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TDMS Study 05161-06 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Southern Research Inst                                   RIDDELLIINE                                      DATE: 11/30/00       
EXPERIMENT: 05161 TEST: 06                                                                                     TIME: 08:19:53       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-55393                              ROUTE: GAVAGE                                                  NTP C#: 61358C       
PATHOLOGIST: FARNELL, D.                                                                                       CAS: 23246-96-0      
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                            MICE/FINAL#1                                                            
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
                                                                                                                                   
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Southern Research Inst                                   RIDDELLIINE                                      DATE: 11/30/00       
EXPERIMENT: 05161 TEST: 06                                                                                     TIME: 08:19:53       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-55393                              ROUTE: GAVAGE                                                  NTP C#: 61358C       
PATHOLOGIST: FARNELL, D.                                                                                       CAS: 23246-96-0      
                                                                                                                                   
                                    RIDDELLIINE                                                                                     
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE MICE                                                                                      
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                          DOSE = 0       MG/KG/DY                               |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 10     CENSORED DEATHS 1    TERMINAL 39        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      475   486   561   599   633   637   675   706   713   713                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      188                                                                       |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                          DOSE = 0.1     MG/KG/DY                               |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 9      CENSORED DEATHS 0    TERMINAL 41        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      434   542   566   587   596   633   634   681   696                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                          DOSE = 0.3     MG/KG/DY                               |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 10     CENSORED DEATHS 0    TERMINAL 40        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      567   592   614   619   657   700   713   720   722   728                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                    RIDDELLIINE                                                                                     
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE MICE                                                                                      
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                          DOSE = 1.0     MG/KG/DY                               |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 12     CENSORED DEATHS 0    TERMINAL 38        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      507   531   552   554   566   582   639   661   661   689                 |                                                 
 |      707   720                                                                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                          DOSE = 3.0     MG/KG/DY                               |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 30     CENSORED DEATHS 0    TERMINAL 20        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      356   550   559   566   568   572   577   587   590   598                 |                                                 
 |      603   603   605   614   633   639   644   647   652   660                 |                                                 
 |      661   664   675   681   685   705   705   716   720   727                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                    RIDDELLIINE                                                                                     
                       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          |   100.0 100.0 100.0 100.0 100.0  98.0  95.9  91.8  87.8  79.6      |                                                 
 |MG/KG/DY   |                                                                    |                                                 
 |           |                                                                    |                                                 
 |0.1        |   100.0 100.0 100.0 100.0 100.0  98.0  96.0  90.0  86.0  82.0      |                                                 
 |MG/KG/DY   |                                                                    |                                                 
 |           |                                                                    |                                                 
 |0.3        |   100.0 100.0 100.0 100.0 100.0 100.0 100.0  96.0  90.0  80.0      |                                                 
 |MG/KG/DY   |                                                                    |                                                 
 |           |                                                                    |                                                 
 |1.0        |   100.0 100.0 100.0 100.0 100.0 100.0  96.0  88.0  82.0  76.0      |                                                 
 |MG/KG/DY   |                                                                    |                                                 
 |           |                                                                    |                                                 
 |3.0        |   100.0 100.0 100.0  98.0  98.0  98.0  98.0  74.0  56.0  40.0      |                                                 
 |MG/KG/DY   |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                    RIDDELLIINE                                                                                     
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE MICE                                                                                      
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
 ===============================================================================================================================    
 |                                               SURVIVAL SUMMARY STATISTICS                                                   |    
 |                                                                                                                             |    
 |                                                                                                                             |    
 |-----------------------------------------------------------------------------------------------------------------------------|    
 |                                                                           DOSE                                              |    
 |                                                                                                                             |    
 |                                0                  0.1                0.3                1.0                3.0              |    
 |                                MG/KG/DY           MG/KG/DY           MG/KG/DY           MG/KG/DY           MG/KG/DY         |    
 |-----------------------------------------------------------------------------------------------------------------------------|    
 |SURVIVAL AT END OF STUDY|       79.6%              82.0%              80.0%              76.0%              40.0%            |    
 |(KAPLAN-MEIER)          |                                                                                                    |    
 |                        |                                                                                                    |    
 |SIGNIFICANCE (B)        |       P<0.001            P=0.989N           P=1.000N           P=0.819            P<0.001          |    
 |(LIFE TABLE)            |                                                                                                    |    
 |                        |                                                                                                    |    
 |MEAN DAY OF             |       619.8              596.6              663.2              614.1              625.4            |    
 |NATURAL DEATHS (C)      |       (28.1)             (26.4)             (19.3)             (21.3)             (13.3)           |    
 |(STANDARD ERROR)        |                                                                                                    |    
 |                        |                                                                                                    |    
 |MEAN LIFE SPAN (D)      |       696.3              705.2              715.8              701.4              666.8            |    
 |(STANDARD ERROR)        |       (13.2)             ( 8.6)             ( 5.3)             ( 8.6)             (10.8)           |    
 |                        |                                                                                                    |    
 ===============================================================================================================================    
                                                                                                                                    
       (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)                                                           
                                                                                                                                   
                                    RIDDELLIINE                                                                                     
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE MICE                                                                                     
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                          DOSE = 0       MG/KG/DY                               |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 12     CENSORED DEATHS 4    TERMINAL 34        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      27    419   475   482   524   566   577   657   675   696                 |                                                 
 |      709   725                                                                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      545   545   545   545                                                     |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                          DOSE = 3.0     MG/KG/DY                               |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 33     CENSORED DEATHS 0    TERMINAL 17        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      434   489   504   530   532   587   591   596   618   637                 |                                                 
 |      637   656   660   669   675   675   681   692   696   696                 |                                                 
 |      696   696   700   709   709   709   709   713   716   720                 |                                                 
 |      720   722   722                                                           |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                    RIDDELLIINE                                                                                     
                       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          |    98.0  98.0  98.0  98.0  96.0  92.0  90.0  85.6  83.4  74.6      |                                                 
 |MG/KG/DY   |                                                                    |                                                 
 |           |                                                                    |                                                 
 |3.0        |   100.0 100.0 100.0 100.0 100.0  98.0  90.0  84.0  74.0  34.0      |                                                 
 |MG/KG/DY   |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                        DOSE                    |                                                 
 |                                                                                |                                                 
 |                                0                         3.0                   |                                                 
 |                                MG/KG/DY                  MG/KG/DY              |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       74.6%                     34.0%                 |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |       P<0.001                   P<0.001               |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       544.3                     651.4                 |                                                 
 |NATURAL DEATHS (C)      |       (55.5)                    (13.5)                |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       670.0                     677.8                 |                                                 
 |(STANDARD ERROR)        |       (17.8)                    (10.3)                |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (A)  FIRST TERMINAL SACRIFICE                                                                                                
       (B)  THE FIRST ENTRY IS THE TREND TEST (TARONE, 1975) RESULT.                                                                
            SUBSEQUENT ENTRIES ARE THE RESULTS OF PAIRWISE TESTS                                                                    
            (COX,1972).  NEGATIVE TRENDS ARE INDICATED BY "N".                                                                      
       (C)  MEAN OF ALL UNCENSORED DEATHS PRIOR TO TERMINAL SACRIFICE                                                               
       (D)  MEAN OF ALL DEATHS (UNCENSORED, CENSORED, TERMINAL SACRIFICE)                                                           
                                                                                                                                   
                                                            RIDDELLIINE                                                             
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        0       MG/KG/DY = 1                                                        
                                                        0.1     MG/KG/DY = 2                                                        
                                                        0.3     MG/KG/DY = 3                                                        
                                                        1.0     MG/KG/DY = 4                                                        
                                                        3.0     MG/KG/DY = 5                                                        
                                                                                                                                    
------------------------------------------------------ SPECIES=MICE SEX=MALE -------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
      |                                                                                                                             
      |                                                                                                                             
  100 + 1                                                       5           2      1    4        3                                  
      |                                                         5           2      1 1  4   4 25 3    3                             
      |                                                                              1      4 2441  2 31 33                         
      |                                                                                         445 2  1  3 1  3                    
P  90 +                                                                                          4  4  2    2  3      3             
E     |                                                                                           554       14     1  3 3           
R     |                                                                                            55 5     24   4 12 21333         
C     |                                                                                               55         4   4211   2       
E  80 +                                                                                                55            4 41 3 1       
N     |                                                                                                                4 4          
T     |                                                                                                 55               4  4       
      |                                                                                                  5  5                       
S  70 +                                                                                                     55                      
U     |                                                                                                                             
R     |                                                                                                      555                    
V     |                                                                                                        5 5                  
I  60 +                                                                                                                             
V     |                                                                                                                             
A     |                                                                                                          5 55               
L     |                                                                                                                             
   50 +                                                                                                             5  5            
      |                                                                                                                             
      |                                                                                                                5 5          
      |                                                                                                                  55         
   40 +                                                                                                                   5 5       
      |                                                                                                                             
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110 
                                                                                                                                    
                                                                   WEEK                                                             
                                                                                                                                    
NOTE: 21 obs hidden.                                                                                                                
                                                                                                                                   
                                                            RIDDELLIINE                                                             
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        0       MG/KG/DY = 1                                                        
                                                        3.0     MG/KG/DY = 2                                                        
                                                                                                                                    
----------------------------------------------------- SPECIES=MICE SEX=FEMALE ------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
      |                                                                                                                             
      |                                                                                                                             
  100 + 1   1                                                               2                                                       
      |     1                                                             1 2        2                                              
      |                                                                   1        112 2    2                                       
      |                                                                             1      1                                        
   90 +                                                                                    12    1  2                               
      |                                                                                          1 12 2                             
P     |                                                                                            1  22  2    1                    
E     |                                                                                                   2 2  1   1                
R  80 +                                                                                                            1  1 1           
C     |                                                                                                     2  2        1 1         
E     |                                                                                                        2 22       1 1       
N     |                                                                                                           22                
T  70 +                                                                                                                             
      |                                                                                                            22               
S     |                                                                                                             222             
U     |                                                                                                                             
R  60 +                                                                                                                             
V     |                                                                                                                             
I     |                                                                                                               2 2           
V     |                                                                                                                             
A  50 +                                                                                                                             
L     |                                                                                                                             
      |                                                                                                                 22          
      |                                                                                                                             
   40 +                                                                                                                             
      |                                                                                                                  22         
      |                                                                                                                   2 2       
      |                                                                                                                             
   30 +                                                                                                                             
      |                                                                                                                             
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110 
                                                                                                                                    
                                                                   WEEK                                                             
                                                                                                                                    
NOTE: 7 obs hidden.