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TDMS Study 93023-06 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Southern Research Inst                                  2,4-HEXADIENAL                                    DATE: 03/14/01       
EXPERIMENT: 93023 TEST: 06                                                                                     TIME: 15:20:00       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-55393                              ROUTE: GAVAGE                                                  NTP C#: 93023B       
PATHOLOGIST: HEATH, JAMES E.                                                                                   CAS: 142-83-6        
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                            FINAL#1/RATS                                                            
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
                                                                                                                                   
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Southern Research Inst                                  2,4-HEXADIENAL                                    DATE: 03/14/01       
EXPERIMENT: 93023 TEST: 06                                                                                     TIME: 15:20:00       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-55393                              ROUTE: GAVAGE                                                  NTP C#: 93023B       
PATHOLOGIST: HEATH, JAMES E.                                                                                   CAS: 142-83-6        
                                                                                                                                   
                                  2,4-HEXADIENAL                                                                                    
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE RATS                                                                                      
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                          DOSE = 0       MG/KG/DY                               |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 12     CENSORED DEATHS 1    TERMINAL 37        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      479   542   554   587   609   629   634   634   655   699                 |                                                 
 |      699   704                                                                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      259                                                                       |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                          DOSE = 22.5    MG/KG/DY                               |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 13     CENSORED DEATHS 2    TERMINAL 35        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      371   509   537   582   634   643   659   662   664   671                 |                                                 
 |      704   704   715                                                           |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      190   345                                                                 |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                          DOSE = 45      MG/KG/DY                               |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 16     CENSORED DEATHS 1    TERMINAL 33        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      483   503   536   553   560   606   620   620   624   629                 |                                                 
 |      663   664   671   686   691   713                                         |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      364                                                                       |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                  2,4-HEXADIENAL                                                                                    
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE RATS                                                                                      
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                          DOSE = 90      MG/KG/DY                               |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 15     CENSORED DEATHS 5    TERMINAL 30        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      350   496   566   574   609   620   636   643   651   655                 |                                                 
 |      659   691   697   705   715                                               |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      148   364   364   575   709                                               |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                  2,4-HEXADIENAL                                                                                    
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE RATS                                                                                      
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
 ==================================================================================                                                 
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |    DOSE                               TIME (DAYS)                              |                                                 
 |                 90   180   270   365   425   485   545   605   665   729 (A)   |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |           |                                                                    |                                                 
 |0          |   100.0 100.0 100.0 100.0 100.0  98.0  95.9  91.8  81.6  75.5      |                                                 
 |MG/KG/DY   |                                                                    |                                                 
 |           |                                                                    |                                                 
 |22.5       |   100.0 100.0 100.0 100.0  97.9  97.9  93.7  91.7  81.2  72.9      |                                                 
 |MG/KG/DY   |                                                                    |                                                 
 |           |                                                                    |                                                 
 |45         |   100.0 100.0 100.0 100.0 100.0  98.0  93.9  89.8  75.5  67.3      |                                                 
 |MG/KG/DY   |                                                                    |                                                 
 |           |                                                                    |                                                 
 |90         |   100.0 100.0 100.0  98.0  98.0  98.0  95.8  91.6  76.3  67.5      |                                                 
 |MG/KG/DY   |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                  DOSE                          |                                                 
 |                                                                                |                                                 
 |                                0            22.5         45           90       |                                                 
 |                                MG/KG/DY     MG/KG/DY     MG/KG/DY     MG/KG/DY |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       75.5%        72.9%        67.3%        67.5%    |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |       P=0.411      P=0.979      P=0.465      P=0.537  |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       618.8        619.6        613.9        617.8    |                                                 
 |NATURAL DEATHS (C)      |       (20.0)       (27.1)       (17.3)       (24.4)   |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       693.1        682.1        684.9        665.9    |                                                 
 |(STANDARD ERROR)        |       (12.0)       (15.6)       (11.4)       (17.4)   |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (A)  FIRST TERMINAL SACRIFICE                                                                                                
       (B)  THE FIRST ENTRY IS THE TREND TEST (TARONE, 1975) RESULT.                                                                
            SUBSEQUENT ENTRIES ARE THE RESULTS OF PAIRWISE TESTS                                                                    
            (COX,1972).  NEGATIVE TRENDS ARE INDICATED BY "N".                                                                      
       (C)  MEAN OF ALL UNCENSORED DEATHS PRIOR TO TERMINAL SACRIFICE                                                               
       (D)  MEAN OF ALL DEATHS (UNCENSORED, CENSORED, TERMINAL SACRIFICE)                                                           
                                                                                                                                   
                                  2,4-HEXADIENAL                                                                                    
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                          DOSE = 0       MG/KG/DY                               |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 13     CENSORED DEATHS 0    TERMINAL 37        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      285   445   511   554   560   629   659   664   704   705                 |                                                 
 |      712   722   727                                                           |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                          DOSE = 22.5    MG/KG/DY                               |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 10     CENSORED DEATHS 1    TERMINAL 39        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      347   544   610   629   634   664   671   719   719   722                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      346                                                                       |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                          DOSE = 45      MG/KG/DY                               |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 8      CENSORED DEATHS 1    TERMINAL 41        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      476   536   544   546   602   610   659   671                             |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      483                                                                       |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                  2,4-HEXADIENAL                                                                                    
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                          DOSE = 90      MG/KG/DY                               |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 13     CENSORED DEATHS 6    TERMINAL 31        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      445   536   560   601   631   636   638   651   666   690                 |                                                 
 |      691   691   721                                                           |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      346   363   364   364   364   405                                         |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                  2,4-HEXADIENAL                                                                                    
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
 ==================================================================================                                                 
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |    DOSE                               TIME (DAYS)                              |                                                 
 |                 90   180   270   365   425   485   545   605   665   729 (A)   |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |           |                                                                    |                                                 
 |0          |   100.0 100.0 100.0  98.0  98.0  96.0  94.0  90.0  84.0  74.0      |                                                 
 |MG/KG/DY   |                                                                    |                                                 
 |           |                                                                    |                                                 
 |22.5       |   100.0 100.0 100.0  98.0  98.0  98.0  95.9  95.9  87.8  79.6      |                                                 
 |MG/KG/DY   |                                                                    |                                                 
 |           |                                                                    |                                                 
 |45         |   100.0 100.0 100.0 100.0 100.0  98.0  93.9  89.8  85.7  83.7      |                                                 
 |MG/KG/DY   |                                                                    |                                                 
 |           |                                                                    |                                                 
 |90         |   100.0 100.0 100.0 100.0 100.0  97.7  95.5  90.9  81.8  70.5      |                                                 
 |MG/KG/DY   |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                  DOSE                          |                                                 
 |                                                                                |                                                 
 |                                0            22.5         45           90       |                                                 
 |                                MG/KG/DY     MG/KG/DY     MG/KG/DY     MG/KG/DY |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       74.0%        79.6%        83.7%        70.5%    |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |       P=0.704      P=0.638N     P=0.383N     P=0.847  |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       605.9        625.9        580.5        627.5    |                                                 
 |NATURAL DEATHS (C)      |       (36.5)       (35.7)       (23.6)       (21.2)   |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       697.0        700.7        700.3        659.2    |                                                 
 |(STANDARD ERROR)        |       (12.0)       (11.6)       ( 9.6)       (17.4)   |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (A)  FIRST TERMINAL SACRIFICE                                                                                                
       (B)  THE FIRST ENTRY IS THE TREND TEST (TARONE, 1975) RESULT.                                                                
            SUBSEQUENT ENTRIES ARE THE RESULTS OF PAIRWISE TESTS                                                                    
            (COX,1972).  NEGATIVE TRENDS ARE INDICATED BY "N".                                                                      
       (C)  MEAN OF ALL UNCENSORED DEATHS PRIOR TO TERMINAL SACRIFICE                                                               
       (D)  MEAN OF ALL DEATHS (UNCENSORED, CENSORED, TERMINAL SACRIFICE)                                                           
                                                                                                                                   
                                                           2,4-HEXADIENAL                                                           
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        0       MG/KG/DY = 1                                                        
                                                        22.5    MG/KG/DY = 2                                                        
                                                        45      MG/KG/DY = 3                                                        
                                                        90      MG/KG/DY = 4                                                        
                                                                                                                                    
------------------------------------------------------ SPECIES=RATS SEX=MALE -------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
      |                                                                                                                             
      |                                                                                                                             
  100 + 1                                                      4  2                 1                                               
      |                                                                                                                             
      |                                                        4  2                 1 432     1                                     
      |                                                                               432    21 14                                  
   95 +                                                                                                                             
      |                                                                                      2 3144 1                               
P     |                                                                                                                             
E     |                                                                                        33 4 1   1   2                       
R  90 +                                                                                         3       1 4122                      
C     |                                                                                                                             
E     |                                                                                                 3 3112   2                  
N     |                                                                                                                             
T  85 +                                                                                                     44                      
      |                                                                                                   331  1                    
S     |                                                                                                      44                     
U     |                                                                                                       41 22   1             
R  80 +                                                                                                    3     3                  
V     |                                                                                                        4 42    2            
I     |                                                                                                               11            
V     |                                                                                                          4   4              
A  75 +                                                                                                          33    1 2  1       
L     |                                                                                                           3 344             
      |                                                                                                               44 2  2       
      |                                                                                                             33              
   70 +                                                                                                              3 434          
      |                                                                                                                             
      |                                                                                                                 34  3       
      |                                                                                                                             
   65 +                                                                                                                             
      |                                                                                                                             
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110 
                                                                                                                                    
                                                                   WEEK                                                             
                                                                                                                                    
NOTE: 17 obs hidden.                                                                                                                
                                                                                                                                   
                                                           2,4-HEXADIENAL                                                           
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        0       MG/KG/DY = 1                                                        
                                                        22.5    MG/KG/DY = 2                                                        
                                                        45      MG/KG/DY = 3                                                        
                                                        90      MG/KG/DY = 4                                                        
                                                                                                                                    
----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
      |                                                                                                                             
      |                                                                                                                             
  100 + 1                                            1         2              4    3                                                
      |                                                                                                                             
      |                                              1         2              1    3         32                                     
      |                                                                       1         1    32          2                          
P  95 +                                                                                      4  4                                   
E     |                                                                                 1       1      4 2 2                        
R     |                                                                                       3        3                            
C     |                                                                                                4   22                       
E  90 +                                                                                         1      3 3 12    2                  
N     |                                                                                                                             
T     |                                                                                                  3 1     12                 
      |                                                                                                     44   32      2          
S  85 +                                                                                                                             
U     |                                                                                                      44  13    1    3       
R     |                                                                                                                             
V     |                                                                                                       4   4      22         
I  80 +                                                                                                           4  4 11 2 2       
V     |                                                                                                                             
A     |                                                                                                                 1 1         
L     |                                                                                                                             
   75 +                                                                                                                             
      |                                                                                                                   1 1       
      |                                                                                                              4   4          
      |                                                                                                                             
   70 +                                                                                                                  4  4       
      |                                                                                                                             
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110 
                                                                                                                                    
                                                                   WEEK                                                             
                                                                                                                                    
NOTE: 11 obs hidden.