TDMS Study 89006-04 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11
LAB: Southern Research Inst AZT/INTERFERON A/INTERFERON AD DATE: 07/12/96
EXPERIMENT: 89006 TEST: 04 TIME: 16:19:24
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: NO1-ES-85225 ROUTE: GAVAGE NTP C#: C89006
PATHOLOGIST: R.B. THOMPSON CAS: 30516-871
------------------------------------------------------------------------------------------------------------------------------------
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 AZT/INTERFERON A/INTERFERON AD DATE: 07/12/96
EXPERIMENT: 89006 TEST: 04 TIME: 16:19:24
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-85225 ROUTE: GAVAGE NTP C#: C89006
PATHOLOGIST: R.B. THOMPSON CAS: 30516-871
AZT/INTERFERON A/INTERFERON AD
STATISTICAL ANALYSIS OF SURVIVAL DATA
MALE MICE
FIRST TERMINAL SACRIFICE AT 729 DAYS
INDIVIDUAL SURVIVAL TIMES (DAYS)
==================================================================================
| DOSE = VEHICLE CONTROL |
| ---------------------------- |
| |
| TOTAL 50 UNCENSORED DEATHS 19 CENSORED DEATHS 0 TERMINAL 31 |
| |
| UNCENSORED DEATHS |
| 393 462 474 554 576 613 638 670 676 677 |
| 690 691 694 697 710 712 714 724 727 |
| CENSORED DEATHS |
| NONE |
| |
|--------------------------------------------------------------------------------|
| DOSE = 30 MG/KG 5000 U |
| ---------------------------- |
| |
| TOTAL 50 UNCENSORED DEATHS 14 CENSORED DEATHS 1 TERMINAL 35 |
| |
| UNCENSORED DEATHS |
| 363 439 473 528 554 557 557 661 680 683 |
| 688 689 715 715 |
| CENSORED DEATHS |
| 339 |
| |
|--------------------------------------------------------------------------------|
| DOSE = 60 MG/KG 5000 U |
| ---------------------------- |
| |
| TOTAL 50 UNCENSORED DEATHS 14 CENSORED DEATHS 1 TERMINAL 35 |
| |
| UNCENSORED DEATHS |
| 169 215 386 480 488 562 581 605 643 646 |
| 652 665 717 726 |
| CENSORED DEATHS |
| 340 |
| |
==================================================================================
AZT/INTERFERON A/INTERFERON AD
STATISTICAL ANALYSIS OF SURVIVAL DATA
MALE MICE
FIRST TERMINAL SACRIFICE AT 729 DAYS
INDIVIDUAL SURVIVAL TIMES (DAYS)
==================================================================================
| DOSE = 120MG/KG 5000 U |
| ---------------------------- |
| |
| TOTAL 50 UNCENSORED DEATHS 16 CENSORED DEATHS 0 TERMINAL 34 |
| |
| UNCENSORED DEATHS |
| 413 466 498 517 526 557 562 565 586 600 |
| 625 632 697 707 725 726 |
| CENSORED DEATHS |
| NONE |
| |
==================================================================================
AZT/INTERFERON A/INTERFERON AD
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 | 100.0 100.0 100.0 100.0 98.0 94.0 94.0 90.0 86.0 62.0 |
|CONTROL | |
| | |
|30 | 100.0 100.0 100.0 98.0 98.0 93.9 91.8 85.7 83.7 71.4 |
|MG/KG 5000 | |
| | |
|60 | 100.0 98.0 96.0 96.0 94.0 91.9 89.9 83.7 75.6 71.5 |
|MG/KG 5000 | |
| | |
|120MG/KG | 100.0 100.0 100.0 100.0 98.0 96.0 90.0 80.0 76.0 68.0 |
|5000 U | |
| | |
==================================================================================
==================================================================================
| SURVIVAL SUMMARY STATISTICS |
| |
| |
|--------------------------------------------------------------------------------|
| DOSE |
| |
| VEHICLE 30 60 120MG/KG |
| CONTROL MG/KG 5000 U MG/KG 5000 U 5000 U |
|--------------------------------------------------------------------------------|
|SURVIVAL AT END OF STUDY| 62.0% 71.4% 71.5% 68.0% |
|(KAPLAN-MEIER) | |
| | |
|SIGNIFICANCE (B) | P=0.836N P=0.505N P=0.547N P=0.782N |
|(LIFE TABLE) | |
| | |
|MEAN DAY OF | 636.4 593.0 538.2 587.6 |
|NATURAL DEATHS (C) | (22.8) (30.4) (46.6) (23.4) |
|(STANDARD ERROR) | |
| | |
|MEAN LIFE SPAN (D) | 693.8 683.1 667.8 683.8 |
|(STANDARD ERROR) | (10.7) (13.9) (18.8) (11.9) |
| | |
==================================================================================
(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 730 DAYS
INDIVIDUAL SURVIVAL TIMES (DAYS)
==================================================================================
| DOSE = VEHICLE CONTROL |
| ---------------------------- |
| |
| TOTAL 50 UNCENSORED DEATHS 13 CENSORED DEATHS 0 TERMINAL 37 |
| |
| UNCENSORED DEATHS |
| 480 575 586 589 596 618 625 651 661 672 |
| 682 701 710 |
| CENSORED DEATHS |
| NONE |
| |
|--------------------------------------------------------------------------------|
| DOSE = 30 MG/KG 5000 U |
| ---------------------------- |
| |
| TOTAL 50 UNCENSORED DEATHS 12 CENSORED DEATHS 0 TERMINAL 38 |
| |
| UNCENSORED DEATHS |
| 554 557 586 592 598 638 640 656 674 698 |
| 712 721 |
| CENSORED DEATHS |
| NONE |
| |
|--------------------------------------------------------------------------------|
| DOSE = 60 MG/KG 5000 U |
| ---------------------------- |
| |
| TOTAL 50 UNCENSORED DEATHS 12 CENSORED DEATHS 2 TERMINAL 36 |
| |
| UNCENSORED DEATHS |
| 318 344 488 494 581 604 620 648 694 714 |
| 722 729 |
| CENSORED DEATHS |
| 3 199 |
| |
==================================================================================
AZT/INTERFERON A/INTERFERON AD
STATISTICAL ANALYSIS OF SURVIVAL DATA
FEMALE MICE
FIRST TERMINAL SACRIFICE AT 730 DAYS
INDIVIDUAL SURVIVAL TIMES (DAYS)
==================================================================================
| DOSE = 120MG/KG 5000 U |
| ---------------------------- |
| |
| TOTAL 50 UNCENSORED DEATHS 17 CENSORED DEATHS 1 TERMINAL 32 |
| |
| UNCENSORED DEATHS |
| 501 557 571 593 616 627 628 630 658 661 |
| 671 676 680 682 687 713 721 |
| CENSORED DEATHS |
| 26 |
| |
==================================================================================
AZT/INTERFERON A/INTERFERON AD
STATISTICAL ANALYSIS OF SURVIVAL DATA
FEMALE MICE
FIRST TERMINAL SACRIFICE AT 730 DAYS
==================================================================================
| KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) |
| |
|--------------------------------------------------------------------------------|
| DOSE TIME (DAYS) |
| 90 180 270 365 425 485 545 605 665 730 (A) |
| |
|--------------------------------------------------------------------------------|
| | |
|VEHICLE | 100.0 100.0 100.0 100.0 100.0 98.0 98.0 90.0 82.0 74.0 |
|CONTROL | |
| | |
|30 | 100.0 100.0 100.0 100.0 100.0 100.0 100.0 90.0 84.0 76.0 |
|MG/KG 5000 | |
| | |
|60 | 100.0 100.0 100.0 95.8 95.8 95.8 91.7 87.5 83.3 75.0 |
|MG/KG 5000 | |
| | |
|120MG/KG | 100.0 100.0 100.0 100.0 100.0 100.0 98.0 91.8 79.6 65.3 |
|5000 U | |
| | |
==================================================================================
==================================================================================
| SURVIVAL SUMMARY STATISTICS |
| |
| |
|--------------------------------------------------------------------------------|
| DOSE |
| |
| VEHICLE 30 60 120MG/KG |
| CONTROL MG/KG 5000 U MG/KG 5000 U 5000 U |
|--------------------------------------------------------------------------------|
|SURVIVAL AT END OF STUDY| 74.0% 76.0% 75.0% 65.3% |
|(KAPLAN-MEIER) | |
| | |
|SIGNIFICANCE (B) | P=0.339 P=0.959N P=1.000N P=0.496 |
|(LIFE TABLE) | |
| | |
|MEAN DAY OF | 626.6 635.5 579.7 639.5 |
|NATURAL DEATHS (C) | (17.5) (16.9) (40.9) (14.2) |
|(STANDARD ERROR) | |
| | |
|MEAN LIFE SPAN (D) | 703.1 707.3 668.8 685.2 |
|(STANDARD ERROR) | ( 7.8) ( 7.0) (21.3) (15.5) |
| | |
==================================================================================
(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/INTERFERON A/INTERFERON AD
KAPLAN-MEIER SURVIVAL CURVES
VEHICLE CONTROL = 1
30 MG/KG 5000 U = 2
60 MG/KG 5000 U = 3
120MG/KG 5000 U = 4
------------------------------------------------------ SPECIES=MICE SEX=MALE -------------------------------------------------------
Plot of SURVIVAL*WEEK. Symbol is value of DOSE.
|
|
100 + 1 3 2 1 4
|
| 3 3 2 1 4 2 14
| 3 3 2 141 4
95 +
| 3 13 4 4 2 1
| 33 4 4 1 1
| 2 2
P 90 + 3 4 43 1 1
E |
R | 43 3 1 1
C | 2 3 3 1 21
E 85 +
N | 4 4 3 3 2112
T | 4 4
| 33
S 80 + 4 4 33 121
U |
R | 44 3 3
V | 4 11
I 75 + 3 2 2
V | 44 33
A | 141 4
L | 23 2
70 +
|
| 4 4
| 1 1
65 +
|
| 1 1
|
60 +
|
--+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
0 10 20 30 40 50 60 70 80 90 100 110
WEEK
NOTE: 10 obs hidden.
AZT/INTERFERON A/INTERFERON AD
KAPLAN-MEIER SURVIVAL CURVES
VEHICLE CONTROL = 1
30 MG/KG 5000 U = 2
60 MG/KG 5000 U = 3
120MG/KG 5000 U = 4
----------------------------------------------------- SPECIES=MICE SEX=FEMALE ------------------------------------------------------
Plot of SURVIVAL*WEEK. Symbol is value of DOSE.
|
|
100 + 1 3 1 4 2
|
| 3 3 1 4 4 1
| 3 3 2 411
95 +
| 33 4 1 1
P | 11
E | 3 3 4 4
R 90 + 3 13414 2
C |
E | 3 11
N | 1 212
T 85 + 3 3
| 4 12 1 2 3
S | 112 2
U | 4 4 3 3
R 80 + 41 1 2 2
V | 3 3
I | 441 1223 3
V | 112 2
A 75 + 44 3
L | 1 1
|
| 44
70 + 4 4
|
| 44
|
65 + 4 4
|
--+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
0 10 20 30 40 50 60 70 80 90 100 110
WEEK
NOTE: 15 obs hidden.