TDMS Study 05130-03 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11
LAB: Microbiological Assoc. DATE: 09/17/94
EXP: 05130 C. I. DIRECT BLUE 218 TIME: 01:47:33
TEST: 03 CAGES FROM 0000 TO LAST CAGE PAGE: 1
TEST TYPE: CHRONIC ROUTE: DOSED FEED NTP C#: 60877B
CONT: N01-ES-5096 CAS: 10401-500
PATHOLOGIST: L. BRENNECKE Hailey, Rick
--------------------------------------------------------------------------------
REASONS FOR REMOVAL:
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REMOVAL DATE RANGE:
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NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11
LAB: Microbiological Assoc. DATE: 09/17/94
EXP: 05130 C. I. DIRECT BLUE 218 TIME: 01:47:33
TEST: 03 CAGES FROM 0000 TO LAST CAGE
TEST TYPE: CHRONIC ROUTE: DOSED FEED NTP C#: 60877B
CONT: N01-ES-5096 CAS: 10401-500
PATHOLOGIST: L. BRENNECKE Hailey, Rick
C. I. DIRECT BLUE 218
STATISTICAL ANALYSIS OF SURVIVAL DATA
MALE RATS
FIRST TERMINAL SACRIFICE AT 729 DAYS
INDIVIDUAL SURVIVAL TIMES (DAYS)
==================================================================================
| DOSE = 0 PPM |
| --------------------- |
| |
| TOTAL 60 UNCENSORED DEATHS 20 CENSORED DEATHS 10 TERMINAL 30 |
| |
| UNCENSORED DEATHS |
| 273 438 506 539 548 570 572 572 581 607 |
| 614 618 629 630 673 673 679 682 693 715 |
| CENSORED DEATHS |
| 460 460 460 460 460 460 460 460 460 460 |
| |
|--------------------------------------------------------------------------------|
| DOSE = 1000 PPM |
| --------------------- |
| |
| TOTAL 60 UNCENSORED DEATHS 25 CENSORED DEATHS 10 TERMINAL 25 |
| |
| UNCENSORED DEATHS |
| 369 601 614 617 618 621 631 637 637 641 |
| 646 651 651 660 670 671 671 673 685 713 |
| 713 714 715 721 726 |
| CENSORED DEATHS |
| 460 460 460 460 460 460 460 460 460 460 |
| |
|--------------------------------------------------------------------------------|
| DOSE = 3000 PPM |
| --------------------- |
| |
| TOTAL 60 UNCENSORED DEATHS 21 CENSORED DEATHS 10 TERMINAL 29 |
| |
| UNCENSORED DEATHS |
| 356 533 537 581 621 632 649 670 671 674 |
| 677 677 680 686 692 692 694 700 709 714 |
| 725 |
| CENSORED DEATHS |
| 460 460 460 460 460 460 460 460 460 460 |
| |
==================================================================================
C. I. DIRECT BLUE 218
STATISTICAL ANALYSIS OF SURVIVAL DATA
MALE RATS
FIRST TERMINAL SACRIFICE AT 729 DAYS
INDIVIDUAL SURVIVAL TIMES (DAYS)
==================================================================================
| DOSE = 10000PPM |
| --------------------- |
| |
| TOTAL 60 UNCENSORED DEATHS 27 CENSORED DEATHS 9 TERMINAL 24 |
| |
| UNCENSORED DEATHS |
| 305 447 450 460 506 506 531 532 566 580 |
| 583 601 610 614 646 646 668 680 680 684 |
| 692 699 702 702 706 722 722 |
| CENSORED DEATHS |
| 460 460 460 460 460 460 460 460 460 |
| |
==================================================================================
C. I. DIRECT BLUE 218
STATISTICAL ANALYSIS OF SURVIVAL DATA
MALE RATS
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) |
| |
|--------------------------------------------------------------------------------|
| | |
|0 PPM | 100.0 100.0 100.0 98.3 98.3 96.7 92.6 82.6 72.5 60.4 |
| | |
| | |
|1000 PPM | 100.0 100.0 100.0 100.0 98.3 98.3 98.3 96.3 72.2 50.2 |
| | |
| | |
|3000 PPM | 100.0 100.0 100.0 98.3 98.3 98.3 94.3 92.3 86.3 58.2 |
| | |
| | |
|10000PPM | 100.0 100.0 100.0 98.3 98.3 93.3 85.4 77.4 69.5 47.7 |
| | |
| | |
==================================================================================
==================================================================================
| SURVIVAL SUMMARY STATISTICS |
| |
| |
|--------------------------------------------------------------------------------|
| DOSE |
| |
| 0 PPM 1000 PPM 3000 PPM 10000PPM |
| |
|--------------------------------------------------------------------------------|
|SURVIVAL AT END OF STUDY| 60.4% 50.2% 58.2% 47.7% |
|(KAPLAN-MEIER) | |
| | |
|SIGNIFICANCE (B) | P=0.285 P=0.670 P=1.000N P=0.314 |
|(LIFE TABLE) | |
| | |
|MEAN DAY OF | 590.6 650.6 646.2 601.5 |
|NATURAL DEATHS (C) | (22.8) (13.9) (18.6) (20.3) |
|(STANDARD ERROR) | |
| | |
|MEAN LIFE SPAN (D) | 638.0 651.5 655.2 631.3 |
|(STANDARD ERROR) | (15.1) (13.4) (13.9) (15.1) |
| | |
==================================================================================
(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)
C. I. DIRECT BLUE 218
STATISTICAL ANALYSIS OF SURVIVAL DATA
FEMALE RATS
FIRST TERMINAL SACRIFICE AT 729 DAYS
INDIVIDUAL SURVIVAL TIMES (DAYS)
==================================================================================
| DOSE = 0 PPM |
| --------------------- |
| |
| TOTAL 60 UNCENSORED DEATHS 16 CENSORED DEATHS 9 TERMINAL 35 |
| |
| UNCENSORED DEATHS |
| 270 428 449 460 499 532 532 642 659 666 |
| 666 671 671 673 684 714 |
| CENSORED DEATHS |
| 461 461 461 461 461 461 461 461 461 |
| |
|--------------------------------------------------------------------------------|
| DOSE = 1000 PPM |
| --------------------- |
| |
| TOTAL 60 UNCENSORED DEATHS 22 CENSORED DEATHS 9 TERMINAL 29 |
| |
| UNCENSORED DEATHS |
| 340 419 452 477 494 504 523 572 621 624 |
| 649 652 659 659 670 681 684 684 699 713 |
| 721 726 |
| CENSORED DEATHS |
| 461 461 461 461 461 461 461 461 461 |
| |
|--------------------------------------------------------------------------------|
| DOSE = 3000 PPM |
| --------------------- |
| |
| TOTAL 60 UNCENSORED DEATHS 19 CENSORED DEATHS 10 TERMINAL 31 |
| |
| UNCENSORED DEATHS |
| 317 428 506 532 533 540 583 587 610 617 |
| 629 639 652 660 669 674 688 706 726 |
| CENSORED DEATHS |
| 461 461 461 461 461 461 461 461 461 461 |
| |
==================================================================================
C. I. DIRECT BLUE 218
STATISTICAL ANALYSIS OF SURVIVAL DATA
FEMALE RATS
FIRST TERMINAL SACRIFICE AT 729 DAYS
INDIVIDUAL SURVIVAL TIMES (DAYS)
==================================================================================
| DOSE = 10000PPM |
| --------------------- |
| |
| TOTAL 60 UNCENSORED DEATHS 25 CENSORED DEATHS 10 TERMINAL 25 |
| |
| UNCENSORED DEATHS |
| 85 176 226 296 484 502 502 554 555 560 |
| 572 595 618 637 639 649 658 658 658 660 |
| 663 665 674 702 719 |
| CENSORED DEATHS |
| 461 461 461 461 461 461 461 461 461 461 |
| |
==================================================================================
C. I. DIRECT BLUE 218
STATISTICAL ANALYSIS OF SURVIVAL DATA
FEMALE RATS
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) |
| |
|--------------------------------------------------------------------------------|
| | |
|0 PPM | 100.0 100.0 98.3 98.3 98.3 93.3 87.4 87.4 83.4 69.5 |
| | |
| | |
|1000 PPM | 100.0 100.0 100.0 98.3 96.7 93.0 87.1 85.1 73.2 57.4 |
| | |
| | |
|3000 PPM | 100.0 100.0 100.0 98.3 98.3 96.7 88.6 84.6 72.5 62.4 |
| | |
| | |
|10000PPM | 98.3 96.7 95.0 93.3 93.3 91.3 87.2 77.1 56.8 50.7 |
| | |
| | |
==================================================================================
==================================================================================
| SURVIVAL SUMMARY STATISTICS |
| |
| |
|--------------------------------------------------------------------------------|
| DOSE |
| |
| 0 PPM 1000 PPM 3000 PPM 10000PPM |
| |
|--------------------------------------------------------------------------------|
|SURVIVAL AT END OF STUDY| 69.5% 57.4% 62.4% 50.7% |
|(KAPLAN-MEIER) | |
| | |
|SIGNIFICANCE (B) | P=0.086 P=0.326 P=0.615 P=0.069 |
|(LIFE TABLE) | |
| | |
|MEAN DAY OF | 576.0 601.0 594.5 548.3 |
|NATURAL DEATHS (C) | (31.7) (23.6) (23.3) (34.3) |
|(STANDARD ERROR) | |
| | |
|MEAN LIFE SPAN (D) | 648.0 641.9 641.8 609.0 |
|(STANDARD ERROR) | (15.7) (15.1) (14.9) (19.7) |
| | |
==================================================================================
(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)
C. I. DIRECT BLUE 218
KAPLAN-MEIER SURVIVAL CURVES
0 PPM = 1
1000 PPM = 2
3000 PPM = 3
10000PPM = 4
------------------------------------------------------ SPECIES=RATS SEX=MALE -------------------------------------------------------
Plot of SURVIVAL*WEEK. Symbol is value of DOSE.
|
|
100 + 1 1 4 3 2
| 1 4 3 2 14 4 1 3 2 2
| 44 1 1 3 22
| 4 4 1 1 3 3
P 90 + 4 4 1 1 3 3
E | 2 2 3 3
R | 4 411
C | 4 14 1 22 33
E 80 + 4 411 22
N | 4 111 33
T | 2 2
| 4 1 4 22133
S 70 + 4 4
U | 41133
R | 22113 3
V | 21 21
I 60 + 44 313 1
V | 44 3 3
A | 22
L | 4 22
50 + 2 2
| 4 4
|
|
40 +
|
--+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
0 10 20 30 40 50 60 70 80 90 100 110
WEEK
NOTE: 19 obs hidden.
C. I. DIRECT BLUE 218
KAPLAN-MEIER SURVIVAL CURVES
0 PPM = 1
1000 PPM = 2
3000 PPM = 3
10000PPM = 4
----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------
Plot of SURVIVAL*WEEK. Symbol is value of DOSE.
|
100 + 1 4 1 3 2
| 4 4 1 3 2 2 1
|
| 4 4 2 1 1 3
95 + 4 4 11 2 3 3
| 4 1 4 1
| 2 2 33
| 421 133
90 +
| 2 2 3 3
| 4 21 4 2 1
|
P 85 + 2 3 32 1 1
E | 22 11
R | 33
C | 4 4 2 2
E 80 + 33
N | 4 4 3 322
T | 4 4 2 2
| 3 3
S 75 + 4 4 3 311
U | 2211
R | 44 33
V | 44 2 1 1
I 70 + 33 1 1
V | 44 3 3
A |
L | 3 3
65 + 2 23 3
| 2 2
| 4 4 3 3
| 22
60 + 22
|
| 2 2
| 4 4
55 + 4 4
|
| 4 4
| 4 4
50 +
|
--+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
0 10 20 30 40 50 60 70 80 90 100 110
WEEK
NOTE: 10 obs hidden.