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TDMS Study 93023-07 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Southern Research Inst                                  2,4-HEXADIENAL                                    DATE: 02/15/01       
EXPERIMENT: 93023 TEST: 07                                                                                     TIME: 11:24:04       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-55393                              ROUTE: GAVAGE                                                  NTP C#: 93023B       
PATHOLOGIST: FARNELL, DANIEL R.                                                                                CAS: 142-83-6        
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                           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                                  2,4-HEXADIENAL                                    DATE: 02/15/01       
EXPERIMENT: 93023 TEST: 07                                                                                     TIME: 11:24:04       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-55393                              ROUTE: GAVAGE                                                  NTP C#: 93023B       
PATHOLOGIST: FARNELL, DANIEL R.                                                                                CAS: 142-83-6        
                                                                                                                                   
                                  2,4-HEXADIENAL                                                                                    
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE MICE                                                                                      
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                          DOSE = 0       MG/KG/DY                               |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 6      CENSORED DEATHS 0    TERMINAL 44        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      568   603   670   698   701   718                                         |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                          DOSE = 30      MG/KG/DY                               |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 11     CENSORED DEATHS 0    TERMINAL 39        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      353   400   504   533   544   631   643   646   650   672                 |                                                 
 |      675                                                                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                          DOSE = 60      MG/KG/DY                               |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 6      CENSORED DEATHS 0    TERMINAL 44        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      352   587   637   649   680   704                                         |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                  2,4-HEXADIENAL                                                                                    
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE MICE                                                                                      
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                          DOSE = 120     MG/KG/DY                               |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 11     CENSORED DEATHS 0    TERMINAL 39        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      239   504   558   573   595   606   627   643   690   709                 |                                                 
 |      713                                                                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                  2,4-HEXADIENAL                                                                                    
                       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          |   100.0 100.0 100.0 100.0 100.0 100.0 100.0  96.0  96.0  88.0      |                                                 
 |MG/KG/DY   |                                                                    |                                                 
 |           |                                                                    |                                                 
 |30         |   100.0 100.0 100.0  98.0  96.0  96.0  90.0  90.0  82.0  78.0      |                                                 
 |MG/KG/DY   |                                                                    |                                                 
 |           |                                                                    |                                                 
 |60         |   100.0 100.0 100.0  98.0  98.0  98.0  98.0  96.0  92.0  88.0      |                                                 
 |MG/KG/DY   |                                                                    |                                                 
 |           |                                                                    |                                                 
 |120        |   100.0 100.0  98.0  98.0  98.0  98.0  96.0  90.0  84.0  78.0      |                                                 
 |MG/KG/DY   |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                  DOSE                          |                                                 
 |                                                                                |                                                 
 |                                0            30           60           120      |                                                 
 |                                MG/KG/DY     MG/KG/DY     MG/KG/DY     MG/KG/DY |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       88.0%        78.0%        88.0%        78.0%    |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |       P=0.387      P=0.237      P=1.000      P=0.253  |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       659.7        568.3        601.5        587.0    |                                                 
 |NATURAL DEATHS (C)      |       (24.7)       (33.7)       (52.5)       (39.9)   |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       720.7        693.6        713.7        697.8    |                                                 
 |(STANDARD ERROR)        |       ( 4.2)       (11.9)       ( 8.3)       (11.9)   |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (A)  FIRST TERMINAL SACRIFICE                                                                                                
       (B)  THE FIRST ENTRY IS THE TREND TEST (TARONE, 1975) RESULT.                                                                
            SUBSEQUENT ENTRIES ARE THE RESULTS OF PAIRWISE TESTS                                                                    
            (COX,1972).  NEGATIVE TRENDS ARE INDICATED BY "N".                                                                      
       (C)  MEAN OF ALL UNCENSORED DEATHS PRIOR TO TERMINAL SACRIFICE                                                               
       (D)  MEAN OF ALL DEATHS (UNCENSORED, CENSORED, TERMINAL SACRIFICE)                                                           
                                                                                                                                   
                                  2,4-HEXADIENAL                                                                                    
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE MICE                                                                                     
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                          DOSE = 0       MG/KG/DY                               |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 8      CENSORED DEATHS 0    TERMINAL 42        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      538   538   609   635   653   698   712   726                             |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                          DOSE = 30      MG/KG/DY                               |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 12     CENSORED DEATHS 1    TERMINAL 37        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      349   587   616   643   649   664   683   684   685   710                 |                                                 
 |      713   713                                                                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      708                                                                       |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                          DOSE = 60      MG/KG/DY                               |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 13     CENSORED DEATHS 0    TERMINAL 37        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      533   587   627   635   637   643   649   661   672   687                 |                                                 
 |      716   725   726                                                           |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                  2,4-HEXADIENAL                                                                                    
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE MICE                                                                                     
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                          DOSE = 120     MG/KG/DY                               |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 10     CENSORED DEATHS 1    TERMINAL 39        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      543   594   614   637   638   643   657   669   716   725                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      239                                                                       |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                  2,4-HEXADIENAL                                                                                    
                       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          |   100.0 100.0 100.0 100.0 100.0 100.0  96.0  96.0  90.0  84.0      |                                                 
 |MG/KG/DY   |                                                                    |                                                 
 |           |                                                                    |                                                 
 |30         |   100.0 100.0 100.0  98.0  98.0  98.0  98.0  96.0  88.0  75.9      |                                                 
 |MG/KG/DY   |                                                                    |                                                 
 |           |                                                                    |                                                 
 |60         |   100.0 100.0 100.0 100.0 100.0 100.0  98.0  96.0  84.0  74.0      |                                                 
 |MG/KG/DY   |                                                                    |                                                 
 |           |                                                                    |                                                 
 |120        |   100.0 100.0 100.0 100.0 100.0 100.0  98.0  95.9  85.7  79.6      |                                                 
 |MG/KG/DY   |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                  DOSE                          |                                                 
 |                                                                                |                                                 
 |                                0            30           60           120      |                                                 
 |                                MG/KG/DY     MG/KG/DY     MG/KG/DY     MG/KG/DY |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       84.0%        75.9%        74.0%        79.6%    |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |       P=0.776      P=0.447      P=0.327      P=0.751  |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       638.6        641.3        653.7        643.6    |                                                 
 |NATURAL DEATHS (C)      |       (26.0)       (28.9)       (15.2)       (17.1)   |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       714.5        707.5        709.4        702.1    |                                                 
 |(STANDARD ERROR)        |       ( 6.2)       ( 8.6)       ( 6.1)       (11.1)   |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (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)                                                           
                                                                                                                                   
                                                           2,4-HEXADIENAL                                                           
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        0       MG/KG/DY = 1                                                        
                                                        30      MG/KG/DY = 2                                                        
                                                        60      MG/KG/DY = 3                                                        
                                                        120     MG/KG/DY = 4                                                        
                                                                                                                                    
------------------------------------------------------ SPECIES=MICE SEX=MALE -------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
      |                                                                                                                             
      |                                                                                                                             
  100 + 1                                      4                2                                 1                                 
      |                                                                                                                             
      |                                        4                2       2              4          1 3   1                           
      |                                                                                                                             
P  96 +                                                                 2              2        4   3   1   3     1                 
E     |                                                                                                                             
R     |                                                                                2     2  4 4         3 3   1   1             
C     |                                                                                                                             
E  92 +                                                                                      22   4   4       3     3 11            
N     |                                                                                                                             
T     |                                                                                       2       4 4   2       3  1 1          
      |                                                                                                                             
S  88 +                                                                                                 4  422         3 1  1       
U     |                                                                                                                             
R     |                                                                                                    4 22                     
V     |                                                                                                                             
I  84 +                                                                                                      4       4              
V     |                                                                                                                             
A     |                                                                                                       2   2  4  4           
L     |                                                                                                                             
   80 +                                                                                                           22                
      |                                                                                                                             
      |                                                                                                            2    4   2       
      |                                                                                                                             
   76 +                                                                                                                             
      |                                                                                                                             
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110 
                                                                                                                                    
                                                                   WEEK                                                             
                                                                                                                                    
NOTE: 10 obs hidden.                                                                                                                
                                                                                                                                   
                                                           2,4-HEXADIENAL                                                           
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        0       MG/KG/DY = 1                                                        
                                                        30      MG/KG/DY = 2                                                        
                                                        60      MG/KG/DY = 3                                                        
                                                        120     MG/KG/DY = 4                                                        
                                                                                                                                    
----------------------------------------------------- SPECIES=MICE SEX=FEMALE ------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
      |                                                                                                                             
      |                                                                                                                             
  100 + 1                                                      2                             14                                     
      |                                                                                                                             
      |                                                        2                             34     2 4                             
      |                                                                                      1      2 4 12 3                        
P  95 +                                                                                                                             
E     |                                                                                                 12 312                      
R     |                                                                                                     1221                    
C     |                                                                                                     44                      
E  90 +                                                                                                     3321 2    1             
N     |                                                                                                                             
T     |                                                                                                      334 2  2 1 1           
      |                                                                                                       34 34     1 1         
S  85 +                                                                                                                             
U     |                                                                                                          33      41 1       
R     |                                                                                                           3 23  2           
V     |                                                                                                                  44         
I  80 +                                                                                                              3   34 4       
V     |                                                                                                                             
A     |                                                                                                                  33         
L     |                                                                                                                 2   2       
   75 +                                                                                                                             
      |                                                                                                                   3 3       
      |                                                                                                                             
      |                                                                                                                             
   70 +                                                                                                                             
      |                                                                                                                             
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110 
                                                                                                                                    
                                                                   WEEK                                                             
                                                                                                                                    
NOTE: 12 obs hidden.