TDMS Study 05007-05 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11
LAB: Southern Research Inst DATE: 09/03/94
EXP: 05007 POLYSORBATE 80 TIME: 11:42:45
TEST: 05 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:
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REMOVAL DATE RANGE:
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NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11
LAB: Southern Research Inst DATE: 09/03/94
EXP: 05007 POLYSORBATE 80 TIME: 11:42:45
TEST: 05 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 MICE
FIRST TERMINAL SACRIFICE AT 729 DAYS
INDIVIDUAL SURVIVAL TIMES (DAYS)
==================================================================================
| DOSE = UNTREATD CONTROL |
| ---------------------------- |
| |
| TOTAL 59 UNCENSORED DEATHS 18 CENSORED DEATHS 8 TERMINAL 33 |
| |
| UNCENSORED DEATHS |
| 90 168 260 272 436 440 472 492 538 575 |
| 580 634 637 639 640 654 707 715 |
| CENSORED DEATHS |
| 457 457 457 457 457 457 457 704 |
| |
|--------------------------------------------------------------------------------|
| DOSE = 2.5% |
| --------------------- |
| |
| TOTAL 60 UNCENSORED DEATHS 19 CENSORED DEATHS 7 TERMINAL 34 |
| |
| UNCENSORED DEATHS |
| 310 361 451 533 541 581 596 598 634 646 |
| 651 672 678 705 706 707 708 708 709 |
| CENSORED DEATHS |
| 457 457 457 457 457 457 457 |
| |
|--------------------------------------------------------------------------------|
| DOSE = 5.0% |
| --------------------- |
| |
| TOTAL 60 UNCENSORED DEATHS 18 CENSORED DEATHS 10 TERMINAL 32 |
| |
| UNCENSORED DEATHS |
| 147 150 170 280 561 570 604 608 613 614 |
| 637 644 645 672 708 709 715 717 |
| CENSORED DEATHS |
| 457 457 457 457 457 457 457 457 457 457 |
| |
==================================================================================
POLYSORBATE 80
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) |
| |
|--------------------------------------------------------------------------------|
| | |
|UNTREATD | 98.3 96.6 94.9 93.2 93.2 87.9 84.0 80.1 70.3 66.3 |
|CONTROL | |
| | |
|2.5% | 100.0 100.0 100.0 96.7 96.7 95.0 91.2 85.5 79.8 64.6 |
| | |
| | |
|5.0% | 100.0 95.0 95.0 93.3 93.3 93.3 93.3 87.2 75.1 64.9 |
| | |
| | |
==================================================================================
==================================================================================
| SURVIVAL SUMMARY STATISTICS |
| |
| |
|--------------------------------------------------------------------------------|
| DOSE |
| |
| UNTREATD 2.5% 5.0% |
| CONTROL |
|--------------------------------------------------------------------------------|
|SURVIVAL AT END OF STUDY| 66.3% 64.6% 64.9% |
|(KAPLAN-MEIER) | |
| | |
|SIGNIFICANCE (B) | P=1.000N P=1.000N P=1.000N |
|(LIFE TABLE) | |
| | |
|MEAN DAY OF | 497.2 605.0 542.4 |
|NATURAL DEATHS (C) | (44.2) (27.4) (47.8) |
|(STANDARD ERROR) | |
| | |
|MEAN LIFE SPAN (D) | 625.6 658.0 627.7 |
|(STANDARD ERROR) | (20.6) (14.7) (20.2) |
| | |
==================================================================================
(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 MICE
FIRST TERMINAL SACRIFICE AT 729 DAYS
INDIVIDUAL SURVIVAL TIMES (DAYS)
==================================================================================
| DOSE = UNTREATD CONTROL |
| ---------------------------- |
| |
| TOTAL 60 UNCENSORED DEATHS 21 CENSORED DEATHS 9 TERMINAL 30 |
| |
| UNCENSORED DEATHS |
| 255 391 557 559 580 586 587 609 614 636 |
| 636 637 653 683 696 700 706 707 707 707 |
| 708 |
| CENSORED DEATHS |
| 458 458 458 458 458 458 458 458 458 |
| |
|--------------------------------------------------------------------------------|
| DOSE = 2.5% |
| --------------------- |
| |
| TOTAL 60 UNCENSORED DEATHS 22 CENSORED DEATHS 10 TERMINAL 28 |
| |
| UNCENSORED DEATHS |
| 114 192 247 437 458 498 499 523 585 588 |
| 588 610 628 637 638 639 651 672 703 706 |
| 707 707 |
| CENSORED DEATHS |
| 458 458 458 458 458 458 458 458 458 458 |
| |
|--------------------------------------------------------------------------------|
| DOSE = 5.0% |
| --------------------- |
| |
| TOTAL 60 UNCENSORED DEATHS 24 CENSORED DEATHS 10 TERMINAL 26 |
| |
| UNCENSORED DEATHS |
| 361 378 409 438 442 447 469 474 477 514 |
| 548 577 581 584 624 629 647 687 693 694 |
| 702 702 717 717 |
| CENSORED DEATHS |
| 458 458 458 458 458 458 458 458 458 458 |
| |
==================================================================================
POLYSORBATE 80
STATISTICAL ANALYSIS OF SURVIVAL DATA
FEMALE 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) |
| |
|--------------------------------------------------------------------------------|
| | |
|UNTREATD | 100.0 100.0 98.3 98.3 96.7 96.7 96.7 86.8 75.0 59.2 |
|CONTROL | |
| | |
|2.5% | 100.0 98.3 95.0 95.0 95.0 91.7 85.6 79.4 67.2 57.0 |
| | |
| | |
|5.0% | 100.0 100.0 100.0 98.3 95.0 83.9 81.8 73.6 67.5 53.2 |
| | |
| | |
==================================================================================
==================================================================================
| SURVIVAL SUMMARY STATISTICS |
| |
| |
|--------------------------------------------------------------------------------|
| DOSE |
| |
| UNTREATD 2.5% 5.0% |
| CONTROL |
|--------------------------------------------------------------------------------|
|SURVIVAL AT END OF STUDY| 59.2% 57.0% 53.2% |
|(KAPLAN-MEIER) | |
| | |
|SIGNIFICANCE (B) | P=0.388 P=0.740 P=0.431 |
|(LIFE TABLE) | |
| | |
|MEAN DAY OF | 615.0 546.7 563.0 |
|NATURAL DEATHS (C) | (24.5) (35.9) (24.1) |
|(STANDARD ERROR) | |
| | |
|MEAN LIFE SPAN (D) | 648.4 617.0 617.4 |
|(STANDARD ERROR) | (15.0) (19.2) (16.6) |
| | |
==================================================================================
(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)
POLYSORBATE 80
KAPLAN-MEIER SURVIVAL CURVES
UNTREATD CONTROL = 1
2.5% = 2
5.0% = 3
------------------------------------------------------ SPECIES=MICE SEX=MALE -------------------------------------------------------
Plot of SURVIVAL*WEEK. Symbol is value of DOSE.
|
|
100 + 1 1 3 2
| 1 33 1 2 2
|
| 3 1 3 1 2 2
95 + 3 113 2 2
| 13 1 3
P | 22
E | 2 332
R 90 + 1 1
C | 32 23
E | 1 1
N | 1 1
T 85 + 233 2
| 1 1 2 2
S |
U | 3 3
R 80 + 1 1 2 2
V | 33
I | 33 22
V | 11 2 2
A 75 + 3 3
L |
| 1 1 3 3
|
70 + 1 12
| 131
|
| 1 1
65 + 23 2
|
--+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
0 10 20 30 40 50 60 70 80 90 100 110
WEEK
NOTE: 5 obs hidden.
POLYSORBATE 80
KAPLAN-MEIER SURVIVAL CURVES
UNTREATD CONTROL = 1
2.5% = 2
5.0% = 3
----------------------------------------------------- SPECIES=MICE SEX=FEMALE ------------------------------------------------------
Plot of SURVIVAL*WEEK. Symbol is value of DOSE.
|
|
100 + 1 2 1 3
| 2 2 1 3 3 1
|
| 2 2 3 1 3 1
95 + 2 3 2
| 23 2
| 1 1
| 2 2 11
90 + 3 3
|
| 33 2 2
| 33 1 1
P 85 + 2 2 11
E | 3 3
R | 1 1
C | 3 3
E 80 + 3 32 2
N |
T | 2 21 1
| 33
S 75 + 22 1 1
U | 3 322
R | 1 1
V |
I 70 + 3 3
V | 22 11
A | 2 2 3
L |
65 + 2 2
| 33
|
| 311
60 +
| 1 1
| 2 3 2
|
55 +
| 3 3
|
|
50 +
|
--+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
0 10 20 30 40 50 60 70 80 90 100 110
WEEK
NOTE: 7 obs hidden.