TDMS Study 05108-02 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11
LAB: Mason DATE: 09/14/94
EXP: 05108 PROMETHAZINE HYDROCHLORIDE TIME: 00:32:16
TEST: 02 CAGES FROM 0000 TO LAST CAGE PAGE: 1
TEST TYPE: CHRONIC ROUTE: GAVAGE NTP C#: C60673
CONT: NO1-ES-45069 CAS: 58-33-3
PATHOLOGIST: R. FLEISCHMAN K. MURTHY
--------------------------------------------------------------------------------
REASONS FOR REMOVAL:
ALL
REMOVAL DATE RANGE:
ALL
TREATMENT GROUPS:
INCLUDE ALL
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11
LAB: Mason DATE: 09/14/94
EXP: 05108 PROMETHAZINE HYDROCHLORIDE TIME: 00:32:16
TEST: 02 CAGES FROM 0000 TO LAST CAGE
TEST TYPE: CHRONIC ROUTE: GAVAGE NTP C#: C60673
CONT: NO1-ES-45069 CAS: 58-33-3
PATHOLOGIST: R. FLEISCHMAN K. MURTHY
PROMETHAZINE HYDROCHLORIDE
STATISTICAL ANALYSIS OF SURVIVAL DATA
MALE MICE
FIRST TERMINAL SACRIFICE AT 729 DAYS
INDIVIDUAL SURVIVAL TIMES (DAYS)
==================================================================================
| DOSE = VEHICLE |
| --------------------- |
| |
| TOTAL 60 UNCENSORED DEATHS 11 CENSORED DEATHS 10 TERMINAL 39 |
| |
| UNCENSORED DEATHS |
| 283 362 516 580 584 627 633 674 676 698 |
| 722 |
| CENSORED DEATHS |
| 458 458 458 458 458 458 460 460 460 460 |
| |
|--------------------------------------------------------------------------------|
| DOSE = 11.25 MG/KG |
| ---------------------------- |
| |
| TOTAL 60 UNCENSORED DEATHS 6 CENSORED DEATHS 10 TERMINAL 44 |
| |
| UNCENSORED DEATHS |
| 128 211 568 600 649 713 |
| CENSORED DEATHS |
| 458 458 458 458 458 458 460 460 460 460 |
| |
|--------------------------------------------------------------------------------|
| DOSE = 22.5 MG/KG |
| ---------------------------- |
| |
| TOTAL 60 UNCENSORED DEATHS 10 CENSORED DEATHS 10 TERMINAL 40 |
| |
| UNCENSORED DEATHS |
| 444 453 522 526 527 528 666 693 710 725 |
| CENSORED DEATHS |
| 458 458 458 458 460 460 460 460 460 460 |
| |
==================================================================================
PROMETHAZINE HYDROCHLORIDE
STATISTICAL ANALYSIS OF SURVIVAL DATA
MALE MICE
FIRST TERMINAL SACRIFICE AT 729 DAYS
INDIVIDUAL SURVIVAL TIMES (DAYS)
==================================================================================
| DOSE = 45.0 MG/KG |
| ---------------------------- |
| |
| TOTAL 60 UNCENSORED DEATHS 6 CENSORED DEATHS 10 TERMINAL 44 |
| |
| UNCENSORED DEATHS |
| 568 631 669 696 703 713 |
| CENSORED DEATHS |
| 458 458 458 458 460 460 460 460 460 460 |
| |
==================================================================================
PROMETHAZINE HYDROCHLORIDE
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) |
| |
|--------------------------------------------------------------------------------|
| | |
|VEHICLE | 100.0 100.0 100.0 96.7 96.7 96.7 94.7 90.6 86.6 78.5 |
| | |
| | |
|11.25 | 100.0 98.3 96.7 96.7 96.7 96.7 96.7 92.6 90.6 88.6 |
|MG/KG | |
| | |
|22.5 | 100.0 100.0 100.0 100.0 100.0 96.7 88.6 88.6 88.6 80.6 |
|MG/KG | |
| | |
|45.0 | 100.0 100.0 100.0 100.0 100.0 100.0 100.0 98.0 96.0 88.0 |
|MG/KG | |
| | |
==================================================================================
==================================================================================
| SURVIVAL SUMMARY STATISTICS |
| |
| |
|--------------------------------------------------------------------------------|
| DOSE |
| |
| VEHICLE 11.25 22.5 45.0 |
| MG/KG MG/KG MG/KG |
|--------------------------------------------------------------------------------|
|SURVIVAL AT END OF STUDY| 78.5% 88.6% 80.6% 88.0% |
|(KAPLAN-MEIER) | |
| | |
|SIGNIFICANCE (B) | P=0.353N P=0.298N P=0.988N P=0.253N |
|(LIFE TABLE) | |
| | |
|MEAN DAY OF | 577.7 478.2 579.4 663.3 |
|NATURAL DEATHS (C) | (42.3) ( 100) (34.1) (22.6) |
|(STANDARD ERROR) | |
| | |
|MEAN LIFE SPAN (D) | 656.2 658.9 659.1 677.5 |
|(STANDARD ERROR) | (15.6) (17.7) (14.7) (13.1) |
| | |
==================================================================================
(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)
PROMETHAZINE HYDROCHLORIDE
STATISTICAL ANALYSIS OF SURVIVAL DATA
FEMALE MICE
FIRST TERMINAL SACRIFICE AT 736 DAYS
INDIVIDUAL SURVIVAL TIMES (DAYS)
==================================================================================
| DOSE = VEHICLE |
| --------------------- |
| |
| TOTAL 60 UNCENSORED DEATHS 11 CENSORED DEATHS 10 TERMINAL 39 |
| |
| UNCENSORED DEATHS |
| 442 529 582 601 622 693 707 715 718 720 |
| 728 |
| CENSORED DEATHS |
| 462 462 462 462 462 462 462 464 464 464 |
| |
|--------------------------------------------------------------------------------|
| DOSE = 3.75 MG/KG |
| ---------------------------- |
| |
| TOTAL 60 UNCENSORED DEATHS 8 CENSORED DEATHS 10 TERMINAL 42 |
| |
| UNCENSORED DEATHS |
| 554 677 693 694 710 722 725 732 |
| CENSORED DEATHS |
| 462 462 462 462 464 464 464 464 464 464 |
| |
|--------------------------------------------------------------------------------|
| DOSE = 7.5 MG/KG |
| ---------------------------- |
| |
| TOTAL 60 UNCENSORED DEATHS 10 CENSORED DEATHS 11 TERMINAL 39 |
| |
| UNCENSORED DEATHS |
| 388 569 626 629 632 640 701 707 731 732 |
| CENSORED DEATHS |
| 371 462 462 462 462 464 464 464 464 464 |
| 723 |
| |
==================================================================================
PROMETHAZINE HYDROCHLORIDE
STATISTICAL ANALYSIS OF SURVIVAL DATA
FEMALE MICE
FIRST TERMINAL SACRIFICE AT 736 DAYS
INDIVIDUAL SURVIVAL TIMES (DAYS)
==================================================================================
| DOSE = 15.0 MG/KG |
| ---------------------------- |
| |
| TOTAL 60 UNCENSORED DEATHS 9 CENSORED DEATHS 10 TERMINAL 41 |
| |
| UNCENSORED DEATHS |
| 66 517 554 561 643 650 679 722 734 |
| CENSORED DEATHS |
| 6 462 462 462 462 464 464 464 464 464 |
| |
==================================================================================
PROMETHAZINE HYDROCHLORIDE
STATISTICAL ANALYSIS OF SURVIVAL DATA
FEMALE MICE
FIRST TERMINAL SACRIFICE AT 736 DAYS
==================================================================================
| KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) |
| |
|--------------------------------------------------------------------------------|
| DOSE TIME (DAYS) |
| 90 180 270 365 425 485 545 605 665 736 (A) |
| |
|--------------------------------------------------------------------------------|
| | |
|VEHICLE | 100.0 100.0 100.0 100.0 100.0 98.3 96.3 92.3 90.3 78.3 |
| | |
| | |
|3.75 | 100.0 100.0 100.0 100.0 100.0 100.0 100.0 98.0 98.0 84.0 |
|MG/KG | |
| | |
|7.5 | 100.0 100.0 100.0 100.0 98.3 98.3 98.3 96.3 88.3 80.2 |
|MG/KG | |
| | |
|15.0 | 98.3 98.3 98.3 98.3 98.3 98.3 96.3 92.3 88.3 82.3 |
|MG/KG | |
| | |
==================================================================================
==================================================================================
| SURVIVAL SUMMARY STATISTICS |
| |
| |
|--------------------------------------------------------------------------------|
| DOSE |
| |
| VEHICLE 3.75 7.5 15.0 |
| MG/KG MG/KG MG/KG |
|--------------------------------------------------------------------------------|
|SURVIVAL AT END OF STUDY| 78.3% 84.0% 80.2% 82.3% |
|(KAPLAN-MEIER) | |
| | |
|SIGNIFICANCE (B) | P=0.893N P=0.553N P=0.983N P=0.819N |
|(LIFE TABLE) | |
| | |
|MEAN DAY OF | 641.5 688.4 635.5 569.6 |
|NATURAL DEATHS (C) | (28.6) (20.3) (32.3) (67.8) |
|(STANDARD ERROR) | |
| | |
|MEAN LIFE SPAN (D) | 673.1 684.2 672.0 657.9 |
|(STANDARD ERROR) | (14.0) (13.3) (14.6) (20.0) |
| | |
==================================================================================
(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)
PROMETHAZINE HYDROCHLORIDE
KAPLAN-MEIER SURVIVAL CURVES
VEHICLE = 1
11.25 MG/KG = 2
22.5 MG/KG = 3
45.0 MG/KG = 4
------------------------------------------------------ SPECIES=MICE SEX=MALE -------------------------------------------------------
Plot of SURVIVAL*WEEK. Symbol is value of DOSE.
|
|
100.69 +
|1 2 1 3 4
| 2 2 1 1 3 3
| 4 4
P 96.67 + 2 1 3 1 3 2
E | 4 4
R | 1 33 21 2
C | 4 4
E 92.64 + 11 2 2
N | 44
T | 1 1 2 2
| 44
S 88.61 + 3 11 3 2 2
U | 4 4
R | 1 31 3
V |
I 84.58 + 3 3
V |
A | 1 1 3 3
L |
80.56 + 1 1 3
|
| 1 1
|
76.53 +
|
-+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+
0 10 20 30 40 50 60 70 80 90 100 110
WEEK
NOTE: 4 obs hidden.
PROMETHAZINE HYDROCHLORIDE
KAPLAN-MEIER SURVIVAL CURVES
VEHICLE = 1
3.75 MG/KG = 2
7.5 MG/KG = 3
15.0 MG/KG = 4
----------------------------------------------------- SPECIES=MICE SEX=FEMALE ------------------------------------------------------
Plot of SURVIVAL*WEEK. Symbol is value of DOSE.
|
|
100.0 +1 4 3 1 2
|
|
| 4 3 1 4 1 2 3 2
97.5 +
|
| 4 1 4 3 1 3 2 2
|
95.0 +
| 44 1 1
P | 22
E |
R 92.5 + 4 1 1334
C | 2 2
E |
N |
T 90.0 + 1 334 1 2 2
|
S |
U | 34 4 1 1
R 87.5 +
V |
I | 4 1 12 2
V |
A 85.0 +
L | 3 4 3
| 22
|
82.5 + 44
|
|
|
80.0 + 11 33
|
|
| 1 1
77.5 +
|
-+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-
0 10 20 30 40 50 60 70 80 90 100 110
WEEK
NOTE: 7 obs hidden.