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TDMS Study 97013-94 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: 94                                                                                     TIME: 14:45:00       
TEST TYPE:  26-39 WEEKS                         CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-65406                              ROUTE: DOSED WATER                                             NTP C#: 97013H       
PATHOLOGIST: MISSING                                                                                           CAS: 7789-38-0       
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                            FINAL#1 MICE                                                            
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               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: 94                                                                                     TIME: 14:45:00       
TEST TYPE:  26-39 WEEKS                         CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-65406                              ROUTE: DOSED WATER                                             NTP C#: 97013H       
PATHOLOGIST: MISSING                                                                                           CAS: 7789-38-0       
                                                                                                                                   
                     WATER DISINFECTION MODEL (SODIUM BROMATE)                                                                      
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE MICE                                                                                      
                       FIRST TERMINAL SACRIFICE AT 295 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 0 MG/L                                   |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 10     UNCENSORED DEATHS 4      CENSORED DEATHS 0    TERMINAL 6         |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      93    185   224   239                                                     |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 80 MG/L                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 10     UNCENSORED DEATHS 3      CENSORED DEATHS 0    TERMINAL 7         |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      89    93    192                                                           |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 400 MG/L                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 10     UNCENSORED DEATHS 4      CENSORED DEATHS 0    TERMINAL 6         |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      144   188   246   277                                                     |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                     WATER DISINFECTION MODEL (SODIUM BROMATE)                                                                      
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE MICE                                                                                      
                       FIRST TERMINAL SACRIFICE AT 295 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 800 MG/L                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 10     UNCENSORED DEATHS 6      CENSORED DEATHS 0    TERMINAL 4         |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      127   218   246   263   277   284                                         |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                     WATER DISINFECTION MODEL (SODIUM BROMATE)                                                                      
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE MICE                                                                                      
                       FIRST TERMINAL SACRIFICE AT 295 DAYS                                                                         
 ==================================================================================                                                 
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |    DOSE                               TIME (DAYS)                              |                                                 
 |                 30    60    90   120   150   180   210   240   270   295 (A)   |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |           |                                                                    |                                                 
 |0 MG/L     |   100.0 100.0 100.0  90.0  90.0  90.0  80.0  70.0  60.0  60.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |80 MG/L    |   100.0 100.0 100.0  80.0  80.0  80.0  70.0  70.0  70.0  70.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |400 MG/L   |   100.0 100.0 100.0 100.0  90.0  90.0  80.0  80.0  70.0  60.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |800 MG/L   |   100.0 100.0 100.0 100.0  90.0  90.0  90.0  80.0  60.0  40.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                  DOSE                          |                                                 
 |                                                                                |                                                 
 |                                0 MG/L       80 MG/L      400 MG/L     800 MG/L |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       60.0%        70.0%        60.0%        40.0%    |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |       P=0.515      P=1.000N     P=1.000N     P=0.826  |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       185.3        124.7        213.8        235.8    |                                                 
 |NATURAL DEATHS (C)      |       (32.8)       (33.7)       (29.7)       (23.8)   |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       251.1        243.9        262.5        259.5    |                                                 
 |(STANDARD ERROR)        |       (21.6)       (27.4)       (17.1)       (16.8)   |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (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 295 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 0 MG/L                                   |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 10     UNCENSORED DEATHS 3      CENSORED DEATHS 0    TERMINAL 7         |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      57    93    246                                                           |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 80 MG/L                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 10     UNCENSORED DEATHS 5      CENSORED DEATHS 0    TERMINAL 5         |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      42    144   255   287   287                                               |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 400 MG/L                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 10     UNCENSORED DEATHS 6      CENSORED DEATHS 0    TERMINAL 4         |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      115   144   173   197   287   287                                         |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                     WATER DISINFECTION MODEL (SODIUM BROMATE)                                                                      
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE MICE                                                                                     
                       FIRST TERMINAL SACRIFICE AT 295 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 800 MG/L                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 10     UNCENSORED DEATHS 8      CENSORED DEATHS 0    TERMINAL 2         |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      8     93    115   188   197   199   273   277                             |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                     WATER DISINFECTION MODEL (SODIUM BROMATE)                                                                      
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE MICE                                                                                     
                       FIRST TERMINAL SACRIFICE AT 295 DAYS                                                                         
 ==================================================================================                                                 
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |    DOSE                               TIME (DAYS)                              |                                                 
 |                 30    60    90   120   150   180   210   240   270   295 (A)   |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |           |                                                                    |                                                 
 |0 MG/L     |   100.0  90.0  90.0  80.0  80.0  80.0  80.0  80.0  70.0  70.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |80 MG/L    |   100.0  90.0  90.0  90.0  80.0  80.0  80.0  80.0  70.0  50.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |400 MG/L   |   100.0 100.0 100.0  90.0  80.0  70.0  60.0  60.0  60.0  40.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |800 MG/L   |    90.0  90.0  90.0  70.0  70.0  70.0  40.0  40.0  40.0  20.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                  DOSE                          |                                                 
 |                                                                                |                                                 
 |                                0 MG/L       80 MG/L      400 MG/L     800 MG/L |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       70.0%        50.0%        40.0%        20.0%    |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |       P=0.030      P=0.740      P=0.470      P=0.089  |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       132.0        203.0        200.5        168.8    |                                                 
 |NATURAL DEATHS (C)      |       (57.9)       (48.1)       (29.6)       (32.5)   |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       246.1        249.0        238.3        194.0    |                                                 
 |(STANDARD ERROR)        |       (29.0)       (27.4)       (23.0)       (30.7)   |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (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.                                           
                                                                                                                                    
       |                                                                                                                            
       |                                                                                                                            
   100 +  1                                 2 1            4     3                                                                  
       |                                                                                                                            
       |                                                                                                                            
       |                                                                                                                            
 P  90 +                                    2 1            4     3              1            4                                      
 E     |                                                                                                                            
 R     |                                                                                                                            
 C     |                                                                                                                            
 E  80 +                                      2                                 1  2         1          3                           
 N     |                                                                                                                            
 T     |                                                                                                                            
       |                                                                                                                            
 S  70 +                                                                           2         1       1  3    4    3       2         
 U     |                                                                                                                            
 R     |                                                                                                                            
 V     |                                                                                                                            
 I  60 +                                                                                             1       4    3       1         
 V     |                                                                                                                            
 A     |                                                                                                                            
 L     |                                                                                                                            
    50 +                                                                                                          4  4              
       |                                                                                                                            
       |                                                                                                                            
       |                                                                                                                            
    40 +                                                                                                             4    4         
       |                                                                                                                            
       ---+------------+------------+------------+------------+------------+------------+------------+------------+------------+--  
          0            5           10           15           20           25           30           35           40           45    
                                                                                                                                    
                                                                   WEEK                                                             
                                                                                                                                    
NOTE: 11 obs hidden.                                                                                                                
                                                                                                                                   
                                             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 +  1    4          2      1                    3                                                                             
       |                                                                                                                            
       |                                                                                                                            
       |                                                                                                                            
    90 +       4          2      1            1       3          2                                                                  
       |                                                                                                                            
       |                                                                                                                            
       |                                                                                                                            
 P  80 +                                      1       4          2         3                            1 2                         
 E     |                                                                                                                            
 R     |                                                                                                                            
 C     |                                                                                                                            
 E  70 +                                              4                    3    4    3                  1 2          2    1         
 N     |                                                                                                                            
 T     |                                                                                                                            
       |                                                                                                                            
 S  60 +                                                                        4    3                               3              
 U     |                                                                                                                            
 R     |                                                                                                                            
 V     |                                                                                                                            
 I  50 +                                                                                                             2    2         
 V     |                                                                                                                            
 A     |                                                                                                                            
 L     |                                                                                                                            
    40 +                                                                             4                         4     3    3         
       |                                                                                                                            
       |                                                                                                                            
       |                                                                                                                            
    30 +                                                                                                       4  4                 
       |                                                                                                                            
       |                                                                                                                            
       |                                                                                                                            
    20 +                                                                                                          4       4         
       |                                                                                                                            
       ---+------------+------------+------------+------------+------------+------------+------------+------------+------------+--  
          0            5           10           15           20           25           30           35           40           45    
                                                                                                                                    
                                                                   WEEK                                                             
                                                                                                                                    
NOTE: 8 obs hidden.