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TDMS Study 93029-04 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: NCTR                                                 LEUKOMALACHITE GREEN                                 DATE: 06/19/03       
EXPERIMENT: 93029 TEST: 04                                                                                     TIME: 07:10:43       
TEST TYPE:  CHRONIC                                                                                            PAGE:       1        
CONT: 224-93-00001                              ROUTE: DOSED FEED                                              NTP C#: C93029       
PATHOLOGIST: MISSING                                                                                           CAS: 129-73-7        
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               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
                                                                                                                                   
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: NCTR                                                 LEUKOMALACHITE GREEN                                 DATE: 06/19/03       
EXPERIMENT: 93029 TEST: 04                                                                                     TIME: 07:10:43       
TEST TYPE:  CHRONIC                                                                                                                 
CONT: 224-93-00001                              ROUTE: DOSED FEED                                              NTP C#: C93029       
PATHOLOGIST: MISSING                                                                                           CAS: 129-73-7        
                                                                                                                                   
                               LEUKOMALACHITE GREEN                                                                                 
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE MICE                                                                                     
                       FIRST TERMINAL SACRIFICE AT 733 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 0 PPM                                    |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 48     UNCENSORED DEATHS 11     CENSORED DEATHS 0    TERMINAL 37        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      122   225   498   518   639   682   682   688   695   700                 |                                                 
 |      732                                                                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 91 PPM                                   |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 48     UNCENSORED DEATHS 7      CENSORED DEATHS 0    TERMINAL 41        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      498   590   675   690   708   709   729                                   |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 204 PPM                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 48     UNCENSORED DEATHS 9      CENSORED DEATHS 0    TERMINAL 39        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      193   498   526   620   627   675   690   700   714                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                               LEUKOMALACHITE GREEN                                                                                 
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE MICE                                                                                     
                       FIRST TERMINAL SACRIFICE AT 733 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 408 PPM                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 48     UNCENSORED DEATHS 9      CENSORED DEATHS 0    TERMINAL 39        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      444   553   560   584   647   718   718   723   724                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                               LEUKOMALACHITE GREEN                                                                                 
                       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)   |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |           |                                                                    |                                                 
 |0 PPM      |   100.0  97.9  95.8  95.8  95.8  95.8  91.7  91.7  89.6  77.1      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |91 PPM     |   100.0 100.0 100.0 100.0 100.0 100.0  97.9  95.8  95.8  85.4      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |204 PPM    |   100.0 100.0  97.9  97.9  97.9  97.9  93.7  93.7  89.6  81.3      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |408 PPM    |   100.0 100.0 100.0 100.0 100.0  97.9  97.9  91.7  89.6  81.3      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                  DOSE                          |                                                 
 |                                                                                |                                                 
 |                                0 PPM        91 PPM       204 PPM      408 PPM  |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       77.1%        85.4%        81.3%        81.3%    |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |       P=0.890N     P=0.389N     P=0.792N     P=0.745N |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       561.9        657.0        582.6        630.1    |                                                 
 |NATURAL DEATHS (C)      |       (62.5)       (31.5)       (54.9)       (33.5)   |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       693.8        721.9        704.8        713.7    |                                                 
 |(STANDARD ERROR)        |       (17.3)       ( 5.8)       (13.0)       ( 8.4)   |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (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)                                                           
                                                                                                                                   
                                                        LEUKOMALACHITE GREEN                                                        
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        0 PPM            = 1                                                        
                                                        91 PPM           = 2                                                        
                                                        204 PPM          = 3                                                        
                                                        408 PPM          = 4                                                        
                                                                                                                                    
----------------------------------------------------- SPECIES=MICE SEX=FEMALE ------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
         |                                                                                                                          
         |                                                                                                                          
  100.00 +1                   1          3                                      4        2                                          
         |                                                                                                                          
         |                    1          3    1                                 4        2       4      2                           
         |                                                                                                                          
P  95.83 +                                    1                                          1    3  44     2            2              
E        |                                                                                                                          
R        |                                                                               1 1  3   4   4     3        2 2            
C        |                                                                                                                          
E  91.67 +                                                                                 1          4     33 14      2  2         
N        |                                                                                                                          
T        |                                                                                                   3 14    31    4        
         |                                                                                                                          
S  87.50 +                                                                                                           3 3  2   2     
U        |                                                                                                                          
R        |                                                                                                            113  44 2     
V        |                                                                                                                          
I  83.33 +                                                                                                             11 3         
V        |                                                                                                                          
A        |                                                                                                                3 4 3     
L        |                                                                                                                          
   79.17 +                                                                                                              1     1     
         |                                                                                                                          
         |                                                                                                                    1     
         |                                                                                                                          
   75.00 +                                                                                                                          
         |                                                                                                                          
         -+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+
          0         10         20         30         40         50         60         70         80         90         100       110
                                                                                                                                    
                                                                     WEEK                                                           
                                                                                                                                    
NOTE: 8 obs hidden.