TDMS Study 88122-07 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11
LAB: Battelle Columbus ELMIRON DATE: 04/23/01
EXPERIMENT: 88122 TEST: 07 TIME: 15:41:23
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: NO1-ES-55388 ROUTE: GAVAGE NTP C#: C88122
PATHOLOGIST: GRUMBEIN, SONDRA CAS: 37319-17-8
------------------------------------------------------------------------------------------------------------------------------------
final#1/Mice
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: 04/23/01
EXPERIMENT: 88122 TEST: 07 TIME: 15:41:23
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-55388 ROUTE: GAVAGE NTP C#: C88122
PATHOLOGIST: GRUMBEIN, SONDRA CAS: 37319-17-8
ELMIRON
STATISTICAL ANALYSIS OF SURVIVAL DATA
MALE MICE
FIRST TERMINAL SACRIFICE AT 730 DAYS
INDIVIDUAL SURVIVAL TIMES (DAYS)
==================================================================================
| DOSE = 0 MG/KG |
| --------------------- |
| |
| TOTAL 50 UNCENSORED DEATHS 11 CENSORED DEATHS 0 TERMINAL 39 |
| |
| UNCENSORED DEATHS |
| 420 477 590 599 606 620 632 646 664 690 |
| 702 |
| CENSORED DEATHS |
| NONE |
| |
|--------------------------------------------------------------------------------|
| DOSE = 56 MG/KG |
| --------------------- |
| |
| TOTAL 50 UNCENSORED DEATHS 9 CENSORED DEATHS 1 TERMINAL 40 |
| |
| UNCENSORED DEATHS |
| 311 346 455 508 508 508 688 707 728 |
| CENSORED DEATHS |
| 11 |
| |
|--------------------------------------------------------------------------------|
| DOSE = 168 MG/KG |
| ---------------------------- |
| |
| TOTAL 50 UNCENSORED DEATHS 12 CENSORED DEATHS 0 TERMINAL 38 |
| |
| UNCENSORED DEATHS |
| 465 548 581 592 597 611 620 641 653 653 |
| 680 725 |
| CENSORED DEATHS |
| NONE |
| |
==================================================================================
ELMIRON
STATISTICAL ANALYSIS OF SURVIVAL DATA
MALE MICE
FIRST TERMINAL SACRIFICE AT 730 DAYS
INDIVIDUAL SURVIVAL TIMES (DAYS)
==================================================================================
| DOSE = 504 MG/KG |
| ---------------------------- |
| |
| TOTAL 50 UNCENSORED DEATHS 18 CENSORED DEATHS 2 TERMINAL 30 |
| |
| UNCENSORED DEATHS |
| 483 492 498 539 576 584 590 617 621 626 |
| 631 646 657 658 668 676 695 721 |
| CENSORED DEATHS |
| 11 17 |
| |
==================================================================================
ELMIRON
STATISTICAL ANALYSIS OF SURVIVAL DATA
MALE MICE
FIRST TERMINAL SACRIFICE AT 730 DAYS
==================================================================================
| KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) |
| |
|--------------------------------------------------------------------------------|
| DOSE TIME (DAYS) |
| 90 180 270 365 425 485 545 605 665 730 (A) |
| |
|--------------------------------------------------------------------------------|
| | |
|0 MG/KG | 100.0 100.0 100.0 100.0 98.0 96.0 96.0 92.0 82.0 78.0 |
| | |
| | |
|56 MG/KG | 100.0 100.0 100.0 95.9 95.9 93.9 87.8 87.8 87.8 81.6 |
| | |
| | |
|168 | 100.0 100.0 100.0 100.0 100.0 98.0 98.0 90.0 80.0 76.0 |
|MG/KG | |
| | |
|504 | 100.0 100.0 100.0 100.0 100.0 97.9 91.7 85.4 70.8 62.5 |
|MG/KG | |
| | |
==================================================================================
==================================================================================
| SURVIVAL SUMMARY STATISTICS |
| |
| |
|--------------------------------------------------------------------------------|
| DOSE |
| |
| 0 MG/KG 56 MG/KG 168 504 |
| MG/KG MG/KG |
|--------------------------------------------------------------------------------|
|SURVIVAL AT END OF STUDY| 78.0% 81.6% 76.0% 62.5% |
|(KAPLAN-MEIER) | |
| | |
|SIGNIFICANCE (B) | P=0.038 P=0.860N P=0.974 P=0.140 |
|(LIFE TABLE) | |
| | |
|MEAN DAY OF | 604.2 528.8 613.8 609.9 |
|NATURAL DEATHS (C) | (25.9) (50.6) (19.2) (16.5) |
|(STANDARD ERROR) | |
| | |
|MEAN LIFE SPAN (D) | 702.3 679.4 702.1 658.1 |
|(STANDARD ERROR) | ( 9.2) (19.6) ( 8.4) (21.3) |
| | |
==================================================================================
(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)
ELMIRON
STATISTICAL ANALYSIS OF SURVIVAL DATA
FEMALE MICE
FIRST TERMINAL SACRIFICE AT 729 DAYS
INDIVIDUAL SURVIVAL TIMES (DAYS)
==================================================================================
| DOSE = 0 MG/KG |
| --------------------- |
| |
| TOTAL 50 UNCENSORED DEATHS 12 CENSORED DEATHS 1 TERMINAL 37 |
| |
| UNCENSORED DEATHS |
| 411 456 536 583 636 647 661 667 685 703 |
| 717 723 |
| CENSORED DEATHS |
| 183 |
| |
|--------------------------------------------------------------------------------|
| DOSE = 56 MG/KG |
| --------------------- |
| |
| TOTAL 50 UNCENSORED DEATHS 11 CENSORED DEATHS 1 TERMINAL 38 |
| |
| UNCENSORED DEATHS |
| 281 485 541 555 642 681 681 703 703 711 |
| 722 |
| CENSORED DEATHS |
| 18 |
| |
|--------------------------------------------------------------------------------|
| DOSE = 168 MG/KG |
| ---------------------------- |
| |
| TOTAL 50 UNCENSORED DEATHS 13 CENSORED DEATHS 0 TERMINAL 37 |
| |
| UNCENSORED DEATHS |
| 313 481 509 589 603 621 638 638 647 653 |
| 667 677 717 |
| CENSORED DEATHS |
| NONE |
| |
==================================================================================
ELMIRON
STATISTICAL ANALYSIS OF SURVIVAL DATA
FEMALE MICE
FIRST TERMINAL SACRIFICE AT 729 DAYS
INDIVIDUAL SURVIVAL TIMES (DAYS)
==================================================================================
| DOSE = 504 MG/KG |
| ---------------------------- |
| |
| TOTAL 50 UNCENSORED DEATHS 16 CENSORED DEATHS 0 TERMINAL 34 |
| |
| UNCENSORED DEATHS |
| 401 509 517 579 621 645 652 660 661 683 |
| 698 701 703 708 717 723 |
| CENSORED DEATHS |
| NONE |
| |
==================================================================================
ELMIRON
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) |
| |
|--------------------------------------------------------------------------------|
| | |
|0 MG/KG | 100.0 100.0 100.0 100.0 98.0 95.9 93.9 91.8 85.7 75.5 |
| | |
| | |
|56 MG/KG | 100.0 100.0 100.0 98.0 98.0 95.9 93.9 91.8 89.8 77.6 |
| | |
| | |
|168 | 100.0 100.0 100.0 98.0 98.0 96.0 94.0 90.0 80.0 74.0 |
|MG/KG | |
| | |
|504 | 100.0 100.0 100.0 100.0 98.0 98.0 94.0 92.0 82.0 68.0 |
|MG/KG | |
| | |
==================================================================================
==================================================================================
| SURVIVAL SUMMARY STATISTICS |
| |
| |
|--------------------------------------------------------------------------------|
| DOSE |
| |
| 0 MG/KG 56 MG/KG 168 504 |
| MG/KG MG/KG |
|--------------------------------------------------------------------------------|
|SURVIVAL AT END OF STUDY| 75.5% 77.6% 74.0% 68.0% |
|(KAPLAN-MEIER) | |
| | |
|SIGNIFICANCE (B) | P=0.359 P=0.962N P=0.968 P=0.544 |
|(LIFE TABLE) | |
| | |
|MEAN DAY OF | 618.8 609.5 596.4 636.1 |
|NATURAL DEATHS (C) | (29.5) (40.8) (29.7) (22.8) |
|(STANDARD ERROR) | |
| | |
|MEAN LIFE SPAN (D) | 691.6 688.5 694.5 699.3 |
|(STANDARD ERROR) | (14.1) (17.7) (11.2) ( 9.4) |
| | |
==================================================================================
(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
KAPLAN-MEIER SURVIVAL CURVES
0 MG/KG = 1
56 MG/KG = 2
168 MG/KG = 3
504 MG/KG = 4
------------------------------------------------------ SPECIES=MICE SEX=MALE -------------------------------------------------------
Plot of SURVIVAL*WEEK. Symbol is value of DOSE.
|
|
100.00 + 1 2 1 3 4
|
| 2 2 1 3 1 4 3
|
95.83 + 2 2 1 44 3 3 1
|
| 2 42 4 3 11
|
91.67 + 4 4 311
|
P | 44 3131
E |
R 87.50 + 2 44 31 1 2
C | 3 131
E | 4 4 2 2
N | 3131
T 83.33 + 2 2
| 1 1
S | 44 22
U | 3 31 1
R 79.17 + 44
V | 3 1 31
I | 4 4
V | 33
A 75.00 + 44
L |
|
|
70.83 + 4 4
|
| 44
|
66.67 + 4 4
|
| 4 4
|
62.50 + 4 4
|
---+----+----+----+----+----+----+----+----+----+----+----+----+----+----+----+----+----+----+----+----+----+--
0 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 85 90 95 100 105
WEEK
NOTE: 7 obs hidden.
ELMIRON
KAPLAN-MEIER SURVIVAL CURVES
0 MG/KG = 1
56 MG/KG = 2
168 MG/KG = 3
504 MG/KG = 4
----------------------------------------------------- SPECIES=MICE SEX=FEMALE ------------------------------------------------------
Plot of SURVIVAL*WEEK. Symbol is value of DOSE.
|
|
100 + 1 2 3 41
|
| 2 3 41 1 32 4
| 1 32 34 12
95 +
| 34 12 2 41 3
P | 4 3 3 4
E | 2 1 12
R 90 + 3 3 121 2
C |
E | 3 314 1
N | 4 11 2 2
T 85 +
| 33 1 1
S | 33 4 4
U | 1 12
R 80 + 3 3 4 41212
V |
I | 33 44 11 2
V | 3 3
A 75 + 1 1
L | 443 3
| 44
|
70 + 44
|
| 4 4
|
65 +
|
--+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
0 10 20 30 40 50 60 70 80 90 100 110
WEEK
NOTE: 10 obs hidden.