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TDMS Study 93020-07 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Southern Research Inst                             DIISOPROPYLCARBODIIMIDE                                DATE: 04/04/03       
EXPERIMENT: 93020 TEST: 07                                                                                     TIME: 07:50:10       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES 05451                              ROUTE: SKIN APPLICATION                                        NTP C#: 93020D       
PATHOLOGIST: HEATH, JAMES                                                                                      CAS: 693-13-0        
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                             DRAFT 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                             DIISOPROPYLCARBODIIMIDE                                DATE: 04/04/03       
EXPERIMENT: 93020 TEST: 07                                                                                     TIME: 07:50:10       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES 05451                              ROUTE: SKIN APPLICATION                                        NTP C#: 93020D       
PATHOLOGIST: HEATH, JAMES                                                                                      CAS: 693-13-0        
                                                                                                                                   
                              DIISOPROPYLCARBODIIMIDE                                                                               
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE RATS                                                                                      
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 0 MG/KG                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 30     CENSORED DEATHS 0    TERMINAL 20        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      463   522   533   533   533   535   582   593   593   599                 |                                                 
 |      606   608   612   637   637   657   662   676   677   677                 |                                                 
 |      687   688   690   692   697   701   705   714   716   716                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 10 MG/KG                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 20     CENSORED DEATHS 0    TERMINAL 30        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      444   485   522   542   546   571   575   593   593   600                 |                                                 
 |      601   603   617   621   654   673   676   682   703   716                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 20 MG/KG                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 18     CENSORED DEATHS 0    TERMINAL 32        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      444   491   556   563   615   645   647   649   652   660                 |                                                 
 |      663   676   686   688   694   696   703   720                             |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                              DIISOPROPYLCARBODIIMIDE                                                                               
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE RATS                                                                                      
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 40 MG/KG                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 33     CENSORED DEATHS 0    TERMINAL 17        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      204   237   237   266   273   277   277   278   278   278                 |                                                 
 |      281   285   290   290   298   298   319   325   513   553                 |                                                 
 |      606   607   617   623   630   634   667   669   676   683                 |                                                 
 |      691   704   706                                                           |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                              DIISOPROPYLCARBODIIMIDE                                                                               
                       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 MG/KG    |   100.0 100.0 100.0 100.0 100.0  98.0  88.0  80.0  66.0  40.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |10 MG/KG   |   100.0 100.0 100.0 100.0 100.0  96.0  92.0  76.0  70.0  60.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |20 MG/KG   |   100.0 100.0 100.0 100.0 100.0  98.0  96.0  92.0  78.0  64.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |40 MG/KG   |   100.0 100.0  92.0  64.0  64.0  64.0  62.0  60.0  48.0  34.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                  DOSE                          |                                                 
 |                                                                                |                                                 
 |                                0 MG/KG      10 MG/KG     20 MG/KG     40 MG/KG |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       40.0%        60.0%        64.0%        34.0%    |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |       P=0.056      P=0.135N     P=0.025N     P=0.141  |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       631.4        600.9        636.0        441.5    |                                                 
 |NATURAL DEATHS (C)      |       (12.8)       (16.0)       (17.8)       (32.6)   |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       670.4        677.7        695.5        539.3    |                                                 
 |(STANDARD ERROR)        |       (10.3)       (11.0)       ( 9.0)       (28.9)   |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (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)                                                           
                                                                                                                                   
                              DIISOPROPYLCARBODIIMIDE                                                                               
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 0 MG/KG                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 20     CENSORED DEATHS 0    TERMINAL 30        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      241   359   394   437   535   550   556   606   621   626                 |                                                 
 |      632   632   654   667   673   676   682   703   710   723                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 10 MG/KG                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 18     CENSORED DEATHS 0    TERMINAL 32        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      248   327   347   513   522   522   554   570   593   595                 |                                                 
 |      621   652   669   677   703   712   723   728                             |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 20 MG/KG                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 18     CENSORED DEATHS 0    TERMINAL 32        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      384   465   535   535   536   570   606   641   646   649                 |                                                 
 |      682   684   686   690   701   703   712   723                             |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                              DIISOPROPYLCARBODIIMIDE                                                                               
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 40 MG/KG                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 49     UNCENSORED DEATHS 24     CENSORED DEATHS 0    TERMINAL 25        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      446   456   469   559   587   593   593   601   617   617                 |                                                 
 |      627   646   662   663   667   670   673   691   697   703                 |                                                 
 |      703   705   713   725                                                     |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                              DIISOPROPYLCARBODIIMIDE                                                                               
                       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 MG/KG    |   100.0 100.0  98.0  96.0  94.0  92.0  90.0  86.0  74.0  60.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |10 MG/KG   |   100.0 100.0  98.0  94.0  94.0  94.0  88.0  80.0  76.0  64.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |20 MG/KG   |   100.0 100.0 100.0 100.0  98.0  96.0  90.0  88.0  80.0  64.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |40 MG/KG   |   100.0 100.0 100.0 100.0 100.0  93.9  93.9  83.7  71.4  51.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                  DOSE                          |                                                 
 |                                                                                |                                                 
 |                                0 MG/KG      10 MG/KG     20 MG/KG     40 MG/KG |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       60.0%        64.0%        64.0%        51.0%    |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |       P=0.415      P=0.838N     P=0.710N     P=0.562  |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       583.9        570.9        619.3        628.5    |                                                 
 |NATURAL DEATHS (C)      |       (29.3)       (33.3)       (22.5)       (16.4)   |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       670.9        672.1        689.5        679.8    |                                                 
 |(STANDARD ERROR)        |       (15.4)       (16.0)       (11.0)       (10.8)   |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (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)                                                           
                                                                                                                                   
                                                      DIISOPROPYLCARBODIIMIDE                                                       
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        0 MG/KG          = 1                                                        
                                                        10 MG/KG         = 2                                                        
                                                        20 MG/KG         = 3                                                        
                                                        40 MG/KG         = 4                                                        
                                                                                                                                    
------------------------------------------------------ SPECIES=RATS SEX=MALE -------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
      |                                                                                                                             
      |                                                                                                                             
  100 + 1                                4                                    2   1                                                 
      |                                  4   4                                2   1  23    1                                        
      |                                      4    4                                  23    1 12 33                                  
      |                                           44                                             3       3                          
   90 +                                            44                                         2   2      3    3                     
      |                                                                                      1    221                               
P     |                                                                                            21 1       33                    
E     |                                                                                               11       3 3                  
R  80 +                                             44                                                 11                           
C     |                                                                                                22        3 3                
E     |                                              44                                                 112 1      333              
N     |                                               44                                                  2    2     33             
T  70 +                                                                                                     1  1   2                
      |                                                4   4                                                   1 1    33            
S     |                                                    44                            4                       1 12  2 3  3       
U     |                                                                                  4     4                       2 2          
R  60 +                                                                                        4        4          1 1   2  2       
V     |                                                                                                                             
I     |                                                                                                 4 4                         
V     |                                                                                                   44         11             
A  50 +                                                                                                    44         11            
L     |                                                                                                     4     4                 
      |                                                                                                           44   111          
      |                                                                                                            44               
   40 +                                                                                                             44   1  1       
      |                                                                                                              4 4            
      |                                                                                                                4    4       
      |                                                                                                                             
   30 +                                                                                                                             
      |                                                                                                                             
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110 
                                                                                                                                    
                                                                   WEEK                                                             
                                                                                                                                    
NOTE: 21 obs hidden.                                                                                                                
                                                                                                                                   
                                                      DIISOPROPYLCARBODIIMIDE                                                       
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        0 MG/KG          = 1                                                        
                                                        10 MG/KG         = 2                                                        
                                                        20 MG/KG         = 3                                                        
                                                        40 MG/KG         = 4                                                        
                                                                                                                                    
----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
      |                                                                                                                             
  100 + 1                                      12                    3        4                                                     
      |                                                                                                                             
      |                                        12           2    1   3        4  43                                                 
      |                                                     2  2 1     1         43          3                                      
   95 +                                                                                                                             
      |                                                        2       1     1    4      2      4                                   
      |                                                                      1           2 2 1                                      
      |                                                                                         4   4                               
   90 +                                                                                      1 1  3 4 4                             
      |                                                                                                                             
      |                                                                                    2   11 3     3                           
      |                                                                                         1 2   441    3                      
P  85 +                                                                                                                             
E     |                                                                                           2   241 1  33                     
R     |                                                                                                   11                        
C     |                                                                                                                             
E  80 +                                                                                               2   211 3     3               
N     |                                                                                                                             
T     |                                                                                                   24  42                    
      |                                                                                                     1  1  2                 
S  75 +                                                                                                       4  4                  
U     |                                                                                                        1  1233              
R     |                                                                                                           11 3 2            
V     |                                                                                                          44                 
I  70 +                                                                                                                22           
V     |                                                                                                                             
A     |                                                                                                           411  32 2         
L     |                                                                                                             1  13 3         
   65 +                                                                                                            4 4              
      |                                                                                                              4411 2 2       
      |                                                                                                                 1 1         
      |                                                                                                               44            
   60 +                                                                                                                   1 1       
      |                                                                                                                             
      |                                                                                                                             
      |                                                                                                                             
   55 +                                                                                                                44           
      |                                                                                                                             
      |                                                                                                                 4 4         
      |                                                                                                                   4 4       
   50 +                                                                                                                             
      |                                                                                                                             
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110 
                                                                                                                                    
                                                                   WEEK                                                             
                                                                                                                                    
NOTE: 19 obs hidden.