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TDMS Study 05161-05 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Southern Research Inst                                   RIDDELLIINE                                      DATE: 12/15/00       
EXPERIMENT: 05161 TEST: 05                                                                                     TIME: 12:15:42       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1-ES-55393                              ROUTE: GAVAGE                                                  NTP C#: 61358C       
PATHOLOGIST: HEATH, JAMES E.                                                                                   CAS: 23246-96-0      
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                        RATS/FINAL#1_FEMALES                                                        
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE 003    0       MG/KG/DY                                                              
                                       INCLUDE 004    0.01    MG/KG/DY                                                              
                                       INCLUDE 005    0.033   MG/KG/DY                                                              
                                       INCLUDE 006    0.1     MG/KG/DY                                                              
                                       INCLUDE 007    0.33    MG/KG/DY                                                              
                                       INCLUDE 008    1.0     MG/KG/DY                                                              
                                                                                                                                   
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Southern Research Inst                                   RIDDELLIINE                                      DATE: 12/15/00       
EXPERIMENT: 05161 TEST: 05                                                                                     TIME: 12:15:42       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1-ES-55393                              ROUTE: GAVAGE                                                  NTP C#: 61358C       
PATHOLOGIST: HEATH, JAMES E.                                                                                   CAS: 23246-96-0      
                                                                                                                                   
                                    RIDDELLIINE                                                                                     
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                          DOSE = 0       MG/KG/DY                               |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 15     CENSORED DEATHS 2    TERMINAL 33        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      393   437   468   483   498   545   611   611   636   640                 |                                                 
 |      672   678   693   710   720                                               |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      626   654                                                                 |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                          DOSE = 0.01    MG/KG/DY                               |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 22     CENSORED DEATHS 6    TERMINAL 22        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      328   407   513   520   541   573   600   605   631   638                 |                                                 
 |      644   647   650   672   675   679   693   698   715   718                 |                                                 
 |      719   725                                                                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      519   612   613   636   636   643                                         |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                          DOSE = 0.033   MG/KG/DY                               |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 19     CENSORED DEATHS 3    TERMINAL 28        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      437   518   532   562   571   572   591   591   616   617                 |                                                 
 |      647   647   654   671   675   688   694   715   715                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      444   647   658                                                           |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                    RIDDELLIINE                                                                                     
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                          DOSE = 0.1     MG/KG/DY                               |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 26     CENSORED DEATHS 2    TERMINAL 22        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      252   307   451   552   561   618   638   638   642   646                 |                                                 
 |      650   651   658   660   664   678   678   680   682   691                 |                                                 
 |      707   707   710   715   718   726                                         |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      293   668                                                                 |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                          DOSE = 0.33    MG/KG/DY                               |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 18     CENSORED DEATHS 3    TERMINAL 29        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      451   463   524   570   576   581   587   590   602   619                 |                                                 
 |      630   654   656   671   680   686   686   697                             |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      654   657   658                                                           |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                          DOSE = 1.0     MG/KG/DY                               |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 50     CENSORED DEATHS 0    TERMINAL 0         |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      350   352   393   400   405   407   423   426   434   440                 |                                                 
 |      447   459   460   461   461   469   470   472   475   476                 |                                                 
 |      478   487   488   503   506   509   516   522   527   528                 |                                                 
 |      528   528   541   542   548   552   552   552   552   556                 |                                                 
 |      569   573   581   587   587   591   608   618   658   668                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                    RIDDELLIINE                                                                                     
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE 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          |   100.0 100.0 100.0 100.0  98.0  92.0  88.0  88.0  79.9  69.4      |                                                 
 |MG/KG/DY   |                                                                    |                                                 
 |           |                                                                    |                                                 
 |0.01       |   100.0 100.0 100.0  98.0  96.0  96.0  89.9  83.8  72.4  51.4      |                                                 
 |MG/KG/DY   |                                                                    |                                                 
 |           |                                                                    |                                                 
 |0.033      |   100.0 100.0 100.0 100.0 100.0  98.0  93.9  83.7  73.4  60.5      |                                                 
 |MG/KG/DY   |                                                                    |                                                 
 |           |                                                                    |                                                 
 |0.1        |   100.0 100.0  98.0  96.0  96.0  93.9  93.9  89.8  69.4  46.3      |                                                 
 |MG/KG/DY   |                                                                    |                                                 
 |           |                                                                    |                                                 
 |0.33       |   100.0 100.0 100.0 100.0 100.0  96.0  94.0  82.0  73.9  63.1      |                                                 
 |MG/KG/DY   |                                                                    |                                                 
 |           |                                                                    |                                                 
 |1.0        |   100.0 100.0 100.0  96.0  86.0  58.0  32.0   8.0   2.0   0.0      |                                                 
 |MG/KG/DY   |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                                    RIDDELLIINE                                                                                     
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
 ===============================================================================================================================    
 |                                               SURVIVAL SUMMARY STATISTICS                                                   |    
 |                                                                                                                             |    
 |                                                                                                                             |    
 |-----------------------------------------------------------------------------------------------------------------------------|    
 |                                                                          DOSE                                               |    
 |                                                                                                                             |    
 |                                0               0.01            0.033           0.1             0.33            1.0          |    
 |                                MG/KG/DY        MG/KG/DY        MG/KG/DY        MG/KG/DY        MG/KG/DY        MG/KG/DY     |    
 |-----------------------------------------------------------------------------------------------------------------------------|    
 |SURVIVAL AT END OF STUDY|       69.4%           51.4%           60.5%           46.3%           63.1%            0.0%        |    
 |(KAPLAN-MEIER)          |                                                                                                    |    
 |                        |                                                                                                    |    
 |SIGNIFICANCE (B)        |       P<0.001         P=0.166         P=0.513         P=0.063         P=0.641         P<0.001      |    
 |(LIFE TABLE)            |                                                                                                    |    
 |                        |                                                                                                    |    
 |MEAN DAY OF             |       586.3           617.8           616.5           626.2           606.8           504.7        |    
 |NATURAL DEATHS (C)      |       (27.7)          (22.0)          (16.9)          (23.2)          (17.2)          (10.3)       |    
 |(STANDARD ERROR)        |                                                                                                    |    
 |                        |                                                                                                    |    
 |MEAN LIFE SPAN (D)      |       682.6           665.8           677.5           665.6           680.7           504.7        |    
 |(STANDARD ERROR)        |       (12.4)          (12.6)          (11.0)          (15.9)          (10.3)          (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                                                        
                                                        0.01    MG/KG/DY = 2                                                        
                                                        0.033   MG/KG/DY = 3                                                        
                                                        0.1     MG/KG/DY = 4                                                        
                                                        0.33    MG/KG/DY = 5                                                        
                                                        1.0     MG/KG/DY = 6                                                        
                                                                                                                                    
----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
      |                                                                                                                             
      |                                                                                                                             
  112 +                                                                                                                             
      |                                                                                                                             
      |                                                                                                                             
      | 1                                       4       4   2  66      1 2   1  5 5      3                                          
   96 +                                                 4       6      662   1  4 1 1    2 23     5                                 
      |                                                                 66      4   1  1   23 14 335                                
P     |                                                                  6 6                  1  4255 32 14  4                      
E     |                                                                    666                        32215 1                       
R  80 +                                                                      66  6                       3351135  1                 
C     |                                                                                                      223  11 1              
E     |                                                                          66                           23 42251  11          
N     |                                                                           66                             4 3 33  1  1       
T  64 +                                                                                                            2422  3  5       
      |                                                                            666                              4424 2  3       
S     |                                                                              6 6                               44           
U     |                                                                                66                               422 2       
R  48 +                                                                                 66 6                             44 4       
V     |                                                                                    66                                       
I     |                                                                                                                             
V     |                                                                                     6 6                                     
A  32 +                                                                                       66                                    
L     |                                                                                                                             
      |                                                                                        66                                   
      |                                                                                         6 6                                 
   16 +                                                                                           666                               
      |                                                                                             6 6                             
      |                                                                                               6 6 6                         
      |                                                                                                   6    6  6                 
    0 +                                                                                                           6                 
      |                                                                                                                             
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110 
                                                                                                                                    
                                                                   WEEK                                                             
                                                                                                                                    
NOTE: 78 obs hidden.