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TDMS Study 92012-06 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Southern Research Inst                                2-METHYLIMIDAZOLE                                   DATE: 02/25/03       
EXPERIMENT: 92012 TEST: 06                                                                                     TIME: 07:42:42       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-85420                              ROUTE: DOSED FEED                                              NTP C#: 92012B       
PATHOLOGIST: HEATH, JAMES E.                                                                                   CAS: 693-98-1        
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                            FINAL#1/MICE                                                            
                                                                                                                                    
                                                                                                                                    
               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: 02/25/03       
EXPERIMENT: 92012 TEST: 06                                                                                     TIME: 07:42:42       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-85420                              ROUTE: DOSED FEED                                              NTP C#: 92012B       
PATHOLOGIST: HEATH, JAMES E.                                                                                   CAS: 693-98-1        
                                                                                                                                   
                                 2-METHYLIMIDAZOLE                                                                                  
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE MICE                                                                                      
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 0PPM                                     |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 7      CENSORED DEATHS 0    TERMINAL 43        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      24    611   650   657   668   668   694                                   |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 625 PPM                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 4      CENSORED DEATHS 0    TERMINAL 46        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      40    657   696   726                                                     |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 1250 PPM                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 14     CENSORED DEATHS 0    TERMINAL 36        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      7     7     7     21    22    400   512   531   611   623                 |                                                 
 |      654   659   706   718                                                     |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                 2-METHYLIMIDAZOLE                                                                                  
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE MICE                                                                                      
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 2500 PPM                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 10     CENSORED DEATHS 0    TERMINAL 40        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      7     7     7     21    531   654   656   693   695   701                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                 2-METHYLIMIDAZOLE                                                                                  
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE MICE                                                                                      
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
 ==================================================================================                                                 
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |    DOSE                               TIME (DAYS)                              |                                                 
 |                 90   180   270   365   425   485   545   605   665   729 (A)   |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |           |                                                                    |                                                 
 |0PPM       |    98.0  98.0  98.0  98.0  98.0  98.0  98.0  98.0  92.0  86.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |625 PPM    |    98.0  98.0  98.0  98.0  98.0  98.0  98.0  98.0  96.0  92.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |1250 PPM   |    90.0  90.0  90.0  90.0  88.0  88.0  84.0  84.0  76.0  72.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |2500 PPM   |    92.0  92.0  92.0  92.0  92.0  92.0  90.0  90.0  86.0  80.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                  DOSE                          |                                                 
 |                                                                                |                                                 
 |                                0PPM         625 PPM      1250 PPM     2500 PPM |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       86.0%        92.0%        72.0%        80.0%    |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |       P=0.197      P=0.497N     P=0.111      P=0.557  |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       567.4        529.8        391.3        397.2    |                                                 
 |NATURAL DEATHS (C)      |       (91.1)       ( 164)       (81.2)       ( 106)   |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       706.4        713.1        634.4        662.6    |                                                 
 |(STANDARD ERROR)        |       (14.4)       (13.8)       (31.0)       (27.8)   |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (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)                                                           
                                                                                                                                   
                                 2-METHYLIMIDAZOLE                                                                                  
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE MICE                                                                                     
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 0PPM                                     |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 4      CENSORED DEATHS 0    TERMINAL 46        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      402   533   651   723                                                     |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 625 PPM                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 49     UNCENSORED DEATHS 6      CENSORED DEATHS 0    TERMINAL 43        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      400   606   620   639   688   720                                         |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 1250 PPM                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 49     UNCENSORED DEATHS 6      CENSORED DEATHS 0    TERMINAL 43        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      128   555   623   658   693   720                                         |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                 2-METHYLIMIDAZOLE                                                                                  
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE MICE                                                                                     
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 2500 PPM                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 5      CENSORED DEATHS 0    TERMINAL 45        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      517   604   664   720   727                                               |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                 2-METHYLIMIDAZOLE                                                                                  
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE MICE                                                                                     
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
 ==================================================================================                                                 
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |    DOSE                               TIME (DAYS)                              |                                                 
 |                 90   180   270   365   425   485   545   605   665   729 (A)   |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |           |                                                                    |                                                 
 |0PPM       |   100.0 100.0 100.0 100.0  98.0  98.0  96.0  96.0  94.0  92.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |625 PPM    |   100.0 100.0 100.0 100.0  98.0  98.0  98.0  98.0  91.8  87.8      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |1250 PPM   |   100.0  98.0  98.0  98.0  98.0  98.0  98.0  95.9  91.8  87.8      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |2500 PPM   |   100.0 100.0 100.0 100.0 100.0 100.0  98.0  96.0  94.0  90.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                  DOSE                          |                                                 
 |                                                                                |                                                 
 |                                0PPM         625 PPM      1250 PPM     2500 PPM |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       92.0%        87.8%        87.8%        90.0%    |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |       P=0.989      P=0.703      P=0.708      P=1.000  |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       577.3        612.2        562.8        646.4    |                                                 
 |NATURAL DEATHS (C)      |       (70.3)       (45.9)       (90.1)       (39.2)   |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       716.9        714.7        708.7        720.7    |                                                 
 |(STANDARD ERROR)        |       ( 7.7)       ( 7.6)       (12.9)       ( 5.0)   |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (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                                                        
                                                        625 PPM          = 2                                                        
                                                        1250 PPM         = 3                                                        
                                                        2500 PPM         = 4                                                        
                                                                                                                                    
------------------------------------------------------ SPECIES=MICE SEX=MALE -------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
      |                                                                                                                             
      |                                                                                                                             
  100 + 13  1  2                                                                                                                    
      |                                                                                                                             
      |     1  2                                                                                         1     2                    
      |                                                                                                                             
   96 +                                                                                                  1    12      2             
      |                                                                                                                             
P     |  3 3                                                                                                  11      2   2         
E     |                                                                                                                             
R  92 +    33                                                                               4                  1  1       2 2       
C     |                                                                                                                             
E     |     3                                                           3                   4                  4                    
N     |                                                                                                                             
T  88 +                                                                 3                3                        1   1             
      |                                                                                                                             
S     |                                                                                  3  3                  4     41     1       
U     |                                                                                                                             
R  84 +                                                                                     3            3           44             
V     |                                                                                                                             
I     |                                                                                                  33           44            
V     |                                                                                                                             
A  80 +                                                                                                   3    3       4    4       
L     |                                                                                                                             
      |                                                                                                        3 3                  
      |                                                                                                                             
   76 +                                                                                                          3     3            
      |                                                                                                                             
      |                                                                                                                3 3          
      |                                                                                                                             
   72 +                                                                                                                  3  3       
      |                                                                                                                             
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110 
                                                                                                                                    
                                                                   WEEK                                                             
                                                                                                                                    
NOTE: 7 obs hidden.                                                                                                                 
                                                                                                                                   
                                                         2-METHYLIMIDAZOLE                                                          
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        0PPM             = 1                                                        
                                                        625 PPM          = 2                                                        
                                                        1250 PPM         = 3                                                        
                                                        2500 PPM         = 4                                                        
                                                                                                                                    
----------------------------------------------------- SPECIES=MICE SEX=FEMALE ------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
      |                                                                                                                             
      |                                                                                                                             
  100 + 1                    3                                          1                4                                          
      |                                                                                                                             
      |                                                                                                                             
      |                                                                                                                             
   98 +                      3                                          1                4   1  3       2                           
      |                                                                                                                             
P     |                                                                                                                             
E     |                                                                                                                             
R  96 +                                                                                      1  3       2 2   1  4                  
C     |                                                                                                                             
E     |                                                                                                                             
N     |                                                                                                                             
T  94 +                                                                                                   2  213 4       41         
      |                                                                                                                             
S     |                                                                                                                             
U     |                                                                                                                             
R  92 +                                                                                                      2 3     2   41 1       
V     |                                                                                                                             
I     |                                                                                                                             
V     |                                                                                                                             
A  90 +                                                                                                              2   24 4       
L     |                                                                                                                             
      |                                                                                                                             
      |                                                                                                                             
   88 +                                                                                                                  2  2       
      |                                                                                                                             
      |                                                                                                                             
      |                                                                                                                             
   86 +                                                                                                                             
      |                                                                                                                             
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110 
                                                                                                                                    
                                                                   WEEK                                                             
                                                                                                                                    
NOTE: 15 obs hidden.