National Toxicology Program

National Toxicology Program
https://ntp.niehs.nih.gov/go/15964

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.                                                                                                                 
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