TDMS Study 05128-06 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11
LAB: Southern Research Inst D & C YELLOW NO. 11 DATE: 04/03/96
EXPERIMENT: 05128 TEST: 06 TIME: 23:52:11
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-95271 ROUTE: DOSED FEED NTP C#: 61789B
PATHOLOGIST: J. E. HEATH CAS: 8003-22-3
------------------------------------------------------------------------------------------------------------------------------------
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11
LAB: Southern Research Inst D & C YELLOW NO. 11 DATE: 04/03/96
EXPERIMENT: 05128 TEST: 06 TIME: 23:52:11
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-95271 ROUTE: DOSED FEED NTP C#: 61789B
PATHOLOGIST: J. E. HEATH CAS: 8003-22-3
D & C YELLOW NO. 11
STATISTICAL ANALYSIS OF SURVIVAL DATA
MALE RATS
FIRST TERMINAL SACRIFICE AT 733 DAYS
INDIVIDUAL SURVIVAL TIMES (DAYS)
==================================================================================
| DOSE = UNTREATDCONTROL |
| ---------------------------- |
| |
| TOTAL 60 UNCENSORED DEATHS 31 CENSORED DEATHS 10 TERMINAL 19 |
| |
| UNCENSORED DEATHS |
| 481 509 530 590 600 615 619 621 622 623 |
| 628 632 632 637 638 650 656 656 667 677 |
| 688 693 695 695 701 702 706 706 716 719 |
| 722 |
| CENSORED DEATHS |
| 357 357 357 357 357 357 357 357 357 357 |
| |
|--------------------------------------------------------------------------------|
| DOSE = 0.05% |
| --------------------- |
| |
| TOTAL 60 UNCENSORED DEATHS 31 CENSORED DEATHS 9 TERMINAL 20 |
| |
| UNCENSORED DEATHS |
| 222 509 509 510 545 546 558 558 560 570 |
| 575 586 593 602 611 628 628 642 656 656 |
| 658 672 677 688 695 712 716 719 719 726 |
| 727 |
| CENSORED DEATHS |
| 357 357 357 357 357 357 357 357 357 |
| |
|--------------------------------------------------------------------------------|
| DOSE = 0.17% |
| --------------------- |
| |
| TOTAL 59 UNCENSORED DEATHS 42 CENSORED DEATHS 9 TERMINAL 8 |
| |
| UNCENSORED DEATHS |
| 246 384 406 453 468 491 499 502 551 590 |
| 600 600 607 610 615 631 646 646 649 649 |
| 649 650 650 659 663 663 667 672 680 686 |
| 686 686 686 692 695 695 695 706 712 714 |
| 719 727 |
| CENSORED DEATHS |
| 357 357 357 357 357 357 357 357 357 |
| |
==================================================================================
D & C YELLOW NO. 11
STATISTICAL ANALYSIS OF SURVIVAL DATA
MALE RATS
FIRST TERMINAL SACRIFICE AT 733 DAYS
INDIVIDUAL SURVIVAL TIMES (DAYS)
==================================================================================
| DOSE = 0.5% |
| --------------------- |
| |
| TOTAL 60 UNCENSORED DEATHS 52 CENSORED DEATHS 6 TERMINAL 2 |
| |
| UNCENSORED DEATHS |
| 302 320 345 345 370 432 481 492 496 498 |
| 498 498 502 505 509 510 534 546 563 566 |
| 568 572 589 590 596 596 602 615 617 624 |
| 624 629 656 656 658 678 678 690 691 693 |
| 695 695 695 700 700 704 706 716 716 722 |
| 726 727 |
| CENSORED DEATHS |
| 357 357 357 357 357 357 |
| |
==================================================================================
D & C YELLOW NO. 11
STATISTICAL ANALYSIS OF SURVIVAL DATA
MALE RATS
FIRST TERMINAL SACRIFICE AT 733 DAYS
==================================================================================
| KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) |
| |
|--------------------------------------------------------------------------------|
| DOSE TIME (DAYS) |
| 90 180 270 365 425 485 545 605 665 733 (A) |
| |
|--------------------------------------------------------------------------------|
| | |
|UNTREATDCON|ROL100.0 100.0 100.0 100.0 100.0 98.0 94.0 90.0 64.0 38.0 |
|U | |
| | |
|0.05% | 100.0 100.0 98.3 98.3 98.3 98.3 90.5 72.8 59.0 39.3 |
| | |
| | |
|0.17% | 100.0 100.0 98.3 98.3 94.3 90.3 84.3 76.2 48.1 16.0 |
| | |
| | |
|0.5% | 100.0 100.0 100.0 93.3 91.5 87.7 69.1 50.4 35.5 3.7 |
| | |
| | |
==================================================================================
==================================================================================
| SURVIVAL SUMMARY STATISTICS |
| |
| |
|--------------------------------------------------------------------------------|
| DOSE |
| |
| UNTREATDCONTR0.05% 0.17% 0.5% |
| U |
|--------------------------------------------------------------------------------|
|SURVIVAL AT END OF STUDY| 38.0% 39.3% 16.0% 3.7% |
|(KAPLAN-MEIER) | |
| | |
|SIGNIFICANCE (B) | P<0.001 P=0.974 P=0.013 P<0.001 |
|(LIFE TABLE) | |
| | |
|MEAN DAY OF | 646.0 612.0 616.5 585.3 |
|NATURAL DEATHS (C) | (10.8) (18.1) (16.1) (15.9) |
|(STANDARD ERROR) | |
| | |
|MEAN LIFE SPAN (D) | 625.4 614.1 592.7 567.4 |
|(STANDARD ERROR) | (17.3) (18.3) (18.2) (16.9) |
| | |
==================================================================================
(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)
D & C YELLOW NO. 11
STATISTICAL ANALYSIS OF SURVIVAL DATA
FEMALE RATS
FIRST TERMINAL SACRIFICE AT 740 DAYS
INDIVIDUAL SURVIVAL TIMES (DAYS)
==================================================================================
| DOSE = UNTREATDCONTROL |
| ---------------------------- |
| |
| TOTAL 60 UNCENSORED DEATHS 28 CENSORED DEATHS 10 TERMINAL 22 |
| |
| UNCENSORED DEATHS |
| 481 537 570 572 572 589 589 602 607 629 |
| 650 651 656 660 671 684 699 700 701 712 |
| 719 722 729 730 730 734 734 734 |
| CENSORED DEATHS |
| 358 358 358 358 358 358 358 358 358 358 |
| |
|--------------------------------------------------------------------------------|
| DOSE = 0.05% |
| --------------------- |
| |
| TOTAL 60 UNCENSORED DEATHS 25 CENSORED DEATHS 9 TERMINAL 26 |
| |
| UNCENSORED DEATHS |
| 308 462 546 548 600 601 622 622 628 629 |
| 631 631 642 645 656 672 688 688 693 695 |
| 705 712 716 726 734 |
| CENSORED DEATHS |
| 358 358 358 358 358 358 358 358 358 |
| |
|--------------------------------------------------------------------------------|
| DOSE = 0.17% |
| --------------------- |
| |
| TOTAL 60 UNCENSORED DEATHS 13 CENSORED DEATHS 10 TERMINAL 37 |
| |
| UNCENSORED DEATHS |
| 456 532 588 597 610 638 658 660 671 701 |
| 719 722 722 |
| CENSORED DEATHS |
| 358 358 358 358 358 358 358 358 358 358 |
| |
==================================================================================
D & C YELLOW NO. 11
STATISTICAL ANALYSIS OF SURVIVAL DATA
FEMALE RATS
FIRST TERMINAL SACRIFICE AT 740 DAYS
INDIVIDUAL SURVIVAL TIMES (DAYS)
==================================================================================
| DOSE = 0.5% |
| --------------------- |
| |
| TOTAL 60 UNCENSORED DEATHS 28 CENSORED DEATHS 9 TERMINAL 23 |
| |
| UNCENSORED DEATHS |
| 147 441 448 469 506 530 568 590 596 648 |
| 656 656 658 658 672 695 700 712 720 723 |
| 723 728 728 728 729 729 733 734 |
| CENSORED DEATHS |
| 358 358 358 358 358 358 358 358 358 |
| |
==================================================================================
D & C YELLOW NO. 11
STATISTICAL ANALYSIS OF SURVIVAL DATA
FEMALE RATS
FIRST TERMINAL SACRIFICE AT 740 DAYS
==================================================================================
| KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) |
| |
|--------------------------------------------------------------------------------|
| DOSE TIME (DAYS) |
| 90 180 270 365 425 485 545 605 665 740 (A) |
| |
|--------------------------------------------------------------------------------|
| | |
|UNTREATDCON|ROL100.0 100.0 100.0 100.0 100.0 98.0 96.0 84.0 72.0 44.0 |
|U | |
| | |
|0.05% | 100.0 100.0 100.0 98.3 98.3 96.4 96.4 88.5 70.8 51.1 |
| | |
| | |
|0.17% | 100.0 100.0 100.0 100.0 100.0 98.0 96.0 92.0 84.0 74.0 |
| | |
| | |
|0.5% | 100.0 98.3 98.3 98.3 98.3 92.4 88.5 82.6 72.8 45.2 |
| | |
| | |
==================================================================================
==================================================================================
| SURVIVAL SUMMARY STATISTICS |
| |
| |
|--------------------------------------------------------------------------------|
| DOSE |
| |
| UNTREATDCONTR0.05% 0.17% 0.5% |
| U |
|--------------------------------------------------------------------------------|
|SURVIVAL AT END OF STUDY| 44.0% 51.1% 74.0% 45.2% |
|(KAPLAN-MEIER) | |
| | |
|SIGNIFICANCE (B) | P=0.882 P=0.769N P=0.006N P=1.000N |
|(LIFE TABLE) | |
| | |
|MEAN DAY OF | 655.9 632.0 636.5 629.5 |
|NATURAL DEATHS (C) | (13.3) (18.5) (22.1) (25.1) |
|(STANDARD ERROR) | |
| | |
|MEAN LIFE SPAN (D) | 637.1 637.7 653.9 631.1 |
|(STANDARD ERROR) | (18.1) (18.3) (18.6) (20.0) |
| | |
==================================================================================
(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)
D & C YELLOW NO. 11
KAPLAN-MEIER SURVIVAL CURVES
UNTREATDCONTROL = 1
0.05% = 2
0.17% = 3
0.5% = 4
------------------------------------------------------ SPECIES=RATS SEX=MALE -------------------------------------------------------
Plot of SURVIVAL*WEEK. Symbol is value of DOSE.
|
100 + 1 2 3 4 1
| 2 3 4 4 4 3 3 1 1
| 3 3 1 1 1
| 4 4 4 3 3 2 2 11
90 + 4 3 4 3 1 1
| 4 33 2 2 11
| 43 3
| 32 2 3
80 + 22 33 11
| 44 22 2 11
| 2233
| 2 2 11
P 70 + 4 44 2 2311
E | 4 4 23211
R | 2 1 1
C | 44 11
E 60 + 4 4 2 21 1
N | 22
T | 44 3 3 2 11
| 211
S 50 + 4 4 2 22
U | 444 33
R | 3 3 1 1
V | 22
I 40 + 4 4 11 2
V | 1 1
A | 4 433
L | 4 33
30 +
|
| 4333
|
20 + 33
| 44 33
| 3 3
| 4 4
10 + 44
|
|
| 4 4
0 +
|
--+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
0 10 20 30 40 50 60 70 80 90 100 110
WEEK
NOTE: 25 obs hidden.
D & C YELLOW NO. 11
KAPLAN-MEIER SURVIVAL CURVES
UNTREATDCONTROL = 1
0.05% = 2
0.17% = 3
0.5% = 4
----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------
Plot of SURVIVAL*WEEK. Symbol is value of DOSE.
|
|
100 + 1 4 2 3 1
| 4 2 44 2 1 312
| 4 4 3122 1 3 3
| 4 4 2 2 3
P 90 + 4 4 1 1 3 3
E | 4 4 42 2 3 3
R | 111 22 3 33
C | 41 1 4 3 3
E 80 + 12 14 3 3
N | 22 33
T | 211 1 3 3
| 22 11
S 70 + 2 1 124
U | 1 1 4
R | 1144
V | 221144
I 60 + 2211
V | 211
A | 21 1
L | 2 2
50 + 22
|
| 11
|
40 +
|
--+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
0 10 20 30 40 50 60 70 80 90 100 110
WEEK
NOTE: 31 obs hidden.