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TDMS Study 56348-03 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Battelle Columbus                                           CITRAL                                        DATE: 06/09/00       
EXPERIMENT: 56348 TEST: 03                                                                                     TIME: 11:16:39       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-55384                              ROUTE: DOSED FEED                                              NTP C#: C56348       
PATHOLOGIST: SINGER, ALLEN                                                                                     CAS: 5392-40-5       
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                         FINAL #1/RATS UNTREATED CONTROL VS VEHICLE CONTROL                                         
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE 001    UNTREAT CONTROL                                                               
                                       INCLUDE 002    UNTREAT CONTROL                                                               
                                       INCLUDE 003    VEHICLE CONTROL                                                               
                                       INCLUDE 004    VEHICLE CONTROL                                                               
                                                                                                                                   
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Battelle Columbus                                           CITRAL                                        DATE: 06/09/00       
EXPERIMENT: 56348 TEST: 03                                                                                     TIME: 11:16:39       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-55384                              ROUTE: DOSED FEED                                              NTP C#: C56348       
PATHOLOGIST: SINGER, ALLEN                                                                                     CAS: 5392-40-5       
                                                                                                                                   
                                      CITRAL                                                                                        
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE RATS                                                                                      
                       FIRST TERMINAL SACRIFICE AT 726 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                          DOSE = UNTREAT CONTROL                                |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 20     CENSORED DEATHS 0    TERMINAL 30        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      450   505   549   589   600   610   610   617   639   639                 |                                                 
 |      653   660   660   674   674   674   688   693   695   712                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                          DOSE = VEHICLE CONTROL                                |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 28     CENSORED DEATHS 0    TERMINAL 22        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      365   446   509   532   610   617   623   628   632   637                 |                                                 
 |      639   639   653   660   660   660   663   674   674   678                 |                                                 
 |      688   688   694   695   695   707   709   722                             |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                      CITRAL                                                                                        
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE RATS                                                                                      
                       FIRST TERMINAL SACRIFICE AT 726 DAYS                                                                         
 ==================================================================================                                                 
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |    DOSE                               TIME (DAYS)                              |                                                 
 |                 90   180   270   365   425   485   545   605   665   726 (A)   |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |           |                                                                    |                                                 
 |UNTREAT    |   100.0 100.0 100.0 100.0 100.0  98.0  96.0  90.0  74.0  60.0      |                                                 
 |CONTROL    |                                                                    |                                                 
 |           |                                                                    |                                                 
 |VEHICLE    |   100.0 100.0 100.0  98.0  98.0  96.0  92.0  92.0  66.0  44.0      |                                                 
 |CONTROL    |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                        DOSE                    |                                                 
 |                                                                                |                                                 
 |                                UNTREAT                   VEHICLE               |                                                 
 |                                CONTROL                   CONTROL               |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       60.0%                     44.0%                 |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |        -----                     -----                |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       629.6                     635.6                 |                                                 
 |NATURAL DEATHS (C)      |       (14.9)                    (15.4)                |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       687.4                     675.4                 |                                                 
 |(STANDARD ERROR)        |       ( 9.0)                    (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)                                                           
                                                                                                                                   
                                      CITRAL                                                                                        
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       FIRST TERMINAL SACRIFICE AT 732 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                          DOSE = UNTREAT CONTROL                                |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 15     CENSORED DEATHS 0    TERMINAL 35        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      508   519   588   595   609   622   627   635   636   650                 |                                                 
 |      686   719   719   719   722                                               |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                          DOSE = VEHICLE CONTROL                                |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 10     CENSORED DEATHS 0    TERMINAL 40        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      62    491   652   677   687   694   697   708   708   715                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                      CITRAL                                                                                        
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       FIRST TERMINAL SACRIFICE AT 732 DAYS                                                                         
 ==================================================================================                                                 
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |    DOSE                               TIME (DAYS)                              |                                                 
 |                 90   180   270   365   425   485   545   605   665   732 (A)   |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |           |                                                                    |                                                 
 |UNTREAT    |   100.0 100.0 100.0 100.0 100.0 100.0  96.0  92.0  80.0  70.0      |                                                 
 |CONTROL    |                                                                    |                                                 
 |           |                                                                    |                                                 
 |VEHICLE    |    98.0  98.0  98.0  98.0  98.0  98.0  96.0  96.0  94.0  80.0      |                                                 
 |CONTROL    |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                        DOSE                    |                                                 
 |                                                                                |                                                 
 |                                UNTREAT                   VEHICLE               |                                                 
 |                                CONTROL                   CONTROL               |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       70.0%                     80.0%                 |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |        -----                     -----                |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       636.9                     609.1                 |                                                 
 |NATURAL DEATHS (C)      |       (17.7)                    (64.2)                |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       703.5                     707.4                 |                                                 
 |(STANDARD ERROR)        |       ( 8.1)                    (14.2)                |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (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)                                                           
                                                                                                                                   
                                                               CITRAL                                                               
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        UNTREAT CONTROL  = 1                                                        
                                                        VEHICLE CONTROL  = 2                                                        
                                                                                                                                    
------------------------------------------------------ SPECIES=RATS SEX=MALE -------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
      |                                                                                                                             
      |                                                                                                                             
  100 + 1                                                         2             1                                                   
      |                                                           2           2 1       1                                           
      |                                                                       2         1   2  1      1                             
      |                                                                                     2         11 2                          
P  90 +                                                                                                1 12                         
E     |                                                                                                                             
R     |                                                                                                  11221                      
C     |                                                                                                                             
E  80 +                                                                                                     21 1                    
N     |                                                                                                        1 1                  
T     |                                                                                                      2 2 1 1                
      |                                                                                                                             
S  70 +                                                                                                                             
U     |                                                                                                            1 1              
R     |                                                                                                          2 2 11             
V     |                                                                                                               1 1           
I  60 +                                                                                                            2 2  1 1         
V     |                                                                                                                             
A     |                                                                                                              22             
L     |                                                                                                                             
   50 +                                                                                                               22            
      |                                                                                                                22           
      |                                                                                                                 2 2         
      |                                                                                                                             
   40 +                                                                                                                             
      |                                                                                                                             
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110 
                                                                                                                                    
                                                                   WEEK                                                             
                                                                                                                                    
NOTE: 12 obs hidden.                                                                                                                
                                                                                                                                   
                                                               CITRAL                                                               
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        UNTREAT CONTROL  = 1                                                        
                                                        VEHICLE CONTROL  = 2                                                        
                                                                                                                                    
----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
      |                                                                                                                             
      |                                                                                                                             
  100 + 1         2                                                                     1                                           
      |                                                                                                                             
      |           2                                                                   2 1  1                                        
      |                                                                               2    1        1          2                    
P  95 +                                                                                                                             
E     |                                                                                             1 1        2   2                
R     |                                                                                               1 1          2 2              
C     |                                                                                                                             
E  90 +                                                                                                 1 1          22             
N     |                                                                                                                             
T     |                                                                                                   11                        
      |                                                                                                    11         2 2           
S  85 +                                                                                                                             
U     |                                                                                                                             
R     |                                                                                                     1 1         22          
V     |                                                                                                                             
I  80 +                                                                                                       1     1    2  2       
V     |                                                                                                                             
A     |                                                                                                             1    1          
L     |                                                                                                                             
   75 +                                                                                                                             
      |                                                                                                                             
      |                                                                                                                  11         
      |                                                                                                                             
   70 +                                                                                                                   1 1       
      |                                                                                                                             
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110 
                                                                                                                                    
                                                                   WEEK                                                             
                                                                                                                                    
NOTE: 1 obs hidden.