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TDMS Study 05211-05 Pathology Tables


NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Southern Research Inst                                      EMODIN                                        DATE: 01/25/01       
EXPERIMENT: 05211 TEST: 05                                                                                     TIME: 13:06:30       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1-ES-85216                              ROUTE: DOSED FEED                                              NTP C#: C62408       
PATHOLOGIST: HEATH, JAMES                                                                                      CAS: 518-82-1        
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                         FINAL#3;REVISION#1                                                         
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    25022 Accidently Killed                                                                      
                                       25019 Moribund Sacrifice                                                                     
                                       25020 Natural Death                                                                          
                                       25021 Terminal Sacrifice                                                                     
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
                                                                                                                                   
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Southern Research Inst                                      EMODIN                                        DATE: 01/25/01       
EXPERIMENT: 05211 TEST: 05                                                                                     TIME: 13:06:30       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1-ES-85216                              ROUTE: DOSED FEED                                              NTP C#: C62408       
PATHOLOGIST: HEATH, JAMES                                                                                      CAS: 518-82-1        
                                                                                                                                   
                                      EMODIN                                                                                        
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE RATS                                                                                      
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 0       PPM                              |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 20     CENSORED DEATHS 0    TERMINAL 30        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      122   216   284   406   472   528   590   590   597   599                 |                                                 
 |      604   617   617   646   679   686   700   704   711   725                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 280     PPM                              |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 29     CENSORED DEATHS 0    TERMINAL 21        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      462   464   491   506   511   555   557   561   584   596                 |                                                 
 |      610   610   617   630   631   632   636   638   665   673                 |                                                 
 |      679   679   679   690   704   704   714   716   725                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 830     PPM                              |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 29     CENSORED DEATHS 0    TERMINAL 21        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      368   373   483   510   533   550   575   602   603   605                 |                                                 
 |      609   617   617   624   631   638   644   645   645   648                 |                                                 
 |      673   689   696   700   700   704   704   720   725                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                      EMODIN                                                                                        
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE RATS                                                                                      
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 2500    PPM                              |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 20     CENSORED DEATHS 0    TERMINAL 30        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      266   449   492   539   590   597   602   605   607   617                 |                                                 
 |      617   634   645   654   668   700   702   711   711   720                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                      EMODIN                                                                                        
                       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)   |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |           |                                                                    |                                                 
 |0       PPM|   100.0  98.0  96.0  94.0  92.0  90.0  88.0  78.0  72.0  60.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |280     PPM|   100.0 100.0 100.0 100.0 100.0  96.0  90.0  80.0  62.0  42.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |830     PPM|   100.0 100.0 100.0 100.0  96.0  94.0  90.0  80.0  60.0  42.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |2500    PPM|   100.0 100.0  98.0  98.0  98.0  96.0  92.0  84.0  72.0  60.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                  DOSE                          |                                                 
 |                                                                                |                                                 
 |                                0       PPM  280     PPM  830     PPM  2500    P|M                                                
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       60.0%        42.0%        42.0%        60.0%    |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |       P=0.396N     P=0.145      P=0.154      P=1.000N |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       554.7        617.9        614.9        606.3    |                                                 
 |NATURAL DEATHS (C)      |       (38.4)       (14.4)       (17.0)       (24.1)   |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       659.3        664.6        662.8        679.9    |                                                 
 |(STANDARD ERROR)        |       (19.4)       (11.4)       (12.7)       (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)                                                           
                                                                                                                                   
                                      EMODIN                                                                                        
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       FIRST TERMINAL SACRIFICE AT 730 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 0       PPM                              |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 17     CENSORED DEATHS 0    TERMINAL 33        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      448   497   527   544   596   610   630   630   645   646                 |                                                 
 |      648   685   686   704   704   725   725                                   |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 280     PPM                              |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 11     CENSORED DEATHS 0    TERMINAL 39        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      396   572   575   600   605   624   634   646   656   690                 |                                                 
 |      716                                                                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                DOSE = 830     PPM                              |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 15     CENSORED DEATHS 0    TERMINAL 35        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      232   527   539   592   617   648   665   665   674   674                 |                                                 
 |      677   702   711   725   725                                               |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                      EMODIN                                                                                        
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       FIRST TERMINAL SACRIFICE AT 730 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = 2500    PPM                              |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 16     CENSORED DEATHS 0    TERMINAL 34        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      360   529   590   592   597   602   603   610   618   646                 |                                                 
 |      657   665   674   689   690   716                                         |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                      EMODIN                                                                                        
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       FIRST TERMINAL SACRIFICE AT 730 DAYS                                                                         
 ==================================================================================                                                 
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |    DOSE                               TIME (DAYS)                              |                                                 
 |                 90   180   270   365   425   485   545   605   665   730 (A)   |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |           |                                                                    |                                                 
 |0       PPM|   100.0 100.0 100.0 100.0 100.0  98.0  92.0  90.0  78.0  66.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |280     PPM|   100.0 100.0 100.0 100.0  98.0  98.0  98.0  90.0  82.0  78.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |830     PPM|   100.0 100.0  98.0  98.0  98.0  98.0  94.0  92.0  84.0  70.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |2500    PPM|   100.0 100.0 100.0  98.0  98.0  98.0  96.0  86.0  76.0  68.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                  DOSE                          |                                                 
 |                                                                                |                                                 
 |                                0       PPM  280     PPM  830     PPM  2500    P|M                                                
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       66.0%        78.0%        70.0%        68.0%    |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |       P=0.762      P=0.285N     P=0.761N     P=1.000N |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       626.5        610.4        624.9        614.9    |                                                 
 |NATURAL DEATHS (C)      |       (19.8)       (25.3)       (32.2)       (20.8)   |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       694.8        703.7        698.5        693.2    |                                                 
 |(STANDARD ERROR)        |       ( 9.6)       ( 8.9)       (11.7)       (10.1)   |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (A)  FIRST TERMINAL SACRIFICE                                                                                                
       (B)  THE FIRST ENTRY IS THE TREND TEST (TARONE, 1975) RESULT.                                                                
            SUBSEQUENT ENTRIES ARE THE RESULTS OF PAIRWISE TESTS                                                                    
            (COX,1972).  NEGATIVE TRENDS ARE INDICATED BY "N".                                                                      
       (C)  MEAN OF ALL UNCENSORED DEATHS PRIOR TO TERMINAL SACRIFICE                                                               
       (D)  MEAN OF ALL DEATHS (UNCENSORED, CENSORED, TERMINAL SACRIFICE)                                                           
                                                                                                                                   
                                                               EMODIN                                                               
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        0       PPM      = 1                                                        
                                                        280     PPM      = 2                                                        
                                                        830     PPM      = 3                                                        
                                                        2500    PPM      = 4                                                        
                                                                                                                                    
------------------------------------------------------ SPECIES=RATS SEX=MALE -------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
      |                                                                                                                             
      |                                                                                                                             
  104 +                                                                                                                             
      |                                                                                                                             
      | 1                   1                     4               3              2                                                  
      |                     1             1       4               33            422                                                 
   96 +                                   1          1             3            4 2 3 2                                             
      |                                              1                  1           3 2 2    4                                      
      |                                                                 1          1    3    3        4                             
      |                                                                            1    2   13 32     44                            
P  88 +                                                                                     1  3   3  1                             
E     |                                                                                         22 3   34                           
R     |                                                                                          2  2 113                           
C     |                                                                                             2  24 4                         
E  80 +                                                                                                112                          
N     |                                                                                                 1 1 4                       
T     |                                                                                                  22 4 4                     
      |                                                                                                   12  14                    
S  72 +                                                                                                    22 14  41                
U     |                                                                                                     33    411 4             
R     |                                                                                                             1 14            
V     |                                                                                                     223       114           
I  64 +                                                                                                      2   2     11           
V     |                                                                                                          2 2    141         
A     |                                                                                                       3    3     41 1       
L     |                                                                                                            3 3              
   56 +                                                                                                              33             
      |                                                                                                            2 2              
      |                                                                                                              2 2            
      |                                                                                                               33            
   48 +                                                                                                                22           
      |                                                                                                                322          
      |                                                                                                                  22         
      |                                                                                                                   2 2       
   40 +                                                                                                                             
      |                                                                                                                             
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110 
                                                                                                                                    
                                                                   WEEK                                                             
                                                                                                                                    
NOTE: 29 obs hidden.                                                                                                                
                                                                                                                                   
                                                               EMODIN                                                               
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        0       PPM      = 1                                                        
                                                        280     PPM      = 2                                                        
                                                        830     PPM      = 3                                                        
                                                        2500    PPM      = 4                                                        
                                                                                                                                    
----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
      |                                                                                                                             
      |                                                                                                                             
  100 + 1                                    3                   4     2      1                                                     
      |                                                                                                                             
      |                                      3                   4     2      1       1     3     2                                 
      |                                                                               1     13    22  4                             
   95 +                                                                                                                             
      |                                                                                     131    2  32                            
P     |                                                                                       1       312 3                         
E     |                                                                                                                             
R  90 +                                                                                                12132  3                     
C     |                                                                                                                             
E     |                                                                                                441 12 3  3                  
N     |                                                                                                 44  2 2                     
T  85 +                                                                                                                             
      |                                                                                                  441  12 3 3                
S     |                                                                                                   4   42     2              
U     |                                                                                                                             
R  80 +                                                                                                       44     2   2          
V     |                                                                                                                             
I     |                                                                                                       14 4 31  3 2  2       
V     |                                                                                                          4 4   33           
A  75 +                                                                                                                             
L     |                                                                                                            414 13 3         
      |                                                                                                                             
      |                                                                                                                             
   70 +                                                                                                              4 1 41 3       
      |                                                                                                                             
      |                                                                                                                  4  4       
      |                                                                                                                   1 1       
   65 +                                                                                                                             
      |                                                                                                                             
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110 
                                                                                                                                    
                                                                   WEEK                                                             
                                                                                                                                    
NOTE: 12 obs hidden.