TDMS Study 05007-06 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11
LAB: Southern Research Inst DATE: 09/03/94
EXP: 05007 POLYSORBATE 80 TIME: 13:00:26
TEST: 06 CAGES FROM 0000 TO LAST CAGE PAGE: 1
TEST TYPE: CHRONIC ROUTE: DOSED FEED NTP C#: 60286
CONT: N01CP9565102 CAS: 9005-65-6
PATHOLOGIST: J. SAGARTZ 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: 05007 POLYSORBATE 80 TIME: 13:00:26
TEST: 06 CAGES FROM 0000 TO LAST CAGE
TEST TYPE: CHRONIC ROUTE: DOSED FEED NTP C#: 60286
CONT: N01CP9565102 CAS: 9005-65-6
PATHOLOGIST: J. SAGARTZ S. EUSTIS
POLYSORBATE 80
STATISTICAL ANALYSIS OF SURVIVAL DATA
MALE 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 |
| 455 464 470 493 561 561 567 585 614 630 |
| 640 640 662 681 688 698 700 701 712 717 |
| 723 |
| CENSORED DEATHS |
| 462 462 462 462 462 462 462 462 462 462 |
| |
|--------------------------------------------------------------------------------|
| DOSE = 2.5% |
| --------------------- |
| |
| TOTAL 60 UNCENSORED DEATHS 32 CENSORED DEATHS 10 TERMINAL 18 |
| |
| UNCENSORED DEATHS |
| 98 477 503 535 589 606 613 616 617 618 |
| 632 635 637 638 640 644 646 658 667 675 |
| 677 683 687 692 695 700 701 701 708 710 |
| 722 724 |
| CENSORED DEATHS |
| 462 462 462 462 462 462 462 462 462 462 |
| |
|--------------------------------------------------------------------------------|
| DOSE = 5.0% |
| --------------------- |
| |
| TOTAL 60 UNCENSORED DEATHS 32 CENSORED DEATHS 10 TERMINAL 18 |
| |
| UNCENSORED DEATHS |
| 258 400 454 458 461 494 503 570 574 575 |
| 597 625 637 644 646 646 647 668 679 682 |
| 682 688 689 699 699 699 699 700 701 709 |
| 710 724 |
| CENSORED DEATHS |
| 462 462 462 462 462 462 462 462 462 462 |
| |
==================================================================================
POLYSORBATE 80
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 94.3 92.3 84.3 74.3 58.2 |
|CONTROL | |
| | |
|2.5% | 100.0 98.3 98.3 98.3 98.3 96.3 92.3 90.3 64.2 36.1 |
| | |
| | |
|5.0% | 100.0 100.0 98.3 98.3 96.7 91.7 87.6 79.4 67.2 36.7 |
| | |
| | |
==================================================================================
==================================================================================
| SURVIVAL SUMMARY STATISTICS |
| |
| |
|--------------------------------------------------------------------------------|
| DOSE |
| |
| UNTREATD 2.5% 5.0% |
| CONTROL |
|--------------------------------------------------------------------------------|
|SURVIVAL AT END OF STUDY| 58.2% 36.1% 36.7% |
|(KAPLAN-MEIER) | |
| | |
|SIGNIFICANCE (B) | P=0.043 P=0.058 P=0.048 |
|(LIFE TABLE) | |
| | |
|MEAN DAY OF | 617.2 629.5 613.0 |
|NATURAL DEATHS (C) | (19.5) (20.1) (19.7) |
|(STANDARD ERROR) | |
| | |
|MEAN LIFE SPAN (D) | 645.4 631.4 622.7 |
|(STANDARD ERROR) | (14.2) (15.6) (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)
POLYSORBATE 80
STATISTICAL ANALYSIS OF SURVIVAL DATA
FEMALE RATS
FIRST TERMINAL SACRIFICE AT 729 DAYS
INDIVIDUAL SURVIVAL TIMES (DAYS)
==================================================================================
| DOSE = UNTREATD CONTROL |
| ---------------------------- |
| |
| TOTAL 60 UNCENSORED DEATHS 27 CENSORED DEATHS 10 TERMINAL 23 |
| |
| UNCENSORED DEATHS |
| 195 367 514 548 561 573 575 594 617 617 |
| 629 630 631 640 644 645 645 646 662 675 |
| 699 701 709 710 710 710 716 |
| CENSORED DEATHS |
| 463 463 463 463 463 463 463 463 463 463 |
| |
|--------------------------------------------------------------------------------|
| DOSE = 2.5% |
| --------------------- |
| |
| TOTAL 60 UNCENSORED DEATHS 25 CENSORED DEATHS 10 TERMINAL 25 |
| |
| UNCENSORED DEATHS |
| 273 323 466 467 467 532 561 610 619 623 |
| 630 637 638 640 640 646 687 700 700 702 |
| 702 716 717 717 724 |
| CENSORED DEATHS |
| 463 463 463 463 463 463 463 463 463 463 |
| |
|--------------------------------------------------------------------------------|
| DOSE = 5.0% |
| --------------------- |
| |
| TOTAL 60 UNCENSORED DEATHS 25 CENSORED DEATHS 10 TERMINAL 25 |
| |
| UNCENSORED DEATHS |
| 316 432 535 567 568 571 610 610 612 612 |
| 619 623 633 634 640 644 694 694 698 699 |
| 700 702 708 716 717 |
| CENSORED DEATHS |
| 463 463 463 463 463 463 463 463 463 463 |
| |
==================================================================================
POLYSORBATE 80
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 96.7 96.7 94.7 84.6 62.4 46.3 |
|CONTROL | |
| | |
|2.5% | 100.0 100.0 100.0 96.7 96.7 90.6 88.6 86.6 68.5 50.3 |
| | |
| | |
|5.0% | 100.0 100.0 100.0 98.3 98.3 96.7 94.7 88.6 68.5 50.3 |
| | |
| | |
==================================================================================
==================================================================================
| SURVIVAL SUMMARY STATISTICS |
| |
| |
|--------------------------------------------------------------------------------|
| DOSE |
| |
| UNTREATD 2.5% 5.0% |
| CONTROL |
|--------------------------------------------------------------------------------|
|SURVIVAL AT END OF STUDY| 46.3% 50.3% 50.3% |
|(KAPLAN-MEIER) | |
| | |
|SIGNIFICANCE (B) | P=0.779N P=0.780N P=0.843N |
|(LIFE TABLE) | |
| | |
|MEAN DAY OF | 613.4 605.5 622.2 |
|NATURAL DEATHS (C) | (21.7) (24.4) (18.6) |
|(STANDARD ERROR) | |
| | |
|MEAN LIFE SPAN (D) | 632.7 633.2 640.2 |
|(STANDARD ERROR) | (15.4) (15.9) (14.3) |
| | |
==================================================================================
(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)
POLYSORBATE 80
KAPLAN-MEIER SURVIVAL CURVES
UNTREATD CONTROL = 1
2.5% = 2
5.0% = 3
------------------------------------------------------ SPECIES=RATS SEX=MALE -------------------------------------------------------
Plot of SURVIVAL*WEEK. Symbol is value of DOSE.
|
|
100 + 1 2 3 1
| 2 3 3 1 112 2
| 33 1 12 2
| 3 1 2 1 2
90 + 33 2 2
| 3 13 1 22
P | 1 12
E | 33 3 1 1
R 80 + 3 2121
C | 331 1
E | 22 1 1
N | 33 11
T 70 + 11
| 22 3
S | 22 23 111
U | 223 11
R 60 + 33 11
V | 22 1 1
I | 223
V | 22
A 50 +
L | 22
| 322
| 33
40 + 2 2
| 3 3 3
| 2 2
|
30 +
|
--+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
0 10 20 30 40 50 60 70 80 90 100 110
WEEK
NOTE: 20 obs hidden.
POLYSORBATE 80
KAPLAN-MEIER SURVIVAL CURVES
UNTREATD CONTROL = 1
2.5% = 2
5.0% = 3
----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------
Plot of SURVIVAL*WEEK. Symbol is value of DOSE.
|
|
104.72 +
|
|1 1 2 3
| 1 2 32 1 3
96.67 + 2 1 3 2 1 3
| 1 3 1 3
| 1 13
| 2 2 11
P 88.61 + 2 211 3
E | 2 1 1 2
R | 1 21
C |
E 80.56 + 311
N | 22
T | 3112
| 11
S 72.50 + 33
U | 11
R | 32 23
V | 22
I 64.44 + 1 1
V | 1 1 22
A | 1 1
L | 11 2
56.39 + 11
| 33
| 22
| 32 2
48.33 + 11
| 1 1
|
|
40.28 +
|
-+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+
0 10 20 30 40 50 60 70 80 90 100 110
WEEK
NOTE: 18 obs hidden.