National Toxicology Program

National Toxicology Program
https://ntp.niehs.nih.gov/go/11595

TDMS Study 97013-92 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Battelle Columbus                          WATER DISINFECTION MODEL (SODIUM BROMATE)                      DATE: 12/08/03       
EXPERIMENT: 97013 TEST: 92                                                                                     TIME: 14:32:29       
TEST TYPE:  26-39 WEEKS                         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:    25019 Moribund Sacrifice                                                                     
                                       25020 Natural Death                                                                          
                                       25021 Terminal Sacrifice                                                                     
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
                                                                                                                                   
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Battelle Columbus                          WATER DISINFECTION MODEL (SODIUM BROMATE)                      DATE: 12/08/03       
EXPERIMENT: 97013 TEST: 92                                                                                     TIME: 14:32:29       
TEST TYPE:  26-39 WEEKS                         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 272 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 0 MG/KG                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 10     UNCENSORED DEATHS 2      CENSORED DEATHS 0    TERMINAL 8         |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      134   218                                                                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 64 MG/KG                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 10     UNCENSORED DEATHS 2      CENSORED DEATHS 0    TERMINAL 8         |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      140   251                                                                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                          DOSE = 128     MG/KG                                  |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 10     UNCENSORED DEATHS 2      CENSORED DEATHS 0    TERMINAL 8         |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      221   251                                                                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                     WATER DISINFECTION MODEL (SODIUM BROMATE)                                                                      
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE MICE                                                                                      
                       FIRST TERMINAL SACRIFICE AT 272 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                          DOSE = 256     MG/KG                                  |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 10     UNCENSORED DEATHS 2      CENSORED DEATHS 0    TERMINAL 8         |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      69    221                                                                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                     WATER DISINFECTION MODEL (SODIUM BROMATE)                                                                      
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE MICE                                                                                      
                       FIRST TERMINAL SACRIFICE AT 272 DAYS                                                                         
 ==================================================================================                                                 
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |    DOSE                               TIME (DAYS)                              |                                                 
 |                 28    56    84   112   140   168   196   224   252   272 (A)   |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |           |                                                                    |                                                 
 |0 MG/KG    |   100.0 100.0 100.0 100.0  90.0  90.0  90.0  90.0  80.0  80.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |64 MG/KG   |   100.0 100.0 100.0 100.0 100.0  90.0  90.0  90.0  90.0  80.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |128        |   100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0  90.0  80.0      |                                                 
 |MG/KG      |                                                                    |                                                 
 |           |                                                                    |                                                 
 |256        |   100.0 100.0  90.0  90.0  90.0  90.0  90.0  90.0  80.0  80.0      |                                                 
 |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%        80.0%        80.0%        80.0%    |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |       P=1.000N     P=1.000N     P=1.000N     P=1.000N |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       176.0        195.5        236.0        145.0    |                                                 
 |NATURAL DEATHS (C)      |       (42.0)       (55.5)       (15.0)       (76.0)   |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       252.8        256.7        264.8        246.6    |                                                 
 |(STANDARD ERROR)        |       (14.2)       (13.1)       ( 5.3)       (20.4)   |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (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 272 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 0 MG/KG                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 9      UNCENSORED DEATHS 2      CENSORED DEATHS 0    TERMINAL 7         |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      217   251                                                                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 64 MG/KG                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 10     UNCENSORED DEATHS 3      CENSORED DEATHS 0    TERMINAL 7         |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      62    144   148                                                           |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                          DOSE = 128     MG/KG                                  |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 10     UNCENSORED DEATHS 2      CENSORED DEATHS 0    TERMINAL 8         |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      127   221                                                                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                     WATER DISINFECTION MODEL (SODIUM BROMATE)                                                                      
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE MICE                                                                                     
                       FIRST TERMINAL SACRIFICE AT 272 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                          DOSE = 256     MG/KG                                  |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 10     UNCENSORED DEATHS 2      CENSORED DEATHS 0    TERMINAL 8         |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      218   257                                                                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                     WATER DISINFECTION MODEL (SODIUM BROMATE)                                                                      
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE MICE                                                                                     
                       FIRST TERMINAL SACRIFICE AT 272 DAYS                                                                         
 ==================================================================================                                                 
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |    DOSE                               TIME (DAYS)                              |                                                 
 |                 28    56    84   112   140   168   196   224   252   272 (A)   |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |           |                                                                    |                                                 
 |0 MG/KG    |   100.0 100.0 100.0 100.0 100.0 100.0 100.0  88.9  88.9  77.8      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |64 MG/KG   |   100.0 100.0  90.0  90.0  90.0  70.0  70.0  70.0  70.0  70.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |128        |   100.0 100.0 100.0 100.0  90.0  90.0  90.0  90.0  80.0  80.0      |                                                 
 |MG/KG      |                                                                    |                                                 
 |           |                                                                    |                                                 
 |256        |   100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0  90.0  80.0      |                                                 
 |MG/KG      |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                  DOSE                          |                                                 
 |                                                                                |                                                 
 |                                0 MG/KG      64 MG/KG     128          256      |                                                 
 |                                                          MG/KG        MG/KG    |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       77.8%        70.0%        80.0%        80.0%    |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |       P=0.891N     P=0.929      P=1.000N     P=1.000N |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       234.0        118.0        174.0        237.5    |                                                 
 |NATURAL DEATHS (C)      |       (17.0)       (28.0)       (47.0)       (19.5)   |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       263.6        225.8        252.4        265.1    |                                                 
 |(STANDARD ERROR)        |       ( 6.3)       (24.6)       (14.8)       ( 5.4)   |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (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.                                           
               (NOTE: 13 obs hidden.)                                                                                               
        P     |                                                                                                                     
        E     |                                                                                                                     
        R 100 +  1                         4                         1                              3                               
        C     |                                                                                                                     
        E     |                                                                                                                     
        N     |                                                                                                                     
        T  90 +                            4                         1                              1          2                    
              |                                                                                                                     
        S     |                                                                                                                     
        U     |                                                                                                                     
        R  80 +                                                                                     1          2      1             
        V     |                                                                                                                     
        I     ---+------------+------------+------------+------------+------------+------------+------------+------------+--        
        V        0            5           10           15           20           25           30           35           40          
        A                                                                                                                           
                                                                   WEEK                                                             
                                                                                                                                    
                                                                                                                                    
                                                                                                                                   
                                             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 +  1                          2                             3                                   1  4                         
       |                                                                                                                            
       |                                                                                                                            
       |                                                                                                                            
 P  95 +                                                                                                                            
 E     |                                                                                                                            
 R     |                                                                                                                            
 C     |                                                                                                                            
 E  90 +                             2                             3     2                                3              4          
 N     |                                                                                               1              1             
 T     |                                                                                                                            
       |                                                                                                                            
 S  85 +                                                                                                                            
 U     |                                                                                                                            
 R     |                                                                                                                            
 V     |                                                                                                                            
 I  80 +                                                                 2  2                             3              4     3    
 V     |                                                                                                                            
 A     |                                                                                                              1        1    
 L     |                                                                                                                            
    75 +                                                                                                                            
       |                                                                                                                            
       |                                                                                                                            
       |                                                                                                                            
    70 +                                                                    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 28 29 30 31 32 33 34 35 36 37 38 39    
                                                                                                                                    
                                                                   WEEK                                                             
                                                                                                                                    
NOTE: 5 obs hidden.                                                                                                                 
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