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TDMS Study 56111-03 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Battelle Columbus                                    TRANS-CINNAMALDEHYDE                                 DATE: 12/11/02       
EXPERIMENT: 56111 TEST: 03                                                                                     TIME: 10:48:25       
TEST TYPE:  CHRONIC                                                                                            PAGE:       1        
CONT: N01-ES-55384                              ROUTE: DOSED FEED                                              NTP C#: 56111B       
PATHOLOGIST: TOFT, JOHN                                                                                        CAS: 14371-10-9      
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    25022 Accidently Killed                                                                      
                                       25018 Dosing Accident                                                                        
                                       25019 Moribund Sacrifice                                                                     
                                       25020 Natural Death                                                                          
                                       25020 Natural Death                                                                          
                                       25017 Scheduled Sacrifice                                                                    
                                       25021 Terminal Sacrifice                                                                     
                                       25007 Wrong Sex                                                                              
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE 003    VEHICLE CONTROL                                                               
                                       INCLUDE 004    VEHICLE CONTROL                                                               
                                       INCLUDE 005    .312%                                                                         
                                       INCLUDE 006    .312%                                                                         
                                       INCLUDE 007    .625%                                                                         
                                       INCLUDE 008    .625%                                                                         
                                       INCLUDE 009    1.25%                                                                         
                                       INCLUDE 010    1.25%                                                                         
                                                                                                                                   
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Battelle Columbus                                    TRANS-CINNAMALDEHYDE                                 DATE: 12/11/02       
EXPERIMENT: 56111 TEST: 03                                                                                     TIME: 10:48:25       
TEST TYPE:  CHRONIC                                                                                                                 
CONT: N01-ES-55384                              ROUTE: DOSED FEED                                              NTP C#: 56111B       
PATHOLOGIST: TOFT, JOHN                                                                                        CAS: 14371-10-9      
                                                                                                                                   
                               TRANS-CINNAMALDEHYDE                                                                                 
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE RATS                                                                                      
                       FIRST TERMINAL SACRIFICE AT 731 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                          DOSE = VEHICLE CONTROL                                |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 19     CENSORED DEATHS 0    TERMINAL 31        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      429   499   505   508   554   577   577   577   598   606                 |                                                 
 |      606   606   624   637   647   653   655   707   724                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = .312%                                    |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 14     CENSORED DEATHS 0    TERMINAL 36        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      170   404   591   593   619   643   648   672   680   682                 |                                                 
 |      682   690   710   725                                                     |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = .625%                                    |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 23     CENSORED DEATHS 0    TERMINAL 27        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      123   178   488   506   535   535   560   577   583   593                 |                                                 
 |      609   614   621   624   624   627   645   655   676   677                 |                                                 
 |      682   695   713                                                           |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                               TRANS-CINNAMALDEHYDE                                                                                 
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE RATS                                                                                      
                       FIRST TERMINAL SACRIFICE AT 731 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 1.25%                                    |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 9      CENSORED DEATHS 0    TERMINAL 41        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      499   633   666   672   675   691   698   709   715                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                               TRANS-CINNAMALDEHYDE                                                                                 
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE RATS                                                                                      
                       FIRST TERMINAL SACRIFICE AT 731 DAYS                                                                         
 ==================================================================================                                                 
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |    DOSE                               TIME (DAYS)                              |                                                 
 |                 90   180   270   365   425   485   545   605   665   731 (A)   |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |           |                                                                    |                                                 
 |VEHICLE    |   100.0 100.0 100.0 100.0 100.0  98.0  92.0  82.0  66.0  62.0      |                                                 
 |CONTROL    |                                                                    |                                                 
 |           |                                                                    |                                                 
 |.312%      |   100.0  98.0  98.0  98.0  96.0  96.0  96.0  92.0  86.0  72.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |.625%      |   100.0  96.0  96.0  96.0  96.0  96.0  88.0  80.0  64.0  54.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |1.25%      |   100.0 100.0 100.0 100.0 100.0 100.0  98.0  98.0  96.0  82.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                  DOSE                          |                                                 
 |                                                                                |                                                 
 |                                VEHICLE      .312%        .625%        1.25%    |                                                 
 |                                CONTROL                                         |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       62.0%        72.0%        54.0%        82.0%    |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |       P=0.064N     P=0.284N     P=0.548      P=0.025N |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       594.2        607.8        571.3        662.0    |                                                 
 |NATURAL DEATHS (C)      |       (16.8)       (39.8)       (30.4)       (22.0)   |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       679.0        696.5        657.5        718.6    |                                                 
 |(STANDARD ERROR)        |       (11.4)       (13.4)       (17.9)       ( 5.3)   |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (A)  FIRST TERMINAL SACRIFICE                                                                                                
       (B)  THE FIRST ENTRY IS THE TREND TEST (TARONE, 1975) RESULT.                                                                
            SUBSEQUENT ENTRIES ARE THE RESULTS OF PAIRWISE TESTS                                                                    
            (COX,1972).  NEGATIVE TRENDS ARE INDICATED BY "N".                                                                      
       (C)  MEAN OF ALL UNCENSORED DEATHS PRIOR TO TERMINAL SACRIFICE                                                               
       (D)  MEAN OF ALL DEATHS (UNCENSORED, CENSORED, TERMINAL SACRIFICE)                                                           
                                                                                                                                   
                               TRANS-CINNAMALDEHYDE                                                                                 
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       FIRST TERMINAL SACRIFICE AT 735 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                          DOSE = VEHICLE CONTROL                                |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 14     CENSORED DEATHS 0    TERMINAL 36        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      523   526   597   620   632   652   670   679   683   690                 |                                                 
 |      690   695   702   734                                                     |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = .312%                                    |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 17     CENSORED DEATHS 0    TERMINAL 33        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      85    561   597   618   620   626   652   652   671   675                 |                                                 
 |      675   681   697   697   701   718   718                                   |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = .625%                                    |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 49     UNCENSORED DEATHS 14     CENSORED DEATHS 0    TERMINAL 35        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      177   459   470   498   543   610   613   632   652   652                 |                                                 
 |      681   702   709   734                                                     |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                               TRANS-CINNAMALDEHYDE                                                                                 
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       FIRST TERMINAL SACRIFICE AT 735 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 1.25%                                    |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 17     CENSORED DEATHS 0    TERMINAL 33        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      172   536   564   568   590   597   634   635   643   665                 |                                                 
 |      669   681   694   697   718   723   726                                   |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                               TRANS-CINNAMALDEHYDE                                                                                 
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       FIRST TERMINAL SACRIFICE AT 735 DAYS                                                                         
 ==================================================================================                                                 
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |    DOSE                               TIME (DAYS)                              |                                                 
 |                 90   180   270   365   425   485   545   605   665   735 (A)   |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |           |                                                                    |                                                 
 |VEHICLE    |   100.0 100.0 100.0 100.0 100.0 100.0  96.0  94.0  88.0  72.0      |                                                 
 |CONTROL    |                                                                    |                                                 
 |           |                                                                    |                                                 
 |.312%      |    98.0  98.0  98.0  98.0  98.0  98.0  98.0  94.0  84.0  66.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |.625%      |   100.0  98.0  98.0  98.0  98.0  93.9  89.8  89.8  79.6  71.4      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |1.25%      |   100.0  98.0  98.0  98.0  98.0  98.0  96.0  88.0  80.0  66.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                  DOSE                          |                                                 
 |                                                                                |                                                 
 |                                VEHICLE      .312%        .625%        1.25%    |                                                 
 |                                CONTROL                                         |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       72.0%        66.0%        71.4%        66.0%    |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |       P=0.652      P=0.642      P=1.000      P=0.609  |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       649.5        626.1        580.9        618.4    |                                                 
 |NATURAL DEATHS (C)      |       (17.0)       (35.4)       (39.1)       (31.3)   |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       711.1        698.0        691.0        695.3    |                                                 
 |(STANDARD ERROR)        |       ( 7.2)       (13.9)       (14.8)       (13.1)   |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (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)                                                           
                                                                                                                                   
                                                        TRANS-CINNAMALDEHYDE                                                        
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        VEHICLE CONTROL  = 1                                                        
                                                        .312%            = 2                                                        
                                                        .625%            = 3                                                        
                                                        1.25%            = 4                                                        
                                                                                                                                    
------------------------------------------------------ SPECIES=RATS SEX=MALE -------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
      |                                                                                                                             
      |                                                                                                                             
  104 +                                                                                                                             
      |                                                                                                                             
      | 1                   3       2                                       1          4                                            
      |                     3       23                                  2   1          1                    4                       
   96 +                              3                                  2            3 11             2     4     4                 
      |                                                                              3  3                                           
P     |                                                                                 1    3  1     2   2       44                
E     |                                                                                         1  1      2  2     4 4              
R  88 +                                                                                      3  3            22      44             
C     |                                                                                         3  3          2   2   4 4           
E     |                                                                                            13  1          2 2   44          
N     |                                                                                             3 311                4  4       
T  80 +                                                                                               3 3                           
      |                                                                                                 33          22              
S     |                                                                                                 1331         2  2           
U     |                                                                                                   311           2 2         
R  72 +                                                                                                     1 1           2 2       
V     |                                                                                                       11                    
I     |                                                                                                    3  3                     
V     |                                                                                                       31       1            
A  64 +                                                                                                        3   3   1  1         
L     |                                                                                                                   1 1       
      |                                                                                                            33               
      |                                                                                                             3 3             
   56 +                                                                                                               3 3           
      |                                                                                                                 3   3       
      |                                                                                                                             
      |                                                                                                                             
   48 +                                                                                                                             
      |                                                                                                                             
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110 
                                                                                                                                    
                                                                   WEEK                                                             
                                                                                                                                    
NOTE: 8 obs hidden.                                                                                                                 
                                                                                                                                   
                                                        TRANS-CINNAMALDEHYDE                                                        
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        VEHICLE CONTROL  = 1                                                        
                                                        .312%            = 2                                                        
                                                        .625%            = 3                                                        
                                                        1.25%            = 4                                                        
                                                                                                                                    
----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
      |                                                                                                                             
      |                                                                                                                             
  100 + 1             2             43                                                     1                                        
      |                                                                                                                             
      |               2             43                                           3         114   2                                  
      |                                                                          3 3        14   2     1                            
   95 +                                                                                                                             
      |                                                                            3   3         44    1  1                         
P     |                                                                                           4   4   1 1                       
E     |                                                                                3      3                                     
R  90 +                                                                                       3       44 3221  1                    
C     |                                                                                                                             
E     |                                                                                                4   24  1  1                 
N     |                                                                                                  3  3     11                
T  85 +                                                                                                                             
      |                                                                                                     34 2  211               
S     |                                                                                                      4   42211              
U     |                                                                                                                             
R  80 +                                                                                                        3 44 3               
V     |                                                                                                                             
I     |                                                                                                           422113            
V     |                                                                                                             2 11            
A  75 +                                                                                                                33           
L     |                                                                                                                13   1       
      |                                                                                                               22 4  1       
      |                                                                                                                     3       
   70 +                                                                                                                2 24         
      |                                                                                                                             
      |                                                                                                                             
      |                                                                                                                  24 2       
   65 +                                                                                                                             
      |                                                                                                                             
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110 
                                                                                                                                    
                                                                   WEEK                                                             
                                                                                                                                    
NOTE: 19 obs hidden.