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TDMS Study 88007-05 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     

LAB: Battelle Columbus                                       SODIUM NITRITE                                    DATE: 10/18/99       

EXPERIMENT: 88007 TEST: 05                                                                                     TIME: 14:02:25       

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

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

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

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

                                                                                                                                    

                                                      FINAL #1 CORE STUDY RATS                                                      

                                                                                                                                    


               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: 10/18/99      

EXPERIMENT: 88007 TEST: 05                                                                                     TIME: 14:02:25      

TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       

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

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


                       STATISTICAL ANALYSIS OF SURVIVAL DATA

                                     MALE RATS

                       FIRST TERMINAL SACRIFICE AT 729 DAYS

                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)

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

 |                                DOSE = 0.0%                                     |

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

 |                                                                                |

 |  TOTAL 50     UNCENSORED DEATHS 21     CENSORED DEATHS 0    TERMINAL 29        |

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      252   400   486   489   523   529   558   573   589   589                 |

 |      605   610   620   624   631   636   648   666   680   683                 |

 |      724                                                                       |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

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

 |                                DOSE = 0.075%                                   |

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

 |                                                                                |

 |  TOTAL 50     UNCENSORED DEATHS 12     CENSORED DEATHS 0    TERMINAL 38        |

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      415   480   481   552   582   601   641   646   669   680                 |

 |      691   693                                                                 |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

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

 |                                DOSE = 0.15%                                    |

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

 |                                                                                |

 |  TOTAL 50     UNCENSORED DEATHS 14     CENSORED DEATHS 0    TERMINAL 36        |

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      400   505   551   582   593   620   680   694   695   697                 |

 |      708   716   724   728                                                     |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

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


                       STATISTICAL ANALYSIS OF SURVIVAL DATA

                                     MALE RATS

                       FIRST TERMINAL SACRIFICE AT 729 DAYS

                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)

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

 |                                DOSE = 0.30%                                    |

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

 |                                                                                |

 |  TOTAL 50     UNCENSORED DEATHS 14     CENSORED DEATHS 0    TERMINAL 36        |

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      520   523   551   589   605   622   636   638   655   697                 |

 |      698   705   710   715                                                     |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

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


                       STATISTICAL ANALYSIS OF SURVIVAL DATA

                                     MALE RATS

                       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)   |

 |                                                                                |

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

 |           |                                                                    |

 |0.0%       |   100.0 100.0  98.0  98.0  96.0  96.0  88.0  78.0  66.0  58.0      |

 |           |                                                                    |

 |           |                                                                    |

 |0.075%     |   100.0 100.0 100.0 100.0  98.0  94.0  94.0  88.0  84.0  76.0      |

 |           |                                                                    |

 |           |                                                                    |

 |0.15%      |   100.0 100.0 100.0 100.0  98.0  98.0  96.0  90.0  88.0  72.0      |

 |           |                                                                    |

 |           |                                                                    |

 |0.30%      |   100.0 100.0 100.0 100.0 100.0 100.0  96.0  90.0  82.0  72.0      |

 |           |                                                                    |

 |           |                                                                    |

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

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

 |                           SURVIVAL SUMMARY STATISTICS                          |

 |                                                                                |

 |                                                                                |

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

 |                                                  DOSE                          |

 |                                                                                |

 |                                0.0%         0.075%       0.15%        0.30%    |

 |                                                                                |

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

 |SURVIVAL AT END OF STUDY|       58.0%        76.0%        72.0%        72.0%    |

 |(KAPLAN-MEIER)          |                                                       |

 |                        |                                                       |

 |SIGNIFICANCE (B)        |       P=0.215N     P=0.075N     P=0.128N     P=0.137N |

 |(LIFE TABLE)            |                                                       |

 |                        |                                                       |

 |MEAN DAY OF             |       576.9        594.3        635.2        633.1    |

 |NATURAL DEATHS (C)      |       (23.3)       (27.1)       (26.2)       (18.3)   |

 |(STANDARD ERROR)        |                                                       |

 |                        |                                                       |

 |MEAN LIFE SPAN (D)      |       665.1        696.7        702.7        702.2    |

 |(STANDARD ERROR)        |       (14.4)       (10.4)       ( 9.3)       ( 7.9)   |

 |                        |                                                       |

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

                                    


       (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)
                                  SODIUM NITRITE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA

                                    FEMALE RATS

                       FIRST TERMINAL SACRIFICE AT 730 DAYS

                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)

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

 |                                DOSE = 0.0%                                     |

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

 |                                                                                |

 |  TOTAL 50     UNCENSORED DEATHS 17     CENSORED DEATHS 0    TERMINAL 33        |

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      511   513   547   548   567   596   601   644   648   661                 |

 |      662   669   669   693   694   714   729                                   |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

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

 |                                DOSE = 0.075%                                   |

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

 |                                                                                |

 |  TOTAL 50     UNCENSORED DEATHS 19     CENSORED DEATHS 0    TERMINAL 31        |

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      332   480   536   541   609   616   648   651   662   665                 |

 |      676   680   685   690   696   706   718   723   728                       |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

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

 |                                DOSE = 0.15%                                    |

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

 |                                                                                |

 |  TOTAL 50     UNCENSORED DEATHS 14     CENSORED DEATHS 0    TERMINAL 36        |

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      337   541   541   554   596   624   626   638   658   668                 |

 |      687   696   723   727                                                     |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

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


                       STATISTICAL ANALYSIS OF SURVIVAL DATA

                                    FEMALE RATS

                       FIRST TERMINAL SACRIFICE AT 730 DAYS

                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)

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

 |                                DOSE = 0.30%                                    |

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

 |                                                                                |

 |  TOTAL 50     UNCENSORED DEATHS 17     CENSORED DEATHS 0    TERMINAL 33        |

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      361   465   474   513   624   626   627   629   658   680                 |

 |      680   694   704   715   718   723   723                                   |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

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


                       STATISTICAL ANALYSIS OF SURVIVAL DATA

                                    FEMALE RATS

                       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)   |

 |                                                                                |

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

 |           |                                                                    |

 |0.0%       |   100.0 100.0 100.0 100.0 100.0 100.0  96.0  86.0  78.0  66.0      |

 |           |                                                                    |

 |           |                                                                    |

 |0.075%     |   100.0 100.0 100.0  98.0  98.0  96.0  92.0  92.0  80.0  62.0      |

 |           |                                                                    |

 |           |                                                                    |

 |0.15%      |   100.0 100.0 100.0  98.0  98.0  98.0  94.0  90.0  82.0  72.0      |

 |           |                                                                    |

 |           |                                                                    |

 |0.30%      |   100.0 100.0 100.0  98.0  98.0  94.0  92.0  92.0  82.0  66.0      |

 |           |                                                                    |

 |           |                                                                    |

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

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

 |                           SURVIVAL SUMMARY STATISTICS                          |

 |                                                                                |

 |                                                                                |

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

 |                                                  DOSE                          |

 |                                                                                |

 |                                0.0%         0.075%       0.15%        0.30%    |

 |                                                                                |

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

 |SURVIVAL AT END OF STUDY|       66.0%        62.0%        72.0%        66.0%    |

 |(KAPLAN-MEIER)          |                                                       |

 |                        |                                                       |

 |SIGNIFICANCE (B)        |       P=0.853N     P=0.890      P=0.657N     P=1.000N |

 |(LIFE TABLE)            |                                                       |

 |                        |                                                       |

 |MEAN DAY OF             |       627.4        633.8        615.4        624.4    |

 |NATURAL DEATHS (C)      |       (16.9)       (22.9)       (27.1)       (26.1)   |

 |(STANDARD ERROR)        |                                                       |

 |                        |                                                       |

 |MEAN LIFE SPAN (D)      |       695.1        693.4        697.9        694.1    |

 |(STANDARD ERROR)        |       ( 8.9)       (10.8)       (10.4)       (11.2)   |

 |                        |                                                       |

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

                                    


       (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=RATS SEX=MALE -------------------------------------------------------



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



      |

      |

  100 + 1                                       1                       3 2                4

      |

      |                                         1                       1 2         2   3

      |                                                                 1            1  3  4   3

   95 +

      |                                                                             2          2    3 4

      |                                                                              1     1   2    2 3 4

      |

   90 +                                                                                    11       2 324 3

      |

P     |                                                                                     1   1      2  3 42      3

E     |                                                                                         1 1         422     3 3

R  85 +

C     |                                                                                           1   1      424  2

E     |                                                                                                        4  2 2 4

N     |

T  80 +                                                                                               1 1           223 3

      |

S     |                                                                                                 11            4433

U     |                                                                                                  11          2 4433 2

R  75 +

V     |                                                                                                   11            44

I     |                                                                                                    11            43 3

V     |

A  70 +

L     |

      |                                                                                                     1 1

      |                                                                                                       1   1

   65 +

      |                                                                                                           1 1

      |

      |

   60 +                                                                                                             1     1

      |

      |                                                                                                                   1 1

      |

   55 +

      |

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

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



                                                                   WEEK



NOTE: 13 obs hidden.
                                                           SODIUM NITRITE

                                                    KAPLAN-MEIER SURVIVAL CURVES

                                                        0.0%             = 1

                                                        0.075%           = 2

                                                        0.15%            = 3

                                                        0.30%            = 4



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



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



      |

      |

  100 + 1                                                    23  4                      1

      |

      |                                                      23  4                4 2   11    3

      |                                                                           442    1   2 1

   95 +

      |                                                                            4     4   22 3

      |                                                                                  4    2131     32  4

      |

P  90 +                                                                                          1     122 3

E     |

R     |                                                                                                  2    2

C     |                                                                                                1   3 1

E  85 +

N     |                                                                                                    4 113 2

T     |                                                                                                       13 13 4

      |

S  80 +                                                                                                          232 3

U     |

R     |                                                                                                          112233

V     |                                                                                                               34  3

I  75 +

V     |                                                                                                           1 21 4 4

A     |                                                                                                              11   3 3

L     |

   70 +                                                                                                               12144

      |

      |                                                                                                                212  1

      |                                                                                                                  22 1

   65 +

      |

      |                                                                                                                   2 2

      |

   60 +

      |

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

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



                                                                   WEEK



NOTE: 19 obs hidden.