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TDMS Study 05161-05 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Southern Research Inst                                   RIDDELLIINE                                      DATE: 12/15/00       
EXPERIMENT: 05161 TEST: 05                                                                                     TIME: 12:21:09       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1-ES-55393                              ROUTE: GAVAGE                                                  NTP C#: 61358C       
PATHOLOGIST: HEATH, JAMES E.                                                                                   CAS: 23246-96-0      
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                         RATS/FINAL#1 MALES                                                         
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE 001    0       MG/KG/DY                                                              
                                       INCLUDE 002    1.0     MG/KG/DY                                                              
                                                                                                                                   
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Southern Research Inst                                   RIDDELLIINE                                      DATE: 12/15/00       
EXPERIMENT: 05161 TEST: 05                                                                                     TIME: 12:21:09       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1-ES-55393                              ROUTE: GAVAGE                                                  NTP C#: 61358C       
PATHOLOGIST: HEATH, JAMES E.                                                                                   CAS: 23246-96-0      
                                                                                                                                   
                                    RIDDELLIINE                                                                                     
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE RATS                                                                                      
                       FIRST TERMINAL SACRIFICE AT 497 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                          DOSE = 0       MG/KG/DY                               |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 1      CENSORED DEATHS 0    TERMINAL 49        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      468                                                                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                          DOSE = 1.0     MG/KG/DY                               |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 45     CENSORED DEATHS 2    TERMINAL 3         |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      204   297   307   314   318   327   342   364   373   373                 |                                                 
 |      375   388   397   397   398   400   400   402   402   403                 |                                                 
 |      407   407   408   410   411   412   414   414   415   415                 |                                                 
 |      418   419   422   424   433   437   440   440   446   449                 |                                                 
 |      457   462   463   477   483                                               |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      266   321                                                                 |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                    RIDDELLIINE                                                                                     
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE RATS                                                                                      
                       FIRST TERMINAL SACRIFICE AT 497 DAYS                                                                         
 ==================================================================================                                                 
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |    DOSE                               TIME (DAYS)                              |                                                 
 |                 50   100   150   200   250   300   350   400   450   497 (A)   |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |           |                                                                    |                                                 
 |0          |   100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0  98.0      |                                                 
 |MG/KG/DY   |                                                                    |                                                 
 |           |                                                                    |                                                 
 |1.0        |   100.0 100.0 100.0 100.0  98.0  96.0  85.7  71.0  18.8   6.3      |                                                 
 |MG/KG/DY   |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                        DOSE                    |                                                 
 |                                                                                |                                                 
 |                                0                         1.0                   |                                                 
 |                                MG/KG/DY                  MG/KG/DY              |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       98.0%                      6.3%                 |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |       P<0.001                   P<0.001               |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       468.0                     399.2                 |                                                 
 |NATURAL DEATHS (C)      |       (  . )                    ( 7.8)                |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       496.4                     400.8                 |                                                 
 |(STANDARD ERROR)        |       ( 0.6)                    ( 8.4)                |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (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)                                                           
                                                                                                                                   
                                                            RIDDELLIINE                                                             
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        0       MG/KG/DY = 1                                                        
                                                        1.0     MG/KG/DY = 2                                                        
                                                                                                                                    
------------------------------------------------------ SPECIES=RATS SEX=MALE -------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
              |                                                                                                                     
              |                                                                                                                     
          100 +  1                                      2                                               1                           
              |                                         2                2                              1    1                      
              |                                                          22 2                                                       
              |                                                             22                                                      
           90 +                                                              22                                                     
              |                                                               2  2                                                  
              |                                                                  2   2                                              
              |                                                                      2 2                                            
           80 +                                                                                                                     
              |                                                                        2  2                                         
              |                                                                           22                                        
              |                                                                                                                     
        P  70 +                                                                            22                                       
        E     |                                                                                                                     
        R     |                                                                                                                     
        C     |                                                                                                                     
        E  60 +                                                                                                                     
        N     |                                                                             2 2                                     
        T     |                                                                                                                     
              |                                                                                                                     
        S  50 +                                                                                                                     
        U     |                                                                                                                     
        R     |                                                                               22                                    
        V     |                                                                                                                     
        I  40 +                                                                                                                     
        V     |                                                                                                                     
        A     |                                                                                                                     
        L     |                                                                                22                                   
           30 +                                                                                 2 2                                 
              |                                                                                   22                                
              |                                                                                                                     
              |                                                                                                                     
           20 +                                                                                    22 2                             
              |                                                                                       22                            
              |                                                                                                                     
              |                                                                                        22                           
           10 +                                                                                         2  2                        
              |                                                                                            2 2                      
              |                                                                                                                     
              |                                                                                                                     
            0 +                                                                                                                     
              |                                                                                                                     
              ---+------------+------------+------------+------------+------------+------------+------------+------------+--        
                 0           10           20           30           40           50           60           70           80          
                                                                                                                                    
                                                                   WEEK                                                             
                                                                                                                                    
NOTE: 3 obs hidden.