National Toxicology Program

National Toxicology Program
https://ntp.niehs.nih.gov/go/18917

TDMS Study 92013-06 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Southern Research Inst                                4-METHYLIMIDAZOLE                                   DATE: 01/12/04       
EXPERIMENT: 92013 TEST: 06                                                                                     TIME: 14:45:36       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-85420                              ROUTE: DOSED FEED                                              NTP C#: 92013B       
PATHOLOGIST: HEATH, JAMES                                                                                      CAS: 822-36-6        
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                           FINAL #1 MICE                                                            
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
                                                                                                                                   
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Southern Research Inst                                4-METHYLIMIDAZOLE                                   DATE: 01/12/04       
EXPERIMENT: 92013 TEST: 06                                                                                     TIME: 14:45:36       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-85420                              ROUTE: DOSED FEED                                              NTP C#: 92013B       
PATHOLOGIST: HEATH, JAMES                                                                                      CAS: 822-36-6        
                                                                                                                                   
                                 4-METHYLIMIDAZOLE                                                                                  
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE MICE                                                                                      
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 0 PPM                                    |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 5      CENSORED DEATHS 0    TERMINAL 45        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      459   513   685   695   715                                               |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 312 PPM                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 6      CENSORED DEATHS 0    TERMINAL 44        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      335   586   613   676   715   716                                         |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 625 PPM                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 8      CENSORED DEATHS 0    TERMINAL 42        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      348   441   522   535   569   623   632   686                             |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                 4-METHYLIMIDAZOLE                                                                                  
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE MICE                                                                                      
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 1250 PPM                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 49     UNCENSORED DEATHS 3      CENSORED DEATHS 0    TERMINAL 46        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      537   628   645                                                           |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                 4-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)   |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |           |                                                                    |                                                 
 |0 PPM      |   100.0 100.0 100.0 100.0 100.0  98.0  96.0  96.0  96.0  90.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |312 PPM    |   100.0 100.0 100.0  98.0  98.0  98.0  98.0  96.0  94.0  88.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |625 PPM    |   100.0 100.0 100.0  98.0  98.0  96.0  92.0  90.0  86.0  84.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |1250 PPM   |   100.0 100.0 100.0 100.0 100.0 100.0  98.0  98.0  93.9  93.9      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                  DOSE                          |                                                 
 |                                                                                |                                                 
 |                                0 PPM        312 PPM      625 PPM      1250 PPM |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       90.0%        88.0%        84.0%        93.9%    |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |       P=0.631N     P=0.990      P=0.514      P=0.735N |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       613.4        606.8        544.5        603.3    |                                                 
 |NATURAL DEATHS (C)      |       (52.9)       (58.5)       (38.8)       (33.5)   |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       717.4        714.3        699.5        721.3    |                                                 
 |(STANDARD ERROR)        |       ( 6.9)       ( 8.6)       (11.3)       ( 4.7)   |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (A)  FIRST TERMINAL SACRIFICE                                                                                                
       (B)  THE FIRST ENTRY IS THE TREND TEST (TARONE, 1975) RESULT.                                                                
            SUBSEQUENT ENTRIES ARE THE RESULTS OF PAIRWISE TESTS                                                                    
            (COX,1972).  NEGATIVE TRENDS ARE INDICATED BY "N".                                                                      
       (C)  MEAN OF ALL UNCENSORED DEATHS PRIOR TO TERMINAL SACRIFICE                                                               
       (D)  MEAN OF ALL DEATHS (UNCENSORED, CENSORED, TERMINAL SACRIFICE)                                                           
                                                                                                                                   
                                 4-METHYLIMIDAZOLE                                                                                  
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE MICE                                                                                     
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 0 PPM                                    |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 7      CENSORED DEATHS 0    TERMINAL 43        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      114   539   539   555   593   706   707                                   |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 312 PPM                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 10     CENSORED DEATHS 0    TERMINAL 40        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      525   629   632   656   668   697   702   705   721   727                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 625 PPM                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 7      CENSORED DEATHS 0    TERMINAL 43        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      539   541   635   684   685   707   720                                   |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                 4-METHYLIMIDAZOLE                                                                                  
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE MICE                                                                                     
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 1250 PPM                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 10     CENSORED DEATHS 0    TERMINAL 40        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      409   447   552   569   640   647   665   685   687   711                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                 4-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)   |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |           |                                                                    |                                                 
 |0 PPM      |   100.0  98.0  98.0  98.0  98.0  98.0  94.0  90.0  90.0  86.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |312 PPM    |   100.0 100.0 100.0 100.0 100.0 100.0  98.0  98.0  92.0  80.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |625 PPM    |   100.0 100.0 100.0 100.0 100.0 100.0  96.0  96.0  94.0  86.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |1250 PPM   |   100.0 100.0 100.0 100.0  98.0  96.0  96.0  92.0  86.0  80.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                  DOSE                          |                                                 
 |                                                                                |                                                 
 |                                0 PPM        312 PPM      625 PPM      1250 PPM |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       86.0%        80.0%        86.0%        80.0%    |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |       P=0.635      P=0.635      P=1.000N     P=0.601  |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       536.1        666.2        644.4        601.2    |                                                 
 |NATURAL DEATHS (C)      |       (75.6)       (19.2)       (28.8)       (33.0)   |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       702.0        716.4        717.2        703.4    |                                                 
 |(STANDARD ERROR)        |       (13.8)       ( 5.1)       ( 5.6)       ( 9.7)   |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (A)  FIRST TERMINAL SACRIFICE                                                                                                
       (B)  THE FIRST ENTRY IS THE TREND TEST (TARONE, 1975) RESULT.                                                                
            SUBSEQUENT ENTRIES ARE THE RESULTS OF PAIRWISE TESTS                                                                    
            (COX,1972).  NEGATIVE TRENDS ARE INDICATED BY "N".                                                                      
       (C)  MEAN OF ALL UNCENSORED DEATHS PRIOR TO TERMINAL SACRIFICE                                                               
       (D)  MEAN OF ALL DEATHS (UNCENSORED, CENSORED, TERMINAL SACRIFICE)                                                           
                                                                                                                                   
                                                         4-METHYLIMIDAZOLE                                                          
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        0 PPM            = 1                                                        
                                                        312 PPM          = 2                                                        
                                                        625 PPM          = 3                                                        
                                                        1250 PPM         = 4                                                        
                                                                                                                                    
------------------------------------------------------ SPECIES=MICE SEX=MALE -------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
      |                                                                                                                             
      |                                                                                                                             
  100 + 1                                                    2 3                 1           4                                      
      |                                                                                                                             
      |                                                                                                                             
      |                                                                                                                             
   98 +                                                      2 3             3   1       1   4      2      4                        
      |                                                                                                                             
      |                                                                                                                             
      |                                                                                                                             
P  96 +                                                                      3           1 3        2    2 4  4     1               
E     |                                                                                                                             
R     |                                                                                                                             
C     |                                                                                                                             
E  94 +                                                                                    3 3           2    4    21 1     4       
N     |                                                                                                                             
T     |                                                                                                                             
      |                                                                                                                             
S  92 +                                                                                      3    3                2  1  1          
U     |                                                                                                                             
R     |                                                                                                                             
V     |                                                                                                                             
I  90 +                                                                                           3       3              1  1       
V     |                                                                                                                             
A     |                                                                                                                             
L     |                                                                                                                             
   88 +                                                                                                   3 3            2  2       
      |                                                                                                                             
      |                                                                                                                             
      |                                                                                                                             
   86 +                                                                                                     3       3               
      |                                                                                                                             
      |                                                                                                                             
      |                                                                                                                             
   84 +                                                                                                             3       3       
      |                                                                                                                             
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110 
                                                                                                                                    
                                                                   WEEK                                                             
                                                                                                                                    
NOTE: 4 obs hidden.                                                                                                                 
                                                                                                                                   
                                                         4-METHYLIMIDAZOLE                                                          
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        0 PPM            = 1                                                        
                                                        312 PPM          = 2                                                        
                                                        625 PPM          = 3                                                        
                                                        1250 PPM         = 4                                                        
                                                                                                                                    
----------------------------------------------------- SPECIES=MICE SEX=FEMALE ------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
      |                                                                                                                             
  100 + 1                  1                                             4                 2 3                                      
      |                                                                                                                             
      |                                                                                                                             
      |                                                                                                                             
   98 +                    1                                             4    4            2 13            2                        
      |                                                                                                                             
      |                                                                                                                             
      |                                                                                                                             
   96 +                                                                       4               34           22                       
      |                                                                                                                             
      |                                                                                                                             
      |                                                                                                                             
P  94 +                                                                                      1 41 4         2  2    3               
E     |                                                                                                                             
R     |                                                                                                                             
C     |                                                                                                                             
E  92 +                                                                                         1 4   1      4 2  2                 
N     |                                                                                                                             
T     |                                                                                                                             
      |                                                                                                                             
S  90 +                                                                                               1      44   2 3 21            
U     |                                                                                                                             
R     |                                                                                                                             
V     |                                                                                                                             
I  88 +                                                                                                       4  4    22 3          
V     |                                                                                                                             
A     |                                                                                                                             
L     |                                                                                                                             
   86 +                                                                                                          4  4  1 3  1       
      |                                                                                                                             
      |                                                                                                                             
      |                                                                                                                             
   84 +                                                                                                             44 2 2          
      |                                                                                                                             
      |                                                                                                                             
      |                                                                                                                             
   82 +                                                                                                              4  422         
      |                                                                                                                             
      |                                                                                                                             
      |                                                                                                                             
   80 +                                                                                                                 4 2 2       
      |                                                                                                                             
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110 
                                                                                                                                    
                                                                   WEEK                                                             
                                                                                                                                    
NOTE: 10 obs hidden.                                                                                                                
NTP is located at the National Institute of Environmental Health Sciences, part of the National Institutes of Health.