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TDMS Study 05187-09 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     

LAB: Battelle Columbus                                       METHYLEUGENOL                                     DATE: 07/20/98       

EXPERIMENT: 05187 TEST: 09                                                                                     TIME: 09:16:17       

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

CONT: NO1-ES-25337                              ROUTE: GAVAGE                                                  NTP C#: 60991B       

PATHOLOGIST: MISSING                                                                                           CAS: 93-15-2         

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

                                                                                                                                    

                                                             STOP STUDY                                                             

                                                                                                                                    


               REASONS FOR REMOVAL:    25022 Accidently Killed                                                                      

                                       25018 Dosing Accident                                                                        

                                       25019 Moribund Sacrifice                                                                     

                                       25020 Natural Death                                                                          

                                       25021 Terminal Sacrifice                                                                     

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

               REMOVAL DATE RANGE:     ALL                                                                                          

                                                                                                                                    

               TREATMENT GROUPS:       INCLUDE 001    0 MG/KG                                                                       

                                       INCLUDE 002    0 MG/KG                                                                       

                                       INCLUDE 009    300     MG/KG                                                                 

                                       INCLUDE 010    300     MG/KG                                                                 
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11    

LAB: Battelle Columbus                                       METHYLEUGENOL                                     DATE: 07/20/98      

EXPERIMENT: 05187 TEST: 09                                                                                     TIME: 09:16:17      

TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       

CONT: NO1-ES-25337                              ROUTE: GAVAGE                                                  NTP C#: 60991B      

PATHOLOGIST: MISSING                                                                                           CAS: 93-15-2        
                                   METHYLEUGENOL


                       STATISTICAL ANALYSIS OF SURVIVAL DATA

                                     MALE RATS

                       FIRST TERMINAL SACRIFICE AT 730 DAYS

                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)

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

 |                                DOSE = 0 MG/KG                                  |

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

 |                                                                                |

 |  TOTAL 50     UNCENSORED DEATHS 30     CENSORED DEATHS 0    TERMINAL 20        |

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      344   521   529   553   564   588   603   610   610   614                 |

 |      617   626   639   642   652   661   662   668   704   704                 |

 |      707   707   712   714   715   718   721   722   722   729                 |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

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

 |                          DOSE = 300     MG/KG                                  |

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

 |                                                                                |

 |  TOTAL 50     UNCENSORED DEATHS 49     CENSORED DEATHS 1    TERMINAL 0         |

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      177   219   299   380   437   495   498   502   506   513                 |

 |      517   521   526   528   528   533   533   537   540   548                 |

 |      553   556   556   557   570   572   572   582   589   589                 |

 |      589   591   592   592   597   601   604   604   608   619                 |

 |      627   631   633   634   638   653   674   680   684                       |

 |  CENSORED DEATHS                                                               |

 |      18                                                                        |

 |                                                                                |

 ==================================================================================
                                   METHYLEUGENOL


                       STATISTICAL ANALYSIS OF SURVIVAL DATA

                                     MALE 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 MG/KG    |   100.0 100.0 100.0  98.0  98.0  98.0  94.0  86.0  66.0  40.0      |

 |           |                                                                    |

 |           |                                                                    |

 |300        |   100.0  98.0  95.9  93.9  91.8  89.8  61.2  22.4   6.1   0.0      |

 |MG/KG      |                                                                    |

 |           |                                                                    |

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

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

 |                           SURVIVAL SUMMARY STATISTICS                          |

 |                                                                                |

 |                                                                                |

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

 |                                                        DOSE                    |

 |                                                                                |

 |                                0 MG/KG                   300                   |

 |                                                          MG/KG                 |

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

 |SURVIVAL AT END OF STUDY|       40.0%                      0.0%                 |

 |(KAPLAN-MEIER)          |                                                       |

 |                        |                                                       |

 |SIGNIFICANCE (B)        |       P<0.001                   P<0.001               |

 |(LIFE TABLE)            |                                                       |

 |                        |                                                       |

 |MEAN DAY OF             |       642.6                     548.7                 |

 |NATURAL DEATHS (C)      |       (15.3)                    (14.5)                |

 |(STANDARD ERROR)        |                                                       |

 |                        |                                                       |

 |MEAN LIFE SPAN (D)      |       677.6                     538.0                 |

 |(STANDARD ERROR)        |       (11.0)                    (17.7)                |

 |                        |                                                       |

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

                                    


       (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)
                                   METHYLEUGENOL


                       STATISTICAL ANALYSIS OF SURVIVAL DATA

                                    FEMALE RATS

                       FIRST TERMINAL SACRIFICE AT 730 DAYS

                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)

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

 |                                DOSE = 0 MG/KG                                  |

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

 |                                                                                |

 |  TOTAL 50     UNCENSORED DEATHS 28     CENSORED DEATHS 0    TERMINAL 22        |

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      241   407   448   459   459   549   555   569   597   598                 |

 |      598   609   616   619   641   641   641   644   653   679                 |

 |      683   698   700   703   711   717   719   724                             |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

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

 |                          DOSE = 300     MG/KG                                  |

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

 |                                                                                |

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

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      183   281   288   331   459   477   519   528   560   571                 |

 |      609   609   611   620   620   637   641   641   642   653                 |

 |      659   660   665   679   679   694   703   703   703   709                 |

 |      711   724   724   724                                                     |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

 ==================================================================================
                                   METHYLEUGENOL


                       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 MG/KG    |   100.0 100.0  98.0  98.0  96.0  90.0  90.0  78.0  62.0  44.0      |

 |           |                                                                    |

 |           |                                                                    |

 |300        |   100.0 100.0  98.0  92.0  92.0  88.0  84.0  80.0  54.0  32.0      |

 |MG/KG      |                                                                    |

 |           |                                                                    |

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

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

 |                           SURVIVAL SUMMARY STATISTICS                          |

 |                                                                                |

 |                                                                                |

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

 |                                                        DOSE                    |

 |                                                                                |

 |                                0 MG/KG                   300                   |

 |                                                          MG/KG                 |

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

 |SURVIVAL AT END OF STUDY|       44.0%                     32.0%                 |

 |(KAPLAN-MEIER)          |                                                       |

 |                        |                                                       |

 |SIGNIFICANCE (B)        |       P=0.343                   P=0.343               |

 |(LIFE TABLE)            |                                                       |

 |                        |                                                       |

 |MEAN DAY OF             |       602.8                     594.6                 |

 |NATURAL DEATHS (C)      |       (21.3)                    (23.9)                |

 |(STANDARD ERROR)        |                                                       |

 |                        |                                                       |

 |MEAN LIFE SPAN (D)      |       658.8                     637.9                 |

 |(STANDARD ERROR)        |       (14.9)                    (18.5)                |

 |                        |                                                       |

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

                                    


       (A)  FIRST TERMINAL SACRIFICE

       (B)  THE FIRST ENTRY IS THE TREND TEST (TARONE, 1975) RESULT.

            SUBSEQUENT ENTRIES ARE THE RESULTS OF PAIRWISE TESTS

            (COX,1972).  NEGATIVE TRENDS ARE INDICATED BY "N".

       (C)  MEAN OF ALL UNCENSORED DEATHS PRIOR TO TERMINAL SACRIFICE

       (D)  MEAN OF ALL DEATHS (UNCENSORED, CENSORED, TERMINAL SACRIFICE)
                                                           METHYLEUGENOL

                                                    KAPLAN-MEIER SURVIVAL CURVES

                                                        0 MG/KG          = 1

                                                        300     MG/KG    = 2



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



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



      |

      |

  100 + 1                            2                         1

      |                              2     2                   1                           1

      |                                    2           2             2                     11  1

      |                                                              2       2                 1 1

   90 +                                                                      2        2          1  1

      |                                                                               22            1   1

      |                                                                                                 11

      |                                                                                222

   80 +                                                                                                  11

      |                                                                                  2 2              11

      |                                                                                    22              1 1

      |                                                                                                      1 1

P  70 +                                                                                     22                 1 1

E     |

R     |                                                                                                          11    1

C     |                                                                                      22

E  60 +                                                                                       22

N     |                                                                                        22

T     |                                                                                                                11

      |                                                                                                                 11

S  50 +                                                                                         2 2

U     |

R     |                                                                                           2 2                    11

V     |                                                                                             2 2                   1 1

I  40 +                                                                                                                     1

V     |

A     |

L     |

   30 +                                                                                               22

      |                                                                                                22

      |

      |

   20 +                                                                                                 2 2

      |                                                                                                   222

      |

      |

   10 +                                                                                                     22

      |                                                                                                      2 2

      |                                                                                                        2   22

      |

    0 +                                                                                                             2

      |

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

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



                                                                   WEEK



NOTE: 7 obs hidden.
                                                           METHYLEUGENOL

                                                    KAPLAN-MEIER SURVIVAL CURVES

                                                        0 MG/KG          = 1

                                                        300     MG/KG    = 2



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



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



      |

      |

  100 + 1                             2        1

      |                               2        1     2                   1

      |                                              22      2           1    1  1

      |                                                      2                   2

   90 +                                                                          1  2          1

      |                                                                             2      2   11

P     |                                                                                    22   1 1    1

E     |                                                                                         2 2

R  80 +                                                                                           2     2

C     |                                                                                                11

E     |                                                                                                 111

N     |                                                                                                   1  1

T  70 +                                                                                                   2 2

      |                                                                                                     22

S     |                                                                                                      1 1

U     |                                                                                                      2 1   1

R  60 +                                                                                                        2 2 11

V     |                                                                                                             1 1

I     |                                                                                                          2 2  11

V     |                                                                                                                11

A  50 +                                                                                                            2  2 11

L     |                                                                                                               22

      |                                                                                                                  11 1

      |                                                                                                                22

   40 +

      |                                                                                                                 2 2

      |

      |                                                                                                                   2 2

   30 +

      |

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

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



                                                                   WEEK



NOTE: 14 obs hidden.