National Toxicology Program

National Toxicology Program
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TR 365 Mouse Pathology Tables

NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11 
LAB: Mason                                                     DATE: 09/04/94   
EXP: 05023               PENTAERYTHRITOL TETRANITRATE          TIME: 02:15:30   
TEST: 02              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                                                          
--------------------------------------------------------------------------------
                                                                                
                                                                                
                                                                                


REASONS FOR REMOVAL:                                                            
                                                                                
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REMOVAL DATE RANGE:                                                             


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TREATMENT GROUPS:                                                               
                                                                                
INCLUDE ALL                                                                     

NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11
LAB: Mason                                                     DATE: 09/04/94  
EXP: 05023               PENTAERYTHRITOL TETRANITRATE          TIME: 02:15:30  
TEST: 02              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 MICE
                       FIRST TERMINAL SACRIFICE AT 729 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = CONTROL                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 49     UNCENSORED DEATHS 23     CENSORED DEATHS 0    TERMINAL 26        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      184   207   247   414   456   456   543   550   564   578                 |
 |      585   600   601   623   660   660   667   682   682   695                 |
 |      715   717   727                                                           |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 2.5%                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 12     CENSORED DEATHS 0    TERMINAL 38        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      269   465   482   543   600   620   655   655   656   691                 |
 |      698   722                                                                 |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 5.0%                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 12     CENSORED DEATHS 0    TERMINAL 38        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      30    182   564   592   614   652   660   682   682   690                 |
 |      694   717                                                                 |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================

                           PENTAERYTHRITOL TETRANITRATE


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


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   729 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |CONTROL    |   100.0 100.0  93.9  93.9  91.8  87.8  85.7  73.5  67.3  53.1      |
 |           |                                                                    |
 |           |                                                                    |
 |2.5%       |   100.0 100.0  98.0  98.0  98.0  94.0  92.0  90.0  82.0  76.0      |
 |           |                                                                    |
 |           |                                                                    |
 |5.0%       |    98.0  98.0  96.0  96.0  96.0  96.0  96.0  92.0  86.0  76.0      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                    DOSE                        |
 |                                                                                |
 |                                CONTROL          2.5%             5.0%          |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       53.1%            76.0%            76.0%         |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.014N         P=0.025N         P=0.023N      |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       557.1            588.0            563.3         |
 |NATURAL DEATHS (C)      |       (33.6)           (37.5)           (63.7)        |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       648.3            695.2            689.2         |
 |(STANDARD ERROR)        |       (19.9)           (12.2)           (17.9)        |
 |                        |                                                       |
 ==================================================================================
                                    


       (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 MICE
                       FIRST TERMINAL SACRIFICE AT 730 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = CONTROL                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 12     CENSORED DEATHS 0    TERMINAL 38        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      338   396   522   549   637   648   654   689   694   696                 |
 |      716   729                                                                 |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 2.5%                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 20     CENSORED DEATHS 0    TERMINAL 30        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      5     421   521   523   568   568   579   586   630   634                 |
 |      662   670   674   674   688   696   714   718   728   728                 |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 5.0%                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 12     CENSORED DEATHS 0    TERMINAL 38        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      258   463   586   605   607   646   654   662   663   675                 |
 |      689   711                                                                 |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================

                           PENTAERYTHRITOL TETRANITRATE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 730 DAYS


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   730 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |CONTROL    |   100.0 100.0 100.0  98.0  96.0  96.0  94.0  92.0  86.0  76.0      |
 |           |                                                                    |
 |           |                                                                    |
 |2.5%       |    98.0  98.0  98.0  98.0  96.0  96.0  92.0  84.0  78.0  60.0      |
 |           |                                                                    |
 |           |                                                                    |
 |5.0%       |   100.0 100.0  98.0  98.0  98.0  96.0  96.0  92.0  82.0  76.0      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                    DOSE                        |
 |                                                                                |
 |                                CONTROL          2.5%             5.0%          |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       76.0%            60.0%            76.0%         |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=1.000          P=0.127          P=1.000       |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       605.7            599.4            601.6         |
 |NATURAL DEATHS (C)      |       (37.1)           (36.2)           (36.4)        |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       700.2            677.7            699.2         |
 |(STANDARD ERROR)        |       (11.5)           (17.0)           (11.5)        |
 |                        |                                                       |
 ==================================================================================
                                    


       (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=MICE SEX=MALE -------------------------------------------------------

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

      |
      |
  100 + 1     3                       1            2
      |
      |       3                      31  1         2                              2
      |                              3   1      1                                 2 2            3
   95 +
      |                                         1                         1         2         2  3    3
      |                                                                                       2       32 3
      |                                                                   1      1
   90 +                                                                                                2 32    3
      |
      |                                                                          1            1           2    2 3
      |                                                                                       11                 3  3
P  85 +
E     |                                                                                        1 1
R     |                                                                                                        2    32
C     |                                                                                          1 1
E  80 +                                                                                            11                22
N     |
T     |                                                                                             1  1              2  32
      |                                                                                                                  32 2
S  75 +
U     |                                                                                                1  1
R     |
V     |                                                                                                   1      1
I  70 +
V     |
A     |                                                                                                          11
L     |
   65 +                                                                                                           1 1
      |
      |
      |                                                                                                             1 1
   60 +
      |                                                                                                               1  1
      |
      |
   55 +                                                                                                                  11
      |
      |                                                                                                                   1 1
      |
   50 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 8 obs hidden.

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

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

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

      |
      |
  100 + 12                                       3            1
      |
      |  2                                       3            1        1   2      3
      |                                                                1   2      3        1        3
   95 +
      |                                                                                    1   1    3   3
      |                                                                                    2   1  2         1
      |
P  90 +                                                                                                 3   1 1
E     |
R     |                                                                                           22          11
C     |                                                                                            22          1 3   1
E  85 +
N     |                                                                                             2      2         11
T     |                                                                                                    22    3 3
      |
S  80 +                                                                                                     2    2 3 31  1
U     |
R     |                                                                                                          22  3  31  1
V     |                                                                                                           22    3   1
I  75 +
V     |
A     |                                                                                                            2 2
L     |
   70 +                                                                                                              22
      |
      |                                                                                                               2 2
      |                                                                                                                 22
   65 +
      |                                                                                                                  22
      |
      |
   60 +                                                                                                                   2 2
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 8 obs hidden.

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