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TDMS Study 91005-08 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Southern Research Inst                             METHYLENE BLUE TRIHYDRATE                              DATE: 04/26/05       
EXPERIMENT: 91005 TEST: 08                                                                                     TIME: 09:35:27       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-05451                              ROUTE: GAVAGE                                                  NTP C#: 91005C       
PATHOLOGIST: FARNELL, DANIEL                                                                                   CAS: 7220-79-3       
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                           FINAL #1 MICE                                                            
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
                                                                                                                                   
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Southern Research Inst                             METHYLENE BLUE TRIHYDRATE                              DATE: 04/26/05       
EXPERIMENT: 91005 TEST: 08                                                                                     TIME: 09:35:27       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-05451                              ROUTE: GAVAGE                                                  NTP C#: 91005C       
PATHOLOGIST: FARNELL, DANIEL                                                                                   CAS: 7220-79-3       
                                                                                                                                   
                             METHYLENE BLUE TRIHYDRATE                                                                              
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE MICE                                                                                      
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 0 MG/KG                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 15     CENSORED DEATHS 0    TERMINAL 35        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      478   530   536   544   548   559   605   605   605   640                 |                                                 
 |      665   673   694   723   723                                               |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                          DOSE = 2.5     MG/KG                                  |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 10     CENSORED DEATHS 2    TERMINAL 38        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      452   627   638   647   670   676   694   704   717   725                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      15    610                                                                 |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                          DOSE = 12.5    MG/KG                                  |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 12     CENSORED DEATHS 0    TERMINAL 38        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      261   605   605   627   638   645   673   680   690   695                 |                                                 
 |      696   727                                                                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                             METHYLENE BLUE TRIHYDRATE                                                                              
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE MICE                                                                                      
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                          DOSE = 25      MG/KG                                  |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 7      CENSORED DEATHS 2    TERMINAL 41        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      506   641   687   690   694   705   716                                   |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      610   610                                                                 |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                             METHYLENE BLUE TRIHYDRATE                                                                              
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE MICE                                                                                      
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
 ==================================================================================                                                 
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |    DOSE                               TIME (DAYS)                              |                                                 
 |                 90   180   270   365   425   485   545   605   665   729 (A)   |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |           |                                                                    |                                                 
 |0 MG/KG    |   100.0 100.0 100.0 100.0 100.0  98.0  92.0  82.0  78.0  70.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |2.5        |   100.0 100.0 100.0 100.0 100.0  98.0  98.0  98.0  91.7  79.2      |                                                 
 |MG/KG      |                                                                    |                                                 
 |           |                                                                    |                                                 
 |12.5       |   100.0 100.0  98.0  98.0  98.0  98.0  98.0  94.0  88.0  76.0      |                                                 
 |MG/KG      |                                                                    |                                                 
 |           |                                                                    |                                                 
 |25         |   100.0 100.0 100.0 100.0 100.0 100.0  98.0  98.0  95.9  85.5      |                                                 
 |MG/KG      |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                  DOSE                          |                                                 
 |                                                                                |                                                 
 |                                0 MG/KG      2.5          12.5         25       |                                                 
 |                                             MG/KG        MG/KG        MG/KG    |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       70.0%        79.2%        76.0%        85.5%    |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |       P=0.131N     P=0.325N     P=0.547N     P=0.081N |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       608.5        655.0        628.5        662.7    |                                                 
 |NATURAL DEATHS (C)      |       (19.6)       (24.9)       (35.2)       (27.6)   |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       692.9        697.5        704.9        715.0    |                                                 
 |(STANDARD ERROR)        |       ( 9.8)       (15.5)       (10.2)       ( 5.8)   |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (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)                                                           
                                                                                                                                   
                             METHYLENE BLUE TRIHYDRATE                                                                              
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE MICE                                                                                     
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 0 MG/KG                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 16     CENSORED DEATHS 1    TERMINAL 33        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      550   568   604   617   627   638   638   650   655   663                 |                                                 
 |      666   673   704   716   718   721                                         |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      185                                                                       |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                          DOSE = 2.5     MG/KG                                  |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 9      CENSORED DEATHS 1    TERMINAL 40        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      521   533   585   589   616   673   680   688   720                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      3                                                                         |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                          DOSE = 12.5    MG/KG                                  |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 7      CENSORED DEATHS 1    TERMINAL 42        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      568   627   645   705   716   716   726                                   |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      283                                                                       |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                             METHYLENE BLUE TRIHYDRATE                                                                              
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE MICE                                                                                     
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                          DOSE = 25      MG/KG                                  |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 7      CENSORED DEATHS 0    TERMINAL 43        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      445   471   528   649   659   680   722                                   |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                             METHYLENE BLUE TRIHYDRATE                                                                              
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE MICE                                                                                     
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
 ==================================================================================                                                 
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |    DOSE                               TIME (DAYS)                              |                                                 
 |                 90   180   270   365   425   485   545   605   665   729 (A)   |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |           |                                                                    |                                                 
 |0 MG/KG    |   100.0 100.0 100.0 100.0 100.0 100.0 100.0  93.9  79.6  67.3      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |2.5        |   100.0 100.0 100.0 100.0 100.0 100.0  95.9  91.8  89.8  81.6      |                                                 
 |MG/KG      |                                                                    |                                                 
 |           |                                                                    |                                                 
 |12.5       |   100.0 100.0 100.0 100.0 100.0 100.0 100.0  98.0  93.9  85.7      |                                                 
 |MG/KG      |                                                                    |                                                 
 |           |                                                                    |                                                 
 |25         |   100.0 100.0 100.0 100.0 100.0  96.0  94.0  94.0  90.0  86.0      |                                                 
 |MG/KG      |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                  DOSE                          |                                                 
 |                                                                                |                                                 
 |                                0 MG/KG      2.5          12.5         25       |                                                 
 |                                             MG/KG        MG/KG        MG/KG    |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       67.3%        81.6%        85.7%        86.0%    |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |       P=0.067N     P=0.179N     P=0.046N     P=0.055N |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       650.5        622.8        671.9        593.4    |                                                 
 |NATURAL DEATHS (C)      |       (12.7)       (23.7)       (22.6)       (41.6)   |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       693.0        695.4        712.1        710.0    |                                                 
 |(STANDARD ERROR)        |       (12.3)       (15.8)       ( 9.7)       ( 8.7)   |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (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)                                                           
                                                                                                                                   
                                                     METHYLENE BLUE TRIHYDRATE                                                      
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        0 MG/KG          = 1                                                        
                                                        2.5     MG/KG    = 2                                                        
                                                        12.5    MG/KG    = 3                                                        
                                                        25      MG/KG    = 4                                                        
                                                                                                                                    
------------------------------------------------------ SPECIES=MICE SEX=MALE -------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
      |                                                                                                                             
      |                                                                                                                             
  100 + 1                                         3                             2   1   4                                           
      |                                                                                                                             
      |                                           3                             2   1   4   1           3  2 4                      
      |                                                                                     11             2 2       4              
P  95 +                                                                                                                             
E     |                                                                                      11         3  3 22                     
R     |                                                                                       11           3 3                      
C     |                                                                                                       2   2  44             
E  90 +                                                                                        11            33   22  44            
N     |                                                                                                                             
T     |                                                                                         1       1     3    2  24 4          
      |                                                                                                            33               
S  85 +                                                                                                               22 4  4       
U     |                                                                                                             33 2 2          
R     |                                                                                                 1    1       33             
V     |                                                                                                                  22         
I  80 +                                                                                                      1   1                  
V     |                                                                                                                   2 2       
A     |                                                                                                          1 1  3   3         
L     |                                                                                                            1  1   3 3       
   75 +                                                                                                                             
      |                                                                                                               1   1         
      |                                                                                                                             
      |                                                                                                                             
   70 +                                                                                                                   1 1       
      |                                                                                                                             
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110 
                                                                                                                                    
                                                                   WEEK                                                             
                                                                                                                                    
NOTE: 5 obs hidden.                                                                                                                 
                                                                                                                                   
                                                     METHYLENE BLUE TRIHYDRATE                                                      
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        0 MG/KG          = 1                                                        
                                                        2.5     MG/KG    = 2                                                        
                                                        12.5    MG/KG    = 3                                                        
                                                        25      MG/KG    = 4                                                        
                                                                                                                                    
----------------------------------------------------- SPECIES=MICE SEX=FEMALE ------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
      |                                                                                                                             
      |                                                                                                                             
  100 + 1                                                                     4            2   1  3                                 
      |                                                                                                                             
      |                                                                       4    4       2 2 1  1        3                        
      |                                                                            4        42    1 2   1  3  3                     
   95 +                                                                                                                             
      |                                                                                     4       2 2 1 1   3        3            
P     |                                                                                                       4  4                  
E     |                                                                                               2  211           3 3          
R  90 +                                                                                                  2 1 1   4 24               
C     |                                                                                                                             
E     |                                                                                                            22    33         
N     |                                                                                                      11     22    3 3       
T  85 +                                                                                                                             
      |                                                                                                       11     2   2          
S     |                                                                                                                             
U     |                                                                                                        1 1       2  2       
R  80 +                                                                                                          11                 
V     |                                                                                                                             
I     |                                                                                                           11                
V     |                                                                                                                             
A  75 +                                                                                                            1   1            
L     |                                                                                                                1 1          
      |                                                                                                                             
      |                                                                                                                             
   70 +                                                                                                                             
      |                                                                                                                             
      |                                                                                                                  1  1       
      |                                                                                                                             
   65 +                                                                                                                             
      |                                                                                                                             
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110 
                                                                                                                                    
                                                                   WEEK                                                             
                                                                                                                                    
NOTE: 9 obs hidden.