TDMS Study 97013-11 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Battelle Columbus WATER DISINFECTION MODEL (SODIUM BROMATE) DATE: 06/18/04 EXPERIMENT: 97013 TEST: 11 TIME: 09:20:18 TEST TYPE: SUBCHRON 26-WEEK CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01-ES-65406 ROUTE: SKIN APPLICATION NTP C#: 97013B PATHOLOGIST: TOFT, JOHN CAS: 7789-38-0 ------------------------------------------------------------------------------------------------------------------------------------ FINAL#1 MICE REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE 001 0 MG/KG INCLUDE 002 0 MG/KG INCLUDE 003 64 MG/KG INCLUDE 004 64 MG/KG INCLUDE 005 128 MG/KG INCLUDE 006 128 MG/KG INCLUDE 007 256 MG/KG INCLUDE 008 256 MG/KG NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Battelle Columbus WATER DISINFECTION MODEL (SODIUM BROMATE) DATE: 06/18/04 EXPERIMENT: 97013 TEST: 11 TIME: 09:20:18 TEST TYPE: SUBCHRON 26-WEEK CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-65406 ROUTE: SKIN APPLICATION NTP C#: 97013B PATHOLOGIST: TOFT, JOHN CAS: 7789-38-0 WATER DISINFECTION MODEL (SODIUM BROMATE) STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 181 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0 MG/KG | | --------------------- | | | | TOTAL 15 UNCENSORED DEATHS 3 CENSORED DEATHS 0 TERMINAL 12 | | | | UNCENSORED DEATHS | | 42 79 146 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 64 MG/KG | | --------------------- | | | | TOTAL 15 UNCENSORED DEATHS 4 CENSORED DEATHS 0 TERMINAL 11 | | | | UNCENSORED DEATHS | | 48 74 136 176 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 128 MG/KG | | ---------------------------- | | | | TOTAL 15 UNCENSORED DEATHS 2 CENSORED DEATHS 0 TERMINAL 13 | | | | UNCENSORED DEATHS | | 68 146 | | CENSORED DEATHS | | NONE | | | ================================================================================== WATER DISINFECTION MODEL (SODIUM BROMATE) STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 181 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 256 MG/KG | | ---------------------------- | | | | TOTAL 15 UNCENSORED DEATHS 0 CENSORED DEATHS 0 TERMINAL 15 | | | | UNCENSORED DEATHS | | NONE | | CENSORED DEATHS | | NONE | | | ================================================================================== WATER DISINFECTION MODEL (SODIUM BROMATE) STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 181 DAYS ================================================================================== | KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) | | | |--------------------------------------------------------------------------------| | DOSE TIME (DAYS) | | 19 38 57 76 95 114 133 152 171 181 (A) | | | |--------------------------------------------------------------------------------| | | | |0 MG/KG | 100.0 100.0 93.3 93.3 86.7 86.7 86.7 86.7 80.0 80.0 | | | | | | | |64 MG/KG | 100.0 100.0 93.3 93.3 86.7 86.7 86.7 80.0 80.0 73.3 | | | | | | | |128 | 100.0 100.0 100.0 93.3 93.3 93.3 93.3 93.3 86.7 86.7 | |MG/KG | | | | | |256 | 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 | |MG/KG | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | 0 MG/KG 64 MG/KG 128 256 | | MG/KG MG/KG | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 80.0% 73.3% 86.7% 100.0% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.101N P=0.987 P=0.961N P=0.224N | |(LIFE TABLE) | | | | | |MEAN DAY OF | 89.0 108.5 107.0 . | |NATURAL DEATHS (C) | (30.4) (29.1) (39.0) ( . ) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 162.6 161.7 171.1 181.0 | |(STANDARD ERROR) | (11.1) (11.0) ( 7.7) ( 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) WATER DISINFECTION MODEL (SODIUM BROMATE) STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 182 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0 MG/KG | | --------------------- | | | | TOTAL 15 UNCENSORED DEATHS 4 CENSORED DEATHS 0 TERMINAL 11 | | | | UNCENSORED DEATHS | | 60 146 158 165 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 64 MG/KG | | --------------------- | | | | TOTAL 15 UNCENSORED DEATHS 5 CENSORED DEATHS 0 TERMINAL 10 | | | | UNCENSORED DEATHS | | 67 71 81 152 165 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 128 MG/KG | | ---------------------------- | | | | TOTAL 15 UNCENSORED DEATHS 4 CENSORED DEATHS 0 TERMINAL 11 | | | | UNCENSORED DEATHS | | 108 137 140 145 | | CENSORED DEATHS | | NONE | | | ================================================================================== WATER DISINFECTION MODEL (SODIUM BROMATE) STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 182 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 256 MG/KG | | ---------------------------- | | | | TOTAL 15 UNCENSORED DEATHS 4 CENSORED DEATHS 0 TERMINAL 11 | | | | UNCENSORED DEATHS | | 69 99 113 116 | | CENSORED DEATHS | | NONE | | | ================================================================================== WATER DISINFECTION MODEL (SODIUM BROMATE) STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 182 DAYS ================================================================================== | KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) | | | |--------------------------------------------------------------------------------| | DOSE TIME (DAYS) | | 19 38 57 76 95 114 133 152 171 182 (A) | | | |--------------------------------------------------------------------------------| | | | |0 MG/KG | 100.0 100.0 100.0 93.3 93.3 93.3 93.3 93.3 80.0 73.3 | | | | | | | |64 MG/KG | 100.0 100.0 100.0 86.7 80.0 80.0 80.0 80.0 73.3 66.7 | | | | | | | |128 | 100.0 100.0 100.0 100.0 100.0 93.3 93.3 73.3 73.3 73.3 | |MG/KG | | | | | |256 | 100.0 100.0 100.0 93.3 93.3 86.7 73.3 73.3 73.3 73.3 | |MG/KG | | | | | ================================================================================== ================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |--------------------------------------------------------------------------------| | DOSE | | | | 0 MG/KG 64 MG/KG 128 256 | | MG/KG MG/KG | |--------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 73.3% 66.7% 73.3% 73.3% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=1.000N P=0.923 P=1.000 P=1.000 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 132.3 107.2 132.5 99.3 | |NATURAL DEATHS (C) | (24.4) (21.2) ( 8.3) (10.7) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 168.7 157.1 168.8 159.9 | |(STANDARD ERROR) | ( 8.3) (11.5) ( 6.2) (10.1) | | | | ================================================================================== (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) WATER DISINFECTION MODEL (SODIUM BROMATE) KAPLAN-MEIER SURVIVAL CURVES 0 MG/KG = 1 64 MG/KG = 2 128 MG/KG = 3 256 MG/KG = 4 ------------------------------------------------------ SPECIES=MICE SEX=MALE ------------------------------------------------------- Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | P 100.00 + 1 1 2 3 4 E | R | C | E 93.33 + 1 2 3 2 1 3 N | T | | S 86.67 + 2 1 2 1 3 U | R | V | I 80.00 + 2 1 1 V | A | L | 73.33 + 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 WEEK NOTE: 5 obs hidden. WATER DISINFECTION MODEL (SODIUM BROMATE) KAPLAN-MEIER SURVIVAL CURVES 0 MG/KG = 1 64 MG/KG = 2 128 MG/KG = 3 256 MG/KG = 4 ----------------------------------------------------- SPECIES=MICE SEX=FEMALE ------------------------------------------------------ Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100.00 + 1 1 2 3 | P | E | R 93.33 + 1 2 2 4 3 3 1 C | E | N | T 86.67 + 2 2 4 4 1 1 | S | U | R 80.00 + 2 3 3 2 1 1 V | I | V | A 73.33 + 4 3 2 1 1 L | | | 66.67 + 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 WEEK NOTE: 8 obs hidden.