TDMS Study 88122-06 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11
LAB: Battelle Columbus ELMIRON DATE: 06/12/01
EXPERIMENT: 88122 TEST: 06 TIME: 09:25:23
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: NO1-ES-55388 ROUTE: GAVAGE NTP C#: C88122
PATHOLOGIST: RYAN, MICHAEL CAS: 37319-17-8
------------------------------------------------------------------------------------------------------------------------------------
FINAL#1
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11
LAB: Battelle Columbus ELMIRON DATE: 06/12/01
EXPERIMENT: 88122 TEST: 06 TIME: 09:25:23
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-55388 ROUTE: GAVAGE NTP C#: C88122
PATHOLOGIST: RYAN, MICHAEL CAS: 37319-17-8
ELMIRON
STATISTICAL ANALYSIS OF SURVIVAL DATA
MALE RATS
FIRST TERMINAL SACRIFICE AT 727 DAYS
INDIVIDUAL SURVIVAL TIMES (DAYS)
==================================================================================
| DOSE = 0 MG/KG |
| --------------------- |
| |
| TOTAL 50 UNCENSORED DEATHS 22 CENSORED DEATHS 2 TERMINAL 26 |
| |
| UNCENSORED DEATHS |
| 475 503 505 519 519 526 547 573 589 630 |
| 640 640 661 685 686 699 707 717 721 724 |
| 724 724 |
| CENSORED DEATHS |
| 111 600 |
| |
|--------------------------------------------------------------------------------|
| DOSE = 14 MG/KG |
| --------------------- |
| |
| TOTAL 50 UNCENSORED DEATHS 19 CENSORED DEATHS 2 TERMINAL 29 |
| |
| UNCENSORED DEATHS |
| 131 313 478 503 533 551 574 645 645 654 |
| 668 674 705 713 713 715 717 719 724 |
| CENSORED DEATHS |
| 223 577 |
| |
|--------------------------------------------------------------------------------|
| DOSE = 42 MG/KG |
| --------------------- |
| |
| TOTAL 50 UNCENSORED DEATHS 25 CENSORED DEATHS 0 TERMINAL 25 |
| |
| UNCENSORED DEATHS |
| 419 462 484 492 521 526 533 561 574 582 |
| 582 586 587 630 630 630 674 674 679 685 |
| 686 686 695 716 717 |
| CENSORED DEATHS |
| NONE |
| |
==================================================================================
ELMIRON
STATISTICAL ANALYSIS OF SURVIVAL DATA
MALE RATS
FIRST TERMINAL SACRIFICE AT 727 DAYS
INDIVIDUAL SURVIVAL TIMES (DAYS)
==================================================================================
| DOSE = 126 MG/KG |
| ---------------------------- |
| |
| TOTAL 50 UNCENSORED DEATHS 17 CENSORED DEATHS 5 TERMINAL 28 |
| |
| UNCENSORED DEATHS |
| 237 261 433 484 604 622 629 640 660 661 |
| 669 679 689 691 707 708 720 |
| CENSORED DEATHS |
| 120 161 352 456 709 |
| |
==================================================================================
ELMIRON
STATISTICAL ANALYSIS OF SURVIVAL DATA
MALE RATS
FIRST TERMINAL SACRIFICE AT 727 DAYS
==================================================================================
| KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) |
| |
|--------------------------------------------------------------------------------|
| DOSE TIME (DAYS) |
| 90 180 270 365 425 485 545 605 665 727 (A) |
| |
|--------------------------------------------------------------------------------|
| | |
|0 MG/KG | 100.0 100.0 100.0 100.0 100.0 98.0 87.8 81.6 73.3 54.4 |
| | |
| | |
|14 MG/KG | 100.0 98.0 98.0 96.0 96.0 93.9 89.8 85.7 79.5 60.7 |
| | |
| | |
|42 MG/KG | 100.0 100.0 100.0 100.0 98.0 94.0 86.0 74.0 68.0 50.0 |
| | |
| | |
|126 | 100.0 100.0 95.8 95.8 95.8 91.5 91.5 89.3 78.4 63.1 |
|MG/KG | |
| | |
==================================================================================
==================================================================================
| SURVIVAL SUMMARY STATISTICS |
| |
| |
|--------------------------------------------------------------------------------|
| DOSE |
| |
| 0 MG/KG 14 MG/KG 42 MG/KG 126 |
| MG/KG |
|--------------------------------------------------------------------------------|
|SURVIVAL AT END OF STUDY| 54.4% 60.7% 50.0% 63.1% |
|(KAPLAN-MEIER) | |
| | |
|SIGNIFICANCE (B) | P=0.621N P=0.659N P=0.604 P=0.563N |
|(LIFE TABLE) | |
| | |
|MEAN DAY OF | 623.4 598.7 600.4 593.8 |
|NATURAL DEATHS (C) | (18.8) (36.0) (17.0) (36.5) |
|(STANDARD ERROR) | |
| | |
|MEAN LIFE SPAN (D) | 666.5 665.2 663.7 645.0 |
|(STANDARD ERROR) | (15.8) (18.5) (12.4) (22.4) |
| | |
==================================================================================
(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)
ELMIRON
STATISTICAL ANALYSIS OF SURVIVAL DATA
FEMALE RATS
FIRST TERMINAL SACRIFICE AT 728 DAYS
INDIVIDUAL SURVIVAL TIMES (DAYS)
==================================================================================
| DOSE = 0 MG/KG |
| --------------------- |
| |
| TOTAL 50 UNCENSORED DEATHS 19 CENSORED DEATHS 1 TERMINAL 30 |
| |
| UNCENSORED DEATHS |
| 406 427 462 509 559 596 596 600 601 621 |
| 629 651 673 678 690 707 719 722 726 |
| CENSORED DEATHS |
| 191 |
| |
|--------------------------------------------------------------------------------|
| DOSE = 28 MG/KG |
| --------------------- |
| |
| TOTAL 50 UNCENSORED DEATHS 18 CENSORED DEATHS 1 TERMINAL 31 |
| |
| UNCENSORED DEATHS |
| 197 333 510 526 539 589 594 622 653 670 |
| 677 678 678 714 715 716 716 719 |
| CENSORED DEATHS |
| 474 |
| |
|--------------------------------------------------------------------------------|
| DOSE = 84 MG/KG |
| --------------------- |
| |
| TOTAL 50 UNCENSORED DEATHS 20 CENSORED DEATHS 2 TERMINAL 28 |
| |
| UNCENSORED DEATHS |
| 375 405 474 483 491 559 614 645 653 664 |
| 667 667 673 678 685 691 711 713 715 723 |
| CENSORED DEATHS |
| 111 545 |
| |
==================================================================================
ELMIRON
STATISTICAL ANALYSIS OF SURVIVAL DATA
FEMALE RATS
FIRST TERMINAL SACRIFICE AT 728 DAYS
INDIVIDUAL SURVIVAL TIMES (DAYS)
==================================================================================
| DOSE = 252 MG/KG |
| ---------------------------- |
| |
| TOTAL 50 UNCENSORED DEATHS 17 CENSORED DEATHS 6 TERMINAL 27 |
| |
| UNCENSORED DEATHS |
| 379 495 518 525 588 603 624 651 656 660 |
| 667 672 678 706 720 723 727 |
| CENSORED DEATHS |
| 111 139 216 273 329 680 |
| |
==================================================================================
ELMIRON
STATISTICAL ANALYSIS OF SURVIVAL DATA
FEMALE RATS
FIRST TERMINAL SACRIFICE AT 728 DAYS
==================================================================================
| KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) |
| |
|--------------------------------------------------------------------------------|
| DOSE TIME (DAYS) |
| 90 180 270 365 425 485 545 605 665 728 (A) |
| |
|--------------------------------------------------------------------------------|
| | |
|0 MG/KG | 100.0 100.0 100.0 100.0 98.0 93.9 91.8 81.6 75.5 61.2 |
| | |
| | |
|28 MG/KG | 100.0 100.0 98.0 96.0 96.0 96.0 89.9 85.8 81.7 63.3 |
| | |
| | |
|84 MG/KG | 100.0 100.0 100.0 100.0 95.9 91.8 89.8 87.7 79.4 58.5 |
| | |
| | |
|252 | 100.0 100.0 100.0 100.0 97.8 97.8 91.1 86.7 77.8 61.9 |
|MG/KG | |
| | |
==================================================================================
==================================================================================
| SURVIVAL SUMMARY STATISTICS |
| |
| |
|--------------------------------------------------------------------------------|
| DOSE |
| |
| 0 MG/KG 28 MG/KG 84 MG/KG 252 |
| MG/KG |
|--------------------------------------------------------------------------------|
|SURVIVAL AT END OF STUDY| 61.2% 63.3% 58.5% 61.9% |
|(KAPLAN-MEIER) | |
| | |
|SIGNIFICANCE (B) | P=1.000N P=0.940N P=0.953 P=1.000N |
|(LIFE TABLE) | |
| | |
|MEAN DAY OF | 609.1 602.6 614.3 623.1 |
|NATURAL DEATHS (C) | (22.6) (33.6) (24.4) (23.2) |
|(STANDARD ERROR) | |
| | |
|MEAN LIFE SPAN (D) | 672.1 677.8 666.5 639.9 |
|(STANDARD ERROR) | (15.3) (15.2) (17.0) (23.1) |
| | |
==================================================================================
(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)
ELMIRON
KAPLAN-MEIER SURVIVAL CURVES
0 MG/KG = 1
14 MG/KG = 2
42 MG/KG = 3
126 MG/KG = 4
------------------------------------------------------ SPECIES=RATS SEX=MALE -------------------------------------------------------
Plot of SURVIVAL*WEEK. Symbol is value of DOSE.
|
100 + 1 2 4 3 1
|
| 2 4 4 2 3 3 1 1
| 4 2 4 3 23 11
95 +
| 4 23321 1
| 32 3 2
| 4 4
90 + 112 2
| 4 4
| 13 1 2 44
| 3 1 31 2
P 85 + 4 4
E | 31 1
R | 3 3 4 4
C | 1 1 22
E 80 + 1 1 2 2
N | 44
T | 22
| 44
S 75 + 1 1 2 2
U | 3 3 1 414 22
R |
V |
I 70 + 4 4
V | 1 1 22
A | 3 3 114
L |
65 + 141
|
| 33 22
| 11
60 +
|
|
| 3 3
55 + 1
| 3 3
|
|
50 + 33
|
--+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
0 10 20 30 40 50 60 70 80 90 100 110
WEEK
NOTE: 15 obs hidden.
ELMIRON
KAPLAN-MEIER SURVIVAL CURVES
0 MG/KG = 1
28 MG/KG = 2
84 MG/KG = 3
252 MG/KG = 4
----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------
Plot of SURVIVAL*WEEK. Symbol is value of DOSE.
|
|
100 + 1 2 3 4 1
|
| 2 2 3 4 1 1 4
| 2 3 1 1 3 2
95 + 4 4
| 1 33 14 42
| 22
| 3 3 1 4 1 4
90 + 3 2 1 21
| 4 4
P | 3 3
E | 2 4 24
R 85 + 3 4 3
C | 2 32
E | 44
N | 1 1 2 32
T 80 + 11 4 422
| 33
S | 1 1 44
U |
R 75 + 1 31
V | 42 2
I |
V | 131 422
A 70 + 1 1
L | 33 4 4
| 1 1
| 3 344
65 + 11
| 22
| 334
| 1
60 + 33
| 3
|
|
55 +
|
--+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
0 10 20 30 40 50 60 70 80 90 100 110
WEEK
NOTE: 13 obs hidden.