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TDMS Study 56111-04 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Battelle Columbus                                    TRANS-CINNAMALDEHYDE                                 DATE: 12/11/02       
EXPERIMENT: 56111 TEST: 04                                                                                     TIME: 10:49:47       
TEST TYPE:  CHRONIC                                                                                            PAGE:       1        
CONT: N01-ES-55384                              ROUTE: DOSED FEED                                              NTP C#: 56111B       
PATHOLOGIST: MARIT, GARY                                                                                       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: 04                                                                                     TIME: 10:49:47       
TEST TYPE:  CHRONIC                                                                                                                 
CONT: N01-ES-55384                              ROUTE: DOSED FEED                                              NTP C#: 56111B       
PATHOLOGIST: MARIT, GARY                                                                                       CAS: 14371-10-9      
                                                                                                                                   
                               TRANS-CINNAMALDEHYDE                                                                                 
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE MICE                                                                                      
                       FIRST TERMINAL SACRIFICE AT 728 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                          DOSE = VEHICLE CONTROL                                |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 3      CENSORED DEATHS 0    TERMINAL 47        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      100   572   708                                                           |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = .312%                                    |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 4      CENSORED DEATHS 0    TERMINAL 46        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      50    594   644   701                                                     |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = .625%                                    |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 11     CENSORED DEATHS 0    TERMINAL 39        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      365   498   533   533   561   566   588   652   652   699                 |                                                 
 |      702                                                                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                               TRANS-CINNAMALDEHYDE                                                                                 
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE MICE                                                                                      
                       FIRST TERMINAL SACRIFICE AT 728 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 1.25%                                    |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 1      CENSORED DEATHS 0    TERMINAL 49        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      596                                                                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                               TRANS-CINNAMALDEHYDE                                                                                 
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE MICE                                                                                      
                       FIRST TERMINAL SACRIFICE AT 728 DAYS                                                                         
 ==================================================================================                                                 
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |    DOSE                               TIME (DAYS)                              |                                                 
 |                 90   180   270   365   425   485   545   605   665   728 (A)   |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |           |                                                                    |                                                 
 |VEHICLE    |   100.0  98.0  98.0  98.0  98.0  98.0  98.0  96.0  96.0  94.0      |                                                 
 |CONTROL    |                                                                    |                                                 
 |           |                                                                    |                                                 
 |.312%      |    98.0  98.0  98.0  98.0  98.0  98.0  98.0  96.0  94.0  92.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |.625%      |   100.0 100.0 100.0  98.0  98.0  98.0  92.0  86.0  82.0  78.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |1.25%      |   100.0 100.0 100.0 100.0 100.0 100.0 100.0  98.0  98.0  98.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                  DOSE                          |                                                 
 |                                                                                |                                                 
 |                                VEHICLE      .312%        .625%        1.25%    |                                                 
 |                                CONTROL                                         |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       94.0%        92.0%        78.0%        98.0%    |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |       P=0.712N     P=0.990      P=0.043      P=0.603N |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       460.0        497.3        577.2        596.0    |                                                 
 |NATURAL DEATHS (C)      |       ( 184)       ( 151)       (29.7)       (  . )   |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       711.9        709.5        694.8        725.4    |                                                 
 |(STANDARD ERROR)        |       (12.9)       (13.8)       (10.9)       ( 2.6)   |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (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 MICE                                                                                     
                       FIRST TERMINAL SACRIFICE AT 733 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                          DOSE = VEHICLE CONTROL                                |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 9      CENSORED DEATHS 0    TERMINAL 41        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      456   463   463   570   609   614   693   698   726                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = .312%                                    |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 13     CENSORED DEATHS 0    TERMINAL 37        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      325   551   558   575   596   628   652   663   668   673                 |                                                 
 |      708   723   728                                                           |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = .625%                                    |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 6      CENSORED DEATHS 0    TERMINAL 44        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      425   568   638   642   691   726                                         |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                               TRANS-CINNAMALDEHYDE                                                                                 
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE MICE                                                                                     
                       FIRST TERMINAL SACRIFICE AT 733 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 1.25%                                    |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 7      CENSORED DEATHS 0    TERMINAL 43        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      226   379   568   587   627   680   726                                   |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                               TRANS-CINNAMALDEHYDE                                                                                 
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE MICE                                                                                     
                       FIRST TERMINAL SACRIFICE AT 733 DAYS                                                                         
 ==================================================================================                                                 
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |    DOSE                               TIME (DAYS)                              |                                                 
 |                 90   180   270   365   425   485   545   605   665   733 (A)   |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |           |                                                                    |                                                 
 |VEHICLE    |   100.0 100.0 100.0 100.0 100.0  94.0  94.0  92.0  88.0  82.0      |                                                 
 |CONTROL    |                                                                    |                                                 
 |           |                                                                    |                                                 
 |.312%      |   100.0 100.0 100.0  98.0  98.0  98.0  98.0  90.0  84.0  74.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |.625%      |   100.0 100.0 100.0 100.0  98.0  98.0  98.0  96.0  92.0  88.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |1.25%      |   100.0 100.0  98.0  98.0  96.0  96.0  96.0  92.0  90.0  86.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                  DOSE                          |                                                 
 |                                                                                |                                                 
 |                                VEHICLE      .312%        .625%        1.25%    |                                                 
 |                                CONTROL                                         |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       82.0%        74.0%        88.0%        86.0%    |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |       P=0.371N     P=0.485      P=0.556N     P=0.788N |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       588.0        619.1        615.0        541.9    |                                                 
 |NATURAL DEATHS (C)      |       (35.8)       (29.6)       (43.8)       (67.1)   |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       706.9        703.4        718.8        706.2    |                                                 
 |(STANDARD ERROR)        |       (10.0)       (10.3)       ( 7.3)       (12.9)   |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (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)                                                           
                                                                                                                                   
                                                        TRANS-CINNAMALDEHYDE                                                        
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        VEHICLE CONTROL  = 1                                                        
                                                        .312%            = 2                                                        
                                                        .625%            = 3                                                        
                                                        1.25%            = 4                                                        
                                                                                                                                    
------------------------------------------------------ SPECIES=MICE SEX=MALE -------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
        |                                                                                                                           
        |                                                                                                                           
  100.0 +1        2       1                                        3                                    4                           
        |                                                                                                                           
        |                                                                                                                           
        |         2       1                                        3                    3          1   24                  4        
   97.5 +                                                                                                                           
        |                                                                                                                           
        |                                                                               3     3    1   2      2          1          
        |                                                                                                                           
   95.0 +                                                                                                                           
        |                                                                                                                           
P       |                                                                                                     2         21 1        
E       |                                                                                                                           
R  92.5 +                                                                                                                           
C       |                                                                                     3   3                     2  2        
E       |                                                                                                                           
N       |                                                                                                                           
T  90.0 +                                                                                                                           
        |                                                                                                                           
S       |                                                                                                                           
U       |                                                                                         3  3                              
R  87.5 +                                                                                                                           
V       |                                                                                                                           
I       |                                                                                            3          3                   
V       |                                                                                                                           
A  85.0 +                                                                                                                           
L       |                                                                                                                           
        |                                                                                                                           
        |                                                                                                                           
   82.5 +                                                                                                                           
        |                                                                                                       3      3            
        |                                                                                                                           
        |                                                                                                                           
   80.0 +                                                                                                              33           
        |                                                                                                                           
        |                                                                                                                           
        |                                                                                                               3  3        
   77.5 +                                                                                                                           
        |                                                                                                                           
        -+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-
         0         10         20         30         40         50         60         70         80         90         100        110
                                                                                                                                    
                                                                    WEEK                                                            
                                                                                                                                    
NOTE: 3 obs hidden.                                                                                                                 
                                                                                                                                   
                                                        TRANS-CINNAMALDEHYDE                                                        
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        VEHICLE CONTROL  = 1                                                        
                                                        .312%            = 2                                                        
                                                        .625%            = 3                                                        
                                                        1.25%            = 4                                                        
                                                                                                                                    
----------------------------------------------------- SPECIES=MICE SEX=FEMALE ------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
      |                                                                                                                             
      |                                                                                                                             
  100 + 1                                   4               2              3     1                                                  
      |                                                                                                                             
      |                                     4               2        4     3     11            2  3                                 
      |                                                              4                         22 3          3                      
P  95 +                                                                                                                             
E     |                                                                           1             2 124                               
R     |                                                                                           124  21  4 3       3              
C     |                                                                                                                             
E  90 +                                                                                                211 2        43    3         
N     |                                                                                                                             
T     |                                                                                                  1 2   2    41    3 3       
      |                                                                                                        2 2   11   4 4       
S  85 +                                                                                                                             
U     |                                                                                                          22   1   1         
R     |                                                                                                           22      1 1       
V     |                                                                                                                             
I  80 +                                                                                                            2    2           
V     |                                                                                                                             
A     |                                                                                                                 2 2         
L     |                                                                                                                             
   75 +                                                                                                                             
      |                                                                                                                   2 2       
      |                                                                                                                             
      |                                                                                                                             
   70 +                                                                                                                             
      |                                                                                                                             
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110 
                                                                                                                                    
                                                                   WEEK                                                             
                                                                                                                                    
NOTE: 7 obs hidden.