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TDMS Study 99034-01 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Battelle Columbus                          TRANSGENIC MODEL EVALUATION II (BENZENE)                       DATE: 11/05/03       
EXPERIMENT: 99034 TEST: 01                                                                                     TIME: 14:56:12       
TEST TYPE:  SUBCHRON 26-WEEK                    CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-65406                              ROUTE: GAVAGE                                                  NTP C#: C99034       
PATHOLOGIST: MISSING                                                                                           CAS: 71-43-2         
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                           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                          TRANSGENIC MODEL EVALUATION II (BENZENE)                       DATE: 11/05/03       
EXPERIMENT: 99034 TEST: 01                                                                                     TIME: 14:56:12       
TEST TYPE:  SUBCHRON 26-WEEK                    CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-65406                              ROUTE: GAVAGE                                                  NTP C#: C99034       
PATHOLOGIST: MISSING                                                                                           CAS: 71-43-2         
                                                                                                                                   
                     TRANSGENIC MODEL EVALUATION II (BENZENE)                                                                       
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE MICE                                                                                      
                       FIRST TERMINAL SACRIFICE AT 188 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 0 MG/KG                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 15     UNCENSORED DEATHS 0      CENSORED DEATHS 0    TERMINAL 15        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |     NONE                                                                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 25 MG/KG                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 15     UNCENSORED DEATHS 0      CENSORED DEATHS 0    TERMINAL 15        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |     NONE                                                                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 50 MG/KG                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 15     UNCENSORED DEATHS 0      CENSORED DEATHS 0    TERMINAL 15        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |     NONE                                                                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                     TRANSGENIC MODEL EVALUATION II (BENZENE)                                                                       
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE MICE                                                                                      
                       FIRST TERMINAL SACRIFICE AT 188 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                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                          DOSE = 200     MG/KG                                  |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 15     UNCENSORED DEATHS 1      CENSORED DEATHS 0    TERMINAL 14        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      11                                                                        |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                     TRANSGENIC MODEL EVALUATION II (BENZENE)                                                                       
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE MICE                                                                                      
                       FIRST TERMINAL SACRIFICE AT 188 DAYS                                                                         
 ==================================================================================                                                 
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |    DOSE                               TIME (DAYS)                              |                                                 
 |                 19    38    57    76    95   114   133   152   171   188 (A)   |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |           |                                                                    |                                                 
 |0 MG/KG    |   100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |25 MG/KG   |   100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |50 MG/KG   |   100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |100        |   100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0      |                                                 
 |MG/KG      |                                                                    |                                                 
 |           |                                                                    |                                                 
 |200        |    93.3  93.3  93.3  93.3  93.3  93.3  93.3  93.3  93.3  93.3      |                                                 
 |MG/KG      |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                     TRANSGENIC MODEL EVALUATION II (BENZENE)                                                                       
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE MICE                                                                                      
                       FIRST TERMINAL SACRIFICE AT 188 DAYS                                                                         
 ===============================================================================================================================    
 |                                               SURVIVAL SUMMARY STATISTICS                                                   |    
 |                                                                                                                             |    
 |                                                                                                                             |    
 |-----------------------------------------------------------------------------------------------------------------------------|    
 |                                                                           DOSE                                              |    
 |                                                                                                                             |    
 |                                0 MG/KG            25 MG/KG           50 MG/KG           100                200              |    
 |                                                                                         MG/KG              MG/KG            |    
 |-----------------------------------------------------------------------------------------------------------------------------|    
 |SURVIVAL AT END OF STUDY|      100.0%             100.0%             100.0%             100.0%              93.3%            |    
 |(KAPLAN-MEIER)          |                                                                                                    |    
 |                        |                                                                                                    |    
 |SIGNIFICANCE (B)        |       P=0.289             -----              -----              -----             P=1.000          |    
 |(LIFE TABLE)            |                                                                                                    |    
 |                        |                                                                                                    |    
 |MEAN DAY OF             |          .                  .                  .                  .                11.0            |    
 |NATURAL DEATHS (C)      |       (  . )             (  . )             (  . )             (  . )             (  . )           |    
 |(STANDARD ERROR)        |                                                                                                    |    
 |                        |                                                                                                    |    
 |MEAN LIFE SPAN (D)      |       188.0              188.0              188.0              188.0              176.2            |    
 |(STANDARD ERROR)        |       ( 0.0)             ( 0.0)             ( 0.0)             ( 0.0)             (11.8)           |    
 |                        |                                                                                                    |    
 ===============================================================================================================================    
                                                                                                                                    
       (A)  FIRST TERMINAL SACRIFICE                                                                                                
       (B)  THE FIRST ENTRY IS THE TREND TEST (TARONE, 1975) RESULT.                                                                
            SUBSEQUENT ENTRIES ARE THE RESULTS OF PAIRWISE TESTS                                                                    
            (COX,1972).  NEGATIVE TRENDS ARE INDICATED BY "N".                                                                      
       (C)  MEAN OF ALL UNCENSORED DEATHS PRIOR TO TERMINAL SACRIFICE                                                               
       (D)  MEAN OF ALL DEATHS (UNCENSORED, CENSORED, TERMINAL SACRIFICE)                                                           
                                                                                                                                   
                     TRANSGENIC MODEL EVALUATION II (BENZENE)                                                                       
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE MICE                                                                                     
                       FIRST TERMINAL SACRIFICE AT 189 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 0 MG/KG                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 15     UNCENSORED DEATHS 0      CENSORED DEATHS 0    TERMINAL 15        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |     NONE                                                                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 25 MG/KG                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 15     UNCENSORED DEATHS 0      CENSORED DEATHS 0    TERMINAL 15        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |     NONE                                                                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 50 MG/KG                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 15     UNCENSORED DEATHS 0      CENSORED DEATHS 0    TERMINAL 15        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |     NONE                                                                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                     TRANSGENIC MODEL EVALUATION II (BENZENE)                                                                       
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE MICE                                                                                     
                       FIRST TERMINAL SACRIFICE AT 189 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                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                          DOSE = 200     MG/KG                                  |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 15     UNCENSORED DEATHS 0      CENSORED DEATHS 0    TERMINAL 15        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |     NONE                                                                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                     TRANSGENIC MODEL EVALUATION II (BENZENE)                                                                       
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE MICE                                                                                     
                       FIRST TERMINAL SACRIFICE AT 189 DAYS                                                                         
 ==================================================================================                                                 
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |    DOSE                               TIME (DAYS)                              |                                                 
 |                 19    38    57    76    95   114   133   152   171   189 (A)   |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |           |                                                                    |                                                 
 |0 MG/KG    |   100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |25 MG/KG   |   100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |50 MG/KG   |   100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |100        |   100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0      |                                                 
 |MG/KG      |                                                                    |                                                 
 |           |                                                                    |                                                 
 |200        |   100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0      |                                                 
 |MG/KG      |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                     TRANSGENIC MODEL EVALUATION II (BENZENE)                                                                       
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE MICE                                                                                     
                       FIRST TERMINAL SACRIFICE AT 189 DAYS                                                                         
 ===============================================================================================================================    
 |                                               SURVIVAL SUMMARY STATISTICS                                                   |    
 |                                                                                                                             |    
 |                                                                                                                             |    
 |-----------------------------------------------------------------------------------------------------------------------------|    
 |                                                                           DOSE                                              |    
 |                                                                                                                             |    
 |                                0 MG/KG            25 MG/KG           50 MG/KG           100                200              |    
 |                                                                                         MG/KG              MG/KG            |    
 |-----------------------------------------------------------------------------------------------------------------------------|    
 |SURVIVAL AT END OF STUDY|      100.0%             100.0%             100.0%             100.0%             100.0%            |    
 |(KAPLAN-MEIER)          |                                                                                                    |    
 |                        |                                                                                                    |    
 |SIGNIFICANCE (B)        |        -----              -----              -----              -----              -----           |    
 |(LIFE TABLE)            |                                                                                                    |    
 |                        |                                                                                                    |    
 |MEAN DAY OF             |          .                  .                  .                  .                  .             |    
 |NATURAL DEATHS (C)      |       (  . )             (  . )             (  . )             (  . )             (  . )           |    
 |(STANDARD ERROR)        |                                                                                                    |    
 |                        |                                                                                                    |    
 |MEAN LIFE SPAN (D)      |       189.0              189.0              189.0              189.0              189.0            |    
 |(STANDARD ERROR)        |       ( 0.0)             ( 0.0)             ( 0.0)             ( 0.0)             ( 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)                                                           
                                                                                                                                   
                                              TRANSGENIC MODEL EVALUATION II (BENZENE)                                              
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        0 MG/KG          = 1                                                        
                                                        25 MG/KG         = 2                                                        
                                                        50 MG/KG         = 3                                                        
                                                        100     MG/KG    = 4                                                        
                                                        200     MG/KG    = 5                                                        
                                                                                                                                    
------------------------------------------------------ SPECIES=MICE SEX=MALE -------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
          (NOTE: 7 obs hidden.)                                                                                                     
P        |                                                                                                                          
E        |                                                                                                                          
R 100.00 +1        5                                                                                                             1  
C        |                                                                                                                          
E        |                                                                                                                          
N        |                                                                                                                          
T  93.33 +         5                                                                                                             5  
         |                                                                                                                          
S        -+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+
U        0.0        2.5        5.0        7.5       10.0       12.5       15.0       17.5       20.0       22.5       25.0      27.5
R                                                                                                                                   
                                                                     WEEK                                                           
                                                                                                                                    
                                                                                                                                    
                                                                                                                                   
                                              TRANSGENIC MODEL EVALUATION II (BENZENE)                                              
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        0 MG/KG          = 1                                                        
                                                        25 MG/KG         = 2                                                        
                                                        50 MG/KG         = 3                                                        
                                                        100     MG/KG    = 4                                                        
                                                        200     MG/KG    = 5                                                        
                                                                                                                                    
----------------------------------------------------- SPECIES=MICE SEX=FEMALE ------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                         (NOTE: 8 obs hidden.)                                                                                      
                  P     |                                                                                                           
                  E     |                                                                                                           
                  R 200 +                                                                                                           
                  C     |                                                                                                           
                  E     |                                                                                                           
                  N     |                                                                                                           
                  T 100 +  1                                                                                  1                     
                        |                                                                                                           
                  S     |                                                                                                           
                  U     |                                                                                                           
                  R   0 +                                                                                                           
                  V     |                                                                                                           
                  I     ---+----------------------------------------------------------------------------------+--                   
                  V        0                                                                                 27                     
                  A                                                                                                                 
                                                                   WEEK