------- | | | | TOTAL 50 UNCENSORED DEATHS 21 CENSORED DEATHS 5 TERMINAL 24 | | | | UNCENSORED DEATHS | | 32 376 491 577 589 597 603 604 610 617 | | 631 631 662 673 695 699 705 722 725 726 | | 726 | | CENSORED DEATHS | | 14 25 25 430 669 | | | ================================================================================== AZT/INTERFERON A/INTERFERON AD STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE 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 | 100.0 100.0 100.0 100.0 100.0 97.9 95.7 91.5 87.2 70.2 | |CONTROL | | | | | |30 | 100.0 100.0 100.0 100.0 100.0 93.6 87.2 82.9 74.1 69.8 | |MG/KG 500 U| | | | | |60 | 100.0 100.0 100.0 100.0 100.0 95.8 93.8 87.5 75.0 66.7 | |MG/KG 500 U| | | | | |120MG/KG | 97.9 97.9 97.9 97.9 95.7 95.7 93.6 82.7 71.8 53.9 | |500 U | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | VEHICLE 30 60 120MG/KG | | CONTROL MG/KG 500 U MG/KG 500 U 500 U | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 70.2% 69.8% 66.7% 53.9% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.402 P=0.906 P=0.752 P=0.138 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 643.7 572.5 612.5 604.3 | |NATURAL DEATHS (C) | (20.9) (21.2) (20.9) (34.1) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 662.3 639.3 663.2 627.0 | |(STANDARD ERROR) | (24.6) (25.0) (21.4) (27.8) | | | | ================================================================================== (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) AZT/INTERFERON A/INTERFERON AD KAPLAN-MEIER SURVIVAL CURVES VEHICLE CONTROL = 1 30 MG/KG 500 U = 2 60 MG/KG 500 U = 3 120MG/KG 500 U = 4 ------------------------------------------------------ SPECIES=MICE SEX=MALE ------------------------------------------------------- Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 2 3 1 4 | | 2 23 1 1 44 3 | 2 1 1 4 4 3 3 95 + | 2 1 2 1 4 4 3 3 | 1 1 4 4 | 2 2 33 90 + 2 1 4 1 4 | P | 2 2 1 1 34 3 E | 1 4 1 R 85 + 3 3 C | 2 2 141 3 3 E | 4141 N | 22 3 3 T 80 + 1 1 | 2 2 S | 2 2 4 41 1 U | R 75 + 2 2 V | 44 11 I | 4 1 1 V | 2 2 A 70 + 4 4 L | 2 2 | | 2 2 65 + 22 | | 22 | 60 + | 22 | | 2 2 55 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 9 obs hidden. AZT/INTERFERON A/INTERFERON AD KAPLAN-MEIER SURVIVAL CURVES VEHICLE CONTROL = 1 30 MG/KG 500 U = 2 60 MG/KG 500 U = 3 120MG/KG 500 U = 4 ----------------------------------------------------- SPECIES=MICE SEX=FEMALE ------------------------------------------------------ Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | 100 + 1 4 2 1 | | 4 4 23 1 1 | 4 3 2 2 4 3 1 1 95 + | 2 4 3 2 14 1 | | 4 13 1 90 + | 22 44 1 1 | 2 2 343 1 1 | P 85 + 2 2 1 1 E | 3 3 R | 22 C | 2 23 3 1 1 E 80 + 44 N | 422 33 T | 3 3 | 22 S 75 + 3 3 11 U | 42 42 R | 2 33 211 V | 4 4 3 3 I 70 + 4 42 1 1 V | 33 A | L | 3 3 65 + 44 | | 4 4 | 60 + | | | 55 + | 4 4 | | 50 + | --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-- 0 10 20 30 40 50 60 70 80 90 100 110 WEEK NOTE: 14 obs hidden.