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TDMS Study 05184-06 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     

LAB: Battelle Northwest                                      GLUTARALDEHYDE                                    DATE: 07/13/98       

EXPERIMENT: 05184 TEST: 06                                                                                     TIME: 08:41:50       

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

CONT: NO1-ES-25335                              ROUTE: RESPIRATORY EXPOSURE WHOLE BODY                         NTP C#: 55425C       

PATHOLOGIST: GRUMBEIN, S.                                                                                      CAS: 111-30-8        

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

                                                                                                                                    

                                                             CORE STUDY                                                             

                                                                                                                                    


               REASONS FOR REMOVAL:    ALL                                                                                          

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

               REMOVAL DATE RANGE:     ALL                                                                                          

                                                                                                                                    

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

LAB: Battelle Northwest                                      GLUTARALDEHYDE                                    DATE: 07/13/98      

EXPERIMENT: 05184 TEST: 06                                                                                     TIME: 08:41:50      

TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       

CONT: NO1-ES-25335                              ROUTE: RESPIRATORY EXPOSURE WHOLE BODY                         NTP C#: 55425C      

PATHOLOGIST: GRUMBEIN, S.                                                                                      CAS: 111-30-8       
                                  GLUTARALDEHYDE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA

                                     MALE MICE

                       FIRST TERMINAL SACRIFICE AT 733 DAYS

                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)

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

 |                                DOSE = CONTROL                                  |

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

 |                                                                                |

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

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      359   454   498   516   532   534   573   602   616   626                 |

 |      670   675   684   684   688   702   712   716   723                       |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

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

 |                                DOSE = 62.5 PPB                                 |

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

 |                                                                                |

 |  TOTAL 50     UNCENSORED DEATHS 23     CENSORED DEATHS 0    TERMINAL 27        |

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      364   402   420   476   517   524   524   539   551   573                 |

 |      588   598   616   640   640   647   666   685   698   706                 |

 |      707   718   723                                                           |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

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

 |                                DOSE = 125 PPB                                  |

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

 |                                                                                |

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

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      279   470   492   504   516   519   605   702   715   719                 |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

 ==================================================================================
                                  GLUTARALDEHYDE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA

                                     MALE MICE

                       FIRST TERMINAL SACRIFICE AT 733 DAYS

                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)

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

 |                                DOSE = 250 PPB                                  |

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

 |                                                                                |

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

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      327   504   558   589   628   641   651   663   672   673                 |

 |      704   723                                                                 |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

 ==================================================================================
                                  GLUTARALDEHYDE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA

                                     MALE MICE

                       FIRST TERMINAL SACRIFICE AT 733 DAYS


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

 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |

 |                                                                                |

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

 |    DOSE                               TIME (DAYS)                              |

 |                 90   180   270   365   425   485   545   605   665   733 (A)   |

 |                                                                                |

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

 |           |                                                                    |

 |CONTROL    |   100.0 100.0 100.0  98.0  98.0  96.0  88.0  84.0  80.0  62.0      |

 |           |                                                                    |

 |           |                                                                    |

 |62.5 PPB   |   100.0 100.0 100.0  98.0  94.0  92.0  84.0  76.0  68.0  54.0      |

 |           |                                                                    |

 |           |                                                                    |

 |125 PPB    |   100.0 100.0 100.0  98.0  98.0  96.0  88.0  86.0  86.0  80.0      |

 |           |                                                                    |

 |           |                                                                    |

 |250 PPB    |   100.0 100.0 100.0  98.0  98.0  98.0  96.0  92.0  84.0  76.0      |

 |           |                                                                    |

 |           |                                                                    |

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

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

 |                           SURVIVAL SUMMARY STATISTICS                          |

 |                                                                                |

 |                                                                                |

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

 |                                                  DOSE                          |

 |                                                                                |

 |                                CONTROL      62.5 PPB     125 PPB      250 PPB  |

 |                                                                                |

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

 |SURVIVAL AT END OF STUDY|       62.0%        54.0%        80.0%        76.0%    |

 |(KAPLAN-MEIER)          |                                                       |

 |                        |                                                       |

 |SIGNIFICANCE (B)        |       P=0.036N     P=0.464      P=0.091N     P=0.192N |

 |(LIFE TABLE)            |                                                       |

 |                        |                                                       |

 |MEAN DAY OF             |       608.6        587.9        552.1        611.1    |

 |NATURAL DEATHS (C)      |       (23.6)       (21.9)       (43.4)       (31.3)   |

 |(STANDARD ERROR)        |                                                       |

 |                        |                                                       |

 |MEAN LIFE SPAN (D)      |       685.7        666.3        696.8        703.7    |

 |(STANDARD ERROR)        |       (12.3)       (14.4)       (13.3)       (10.4)   |

 |                        |                                                       |

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

                                    


       (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)
                                  GLUTARALDEHYDE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA

                                    FEMALE MICE

                       FIRST TERMINAL SACRIFICE AT 735 DAYS

                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)

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

 |                                DOSE = CONTROL                                  |

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

 |                                                                                |

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

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      248   507   532   558   614   616   655   657   664   681                 |

 |      686   701   702   704   708   734                                         |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

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

 |                                DOSE = 62.5 PPB                                 |

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

 |                                                                                |

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

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      463   492   527   551   598   610   672   706   707   708                 |

 |      708   714   728                                                           |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

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

 |                                DOSE = 125 PPB                                  |

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

 |                                                                                |

 |  TOTAL 50     UNCENSORED DEATHS 14     CENSORED DEATHS 1    TERMINAL 35        |

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      502   524   570   635   640   672   672   686   687   702                 |

 |      704   715   719   723                                                     |

 |  CENSORED DEATHS                                                               |

 |      666                                                                       |

 |                                                                                |

 ==================================================================================
                                  GLUTARALDEHYDE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA

                                    FEMALE MICE

                       FIRST TERMINAL SACRIFICE AT 735 DAYS

                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)

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

 |                                DOSE = 250 PPB                                  |

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

 |                                                                                |

 |  TOTAL 50     UNCENSORED DEATHS 18     CENSORED DEATHS 0    TERMINAL 32        |

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      401   492   502   542   552   560   588   616   631   660                 |

 |      685   686   701   707   712   723   723   723                             |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

 ==================================================================================
                                  GLUTARALDEHYDE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA

                                    FEMALE MICE

                       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  98.0  98.0  98.0  98.0  94.0  92.0  82.0  68.0      |

 |           |                                                                    |

 |           |                                                                    |

 |62.5 PPB   |   100.0 100.0 100.0 100.0 100.0  98.0  94.0  90.0  88.0  74.0      |

 |           |                                                                    |

 |           |                                                                    |

 |125 PPB    |   100.0 100.0 100.0 100.0 100.0 100.0  96.0  94.0  90.0  71.6      |

 |           |                                                                    |

 |           |                                                                    |

 |250 PPB    |   100.0 100.0 100.0 100.0  98.0  98.0  92.0  86.0  80.0  64.0      |

 |           |                                                                    |

 |           |                                                                    |

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

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

 |                           SURVIVAL SUMMARY STATISTICS                          |

 |                                                                                |

 |                                                                                |

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

 |                                                  DOSE                          |

 |                                                                                |

 |                                CONTROL      62.5 PPB     125 PPB      250 PPB  |

 |                                                                                |

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

 |SURVIVAL AT END OF STUDY|       68.0%        74.0%        71.6%        64.0%    |

 |(KAPLAN-MEIER)          |                                                       |

 |                        |                                                       |

 |SIGNIFICANCE (B)        |       P=0.573      P=0.611N     P=0.771N     P=0.811  |

 |(LIFE TABLE)            |                                                       |

 |                        |                                                       |

 |MEAN DAY OF             |       622.9        629.5        653.6        622.4    |

 |NATURAL DEATHS (C)      |       (30.0)       (26.3)       (19.3)       (22.7)   |

 |(STANDARD ERROR)        |                                                       |

 |                        |                                                       |

 |MEAN LIFE SPAN (D)      |       699.1        707.6        710.8        694.5    |

 |(STANDARD ERROR)        |       (12.0)       ( 9.4)       ( 7.5)       (11.1)   |

 |                        |                                                       |

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

                                    


       (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)
                                                           GLUTARALDEHYDE

                                                    KAPLAN-MEIER SURVIVAL CURVES

                                                        CONTROL          = 1

                                                        62.5 PPB         = 2

                                                        125 PPB          = 3

                                                        250 PPB          = 4



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



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



      |

  100 + 1                                           3       4    1

      |

      |                                             3       4    1      2       1  3   4

      |                                                                 2 2     1  3  31        4

   95 +

      |                                                                   2        2  31 1      4     4

      |                                                                            2   3 1  1         4    4

      |

   90 +                                                                                  2 211             4 4

      |

      |                                                                                    3 1    1     3    44

      |                                                                                    2 2    1    13     4  4     3

P  85 +

E     |                                                                                      2 2       1 1       44    3 3

R     |                                                                                        2  2      1 1      44

C     |

E  80 +                                                                                           2 2      1      14   4 3  3

N     |

T     |                                                                                             2  2          11   4  4

      |                                                                                                2 2         11     4 4

S  75 +

U     |                                                                                                  2   2

R     |                                                                                                             11

V     |

I  70 +                                                                                                      22      1 1

V     |

A     |                                                                                                       2   2    11

L     |                                                                                                           2 2   11

   65 +

      |                                                                                                             2 2  11

      |                                                                                                               22  1 1

      |

   60 +

      |

      |                                                                                                                2 2

      |                                                                                                                  22

   55 +

      |                                                                                                                   2 2

      |

      |

   50 +

      |

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

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



                                                                   WEEK



NOTE: 11 obs hidden.
                                                           GLUTARALDEHYDE

                                                    KAPLAN-MEIER SURVIVAL CURVES

                                                        CONTROL          = 1

                                                        62.5 PPB         = 2

                                                        125 PPB          = 3

                                                        250 PPB          = 4



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



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



      |

      |

  100 + 1                                       1                       4         2    3

      |

      |                                         1                       4         2   231  3

      |                                                                               241  31     3

   95 +

      |                                                                                4    1 421 3         3

      |                                                                                       421      2 1  33

      |

P  90 +                                                                                        44      2 2   3    3

E     |

R     |                                                                                         4   4    1     1  2

C     |                                                                                             4    4        2 3  2

E  85 +

N     |                                                                                                  4  4  1 1  33

T     |                                                                                                     4    1  1  22

      |                                                                                                              3 3

S  80 +                                                                                                          4  4

U     |

R     |                                                                                                             1  1 3

V     |                                                                                                             4  42 2

I  75 +

V     |                                                                                                                  32 2

A     |                                                                                                                11

L     |                                                                                                                   3 3

   70 +                                                                                                                 1 4 1

      |

      |                                                                                                                     1

      |

   65 +

      |                                                                                                                   4 4

      |

      |

   60 +

      |

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

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



                                                                   WEEK



NOTE: 16 obs hidden.