National Toxicology Program

National Toxicology Program
https://ntp.niehs.nih.gov/go/20727

TDMS Study 97013-09 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: 09                                                                                     TIME: 11:08:07       
TEST TYPE:  SUBCHRON 26-WEEK                    CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-65406                              ROUTE: DOSED WATER                                             NTP C#: 97013A       
PATHOLOGIST: TOFT, JOHN                                                                                        CAS: 7789-38-0       
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                           FINAL #1 MICE                                                            
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE 001    0 MG/L                                                                        
                                       INCLUDE 002    0 MG/L                                                                        
                                       INCLUDE 003    80 MG/L                                                                       
                                       INCLUDE 004    80 MG/L                                                                       
                                       INCLUDE 005    400 MG/L                                                                      
                                       INCLUDE 006    400 MG/L                                                                      
                                       INCLUDE 007    800 MG/L                                                                      
                                       INCLUDE 008    800 MG/L                                                                      
                                                                                                                                   
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Battelle Columbus                          WATER DISINFECTION MODEL (SODIUM BROMATE)                      DATE: 06/18/04       
EXPERIMENT: 97013 TEST: 09                                                                                     TIME: 11:08:07       
TEST TYPE:  SUBCHRON 26-WEEK                    CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-65406                              ROUTE: DOSED WATER                                             NTP C#: 97013A       
PATHOLOGIST: TOFT, JOHN                                                                                        CAS: 7789-38-0       
                                                                                                                                   
                     WATER DISINFECTION MODEL (SODIUM BROMATE)                                                                      
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE MICE                                                                                      
                       FIRST TERMINAL SACRIFICE AT 183 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 0 MG/L                                   |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 15     UNCENSORED DEATHS 2      CENSORED DEATHS 0    TERMINAL 13        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      29    171                                                                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 80 MG/L                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 15     UNCENSORED DEATHS 2      CENSORED DEATHS 0    TERMINAL 13        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      154   182                                                                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 400 MG/L                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 15     UNCENSORED DEATHS 1      CENSORED DEATHS 0    TERMINAL 14        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      144                                                                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                     WATER DISINFECTION MODEL (SODIUM BROMATE)                                                                      
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE MICE                                                                                      
                       FIRST TERMINAL SACRIFICE AT 183 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 800 MG/L                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 15     UNCENSORED DEATHS 1      CENSORED DEATHS 0    TERMINAL 14        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      156                                                                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                     WATER DISINFECTION MODEL (SODIUM BROMATE)                                                                      
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE MICE                                                                                      
                       FIRST TERMINAL SACRIFICE AT 183 DAYS                                                                         
 ==================================================================================                                                 
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |    DOSE                               TIME (DAYS)                              |                                                 
 |                 19    38    57    76    95   114   133   152   171   183 (A)   |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |           |                                                                    |                                                 
 |0 MG/L     |   100.0  93.3  93.3  93.3  93.3  93.3  93.3  93.3  93.3  86.7      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |80 MG/L    |   100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0  93.3  86.7      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |400 MG/L   |   100.0 100.0 100.0 100.0 100.0 100.0 100.0  93.3  93.3  93.3      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |800 MG/L   |   100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0  93.3  93.3      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                  DOSE                          |                                                 
 |                                                                                |                                                 
 |                                0 MG/L       80 MG/L      400 MG/L     800 MG/L |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       86.7%        86.7%        93.3%        93.3%    |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |       P=0.620N     P=1.000N     P=0.984N     P=0.984N |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       100.0        168.0        144.0        156.0    |                                                 
 |NATURAL DEATHS (C)      |       (71.0)       (14.0)       (  . )       (  . )   |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       171.9        181.0        180.4        181.2    |                                                 
 |(STANDARD ERROR)        |       (10.2)       ( 1.9)       ( 2.6)       ( 1.8)   |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (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)                                                           
                                                                                                                                   
                     WATER DISINFECTION MODEL (SODIUM BROMATE)                                                                      
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE MICE                                                                                     
                       FIRST TERMINAL SACRIFICE AT 184 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 0 MG/L                                   |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 15     UNCENSORED DEATHS 5      CENSORED DEATHS 0    TERMINAL 10        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      28    49    123   171   177                                               |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 80 MG/L                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 15     UNCENSORED DEATHS 6      CENSORED DEATHS 0    TERMINAL 9         |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      49    51    91    100   140   144                                         |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 400 MG/L                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 15     UNCENSORED DEATHS 5      CENSORED DEATHS 0    TERMINAL 10        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      28    92    153   161   181                                               |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                     WATER DISINFECTION MODEL (SODIUM BROMATE)                                                                      
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE MICE                                                                                     
                       FIRST TERMINAL SACRIFICE AT 184 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 800 MG/L                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 15     UNCENSORED DEATHS 3      CENSORED DEATHS 0    TERMINAL 12        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      9     28    142                                                           |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                     WATER DISINFECTION MODEL (SODIUM BROMATE)                                                                      
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE MICE                                                                                     
                       FIRST TERMINAL SACRIFICE AT 184 DAYS                                                                         
 ==================================================================================                                                 
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |    DOSE                               TIME (DAYS)                              |                                                 
 |                 19    38    57    76    95   114   133   152   171   184 (A)   |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |           |                                                                    |                                                 
 |0 MG/L     |   100.0  93.3  86.7  86.7  86.7  86.7  80.0  80.0  80.0  66.7      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |80 MG/L    |   100.0 100.0  86.7  86.7  80.0  73.3  73.3  60.0  60.0  60.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |400 MG/L   |   100.0  93.3  93.3  93.3  86.7  86.7  86.7  86.7  73.3  66.7      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |800 MG/L   |    93.3  86.7  86.7  86.7  86.7  86.7  86.7  80.0  80.0  80.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                  DOSE                          |                                                 
 |                                                                                |                                                 
 |                                0 MG/L       80 MG/L      400 MG/L     800 MG/L |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       66.7%        60.0%        66.7%        80.0%    |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |       P=0.414N     P=0.905      P=1.000N     P=0.728N |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       109.6         95.8        123.0         59.7    |                                                 
 |NATURAL DEATHS (C)      |       (30.7)       (16.8)       (28.0)       (41.5)   |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       159.2        148.7        163.7        159.1    |                                                 
 |(STANDARD ERROR)        |       (13.3)       (13.2)       (11.6)       (15.0)   |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (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)                                              
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        0 MG/L           = 1                                                        
                                                        80 MG/L          = 2                                                        
                                                        400 MG/L         = 3                                                        
                                                        800 MG/L         = 4                                                        
                                                                                                                                    
------------------------------------------------------ SPECIES=MICE SEX=MALE -------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
              (NOTE: 5 obs hidden.)                                                                                                 
    P        |                                                                                                                      
    E        |                                                                                                                      
    R 100.00 +  1                   1                                                               3   2   4                       
    C        |                                                                                                                      
    E        |                                                                                                                      
    N        |                                                                                                                      
    T  93.33 +                      1                                                               3   2   4       1   2   3       
             |                                                                                                                      
    S        |                                                                                                                      
    U        |                                                                                                                      
    R  86.67 +                                                                                                      1   2   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       
    A                                                                                                                               
                                                                    WEEK                                                            
                                                                                                                                    
                                                                                                                                    
                                                                                                                                   
                                             WATER DISINFECTION MODEL (SODIUM BROMATE)                                              
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        0 MG/L           = 1                                                        
                                                        80 MG/L          = 2                                                        
                                                        400 MG/L         = 3                                                        
                                                        800 MG/L         = 4                                                        
                                                                                                                                    
----------------------------------------------------- SPECIES=MICE SEX=FEMALE ------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
             |                                                                                                                      
             |                                                                                                                      
      100.00 +  1       4       1           2                                                                                       
             |                                                                                                                      
             |                                                                                                                      
             |                                                                                                                      
    P  93.33 +          4       1           1   2                       3                                                           
    E        |                                                                                                                      
    R        |                                                                                                                      
    C        |                                                                                                                      
    E  86.67 +                  4           1   2                   2   3               1           4   3                           
    N        |                                                                                                                      
    T        |                                                                                                                      
             |                                                                                                                      
    S  80.00 +                                                      2       2           1           4   3   3       1       4       
    U        |                                                                                                                      
    R        |                                                                                                                      
    V        |                                                                                                                      
    I  73.33 +                                                              2                   2           3       1   1           
    V        |                                                                                                                      
    A        |                                                                                                                      
    L        |                                                                                                                      
       66.67 +                                                                                  2   2                   1   1       
             |                                                                                                                      
             |                                                                                                                      
             |                                                                                                                      
       60.00 +                                                                                      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  27       
                                                                                                                                    
                                                                    WEEK                                                            
                                                                                                                                    
NOTE: 10 obs hidden.                                                                                                                
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