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TDMS Study 56348-04 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Battelle Columbus                                           CITRAL                                        DATE: 12/19/00       
EXPERIMENT: 56348 TEST: 04                                                                                     TIME: 11:28:11       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-55384                              ROUTE: DOSED FEED                                              NTP C#: C56348       
PATHOLOGIST: DR. M. RYAN                                                                                           CAS: 5392-40-5       
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                            MICE/Untreated 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: 12/19/00       
EXPERIMENT: 56348 TEST: 04                                                                                     TIME: 11:28:11       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-55384                              ROUTE: DOSED FEED                                              NTP C#: C56348       
PATHOLOGIST: DR. M. RYAN                                                                                           CAS: 5392-40-5       
                                                                                                                                   
                                      CITRAL                                                                                        
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE MICE                                                                                      
                       FIRST TERMINAL SACRIFICE AT 727 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                          DOSE = UNTREAT CONTROL                                |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 2      CENSORED DEATHS 0    TERMINAL 48        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      397   626                                                                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                          DOSE = VEHICLE CONTROL                                |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 7      CENSORED DEATHS 0    TERMINAL 43        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      121   310   530   530   626   682   682                                   |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                      CITRAL                                                                                        
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE MICE                                                                                      
                       FIRST TERMINAL SACRIFICE AT 727 DAYS                                                                         
 ==================================================================================                                                 
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |    DOSE                               TIME (DAYS)                              |                                                 
 |                 90   180   270   365   425   485   545   605   665   727 (A)   |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |           |                                                                    |                                                 
 |UNTREAT    |   100.0 100.0 100.0 100.0  98.0  98.0  98.0  98.0  96.0  96.0      |                                                 
 |CONTROL    |                                                                    |                                                 
 |           |                                                                    |                                                 
 |VEHICLE    |   100.0  98.0  98.0  96.0  96.0  96.0  92.0  92.0  90.0  86.0      |                                                 
 |CONTROL    |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                        DOSE                    |                                                 
 |                                                                                |                                                 
 |                                UNTREAT                   VEHICLE               |                                                 
 |                                CONTROL                   CONTROL               |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       96.0%                     86.0%                 |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |        -----                     -----                |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       511.5                     497.3                 |                                                 
 |NATURAL DEATHS (C)      |       ( 115)                    (79.2)                |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       718.4                     694.8                 |                                                 
 |(STANDARD ERROR)        |       ( 6.9)                    (15.4)                |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (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 MICE                                                                                     
                       FIRST TERMINAL SACRIFICE AT 733 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                          DOSE = UNTREAT CONTROL                                |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 9      CENSORED DEATHS 1    TERMINAL 40        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      242   242   243   544   545   557   660   709   722                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      9                                                                         |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                          DOSE = VEHICLE CONTROL                                |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 8      CENSORED DEATHS 1    TERMINAL 41        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      441   470   625   633   680   688   709   719                             |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      114                                                                       |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                      CITRAL                                                                                        
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE MICE                                                                                     
                       FIRST TERMINAL SACRIFICE AT 733 DAYS                                                                         
 ==================================================================================                                                 
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |    DOSE                               TIME (DAYS)                              |                                                 
 |                 90   180   270   365   425   485   545   605   665   733 (A)   |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |           |                                                                    |                                                 
 |UNTREAT    |   100.0 100.0  93.9  93.9  93.9  93.9  89.8  87.8  85.7  81.6      |                                                 
 |CONTROL    |                                                                    |                                                 
 |           |                                                                    |                                                 
 |VEHICLE    |   100.0 100.0 100.0 100.0 100.0  95.9  95.9  95.9  91.8  83.7      |                                                 
 |CONTROL    |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                        DOSE                    |                                                 
 |                                                                                |                                                 
 |                                UNTREAT                   VEHICLE               |                                                 
 |                                CONTROL                   CONTROL               |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       81.6%                     83.7%                 |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |        -----                     -----                |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       496.0                     620.6                 |                                                 
 |NATURAL DEATHS (C)      |       (67.2)                    (38.0)                |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       675.9                     702.6                 |                                                 
 |(STANDARD ERROR)        |       (22.1)                    (14.6)                |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (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=MICE SEX=MALE -------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
      |                                                                                                                             
      |                                                                                                                             
  100 + 1                   2                                          1                                                            
      |                                                                                                                             
      |                                                                                                                             
      |                                                                                                                             
   98 +                     2                             2            1                                   1                        
      |                                                                                                                             
P     |                                                                                                                             
E     |                                                                                                                             
R  96 +                                                   2                                 2              1              1         
C     |                                                                                                                             
E     |                                                                                                                             
N     |                                                                                                                             
T  94 +                                                                                                                             
      |                                                                                                                             
S     |                                                                                                                             
U     |                                                                                                                             
R  92 +                                                                                     2              2                        
V     |                                                                                                                             
I     |                                                                                                                             
V     |                                                                                                                             
A  90 +                                                                                                    2        2               
L     |                                                                                                                             
      |                                                                                                                             
      |                                                                                                                             
   88 +                                                                                                                             
      |                                                                                                                             
      |                                                                                                                             
      |                                                                                                                             
   86 +                                                                                                             2     2         
      |                                                                                                                             
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110 
                                                                                                                                    
                                                                   WEEK                                                             
                                                                                                                                    
NOTE: 1 obs hidden.                                                                                                                 
                                                                                                                                   
                                                               CITRAL                                                               
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        UNTREAT CONTROL  = 1                                                        
                                                        VEHICLE CONTROL  = 2                                                        
                                                                                                                                    
----------------------------------------------------- SPECIES=MICE SEX=FEMALE ------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
         |                                                                                                                          
         |                                                                                                                          
  100.00 +1                                      1                             2                                                    
         |                                                                                                                          
         |                                                                                                                          
         |                                                                                                                          
   97.96 +                                                                     2     2                                              
         |                                                                                                                          
         |                                                                                                                          
         |                                                                                                                          
   95.92 +                                                                           2                       2                      
         |                                                                                                                          
P        |                                                                                                                          
E        |                                                                                                                          
R  93.88 +                                       1                                              1            22                     
C        |                                                                                                                          
E        |                                                                                                                          
N        |                                                                                                                          
T  91.84 +                                                                                                    2       2             
         |                                                                                                                          
S        |                                                                                                                          
U        |                                                                                                                          
R  89.80 +                                                                                      1 1                   22            
V        |                                                                                                                          
I        |                                                                                                                          
V        |                                                                                                                          
A  87.76 +                                                                                        1                1   2  2         
L        |                                                                                                                          
         |                                                                                                                          
         |                                                                                                                          
   85.71 +                                                                                                         1      12        
         |                                                                                                                          
         |                                                                                                                          
         |                                                                                                                          
   83.67 +                                                                                                                121 2     
         |                                                                                                                          
         |                                                                                                                          
         |                                                                                                                          
   81.63 +                                                                                                                  1 1     
         |                                                                                                                          
         -+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+
          0         10         20         30         40         50         60         70         80         90         100       110
                                                                                                                                    
                                                                     WEEK                                                           
                                                                                                                                    
NOTE: 2 obs hidden.