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TR 365 Rat Pathology Tables

NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11 
LAB: Mason                                                     DATE: 09/04/94   
EXP: 05023               PENTAERYTHRITOL TETRANITRATE          TIME: 00:50:50   
TEST: 01              CAGES FROM 0000 TO LAST CAGE             PAGE:   1        
TEST TYPE: CHRONIC          ROUTE: DOSED FEED                  NTP C#: 55743    
CONT: N01CP9561901                                             CAS: 78-11-5     
PATHOLOGIST: K. MURTHY                                                          
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NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11
LAB: Mason                                                     DATE: 09/04/94  
EXP: 05023               PENTAERYTHRITOL TETRANITRATE          TIME: 00:50:50  
TEST: 01              CAGES FROM 0000 TO LAST CAGE                             
TEST TYPE: CHRONIC          ROUTE: DOSED FEED                  NTP C#: 55743   
CONT: N01CP9561901                                             CAS: 78-11-5    
PATHOLOGIST: K. MURTHY                                                         

                           PENTAERYTHRITOL TETRANITRATE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 735 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = CONTROL                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 28     CENSORED DEATHS 0    TERMINAL 22        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      413   479   534   564   577   589   615   625   629   632                 |
 |      639   640   641   641   641   646   660   660   660   672                 |
 |      681   695   702   711   711   711   718   731                             |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 2.5%                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 21     CENSORED DEATHS 0    TERMINAL 29        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      326   501   562   564   622   630   640   640   641   645                 |
 |      658   672   674   674   695   696   711   716   718   723                 |
 |      730                                                                       |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 5.0%                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 21     CENSORED DEATHS 0    TERMINAL 29        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      560   562   589   622   641   648   669   674   680   681                 |
 |      687   703   707   709   711   715   718   725   727   729                 |
 |      731                                                                       |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================

                           PENTAERYTHRITOL TETRANITRATE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 735 DAYS


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   735 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |CONTROL    |   100.0 100.0 100.0 100.0  98.0  96.0  94.0  88.0  62.0  44.0      |
 |           |                                                                    |
 |           |                                                                    |
 |2.5%       |   100.0 100.0 100.0  98.0  98.0  98.0  96.0  92.0  78.0  58.0      |
 |           |                                                                    |
 |           |                                                                    |
 |5.0%       |   100.0 100.0 100.0 100.0 100.0 100.0 100.0  94.0  88.0  58.0      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                    DOSE                        |
 |                                                                                |
 |                                CONTROL          2.5%             5.0%          |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       44.0%            58.0%            58.0%         |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.086N         P=0.177N         P=0.099N      |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       636.3            639.9            675.6         |
 |NATURAL DEATHS (C)      |       (13.7)           (20.2)           (11.7)        |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       679.7            695.1            710.1         |
 |(STANDARD ERROR)        |       (10.3)           (10.7)           ( 6.4)        |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                           PENTAERYTHRITOL TETRANITRATE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 735 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = CONTROL                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 17     CENSORED DEATHS 0    TERMINAL 33        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      441   504   557   563   567   610   628   639   644   646                 |
 |      647   660   682   710   718   722   723                                   |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.62%                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 17     CENSORED DEATHS 0    TERMINAL 33        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      200   443   547   568   585   585   586   639   639   641                 |
 |      653   673   695   699   708   715   722                                   |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 1.25%                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 19     CENSORED DEATHS 0    TERMINAL 31        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      441   442   506   508   589   596   634   639   662   667                 |
 |      667   680   683   689   689   701   708   709   724                       |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================

                           PENTAERYTHRITOL TETRANITRATE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 735 DAYS


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   735 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |CONTROL    |   100.0 100.0 100.0 100.0 100.0  98.0  96.0  90.0  76.0  66.0      |
 |           |                                                                    |
 |           |                                                                    |
 |0.62%      |   100.0 100.0  98.0  98.0  98.0  96.0  96.0  86.0  78.0  66.0      |
 |           |                                                                    |
 |           |                                                                    |
 |1.25%      |   100.0 100.0 100.0 100.0 100.0  96.0  92.0  88.0  82.0  62.0      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                    DOSE                        |
 |                                                                                |
 |                                CONTROL          0.62%            1.25%         |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       66.0%            66.0%            62.0%         |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.774          P=1.000          P=0.846       |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       627.1            605.8            628.1         |
 |NATURAL DEATHS (C)      |       (19.3)           (30.9)           (20.7)        |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       698.3            691.1            694.4         |
 |(STANDARD ERROR)        |       ( 9.7)           (13.5)           (10.7)        |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                                                    PENTAERYTHRITOL TETRANITRATE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        CONTROL          = 1
                                                        2.5%             = 2
                                                        5.0%             = 3

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

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

      |
      |
  100 + 1                                                   2            1                      3
      |                                                     2            1          1  2        33
      |                                                                             1  2     1   1    3   3
      |                                                                                          1 1      2  3
P  90 +                                                                                            1  1   22 33
E     |                                                                                               1  1 2 23   3
R     |                                                                                                  1 1      333
C     |                                                                                                    1122
E  80 +                                                                                                     1122    33
N     |                                                                                                        2  2  3 3
T     |                                                                                                           22   33
      |                                                                                                            2  2
S  70 +                                                                                                      11         33
U     |                                                                                                       1  1    2 2
R     |                                                                                                                 223
V     |                                                                                                          11      22 3
I  60 +                                                                                                           1 1     2 2
V     |                                                                                                             1 1     2
A     |                                                                                                               111
L     |
   50 +
      |                                                                                                                 11
      |                                                                                                                  1  1
      |
   40 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 14 obs hidden.

                                                    PENTAERYTHRITOL TETRANITRATE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        CONTROL          = 1
                                                        0.62%            = 2
                                                        1.25%            = 3

----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------

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

      |
      |
  100 + 1                               2                                    1
      |
      |                                 2                                    12        1
      |
   96 +                                                                       2        13      21
      |
      |                                                                                        2112
      |
   92 +                                                                                 3         2 2 3
      |
      |                                                                                          1    33 1
      |
P  88 +                                                                                                3 1 13
E     |
R     |                                                                                             2      131
C     |
E  84 +                                                                                                      3   3
N     |
T     |                                                                                                      11  33
      |
S  80 +                                                                                                      2 2
U     |
R     |                                                                                                       12 1323
V     |
I  76 +                                                                                                          1 21 2
V     |
A     |                                                                                                             13  1
L     |
   72 +                                                                                                               2 11
      |
      |                                                                                                              3 3211
      |
   68 +                                                                                                                3322
      |
      |                                                                                                                   1 1
      |
   64 +                                                                                                                 3 3
      |
      |                                                                                                                   3 3
      |
   60 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 13 obs hidden.

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