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TDMS Study 97013-08 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Battelle Columbus                       WATER DISINFECTION MODEL (BROMODICHLOROMETHANE)                   DATE: 06/11/04       
EXPERIMENT: 97013 TEST: 08                                                                                     TIME: 10:50:24       
TEST TYPE:  SUBCHRON 26-WEEK                    CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-65406                              ROUTE: GAVAGE                                                  NTP C#: 97013G       
PATHOLOGIST: MISSING                                                                                           CAS: 75-27-4         
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                            FINAL#1 MICE                                                            
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE 001    0 MG/KG                                                                       
                                       INCLUDE 002    0 MG/KG                                                                       
                                       INCLUDE 003    25 MG/KG                                                                      
                                       INCLUDE 004    25 MG/KG                                                                      
                                       INCLUDE 005    50 MG/KG                                                                      
                                       INCLUDE 006    50 MG/KG                                                                      
                                       INCLUDE 007    100     MG/KG                                                                 
                                       INCLUDE 008    100     MG/KG                                                                 
                                                                                                                                   
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Battelle Columbus                       WATER DISINFECTION MODEL (BROMODICHLOROMETHANE)                   DATE: 06/11/04       
EXPERIMENT: 97013 TEST: 08                                                                                     TIME: 10:50:24       
TEST TYPE:  SUBCHRON 26-WEEK                    CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-65406                              ROUTE: GAVAGE                                                  NTP C#: 97013G       
PATHOLOGIST: MISSING                                                                                           CAS: 75-27-4         
                                                                                                                                   
                  WATER DISINFECTION MODEL (BROMODICHLOROMETHANE)                                                                   
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE MICE                                                                                      
                       FIRST TERMINAL SACRIFICE AT 182 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 0 MG/KG                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 15     UNCENSORED DEATHS 1      CENSORED DEATHS 1    TERMINAL 13        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      98                                                                        |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      41                                                                        |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 25 MG/KG                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 15     UNCENSORED DEATHS 1      CENSORED DEATHS 0    TERMINAL 14        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      143                                                                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 50 MG/KG                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 15     UNCENSORED DEATHS 3      CENSORED DEATHS 0    TERMINAL 12        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      113   113   142                                                           |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                  WATER DISINFECTION MODEL (BROMODICHLOROMETHANE)                                                                   
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE MICE                                                                                      
                       FIRST TERMINAL SACRIFICE AT 182 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                          DOSE = 100     MG/KG                                  |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 15     UNCENSORED DEATHS 0      CENSORED DEATHS 0    TERMINAL 15        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |     NONE                                                                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                  WATER DISINFECTION MODEL (BROMODICHLOROMETHANE)                                                                   
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE MICE                                                                                      
                       FIRST TERMINAL SACRIFICE AT 182 DAYS                                                                         
 ==================================================================================                                                 
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |    DOSE                               TIME (DAYS)                              |                                                 
 |                 19    38    57    76    95   114   133   152   171   182 (A)   |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |           |                                                                    |                                                 
 |0 MG/KG    |   100.0 100.0 100.0 100.0 100.0  92.9  92.9  92.9  92.9  92.9      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |25 MG/KG   |   100.0 100.0 100.0 100.0 100.0 100.0 100.0  93.3  93.3  93.3      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |50 MG/KG   |   100.0 100.0 100.0 100.0 100.0 100.0  86.7  80.0  80.0  80.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |100        |   100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0      |                                                 
 |MG/KG      |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                  DOSE                          |                                                 
 |                                                                                |                                                 
 |                                0 MG/KG      25 MG/KG     50 MG/KG     100      |                                                 
 |                                                                       MG/KG    |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       92.9%        93.3%        80.0%       100.0%    |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |       P=0.761N     P=1.000N     P=0.678      P=0.972N |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |        98.0        143.0        122.7           .     |                                                 
 |NATURAL DEATHS (C)      |       (  . )       (  . )       ( 9.7)       (  . )   |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       167.0        179.4        170.1        182.0    |                                                 
 |(STANDARD ERROR)        |       (10.6)       ( 2.6)       ( 6.6)       ( 0.0)   |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (A)  FIRST TERMINAL SACRIFICE                                                                                                
       (B)  THE FIRST ENTRY IS THE TREND TEST (TARONE, 1975) RESULT.                                                                
            SUBSEQUENT ENTRIES ARE THE RESULTS OF PAIRWISE TESTS                                                                    
            (COX,1972).  NEGATIVE TRENDS ARE INDICATED BY "N".                                                                      
       (C)  MEAN OF ALL UNCENSORED DEATHS PRIOR TO TERMINAL SACRIFICE                                                               
       (D)  MEAN OF ALL DEATHS (UNCENSORED, CENSORED, TERMINAL SACRIFICE)                                                           
                                                                                                                                   
                  WATER DISINFECTION MODEL (BROMODICHLOROMETHANE)                                                                   
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE MICE                                                                                     
                       FIRST TERMINAL SACRIFICE AT 183 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 0 MG/KG                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 15     UNCENSORED DEATHS 3      CENSORED DEATHS 1    TERMINAL 11        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      160   161   168                                                           |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      41                                                                        |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 25 MG/KG                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 15     UNCENSORED DEATHS 1      CENSORED DEATHS 0    TERMINAL 14        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      143                                                                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 50 MG/KG                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 15     UNCENSORED DEATHS 2      CENSORED DEATHS 0    TERMINAL 13        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      104   126                                                                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                  WATER DISINFECTION MODEL (BROMODICHLOROMETHANE)                                                                   
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE MICE                                                                                     
                       FIRST TERMINAL SACRIFICE AT 183 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                          DOSE = 100     MG/KG                                  |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 15     UNCENSORED DEATHS 1      CENSORED DEATHS 1    TERMINAL 13        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      127                                                                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      41                                                                        |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                  WATER DISINFECTION MODEL (BROMODICHLOROMETHANE)                                                                   
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE 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/KG    |   100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0  85.7  78.6      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |25 MG/KG   |   100.0 100.0 100.0 100.0 100.0 100.0 100.0  93.3  93.3  93.3      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |50 MG/KG   |   100.0 100.0 100.0 100.0 100.0  93.3  86.7  86.7  86.7  86.7      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |100        |   100.0 100.0 100.0 100.0 100.0 100.0  92.9  92.9  92.9  92.9      |                                                 
 |MG/KG      |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                  DOSE                          |                                                 
 |                                                                                |                                                 
 |                                0 MG/KG      25 MG/KG     50 MG/KG     100      |                                                 
 |                                                                       MG/KG    |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       78.6%        93.3%        86.7%        92.9%    |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |       P=0.587N     P=0.565N     P=0.987N     P=0.616N |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       163.0        143.0        115.0        127.0    |                                                 
 |NATURAL DEATHS (C)      |       ( 2.5)       (  . )       (11.0)       (  . )   |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       169.5        180.3        173.9        169.8    |                                                 
 |(STANDARD ERROR)        |       ( 9.4)       ( 2.7)       ( 6.3)       ( 9.9)   |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (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/KG          = 1                                                        
                                                        25 MG/KG         = 2                                                        
                                                        50 MG/KG         = 3                                                        
                                                        100     MG/KG    = 4                                                        
                                                                                                                                    
------------------------------------------------------ SPECIES=MICE SEX=MALE -------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
      |                                                                                                                             
  100 + 1                                                             1            3                2                     4         
      |                                                                                                                             
      |                                                                                                                             
      |                                                                                                                             
   98 +                                                                                                                             
      |                                                                                                                             
      |                                                                                                                             
      |                                                                                                                             
   96 +                                                                                                                             
      |                                                                                                                             
      |                                                                                                                             
      |                                                                                                                             
P  94 +                                                                                                                             
E     |                                                                                             2                     2         
R     |                                                               1                                                   1         
C     |                                                                                                                             
E  92 +                                                                                                                             
N     |                                                                                                                             
T     |                                                                                                                             
      |                                                                                                                             
S  90 +                                                                                                                             
U     |                                                                                                                             
R     |                                                                                                                             
V     |                                                                                                                             
I  88 +                                                                                                                             
V     |                                                                                                                             
A     |                                                                                                                             
L     |                                                                            3                3                               
   86 +                                                                                                                             
      |                                                                                                                             
      |                                                                                                                             
      |                                                                                                                             
   84 +                                                                                                                             
      |                                                                                                                             
      |                                                                                                                             
      |                                                                                                                             
   82 +                                                                                                                             
      |                                                                                                                             
      |                                                                                                                             
      |                                                                                                                             
   80 +                                                                                             3                     3         
      |                                                                                                                             
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
       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: 3 obs hidden.                                                                                                                 
                                                                                                                                   
                                          WATER DISINFECTION MODEL (BROMODICHLOROMETHANE)                                           
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        0 MG/KG          = 1                                                        
                                                        25 MG/KG         = 2                                                        
                                                        50 MG/KG         = 3                                                        
                                                        100     MG/KG    = 4                                                        
                                                                                                                                    
----------------------------------------------------- SPECIES=MICE SEX=FEMALE ------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
             |                                                                                                                      
             |                                                                                                                      
       100.0 +  1                                                           3               4       2       1                       
             |                                                                                                                      
             |                                                                                                                      
             |                                                                                                                      
        97.5 +                                                                                                                      
             |                                                                                                                      
             |                                                                                                                      
             |                                                                                                                      
        95.0 +                                                                                                                      
             |                                                                                                                      
     P       |                                                                                                                      
     E       |                                                              3           3   4       2                       2       
     R  92.5 +                                                                                                                      
     C       |                                                                                                                      
     E       |                                                                                                                      
     N       |                                                                                                                      
     T  90.0 +                                                                                                                      
             |                                                                                                                      
     S       |                                                                                                                      
     U       |                                                                                                                      
     R  87.5 +                                                                                                                      
     V       |                                                                          3                                   3       
     I       |                                                                                                                      
     V       |                                                                                              1   1                   
     A  85.0 +                                                                                                                      
     L       |                                                                                                                      
             |                                                                                                                      
             |                                                                                                                      
        82.5 +                                                                                                                      
             |                                                                                                                      
             |                                                                                                                      
             |                                                                                                                      
        80.0 +                                                                                                                      
             |                                                                                                                      
             |                                                                                                  1           1       
             |                                                                                                                      
        77.5 +                                                                                                                      
             |                                                                                                                      
             ---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+--     
                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.