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TDMS Study 88007-06 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     

LAB: Battelle Columbus                                       SODIUM NITRITE                                    DATE: 05/13/99       

EXPERIMENT: 88007 TEST: 06                                                                                     TIME: 09:45:58       

TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        

CONT: NO1-ES-55384                              ROUTE: DOSED WATER                                             NTP C#: C88007       

PATHOLOGIST: TOFT, JOHN                                                                                        CAS: 7632-00-0       

------------------------------------------------------------------------------------------------------------------------------------

                                                                                                                                    

                                                        2 YEAR CHRONIC MICE                                                         

                                                                                                                                    


               REASONS FOR REMOVAL:    ALL                                                                                          

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

               REMOVAL DATE RANGE:     ALL                                                                                          

                                                                                                                                    

               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11    

LAB: Battelle Columbus                                       SODIUM NITRITE                                    DATE: 05/13/99      

EXPERIMENT: 88007 TEST: 06                                                                                     TIME: 09:45:58      

TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       

CONT: NO1-ES-55384                              ROUTE: DOSED WATER                                             NTP C#: C88007      

PATHOLOGIST: TOFT, JOHN                                                                                        CAS: 7632-00-0      
                                  SODIUM NITRITE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA

                                     MALE MICE

                       FIRST TERMINAL SACRIFICE AT 727 DAYS

                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)

 ==================================================================================

 |                                DOSE = 0.0%                                     |

 |                             ---------------------                              |

 |                                                                                |

 |  TOTAL 50     UNCENSORED DEATHS 11     CENSORED DEATHS 0    TERMINAL 39        |

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      501   526   617   643   647   652   661   687   701   705                 |

 |      713                                                                       |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

 |--------------------------------------------------------------------------------|

 |                                DOSE = 0.075%                                   |

 |                             ---------------------                              |

 |                                                                                |

 |  TOTAL 50     UNCENSORED DEATHS 5      CENSORED DEATHS 0    TERMINAL 45        |

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      444   601   612   637   644                                               |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

 |--------------------------------------------------------------------------------|

 |                                DOSE = 0.15%                                    |

 |                             ---------------------                              |

 |                                                                                |

 |  TOTAL 50     UNCENSORED DEATHS 8      CENSORED DEATHS 0    TERMINAL 42        |

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      577   596   641   643   643   664   667   707                             |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

 ==================================================================================
                                  SODIUM NITRITE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA

                                     MALE MICE

                       FIRST TERMINAL SACRIFICE AT 727 DAYS

                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)

 ==================================================================================

 |                                DOSE = 0.30%                                    |

 |                             ---------------------                              |

 |                                                                                |

 |  TOTAL 50     UNCENSORED DEATHS 11     CENSORED DEATHS 0    TERMINAL 39        |

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      472   502   549   556   583   594   629   654   665   685                 |

 |      698                                                                       |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

 ==================================================================================
                                  SODIUM NITRITE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA

                                     MALE MICE

                       FIRST TERMINAL SACRIFICE AT 727 DAYS


 ==================================================================================

 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |

 |                                                                                |

 |--------------------------------------------------------------------------------|

 |    DOSE                               TIME (DAYS)                              |

 |                 90   180   270   365   425   485   545   605   665   727 (A)   |

 |                                                                                |

 |--------------------------------------------------------------------------------|

 |           |                                                                    |

 |0.0%       |   100.0 100.0 100.0 100.0 100.0 100.0  96.0  96.0  86.0  78.0      |

 |           |                                                                    |

 |           |                                                                    |

 |0.075%     |   100.0 100.0 100.0 100.0 100.0  98.0  98.0  96.0  90.0  90.0      |

 |           |                                                                    |

 |           |                                                                    |

 |0.15%      |   100.0 100.0 100.0 100.0 100.0 100.0 100.0  96.0  88.0  84.0      |

 |           |                                                                    |

 |           |                                                                    |

 |0.30%      |   100.0 100.0 100.0 100.0 100.0  98.0  96.0  88.0  82.0  78.0      |

 |           |                                                                    |

 |           |                                                                    |

 ==================================================================================

 ==================================================================================

 |                           SURVIVAL SUMMARY STATISTICS                          |

 |                                                                                |

 |                                                                                |

 |--------------------------------------------------------------------------------|

 |                                                  DOSE                          |

 |                                                                                |

 |                                0.0%         0.075%       0.15%        0.30%    |

 |                                                                                |

 |--------------------------------------------------------------------------------|

 |SURVIVAL AT END OF STUDY|       78.0%        90.0%        84.0%        78.0%    |

 |(KAPLAN-MEIER)          |                                                       |

 |                        |                                                       |

 |SIGNIFICANCE (B)        |       P=0.659      P=0.199N     P=0.616N     P=1.000  |

 |(LIFE TABLE)            |                                                       |

 |                        |                                                       |

 |MEAN DAY OF             |       641.2        587.6        642.3        598.8    |

 |NATURAL DEATHS (C)      |       (21.1)       (36.8)       (14.4)       (22.5)   |

 |(STANDARD ERROR)        |                                                       |

 |                        |                                                       |

 |MEAN LIFE SPAN (D)      |       708.1        713.1        713.4        698.8    |

 |(STANDARD ERROR)        |       ( 6.8)       ( 6.8)       ( 4.9)       ( 9.0)   |

 |                        |                                                       |

 ==================================================================================

                                    


       (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)
                                  SODIUM NITRITE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA

                                    FEMALE MICE

                       FIRST TERMINAL SACRIFICE AT 728 DAYS

                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)

 ==================================================================================

 |                                DOSE = 0.0%                                     |

 |                             ---------------------                              |

 |                                                                                |

 |  TOTAL 50     UNCENSORED DEATHS 10     CENSORED DEATHS 0    TERMINAL 40        |

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      456   547   565   580   586   615   622   631   663   716                 |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

 |--------------------------------------------------------------------------------|

 |                                DOSE = 0.075%                                   |

 |                             ---------------------                              |

 |                                                                                |

 |  TOTAL 50     UNCENSORED DEATHS 16     CENSORED DEATHS 0    TERMINAL 34        |

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      484   605   643   650   651   651   652   659   659   664                 |

 |      667   673   673   683   706   709                                         |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

 |--------------------------------------------------------------------------------|

 |                                DOSE = 0.15%                                    |

 |                             ---------------------                              |

 |                                                                                |

 |  TOTAL 50     UNCENSORED DEATHS 13     CENSORED DEATHS 0    TERMINAL 37        |

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      477   524   610   617   621   677   687   691   706   716                 |

 |      716   723   726                                                           |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

 ==================================================================================
                                  SODIUM NITRITE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA

                                    FEMALE MICE

                       FIRST TERMINAL SACRIFICE AT 728 DAYS

                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)

 ==================================================================================

 |                                DOSE = 0.30%                                    |

 |                             ---------------------                              |

 |                                                                                |

 |  TOTAL 50     UNCENSORED DEATHS 9      CENSORED DEATHS 0    TERMINAL 41        |

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      401   484   520   567   659   673   687   705   708                       |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

 ==================================================================================
                                  SODIUM NITRITE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA

                                    FEMALE MICE

                       FIRST TERMINAL SACRIFICE AT 728 DAYS


 ==================================================================================

 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |

 |                                                                                |

 |--------------------------------------------------------------------------------|

 |    DOSE                               TIME (DAYS)                              |

 |                 90   180   270   365   425   485   545   605   665   728 (A)   |

 |                                                                                |

 |--------------------------------------------------------------------------------|

 |           |                                                                    |

 |0.0%       |   100.0 100.0 100.0 100.0 100.0  98.0  98.0  90.0  82.0  80.0      |

 |           |                                                                    |

 |           |                                                                    |

 |0.075%     |   100.0 100.0 100.0 100.0 100.0  98.0  98.0  96.0  80.0  68.0      |

 |           |                                                                    |

 |           |                                                                    |

 |0.15%      |   100.0 100.0 100.0 100.0 100.0  98.0  96.0  96.0  90.0  74.0      |

 |           |                                                                    |

 |           |                                                                    |

 |0.30%      |   100.0 100.0 100.0 100.0  98.0  96.0  94.0  92.0  90.0  82.0      |

 |           |                                                                    |

 |           |                                                                    |

 ==================================================================================

 ==================================================================================

 |                           SURVIVAL SUMMARY STATISTICS                          |

 |                                                                                |

 |                                                                                |

 |--------------------------------------------------------------------------------|

 |                                                  DOSE                          |

 |                                                                                |

 |                                0.0%         0.075%       0.15%        0.30%    |

 |                                                                                |

 |--------------------------------------------------------------------------------|

 |SURVIVAL AT END OF STUDY|       80.0%        68.0%        74.0%        82.0%    |

 |(KAPLAN-MEIER)          |                                                       |

 |                        |                                                       |

 |SIGNIFICANCE (B)        |       P=0.537N     P=0.340      P=0.721      P=0.963N |

 |(LIFE TABLE)            |                                                       |

 |                        |                                                       |

 |MEAN DAY OF             |       598.1        651.8        653.2        600.4    |

 |NATURAL DEATHS (C)      |       (22.2)       (12.7)       (22.1)       (37.2)   |

 |(STANDARD ERROR)        |                                                       |

 |                        |                                                       |

 |MEAN LIFE SPAN (D)      |       702.0        703.6        708.5        705.0    |

 |(STANDARD ERROR)        |       ( 8.6)       ( 6.5)       ( 7.3)       ( 9.5)   |

 |                        |                                                       |

 ==================================================================================

                                    


       (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)
                                                           SODIUM NITRITE

                                                    KAPLAN-MEIER SURVIVAL CURVES

                                                        0.0%             = 1

                                                        0.075%           = 2

                                                        0.15%            = 3

                                                        0.30%            = 4



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



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



              |

              |

          100 +  1                                                               2   4   1          3

              |

              |                                                                  2   4   1   1      3  2

              |

        P  96 +                                                                          4   1  4      2 21  3

        E     |

        R     |                                                                                 44       21 21

        C     |

        E  92 +                                                                                  4   4      211

        N     |

        T     |                                                                                      44      2113        2

              |

        S  88 +                                                                                       4    4   113

        U     |

        R     |                                                                                            4   413  1 3

        V     |

        I  84 +                                                                                                44   1 1  3

        V     |

        A     |                                                                                                 4  4

        L     |

           80 +                                                                                                    4 411

              |

              |                                                                                                      4 1 1

              |

           76 +

              |

              ---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+--

                 0   4   8  12  16  20  24  28  32  36  40  44  48  52  56  60  64  68  72  76  80  84  88  92  96  100 104



                                                                   WEEK



NOTE: 11 obs hidden.
                                                           SODIUM NITRITE

                                                    KAPLAN-MEIER SURVIVAL CURVES

                                                        0.0%             = 1

                                                        0.075%           = 2

                                                        0.15%            = 3

                                                        0.30%            = 4



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



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



      |

      |

  100 + 1                                                               4        1  32

      |

      |                                                                 4        1  32     3   1        2

      |                                                                              4     3   1 1      23   2

   95 +

      |                                                                                    4     1 1     33  22

P     |                                                                                          4 11            4

E     |

R  90 +                                                                                             1    13      4 3

C     |

E     |                                                                                                  11   22   3 3

N     |                                                                                                   1 1  2 2   4 4

T  85 +

      |                                                                                                     1    1   3 34

S     |                                                                                                          1     3414

U     |

R  80 +                                                                                                          22      11

V     |

I     |                                                                                                           22     33

V     |

A  75 +

L     |                                                                                                            22     3

      |                                                                                                             2  2

      |

   70 +                                                                                                                22

      |

      |                                                                                                                 2 2

      |

   65 +

      |

      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--

        0         10         20         30         40         50         60         70         80         90         100        110



                                                                   WEEK



NOTE: 11 obs hidden.