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TDMS Study 97013-05 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Battelle Columbus                       WATER DISINFECTION MODEL (BROMODICHLOROMETHANE)                   DATE: 06/11/04       
EXPERIMENT: 97013 TEST: 05                                                                                     TIME: 10:45:28       
TEST TYPE:  SUBCHRON 26-WEEK                    CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1-ES-65406                              ROUTE: DOSED WATER                                             NTP C#: 97013E       
PATHOLOGIST: MISSING                                                                                           CAS: 75-27-4         
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                            FINAL#1 MICE                                                            
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE 001    0 MG/L                                                                        
                                       INCLUDE 002    0 MG/L                                                                        
                                       INCLUDE 003    175 MG/L                                                                      
                                       INCLUDE 004    175 MG/L                                                                      
                                       INCLUDE 005    350 MG/L                                                                      
                                       INCLUDE 006    350 MG/L                                                                      
                                       INCLUDE 007    700 MG/L                                                                      
                                       INCLUDE 008    700 MG/L                                                                      
                                                                                                                                   
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Battelle Columbus                       WATER DISINFECTION MODEL (BROMODICHLOROMETHANE)                   DATE: 06/11/04       
EXPERIMENT: 97013 TEST: 05                                                                                     TIME: 10:45:28       
TEST TYPE:  SUBCHRON 26-WEEK                    CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1-ES-65406                              ROUTE: DOSED WATER                                             NTP C#: 97013E       
PATHOLOGIST: MISSING                                                                                           CAS: 75-27-4         
                                                                                                                                   
                  WATER DISINFECTION MODEL (BROMODICHLOROMETHANE)                                                                   
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE MICE                                                                                      
                       FIRST TERMINAL SACRIFICE AT 183 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 0 MG/L                                   |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 15     UNCENSORED DEATHS 2      CENSORED DEATHS 0    TERMINAL 13        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      129   158                                                                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 175 MG/L                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 15     UNCENSORED DEATHS 3      CENSORED DEATHS 0    TERMINAL 12        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      72    103   136                                                           |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 350 MG/L                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 15     UNCENSORED DEATHS 3      CENSORED DEATHS 0    TERMINAL 12        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      136   164   164                                                           |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                  WATER DISINFECTION MODEL (BROMODICHLOROMETHANE)                                                                   
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE MICE                                                                                      
                       FIRST TERMINAL SACRIFICE AT 183 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 700 MG/L                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 15     UNCENSORED DEATHS 1      CENSORED DEATHS 0    TERMINAL 14        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      154                                                                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                  WATER DISINFECTION MODEL (BROMODICHLOROMETHANE)                                                                   
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE MICE                                                                                      
                       FIRST TERMINAL SACRIFICE AT 183 DAYS                                                                         
 ==================================================================================                                                 
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |    DOSE                               TIME (DAYS)                              |                                                 
 |                 19    38    57    76    95   114   133   152   171   183 (A)   |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |           |                                                                    |                                                 
 |0 MG/L     |   100.0 100.0 100.0 100.0 100.0 100.0 100.0  93.3  86.7  86.7      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |175 MG/L   |   100.0 100.0 100.0  93.3  93.3  86.7  86.7  80.0  80.0  80.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |350 MG/L   |   100.0 100.0 100.0 100.0 100.0 100.0 100.0  93.3  80.0  80.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |700 MG/L   |   100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0  93.3  93.3      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                  DOSE                          |                                                 
 |                                                                                |                                                 
 |                                0 MG/L       175 MG/L     350 MG/L     700 MG/L |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       86.7%        80.0%        80.0%        93.3%    |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |       P=0.635N     P=0.922      P=1.000      P=0.984N |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       143.5        103.7        154.7        154.0    |                                                 
 |NATURAL DEATHS (C)      |       (14.5)       (18.5)       ( 9.3)       (  . )   |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       177.7        167.1        177.3        181.1    |                                                 
 |(STANDARD ERROR)        |       ( 3.9)       ( 9.0)       ( 3.4)       ( 1.9)   |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (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 (BROMODICHLOROMETHANE)                                                                   
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE MICE                                                                                     
                       FIRST TERMINAL SACRIFICE AT 184 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 0 MG/L                                   |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 15     UNCENSORED DEATHS 5      CENSORED DEATHS 0    TERMINAL 10        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      53    64    109   110   144                                               |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 175 MG/L                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 15     UNCENSORED DEATHS 2      CENSORED DEATHS 0    TERMINAL 13        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      78    78                                                                  |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 350 MG/L                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 15     UNCENSORED DEATHS 4      CENSORED DEATHS 0    TERMINAL 11        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      34    126   164   164                                                     |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                  WATER DISINFECTION MODEL (BROMODICHLOROMETHANE)                                                                   
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE MICE                                                                                     
                       FIRST TERMINAL SACRIFICE AT 184 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 700 MG/L                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 15     UNCENSORED DEATHS 2      CENSORED DEATHS 0    TERMINAL 13        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      162   164                                                                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                  WATER DISINFECTION MODEL (BROMODICHLOROMETHANE)                                                                   
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE MICE                                                                                     
                       FIRST TERMINAL SACRIFICE AT 184 DAYS                                                                         
 ==================================================================================                                                 
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |    DOSE                               TIME (DAYS)                              |                                                 
 |                 19    38    57    76    95   114   133   152   171   184 (A)   |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |           |                                                                    |                                                 
 |0 MG/L     |   100.0 100.0  93.3  86.7  86.7  73.3  73.3  66.7  66.7  66.7      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |175 MG/L   |   100.0 100.0 100.0 100.0  86.7  86.7  86.7  86.7  86.7  86.7      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |350 MG/L   |   100.0  93.3  93.3  93.3  93.3  93.3  86.7  86.7  73.3  73.3      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |700 MG/L   |   100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0  86.7  86.7      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                  DOSE                          |                                                 
 |                                                                                |                                                 
 |                                0 MG/L       175 MG/L     350 MG/L     700 MG/L |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       66.7%        86.7%        73.3%        86.7%    |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |       P=0.343N     P=0.381N     P=0.855N     P=0.297N |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |        96.0         78.0        122.0        163.0    |                                                 
 |NATURAL DEATHS (C)      |       (16.6)       ( 0.0)       (30.7)       ( 1.0)   |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       154.7        169.9        167.5        181.2    |                                                 
 |(STANDARD ERROR)        |       (12.2)       ( 9.6)       (10.4)       ( 1.9)   |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (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 (BROMODICHLOROMETHANE)                                           
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        0 MG/L           = 1                                                        
                                                        175 MG/L         = 2                                                        
                                                        350 MG/L         = 3                                                        
                                                        700 MG/L         = 4                                                        
                                                                                                                                    
------------------------------------------------------ SPECIES=MICE SEX=MALE -------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
    P        |                                                                                                                      
    E        |                                                                                                                      
    R 100.00 +  1                                           2                               1   3       4                           
    C        |                                                                                                                      
    E        |                                                                                                                      
    N        |                                                                                                                      
    T  93.33 +                                              2               2               1   3       4   1   3           4       
             |                                                                                                                      
    S        |                                                                                                                      
    U        |                                                                                                                      
    R  86.67 +                                                              2                   2           1               1       
    V        |                                                                                                                      
    I        |                                                                                                                      
    V        |                                                                                                                      
    A  80.00 +                                                                                  2               3           2       
    L        |                                                                                                                      
             ---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+--     
                0   1   2   3   4   5   6   7   8   9  10  11  12  13  14  15  16  17  18  19  20  21  22  23  24  25  26  27       
                                                                                                                                    
                                                                    WEEK                                                            
                                                                                                                                    
NOTE: 4 obs hidden.                                                                                                                 
                                                                                                                                   
                                          WATER DISINFECTION MODEL (BROMODICHLOROMETHANE)                                           
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        0 MG/L           = 1                                                        
                                                        175 MG/L         = 2                                                        
                                                        350 MG/L         = 3                                                        
                                                        700 MG/L         = 4                                                        
                                                                                                                                    
----------------------------------------------------- SPECIES=MICE SEX=FEMALE ------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
         |                                                                                                                          
         |                                                                                                                          
  100.00 +1                     3            1                 2                                                    4               
         |                                                                                                                          
P        |                                                                                                                          
E        |                                                                                                                          
R  93.33 +                      3            1        1                                  3                                          
C        |                                                                                                                          
E        |                                                                                                                          
N        |                                                                                                                          
T  86.67 +                                            1        2                1        3                          3            2  
         |                                                                                                                          
S        |                                                                                                                          
U        |                                                                                                                          
R  80.00 +                                                                                                                          
V        |                                                                                                                          
I        |                                                                                                                          
V        |                                                                                                                          
A  73.33 +                                                                      1                     1             3            3  
L        |                                                                                                                          
         |                                                                                                                          
         |                                                                                                                          
   66.67 +                                                                                            1                          1  
         |                                                                                                                          
         -+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+
         0.0        2.5        5.0        7.5       10.0       12.5       15.0       17.5       20.0       22.5       25.0      27.5
                                                                                                                                    
                                                                     WEEK                                                           
                                                                                                                                    
NOTE: 5 obs hidden.