TDMS Study 99039-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11
LAB: BIORELIANCE TRANSGENIC MODEL EVALUATION II DATE: 02/21/03
EXPERIMENT: 99039 TEST: 01 TIME: 10:25:00
TEST TYPE: 26-39 WEEKS CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: NO1-ES-75408 ROUTE: DOSED FEED NTP C#: C99039
PATHOLOGIST: LANNING, LYNDA CAS: 55589-62-3
------------------------------------------------------------------------------------------------------------------------------------
FINAL#3/TG.AC MICE
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE 001 VEHICLE CONTROL
INCLUDE 002 0.3%
INCLUDE 003 1.0 %
INCLUDE 004 3.0 %
INCLUDE 006 VEHICLE CONTROL
INCLUDE 007 0.3 %
INCLUDE 008 1.0%
INCLUDE 009 3.0%
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11
LAB: BIORELIANCE TRANSGENIC MODEL EVALUATION II DATE: 02/21/03
EXPERIMENT: 99039 TEST: 01 TIME: 10:25:00
TEST TYPE: 26-39 WEEKS CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-75408 ROUTE: DOSED FEED NTP C#: C99039
PATHOLOGIST: LANNING, LYNDA CAS: 55589-62-3
TRANSGENIC MODEL EVALUATION II (ACESULFAME POTASSIUM)
STATISTICAL ANALYSIS OF SURVIVAL DATA
MALE MICE
FIRST TERMINAL SACRIFICE AT 274 DAYS
INDIVIDUAL SURVIVAL TIMES (DAYS)
==================================================================================
| DOSE = VEHICLE CONTROL |
| ---------------------------- |
| |
| TOTAL 15 UNCENSORED DEATHS 2 CENSORED DEATHS 0 TERMINAL 13 |
| |
| UNCENSORED DEATHS |
| 148 157 |
| CENSORED DEATHS |
| NONE |
| |
|--------------------------------------------------------------------------------|
| DOSE = 0.3% |
| --------------------- |
| |
| TOTAL 15 UNCENSORED DEATHS 4 CENSORED DEATHS 0 TERMINAL 11 |
| |
| UNCENSORED DEATHS |
| 71 148 233 271 |
| CENSORED DEATHS |
| NONE |
| |
|--------------------------------------------------------------------------------|
| DOSE = 1.0 % |
| --------------------- |
| |
| TOTAL 15 UNCENSORED DEATHS 2 CENSORED DEATHS 0 TERMINAL 13 |
| |
| UNCENSORED DEATHS |
| 192 264 |
| CENSORED DEATHS |
| NONE |
| |
==================================================================================
TRANSGENIC MODEL EVALUATION II (ACESULFAME POTASSIUM)
STATISTICAL ANALYSIS OF SURVIVAL DATA
MALE MICE
FIRST TERMINAL SACRIFICE AT 274 DAYS
INDIVIDUAL SURVIVAL TIMES (DAYS)
==================================================================================
| DOSE = 3.0 % |
| --------------------- |
| |
| TOTAL 15 UNCENSORED DEATHS 1 CENSORED DEATHS 0 TERMINAL 14 |
| |
| UNCENSORED DEATHS |
| 172 |
| CENSORED DEATHS |
| NONE |
| |
==================================================================================
TRANSGENIC MODEL EVALUATION II (ACESULFAME POTASSIUM)
STATISTICAL ANALYSIS OF SURVIVAL DATA
MALE MICE
FIRST TERMINAL SACRIFICE AT 274 DAYS
==================================================================================
| KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) |
| |
|--------------------------------------------------------------------------------|
| DOSE TIME (DAYS) |
| 28 56 84 112 140 168 196 224 252 274 (A) |
| |
|--------------------------------------------------------------------------------|
| | |
|VEHICLE | 100.0 100.0 100.0 100.0 100.0 86.7 86.7 86.7 86.7 86.7 |
|CONTROL | |
| | |
|0.3% | 100.0 100.0 93.3 93.3 93.3 86.7 86.7 86.7 80.0 73.3 |
| | |
| | |
|1.0 % | 100.0 100.0 100.0 100.0 100.0 100.0 100.0 93.3 93.3 86.7 |
| | |
| | |
|3.0 % | 100.0 100.0 100.0 100.0 100.0 100.0 93.3 93.3 93.3 93.3 |
| | |
| | |
==================================================================================
==================================================================================
| SURVIVAL SUMMARY STATISTICS |
| |
| |
|--------------------------------------------------------------------------------|
| DOSE |
| |
| VEHICLE 0.3% 1.0 % 3.0 % |
| CONTROL |
|--------------------------------------------------------------------------------|
|SURVIVAL AT END OF STUDY| 86.7% 73.3% 86.7% 93.3% |
|(KAPLAN-MEIER) | |
| | |
|SIGNIFICANCE (B) | P=0.430N P=0.638 P=1.000N P=0.951N |
|(LIFE TABLE) | |
| | |
|MEAN DAY OF | 152.5 180.8 228.0 172.0 |
|NATURAL DEATHS (C) | ( 4.5) (44.7) (36.0) ( . ) |
|(STANDARD ERROR) | |
| | |
|MEAN LIFE SPAN (D) | 257.8 249.1 267.9 267.2 |
|(STANDARD ERROR) | (11.0) (15.4) ( 5.5) ( 6.8) |
| | |
==================================================================================
(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)
TRANSGENIC MODEL EVALUATION II (ACESULFAME POTASSIUM)
STATISTICAL ANALYSIS OF SURVIVAL DATA
FEMALE MICE
FIRST TERMINAL SACRIFICE AT 274 DAYS
INDIVIDUAL SURVIVAL TIMES (DAYS)
==================================================================================
| DOSE = VEHICLE CONTROL |
| ---------------------------- |
| |
| TOTAL 15 UNCENSORED DEATHS 3 CENSORED DEATHS 0 TERMINAL 12 |
| |
| UNCENSORED DEATHS |
| 224 236 240 |
| CENSORED DEATHS |
| NONE |
| |
|--------------------------------------------------------------------------------|
| DOSE = 0.3 % |
| --------------------- |
| |
| TOTAL 15 UNCENSORED DEATHS 3 CENSORED DEATHS 0 TERMINAL 12 |
| |
| UNCENSORED DEATHS |
| 77 196 256 |
| CENSORED DEATHS |
| NONE |
| |
|--------------------------------------------------------------------------------|
| DOSE = 1.0% |
| --------------------- |
| |
| TOTAL 15 UNCENSORED DEATHS 3 CENSORED DEATHS 0 TERMINAL 12 |
| |
| UNCENSORED DEATHS |
| 207 232 270 |
| CENSORED DEATHS |
| NONE |
| |
==================================================================================
TRANSGENIC MODEL EVALUATION II (ACESULFAME POTASSIUM)
STATISTICAL ANALYSIS OF SURVIVAL DATA
FEMALE MICE
FIRST TERMINAL SACRIFICE AT 274 DAYS
INDIVIDUAL SURVIVAL TIMES (DAYS)
==================================================================================
| DOSE = 3.0% |
| --------------------- |
| |
| TOTAL 15 UNCENSORED DEATHS 3 CENSORED DEATHS 0 TERMINAL 12 |
| |
| UNCENSORED DEATHS |
| 156 232 255 |
| CENSORED DEATHS |
| NONE |
| |
==================================================================================
TRANSGENIC MODEL EVALUATION II (ACESULFAME POTASSIUM)
STATISTICAL ANALYSIS OF SURVIVAL DATA
FEMALE MICE
FIRST TERMINAL SACRIFICE AT 274 DAYS
==================================================================================
| KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) |
| |
|--------------------------------------------------------------------------------|
| DOSE TIME (DAYS) |
| 28 56 84 112 140 168 196 224 252 274 (A) |
| |
|--------------------------------------------------------------------------------|
| | |
|VEHICLE | 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 80.0 80.0 |
|CONTROL | |
| | |
|0.3 % | 100.0 100.0 93.3 93.3 93.3 93.3 93.3 86.7 86.7 80.0 |
| | |
| | |
|1.0% | 100.0 100.0 100.0 100.0 100.0 100.0 100.0 93.3 86.7 80.0 |
| | |
| | |
|3.0% | 100.0 100.0 100.0 100.0 100.0 93.3 93.3 93.3 86.7 80.0 |
| | |
| | |
==================================================================================
==================================================================================
| SURVIVAL SUMMARY STATISTICS |
| |
| |
|--------------------------------------------------------------------------------|
| DOSE |
| |
| VEHICLE 0.3 % 1.0% 3.0% |
| CONTROL |
|--------------------------------------------------------------------------------|
|SURVIVAL AT END OF STUDY| 80.0% 80.0% 80.0% 80.0% |
|(KAPLAN-MEIER) | |
| | |
|SIGNIFICANCE (B) | P=1.000 P=1.000 P=1.000 P=1.000 |
|(LIFE TABLE) | |
| | |
|MEAN DAY OF | 233.3 176.3 236.3 214.3 |
|NATURAL DEATHS (C) | ( 4.8) (52.6) (18.3) (29.9) |
|(STANDARD ERROR) | |
| | |
|MEAN LIFE SPAN (D) | 265.9 254.5 266.5 262.1 |
|(STANDARD ERROR) | ( 4.4) (13.7) ( 5.1) ( 8.1) |
| | |
==================================================================================
(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)
TRANSGENIC MODEL EVALUATION II (ACESULFAME POTASSIUM)
KAPLAN-MEIER SURVIVAL CURVES
VEHICLE CONTROL = 1
0.3% = 2
1.0 % = 3
3.0 % = 4
------------------------------------------------------ SPECIES=MICE SEX=MALE -------------------------------------------------------
Plot of SURVIVAL*WEEK. Symbol is value of DOSE.
|
|
P 100.00 +1 2 1 4 3
E |
R |
C |
E 93.33 + 2 1 1 4 3 3 4
N |
T |
|
S 86.67 + 2 1 2 3 1
U |
R |
V |
I 80.00 + 2 2
V |
A |
L |
73.33 + 2 2
|
-+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+-
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40
WEEK
NOTE: 5 obs hidden.
TRANSGENIC MODEL EVALUATION II (ACESULFAME POTASSIUM)
KAPLAN-MEIER SURVIVAL CURVES
VEHICLE CONTROL = 1
0.3 % = 2
1.0% = 3
3.0% = 4
----------------------------------------------------- SPECIES=MICE SEX=FEMALE ------------------------------------------------------
Plot of SURVIVAL*WEEK. Symbol is value of DOSE.
P |
E |
R 100.00 + 1 2 4 3 1
C |
E |
N |
T 93.33 + 2 4 2 3 1 1
|
S |
U |
R 86.67 + 2 1 1 2 3
V |
I |
V |
A 80.00 + 1 2 3 1
L |
---+------------+------------+------------+------------+------------+------------+------------+------------+--
0 5 10 15 20 25 30 35 40
WEEK
NOTE: 12 obs hidden.