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TDMS Study 92013-05 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Southern Research Inst                                4-METHYLIMIDAZOLE                                   DATE: 12/06/04       
EXPERIMENT: 92013 TEST: 05                                                                                     TIME: 08:46:17       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-85420                              ROUTE: DOSED FEED                                              NTP C#: 92013B       
PATHOLOGIST: FARNELL, DANIEL R.                                                                                CAS: 822-36-6        
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                           FINAL #1 RATS                                                            
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
                                                                                                                                   
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Southern Research Inst                                4-METHYLIMIDAZOLE                                   DATE: 12/06/04       
EXPERIMENT: 92013 TEST: 05                                                                                     TIME: 08:46:17       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-85420                              ROUTE: DOSED FEED                                              NTP C#: 92013B       
PATHOLOGIST: FARNELL, DANIEL R.                                                                                CAS: 822-36-6        
                                                                                                                                   
                                 4-METHYLIMIDAZOLE                                                                                  
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE RATS                                                                                      
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 0 PPM                                    |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 19     CENSORED DEATHS 0    TERMINAL 31        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      464   547   582   589   597   642   653   667   667   685                 |                                                 
 |      685   700   700   700   705   709   712   722   723                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 625 PPM                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 16     CENSORED DEATHS 0    TERMINAL 34        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      275   275   477   516   547   567   577   593   621   637                 |                                                 
 |      665   694   695   700   700   712                                         |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 1250 PPM                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 17     CENSORED DEATHS 0    TERMINAL 33        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      493   498   531   538   594   605   635   642   642   650                 |                                                 
 |      653   694   700   700   706   712   717                                   |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                 4-METHYLIMIDAZOLE                                                                                  
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE RATS                                                                                      
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 2500 PPM                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 18     CENSORED DEATHS 0    TERMINAL 32        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      369   384   584   607   622   622   628   632   650   650                 |                                                 
 |      651   653   663   666   670   689   693   704                             |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                 4-METHYLIMIDAZOLE                                                                                  
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE RATS                                                                                      
                       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      |   100.0 100.0 100.0 100.0 100.0  98.0  98.0  90.0  86.0  62.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |625 PPM    |   100.0 100.0 100.0  96.0  96.0  94.0  92.0  84.0  78.0  68.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |1250 PPM   |   100.0 100.0 100.0 100.0 100.0 100.0  92.0  88.0  78.0  66.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |2500 PPM   |   100.0 100.0 100.0 100.0  96.0  96.0  96.0  94.0  74.0  64.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                  DOSE                          |                                                 
 |                                                                                |                                                 
 |                                0 PPM        625 PPM      1250 PPM     2500 PPM |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       62.0%        68.0%        66.0%        64.0%    |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |       P=0.964      P=0.842N     P=0.926N     P=1.000  |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       655.2        578.2        630.0        618.7    |                                                 
 |NATURAL DEATHS (C)      |       (16.0)       (34.6)       (18.3)       (22.0)   |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       701.0        680.7        695.3        689.3    |                                                 
 |(STANDARD ERROR)        |       ( 7.9)       (14.8)       ( 9.1)       (10.8)   |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (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)                                                           
                                                                                                                                   
                                 4-METHYLIMIDAZOLE                                                                                  
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 0 PPM                                    |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 7      CENSORED DEATHS 0    TERMINAL 43        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      16    302   498   624   667   694   700                                   |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 1250 PPM                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 11     CENSORED DEATHS 0    TERMINAL 39        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      421   434   463   536   636   653   657   677   700   705                 |                                                 
 |      712                                                                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 2500 PPM                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 16     CENSORED DEATHS 0    TERMINAL 34        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      104   383   552   555   578   581   619   635   636   638                 |                                                 
 |      653   672   693   700   700   728                                         |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                 4-METHYLIMIDAZOLE                                                                                  
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 5000 PPM                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 15     CENSORED DEATHS 0    TERMINAL 35        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      323   368   538   541   541   628   642   642   654   666                 |                                                 
 |      686   688   705   712   717                                               |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                 4-METHYLIMIDAZOLE                                                                                  
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       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      |    98.0  98.0  98.0  96.0  96.0  96.0  94.0  94.0  92.0  86.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |1250 PPM   |   100.0 100.0 100.0 100.0  98.0  94.0  92.0  92.0  86.0  78.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |2500 PPM   |   100.0  98.0  98.0  98.0  96.0  96.0  96.0  88.0  78.0  68.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |5000 PPM   |   100.0 100.0 100.0  98.0  96.0  96.0  90.0  90.0  82.0  70.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                  DOSE                          |                                                 
 |                                                                                |                                                 
 |                                0 PPM        1250 PPM     2500 PPM     5000 PPM |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       86.0%        78.0%        68.0%        70.0%    |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |       P=0.078      P=0.449      P=0.060      P=0.099  |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       500.1        599.5        589.2        603.4    |                                                 
 |NATURAL DEATHS (C)      |       (96.9)       (34.3)       (38.4)       (31.3)   |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       697.0        700.5        684.3        691.3    |                                                 
 |(STANDARD ERROR)        |       (17.0)       (10.6)       (15.2)       (12.3)   |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (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)                                                           
                                                                                                                                   
                                                         4-METHYLIMIDAZOLE                                                          
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        0 PPM            = 1                                                        
                                                        625 PPM          = 2                                                        
                                                        1250 PPM         = 3                                                        
                                                        2500 PPM         = 4                                                        
                                                                                                                                    
------------------------------------------------------ SPECIES=RATS SEX=MALE -------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
      |                                                                                                                             
  100 + 1                                           2             4               1   3                                             
      |                                                                                                                             
      |                                                           4  4            1   33       1                                    
      |                                                                                                                             
   96 +                                             2                4              2  3    3  1    1                               
      |                                                                                                                             
      |                                                                             2    2  33      1 1 4                           
      |                                                                                                                             
   92 +                                                                                  2   3 2      114 4                         
      |                                                                                                                             
      |                                                                                        2 2    313    1                      
      |                                                                                                                             
P  88 +                                                                                          2 2    3 4431 1                    
E     |                                                                                                                             
R     |                                                                                            2  2    433 1  1                 
C     |                                                                                                                             
E  84 +                                                                                               2   2 4 4                     
N     |                                                                                                                             
T     |                                                                                                   2 233   1 1               
      |                                                                                                                             
S  80 +                                                                                                     2 33 2                  
U     |                                                                                                                             
R     |                                                                                                       43 2  1 1             
V     |                                                                                                                             
I  76 +                                                                                                        4 4                  
V     |                                                                                                                             
A     |                                                                                                          44                 
L     |                                                                                                                             
   72 +                                                                                                               11            
      |                                                                                                                             
      |                                                                                                           4  4211           
      |                                                                                                                             
   68 +                                                                                                                 23  2       
      |                                                                                                                             
      |                                                                                                              4 4131 3       
      |                                                                                                                             
   64 +                                                                                                                4    4       
      |                                                                                                                             
      |                                                                                                                   1 1       
      |                                                                                                                             
   60 +                                                                                                                             
      |                                                                                                                             
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110 
                                                                                                                                    
                                                                   WEEK                                                             
                                                                                                                                    
NOTE: 16 obs hidden.                                                                                                                
                                                                                                                                   
                                                         4-METHYLIMIDAZOLE                                                          
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        0 PPM            = 1                                                        
                                                        1250 PPM         = 2                                                        
                                                        2500 PPM         = 3                                                        
                                                        5000 PPM         = 4                                                        
                                                                                                                                    
----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
      |                                                                                                                             
      |                                                                                                                             
  100 + 1  1             3                                  4              2                                                        
      |                                                                                                                             
      |    1             3                              1   4     4  3     22                                                       
      |                                                                                                                             
   96 +                                                 1         4  3      2     2    1     4 3                                    
      |                                                                                                                             
      |                                                                           2    1     2433          1                        
      |                                                                                                                             
P  92 +                                                                                      2  3  3       12     1                 
E     |                                                                                                                             
R     |                                                                                       4            42  2  1   1             
C     |                                                                                                                             
E  88 +                                                                                            3      34 4                      
N     |                                                                                                                             
T     |                                                                                                   3 3  2   2  1     1       
      |                                                                                                                             
S  84 +                                                                                                      4 4   2  2             
U     |                                                                                                                             
R     |                                                                                                     33 4  4   22            
V     |                                                                                                                             
I  80 +                                                                                                      3 3  4 4  22           
V     |                                                                                                                             
A     |                                                                                                        3  3 44  2   2       
L     |                                                                                                                             
   76 +                                                                                                           3  3 4            
      |                                                                                                                             
      |                                                                                                              3344           
      |                                                                                                                             
   72 +                                                                                                                 44          
      |                                                                                                                             
      |                                                                                                               3  43 4       
      |                                                                                                                             
   68 +                                                                                                                   3 3       
      |                                                                                                                             
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110 
                                                                                                                                    
                                                                   WEEK                                                             
                                                                                                                                    
NOTE: 5 obs hidden.