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TDMS Study 55301-06 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: TSI Mason Research                                         PYRIDINE                                       DATE: 10/08/97       
EXPERIMENT: 55301 TEST: 06                                                                                     TIME: 12:24:06       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-95268                              ROUTE: DOSED WATER                                             NTP C#: 55301B       
PATHOLOGIST: D. SAUER                                                                                          CAS: 110-86-1        
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               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11    
LAB: TSI Mason Research                                         PYRIDINE                                       DATE: 10/08/97      
EXPERIMENT: 55301 TEST: 06                                                                                     TIME: 12:24:06      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01-ES-95268                              ROUTE: DOSED WATER                                             NTP C#: 55301B      
PATHOLOGIST: D. SAUER                                                                                          CAS: 110-86-1       
                                     PYRIDINE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 722 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0 PPM                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 28     CENSORED DEATHS 0    TERMINAL 22        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      283   468   536   557   559   572   576   587   589   592                 |
 |      598   601   616   618   624   639   644   644   654   660                 |
 |      674   676   681   695   701   705   707   717                             |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 100 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 36     CENSORED DEATHS 0    TERMINAL 14        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      336   352   372   445   470   479   486   506   536   541                 |
 |      549   552   561   573   581   593   595   610   611   634                 |
 |      638   639   642   647   649   651   660   668   679   682                 |
 |      690   697   698   710   714   716                                         |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 200 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 39     CENSORED DEATHS 0    TERMINAL 11        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      354   404   447   473   479   481   486   487   494   500                 |
 |      501   510   515   520   548   561   575   588   608   622                 |
 |      628   630   631   632   645   650   660   664   674   675                 |
 |      682   683   688   700   704   704   705   713   721                       |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                                     PYRIDINE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 722 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 400 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 43     CENSORED DEATHS 0    TERMINAL 7         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      94    443   450   463   464   466   467   468   483   486                 |
 |      489   493   499   511   531   532   539   545   550   552                 |
 |      553   553   556   562   568   574   580   582   587   595                 |
 |      606   616   627   629   631   658   660   674   682   683                 |
 |      685   687   709                                                           |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                                     PYRIDINE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 722 DAYS

 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   722 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0 PPM      |   100.0 100.0 100.0  98.0  98.0  96.0  94.0  76.0  60.0  44.0      |
 |           |                                                                    |
 |           |                                                                    |
 |100 PPM    |   100.0 100.0 100.0  96.0  94.0  88.0  80.0  66.0  46.0  28.0      |
 |           |                                                                    |
 |           |                                                                    |
 |200 PPM    |   100.0 100.0 100.0  98.0  96.0  88.0  72.0  64.0  44.0  22.0      |
 |           |                                                                    |
 |           |                                                                    |
 |400 PPM    |   100.0  98.0  98.0  98.0  98.0  82.0  64.0  40.0  26.0  14.0      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                0 PPM        100 PPM      200 PPM      400 PPM  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       44.0%        28.0%        22.0%        14.0%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P<0.001      P=0.090      P=0.020      P<0.001  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       613.3        587.8        588.3        553.1    |
 |NATURAL DEATHS (C)      |       (16.6)       (17.1)       (15.7)       (15.9)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       661.1        625.4        617.7        576.7    |
 |(STANDARD ERROR)        |       (12.0)       (15.0)       (14.5)       (16.0)   |
 |                        |                                                       |
 ==================================================================================
                                    

       (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)
                                                              PYRIDINE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0 PPM            = 1
                                                        100 PPM          = 2
                                                        200 PPM          = 3
                                                        400 PPM          = 4

------------------------------------------------------ SPECIES=RATS SEX=MALE -------------------------------------------------------

                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.

      |
      |
  100 + 1              4                             1       2  3
      |                4                             1       2  2       3     4   1
      |                                                         2  2    3     2 4 13         1  1
      |                                                                       2    23
   90 +                                                                            22           1 1
      |                                                                             22            11
      |                                                                           4 423 2    2     11 1
      |                                                                             4433     22
   80 +                                                                                       22      11
      |                                                                              4433
P     |                                                                               4433 3   2 22    1 11
E     |                                                                                 4  34  3  22      11
R  70 +                                                                                        3 3 2  2    1 1
C     |                                                                                     44   3 3
E     |                                                                                      444   33 2 32   1 1
N     |                                                                                                 323 2  1 1
T  60 +                                                                                                   3322   1 1
      |
S     |                                                                                        444         3322    11 1
U     |                                                                                          44         3 3       11
R  50 +
V     |                                                                                           44          2  2
I     |                                                                                            44            222   1 11
V     |                                                                                             4 4            22
A  40 +                                                                                               4 4          322
L     |                                                                                                 44           22
      |                                                                                                  4 4        332 2
      |                                                                                                    44         33
   30 +                                                                                                     4  4        22
      |                                                                                                        4 4       22
      |                                                                                                          4 44  333
      |                                                                                                                  33
   20 +
      |                                                                                                             44
      |                                                                                                              4  4 4
      |
   10 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 38 obs hidden.