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TDMS Study 05187-06 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     

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

EXPERIMENT: 05187 TEST: 06                                                                                     TIME: 10:26:52       

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

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

PATHOLOGIST: TOFT, J.                                                                                          CAS: 93-15-2         

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

                                                                                                                                    

                                                             CORE STUDY                                                             

                                                                                                                                    


               REASONS FOR REMOVAL:    ALL                                                                                          

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

               REMOVAL DATE RANGE:     ALL                                                                                          

                                                                                                                                    

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

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

EXPERIMENT: 05187 TEST: 06                                                                                     TIME: 10:26:52      

TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       

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

PATHOLOGIST: TOFT, J.                                                                                          CAS: 93-15-2        
                                   METHYLEUGENOL


                       STATISTICAL ANALYSIS OF SURVIVAL DATA

                                     MALE MICE

                       FIRST TERMINAL SACRIFICE AT 730 DAYS

                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)

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

 |                                DOSE = 0 MG/KG                                  |

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

 |                                                                                |

 |  TOTAL 50     UNCENSORED DEATHS 11     CENSORED DEATHS 1    TERMINAL 38        |

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      430   477   537   540   554   570   580   583   604   670                 |

 |      693                                                                       |

 |  CENSORED DEATHS                                                               |

 |      522                                                                       |

 |                                                                                |

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

 |                                DOSE = 37 MG/KG                                 |

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

 |                                                                                |

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

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      488   546   593   593   614   636   655   670   673   687                 |

 |      694   694   712   729                                                     |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

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

 |                                DOSE = 75 MG/KG                                 |

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

 |                                                                                |

 |  TOTAL 50     UNCENSORED DEATHS 12     CENSORED DEATHS 1    TERMINAL 37        |

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      326   486   522   522   572   575   589   614   630   639                 |

 |      691   722                                                                 |

 |  CENSORED DEATHS                                                               |

 |      37                                                                        |

 |                                                                                |

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


                       STATISTICAL ANALYSIS OF SURVIVAL DATA

                                     MALE MICE

                       FIRST TERMINAL SACRIFICE AT 730 DAYS

                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)

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

 |                          DOSE = 150     MG/KG                                  |

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

 |                                                                                |

 |  TOTAL 50     UNCENSORED DEATHS 13     CENSORED DEATHS 2    TERMINAL 35        |

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      459   512   543   554   561   569   579   583   604   660                 |

 |      673   688   727                                                           |

 |  CENSORED DEATHS                                                               |

 |      339   705                                                                 |

 |                                                                                |

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


                       STATISTICAL ANALYSIS OF SURVIVAL DATA

                                     MALE MICE

                       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    |   100.0 100.0 100.0 100.0 100.0  96.0  91.9  81.7  81.7  77.6      |

 |           |                                                                    |

 |           |                                                                    |

 |37 MG/KG   |   100.0 100.0 100.0 100.0 100.0 100.0  98.0  92.0  86.0  72.0      |

 |           |                                                                    |

 |           |                                                                    |

 |75 MG/KG   |   100.0 100.0 100.0  98.0  98.0  98.0  91.8  85.7  79.6  75.5      |

 |           |                                                                    |

 |           |                                                                    |

 |150        |   100.0 100.0 100.0 100.0 100.0  98.0  93.9  81.6  79.6  73.4      |

 |MG/KG      |                                                                    |

 |           |                                                                    |

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

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

 |                           SURVIVAL SUMMARY STATISTICS                          |

 |                                                                                |

 |                                                                                |

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

 |                                                  DOSE                          |

 |                                                                                |

 |                                0 MG/KG      37 MG/KG     75 MG/KG     150      |

 |                                                                       MG/KG    |

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

 |SURVIVAL AT END OF STUDY|       77.6%        72.0%        75.5%        73.4%    |

 |(KAPLAN-MEIER)          |                                                       |

 |                        |                                                       |

 |SIGNIFICANCE (B)        |       P=0.815      P=0.825      P=1.000      P=0.829  |

 |(LIFE TABLE)            |                                                       |

 |                        |                                                       |

 |MEAN DAY OF             |       567.1        641.7        574.0        593.2    |

 |NATURAL DEATHS (C)      |       (22.8)       (18.2)       (30.1)       (20.9)   |

 |(STANDARD ERROR)        |                                                       |

 |                        |                                                       |

 |MEAN LIFE SPAN (D)      |       690.0        705.3        678.7        686.1    |

 |(STANDARD ERROR)        |       (11.3)       ( 7.5)       (17.6)       (12.3)   |

 |                        |                                                       |

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

                                    


       (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 MICE

                       FIRST TERMINAL SACRIFICE AT 731 DAYS

                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)

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

 |                                DOSE = 0 MG/KG                                  |

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

 |                                                                                |

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

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      178   564   579   610   630   632   652   663   665   665                 |

 |      670   673   673   695   702   706   717   718   728                       |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

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

 |                                DOSE = 37 MG/KG                                 |

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

 |                                                                                |

 |  TOTAL 50     UNCENSORED DEATHS 31     CENSORED DEATHS 1    TERMINAL 18        |

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      477   493   516   519   562   562   567   578   582   596                 |

 |      604   605   605   617   620   627   629   632   633   649                 |

 |      652   658   661   664   675   675   687   719   720   720                 |

 |      726                                                                       |

 |  CENSORED DEATHS                                                               |

 |      721                                                                       |

 |                                                                                |

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

 |                                DOSE = 75 MG/KG                                 |

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

 |                                                                                |

 |  TOTAL 50     UNCENSORED DEATHS 31     CENSORED DEATHS 1    TERMINAL 18        |

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      465   484   489   520   521   545   582   590   597   611                 |

 |      619   628   633   637   641   652   658   659   659   661                 |

 |      690   694   694   698   704   714   717   720   722   727                 |

 |      728                                                                       |

 |  CENSORED DEATHS                                                               |

 |      371                                                                       |

 |                                                                                |

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


                       STATISTICAL ANALYSIS OF SURVIVAL DATA

                                    FEMALE MICE

                       FIRST TERMINAL SACRIFICE AT 731 DAYS

                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)

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

 |                          DOSE = 150     MG/KG                                  |

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

 |                                                                                |

 |  TOTAL 50     UNCENSORED DEATHS 48     CENSORED DEATHS 0    TERMINAL 2         |

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      379   450   477   505   505   518   537   548   577   588                 |

 |      592   596   601   603   607   615   624   626   626   627                 |

 |      634   652   652   654   659   662   666   676   676   676                 |

 |      678   679   680   681   686   686   686   687   689   692                 |

 |      705   711   712   717   717   718   723   730                             |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

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


                       STATISTICAL ANALYSIS OF SURVIVAL DATA

                                    FEMALE MICE

                       FIRST TERMINAL SACRIFICE AT 731 DAYS


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

 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |

 |                                                                                |

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

 |    DOSE                               TIME (DAYS)                              |

 |                 90   180   270   365   425   485   545   605   665   731 (A)   |

 |                                                                                |

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

 |           |                                                                    |

 |0 MG/KG    |   100.0  98.0  98.0  98.0  98.0  98.0  98.0  94.0  80.0  62.0      |

 |           |                                                                    |

 |           |                                                                    |

 |37 MG/KG   |   100.0 100.0 100.0 100.0 100.0  98.0  92.0  74.0  52.0  37.9      |

 |           |                                                                    |

 |           |                                                                    |

 |75 MG/KG   |   100.0 100.0 100.0 100.0 100.0  95.9  87.8  81.6  59.2  36.7      |

 |           |                                                                    |

 |           |                                                                    |

 |150        |   100.0 100.0 100.0 100.0  98.0  94.0  86.0  72.0  48.0   4.0      |

 |MG/KG      |                                                                    |

 |           |                                                                    |

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

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

 |                           SURVIVAL SUMMARY STATISTICS                          |

 |                                                                                |

 |                                                                                |

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

 |                                                  DOSE                          |

 |                                                                                |

 |                                0 MG/KG      37 MG/KG     75 MG/KG     150      |

 |                                                                       MG/KG    |

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

 |SURVIVAL AT END OF STUDY|       62.0%        37.9%        36.7%         4.0%    |

 |(KAPLAN-MEIER)          |                                                       |

 |                        |                                                       |

 |SIGNIFICANCE (B)        |       P<0.001      P=0.009      P=0.013      P<0.001  |

 |(LIFE TABLE)            |                                                       |

 |                        |                                                       |

 |MEAN DAY OF             |       637.9        620.3        634.2        633.0    |

 |NATURAL DEATHS (C)      |       (27.6)       (11.8)       (13.9)       (11.3)   |

 |(STANDARD ERROR)        |                                                       |

 |                        |                                                       |

 |MEAN LIFE SPAN (D)      |       695.6        662.2        663.8        636.9    |

 |(STANDARD ERROR)        |       (12.2)       (10.6)       (12.4)       (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)
                                                           METHYLEUGENOL

                                                    KAPLAN-MEIER SURVIVAL CURVES

                                                        0 MG/KG          = 1

                                                        37 MG/KG         = 2

                                                        75 MG/KG         = 3

                                                        150     MG/KG    = 4



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



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



      |

      |

  100 + 1                                                   3               1    4   2

      |

      |                                                     3               1    4  12   4    2

      |                                                                             13   4 3 12       2

P  95 +

E     |                                                                                      11 4

R     |                                                                                       1 1     2  2

C     |                                                                                    3    443

E  90 +                                                                                         1413     2  2

N     |

T     |                                                                                           11  3     2  2

      |                                                                                            11 3  3     2  2

S  85 +

U     |                                                                                             1   13 3      22

R     |                                                                                                            2 2

V     |                                                                                                 1  3 3   41

I  80 +                                                                                                      3   414 12

V     |

A     |                                                                                                            4 1    3 1

L     |                                                                                                               2 2

   75 +                                                                                                              4    3 3

      |                                                                                                                 2 4 2

      |                                                                                                                     2

      |

   70 +

      |

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

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



                                                                   WEEK



NOTE: 22 obs hidden.
                                                           METHYLEUGENOL

                                                    KAPLAN-MEIER SURVIVAL CURVES

                                                        0 MG/KG          = 1

                                                        37 MG/KG         = 2

                                                        75 MG/KG         = 3

                                                        150     MG/KG    = 4



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



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



      |

  100 + 1                            1                               4            3 2

      |                              1                               4          4 3 232          1

      |                                                                         4   432 42 2     1 1     1

      |                                                                                    2     2       1 1

   90 +                                                                                 44 3  3            11

      |                                                                                  4   43     3       1  1

      |                                                                                      4 4 2 22 3        1 1

      |                                                                                            42 32 3

   80 +                                                                                             4 42233      11

      |                                                                                               44  33      11

      |                                                                                                42 233      1  1

      |                                                                                                     33        11

P  70 +                                                                                                 4422 3 3

E     |                                                                                                  4 4           1 1

R     |                                                                                                    22  3 3       11

C     |                                                                                                     2 2           1 1

E  60 +                                                                                                    44 22 3   3

N     |                                                                                                     4  4     33

T     |                                                                                                        2 2

      |                                                                                                        4 2 2

S  50 +                                                                                                               333

U     |                                                                                                          442 2  33

R     |                                                                                                           44 2   2

V     |                                                                                                                  33

I  40 +                                                                                                                  22

V     |                                                                                                                   2 2

A     |                                                                                                            44

L     |

   30 +

      |

      |                                                                                                             44

      |

   20 +                                                                                                              4 4

      |                                                                                                                44

      |                                                                                                                 44

      |

   10 +

      |                                                                                                                  44

      |                                                                                                                   4 4

      |

    0 +

      |

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

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



                                                                   WEEK



NOTE: 20 obs hidden.