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TDMS Study 05203-09 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Southern Research Inst                                  O-NITROTOLUENE                                    DATE: 11/16/00       
EXPERIMENT: 05203 TEST: 09                                                                                     TIME: 10:15:25       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-55393                              ROUTE: DOSED FEED                                              NTP C#: 62340D       
PATHOLOGIST: FARNELL, D.                                                                                       CAS: 88-72-2         
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                           MICE, FINAL#1                                                            
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
                                                                                                                                   
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Southern Research Inst                                  O-NITROTOLUENE                                    DATE: 11/16/00       
EXPERIMENT: 05203 TEST: 09                                                                                     TIME: 10:15:25       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-55393                              ROUTE: DOSED FEED                                              NTP C#: 62340D       
PATHOLOGIST: FARNELL, D.                                                                                       CAS: 88-72-2         
                                                                                                                                   
                                  O-NITROTOLUENE                                                                                    
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE MICE                                                                                      
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 0 PPM                                    |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 60     UNCENSORED DEATHS 8      CENSORED DEATHS 0    TERMINAL 52        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      263   592   596   618   637   649   710   719                             |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 1250 PPM                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 60     UNCENSORED DEATHS 26     CENSORED DEATHS 0    TERMINAL 34        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      451   460   463   469   485   526   542   545   559   572                 |                                                 
 |      575   592   604   630   633   641   641   655   686   688                 |                                                 
 |      690   690   710   717   726   728                                         |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 2500 PPM                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 60     UNCENSORED DEATHS 60     CENSORED DEATHS 0    TERMINAL 0         |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      270   303   365   410   419   423   434   451   451   466                 |                                                 
 |      467   469   470   476   485   492   492   496   497   504                 |                                                 
 |      516   517   520   522   523   526   531   533   534   539                 |                                                 
 |      540   544   548   548   553   554   556   556   557   560                 |                                                 
 |      560   563   564   566   566   567   569   569   569   572                 |                                                 
 |      572   588   588   590   592   596   619   624   645   706                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                  O-NITROTOLUENE                                                                                    
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE MICE                                                                                      
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 5000 PPM                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 60     UNCENSORED DEATHS 60     CENSORED DEATHS 0    TERMINAL 0         |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      277   295   297   302   312   326   339   345   350   354                 |                                                 
 |      358   365   368   368   368   368   371   372   374   375                 |                                                 
 |      375   375   376   380   386   391   391   391   392   392                 |                                                 
 |      392   393   394   394   396   401   403   403   405   406                 |                                                 
 |      406   408   408   408   409   409   409   412   414   414                 |                                                 
 |      414   414   420   422   422   427   440   449   450   462                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                  O-NITROTOLUENE                                                                                    
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE MICE                                                                                      
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
 ==================================================================================                                                 
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |    DOSE                               TIME (DAYS)                              |                                                 
 |                 90   180   270   365   425   485   545   605   665   729 (A)   |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |           |                                                                    |                                                 
 |0 PPM      |   100.0 100.0  98.3  98.3  98.3  98.3  98.3  95.0  90.0  86.7      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |1250 PPM   |   100.0 100.0 100.0 100.0 100.0  91.7  86.7  78.3  70.0  56.7      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |2500 PPM   |   100.0 100.0  98.3  95.0  90.0  75.0  46.7   6.7   1.7   0.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |5000 PPM   |   100.0 100.0 100.0  80.0   8.3   0.0   0.0   0.0   0.0   0.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                  DOSE                          |                                                 
 |                                                                                |                                                 
 |                                0 PPM        1250 PPM     2500 PPM     5000 PPM |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       86.7%        56.7%         0.0%         0.0%    |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |       P<0.001      P<0.001      P<0.001      P<0.001  |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       598.0        603.0        523.4        385.6    |                                                 
 |NATURAL DEATHS (C)      |       (50.7)       (17.7)       ( 9.7)       ( 4.9)   |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       711.5        674.4        523.4        385.6    |                                                 
 |(STANDARD ERROR)        |       ( 8.6)       (11.1)       ( 9.7)       ( 4.9)   |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (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)                                                           
                                                                                                                                   
                                  O-NITROTOLUENE                                                                                    
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE MICE                                                                                     
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 0 PPM                                    |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 60     UNCENSORED DEATHS 8      CENSORED DEATHS 0    TERMINAL 52        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      299   362   483   562   592   710   710   725                             |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 1250 PPM                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 60     UNCENSORED DEATHS 14     CENSORED DEATHS 0    TERMINAL 46        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      266   312   343   497   553   608   612   644   658   660                 |                                                 
 |      679   712   721   723                                                     |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 2500 PPM                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 60     UNCENSORED DEATHS 13     CENSORED DEATHS 0    TERMINAL 47        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      553   618   624   661   671   672   673   690   701   701                 |                                                 
 |      709   710   715                                                           |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                  O-NITROTOLUENE                                                                                    
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE MICE                                                                                     
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 5000 PPM                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 60     UNCENSORED DEATHS 55     CENSORED DEATHS 0    TERMINAL 5         |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      403   409   444   444   488   507   516   522   548   567                 |                                                 
 |      567   569   575   579   581   583   583   588   590   597                 |                                                 
 |      605   608   609   610   611   619   624   629   630   640                 |                                                 
 |      643   647   658   659   661   661   668   669   671   675                 |                                                 
 |      677   679   685   686   686   688   690   690   693   696                 |                                                 
 |      702   710   710   722   725                                               |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                  O-NITROTOLUENE                                                                                    
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE MICE                                                                                     
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
 ==================================================================================                                                 
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |    DOSE                               TIME (DAYS)                              |                                                 
 |                 90   180   270   365   425   485   545   605   665   729 (A)   |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |           |                                                                    |                                                 
 |0 PPM      |   100.0 100.0 100.0  96.7  96.7  95.0  95.0  91.7  91.7  86.7      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |1250 PPM   |   100.0 100.0  98.3  95.0  95.0  95.0  93.3  91.7  83.3  76.7      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |2500 PPM   |   100.0 100.0 100.0 100.0 100.0 100.0 100.0  98.3  93.3  78.3      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |5000 PPM   |   100.0 100.0 100.0 100.0  96.7  93.3  86.7  65.0  40.0   8.3      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                  DOSE                          |                                                 
 |                                                                                |                                                 
 |                                0 PPM        1250 PPM     2500 PPM     5000 PPM |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       86.7%        76.7%        78.3%         8.3%    |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |       P<0.001      P=0.236      P=0.355      P<0.001  |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       555.4        570.6        669.1        616.3    |                                                 
 |NATURAL DEATHS (C)      |       (57.7)       (41.9)       (12.9)       (10.6)   |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       705.9        692.0        716.0        625.7    |                                                 
 |(STANDARD ERROR)        |       (10.6)       (12.9)       ( 4.2)       (10.6)   |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (A)  FIRST TERMINAL SACRIFICE                                                                                                
       (B)  THE FIRST ENTRY IS THE TREND TEST (TARONE, 1975) RESULT.                                                                
            SUBSEQUENT ENTRIES ARE THE RESULTS OF PAIRWISE TESTS                                                                    
            (COX,1972).  NEGATIVE TRENDS ARE INDICATED BY "N".                                                                      
       (C)  MEAN OF ALL UNCENSORED DEATHS PRIOR TO TERMINAL SACRIFICE                                                               
       (D)  MEAN OF ALL DEATHS (UNCENSORED, CENSORED, TERMINAL SACRIFICE)                                                           
                                                                                                                                   
                                                           O-NITROTOLUENE                                                           
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        0 PPM            = 1                                                        
                                                        1250 PPM         = 2                                                        
                                                        2500 PPM         = 3                                                        
                                                        5000 PPM         = 4                                                        
                                                                                                                                    
------------------------------------------------------ SPECIES=MICE SEX=MALE -------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
         |                                                                                                                          
         |                                                                                                                          
  106.67 +                                                                                                                          
         |                                                                                                                          
         |1                                         134  43                       22                    1                           
         |                                               43         3      3       22                   11  1                       
   93.33 +                                                4 4 4            333      2  2      2             1 1 1                   
         |                                                    4 44           33   3           2 2               1         11        
         |                                                       44               3 3           2 2 2                      1  1     
         |                                                        444                               22  2                           
P  80.00 +                                                                          33                  2 2  2                      
E        |                                                                           3 33                    222                    
R        |                                                          44                                         2 2                  
C        |                                                                              33                       2    22            
E  66.67 +                                                                               3 3                                        
N        |                                                           4 4                   3 3                         2  22        
T        |                                                             44                    33                            22       
         |                                                                                    33                            2 2     
S  53.33 +                                                                                                                          
U        |                                                              44                     33                                   
R        |                                                                                      33                                  
V        |                                                               44                      33                                 
I  40.00 +                                                                                                                          
V        |                                                                                                                          
A        |                                                                44                      33                                
L        |                                                                                                                          
   26.67 +                                                                                                                          
         |                                                                                         33                               
         |                                                                 44                                                       
         |                                                                                          3 3                             
   13.33 +                                                                  44                        3 3                           
         |                                                                                              33                          
         |                                                                   4 4  4                      3  33                      
         |                                                                        44                         3  3        3          
    0.00 +                                                                         4                                     3          
         |                                                                                                                          
         -+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+
          0         10         20         30         40         50         60         70         80         90         100       110
                                                                                                                                    
                                                                     WEEK                                                           
                                                                                                                                    
NOTE: 28 obs hidden.                                                                                                                
                                                                                                                                   
                                                           O-NITROTOLUENE                                                           
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        0 PPM            = 1                                                        
                                                        1250 PPM         = 2                                                        
                                                        2500 PPM         = 3                                                        
                                                        5000 PPM         = 4                                                        
                                                                                                                                    
----------------------------------------------------- SPECIES=MICE SEX=FEMALE ------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
      |                                                                                                                             
  100 + 1                                         2    1                4                      3                                    
      |                                           2    1  2   2  1      44    4     1          3          33                        
      |                                                       2                     1 2          1         3     3                  
      |                                                                       4      42 4      2 1    1 2        33     1           
   90 +                                                                                 44              22        33                
      |                                                                                  4 4   4         2   2 2   3 3 31 1 1       
      |                                                                                        4 4             2 2                  
      |                                                                                          44              2 2   32           
   80 +                                                                                           44                    22          
      |                                                                                                                  22 2       
      |                                                                                            44                               
      |                                                                                                                             
P  70 +                                                                                             4 4                             
E     |                                                                                               444                           
R     |                                                                                                                             
C     |                                                                                                 44                          
E  60 +                                                                                                                             
N     |                                                                                                  444                        
T     |                                                                                                                             
      |                                                                                                    4 4                      
S  50 +                                                                                                                             
U     |                                                                                                      444                    
R     |                                                                                                        4 4                  
V     |                                                                                                                             
I  40 +                                                                                                          44                 
V     |                                                                                                                             
A     |                                                                                                           44                
L     |                                                                                                                             
   30 +                                                                                                            44               
      |                                                                                                                             
      |                                                                                                             44              
      |                                                                                                                             
   20 +                                                                                                                             
      |                                                                                                              444            
      |                                                                                                                44           
      |                                                                                                                 4 4         
   10 +                                                                                                                             
      |                                                                                                                   4 4       
      |                                                                                                                             
      |                                                                                                                             
    0 +                                                                                                                             
      |                                                                                                                             
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110 
                                                                                                                                    
                                                                   WEEK                                                             
                                                                                                                                    
NOTE: 25 obs hidden.