TDMS Study 96003-03 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: BIORELIANCE ALLYL BROMIDE DATE: 11/14/03 EXPERIMENT: 96003 TEST: 03 TIME: 14:44:36 TEST TYPE: 26-39 WEEKS CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: NO1-ES-25408 ROUTE: GAVAGE NTP C#: 96003C PATHOLOGIST: LANNING, LYNDA CAS: 106-95-6 ------------------------------------------------------------------------------------------------------------------------------------ REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE 001 VEHICLE CONTROL INCLUDE 002 0.5 MG/KG INCLUDE 003 1 MG/KG INCLUDE 004 2 MG/KG INCLUDE 005 4 MG/KG INCLUDE 006 8 MG/KG INCLUDE 008 VEHICLE CONTROL INCLUDE 009 0.5 MG/KG INCLUDE 010 1 MG/KG INCLUDE 011 2 MG/KG INCLUDE 012 4 MG/KG INCLUDE 013 8 MG/KG NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: BIORELIANCE ALLYL BROMIDE DATE: 11/14/03 EXPERIMENT: 96003 TEST: 03 TIME: 14:44:36 TEST TYPE: 26-39 WEEKS CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-25408 ROUTE: GAVAGE NTP C#: 96003C PATHOLOGIST: LANNING, LYNDA CAS: 106-95-6 ALLYL BROMIDE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 275 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = VEHICLE CONTROL | | ---------------------------- | | | | TOTAL 15 UNCENSORED DEATHS 3 CENSORED DEATHS 0 TERMINAL 12 | | | | UNCENSORED DEATHS | | 173 241 245 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 0.5 MG/KG | | ---------------------------- | | | | TOTAL 15 UNCENSORED DEATHS 5 CENSORED DEATHS 1 TERMINAL 9 | | | | UNCENSORED DEATHS | | 163 169 186 206 219 | | CENSORED DEATHS | | 8 | | | |--------------------------------------------------------------------------------| | DOSE = 1 MG/KG | | --------------------- | | | | TOTAL 15 UNCENSORED DEATHS 6 CENSORED DEATHS 0 TERMINAL 9 | | | | UNCENSORED DEATHS | | 69 117 150 165 206 226 | | CENSORED DEATHS | | NONE | | | ================================================================================== ALLYL BROMIDE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 275 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 2 MG/KG | | --------------------- | | | | TOTAL 15 UNCENSORED DEATHS 2 CENSORED DEATHS 1 TERMINAL 12 | | | | UNCENSORED DEATHS | | 142 165 | | CENSORED DEATHS | | 12 | | | |--------------------------------------------------------------------------------| | DOSE = 4 MG/KG | | --------------------- | | | | TOTAL 15 UNCENSORED DEATHS 8 CENSORED DEATHS 1 TERMINAL 6 | | | | UNCENSORED DEATHS | | 127 129 167 201 218 222 238 241 | | CENSORED DEATHS | | 4 | | | |--------------------------------------------------------------------------------| | DOSE = 8 MG/KG | | --------------------- | | | | TOTAL 15 UNCENSORED DEATHS 3 CENSORED DEATHS 1 TERMINAL 11 | | | | UNCENSORED DEATHS | | 107 108 243 | | CENSORED DEATHS | | 5 | | | ================================================================================== ALLYL BROMIDE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE 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 | 100.0 100.0 100.0 100.0 100.0 100.0 93.3 93.3 80.0 80.0 | |CONTROL | | | | | |0.5 | 100.0 100.0 100.0 100.0 100.0 92.9 78.6 64.3 64.3 64.3 | |MG/KG | | | | | |1 MG/KG | 100.0 100.0 93.3 93.3 86.7 73.3 73.3 66.7 60.0 60.0 | | | | | | | |2 MG/KG | 100.0 100.0 100.0 100.0 100.0 85.7 85.7 85.7 85.7 85.7 | | | | | | | |4 MG/KG | 100.0 100.0 100.0 100.0 85.7 85.7 78.6 64.3 42.9 42.9 | | | | | | | |8 MG/KG | 100.0 100.0 100.0 85.7 85.7 85.7 85.7 85.7 78.6 78.6 | | | | | | | ================================================================================== ALLYL BROMIDE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 275 DAYS =============================================================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |-----------------------------------------------------------------------------------------------------------------------------| | DOSE | | | | VEHICLE 0.5 1 MG/KG 2 MG/KG 4 MG/KG 8 MG/KG | | CONTROL MG/KG | |-----------------------------------------------------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 80.0% 64.3% 60.0% 85.7% 42.9% 78.6% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=1.000 P=0.480 P=0.304 P=1.000N P=0.055 P=1.000 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 219.7 188.6 155.5 153.5 192.9 152.7 | |NATURAL DEATHS (C) | (23.4) (10.7) (23.5) (11.5) (16.4) (45.2) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 263.9 228.4 227.2 241.3 213.1 232.5 | |(STANDARD ERROR) | ( 7.1) (19.3) (18.0) (19.7) (20.1) (22.1) | | | | =============================================================================================================================== (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) ALLYL BROMIDE 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 2 TERMINAL 9 | | | | UNCENSORED DEATHS | | 151 154 229 263 | | CENSORED DEATHS | | 214 217 | | | |--------------------------------------------------------------------------------| | DOSE = 0.5 MG/KG | | ---------------------------- | | | | TOTAL 15 UNCENSORED DEATHS 5 CENSORED DEATHS 0 TERMINAL 10 | | | | UNCENSORED DEATHS | | 147 162 200 218 219 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 1 MG/KG | | --------------------- | | | | TOTAL 15 UNCENSORED DEATHS 7 CENSORED DEATHS 0 TERMINAL 8 | | | | UNCENSORED DEATHS | | 102 149 164 193 194 234 246 | | CENSORED DEATHS | | NONE | | | ================================================================================== ALLYL BROMIDE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 275 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 2 MG/KG | | --------------------- | | | | TOTAL 15 UNCENSORED DEATHS 7 CENSORED DEATHS 0 TERMINAL 8 | | | | UNCENSORED DEATHS | | 136 193 196 215 241 242 246 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 4 MG/KG | | --------------------- | | | | TOTAL 15 UNCENSORED DEATHS 4 CENSORED DEATHS 0 TERMINAL 11 | | | | UNCENSORED DEATHS | | 86 188 200 216 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 8 MG/KG | | --------------------- | | | | TOTAL 15 UNCENSORED DEATHS 3 CENSORED DEATHS 0 TERMINAL 12 | | | | UNCENSORED DEATHS | | 213 241 246 | | CENSORED DEATHS | | NONE | | | ================================================================================== ALLYL BROMIDE 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 | 100.0 100.0 100.0 100.0 100.0 86.7 86.7 86.7 78.8 70.9 | |CONTROL | | | | | |0.5 | 100.0 100.0 100.0 100.0 100.0 86.7 86.7 66.7 66.7 66.7 | |MG/KG | | | | | |1 MG/KG | 100.0 100.0 100.0 93.3 93.3 80.0 80.0 66.7 53.3 53.3 | | | | | | | |2 MG/KG | 100.0 100.0 100.0 100.0 93.3 93.3 93.3 73.3 53.3 53.3 | | | | | | | |4 MG/KG | 100.0 100.0 100.0 93.3 93.3 93.3 86.7 73.3 73.3 73.3 | | | | | | | |8 MG/KG | 100.0 100.0 100.0 100.0 100.0 100.0 100.0 93.3 80.0 80.0 | | | | | | | ================================================================================== ALLYL BROMIDE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 275 DAYS =============================================================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |-----------------------------------------------------------------------------------------------------------------------------| | DOSE | | | | VEHICLE 0.5 1 MG/KG 2 MG/KG 4 MG/KG 8 MG/KG | | CONTROL MG/KG | |-----------------------------------------------------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 70.9% 66.7% 53.3% 53.3% 73.3% 80.0% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.265N P=1.000 P=0.454 P=0.524 P=1.000N P=0.816N | |(LIFE TABLE) | | | | | |MEAN DAY OF | 199.3 189.2 183.1 209.9 172.5 233.3 | |NATURAL DEATHS (C) | (27.9) (14.8) (18.8) (14.9) (29.4) (10.3) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 246.9 246.4 232.1 244.6 247.7 266.7 | |(STANDARD ERROR) | (11.4) (11.7) (14.9) (10.9) (14.0) ( 4.8) | | | | =============================================================================================================================== (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) ALLYL BROMIDE KAPLAN-MEIER SURVIVAL CURVES VEHICLE CONTROL = 1 0.5 MG/KG = 2 1 MG/KG = 3 2 MG/KG = 4 4 MG/KG = 5 8 MG/KG = 6 ------------------------------------------------------ SPECIES=MICE SEX=MALE ------------------------------------------------------- Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100 + 1 3 6 5 4 2 1 | | | 3 3 4 2 1 1 P 90 + E | 3 3 R | 6 5 4 2 2 6 4 C | E 80 + 3 3 1 1 N | 5 2 5 2 6 6 T | | 3 5 2 2 S 70 + U | 3 3 R | 2 2 V | I 60 + 3 3 V | 5 5 A | L | 50 + 5 5 | | | 5 5 40 + | ---+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+-- 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: 10 obs hidden. ALLYL BROMIDE KAPLAN-MEIER SURVIVAL CURVES VEHICLE CONTROL = 1 0.5 MG/KG = 2 1 MG/KG = 3 2 MG/KG = 4 4 MG/KG = 5 8 MG/KG = 6 ----------------------------------------------------- SPECIES=MICE SEX=FEMALE ------------------------------------------------------ Plot of SURVIVAL*WEEK. Symbol is value of DOSE. 100 + 1 5 3 4 2 1 6 | | | 95 + | 5 3 4 2 3 2 5 4 6 6 | | 90 + | | | 1 2 5 2 1 6 6 P 85 + E | R | C | E 80 + 3 3 2 4 2 6 6 N | 1 1 T | | S 75 + U | 4 4 5 R | V | 1 1 I 70 + V | A | L | 3 2 3 2 65 + | | | 60 + 3 4 3 | | | 55 + | 3 3 | | 50 + ---+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+-- 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: 15 obs hidden.