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TDMS Study 05184-05 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     

LAB: Battelle Northwest                                      GLUTARALDEHYDE                                    DATE: 09/14/98       

EXPERIMENT: 05184 TEST: 05                                                                                     TIME: 08:32:54       

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

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

PATHOLOGIST: RENNE, ROGER                                                                                      CAS: 111-30-8        

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

                                                                                                                                    

                                                           2 YEAR CHRONIC                                                           

                                                                                                                                    


               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: 09/14/98      

EXPERIMENT: 05184 TEST: 05                                                                                     TIME: 08:32:54      

TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       

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

PATHOLOGIST: RENNE, ROGER                                                                                      CAS: 111-30-8       
                                  GLUTARALDEHYDE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA

                                     MALE RATS

                       FIRST TERMINAL SACRIFICE AT 729 DAYS

                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)

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

 |                                DOSE = CONTROL                                  |

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

 |                                                                                |

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

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      117   392   452   495   498   502   514   543   544   555                 |

 |      556   580   583   583   601   602   602   612   612   617                 |

 |      637   637   638   652   652   652   657   676   689   689                 |

 |      694   694   702   702   708   708   717   717                             |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

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

 |                                DOSE = 250 PPB                                  |

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

 |                                                                                |

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

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      356   449   495   533   550   569   577   579   607   613                 |

 |      615   617   621   625   632   634   638   647   652   654                 |

 |      666   666   671   675   689   694   694   694   708   708                 |

 |      708   712   712   712   716   724                                         |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

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

 |                                DOSE = 500 PPB                                  |

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

 |                                                                                |

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

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      365   393   481   512   524   525   526   526   533   561                 |

 |      581   587   593   608   609   612   617   617   632   638                 |

 |      645   652   652   654   656   661   664   666   682   686                 |

 |      688   688   689   689   702   705   708   711   716   721                 |

 |      726                                                                       |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

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


                       STATISTICAL ANALYSIS OF SURVIVAL DATA

                                     MALE RATS

                       FIRST TERMINAL SACRIFICE AT 729 DAYS

                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)

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

 |                                DOSE = 750 PPB                                  |

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

 |                                                                                |

 |  TOTAL 50     UNCENSORED DEATHS 44     CENSORED DEATHS 0    TERMINAL 6         |

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      23    99    100   105   106   106   106   107   111   262                 |

 |      393   449   468   474   492   502   508   561   564   586                 |

 |      589   589   593   603   608   620   625   634   638   638                 |

 |      646   652   666   673   683   689   708   708   708   712                 |

 |      716   718   720   721                                                     |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

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


                       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)   |

 |                                                                                |

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

 |           |                                                                    |

 |CONTROL    |   100.0  98.0  98.0  98.0  96.0  94.0  82.0  66.0  46.0  24.0      |

 |           |                                                                    |

 |           |                                                                    |

 |250 PPB    |   100.0 100.0 100.0  98.0  98.0  96.0  92.0  84.0  60.0  28.0      |

 |           |                                                                    |

 |           |                                                                    |

 |500 PPB    |   100.0 100.0 100.0  98.0  96.0  94.0  82.0  74.0  46.0  18.0      |

 |           |                                                                    |

 |           |                                                                    |

 |750 PPB    |    98.0  82.0  80.0  80.0  78.0  72.0  66.0  52.0  36.0  12.0      |

 |           |                                                                    |

 |           |                                                                    |

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

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

 |                           SURVIVAL SUMMARY STATISTICS                          |

 |                                                                                |

 |                                                                                |

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

 |                                                  DOSE                          |

 |                                                                                |

 |                                CONTROL      250 PPB      500 PPB      750 PPB  |

 |                                                                                |

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

 |SURVIVAL AT END OF STUDY|       24.0%        28.0%        18.0%        12.0%    |

 |(KAPLAN-MEIER)          |                                                       |

 |                        |                                                       |

 |SIGNIFICANCE (B)        |       P=0.032       -----       P=0.788      P=0.094  |

 |(LIFE TABLE)            |                                                       |

 |                        |                                                       |

 |MEAN DAY OF             |       599.5        633.7        619.5        499.5    |

 |NATURAL DEATHS (C)      |       (18.4)       (13.5)       (13.5)       (34.4)   |

 |(STANDARD ERROR)        |                                                       |

 |                        |                                                       |

 |MEAN LIFE SPAN (D)      |       630.6        660.4        639.2        527.1    |

 |(STANDARD ERROR)        |       (16.0)       (11.5)       (12.5)       (32.0)   |

 |                        |                                                       |

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

                                    


       (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)
                                  GLUTARALDEHYDE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA

                                    FEMALE RATS

                       FIRST TERMINAL SACRIFICE AT 730 DAYS

                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)

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

 |                                DOSE = CONTROL                                  |

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

 |                                                                                |

 |  TOTAL 50     UNCENSORED DEATHS 24     CENSORED DEATHS 0    TERMINAL 26        |

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      119   518   533   542   550   566   589   589   589   598                 |

 |      638   651   660   666   674   680   680   682   694   698                 |

 |      703   708   712   722                                                     |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

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

 |                                DOSE = 250 PPB                                  |

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

 |                                                                                |

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

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      117   178   437   542   561   561   589   593   606   612                 |

 |      615   617   666   674   675   694   720   724   726                       |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

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

 |                                DOSE = 500 PPB                                  |

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

 |                                                                                |

 |  TOTAL 50     UNCENSORED DEATHS 35     CENSORED DEATHS 0    TERMINAL 15        |

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      276   355   357   455   469   508   513   533   533   543                 |

 |      544   558   583   589   614   617   617   619   634   638                 |

 |      638   654   660   662   674   674   676   676   680   703                 |

 |      709   711   715   716   724                                               |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

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


                       STATISTICAL ANALYSIS OF SURVIVAL DATA

                                    FEMALE RATS

                       FIRST TERMINAL SACRIFICE AT 730 DAYS

                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)

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

 |                                DOSE = 750 PPB                                  |

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

 |                                                                                |

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

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      32    106   108   113   113   117   253   375   432   463                 |

 |      474   474   512   514   516   528   567   569   583   628                 |

 |      630   641   652   654   654   654   677   680   698   702                 |

 |      708   716   716   717   718   721                                         |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

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


                       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)   |

 |                                                                                |

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

 |           |                                                                    |

 |CONTROL    |   100.0  98.0  98.0  98.0  98.0  98.0  92.0  80.0  74.0  52.0      |

 |           |                                                                    |

 |           |                                                                    |

 |250 PPB    |   100.0  96.0  96.0  96.0  96.0  94.0  92.0  84.0  76.0  62.0      |

 |           |                                                                    |

 |           |                                                                    |

 |500 PPB    |   100.0 100.0 100.0  94.0  94.0  90.0  78.0  72.0  52.0  30.0      |

 |           |                                                                    |

 |           |                                                                    |

 |750 PPB    |    98.0  88.0  86.0  86.0  84.0  76.0  68.0  62.0  48.0  28.0      |

 |           |                                                                    |

 |           |                                                                    |

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

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

 |                           SURVIVAL SUMMARY STATISTICS                          |

 |                                                                                |

 |                                                                                |

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

 |                                                  DOSE                          |

 |                                                                                |

 |                                CONTROL      250 PPB      500 PPB      750 PPB  |

 |                                                                                |

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

 |SURVIVAL AT END OF STUDY|       52.0%        62.0%        30.0%        28.0%    |

 |(KAPLAN-MEIER)          |                                                       |

 |                        |                                                       |

 |SIGNIFICANCE (B)        |       P<0.001       -----       P=0.023      P=0.008  |

 |(LIFE TABLE)            |                                                       |

 |                        |                                                       |

 |MEAN DAY OF             |       615.0        574.1        595.1        511.5    |

 |NATURAL DEATHS (C)      |       (25.2)       (38.3)       (18.7)       (36.1)   |

 |(STANDARD ERROR)        |                                                       |

 |                        |                                                       |

 |MEAN LIFE SPAN (D)      |       674.8        670.7        635.5        572.7    |

 |(STANDARD ERROR)        |       (14.5)       (17.9)       (15.7)       (29.4)   |

 |                        |                                                       |

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

                                    


       (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

                                                    KAPLAN-MEIER SURVIVAL CURVES

                                                        CONTROL          = 1

                                                        250 PPB          = 2

                                                        500 PPB          = 3

                                                        750 PPB          = 4



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



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



      |

      |

  100 + 1   4              1                                    2 3

      |     4            4 1                                    2 3   13        2

      |                                                               13        1   3 1  3   2

      |                  44                                                           11 3 3 2 2

   90 +                                                                                        2  2

      |                                                                                1 1 33     22

      |                                                                                  1  331    2    2

      |                   4                       4                                          31 13      22

   80 +                                           4                    4                         3 3

      |                                                                4        4               1  13    22

P     |                                                                         4 44               11 3 3 22

E     |                                                                            4  4             1  1   22

R  70 +                                                                               44                33

C     |                                                                                44                33 22

E     |                                                                                 4        4     1 13 3222

N     |                                                                                          4  4    11 33

T  60 +                                                                                             4 4   1 1332  2

      |                                                                                                       33

S     |                                                                                               4 4   11 1  22

U     |                                                                                                            2 2

R  50 +                                                                                                 4 4    3 3   22

V     |                                                                                                   44

I     |                                                                                                    444 1 331312 2

V     |

A  40 +                                                                                                      44     311

L     |                                                                                                       44

      |                                                                                                        4  44  11

      |                                                                                                            443 112

   30 +                                                                                                             44   22

      |                                                                                                              4 3112 2

      |                                                                                                                 31  1

      |

   20 +                                                                                                                 433

      |                                                                                                                   3 3

      |

      |                                                                                                                  4  4

   10 +

      |

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

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



                                                                   WEEK



NOTE: 25 obs hidden.
                                                           GLUTARALDEHYDE

                                                    KAPLAN-MEIER SURVIVAL CURVES

                                                        CONTROL          = 1

                                                        250 PPB          = 2

                                                        500 PPB          = 3

                                                        750 PPB          = 4



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



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



      |

      |

  100 + 1     4            1                        3

      |       4           41         2              3           3                        1

      |                   44         2                          3            2  3        1   11

      |                                                                         3 3           11 2

   90 +                                                                           3     3      1 1

      |                    4                     4                                      33       1    1

      |                                          4                 4        4            3   3        2 2

      |                                                                     4     4          33       1122

P  80 +                                                                           44                   1     1

E     |                                                                                       3 3        22  11

R     |                                                                            4     4      3   3 3   2   1  112

C     |                                                                                               3  3        11

E  70 +                                                                                  4  4            33        11 2

N     |                                                                                     4    4                    2  2

T     |                                                                                          44 4     3 3       1 1  22

      |                                                                                             4      433            2 2

S  60 +                                                                                                               11

U     |                                                                                                    4 3 3       11

R     |                                                                                                      4 3 3      1 1

V     |                                                                                                          3 3      1 1

I  50 +

V     |                                                                                                        4   4

A     |                                                                                                            33 4

L     |                                                                                                             3 43

   40 +                                                                                                                33

      |                                                                                                                 44

      |                                                                                                                 33

      |                                                                                                                  33

   30 +                                                                                                                   3 3

      |                                                                                                                  4  4

      |

      |

   20 +

      |

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

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



                                                                   WEEK



NOTE: 26 obs hidden.