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TDMS Study 56348-03 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Battelle Columbus                                           CITRAL                                        DATE: 07/05/01       
EXPERIMENT: 56348 TEST: 03                                                                                     TIME: 13:28:55       
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       
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE 001    UNTREAT CONTROL                                                               
                                       INCLUDE 002    UNTREAT CONTROL                                                               
                                       INCLUDE 005    1000 PPM                                                                      
                                       INCLUDE 006    1000 PPM                                                                      
                                       INCLUDE 007    2000 PPM                                                                      
                                       INCLUDE 008    2000 PPM                                                                      
                                       INCLUDE 009    4000 PPM                                                                      
                                       INCLUDE 010    4000 PPM                                                                      
                                                                                                                                   
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Battelle Columbus                                           CITRAL                                        DATE: 07/05/01       
EXPERIMENT: 56348 TEST: 03                                                                                     TIME: 13:28:55       
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 = 1000 PPM                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 18     CENSORED DEATHS 0    TERMINAL 32        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      478   505   526   639   639   660   671   674   688   692                 |                                                 
 |      694   695   695   709   709   716   720   725                             |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 2000 PPM                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 15     CENSORED DEATHS 0    TERMINAL 35        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      573   600   624   639   660   674   688   701   709   709                 |                                                 
 |      712   720   720   722   723                                               |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                      CITRAL                                                                                        
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE RATS                                                                                      
                       FIRST TERMINAL SACRIFICE AT 726 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 4000 PPM                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 16     CENSORED DEATHS 0    TERMINAL 34        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      397   520   544   596   628   636   639   655   674   680                 |                                                 
 |      684   695   709   709   720   723                                         |                                                 
 |  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    |                                                                    |                                                 
 |           |                                                                    |                                                 
 |1000 PPM   |   100.0 100.0 100.0 100.0 100.0  98.0  94.0  94.0  88.0  64.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |2000 PPM   |   100.0 100.0 100.0 100.0 100.0 100.0 100.0  96.0  90.0  70.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |4000 PPM   |   100.0 100.0 100.0 100.0  98.0  98.0  94.0  92.0  84.0  68.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                  DOSE                          |                                                 
 |                                                                                |                                                 
 |                                UNTREAT      1000 PPM     2000 PPM     4000 PPM |                                                 
 |                                CONTROL                                         |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       60.0%        64.0%        70.0%        68.0%    |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |       P=0.364N     P=0.597N     P=0.237N     P=0.442N |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       629.6        657.5        678.3        638.1    |                                                 
 |NATURAL DEATHS (C)      |       (14.9)       (17.8)       (12.6)       (21.9)   |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       687.4        701.3        711.7        697.9    |                                                 
 |(STANDARD ERROR)        |       ( 9.0)       ( 7.9)       ( 4.8)       ( 9.0)   |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (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)                                                           
                                                                                                                                   
                                      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 = 1000 PPM                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 14     CENSORED DEATHS 0    TERMINAL 36        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      400   515   582   594   612   645   659   662   687   694                 |                                                 
 |      708   708   708   712                                                     |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 2000 PPM                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 14     CENSORED DEATHS 0    TERMINAL 36        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      445   453   504   510   595   638   649   673   690   694                 |                                                 
 |      694   714   719   721                                                     |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                      CITRAL                                                                                        
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       FIRST TERMINAL SACRIFICE AT 732 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 4000 PPM                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 14     CENSORED DEATHS 0    TERMINAL 36        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      386   432   473   491   519   588   617   617   687   687                 |                                                 
 |      687   694   708   719                                                     |                                                 
 |  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    |                                                                    |                                                 
 |           |                                                                    |                                                 
 |1000 PPM   |   100.0 100.0 100.0 100.0  98.0  98.0  96.0  92.0  84.0  72.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |2000 PPM   |   100.0 100.0 100.0 100.0 100.0  96.0  92.0  90.0  86.0  72.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |4000 PPM   |   100.0 100.0 100.0 100.0  98.0  94.0  90.0  88.0  84.0  72.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                  DOSE                          |                                                 
 |                                                                                |                                                 
 |                                UNTREAT      1000 PPM     2000 PPM     4000 PPM |                                                 
 |                                CONTROL                                         |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       70.0%        72.0%        72.0%        72.0%    |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |       P=1.000N     P=0.973N     P=0.983N     P=1.000N |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       636.9        634.7        621.4        593.2    |                                                 
 |NATURAL DEATHS (C)      |       (17.7)       (23.9)       (27.1)       (30.2)   |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       703.5        704.8        701.0        693.1    |                                                 
 |(STANDARD ERROR)        |       ( 8.1)       ( 9.0)       (10.2)       (12.1)   |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (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                                                        
                                                        1000 PPM         = 2                                                        
                                                        2000 PPM         = 3                                                        
                                                        4000 PPM         = 4                                                        
                                                                                                                                    
------------------------------------------------------ SPECIES=RATS SEX=MALE -------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
      |                                                                                                                             
  100 + 1                                                              4        1   2             3                                 
      |                                                                                                                             
      |                                                                4        1   2   1  4      3    3                            
      |                                                                                                                             
   96 +                                                                                 1  42 41       3   3                        
      |                                                                                                                             
      |                                                                                     2 41      14   3 2                      
      |                                                                                                                             
   92 +                                                                                               11   4 3   3                  
      |                                                                                                                             
      |                                                                                                1 1 442   2 3                
      |                                                                                                                             
P  88 +                                                                                                     44   223 3              
E     |                                                                                                                             
R     |                                                                                                  11  4 4  22 3 3            
C     |                                                                                                                             
E  84 +                                                                                                   1  1 4   2 2 33           
N     |                                                                                                                             
T     |                                                                                                            44               
      |                                                                                                                             
S  80 +                                                                                                      1 1     22             
U     |                                                                                                                             
R     |                                                                                                        1 1  4 4 33          
V     |                                                                                                                             
I  76 +                                                                                                               4 4           
V     |                                                                                                                             
A     |                                                                                                          1 1  2 233         
L     |                                                                                                                             
   72 +                                                                                                                 44          
      |                                                                                                                             
      |                                                                                                                 223         
      |                                                                                                                             
   68 +                                                                                                            1 1    4         
      |                                                                                                                             
      |                                                                                                                  22         
      |                                                                                                                             
   64 +                                                                                                              11   2         
      |                                                                                                                             
      |                                                                                                               1 1           
      |                                                                                                                             
   60 +                                                                                                                 1 1         
      |                                                                                                                             
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110 
                                                                                                                                    
                                                                   WEEK                                                             
                                                                                                                                    
NOTE: 11 obs hidden.                                                                                                                
                                                                                                                                   
                                                               CITRAL                                                               
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        UNTREAT CONTROL  = 1                                                        
                                                        1000 PPM         = 2                                                        
                                                        2000 PPM         = 3                                                        
                                                        4000 PPM         = 4                                                        
                                                                                                                                    
----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
      |                                                                                                                             
      |                                                                                                                             
  100 + 1                                                             4 2     3         1                                           
      |                                                                                                                             
      |                                                               4 2   4 3 3       12 1                                        
      |                                                                                                                             
   96 +                                                                     4   3  4   3 2 1        1                               
      |                                                                                                                             
      |                                                                            4  433           1 1                             
      |                                                                                                                             
P  92 +                                                                               4 3  4          1 12                          
E     |                                                                                                                             
R     |                                                                                    4        4 3 121  32                     
C     |                                                                                                                             
E  88 +                                                                                             4     11 32  2                  
N     |                                                                                                                             
T     |                                                                                                    11 3    3                
      |                                                                                                                             
S  84 +                                                                                                   4      2 3 2              
U     |                                                                                                                             
R     |                                                                                                     1 1      22             
V     |                                                                                                                             
I  80 +                                                                                                       1     1 2 2           
V     |                                                                                                                             
A     |                                                                                                             143 31          
L     |                                                                                                                             
   76 +                                                                                                               4 33          
      |                                                                                                                             
      |                                                                                                                 44          
      |                                                                                                                             
   72 +                                                                                                                 211 2       
      |                                                                                                                             
      |                                                                                                                   1 1       
      |                                                                                                                             
   68 +                                                                                                                             
      |                                                                                                                             
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110 
                                                                                                                                    
                                                                   WEEK                                                             
                                                                                                                                    
NOTE: 20 obs hidden.