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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: 09:16:03       

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         

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

                                                                                                                                    

                                                             CORE 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 003    37 MG/KG                                                                      

                                       INCLUDE 004    37 MG/KG                                                                      

                                       INCLUDE 005    75 MG/KG                                                                      

                                       INCLUDE 006    75 MG/KG                                                                      

                                       INCLUDE 007    150     MG/KG                                                                 

                                       INCLUDE 008    150     MG/KG                                                                 
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11    

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

EXPERIMENT: 05187 TEST: 09                                                                                     TIME: 09:16:03      

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 = 37 MG/KG                                 |

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

 |                                                                                |

 |  TOTAL 50     UNCENSORED DEATHS 33     CENSORED DEATHS 1    TERMINAL 16        |

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      403   406   431   535   542   572   575   579   579   589                 |

 |      596   602   606   625   638   639   650   660   661   664                 |

 |      673   674   680   695   703   704   704   704   712   718                 |

 |      718   718   725                                                           |

 |  CENSORED DEATHS                                                               |

 |      591                                                                       |

 |                                                                                |

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

 |                                DOSE = 75 MG/KG                                 |

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

 |                                                                                |

 |  TOTAL 50     UNCENSORED DEATHS 32     CENSORED DEATHS 3    TERMINAL 15        |

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      438   467   502   521   568   572   582   595   596   601                 |

 |      610   619   630   638   639   642   642   651   659   661                 |

 |      664   673   674   692   695   695   695   696   696   706                 |

 |      709   712                                                                 |

 |  CENSORED DEATHS                                                               |

 |      15    522   658                                                           |

 |                                                                                |

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


                       STATISTICAL ANALYSIS OF SURVIVAL DATA

                                     MALE RATS

                       FIRST TERMINAL SACRIFICE AT 730 DAYS

                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)

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

 |                          DOSE = 150     MG/KG                                  |

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

 |                                                                                |

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

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      337   409   457   467   495   502   523   546   547   568                 |

 |      575   583   584   598   598   600   602   607   610   614                 |

 |      621   625   633   638   642   642   642   646   648   650                 |

 |      654   658   659   660   660   660   660   661   669   670                 |

 |      680   680   683   684   688   688   700   704   712                       |

 |  CENSORED DEATHS                                                               |

 |      699                                                                       |

 |                                                                                |

 ==================================================================================
                                   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      |

 |           |                                                                    |

 |           |                                                                    |

 |37 MG/KG   |   100.0 100.0 100.0 100.0  96.0  94.0  90.0  75.9  59.5  32.8      |

 |           |                                                                    |

 |           |                                                                    |

 |75 MG/KG   |   100.0 100.0 100.0 100.0 100.0  95.9  91.8  79.3  56.1  32.4      |

 |           |                                                                    |

 |           |                                                                    |

 |150        |   100.0 100.0 100.0  98.0  96.0  92.0  86.0  66.0  24.0   0.0      |

 |MG/KG      |                                                                    |

 |           |                                                                    |

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

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

 |                           SURVIVAL SUMMARY STATISTICS                          |

 |                                                                                |

 |                                                                                |

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

 |                                                  DOSE                          |

 |                                                                                |

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

 |                                                                       MG/KG    |

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

 |SURVIVAL AT END OF STUDY|       40.0%        32.8%        32.4%         0.0%    |

 |(KAPLAN-MEIER)          |                                                       |

 |                        |                                                       |

 |SIGNIFICANCE (B)        |       P<0.001      P=0.389      P=0.294      P<0.001  |

 |(LIFE TABLE)            |                                                       |

 |                        |                                                       |

 |MEAN DAY OF             |       642.6        626.7        629.4        613.0    |

 |NATURAL DEATHS (C)      |       (15.3)       (15.3)       (12.6)       (11.3)   |

 |(STANDARD ERROR)        |                                                       |

 |                        |                                                       |

 |MEAN LIFE SPAN (D)      |       677.6        659.0        645.7        614.8    |

 |(STANDARD ERROR)        |       (11.0)       (12.3)       (16.7)       (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


                       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 = 37 MG/KG                                 |

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

 |                                                                                |

 |  TOTAL 50     UNCENSORED DEATHS 25     CENSORED DEATHS 0    TERMINAL 25        |

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      347   443   450   520   564   569   588   606   609   611                 |

 |      611   618   620   637   646   650   665   673   683   683                 |

 |      694   703   717   718   724                                               |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

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

 |                                DOSE = 75 MG/KG                                 |

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

 |                                                                                |

 |  TOTAL 50     UNCENSORED DEATHS 27     CENSORED DEATHS 1    TERMINAL 22        |

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      297   515   527   541   557   595   609   613   625   627                 |

 |      629   637   676   676   676   683   683   690   690   702                 |

 |      703   712   714   717   717   721   724                                   |

 |  CENSORED DEATHS                                                               |

 |      444                                                                       |

 |                                                                                |

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


                       STATISTICAL ANALYSIS OF SURVIVAL DATA

                                    FEMALE RATS

                       FIRST TERMINAL SACRIFICE AT 730 DAYS

                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)

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

 |                          DOSE = 150     MG/KG                                  |

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

 |                                                                                |

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

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      483   483   508   527   534   541   548   553   572   576                 |

 |      589   591   600   605   609   609   611   620   620   620                 |

 |      632   641   647   652   660   667   676   679   679   694                 |

 |      702   703   711   711   717   723   724   724                             |

 |  CENSORED DEATHS                                                               |

 |      590                                                                       |

 |                                                                                |

 ==================================================================================
                                   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      |

 |           |                                                                    |

 |           |                                                                    |

 |37 MG/KG   |   100.0 100.0 100.0  98.0  98.0  94.0  92.0  86.0  66.0  50.0      |

 |           |                                                                    |

 |           |                                                                    |

 |75 MG/KG   |   100.0 100.0 100.0  98.0  98.0  98.0  91.9  87.8  75.5  44.9      |

 |           |                                                                    |

 |           |                                                                    |

 |150        |   100.0 100.0 100.0 100.0 100.0  96.0  88.0  71.8  49.3  22.6      |

 |MG/KG      |                                                                    |

 |           |                                                                    |

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

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

 |                           SURVIVAL SUMMARY STATISTICS                          |

 |                                                                                |

 |                                                                                |

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

 |                                                  DOSE                          |

 |                                                                                |

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

 |                                                                       MG/KG    |

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

 |SURVIVAL AT END OF STUDY|       44.0%        50.0%        44.9%        22.6%    |

 |(KAPLAN-MEIER)          |                                                       |

 |                        |                                                       |

 |SIGNIFICANCE (B)        |       P=0.015      P=0.640N     P=0.807N     P=0.053  |

 |(LIFE TABLE)            |                                                       |

 |                        |                                                       |

 |MEAN DAY OF             |       602.8        614.0        639.1        624.8    |

 |NATURAL DEATHS (C)      |       (21.3)       (18.6)       (17.8)       (11.4)   |

 |(STANDARD ERROR)        |                                                       |

 |                        |                                                       |

 |MEAN LIFE SPAN (D)      |       658.8        672.0        675.2        647.2    |

 |(STANDARD ERROR)        |       (14.9)       (12.4)       (12.4)       (10.7)   |

 |                        |                                                       |

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

                                    


       (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

                                                    KAPLAN-MEIER SURVIVAL CURVES

                                                        0 MG/KG          = 1

                                                        37 MG/KG         = 2

                                                        75 MG/KG         = 3

                                                        150     MG/KG    = 4



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



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



      |

  100 + 1                                                     41        2    3

      |                                                       41         4   3    3        1

      |                                                                 24  2    43    3   112 1

      |                                                                           4   4    3 221 13

   90 +                                                                               44      2  12 1

      |                                                                                4   4      221   1

      |                                                                                    4  44    3 3 11

      |                                                                                        4  42  23

   80 +                                                                                           44  22 11

      |                                                                                            44    311

      |                                                                                             4  22 31 1

      |                                                                                                    2 1 1

P  70 +                                                                                                        1 1

E     |                                                                                                      22

R     |                                                                                                444   32  11    1

C     |                                                                                                       3  3

E  60 +                                                                                                  44      2 2

N     |                                                                                                   44

T     |                                                                                                    444   3 22  11

      |                                                                                                            3232211

S  50 +                                                                                                              33

U     |

R     |                                                                                                      44          11

V     |                                                                                                                22 1 1

I  40 +                                                                                                       44      3322  1

V     |                                                                                                                33

A     |                                                                                                        4 4       22

L     |                                                                                                                 3 2 2

   30 +

      |

      |                                                                                                          44

      |

   20 +                                                                                                           4 4

      |

      |

      |                                                                                                             44

   10 +

      |                                                                                                              44

      |                                                                                                               44

      |                                                                                                                44

    0 +                                                                                                                 4

      |

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

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



                                                                   WEEK



NOTE: 31 obs hidden.
                                                           METHYLEUGENOL

                                                    KAPLAN-MEIER SURVIVAL CURVES

                                                        0 MG/KG          = 1

                                                        37 MG/KG         = 2

                                                        75 MG/KG         = 3

                                                        150     MG/KG    = 4



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



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



      |

      |

  100 + 1                                      1       3       2                    4

      |                                        1       3       2         1    2          3

      |                                                                  1    1 21  4   43 23 3

      |                                                                                    2443 32

   90 +                                                                          1           441322   3

      |                                                                                       411 2 2 3 3

      |                                                                                        41 1 2  123

      |                                                                                           44    22 3

P  80 +                                                                                            4  4

E     |                                                                                                112233

R     |                                                                                               44111 2      3

C     |                                                                                                   1 212

E  70 +                                                                                                            33

N     |                                                                                                 44    2  2

T     |                                                                                                  44  1 1 2 223

      |                                                                                                        1   1 3 3

S  60 +                                                                                                   4 4      11 2

U     |                                                                                                     44      1 123

R     |                                                                                                      44       11 2

V     |                                                                                                       44 4     1122

I  50 +                                                                                                          44     112 2

V     |                                                                                                           44     33

A     |                                                                                                                  11 1

L     |

   40 +                                                                                                            4  44

      |

      |                                                                                                                44

      |

   30 +                                                                                                                 44

      |                                                                                                                  44

      |

      |                                                                                                                   4 4

   20 +

      |

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

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



                                                                   WEEK



NOTE: 32 obs hidden.