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TDMS Study 88122-07 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Battelle Columbus                                          ELMIRON                                        DATE: 04/23/01       
EXPERIMENT: 88122 TEST: 07                                                                                     TIME: 15:41:23       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1-ES-55388                              ROUTE: GAVAGE                                                  NTP C#: C88122       
PATHOLOGIST: GRUMBEIN, SONDRA                                                                                  CAS: 37319-17-8      
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                            final#1/Mice                                                            
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
                                                                                                                                   
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Battelle Columbus                                          ELMIRON                                        DATE: 04/23/01       
EXPERIMENT: 88122 TEST: 07                                                                                     TIME: 15:41:23       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1-ES-55388                              ROUTE: GAVAGE                                                  NTP C#: C88122       
PATHOLOGIST: GRUMBEIN, SONDRA                                                                                  CAS: 37319-17-8      
                                                                                                                                   
                                      ELMIRON                                                                                       
                       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 11     CENSORED DEATHS 0    TERMINAL 39        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      420   477   590   599   606   620   632   646   664   690                 |                                                 
 |      702                                                                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 56 MG/KG                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 9      CENSORED DEATHS 1    TERMINAL 40        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      311   346   455   508   508   508   688   707   728                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      11                                                                        |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                          DOSE = 168     MG/KG                                  |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 12     CENSORED DEATHS 0    TERMINAL 38        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      465   548   581   592   597   611   620   641   653   653                 |                                                 
 |      680   725                                                                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                      ELMIRON                                                                                       
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE MICE                                                                                      
                       FIRST TERMINAL SACRIFICE AT 730 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                          DOSE = 504     MG/KG                                  |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 18     CENSORED DEATHS 2    TERMINAL 30        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      483   492   498   539   576   584   590   617   621   626                 |                                                 
 |      631   646   657   658   668   676   695   721                             |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      11    17                                                                  |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                      ELMIRON                                                                                       
                       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  98.0  96.0  96.0  92.0  82.0  78.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |56 MG/KG   |   100.0 100.0 100.0  95.9  95.9  93.9  87.8  87.8  87.8  81.6      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |168        |   100.0 100.0 100.0 100.0 100.0  98.0  98.0  90.0  80.0  76.0      |                                                 
 |MG/KG      |                                                                    |                                                 
 |           |                                                                    |                                                 
 |504        |   100.0 100.0 100.0 100.0 100.0  97.9  91.7  85.4  70.8  62.5      |                                                 
 |MG/KG      |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                  DOSE                          |                                                 
 |                                                                                |                                                 
 |                                0 MG/KG      56 MG/KG     168          504      |                                                 
 |                                                          MG/KG        MG/KG    |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       78.0%        81.6%        76.0%        62.5%    |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |       P=0.038      P=0.860N     P=0.974      P=0.140  |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       604.2        528.8        613.8        609.9    |                                                 
 |NATURAL DEATHS (C)      |       (25.9)       (50.6)       (19.2)       (16.5)   |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       702.3        679.4        702.1        658.1    |                                                 
 |(STANDARD ERROR)        |       ( 9.2)       (19.6)       ( 8.4)       (21.3)   |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (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)                                                           
                                                                                                                                   
                                      ELMIRON                                                                                       
                       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 12     CENSORED DEATHS 1    TERMINAL 37        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      411   456   536   583   636   647   661   667   685   703                 |                                                 
 |      717   723                                                                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      183                                                                       |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 56 MG/KG                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 11     CENSORED DEATHS 1    TERMINAL 38        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      281   485   541   555   642   681   681   703   703   711                 |                                                 
 |      722                                                                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      18                                                                        |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                          DOSE = 168     MG/KG                                  |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 13     CENSORED DEATHS 0    TERMINAL 37        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      313   481   509   589   603   621   638   638   647   653                 |                                                 
 |      667   677   717                                                           |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                      ELMIRON                                                                                       
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE MICE                                                                                     
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                          DOSE = 504     MG/KG                                  |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 16     CENSORED DEATHS 0    TERMINAL 34        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      401   509   517   579   621   645   652   660   661   683                 |                                                 
 |      698   701   703   708   717   723                                         |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                      ELMIRON                                                                                       
                       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    |   100.0 100.0 100.0 100.0  98.0  95.9  93.9  91.8  85.7  75.5      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |56 MG/KG   |   100.0 100.0 100.0  98.0  98.0  95.9  93.9  91.8  89.8  77.6      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |168        |   100.0 100.0 100.0  98.0  98.0  96.0  94.0  90.0  80.0  74.0      |                                                 
 |MG/KG      |                                                                    |                                                 
 |           |                                                                    |                                                 
 |504        |   100.0 100.0 100.0 100.0  98.0  98.0  94.0  92.0  82.0  68.0      |                                                 
 |MG/KG      |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                  DOSE                          |                                                 
 |                                                                                |                                                 
 |                                0 MG/KG      56 MG/KG     168          504      |                                                 
 |                                                          MG/KG        MG/KG    |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       75.5%        77.6%        74.0%        68.0%    |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |       P=0.359      P=0.962N     P=0.968      P=0.544  |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       618.8        609.5        596.4        636.1    |                                                 
 |NATURAL DEATHS (C)      |       (29.5)       (40.8)       (29.7)       (22.8)   |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       691.6        688.5        694.5        699.3    |                                                 
 |(STANDARD ERROR)        |       (14.1)       (17.7)       (11.2)       ( 9.4)   |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (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)                                                           
                                                                                                                                   
                                                              ELMIRON                                                               
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        0 MG/KG          = 1                                                        
                                                        56 MG/KG         = 2                                                        
                                                        168     MG/KG    = 3                                                        
                                                        504     MG/KG    = 4                                                        
                                                                                                                                    
------------------------------------------------------ SPECIES=MICE SEX=MALE -------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
               |                                                                                                                    
               |                                                                                                                    
        100.00 +  1                                            2              1      3 4                                            
               |                                                                                                                    
               |                                               2    2         1      3 1 4       3                                  
               |                                                                                                                    
         95.83 +                                                    2              2   1 44      3   3 1                            
               |                                                                                                                    
               |                                                                   2      42   4     3 11                           
               |                                                                                                                    
         91.67 +                                                                               4     4 311                          
               |                                                                                                                    
      P        |                                                                                     44 3131                        
      E        |                                                                                                                    
      R  87.50 +                                                                           2          44  31 1       2              
      C        |                                                                                           3 131                    
      E        |                                                                                       4   4         2 2            
      N        |                                                                                              3131                  
      T  83.33 +                                                                                                       2  2         
               |                                                                                                 1   1              
      S        |                                                                                           44             22        
      U        |                                                                                                3   31 1            
      R  79.17 +                                                                                            44                      
      V        |                                                                                                    3  1  31        
      I        |                                                                                             4 4                    
      V        |                                                                                                          33        
      A  75.00 +                                                                                               44                   
      L        |                                                                                                                    
               |                                                                                                                    
               |                                                                                                                    
         70.83 +                                                                                                4 4                 
               |                                                                                                                    
               |                                                                                                  44                
               |                                                                                                                    
         66.67 +                                                                                                   4  4             
               |                                                                                                                    
               |                                                                                                      4  4          
               |                                                                                                                    
         62.50 +                                                                                                         4 4        
               |                                                                                                                    
               ---+----+----+----+----+----+----+----+----+----+----+----+----+----+----+----+----+----+----+----+----+----+--      
                  0    5   10   15   20   25   30   35   40   45   50   55   60   65   70   75   80   85   90   95   100  105       
                                                                                                                                    
                                                                     WEEK                                                           
                                                                                                                                    
NOTE: 7 obs hidden.                                                                                                                 
                                                                                                                                   
                                                              ELMIRON                                                               
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        0 MG/KG          = 1                                                        
                                                        56 MG/KG         = 2                                                        
                                                        168     MG/KG    = 3                                                        
                                                        504     MG/KG    = 4                                                        
                                                                                                                                    
----------------------------------------------------- SPECIES=MICE SEX=FEMALE ------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
      |                                                                                                                             
      |                                                                                                                             
  100 + 1                                            2    3             41                                                          
      |                                                                                                                             
      |                                              2    3             41       1  32  4                                           
      |                                                                          1  32  34   12                                     
   95 +                                                                                                                             
      |                                                                                 34   12 2  41 3                             
P     |                                                                                            4  3 3 4                         
E     |                                                                                         2   1       12                      
R  90 +                                                                                                 3 3 121     2               
C     |                                                                                                                             
E     |                                                                                                   3  314 1                  
N     |                                                                                                        4 11 2  2            
T  85 +                                                                                                                             
      |                                                                                                      33   1 1               
S     |                                                                                                       33 4  4               
U     |                                                                                                             1  12           
R  80 +                                                                                                        3  3 4 41212         
V     |                                                                                                                             
I     |                                                                                                           33  44 11 2       
V     |                                                                                                            3     3          
A  75 +                                                                                                                   1 1       
L     |                                                                                                                443  3       
      |                                                                                                                 44          
      |                                                                                                                             
   70 +                                                                                                                  44         
      |                                                                                                                             
      |                                                                                                                   4 4       
      |                                                                                                                             
   65 +                                                                                                                             
      |                                                                                                                             
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110 
                                                                                                                                    
                                                                   WEEK                                                             
                                                                                                                                    
NOTE: 10 obs hidden.