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TDMS Study 50215-03 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Battelle Columbus                                       ACRYLONITRILE                                     DATE: 10/31/00       
EXPERIMENT: 50215 TEST: 03                                                                                     TIME: 12:50:18       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-55388                              ROUTE: GAVAGE                                                  NTP C#: 50215B       
PATHOLOGIST: MISSING                                                                                           CAS: 107-13-1        
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                            MICE FINAL#1                                                            
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
                                                                                                                                   
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Battelle Columbus                                       ACRYLONITRILE                                     DATE: 10/31/00       
EXPERIMENT: 50215 TEST: 03                                                                                     TIME: 12:50:18       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-55388                              ROUTE: GAVAGE                                                  NTP C#: 50215B       
PATHOLOGIST: MISSING                                                                                           CAS: 107-13-1        
                                                                                                                                   
                                   ACRYLONITRILE                                                                                    
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE MICE                                                                                      
                       FIRST TERMINAL SACRIFICE AT 730 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 0 MG/KG                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 12     CENSORED DEATHS 0    TERMINAL 38        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      464   528   582   607   617   633   636   664   712   714                 |                                                 
 |      723   723                                                                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                          DOSE = 2.5    MG/KG                                   |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 6      CENSORED DEATHS 2    TERMINAL 42        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      518   535   637   689   689   714                                         |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      3     4                                                                   |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 10 MG/KG                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 11     CENSORED DEATHS 0    TERMINAL 39        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      211   497   512   515   563   610   626   685   702   709                 |                                                 
 |      714                                                                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                   ACRYLONITRILE                                                                                    
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE MICE                                                                                      
                       FIRST TERMINAL SACRIFICE AT 730 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 20 MG/KG                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 36     CENSORED DEATHS 0    TERMINAL 14        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      113   113   114   211   239   274   283   337   410   477                 |                                                 
 |      492   494   502   505   520   525   540   547   553   554                 |                                                 
 |      554   554   569   588   603   642   656   673   679   695                 |                                                 
 |      709   715   716   724   726   728                                         |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                   ACRYLONITRILE                                                                                    
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE MICE                                                                                      
                       FIRST TERMINAL SACRIFICE AT 730 DAYS                                                                         
 ==================================================================================                                                 
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |    DOSE                               TIME (DAYS)                              |                                                 
 |                 90   180   270   365   425   485   545   605   665   730 (A)   |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |           |                                                                    |                                                 
 |0 MG/KG    |   100.0 100.0 100.0 100.0 100.0  98.0  96.0  94.0  84.0  76.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |2.5        |   100.0 100.0 100.0 100.0 100.0 100.0  95.8  95.8  93.7  87.5      |                                                 
 |MG/KG      |                                                                    |                                                 
 |           |                                                                    |                                                 
 |10 MG/KG   |   100.0 100.0  98.0  98.0  98.0  98.0  92.0  90.0  86.0  78.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |20 MG/KG   |   100.0  94.0  90.0  84.0  82.0  80.0  66.0  50.0  46.0  28.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                  DOSE                          |                                                 
 |                                                                                |                                                 
 |                                0 MG/KG      2.5          10 MG/KG     20 MG/KG |                                                 
 |                                             MG/KG                              |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       76.0%        87.5%        78.0%        28.0%    |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |       P<0.001      P=0.222N     P=1.000N     P<0.001  |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       633.6        630.3        576.7        509.3    |                                                 
 |NATURAL DEATHS (C)      |       (23.5)       (34.5)       (44.3)       (30.9)   |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       706.9        689.0        696.3        571.1    |                                                 
 |(STANDARD ERROR)        |       ( 8.0)       (20.9)       (13.0)       (26.3)   |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (A)  FIRST TERMINAL SACRIFICE                                                                                                
       (B)  THE FIRST ENTRY IS THE TREND TEST (TARONE, 1975) RESULT.                                                                
            SUBSEQUENT ENTRIES ARE THE RESULTS OF PAIRWISE TESTS                                                                    
            (COX,1972).  NEGATIVE TRENDS ARE INDICATED BY "N".                                                                      
       (C)  MEAN OF ALL UNCENSORED DEATHS PRIOR TO TERMINAL SACRIFICE                                                               
       (D)  MEAN OF ALL DEATHS (UNCENSORED, CENSORED, TERMINAL SACRIFICE)                                                           
                                                                                                                                   
                                   ACRYLONITRILE                                                                                    
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE MICE                                                                                     
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 0 MG/KG                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 11     CENSORED DEATHS 0    TERMINAL 39        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      338   562   638   653   659   673   677   701   704   708                 |                                                 
 |      708                                                                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                          DOSE = 2.5    MG/KG                                   |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 18     CENSORED DEATHS 0    TERMINAL 32        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      354   424   468   563   633   640   643   647   648   653                 |                                                 
 |      665   673   683   688   694   696   721   724                             |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 10 MG/KG                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 11     CENSORED DEATHS 0    TERMINAL 39        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      190   516   639   645   646   695   708   711   715   716                 |                                                 
 |      721                                                                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                   ACRYLONITRILE                                                                                    
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE MICE                                                                                     
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 20 MG/KG                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 26     CENSORED DEATHS 1    TERMINAL 23        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      135   135   185   352   352   352   382   386   429   494                 |                                                 
 |      513   547   555   580   582   640   642   649   649   660                 |                                                 
 |      667   680   704   704   711   722                                         |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      113                                                                       |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                   ACRYLONITRILE                                                                                    
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE MICE                                                                                     
                       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  98.0  98.0  98.0  98.0  96.0  90.0  78.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |2.5        |   100.0 100.0 100.0  98.0  96.0  94.0  94.0  92.0  78.0  64.0      |                                                 
 |MG/KG      |                                                                    |                                                 
 |           |                                                                    |                                                 
 |10 MG/KG   |   100.0 100.0  98.0  98.0  98.0  98.0  96.0  96.0  90.0  78.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |20 MG/KG   |   100.0  95.9  93.9  87.8  83.7  81.6  77.6  69.4  59.2  46.9      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                  DOSE                          |                                                 
 |                                                                                |                                                 
 |                                0 MG/KG      2.5          10 MG/KG     20 MG/KG |                                                 
 |                                             MG/KG                              |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       78.0%        64.0%        78.0%        46.9%    |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |       P=0.002      P=0.156      P=1.000N     P=0.001  |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       638.3        623.2        627.5        515.7    |                                                 
 |NATURAL DEATHS (C)      |       (32.7)       (24.6)       (47.4)       (35.6)   |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       709.0        690.9        706.7        605.7    |                                                 
 |(STANDARD ERROR)        |       ( 8.8)       (11.3)       (11.7)       (25.8)   |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (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)                                                           
                                                                                                                                   
                                                           ACRYLONITRILE                                                            
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        0 MG/KG          = 1                                                        
                                                        2.5    MG/KG     = 2                                                        
                                                        10 MG/KG         = 3                                                        
                                                        20 MG/KG         = 4                                                        
                                                                                                                                    
------------------------------------------------------ SPECIES=MICE SEX=MALE -------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
      |                                                                                                                             
      |                                                                                                                             
  100 + 1                  4              3                                       1      2                                          
      |                                   3                                       1   3  2  12                                      
      |                    4              4                                           3  3  12      1   1   2        2              
      |                                   4    4                                         3       3      1 1                         
   90 +                                        4    4                                            3       31 1        2  2           
      |                                             44                                                   3 3            2   2       
      |                                              4        4          4                                 31    1  3  31           
      |                                                                  4          4                                  33           
P  80 +                                                                             4 4                                 1 1         
E     |                                                                                                                 3   3       
R     |                                                                               444                                 1 1       
C     |                                                                                 4  4                                        
E  70 +                                                                                                                             
N     |                                                                                    4  4                                     
T     |                                                                                       44                                    
      |                                                                                        44                                   
S  60 +                                                                                                                             
U     |                                                                                                                             
R     |                                                                                         4 4 4                               
V     |                                                                                             4   4                           
I  50 +                                                                                                 4    4                      
V     |                                                                                                      4 4                    
A     |                                                                                                        4   4                
L     |                                                                                                            4  4             
   40 +                                                                                                               4 4           
      |                                                                                                                 44          
      |                                                                                                                  44         
      |                                                                                                                             
   30 +                                                                                                                             
      |                                                                                                                   4 4       
      |                                                                                                                             
      |                                                                                                                             
   20 +                                                                                                                             
      |                                                                                                                             
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110 
                                                                                                                                    
                                                                   WEEK                                                             
                                                                                                                                    
NOTE: 10 obs hidden.                                                                                                                
                                                                                                                                   
                                                           ACRYLONITRILE                                                            
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        0 MG/KG          = 1                                                        
                                                        2.5    MG/KG     = 2                                                        
                                                        10 MG/KG         = 3                                                        
                                                        20 MG/KG         = 4                                                        
                                                                                                                                    
----------------------------------------------------- SPECIES=MICE SEX=FEMALE ------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
      |                                                                                                                             
      |                                                                                                                             
  100 + 1                     4        3                      1 2                                                                   
      |                                3                      1 2          2             3       1                                  
      |                       4       4                         4          2      2      3       1           131                    
      |                                                                                          2          2  1 1                  
P  90 +                                                                                                     223  1 1  3             
E     |                                                         4    4                                                3 3           
R     |                                                              44                                      22    1   133          
C     |                                                               4     4         4                       22       11           
E  80 +                                                                               4  4                     2 2                  
N     |                                                                                  4     4                 2 2    13  1       
T     |                                                                                        44                  222              
      |                                                                                         4  44                22             
S  70 +                                                                                             4        4                      
U     |                                                                                                               2  2          
R     |                                                                                                      44          22 2       
V     |                                                                                                                             
I  60 +                                                                                                       4  44                 
V     |                                                                                                           4 4               
A     |                                                                                                             4  4            
L     |                                                                                                                             
   50 +                                                                                                                44 4         
      |                                                                                                                   4 4       
      |                                                                                                                             
      |                                                                                                                             
   40 +                                                                                                                             
      |                                                                                                                             
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110 
                                                                                                                                    
                                                                   WEEK                                                             
                                                                                                                                    
NOTE: 16 obs hidden.