TDMS Study 05021-03 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11
LAB: Southern Research Inst DATE: 09/03/94
EXP: 05021 CI PIGMENT RED 23 TIME: 21:21:31
TEST: 03 CAGES FROM 0000 TO LAST CAGE PAGE: 1
TEST TYPE: CHRONIC ROUTE: DOSED FEED NTP C#: 60377
CONT: N01ES9565102 CAS: 6471-49-4
PATHOLOGIST: P. HILDEBRANDT S. EUSTIS
--------------------------------------------------------------------------------
REASONS FOR REMOVAL:
ALL
REMOVAL DATE RANGE:
ALL
TREATMENT GROUPS:
INCLUDE ALL
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11
LAB: Southern Research Inst DATE: 09/03/94
EXP: 05021 CI PIGMENT RED 23 TIME: 21:21:31
TEST: 03 CAGES FROM 0000 TO LAST CAGE
TEST TYPE: CHRONIC ROUTE: DOSED FEED NTP C#: 60377
CONT: N01ES9565102 CAS: 6471-49-4
PATHOLOGIST: P. HILDEBRANDT S. EUSTIS
CI PIGMENT RED 23
STATISTICAL ANALYSIS OF SURVIVAL DATA
MALE RATS
FIRST TERMINAL SACRIFICE AT 729 DAYS
INDIVIDUAL SURVIVAL TIMES (DAYS)
==================================================================================
| DOSE = UNTREATD CONTROL |
| ---------------------------- |
| |
| TOTAL 60 UNCENSORED DEATHS 28 CENSORED DEATHS 10 TERMINAL 22 |
| |
| UNCENSORED DEATHS |
| 448 502 513 535 563 564 582 582 585 597 |
| 605 612 612 612 612 612 630 631 640 640 |
| 655 676 676 681 700 707 709 728 |
| CENSORED DEATHS |
| 456 456 456 456 457 457 457 457 457 457 |
| |
|--------------------------------------------------------------------------------|
| DOSE = 1.0% |
| --------------------- |
| |
| TOTAL 60 UNCENSORED DEATHS 21 CENSORED DEATHS 10 TERMINAL 29 |
| |
| UNCENSORED DEATHS |
| 301 477 513 513 557 592 592 592 604 610 |
| 644 647 675 681 686 686 699 711 720 723 |
| 728 |
| CENSORED DEATHS |
| 456 456 456 456 456 457 457 457 457 457 |
| |
|--------------------------------------------------------------------------------|
| DOSE = 2.5% |
| --------------------- |
| |
| TOTAL 60 UNCENSORED DEATHS 14 CENSORED DEATHS 10 TERMINAL 36 |
| |
| UNCENSORED DEATHS |
| 479 535 591 591 617 618 620 666 673 674 |
| 681 693 711 727 |
| CENSORED DEATHS |
| 456 456 456 456 456 456 456 457 457 457 |
| |
==================================================================================
CI PIGMENT RED 23
STATISTICAL ANALYSIS OF SURVIVAL DATA
MALE RATS
FIRST TERMINAL SACRIFICE AT 729 DAYS
INDIVIDUAL SURVIVAL TIMES (DAYS)
==================================================================================
| DOSE = 5.0% |
| --------------------- |
| |
| TOTAL 60 UNCENSORED DEATHS 16 CENSORED DEATHS 9 TERMINAL 35 |
| |
| UNCENSORED DEATHS |
| 242 412 513 514 612 618 618 629 648 664 |
| 676 687 688 696 718 727 |
| CENSORED DEATHS |
| 456 456 456 456 457 457 457 457 457 |
| |
==================================================================================
CI PIGMENT RED 23
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) |
| |
|--------------------------------------------------------------------------------|
| | |
|UNTREATD | 100.0 100.0 100.0 100.0 100.0 98.3 92.3 78.3 58.2 44.1 |
|CONTROL | |
| | |
|1.0% | 100.0 100.0 100.0 98.3 98.3 96.3 92.3 82.3 76.3 58.2 |
| | |
| | |
|2.5% | 100.0 100.0 100.0 100.0 100.0 98.0 96.0 92.0 86.0 72.0 |
| | |
| | |
|5.0% | 100.0 100.0 98.3 98.3 96.7 96.7 92.7 92.7 80.9 69.0 |
| | |
| | |
==================================================================================
==================================================================================
| SURVIVAL SUMMARY STATISTICS |
| |
| |
|--------------------------------------------------------------------------------|
| DOSE |
| |
| UNTREATD 1.0% 2.5% 5.0% |
| CONTROL |
|--------------------------------------------------------------------------------|
|SURVIVAL AT END OF STUDY| 44.1% 58.2% 72.0% 69.0% |
|(KAPLAN-MEIER) | |
| | |
|SIGNIFICANCE (B) | P=0.011N P=0.175N P=0.005N P=0.015N |
|(LIFE TABLE) | |
| | |
|MEAN DAY OF | 614.6 616.7 634.0 603.9 |
|NATURAL DEATHS (C) | (12.5) (22.6) (18.6) (32.1) |
|(STANDARD ERROR) | |
| | |
|MEAN LIFE SPAN (D) | 630.2 644.3 661.4 654.8 |
|(STANDARD ERROR) | (13.5) (15.0) (13.6) (15.4) |
| | |
==================================================================================
(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)
CI PIGMENT RED 23
STATISTICAL ANALYSIS OF SURVIVAL DATA
FEMALE RATS
FIRST TERMINAL SACRIFICE AT 729 DAYS
INDIVIDUAL SURVIVAL TIMES (DAYS)
==================================================================================
| DOSE = UNTREATD CONTROL |
| ---------------------------- |
| |
| TOTAL 60 UNCENSORED DEATHS 21 CENSORED DEATHS 10 TERMINAL 29 |
| |
| UNCENSORED DEATHS |
| 249 378 412 494 507 533 578 582 591 591 |
| 606 618 648 655 675 676 681 687 693 696 |
| 718 |
| CENSORED DEATHS |
| 458 458 458 458 458 459 459 459 459 459 |
| |
|--------------------------------------------------------------------------------|
| DOSE = 1.0% |
| --------------------- |
| |
| TOTAL 60 UNCENSORED DEATHS 16 CENSORED DEATHS 10 TERMINAL 34 |
| |
| UNCENSORED DEATHS |
| 242 407 514 592 612 645 651 673 673 673 |
| 673 686 693 697 703 727 |
| CENSORED DEATHS |
| 458 458 458 458 458 458 458 459 459 459 |
| |
|--------------------------------------------------------------------------------|
| DOSE = 2.5% |
| --------------------- |
| |
| TOTAL 60 UNCENSORED DEATHS 17 CENSORED DEATHS 10 TERMINAL 33 |
| |
| UNCENSORED DEATHS |
| 325 457 491 501 546 564 572 595 612 618 |
| 631 651 655 662 688 688 693 |
| CENSORED DEATHS |
| 458 458 458 458 458 459 459 459 459 459 |
| |
==================================================================================
CI PIGMENT RED 23
STATISTICAL ANALYSIS OF SURVIVAL DATA
FEMALE RATS
FIRST TERMINAL SACRIFICE AT 729 DAYS
INDIVIDUAL SURVIVAL TIMES (DAYS)
==================================================================================
| DOSE = 5.0% |
| --------------------- |
| |
| TOTAL 60 UNCENSORED DEATHS 10 CENSORED DEATHS 10 TERMINAL 40 |
| |
| UNCENSORED DEATHS |
| 505 535 592 592 610 618 624 627 627 707 |
| CENSORED DEATHS |
| 458 458 458 459 459 459 459 459 459 459 |
| |
==================================================================================
CI PIGMENT RED 23
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) |
| |
|--------------------------------------------------------------------------------|
| | |
|UNTREATD | 100.0 100.0 98.3 98.3 95.0 95.0 88.9 80.9 72.8 58.6 |
|CONTROL | |
| | |
|1.0% | 100.0 100.0 98.3 98.3 96.7 96.7 94.7 92.6 86.6 68.5 |
| | |
| | |
|2.5% | 100.0 100.0 100.0 98.3 98.3 96.7 92.6 84.6 72.5 66.5 |
| | |
| | |
|5.0% | 100.0 100.0 100.0 100.0 100.0 100.0 96.0 92.0 82.0 80.0 |
| | |
| | |
==================================================================================
==================================================================================
| SURVIVAL SUMMARY STATISTICS |
| |
| |
|--------------------------------------------------------------------------------|
| DOSE |
| |
| UNTREATD 1.0% 2.5% 5.0% |
| CONTROL |
|--------------------------------------------------------------------------------|
|SURVIVAL AT END OF STUDY| 58.6% 68.5% 66.5% 80.0% |
|(KAPLAN-MEIER) | |
| | |
|SIGNIFICANCE (B) | P=0.043N P=0.306N P=0.547N P=0.029N |
|(LIFE TABLE) | |
| | |
|MEAN DAY OF | 584.2 616.3 585.2 603.7 |
|NATURAL DEATHS (C) | (26.3) (32.1) (23.8) (17.4) |
|(STANDARD ERROR) | |
| | |
|MEAN LIFE SPAN (D) | 633.2 653.8 643.2 663.1 |
|(STANDARD ERROR) | (16.1) (15.4) (15.0) (13.6) |
| | |
==================================================================================
(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)
CI PIGMENT RED 23
KAPLAN-MEIER SURVIVAL CURVES
UNTREATD CONTROL = 1
1.0% = 2
2.5% = 3
5.0% = 4
------------------------------------------------------ SPECIES=RATS SEX=MALE -------------------------------------------------------
Plot of SURVIVAL*WEEK. Symbol is value of DOSE.
|
|
104.35 +
|
|1 4 2 1 3
| 4 2 4 1 2 1 3
96.33 + 4 2 1 1 3 3
| 1 1
| 2 1 21 3 43
| 2 2 44
P 88.30 + 1 1
E | 34 3
R | 2 2 4 4 33
C | 1 122 4 4
E 80.27 + 112 2 4 33
N | 11 22 433
T | 2 2 3 3
| 2244 3 3
S 72.24 + 4 43 3
U | 44
R | 1 1 2 2 4 4
V | 11 2 2
I 64.22 + 11 22
V | 22
A | 1 1
L | 1 1 2 2
56.19 +
| 11
| 1 1
| 11
48.16 + 11
| 1 1
| 1 1
|
40.14 +
|
-+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+
0 10 20 30 40 50 60 70 80 90 100 110
WEEK
NOTE: 10 obs hidden.
CI PIGMENT RED 23
KAPLAN-MEIER SURVIVAL CURVES
UNTREATD CONTROL = 1
1.0% = 2
2.5% = 3
5.0% = 4
----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------
Plot of SURVIVAL*WEEK. Symbol is value of DOSE.
|
|
100 + 1 21 3 4
| 21 3 1 2 3
| 4 4
| 1 1 3 3 2 4 4
95 + 1 13 2 2
|
| 131 3 2 2
| 1 13 3 2 2
90 + 44
| 1 331
P | 11 44
E | 3 3 2 2
R 85 + 1 1 3
C |
E | 334 4
N | 1 1
T 80 + 3 3 4 4
| 1 1 3 3 22
S |
U | 1 13 22
R 75 + 11 3 22
V |
I | 1 3 1 322
V |
A 70 + 2 2
L | 11 2 2
|
| 11 3
65 +
|
| 11
| 1 1
60 +
| 1 1
|
|
55 +
|
--+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
0 10 20 30 40 50 60 70 80 90 100 110
WEEK
NOTE: 11 obs hidden.