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TDMS Study 88122-07 Pathology Tables

                                                                                                                                   
NTP                                          MEAN BODY WEIGHTS AND SURVIVAL TABLE                                 REPORT: EISRPT41  
LAB: Battelle Columbus                                      ELMIRON                                                 DATE: 04/24/01  
EXPERIMENT: 88122 TEST: 07                                                                                        TIME: 17:03:25    
                                                CAGES FROM 0000 TO LAST CAGE                                      PAGE:    1        
TEST TYPE: CHRONIC                                  ROUTE: GAVAGE                                                 NTP:  C88122      
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                                                            Final#1/Mice                                                            
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
                                                                                                                                   
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
NTP                                          MEAN BODY WEIGHTS AND SURVIVAL TABLE                                 REPORT: EISRPT41  
LAB: BATTELLE COLUMBUS LABORATORY                     ELMIRON                                                     DATE: 04/24/01    
EXPERIMENT: 88122 TEST: 07                                                                                        TIME: 17:12:01    
SPECIES: MICE, B6C3F1                                                                                                               
TEST TYPE: TWO YEAR                                 ROUTE: ORAL GAVAGE                                            NTP:  C88122      
CONT: NO1-ES-55388                                                                                                CAS: 37319-17-8   
                                                                                                                                   
                                                                                                                                    
                             MEAN BODY WEIGHTS AND SURVIVAL OF MALE MICE IN THE                                                     
                                   TWO YEAR ORAL GAVAGE STUDY OF ELMIRON                                                            
==========================================================================================================                          
WEEK     0 MG/KG                56 MG/KG                 168     MG/KG            504     MG/KG                                     
         ----------------       ----------------         ----------------         ----------------                                  
          AV.WT.     NO.       AV.WT.  PERCENT  NO.     AV.WT.  PERCENT  NO.     AV.WT.  PERCENT  NO.                               
         (GRAMS)     (A)       (GRAMS)  OF CNTL  (A)    (GRAMS)  OF CNTL  (A)    (GRAMS)  OF CNTL  (A)                              
=========================================================================================================                           
  B        22.8       50        22.5     98.7    50      22.8    100.0    50      22.7     99.6    50                               
  1        22.8       50        22.5     98.7    50      22.8    100.0    50      22.7     99.6    50                               
  5        28.3       50        27.8     98.2    49      28.5    100.7    50      28.4    100.4    48                               
  9        33.3       50        32.2     96.7    49      32.9     98.8    50      33.9    101.8    48                               
 13        37.0       50        35.2     95.1    49      36.4     98.4    50      36.5     98.6    48                               
 17        40.6       50        38.8     95.6    49      39.9     98.3    50      40.4     99.5    48                               
 21        42.7       50        41.1     96.3    49      43.5    101.9    50      43.3    101.4    48                               
 25        46.9       50        44.7     95.3    49      46.5     99.1    50      47.1    100.4    48                               
 29        48.4       50        46.6     96.3    49      48.2     99.6    50      48.7    100.6    48                               
 33        49.0       50        47.3     96.5    49      49.3    100.6    50      49.9    101.8    48                               
 37        49.4       50        47.9     97.0    49      49.4    100.0    50      50.0    101.2    48                               
 41        50.9       50        49.8     97.8    49      51.3    100.8    50      51.9    102.0    48                               
 45        51.3       50        49.7     96.9    49      51.7    100.8    50      52.3    101.9    48                               
 49        51.9       50        50.1     96.5    48      51.9    100.0    50      52.1    100.4    48                               
 53        52.3       50        50.8     97.1    47      52.6    100.6    50      52.7    100.8    48                               
 57        52.5       50        51.3     97.7    47      53.0    101.0    50      52.7    100.4    48                               
 61        51.9       49        51.1     98.5    47      51.8     99.8    50      52.7    101.5    48                               
 65        52.3       49        51.7     98.9    47      52.6    100.6    50      52.9    101.1    48                               
 69        51.9       49        51.4     99.0    46      52.4    101.0    49      51.8     99.8    48                               
 73        51.5       48        50.6     98.3    46      51.4     99.8    49      51.6    100.2    45                               
 77        50.7       48        50.8    100.2    43      50.2     99.0    49      49.9     98.4    45                               
 81        51.1       48        50.4     98.6    43      49.8     97.5    48      49.9     97.7    44                               
 85        51.0       48        51.3    100.6    43      50.3     98.6    47      49.9     97.8    42                               
 89        52.2       45        51.3     98.3    43      50.8     97.3    44      50.5     96.7    40                               
 93        51.2       43        50.6     98.8    43      50.3     98.2    42      49.0     95.7    37                               
 97        50.4       41        48.7     96.6    43      49.5     98.2    40      49.1     97.4    33                               
100        49.2       40        47.4     96.3    42      48.3     98.2    39      47.1     95.7    31                               
TERM. SAC.            39                         40                       38                       30                               
==========================================================================================================                          
    (A) NUMBER OF ANIMALS WEIGHED.  AT TERMINAL SACRIFICE, NUMBER                                                                   
        OF ANIMALS ALIVE ON FIRST DAY OF TERMINAL SACRIFICE.                                                                        
    (B) REFERS TO THE BEGINNING (INITIAL) BODY WEIGHT.                                                                              
    (I) INTERIM SACRIFICE OCCURRED IN THIS WEEK.                                                                                    
    (*) THE NUMBER OF ANIMALS WEIGHED FOR THIS WEEK                                                                                 
         IS LESS THAN THE NUMBER OF ANIMALS SURVIVING.                                                                              
                                                                                                                                   
                                                                                                                                    
                             MEAN BODY WEIGHTS AND SURVIVAL OF FEMALE MICE IN THE                                                   
                                   TWO YEAR ORAL GAVAGE STUDY OF ELMIRON                                                            
==========================================================================================================                          
WEEK     0 MG/KG                56 MG/KG                 168     MG/KG            504     MG/KG                                     
         ----------------       ----------------         ----------------         ----------------                                  
          AV.WT.     NO.       AV.WT.  PERCENT  NO.     AV.WT.  PERCENT  NO.     AV.WT.  PERCENT  NO.                               
         (GRAMS)     (A)       (GRAMS)  OF CNTL  (A)    (GRAMS)  OF CNTL  (A)    (GRAMS)  OF CNTL  (A)                              
=========================================================================================================                           
  B        18.5       50        18.4     99.5    50      18.6    100.5    50      18.5    100.0    50                               
  1        18.5       50        18.4     99.5    50      18.6    100.5    50      18.5    100.0    50                               
  5        21.0       50        22.0    104.8    49      22.7    108.1    50      22.3    106.2    50                               
  9        26.2       50        24.9     95.0    49      26.4    100.8    50      25.9     98.9    50                               
 13        29.8       50        28.7     96.3    49      29.3     98.3    50      29.6     99.3    50                               
 17        33.4       50        32.4     97.0    49      32.6     97.6    50      32.9     98.5    50                               
 21        36.2       50        34.9     96.4    49      36.1     99.7    50      36.2    100.0    50                               
 25        39.9       50        39.4     98.7    49      39.1     98.0    50      39.7     99.5    50                               
 29        43.1       49        42.9     99.5    49      42.7     99.1    50      43.7    101.4    50                               
 33        45.0       49        45.2    100.4    49      44.5     98.9    50      45.3    100.7    50                               
 37        48.2       49        48.0     99.6    49      47.3     98.1    50      48.3    100.2    50                               
 41        51.1       49        51.7    101.2    48      50.7     99.2    50      51.5    100.8    50                               
 45        54.6       49        54.8    100.4    48      53.3     97.6    50      54.3     99.5    50                               
 49        57.6       49        57.2     99.3    48      56.5     98.1    49      56.2     97.6    50                               
 53        58.5       49        58.4     99.8    48      57.7     98.6    49      56.9     97.3    50                               
 57        59.8       49        59.8    100.0    48      59.9    100.2    49      57.0     95.3    50                               
 61        61.2       48        60.7     99.2    48      60.5     98.9    49      57.0     93.1    49                               
 65        61.7       48        60.9     98.7    48      61.0     98.9    49      57.1     92.5    49                               
 69        62.9       47        61.0     97.0    48      61.0     97.0    49      55.4     88.1    49                               
 73        61.4       47        60.6     98.7    47      60.4     98.4    48      53.9     87.8    49                               
 77        59.9       47        58.8     98.2    47      58.3     97.3    47      52.0     86.8    47                               
 81        61.1       46        58.1     95.1    45      58.3     95.4    47      49.9     81.7    47                               
 85        59.7       45        58.2     97.5    45      58.2     97.5    46      49.0     82.1    46                               
 89        61.4       45        58.6     95.4    45      58.3     95.0    45      48.0     78.2    46                               
 93        61.0       44        57.4     94.1    44      57.9     94.9    42      47.5     77.9    44                               
 97        62.0       41        56.4     91.0    44      57.2     92.3    39      45.9     74.0    41                               
100        60.9       40        55.2     90.6    42      56.0     92.0    38      43.9     72.1    40                               
TERM. SAC.            37                         38                       37                       34                               
==========================================================================================================                          
    (A) NUMBER OF ANIMALS WEIGHED.  AT TERMINAL SACRIFICE, NUMBER                                                                   
        OF ANIMALS ALIVE ON FIRST DAY OF TERMINAL SACRIFICE.                                                                        
    (B) REFERS TO THE BEGINNING (INITIAL) BODY WEIGHT.                                                                              
    (I) INTERIM SACRIFICE OCCURRED IN THIS WEEK.                                                                                    
    (*) THE NUMBER OF ANIMALS WEIGHED FOR THIS WEEK                                                                                 
         IS LESS THAN THE NUMBER OF ANIMALS SURVIVING.