TDMS Study 99033-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11
LAB: BIORELIANCE TRANSGENIC MODEL EVALUATION II (ASPARTAME) DATE: 03/05/03
EXPERIMENT: 99033 TEST: 01 TIME: 11:30:02
TEST TYPE: 26-39 WEEKS CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-65406 ROUTE: DOSED FEED NTP C#: C99033
PATHOLOGIST: LANNING, LYNDA CAS: 22839-47-0
------------------------------------------------------------------------------------------------------------------------------------
FINAL #3 TG.AC MICE
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE 001 VEHICLE CONTROL
INCLUDE 002 3125 PPM
INCLUDE 003 6250 PPM
INCLUDE 004 12500 PPM
INCLUDE 005 25000 PPM
INCLUDE 006 50000 PPM
INCLUDE 008 VEHICLE CONTROL
INCLUDE 009 3125 PPM
INCLUDE 010 6250 PPM
INCLUDE 011 12500 PPM
INCLUDE 012 25000 PPM
INCLUDE 013 50000 PPM
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11
LAB: BIORELIANCE TRANSGENIC MODEL EVALUATION II (ASPARTAME) DATE: 03/05/03
EXPERIMENT: 99033 TEST: 01 TIME: 11:30:02
TEST TYPE: 26-39 WEEKS CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-65406 ROUTE: DOSED FEED NTP C#: C99033
PATHOLOGIST: LANNING, LYNDA CAS: 22839-47-0
TRANSGENIC MODEL EVALUATION II (ASPARTAME)
STATISTICAL ANALYSIS OF SURVIVAL DATA
MALE MICE
FIRST TERMINAL SACRIFICE AT 274 DAYS
INDIVIDUAL SURVIVAL TIMES (DAYS)
==================================================================================
| DOSE = VEHICLE CONTROL |
| ---------------------------- |
| |
| TOTAL 15 UNCENSORED DEATHS 6 CENSORED DEATHS 0 TERMINAL 9 |
| |
| UNCENSORED DEATHS |
| 76 183 197 271 271 271 |
| CENSORED DEATHS |
| NONE |
| |
|--------------------------------------------------------------------------------|
| DOSE = 3125 PPM |
| --------------------- |
| |
| TOTAL 15 UNCENSORED DEATHS 3 CENSORED DEATHS 0 TERMINAL 12 |
| |
| UNCENSORED DEATHS |
| 198 271 271 |
| CENSORED DEATHS |
| NONE |
| |
|--------------------------------------------------------------------------------|
| DOSE = 6250 PPM |
| --------------------- |
| |
| TOTAL 15 UNCENSORED DEATHS 7 CENSORED DEATHS 0 TERMINAL 8 |
| |
| UNCENSORED DEATHS |
| 78 132 138 150 197 207 271 |
| CENSORED DEATHS |
| NONE |
| |
==================================================================================
TRANSGENIC MODEL EVALUATION II (ASPARTAME)
STATISTICAL ANALYSIS OF SURVIVAL DATA
MALE MICE
FIRST TERMINAL SACRIFICE AT 274 DAYS
INDIVIDUAL SURVIVAL TIMES (DAYS)
==================================================================================
| DOSE = 12500 PPM |
| --------------------- |
| |
| TOTAL 15 UNCENSORED DEATHS 3 CENSORED DEATHS 0 TERMINAL 12 |
| |
| UNCENSORED DEATHS |
| 199 206 271 |
| CENSORED DEATHS |
| NONE |
| |
|--------------------------------------------------------------------------------|
| DOSE = 25000 PPM |
| --------------------- |
| |
| TOTAL 15 UNCENSORED DEATHS 4 CENSORED DEATHS 0 TERMINAL 11 |
| |
| UNCENSORED DEATHS |
| 96 138 239 261 |
| CENSORED DEATHS |
| NONE |
| |
|--------------------------------------------------------------------------------|
| DOSE = 50000 PPM |
| --------------------- |
| |
| TOTAL 15 UNCENSORED DEATHS 5 CENSORED DEATHS 0 TERMINAL 10 |
| |
| UNCENSORED DEATHS |
| 141 180 180 200 271 |
| CENSORED DEATHS |
| NONE |
| |
==================================================================================
TRANSGENIC MODEL EVALUATION II (ASPARTAME)
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 93.3 93.3 93.3 93.3 86.7 80.0 80.0 60.0 |
|CONTROL | |
| | |
|3125 PPM | 100.0 100.0 100.0 100.0 100.0 100.0 100.0 93.3 93.3 80.0 |
| | |
| | |
|6250 PPM | 100.0 100.0 93.3 93.3 86.7 73.3 73.3 60.0 60.0 53.3 |
| | |
| | |
|12500 PPM| 100.0 100.0 100.0 100.0 100.0 100.0 100.0 86.7 86.7 80.0 |
| | |
| | |
|25000 PPM| 100.0 100.0 100.0 93.3 93.3 86.7 86.7 86.7 80.0 73.3 |
| | |
| | |
|50000 PPM| 100.0 100.0 100.0 100.0 100.0 93.3 80.0 73.3 73.3 66.7 |
| | |
| | |
==================================================================================
TRANSGENIC MODEL EVALUATION II (ASPARTAME)
STATISTICAL ANALYSIS OF SURVIVAL DATA
MALE MICE
FIRST TERMINAL SACRIFICE AT 274 DAYS
===============================================================================================================================
| SURVIVAL SUMMARY STATISTICS |
| |
| |
|-----------------------------------------------------------------------------------------------------------------------------|
| DOSE |
| |
| VEHICLE 3125 PPM 6250 PPM 12500 PPM 25000 PPM 50000 PPM |
| CONTROL |
|-----------------------------------------------------------------------------------------------------------------------------|
|SURVIVAL AT END OF STUDY| 60.0% 80.0% 53.3% 80.0% 73.3% 66.7% |
|(KAPLAN-MEIER) | |
| | |
|SIGNIFICANCE (B) | P=1.000N P=0.362N P=0.768 P=0.399N P=0.771N P=1.000N |
|(LIFE TABLE) | |
| | |
|MEAN DAY OF | 211.5 246.7 167.6 225.3 183.5 194.4 |
|NATURAL DEATHS (C) | (31.6) (24.3) (23.7) (22.9) (39.6) (21.4) |
|(STANDARD ERROR) | |
| | |
|MEAN LIFE SPAN (D) | 249.0 268.5 224.3 264.3 249.9 247.5 |
|(STANDARD ERROR) | (14.5) ( 5.0) (17.7) ( 6.5) (14.3) (12.0) |
| | |
===============================================================================================================================
(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)
TRANSGENIC MODEL EVALUATION II (ASPARTAME)
STATISTICAL ANALYSIS OF SURVIVAL DATA
FEMALE MICE
FIRST TERMINAL SACRIFICE AT 275 DAYS
INDIVIDUAL SURVIVAL TIMES (DAYS)
==================================================================================
| DOSE = VEHICLE CONTROL |
| ---------------------------- |
| |
| TOTAL 15 UNCENSORED DEATHS 4 CENSORED DEATHS 0 TERMINAL 11 |
| |
| UNCENSORED DEATHS |
| 109 200 242 270 |
| CENSORED DEATHS |
| NONE |
| |
|--------------------------------------------------------------------------------|
| DOSE = 3125 PPM |
| --------------------- |
| |
| TOTAL 15 UNCENSORED DEATHS 5 CENSORED DEATHS 0 TERMINAL 10 |
| |
| UNCENSORED DEATHS |
| 81 192 198 206 271 |
| CENSORED DEATHS |
| NONE |
| |
|--------------------------------------------------------------------------------|
| DOSE = 6250 PPM |
| --------------------- |
| |
| TOTAL 15 UNCENSORED DEATHS 6 CENSORED DEATHS 0 TERMINAL 9 |
| |
| UNCENSORED DEATHS |
| 61 67 113 148 200 207 |
| CENSORED DEATHS |
| NONE |
| |
==================================================================================
TRANSGENIC MODEL EVALUATION II (ASPARTAME)
STATISTICAL ANALYSIS OF SURVIVAL DATA
FEMALE MICE
FIRST TERMINAL SACRIFICE AT 275 DAYS
INDIVIDUAL SURVIVAL TIMES (DAYS)
==================================================================================
| DOSE = 12500 PPM |
| --------------------- |
| |
| TOTAL 15 UNCENSORED DEATHS 6 CENSORED DEATHS 0 TERMINAL 9 |
| |
| UNCENSORED DEATHS |
| 97 134 165 165 184 271 |
| CENSORED DEATHS |
| NONE |
| |
|--------------------------------------------------------------------------------|
| DOSE = 25000 PPM |
| --------------------- |
| |
| TOTAL 15 UNCENSORED DEATHS 4 CENSORED DEATHS 0 TERMINAL 11 |
| |
| UNCENSORED DEATHS |
| 23 267 269 270 |
| CENSORED DEATHS |
| NONE |
| |
|--------------------------------------------------------------------------------|
| DOSE = 50000 PPM |
| --------------------- |
| |
| TOTAL 15 UNCENSORED DEATHS 7 CENSORED DEATHS 0 TERMINAL 8 |
| |
| UNCENSORED DEATHS |
| 79 92 92 151 184 215 269 |
| CENSORED DEATHS |
| NONE |
| |
==================================================================================
TRANSGENIC MODEL EVALUATION II (ASPARTAME)
STATISTICAL ANALYSIS OF SURVIVAL DATA
FEMALE MICE
FIRST TERMINAL SACRIFICE AT 275 DAYS
==================================================================================
| KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) |
| |
|--------------------------------------------------------------------------------|
| DOSE TIME (DAYS) |
| 28 56 84 112 140 168 196 224 252 275 (A) |
| |
|--------------------------------------------------------------------------------|
| | |
|VEHICLE | 100.0 100.0 100.0 93.3 93.3 93.3 93.3 86.7 80.0 73.3 |
|CONTROL | |
| | |
|3125 PPM | 100.0 100.0 93.3 93.3 93.3 93.3 86.7 73.3 73.3 66.7 |
| | |
| | |
|6250 PPM | 100.0 100.0 86.7 86.7 80.0 73.3 73.3 60.0 60.0 60.0 |
| | |
| | |
|12500 PPM| 100.0 100.0 100.0 93.3 86.7 73.3 66.7 66.7 66.7 60.0 |
| | |
| | |
|25000 PPM| 93.3 93.3 93.3 93.3 93.3 93.3 93.3 93.3 93.3 73.3 |
| | |
| | |
|50000 PPM| 100.0 100.0 93.3 80.0 80.0 73.3 66.7 60.0 60.0 53.3 |
| | |
| | |
==================================================================================
TRANSGENIC MODEL EVALUATION II (ASPARTAME)
STATISTICAL ANALYSIS OF SURVIVAL DATA
FEMALE MICE
FIRST TERMINAL SACRIFICE AT 275 DAYS
===============================================================================================================================
| SURVIVAL SUMMARY STATISTICS |
| |
| |
|-----------------------------------------------------------------------------------------------------------------------------|
| DOSE |
| |
| VEHICLE 3125 PPM 6250 PPM 12500 PPM 25000 PPM 50000 PPM |
| CONTROL |
|-----------------------------------------------------------------------------------------------------------------------------|
|SURVIVAL AT END OF STUDY| 73.3% 66.7% 60.0% 60.0% 73.3% 53.3% |
|(KAPLAN-MEIER) | |
| | |
|SIGNIFICANCE (B) | P=0.454 P=0.916 P=0.541 P=0.596 P=1.000N P=0.329 |
|(LIFE TABLE) | |
| | |
|MEAN DAY OF | 205.3 189.6 132.7 169.3 207.3 154.6 |
|NATURAL DEATHS (C) | (35.2) (30.6) (25.9) (23.9) (61.4) (27.2) |
|(STANDARD ERROR) | |
| | |
|MEAN LIFE SPAN (D) | 256.4 246.5 218.1 232.7 256.9 218.8 |
|(STANDARD ERROR) | (11.8) (14.3) (21.1) (16.5) (16.7) (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)
TRANSGENIC MODEL EVALUATION II (ASPARTAME)
KAPLAN-MEIER SURVIVAL CURVES
VEHICLE CONTROL = 1
3125 PPM = 2
6250 PPM = 3
12500 PPM = 4
25000 PPM = 5
50000 PPM = 6
------------------------------------------------------ SPECIES=MICE SEX=MALE -------------------------------------------------------
Plot of SURVIVAL*WEEK. Symbol is value of DOSE.
|
|
100.00 +1 1 3 5 6 2
|
|
|
93.33 + 1 3 5 3 5 6 6 1 2 4 2
|
P |
E |
R 86.67 + 3 3 1 1 4 5 4
C |
E |
N |
T 80.00 + 3 3 6 1 5 5 1 2
|
S |
U |
R 73.33 + 3 3 5 6 5
V |
I |
V |
A 66.67 + 3 3 6 6
L |
|
|
60.00 + 3 1 1
|
|
|
53.33 + 3 3
|
-+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+-
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: 14 obs hidden.
TRANSGENIC MODEL EVALUATION II (ASPARTAME)
KAPLAN-MEIER SURVIVAL CURVES
VEHICLE CONTROL = 1
3125 PPM = 2
6250 PPM = 3
12500 PPM = 4
25000 PPM = 5
50000 PPM = 6
----------------------------------------------------- SPECIES=MICE SEX=FEMALE ------------------------------------------------------
Plot of SURVIVAL*WEEK. Symbol is value of DOSE.
|
|
100.00 +1 5 3 2 4 1
|
|
|
93.33 + 5 3 3 2 4 1 4 2 1 5
|
P |
E |
R 86.67 + 3 3 4 4 2 1 1
C |
E |
N |
T 80.00 + 6 3 3 2 2 1 1
|
S |
U |
R 73.33 + 3 4 4 3 2 1 1
V |
I |
V |
A 66.67 + 4 3 3 6 2 2
L |
|
|
60.00 + 3 6 4 3
|
|
|
53.33 + 6 6
|
-+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+-
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: 19 obs hidden.