TDMS Study 96003-05 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: BIORELIANCE ALLYL BROMIDE DATE: 11/14/03 EXPERIMENT: 96003 TEST: 05 TIME: 14:49:10 TEST TYPE: 26-39 WEEKS CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: NO1-ES-25408 ROUTE: GAVAGE NTP C#: C96003 PATHOLOGIST: LANNING, LYNDA CAS: 106-95-6 ------------------------------------------------------------------------------------------------------------------------------------ REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: BIORELIANCE ALLYL BROMIDE DATE: 11/14/03 EXPERIMENT: 96003 TEST: 05 TIME: 14:49:10 TEST TYPE: 26-39 WEEKS CAGES FROM 0000 TO LAST CAGE CONT: NO1-ES-25408 ROUTE: GAVAGE NTP C#: C96003 PATHOLOGIST: LANNING, LYNDA CAS: 106-95-6 ALLYL BROMIDE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 274 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = VEHICLE CONTROL | | ---------------------------- | | | | TOTAL 15 UNCENSORED DEATHS 0 CENSORED DEATHS 0 TERMINAL 15 | | | | UNCENSORED DEATHS | | NONE | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 0.5 MG/KG | | ---------------------------- | | | | TOTAL 15 UNCENSORED DEATHS 1 CENSORED DEATHS 0 TERMINAL 14 | | | | UNCENSORED DEATHS | | 238 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 1 MG/KG | | --------------------- | | | | TOTAL 15 UNCENSORED DEATHS 0 CENSORED DEATHS 0 TERMINAL 15 | | | | UNCENSORED DEATHS | | NONE | | CENSORED DEATHS | | NONE | | | ================================================================================== ALLYL BROMIDE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 274 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 2 MG/KG | | --------------------- | | | | TOTAL 15 UNCENSORED DEATHS 0 CENSORED DEATHS 0 TERMINAL 15 | | | | UNCENSORED DEATHS | | NONE | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 4 MG/KG | | --------------------- | | | | TOTAL 15 UNCENSORED DEATHS 2 CENSORED DEATHS 0 TERMINAL 13 | | | | UNCENSORED DEATHS | | 224 271 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 8 MG/KG | | --------------------- | | | | TOTAL 15 UNCENSORED DEATHS 0 CENSORED DEATHS 0 TERMINAL 15 | | | | UNCENSORED DEATHS | | NONE | | CENSORED DEATHS | | NONE | | | ================================================================================== ALLYL BROMIDE 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 | 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 | |CONTROL | | | | | |0.5 | 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 93.3 93.3 | |MG/KG | | | | | |1 MG/KG | 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 | | | | | | | |2 MG/KG | 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 | | | | | | | |4 MG/KG | 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 93.3 86.7 | | | | | | | |8 MG/KG | 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 | | | | | | | ================================================================================== ALLYL BROMIDE STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 274 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| 100.0% 93.3% 100.0% 100.0% 86.7% 100.0% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=1.000 P=1.000 ----- ----- P=0.464 ----- | |(LIFE TABLE) | | | | | |MEAN DAY OF | . 238.0 . . 247.5 . | |NATURAL DEATHS (C) | ( . ) ( . ) ( . ) ( . ) (23.5) ( . ) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 274.0 271.6 274.0 274.0 270.5 274.0 | |(STANDARD ERROR) | ( 0.0) ( 2.4) ( 0.0) ( 0.0) ( 3.3) ( 0.0) | | | | =============================================================================================================================== (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) ALLYL BROMIDE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 277 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = VEHICLE CONTROL | | ---------------------------- | | | | TOTAL 15 UNCENSORED DEATHS 2 CENSORED DEATHS 0 TERMINAL 13 | | | | UNCENSORED DEATHS | | 224 258 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 0.5 MG/KG | | ---------------------------- | | | | TOTAL 15 UNCENSORED DEATHS 1 CENSORED DEATHS 0 TERMINAL 14 | | | | UNCENSORED DEATHS | | 251 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 1 MG/KG | | --------------------- | | | | TOTAL 15 UNCENSORED DEATHS 2 CENSORED DEATHS 0 TERMINAL 13 | | | | UNCENSORED DEATHS | | 224 237 | | CENSORED DEATHS | | NONE | | | ================================================================================== ALLYL BROMIDE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 277 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 2 MG/KG | | --------------------- | | | | TOTAL 15 UNCENSORED DEATHS 1 CENSORED DEATHS 0 TERMINAL 14 | | | | UNCENSORED DEATHS | | 250 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 4 MG/KG | | --------------------- | | | | TOTAL 15 UNCENSORED DEATHS 0 CENSORED DEATHS 0 TERMINAL 15 | | | | UNCENSORED DEATHS | | NONE | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 8 MG/KG | | --------------------- | | | | TOTAL 15 UNCENSORED DEATHS 2 CENSORED DEATHS 0 TERMINAL 13 | | | | UNCENSORED DEATHS | | 269 271 | | CENSORED DEATHS | | NONE | | | ================================================================================== ALLYL BROMIDE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 277 DAYS ================================================================================== | KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) | | | |--------------------------------------------------------------------------------| | DOSE TIME (DAYS) | | 28 56 84 112 140 168 196 224 252 277 (A) | | | |--------------------------------------------------------------------------------| | | | |VEHICLE | 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 93.3 86.7 | |CONTROL | | | | | |0.5 | 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 93.3 | |MG/KG | | | | | |1 MG/KG | 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 86.7 86.7 | | | | | | | |2 MG/KG | 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 93.3 | | | | | | | |4 MG/KG | 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 | | | | | | | |8 MG/KG | 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 86.7 | | | | | | | ================================================================================== ALLYL BROMIDE STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 277 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| 86.7% 93.3% 86.7% 93.3% 100.0% 86.7% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=1.000N P=0.984N P=1.000 P=0.984N P=0.464N P=1.000N | |(LIFE TABLE) | | | | | |MEAN DAY OF | 241.0 251.0 230.5 250.0 . 270.0 | |NATURAL DEATHS (C) | (17.0) ( . ) ( 6.5) ( . ) ( . ) ( 1.0) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 272.2 275.3 270.8 275.2 277.0 276.1 | |(STANDARD ERROR) | ( 3.7) ( 1.7) ( 4.3) ( 1.8) ( 0.0) ( 0.6) | | | | =============================================================================================================================== (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. (NOTE: 8 obs hidden.) P | E | R 100.00 +1 5 2 1 C | E | N | T 93.33 + 5 2 5 2 | S | U | R 86.67 + 5 5 V | I -+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+- V 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 A WEEK 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. (NOTE: 12 obs hidden.) P | E | R 100.00 +1 1 2 6 5 C | E | N | T 93.33 + 1 3 2 1 2 | S | U | R 86.67 + 3 1 6 1 V | I -+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+- V 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 A WEEK