National Toxicology Program

National Toxicology Program
https://ntp.niehs.nih.gov/go/13626

TDMS Study 97013-99 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Battelle Columbus                       WATER DISINFECTION MODEL (BROMODICHLOROMETHANE)                   DATE: 11/05/03       
EXPERIMENT: 97013 TEST: 99                                                                                     TIME: 10:08:09       
TEST TYPE:  SUBCHRON 26-WEEK                    CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1-ES-65406                              ROUTE: SKIN APPLICATION                                        NTP C#: 97013F       
PATHOLOGIST: MISSING                                                                                           CAS: 75-27-4         
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                            FINAL#1 MICE                                                            
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
                                                                                                                                   
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Battelle Columbus                       WATER DISINFECTION MODEL (BROMODICHLOROMETHANE)                   DATE: 11/05/03       
EXPERIMENT: 97013 TEST: 99                                                                                     TIME: 10:08:09       
TEST TYPE:  SUBCHRON 26-WEEK                    CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1-ES-65406                              ROUTE: SKIN APPLICATION                                        NTP C#: 97013F       
PATHOLOGIST: MISSING                                                                                           CAS: 75-27-4         
                                                                                                                                   
                  WATER DISINFECTION MODEL (BROMODICHLOROMETHANE)                                                                   
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE MICE                                                                                      
                       FIRST TERMINAL SACRIFICE AT 274 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 0 MG/KG                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 10     UNCENSORED DEATHS 4      CENSORED DEATHS 0    TERMINAL 6         |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      153   202   211   233                                                     |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 64 MG/KG                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 10     UNCENSORED DEATHS 2      CENSORED DEATHS 0    TERMINAL 8         |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      91    145                                                                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                          DOSE = 128     MG/KG                                  |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 10     UNCENSORED DEATHS 1      CENSORED DEATHS 0    TERMINAL 9         |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      260                                                                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                  WATER DISINFECTION MODEL (BROMODICHLOROMETHANE)                                                                   
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE MICE                                                                                      
                       FIRST TERMINAL SACRIFICE AT 274 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                          DOSE = 256     MG/KG                                  |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 10     UNCENSORED DEATHS 2      CENSORED DEATHS 0    TERMINAL 8         |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      166   260                                                                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                  WATER DISINFECTION MODEL (BROMODICHLOROMETHANE)                                                                   
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE MICE                                                                                      
                       FIRST TERMINAL SACRIFICE AT 274 DAYS                                                                         
 ==================================================================================                                                 
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |    DOSE                               TIME (DAYS)                              |                                                 
 |                 28    56    84   112   140   168   196   224   252   274 (A)   |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |           |                                                                    |                                                 
 |0 MG/KG    |   100.0 100.0 100.0 100.0 100.0  90.0  90.0  70.0  60.0  60.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |64 MG/KG   |   100.0 100.0 100.0  90.0  90.0  80.0  80.0  80.0  80.0  80.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |128        |   100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0  90.0      |                                                 
 |MG/KG      |                                                                    |                                                 
 |           |                                                                    |                                                 
 |256        |   100.0 100.0 100.0 100.0 100.0 100.0  90.0  90.0  90.0  80.0      |                                                 
 |MG/KG      |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                  DOSE                          |                                                 
 |                                                                                |                                                 
 |                                0 MG/KG      64 MG/KG     128          256      |                                                 
 |                                                          MG/KG        MG/KG    |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       60.0%        80.0%        90.0%        80.0%    |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |       P=0.424N     P=0.730N     P=0.242N     P=0.556N |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       199.8        118.0        260.0        213.0    |                                                 
 |NATURAL DEATHS (C)      |       (16.9)       (27.0)       (  . )       (47.0)   |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       244.3        242.8        272.6        261.8    |                                                 
 |(STANDARD ERROR)        |       (13.6)       (21.2)       ( 1.4)       (10.7)   |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (A)  FIRST TERMINAL SACRIFICE                                                                                                
       (B)  THE FIRST ENTRY IS THE TREND TEST (TARONE, 1975) RESULT.                                                                
            SUBSEQUENT ENTRIES ARE THE RESULTS OF PAIRWISE TESTS                                                                    
            (COX,1972).  NEGATIVE TRENDS ARE INDICATED BY "N".                                                                      
       (C)  MEAN OF ALL UNCENSORED DEATHS PRIOR TO TERMINAL SACRIFICE                                                               
       (D)  MEAN OF ALL DEATHS (UNCENSORED, CENSORED, TERMINAL SACRIFICE)                                                           
                                                                                                                                   
                  WATER DISINFECTION MODEL (BROMODICHLOROMETHANE)                                                                   
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE MICE                                                                                     
                       FIRST TERMINAL SACRIFICE AT 274 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 0 MG/KG                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 10     UNCENSORED DEATHS 5      CENSORED DEATHS 0    TERMINAL 5         |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      51    96    98    117   254                                               |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 64 MG/KG                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 10     UNCENSORED DEATHS 6      CENSORED DEATHS 0    TERMINAL 4         |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      83    94    96    104   190   196                                         |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                          DOSE = 128     MG/KG                                  |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 10     UNCENSORED DEATHS 3      CENSORED DEATHS 0    TERMINAL 7         |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      226   229   233                                                           |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                  WATER DISINFECTION MODEL (BROMODICHLOROMETHANE)                                                                   
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE MICE                                                                                     
                       FIRST TERMINAL SACRIFICE AT 274 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                          DOSE = 256     MG/KG                                  |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 10     UNCENSORED DEATHS 5      CENSORED DEATHS 0    TERMINAL 5         |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      37    99    133   184   217                                               |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                  WATER DISINFECTION MODEL (BROMODICHLOROMETHANE)                                                                   
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE MICE                                                                                     
                       FIRST TERMINAL SACRIFICE AT 274 DAYS                                                                         
 ==================================================================================                                                 
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |    DOSE                               TIME (DAYS)                              |                                                 
 |                 28    56    84   112   140   168   196   224   252   274 (A)   |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |           |                                                                    |                                                 
 |0 MG/KG    |   100.0  90.0  90.0  70.0  60.0  60.0  60.0  60.0  60.0  50.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |64 MG/KG   |   100.0 100.0 100.0  60.0  60.0  60.0  50.0  40.0  40.0  40.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |128        |   100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0  70.0  70.0      |                                                 
 |MG/KG      |                                                                    |                                                 
 |           |                                                                    |                                                 
 |256        |   100.0  90.0  90.0  80.0  70.0  70.0  60.0  50.0  50.0  50.0      |                                                 
 |MG/KG      |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                  DOSE                          |                                                 
 |                                                                                |                                                 
 |                                0 MG/KG      64 MG/KG     128          256      |                                                 
 |                                                          MG/KG        MG/KG    |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       50.0%        40.0%        70.0%        50.0%    |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |       P=0.849N     P=0.879      P=0.472N     P=1.000N |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       123.2        127.2        229.3        134.0    |                                                 
 |NATURAL DEATHS (C)      |       (34.4)       (21.0)       ( 2.0)       (31.6)   |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       198.6        185.9        260.6        204.0    |                                                 
 |(STANDARD ERROR)        |       (29.9)       (26.9)       ( 6.8)       (27.7)   |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (A)  FIRST TERMINAL SACRIFICE                                                                                                
       (B)  THE FIRST ENTRY IS THE TREND TEST (TARONE, 1975) RESULT.                                                                
            SUBSEQUENT ENTRIES ARE THE RESULTS OF PAIRWISE TESTS                                                                    
            (COX,1972).  NEGATIVE TRENDS ARE INDICATED BY "N".                                                                      
       (C)  MEAN OF ALL UNCENSORED DEATHS PRIOR TO TERMINAL SACRIFICE                                                               
       (D)  MEAN OF ALL DEATHS (UNCENSORED, CENSORED, TERMINAL SACRIFICE)                                                           
                                                                                                                                   
                                          WATER DISINFECTION MODEL (BROMODICHLOROMETHANE)                                           
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        0 MG/KG          = 1                                                        
                                                        64 MG/KG         = 2                                                        
                                                        128     MG/KG    = 3                                                        
                                                        256     MG/KG    = 4                                                        
                                                                                                                                    
------------------------------------------------------ SPECIES=MICE SEX=MALE -------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
      |                                                                                                                             
      |                                                                                                                             
P 100 +  1                                      2                          1     4                                         3        
E     |                                                                                                                             
R     |                                                                                                                             
C     |                                                                                                                             
E  90 +                                         2                       2  1     4              1                          3     3  
N     |                                                                                                                             
T     |                                                                                                                             
      |                                                                                                                             
S  80 +                                                                 2                       1     1                    4     2  
U     |                                                                                                                             
R     |                                                                                                                             
V     |                                                                                                                             
I  70 +                                                                                               1        1                    
V     |                                                                                                                             
A     |                                                                                                                             
L     |                                                                                                                             
   60 +                                                                                                        1                 1  
      |                                                                                                                             
      ---+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--+--
         0  1  2  3  4  5  6  7  8  9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40  
                                                                                                                                    
                                                                   WEEK                                                             
                                                                                                                                    
NOTE: 5 obs hidden.                                                                                                                 
                                                                                                                                   
                                          WATER DISINFECTION MODEL (BROMODICHLOROMETHANE)                                           
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        0 MG/KG          = 1                                                        
                                                        64 MG/KG         = 2                                                        
                                                        128     MG/KG    = 3                                                        
                                                        256     MG/KG    = 4                                                        
                                                                                                                                    
----------------------------------------------------- SPECIES=MICE SEX=FEMALE ------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
      |                                                                                                                             
      |                                                                                                                             
  100 +  1                 4     1           2                                                              3                       
      |                                                                                                                             
      |                                                                                                                             
      |                                                                                                                             
P  90 +                    4     1           2     1  4                                                                             
E     |                                                                                                                             
R     |                                                                                                                             
C     |                                                                                                                             
E  80 +                                               4           4                                         3  3                    
N     |                                                                                                                             
T     |                                                                                                                             
      |                                                                                                                             
S  70 +                                            1  2     1     4                       4                    3                 3  
U     |                                                                                                                             
R     |                                                                                                                             
V     |                                                                                                                             
I  60 +                                               2     1                             4  2        4                 1           
V     |                                                                                                                             
A     |                                                                                                                             
L     |                                                                                                                             
   50 +                                                                                               4                 1        1  
      |                                                                                                                             
      |                                                                                                                             
      |                                                                                                                             
   40 +                                                                                      2                                   2  
      |                                                                                                                             
      ---+-----+-----+-----+-----+-----+-----+-----+-----+-----+-----+-----+-----+-----+-----+-----+-----+-----+-----+-----+-----+--
         0     2     4     6     8    10    12    14    16    18    20    22    24    26    28    30    32    34    36    38    40  
                                                                                                                                    
                                                                   WEEK                                                             
                                                                                                                                    
NOTE: 6 obs hidden.                                                                                                                 
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