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TDMS Study 61427-07 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Battelle Northwest                                    VANADIUM PENTOXIDE                                  DATE: 11/19/01       
EXPERIMENT: 61427 TEST: 07                                                                                     TIME: 10:14:07       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1-ES-55392                              ROUTE: RESPIRATORY EXPOSURE WHOLE BODY                         NTP C#: 61427B       
PATHOLOGIST: RENNE, ROGER                    MILLER, RODNEY                                                    CAS: 1314-62-1       
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                            FINAL#2/RATS                                                            
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
                                                                                                                                   
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Battelle Northwest                                    VANADIUM PENTOXIDE                                  DATE: 11/19/01       
EXPERIMENT: 61427 TEST: 07                                                                                     TIME: 10:14:07       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1-ES-55392                              ROUTE: RESPIRATORY EXPOSURE WHOLE BODY                         NTP C#: 61427B       
PATHOLOGIST: RENNE, ROGER                    MILLER, RODNEY                                                    CAS: 1314-62-1       
                                                                                                                                   
                                VANADIUM PENTOXIDE                                                                                  
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE RATS                                                                                      
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = CONTROL                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 30     CENSORED DEATHS 0    TERMINAL 20        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      373   477   502   561   589   589   589   610   612   617                 |                                                 
 |      617   619   624   628   636   638   650   652   666   666                 |                                                 
 |      666   666   669   677   694   701   705   708   708   710                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                          DOSE = 0.5     MG/M3                                  |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 21     CENSORED DEATHS 0    TERMINAL 29        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      311   353   485   493   548   571   584   608   620   652                 |                                                 
 |      652   673   677   680   684   694   708   708   709   714                 |                                                 
 |      716                                                                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                          DOSE = 1.0     MG/M3                                  |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 24     CENSORED DEATHS 0    TERMINAL 26        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      392   519   528   551   584   633   633   653   655   661                 |                                                 
 |      661   671   680   684   694   698   703   708   712   712                 |                                                 
 |      717   722   725   728                                                     |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                VANADIUM PENTOXIDE                                                                                  
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE RATS                                                                                      
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                          DOSE = 2.0     MG/M3                                  |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 23     CENSORED DEATHS 0    TERMINAL 27        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      332   390   533   538   542   552   558   561   578   616                 |                                                 
 |      623   629   631   636   642   661   675   684   685   687                 |                                                 
 |      695   712   723                                                           |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                VANADIUM PENTOXIDE                                                                                  
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE RATS                                                                                      
                       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)   |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |           |                                                                    |                                                 
 |CONTROL    |   100.0 100.0 100.0 100.0  98.0  96.0  94.0  86.0  64.0  40.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |0.5        |   100.0 100.0 100.0  96.0  96.0  94.0  92.0  86.0  78.0  58.0      |                                                 
 |MG/M3      |                                                                    |                                                 
 |           |                                                                    |                                                 
 |1.0        |   100.0 100.0 100.0 100.0  98.0  98.0  94.0  90.0  78.0  52.0      |                                                 
 |MG/M3      |                                                                    |                                                 
 |           |                                                                    |                                                 
 |2.0        |   100.0 100.0 100.0  98.0  96.0  96.0  90.0  82.0  68.0  54.0      |                                                 
 |MG/M3      |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                  DOSE                          |                                                 
 |                                                                                |                                                 
 |                                CONTROL      0.5          1.0          2.0      |                                                 
 |                                             MG/M3        MG/M3        MG/M3    |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       40.0%        58.0%        52.0%        54.0%    |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |       P=0.386N     P=0.085N     P=0.138N     P=0.289N |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       627.3        611.4        651.0        603.6    |                                                 
 |NATURAL DEATHS (C)      |       (13.6)       (25.4)       (16.8)       (20.2)   |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       668.0        679.6        691.6        671.3    |                                                 
 |(STANDARD ERROR)        |       (10.8)       (13.4)       ( 9.7)       (12.8)   |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (A)  FIRST TERMINAL SACRIFICE                                                                                                
       (B)  THE FIRST ENTRY IS THE TREND TEST (TARONE, 1975) RESULT.                                                                
            SUBSEQUENT ENTRIES ARE THE RESULTS OF PAIRWISE TESTS                                                                    
            (COX,1972).  NEGATIVE TRENDS ARE INDICATED BY "N".                                                                      
       (C)  MEAN OF ALL UNCENSORED DEATHS PRIOR TO TERMINAL SACRIFICE                                                               
       (D)  MEAN OF ALL DEATHS (UNCENSORED, CENSORED, TERMINAL SACRIFICE)                                                           
                                                                                                                                   
                                VANADIUM PENTOXIDE                                                                                  
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       FIRST TERMINAL SACRIFICE AT 731 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = CONTROL                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 17     CENSORED DEATHS 0    TERMINAL 33        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      234   458   463   519   548   624   625   638   638   638                 |                                                 
 |      666   666   698   708   717   720   722                                   |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                          DOSE = 0.5     MG/M3                                  |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 26     CENSORED DEATHS 0    TERMINAL 24        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      366   408   499   533   540   571   571   582   608   612                 |                                                 
 |      633   652   667   668   675   694   695   696   701   708                 |                                                 
 |      710   712   717   717   717   722                                         |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                          DOSE = 1.0     MG/M3                                  |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 21     CENSORED DEATHS 0    TERMINAL 29        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      139   421   433   499   570   572   589   617   638   652                 |                                                 
 |      652   661   680   683   689   698   698   707   710   712                 |                                                 
 |      725                                                                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                VANADIUM PENTOXIDE                                                                                  
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       FIRST TERMINAL SACRIFICE AT 731 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                          DOSE = 2.0     MG/M3                                  |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 20     CENSORED DEATHS 0    TERMINAL 30        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      332   440   455   514   569   589   597   612   617   636                 |                                                 
 |      638   647   653   668   680   694   706   715   717   725                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                VANADIUM PENTOXIDE                                                                                  
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       FIRST TERMINAL SACRIFICE AT 731 DAYS                                                                         
 ==================================================================================                                                 
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |    DOSE                               TIME (DAYS)                              |                                                 
 |                 90   180   270   365   425   485   545   605   665   731 (A)   |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |           |                                                                    |                                                 
 |CONTROL    |   100.0 100.0  98.0  98.0  98.0  94.0  92.0  90.0  80.0  66.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |0.5        |   100.0 100.0 100.0 100.0  96.0  96.0  90.0  84.0  76.0  48.0      |                                                 
 |MG/M3      |                                                                    |                                                 
 |           |                                                                    |                                                 
 |1.0        |   100.0  98.0  98.0  98.0  96.0  94.0  92.0  86.0  76.0  58.0      |                                                 
 |MG/M3      |                                                                    |                                                 
 |           |                                                                    |                                                 
 |2.0        |   100.0 100.0 100.0  98.0  98.0  94.0  92.0  86.0  74.0  60.0      |                                                 
 |MG/M3      |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                  DOSE                          |                                                 
 |                                                                                |                                                 
 |                                CONTROL      0.5          1.0          2.0      |                                                 
 |                                             MG/M3        MG/M3        MG/M3    |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       66.0%        48.0%        58.0%        60.0%    |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |       P=0.917      P=0.119      P=0.522      P=0.621  |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       604.8        629.8        606.9        610.2    |                                                 
 |NATURAL DEATHS (C)      |       (30.9)       (19.1)       (30.3)       (23.3)   |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       688.1        678.4        678.9        682.7    |                                                 
 |(STANDARD ERROR)        |       (13.4)       (12.2)       (15.3)       (12.5)   |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (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)                                                           
                                                                                                                                   
                                                         VANADIUM PENTOXIDE                                                         
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        CONTROL          = 1                                                        
                                                        0.5     MG/M3    = 2                                                        
                                                        1.0     MG/M3    = 3                                                        
                                                        2.0     MG/M3    = 4                                                        
                                                                                                                                    
------------------------------------------------------ SPECIES=RATS SEX=MALE -------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
      |                                                                                                                             
      |                                                                                                                             
  100 + 1                                                 2  4     1  3                                                             
      |                                                   2  4  2  1  3             1      3                                        
      |                                                         2     4             1221   334 3 1                                  
      |                                                                               2      442 1  3 1                             
P  90 +                                                                                       42  2 3       3                       
E     |                                                                                        44 2 2                               
R     |                                                                                         44 42 1 212 3  3                    
C     |                                                                                            4     11    2 3                  
E  80 +                                                                                                  44                         
N     |                                                                                                   44   2 332                
T     |                                                                                                   114     322               
      |                                                                                                    114      3 3             
S  70 +                                                                                                     11   4  2 2             
U     |                                                                                                      11  4 4  232           
R     |                                                                                                       11  144  33           
V     |                                                                                                             44              
I  60 +                                                                                                              44 22          
V     |                                                                                                               4 423 2       
A     |                                                                                                           11    4 4 4       
L     |                                                                                                            1  1   3 3       
   50 +                                                                                                               11            
      |                                                                                                                             
      |                                                                                                                11           
      |                                                                                                                             
   40 +                                                                                                                 1   1       
      |                                                                                                                             
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110 
                                                                                                                                    
                                                                   WEEK                                                             
                                                                                                                                    
NOTE: 24 obs hidden.                                                                                                                
                                                                                                                                   
                                                         VANADIUM PENTOXIDE                                                         
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        CONTROL          = 1                                                        
                                                        0.5     MG/M3    = 2                                                        
                                                        1.0     MG/M3    = 3                                                        
                                                        2.0     MG/M3    = 4                                                        
                                                                                                                                    
----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
      |                                                                                                                             
      |                                                                                                                             
  100 + 1                     3              1               4    2                                                                 
      |                       3              1               4    2      2 3 4   1                                                  
      |                                                                  2 334  411    2 4 1 2                                      
      |                                                                                3 4 1 221  3                                 
P  90 +                                                                                       21  2   4    1                        
E     |                                                                                           3   34                            
R     |                                                                                           2 2 342431 1                      
C     |                                                                                                 224 43 3                    
E  80 +                                                                                                  2  21    1                 
N     |                                                                                                     2442 3                  
T     |                                                                                                       42 31 3 1 1           
      |                                                                                                           2233  11          
S  70 +                                                                                                            2432             
U     |                                                                                                               44 11         
R     |                                                                                                               22341 1       
V     |                                                                                                                2244         
I  60 +                                                                                                                 3 3 4       
V     |                                                                                                                   3 3       
A     |                                                                                                                 22          
L     |                                                                                                                             
   50 +                                                                                                                  22         
      |                                                                                                                   2 2       
      |                                                                                                                             
      |                                                                                                                             
   40 +                                                                                                                             
      |                                                                                                                             
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110 
                                                                                                                                    
                                                                   WEEK                                                             
                                                                                                                                    
NOTE: 33 obs hidden.