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TDMS Study 55301-04 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: TSI Mason Research                                         PYRIDINE                                       DATE: 11/19/96       
EXPERIMENT: 55301 TEST: 04                                                                                     TIME: 16:09:03       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-95268                              ROUTE: DOSED WATER                                             NTP C#: 55301B       
PATHOLOGIST: F. VOELKER                      STEDHAM, MICHAEL                                                  CAS: 110-86-1        
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                             CORE STUDY                                                             
                                                                                                                                    

               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: 11/19/96      
EXPERIMENT: 55301 TEST: 04                                                                                     TIME: 16:09:03      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01-ES-95268                              ROUTE: DOSED WATER                                             NTP C#: 55301B      
PATHOLOGIST: F. VOELKER                      STEDHAM, MICHAEL                                                  CAS: 110-86-1       
                                     PYRIDINE

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0 PPM                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 13     CENSORED DEATHS 2    TERMINAL 35        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      520   542   598   621   633   637   639   653   663   670                 |
 |      672   706   714                                                           |
 |  CENSORED DEATHS                                                               |
 |      118   574                                                                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 250 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 21     CENSORED DEATHS 1    TERMINAL 28        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      237   522   532   546   549   561   587   591   595   608                 |
 |      638   645   650   674   676   677   680   692   696   702                 |
 |      715                                                                       |
 |  CENSORED DEATHS                                                               |
 |      8                                                                         |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 500 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 14     CENSORED DEATHS 1    TERMINAL 35        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      226   513   514   526   586   623   630   637   642   643                 |
 |      657   661   664   708                                                     |
 |  CENSORED DEATHS                                                               |
 |      3                                                                         |
 |                                                                                |
 ==================================================================================
                                     PYRIDINE

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 1000 PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 12     CENSORED DEATHS 3    TERMINAL 35        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      406   432   594   624   639   649   665   672   680   686                 |
 |      699   709                                                                 |
 |  CENSORED DEATHS                                                               |
 |      3     9     59                                                            |
 |                                                                                |
 ==================================================================================
                                     PYRIDINE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       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      |   100.0 100.0 100.0 100.0 100.0 100.0  95.9  93.8  81.3  73.0      |
 |           |                                                                    |
 |           |                                                                    |
 |250 PPM    |   100.0 100.0  98.0  98.0  98.0  98.0  93.9  81.6  73.5  57.1      |
 |           |                                                                    |
 |           |                                                                    |
 |500 PPM    |   100.0 100.0  98.0  98.0  98.0  98.0  91.8  89.8  73.5  71.4      |
 |           |                                                                    |
 |           |                                                                    |
 |1000 PPM   |   100.0 100.0 100.0 100.0  97.9  95.7  95.7  93.6  85.1  74.5      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                0 PPM        250 PPM      500 PPM      1000 PPM |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       73.0%        57.1%        71.4%        74.5%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.507N     P=0.138      P=0.928      P=1.000N |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       636.0        608.2        587.9        621.3    |
 |NATURAL DEATHS (C)      |       (15.7)       (22.8)       (32.1)       (28.8)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       684.6        659.9        670.1        655.9    |
 |(STANDARD ERROR)        |       (13.6)       (18.2)       (18.3)       (24.6)   |
 |                        |                                                       |
 ==================================================================================
                                    

       (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

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 729 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0 PPM                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 15     CENSORED DEATHS 3    TERMINAL 32        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      375   476   565   568   625   644   644   662   670   687                 |
 |      691   697   711   714   719                                               |
 |  CENSORED DEATHS                                                               |
 |      64    151   554                                                           |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 125 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 14     CENSORED DEATHS 6    TERMINAL 30        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      372   573   599   605   608   642   649   674   677   680                 |
 |      696   711   713   724                                                     |
 |  CENSORED DEATHS                                                               |
 |      4     16    20    172   419   555                                         |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 250 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 24     CENSORED DEATHS 4    TERMINAL 22        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      417   509   556   564   583   624   632   633   642   648                 |
 |      659   678   684   692   696   697   699   700   700   708                 |
 |      712   722   723   727                                                     |
 |  CENSORED DEATHS                                                               |
 |      3     33    40    175                                                     |
 |                                                                                |
 ==================================================================================
                                     PYRIDINE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 729 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 500 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 16     CENSORED DEATHS 5    TERMINAL 29        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      14    299   366   479   510   526   595   615   626   677                 |
 |      680   686   690   690   700   703                                         |
 |  CENSORED DEATHS                                                               |
 |      12    15    188   430   571                                               |
 |                                                                                |
 ==================================================================================
                                     PYRIDINE

                       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 PPM      |   100.0 100.0 100.0 100.0  97.9  95.8  95.8  91.6  83.1  68.1      |
 |           |                                                                    |
 |           |                                                                    |
 |125 PPM    |   100.0 100.0 100.0 100.0  97.8  97.8  97.8  91.0  84.2  68.3      |
 |           |                                                                    |
 |           |                                                                    |
 |250 PPM    |   100.0 100.0 100.0 100.0  97.8  97.8  95.7  89.1  76.1  47.8      |
 |           |                                                                    |
 |           |                                                                    |
 |500 PPM    |    98.0  98.0  98.0  95.8  93.7  91.5  87.2  84.9  80.5  64.8      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                0 PPM        125 PPM      250 PPM      500 PPM  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       68.1%        68.3%        47.8%        64.8%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.487      P=1.000N     P=0.090      P=0.755  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       629.9        637.4        650.2        553.5    |
 |NATURAL DEATHS (C)      |       (25.2)       (24.0)       (15.7)       (47.4)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       670.9        639.6        637.9        624.3    |
 |(STANDARD ERROR)        |       (19.4)       (27.1)       (26.0)       (28.0)   |
 |                        |                                                       |
 ==================================================================================
                                    

       (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
                                                        250 PPM          = 2
                                                        500 PPM          = 3
                                                        1000 PPM         = 4

------------------------------------------------------ SPECIES=MICE SEX=MALE -------------------------------------------------------

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

         |
         |
  106.12 +
         |
         |
         |1                                   32                          4                  1
P  97.96 +                                    32                          4   4            3 1  1
E        |                                                                    4              22 1       41
R        |                                                                                 3  2 2       41  14
C        |                                                                                    3 22    3     1414
E  89.80 +                                                                                       2 2  3     3  44
N        |                                                                                         2  2     33114  4
T        |                                                                                            2 2    331 1 44
         |                                                                                                    33 1 14 4
S  81.63 +                                                                                              2 2        11
U        |                                                                                                2    2 3    4 4
R        |                                                                                                     223 31   414
V        |                                                                                                               11
I  73.47 +                                                                                                      2  3 2    1 1
V        |                                                                                                                3 3
A        |
L        |                                                                                                           22
   65.31 +                                                                                                            22
         |                                                                                                             22
         |                                                                                                              22
         |                                                                                                               2 2
   57.14 +                                                                                                                 22
         |
         -+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+
          0         10         20         30         40         50         60         70         80         90         100       110

                                                                     WEEK

NOTE: 9 obs hidden.
                                                              PYRIDINE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0 PPM            = 1
                                                        125 PPM          = 2
                                                        250 PPM          = 3
                                                        500 PPM          = 4

----------------------------------------------------- SPECIES=MICE SEX=FEMALE ------------------------------------------------------

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

      |
      |
  100 + 1 4                                                        1      3
      |   4                                            4           1      3        1    3         2
      |                                                4          4                1    3       312    2
      |                                                           4                 4   4       311 3  22  1
P  90 +                                                                                 4   4       3      1 1
E     |                                                                                     4         4 2  3322
R     |                                                                                               4  4   12  1 2
C     |                                                                                                  4 433   11
E  80 +                                                                                                    4 33   1221
N     |                                                                                                       3  3 4211
T     |                                                                                                          3 3341 1
      |                                                                                                             33
S  70 +                                                                                                              33 112
U     |                                                                                                               44 12 1
R     |                                                                                                                4    4
V     |
I  60 +
V     |                                                                                                               3 3
A     |                                                                                                                 3 3
L     |
   50 +
      |                                                                                                                   3 3
      |
      |
   40 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 22 obs hidden.