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TDMS Study 88122-06 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Battelle Columbus                                          ELMIRON                                        DATE: 06/12/01       
EXPERIMENT: 88122 TEST: 06                                                                                     TIME: 09:25:23       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1-ES-55388                              ROUTE: GAVAGE                                                  NTP C#: C88122       
PATHOLOGIST: RYAN, MICHAEL                                                                                     CAS: 37319-17-8      
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                              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                                          ELMIRON                                        DATE: 06/12/01       
EXPERIMENT: 88122 TEST: 06                                                                                     TIME: 09:25:23       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1-ES-55388                              ROUTE: GAVAGE                                                  NTP C#: C88122       
PATHOLOGIST: RYAN, MICHAEL                                                                                     CAS: 37319-17-8      
                                                                                                                                   
                                      ELMIRON                                                                                       
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE RATS                                                                                      
                       FIRST TERMINAL SACRIFICE AT 727 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 0 MG/KG                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 22     CENSORED DEATHS 2    TERMINAL 26        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      475   503   505   519   519   526   547   573   589   630                 |                                                 
 |      640   640   661   685   686   699   707   717   721   724                 |                                                 
 |      724   724                                                                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      111   600                                                                 |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 14 MG/KG                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 19     CENSORED DEATHS 2    TERMINAL 29        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      131   313   478   503   533   551   574   645   645   654                 |                                                 
 |      668   674   705   713   713   715   717   719   724                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      223   577                                                                 |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 42 MG/KG                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 25     CENSORED DEATHS 0    TERMINAL 25        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      419   462   484   492   521   526   533   561   574   582                 |                                                 
 |      582   586   587   630   630   630   674   674   679   685                 |                                                 
 |      686   686   695   716   717                                               |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                      ELMIRON                                                                                       
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE RATS                                                                                      
                       FIRST TERMINAL SACRIFICE AT 727 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                          DOSE = 126     MG/KG                                  |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 17     CENSORED DEATHS 5    TERMINAL 28        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      237   261   433   484   604   622   629   640   660   661                 |                                                 
 |      669   679   689   691   707   708   720                                   |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      120   161   352   456   709                                               |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                      ELMIRON                                                                                       
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE RATS                                                                                      
                       FIRST TERMINAL SACRIFICE AT 727 DAYS                                                                         
 ==================================================================================                                                 
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |    DOSE                               TIME (DAYS)                              |                                                 
 |                 90   180   270   365   425   485   545   605   665   727 (A)   |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |           |                                                                    |                                                 
 |0 MG/KG    |   100.0 100.0 100.0 100.0 100.0  98.0  87.8  81.6  73.3  54.4      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |14 MG/KG   |   100.0  98.0  98.0  96.0  96.0  93.9  89.8  85.7  79.5  60.7      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |42 MG/KG   |   100.0 100.0 100.0 100.0  98.0  94.0  86.0  74.0  68.0  50.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |126        |   100.0 100.0  95.8  95.8  95.8  91.5  91.5  89.3  78.4  63.1      |                                                 
 |MG/KG      |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                  DOSE                          |                                                 
 |                                                                                |                                                 
 |                                0 MG/KG      14 MG/KG     42 MG/KG     126      |                                                 
 |                                                                       MG/KG    |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       54.4%        60.7%        50.0%        63.1%    |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |       P=0.621N     P=0.659N     P=0.604      P=0.563N |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       623.4        598.7        600.4        593.8    |                                                 
 |NATURAL DEATHS (C)      |       (18.8)       (36.0)       (17.0)       (36.5)   |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       666.5        665.2        663.7        645.0    |                                                 
 |(STANDARD ERROR)        |       (15.8)       (18.5)       (12.4)       (22.4)   |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (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                                                                                       
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       FIRST TERMINAL SACRIFICE AT 728 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 0 MG/KG                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 19     CENSORED DEATHS 1    TERMINAL 30        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      406   427   462   509   559   596   596   600   601   621                 |                                                 
 |      629   651   673   678   690   707   719   722   726                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      191                                                                       |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 28 MG/KG                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 18     CENSORED DEATHS 1    TERMINAL 31        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      197   333   510   526   539   589   594   622   653   670                 |                                                 
 |      677   678   678   714   715   716   716   719                             |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      474                                                                       |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 84 MG/KG                                 |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 20     CENSORED DEATHS 2    TERMINAL 28        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      375   405   474   483   491   559   614   645   653   664                 |                                                 
 |      667   667   673   678   685   691   711   713   715   723                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      111   545                                                                 |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                      ELMIRON                                                                                       
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       FIRST TERMINAL SACRIFICE AT 728 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                          DOSE = 252     MG/KG                                  |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 17     CENSORED DEATHS 6    TERMINAL 27        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      379   495   518   525   588   603   624   651   656   660                 |                                                 
 |      667   672   678   706   720   723   727                                   |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      111   139   216   273   329   680                                         |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                      ELMIRON                                                                                       
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       FIRST TERMINAL SACRIFICE AT 728 DAYS                                                                         
 ==================================================================================                                                 
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |    DOSE                               TIME (DAYS)                              |                                                 
 |                 90   180   270   365   425   485   545   605   665   728 (A)   |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |           |                                                                    |                                                 
 |0 MG/KG    |   100.0 100.0 100.0 100.0  98.0  93.9  91.8  81.6  75.5  61.2      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |28 MG/KG   |   100.0 100.0  98.0  96.0  96.0  96.0  89.9  85.8  81.7  63.3      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |84 MG/KG   |   100.0 100.0 100.0 100.0  95.9  91.8  89.8  87.7  79.4  58.5      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |252        |   100.0 100.0 100.0 100.0  97.8  97.8  91.1  86.7  77.8  61.9      |                                                 
 |MG/KG      |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                  DOSE                          |                                                 
 |                                                                                |                                                 
 |                                0 MG/KG      28 MG/KG     84 MG/KG     252      |                                                 
 |                                                                       MG/KG    |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       61.2%        63.3%        58.5%        61.9%    |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |       P=1.000N     P=0.940N     P=0.953      P=1.000N |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       609.1        602.6        614.3        623.1    |                                                 
 |NATURAL DEATHS (C)      |       (22.6)       (33.6)       (24.4)       (23.2)   |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       672.1        677.8        666.5        639.9    |                                                 
 |(STANDARD ERROR)        |       (15.3)       (15.2)       (17.0)       (23.1)   |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (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                                                        
                                                        14 MG/KG         = 2                                                        
                                                        42 MG/KG         = 3                                                        
                                                        126     MG/KG    = 4                                                        
                                                                                                                                    
------------------------------------------------------ SPECIES=RATS SEX=MALE -------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
      |                                                                                                                             
  100 + 1                    2               4                            3        1                                                
      |                                                                                                                             
      |                      2               4    4       2               3      3 1   1                                            
      |                                           4       2                 4    3  23 11                                           
   95 +                                                                                                                             
      |                                                                     4       23321  1                                        
      |                                                                               32   3 2                                      
      |                                                                              4                  4                           
   90 +                                                                                    112 2                                    
      |                                                                                                 4 4                         
      |                                                                                     13 1  2       44                        
      |                                                                                      3 1 31           2                     
P  85 +                                                                                                    4 4                      
E     |                                                                                          31   1                             
R     |                                                                                           3 3        4   4                  
C     |                                                                                               1    1  22                    
E  80 +                                                                                                    1 1 2  2                 
N     |                                                                                                          44                 
T     |                                                                                                           22                
      |                                                                                                           44                
S  75 +                                                                                                      1   1 2   2            
U     |                                                                                             3      3     1 414 22           
R     |                                                                                                                             
V     |                                                                                                                             
I  70 +                                                                                                              4 4            
V     |                                                                                                             1 1 22          
A     |                                                                                                    3       3  114           
L     |                                                                                                                             
   65 +                                                                                                                141          
      |                                                                                                                             
      |                                                                                                            33    22         
      |                                                                                                                  11         
   60 +                                                                                                                             
      |                                                                                                                             
      |                                                                                                                             
      |                                                                                                             3 3             
   55 +                                                                                                                   1         
      |                                                                                                               3  3          
      |                                                                                                                             
      |                                                                                                                             
   50 +                                                                                                                  33         
      |                                                                                                                             
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110 
                                                                                                                                    
                                                                   WEEK                                                             
                                                                                                                                    
NOTE: 15 obs hidden.                                                                                                                
                                                                                                                                   
                                                              ELMIRON                                                               
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        0 MG/KG          = 1                                                        
                                                        28 MG/KG         = 2                                                        
                                                        84 MG/KG         = 3                                                        
                                                        252     MG/KG    = 4                                                        
                                                                                                                                    
----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
      |                                                                                                                             
      |                                                                                                                             
  100 + 1                               2                          3 4  1                                                           
      |                                                                                                                             
      |                                 2                    2     3 4  1  1          4                                             
      |                                                      2          3  1     1 3    2                                           
   95 +                                                                               4  4                                          
      |                                                                          1 33   14 42                                       
      |                                                                                     22                                      
      |                                                                             3 3 1  4    1   4                               
   90 +                                                                               3      2  1     21                            
      |                                                                                             4   4                           
P     |                                                                                         3        3                          
E     |                                                                                               2 4 24                        
R  85 +                                                                                                  3 4  3                     
C     |                                                                                                   2   32                    
E     |                                                                                                       44                    
N     |                                                                                                1  1    2 32                 
T  80 +                                                                                                   11   4 422                
      |                                                                                                          33                 
S     |                                                                                                    1  1  44                 
U     |                                                                                                                             
R  75 +                                                                                                       1   31                
V     |                                                                                                           42    2           
I     |                                                                                                                             
V     |                                                                                                            131 422          
A  70 +                                                                                                              1 1            
L     |                                                                                                             33 4 4          
      |                                                                                                                1 1          
      |                                                                                                              3  344         
   65 +                                                                                                                  11         
      |                                                                                                                  22         
      |                                                                                                                 334         
      |                                                                                                                   1         
   60 +                                                                                                                  33         
      |                                                                                                                   3         
      |                                                                                                                             
      |                                                                                                                             
   55 +                                                                                                                             
      |                                                                                                                             
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110 
                                                                                                                                    
                                                                   WEEK                                                             
                                                                                                                                    
NOTE: 13 obs hidden.