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TDMS Study 92012-05 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Southern Research Inst                                2-METHYLIMIDAZOLE                                   DATE: 02/24/03       
EXPERIMENT: 92012 TEST: 05                                                                                     TIME: 14:36:23       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-85420                              ROUTE: DOSED FEED                                              NTP C#: 92012B       
PATHOLOGIST: FARNELL, DANIEL R.                                                                                CAS: 693-98-1        
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                           FINAL #1/RATS                                                            
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    25019 Moribund Sacrifice                                                                     
                                       25020 Natural Death                                                                          
                                       25021 Terminal Sacrifice                                                                     
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
                                                                                                                                   
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Southern Research Inst                                2-METHYLIMIDAZOLE                                   DATE: 02/24/03       
EXPERIMENT: 92012 TEST: 05                                                                                     TIME: 14:36:23       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-85420                              ROUTE: DOSED FEED                                              NTP C#: 92012B       
PATHOLOGIST: FARNELL, DANIEL R.                                                                                CAS: 693-98-1        
                                                                                                                                   
                                 2-METHYLIMIDAZOLE                                                                                  
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE RATS                                                                                      
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 0PPM                                     |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 15     CENSORED DEATHS 0    TERMINAL 35        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      315   572   603   638   643   651   668   680   689   694                 |                                                 
 |      694   696   716   722   726                                               |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 300 PPM                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 10     CENSORED DEATHS 0    TERMINAL 40        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      507   521   548   572   605   608   660   668   675   693                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 1000 PPM                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 14     CENSORED DEATHS 0    TERMINAL 36        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      392   439   471   538   548   583   641   644   668   673                 |                                                 
 |      694   696   703   717                                                     |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                 2-METHYLIMIDAZOLE                                                                                  
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE RATS                                                                                      
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 3000 PPM                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 15     CENSORED DEATHS 0    TERMINAL 35        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      249   395   491   562   574   598   598   605   618   687                 |                                                 
 |      689   689   689   702   706                                               |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                 2-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)   |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |           |                                                                    |                                                 
 |0PPM       |   100.0 100.0 100.0  98.0  98.0  98.0  98.0  94.0  88.0  70.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |300 PPM    |   100.0 100.0 100.0 100.0 100.0 100.0  96.0  90.0  86.0  80.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |1000 PPM   |   100.0 100.0 100.0 100.0  98.0  94.0  92.0  88.0  84.0  72.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |3000 PPM   |   100.0 100.0  98.0  98.0  96.0  96.0  94.0  84.0  82.0  70.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                  DOSE                          |                                                 
 |                                                                                |                                                 
 |                                0PPM         300 PPM      1000 PPM     3000 PPM |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       70.0%        80.0%        72.0%        70.0%    |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |       P=0.606      P=0.438N     P=1.000N     P=1.000  |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       647.1        605.7        600.5        590.1    |                                                 
 |NATURAL DEATHS (C)      |       (26.2)       (21.2)       (28.6)       (33.2)   |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       704.4        704.3        693.0        687.3    |                                                 
 |(STANDARD ERROR)        |       ( 9.4)       ( 8.1)       (11.3)       (13.3)   |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (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)                                                           
                                                                                                                                   
                                 2-METHYLIMIDAZOLE                                                                                  
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 0PPM                                     |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 10     CENSORED DEATHS 0    TERMINAL 40        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      328   583   588   602   605   616   653   658   671   703                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 1000 PPM                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 11     CENSORED DEATHS 0    TERMINAL 39        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      425   483   483   538   538   598   638   638   680   680                 |                                                 
 |      702                                                                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 2500 PPM                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 22     CENSORED DEATHS 0    TERMINAL 28        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      244   332   496   526   532   548   548   548   580   598                 |                                                 
 |      605   638   638   641   646   665   668   680   701   702                 |                                                 
 |      702   710                                                                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                 2-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 8      CENSORED DEATHS 0    TERMINAL 42        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      434   638   644   675   689   696   722   722                             |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                 2-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)   |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |           |                                                                    |                                                 
 |0PPM       |   100.0 100.0 100.0  98.0  98.0  98.0  98.0  90.0  84.0  80.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |1000 PPM   |   100.0 100.0 100.0 100.0  98.0  94.0  90.0  88.0  84.0  78.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |2500 PPM   |   100.0 100.0  98.0  96.0  96.0  96.0  90.0  78.0  68.0  56.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |5000 PPM   |   100.0 100.0 100.0 100.0 100.0  98.0  98.0  98.0  94.0  84.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                  DOSE                          |                                                 
 |                                                                                |                                                 
 |                                0PPM         1000 PPM     2500 PPM     5000 PPM |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       80.0%        78.0%        56.0%        84.0%    |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |       P=0.821N     P=0.958      P=0.016      P=0.697N |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       600.7        582.1        588.5        652.5    |                                                 
 |NATURAL DEATHS (C)      |       (32.7)       (28.3)       (25.1)       (33.1)   |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       703.3        696.7        667.2        716.8    |                                                 
 |(STANDARD ERROR)        |       ( 9.7)       (10.6)       (14.8)       ( 6.4)   |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (A)  FIRST TERMINAL SACRIFICE                                                                                                
       (B)  THE FIRST ENTRY IS THE TREND TEST (TARONE, 1975) RESULT.                                                                
            SUBSEQUENT ENTRIES ARE THE RESULTS OF PAIRWISE TESTS                                                                    
            (COX,1972).  NEGATIVE TRENDS ARE INDICATED BY "N".                                                                      
       (C)  MEAN OF ALL UNCENSORED DEATHS PRIOR TO TERMINAL SACRIFICE                                                               
       (D)  MEAN OF ALL DEATHS (UNCENSORED, CENSORED, TERMINAL SACRIFICE)                                                           
                                                                                                                                   
                                                         2-METHYLIMIDAZOLE                                                          
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        0PPM             = 1                                                        
                                                        300 PPM          = 2                                                        
                                                        1000 PPM         = 3                                                        
                                                        3000 PPM         = 4                                                        
                                                                                                                                    
------------------------------------------------------ SPECIES=RATS SEX=MALE -------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
      |                                                                                                                             
      |                                                                                                                             
  100 + 1                                       4         1           3                 2                                           
      |                                                                                                                             
      |                                         4         1           34     3          2  2      1                                 
      |                                                                4     3     3  4    2   2  1     1                           
P  95 +                                                                                                                             
E     |                                                                            3  4      3 2 42     1    1                      
R     |                                                                                      3 3 42     2                           
C     |                                                                                                                             
E  90 +                                                                                        3  4 3  4     11                     
N     |                                                                                                                             
T     |                                                                                             3   2    31  21                 
      |                                                                                                44        21 1               
S  85 +                                                                                                                             
U     |                                                                                                 4 4  3    2211              
R     |                                                                                                   4       32 11             
V     |                                                                                                                             
I  80 +                                                                                                            3 23     2       
V     |                                                                                                                             
A     |                                                                                                                             
L     |                                                                                                               13 1          
   75 +                                                                                                                             
      |                                                                                                              4 3 11         
      |                                                                                                                  3  3       
      |                                                                                                                             
   70 +                                                                                                                4  1 1       
      |                                                                                                                             
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110 
                                                                                                                                    
                                                                   WEEK                                                             
                                                                                                                                    
NOTE: 13 obs hidden.                                                                                                                
                                                                                                                                   
                                                         2-METHYLIMIDAZOLE                                                          
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        0PPM             = 1                                                        
                                                        1000 PPM         = 2                                                        
                                                        2500 PPM         = 3                                                        
                                                        5000 PPM         = 4                                                        
                                                                                                                                    
----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
      |                                                                                                                             
      |                                                                                                                             
  100 + 1                                      3            1              24                                                       
      |                                                                                                                             
      |                                        3            13             24       2               1        4                      
      |                                                      3                        3                                             
   95 +                                                                                                                             
      |                                                                             2 3     32      1  1     4     4                
      |                                                                                                11          4 4              
      |                                                                                                                             
   90 +                                                                                     32 3       211           44             
      |                                                                                                                             
P     |                                                                                                2 1   2 1      4   4         
E     |                                                                                                                             
R  85 +                                                                                                                             
C     |                                                                                        3   3         2 1  1 2     4 4       
E     |                                                                                            3   3          1    1            
N     |                                                                                                                             
T  80 +                                                                                                33           2  1    1       
      |                                                                                                                             
S     |                                                                                                 3    3         2    2       
U     |                                                                                                                             
R  75 +                                                                                                                             
V     |                                                                                                                             
I     |                                                                                                      33                     
V     |                                                                                                                             
A  70 +                                                                                                       3  3                  
L     |                                                                                                                             
      |                                                                                                          33                 
      |                                                                                                           3 3               
   65 +                                                                                                                             
      |                                                                                                             3  3            
      |                                                                                                                             
      |                                                                                                                             
   60 +                                                                                                                             
      |                                                                                                                             
      |                                                                                                                33           
      |                                                                                                                 3   3       
   55 +                                                                                                                             
      |                                                                                                                             
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110 
                                                                                                                                    
                                                                   WEEK                                                             
                                                                                                                                    
NOTE: 4 obs hidden.