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TDMS Study 93005-04 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: NCTR                                                    MALACHITE GREEN                                   DATE: 06/19/03       
EXPERIMENT: 93005 TEST: 04                                                                                     TIME: 07:27:20       
TEST TYPE:  CHRONIC                                                                                            PAGE:       1        
CONT: 224-93-00001                              ROUTE: DOSED FEED                                              NTP C#: C93005       
PATHOLOGIST: TROTTER, RONALD                                                                                   CAS: 569-64-2        
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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                                                    MALACHITE GREEN                                   DATE: 06/19/03       
EXPERIMENT: 93005 TEST: 04                                                                                     TIME: 07:27:20       
TEST TYPE:  CHRONIC                                                                                                                 
CONT: 224-93-00001                              ROUTE: DOSED FEED                                              NTP C#: C93005       
PATHOLOGIST: TROTTER, RONALD                                                                                   CAS: 569-64-2        
                                                                                                                                   
                                  MALACHITE GREEN                                                                                   
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE MICE                                                                                     
                       FIRST TERMINAL SACRIFICE AT 727 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 0 PPM                                    |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 48     UNCENSORED DEATHS 8      CENSORED DEATHS 0    TERMINAL 40        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      378   562   599   647   673   676   676   694                             |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 100 PPM                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 48     UNCENSORED DEATHS 4      CENSORED DEATHS 0    TERMINAL 44        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      596   644   659   711                                                     |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 225 PPM                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 48     UNCENSORED DEATHS 7      CENSORED DEATHS 1    TERMINAL 40        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      252   442   444   568   673   694   707                                   |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      226                                                                       |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                  MALACHITE GREEN                                                                                   
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE MICE                                                                                     
                       FIRST TERMINAL SACRIFICE AT 727 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 450 PPM                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 48     UNCENSORED DEATHS 7      CENSORED DEATHS 0    TERMINAL 41        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      161   318   626   633   673   704   723                                   |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                  MALACHITE GREEN                                                                                   
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE 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)   |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |           |                                                                    |                                                 
 |0 PPM      |   100.0 100.0 100.0 100.0  97.9  97.9  97.9  93.7  91.7  83.3      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |100 PPM    |   100.0 100.0 100.0 100.0 100.0 100.0 100.0  97.9  93.7  91.7      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |225 PPM    |   100.0 100.0  97.9  97.9  97.9  93.6  93.6  91.5  91.5  85.1      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |450 PPM    |   100.0  97.9  97.9  95.8  95.8  95.8  95.8  95.8  91.7  85.4      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                  DOSE                          |                                                 
 |                                                                                |                                                 
 |                                0 PPM        100 PPM      225 PPM      450 PPM  |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       83.3%        91.7%        85.1%        85.4%    |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |       P=1.000      P=0.346N     P=1.000N     P=0.991N |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       613.1        652.5        540.0        548.3    |                                                 
 |NATURAL DEATHS (C)      |       (37.1)       (23.7)       (64.0)       (82.6)   |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       708.0        720.8        689.3        700.9    |                                                 
 |(STANDARD ERROR)        |       ( 8.5)       ( 3.5)       (16.3)       (14.5)   |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (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)                                                           
                                                                                                                                   
                                                          MALACHITE GREEN                                                           
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        0 PPM            = 1                                                        
                                                        100 PPM          = 2                                                        
                                                        225 PPM          = 3                                                        
                                                        450 PPM          = 4                                                        
                                                                                                                                    
----------------------------------------------------- SPECIES=MICE SEX=FEMALE ------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
      |                                                                                                                             
      |                                                                                                                             
  100 + 1                        4              3                  1                                   2                            
      |                                                                                                                             
      |                                                                                                                             
      |                                                                                                                             
   98 +                          4              3          4       1          3                  1     2     2                      
      |                                                                                                                             
      |                                                                                                                             
      |                                                                                                                             
   96 +                                                    4                                     1     1   4 2   2                  
      |                                                                                                                             
P     |                                                                                                                             
E     |                                                                                                                             
R  94 +                                                                                                1   44 1  2      2           
C     |                                                                       3                   3                                 
E     |                                                                                                                             
N     |                                                                                                                             
T  92 +                                                                                                                             
      |                                                                                           3         4 1    1    2 2         
S     |                                                                                                                             
U     |                                                                                                                             
R  90 +                                                                                                                             
V     |                                                                                                            3  34            
I     |                                                                                                                             
V     |                                                                                                                             
A  88 +                                                                                                                             
L     |                                                                                                                4  4         
      |                                                                                                               33            
      |                                                                                                                             
   86 +                                                                                                                             
      |                                                                                                            1  1   4         
      |                                                                                                                3  3         
      |                                                                                                                             
   84 +                                                                                                                             
      |                                                                                                               1   1         
      |                                                                                                                             
      |                                                                                                                             
   82 +                                                                                                                             
      |                                                                                                                             
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110 
                                                                                                                                    
                                                                   WEEK                                                             
                                                                                                                                    
NOTE: 6 obs hidden.