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TDMS Study 93029-03 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: NCTR                                                 LEUKOMALACHITE GREEN                                 DATE: 06/18/03       
EXPERIMENT: 93029 TEST: 03                                                                                     TIME: 15:14:50       
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: 06/18/03       
EXPERIMENT: 93029 TEST: 03                                                                                     TIME: 15:14:50       
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                                                                        
                                     MALE RATS                                                                                      
                       FIRST TERMINAL SACRIFICE AT 733 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 0 PPM                                    |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 48     UNCENSORED DEATHS 24     CENSORED DEATHS 0    TERMINAL 24        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      541   564   564   577   599   613   613   623   632   639                 |                                                 
 |      653   659   662   662   666   690   698   701   706   717                 |                                                 
 |      718   725   731   732                                                     |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 91 PPM                                   |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 47     UNCENSORED DEATHS 17     CENSORED DEATHS 0    TERMINAL 30        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      487   567   579   604   606   615   620   629   636   667                 |                                                 
 |      671   697   709   724   729   729   732                                   |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 272 PPM                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 48     UNCENSORED DEATHS 14     CENSORED DEATHS 0    TERMINAL 34        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      435   439   477   543   599   629   652   662   668   698                 |                                                 
 |      701   703   722   724                                                     |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                               LEUKOMALACHITE GREEN                                                                                 
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE RATS                                                                                      
                       FIRST TERMINAL SACRIFICE AT 733 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 543 PPM                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 47     UNCENSORED DEATHS 17     CENSORED DEATHS 0    TERMINAL 30        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      475   505   601   645   645   658   660   661   661   676                 |                                                 
 |      679   687   698   707   713   717   724                                   |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                               LEUKOMALACHITE GREEN                                                                                 
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE RATS                                                                                      
                       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      |   100.0 100.0 100.0 100.0 100.0 100.0  97.9  89.6  70.8  50.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |91 PPM     |   100.0 100.0 100.0 100.0 100.0 100.0  97.9  91.5  80.9  63.8      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |272 PPM    |   100.0 100.0 100.0 100.0 100.0  93.8  91.7  89.6  83.3  70.8      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |543 PPM    |   100.0 100.0 100.0 100.0 100.0  97.9  95.7  93.6  80.9  63.8      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                  DOSE                          |                                                 
 |                                                                                |                                                 
 |                                0 PPM        91 PPM       272 PPM      543 PPM  |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       50.0%        63.8%        70.8%        63.8%    |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |       P=0.265N     P=0.240N     P=0.071N     P=0.230N |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       653.5        647.1        618.0        653.6    |                                                 
 |NATURAL DEATHS (C)      |       (11.8)       (16.7)       (27.7)       (16.8)   |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       693.3        701.9        699.5        704.3    |                                                 
 |(STANDARD ERROR)        |       ( 8.2)       ( 8.5)       (11.0)       ( 8.2)   |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (A)  FIRST TERMINAL SACRIFICE                                                                                                
       (B)  THE FIRST ENTRY IS THE TREND TEST (TARONE, 1975) RESULT.                                                                
            SUBSEQUENT ENTRIES ARE THE RESULTS OF PAIRWISE TESTS                                                                    
            (COX,1972).  NEGATIVE TRENDS ARE INDICATED BY "N".                                                                      
       (C)  MEAN OF ALL UNCENSORED DEATHS PRIOR TO TERMINAL SACRIFICE                                                               
       (D)  MEAN OF ALL DEATHS (UNCENSORED, CENSORED, TERMINAL SACRIFICE)                                                           
                                                                                                                                   
                               LEUKOMALACHITE GREEN                                                                                 
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       FIRST TERMINAL SACRIFICE AT 734 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 0 PPM                                    |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 48     UNCENSORED DEATHS 15     CENSORED DEATHS 0    TERMINAL 33        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      552   578   585   589   627   635   653   662   662   669                 |                                                 
 |      673   714   718   719   719                                               |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 91 PPM                                   |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 48     UNCENSORED DEATHS 12     CENSORED DEATHS 0    TERMINAL 36        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      60    561   605   625   657   683   690   709   714   716                 |                                                 
 |      725   732                                                                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 272 PPM                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 48     UNCENSORED DEATHS 13     CENSORED DEATHS 0    TERMINAL 35        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      102   470   482   599   626   657   676   698   709   709                 |                                                 
 |      709   719   724                                                           |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                               LEUKOMALACHITE GREEN                                                                                 
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       FIRST TERMINAL SACRIFICE AT 734 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 543 PPM                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 48     UNCENSORED DEATHS 14     CENSORED DEATHS 0    TERMINAL 34        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      405   484   536   570   585   632   633   640   648   654                 |                                                 
 |      669   676   719   733                                                     |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                               LEUKOMALACHITE GREEN                                                                                 
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       FIRST TERMINAL SACRIFICE AT 734 DAYS                                                                         
 ==================================================================================                                                 
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |    DOSE                               TIME (DAYS)                              |                                                 
 |                 90   180   270   365   425   485   545   605   665   734 (A)   |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |           |                                                                    |                                                 
 |0 PPM      |   100.0 100.0 100.0 100.0 100.0 100.0 100.0  91.7  81.2  68.7      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |91 PPM     |    97.9  97.9  97.9  97.9  97.9  97.9  97.9  93.7  89.6  75.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |272 PPM    |   100.0  97.9  97.9  97.9  97.9  93.7  93.7  91.7  87.5  72.9      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |543 PPM    |   100.0 100.0 100.0 100.0  97.9  95.8  93.7  89.6  79.2  70.8      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                  DOSE                          |                                                 
 |                                                                                |                                                 
 |                                0 PPM        91 PPM       272 PPM      543 PPM  |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       68.7%        75.0%        72.9%        70.8%    |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |       P=0.981      P=0.590N     P=0.787N     P=1.000N |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       650.3        623.1        606.2        613.1    |                                                 
 |NATURAL DEATHS (C)      |       (14.3)       (53.4)       (48.2)       (24.1)   |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       707.9        706.3        699.4        698.8    |                                                 
 |(STANDARD ERROR)        |       ( 7.1)       (14.7)       (15.1)       (10.5)   |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (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)                                                           
                                                                                                                                   
                                                        LEUKOMALACHITE GREEN                                                        
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        0 PPM            = 1                                                        
                                                        91 PPM           = 2                                                        
                                                        272 PPM          = 3                                                        
                                                        543 PPM          = 4                                                        
                                                                                                                                    
------------------------------------------------------ SPECIES=RATS SEX=MALE -------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
      |                                                                                                                             
  100 + 1                                                                    3     4 2        1                                     
      |                                                                                                                             
      |                                                                            4 2  4     1  1                                  
      |                                                                      3      3   4        2 2   4                            
   95 +                                                                                                                             
      |                                                                             3         3  1 1   42     4                     
      |                                                                                                                             
      |                                                                                       3    1   1                            
   90 +                                                                                                1 1 3                        
      |                                                                                                 22    44                    
      |                                                                                                  223   3 4                  
      |                                                                                                                             
P  85 +                                                                                                  112   3 3                  
E     |                                                                                                   1 1    33                 
R     |                                                                                                    22                       
C     |                                                                                                     11   424  3             
E  80 +                                                                                                                             
N     |                                                                                                      1 1      33            
T     |                                                                                                        1 1                  
      |                                                                                                           24 42             
S  75 +                                                                                                              4232 3         
U     |                                                                                                                             
R     |                                                                                                               442 2         
V     |                                                                                                          11       3 3       
I  70 +                                                                                                                44 2 2       
V     |                                                                                                           1  1              
A     |                                                                                                                 44          
L     |                                                                                                              11  44         
   65 +                                                                                                               11            
      |                                                                                                                   4 2       
      |                                                                                                                             
      |                                                                                                                             
   60 +                                                                                                                1 1          
      |                                                                                                                             
      |                                                                                                                             
      |                                                                                                                  11         
   55 +                                                                                                                             
      |                                                                                                                   1 1       
      |                                                                                                                             
      |                                                                                                                             
   50 +                                                                                                                     1       
      |                                                                                                                             
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110 
                                                                                                                                    
                                                                   WEEK                                                             
                                                                                                                                    
NOTE: 13 obs hidden.                                                                                                                
                                                                                                                                   
                                                        LEUKOMALACHITE GREEN                                                        
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        0 PPM            = 1                                                        
                                                        91 PPM           = 2                                                        
                                                        272 PPM          = 3                                                        
                                                        543 PPM          = 4                                                        
                                                                                                                                    
----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
         |                                                                                                                          
         |                                                                                                                          
  100.00 +1         2      3                                              4                      1                                  
         |                                                                                                                          
         |          2      3                                              4          3 4         1 2 1                              
         |                                                                                                                          
   95.83 +                                                                           334       4   2 11   2                         
         |                                                                                                                          
         |                                                                            3        4    4 1 132  2                      
         |                                                                                                                          
P  91.67 +                                                                                          4 4 13   1   2                  
E        |                                                                                                                          
R        |                                                                                            4      11  2    2             
C        |                                                                                                                          
E  87.50 +                                                                                                    1  1   322            
N        |                                                                                                                          
T        |                                                                                                    44 1 1 3 23 2         
         |                                                                                                                          
S  83.33 +                                                                                                     44       3 3         
U        |                                                                                                                          
R        |                                                                                                      44 11     22        
V        |                                                                                                                          
I  79.17 +                                                                                                       4  11     22       
V        |                                                                                                                          
A        |                                                                                                          41    132 2     
L        |                                                                                                                          
   75.00 +                                                                                                           4    113 2     
         |                                                                                                                          
         |                                                                                                                 43 3     
         |                                                                                                                          
   70.83 +                                                                                                                    4     
         |                                                                                                                          
         |                                                                                                                 1  1     
         |                                                                                                                          
   66.67 +                                                                                                                          
         |                                                                                                                          
         -+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+
          0         10         20         30         40         50         60         70         80         90         100       110
                                                                                                                                    
                                                                     WEEK                                                           
                                                                                                                                    
NOTE: 15 obs hidden.