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TDMS Study 88036-04 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     

LAB: Battelle Columbus                                       ANTHRAQUINONE                                     DATE: 12/11/98       

EXPERIMENT: 88036 TEST: 04                                                                                     TIME: 09:07:54       

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

CONT: NO1-ES-25337                              ROUTE: DOSED FEED                                              NTP C#: C88036       

PATHOLOGIST: RYAN, M.                                                                                          CAS: 84-65-1         

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

                                                                                                                                    

                                                        2 YEAR CHRONIC MICE                                                         

                                                                                                                                    


               REASONS FOR REMOVAL:    ALL                                                                                          

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

               REMOVAL DATE RANGE:     ALL                                                                                          

                                                                                                                                    

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

LAB: Battelle Columbus                                       ANTHRAQUINONE                                     DATE: 12/11/98      

EXPERIMENT: 88036 TEST: 04                                                                                     TIME: 09:07:54      

TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       

CONT: NO1-ES-25337                              ROUTE: DOSED FEED                                              NTP C#: C88036      

PATHOLOGIST: RYAN, M.                                                                                          CAS: 84-65-1        
                                   ANTHRAQUINONE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA

                                     MALE MICE

                       FIRST TERMINAL SACRIFICE AT 729 DAYS

                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)

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

 |                                DOSE = 0 PPM                                    |

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

 |                                                                                |

 |  TOTAL 50     UNCENSORED DEATHS 5      CENSORED DEATHS 0    TERMINAL 45        |

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      15    550   662   702   710                                               |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

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

 |                                DOSE = 833 PPM                                  |

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

 |                                                                                |

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

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      456   464   601   657   658   662   666   677   710                       |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

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

 |                                DOSE = 2500 PPM                                 |

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

 |                                                                                |

 |  TOTAL 50     UNCENSORED DEATHS 7      CENSORED DEATHS 0    TERMINAL 43        |

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      453   481   491   662   685   711   727                                   |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

 ==================================================================================
                                   ANTHRAQUINONE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA

                                     MALE MICE

                       FIRST TERMINAL SACRIFICE AT 729 DAYS

                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)

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

 |                                DOSE = 7500 PPM                                 |

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

 |                                                                                |

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

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      456   490   497   540   554   559   569   570   586   590                 |

 |      617   621   621   623   638   638   642   647   647   658                 |

 |      664   687   690   690   702   707   708                                   |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

 ==================================================================================
                                   ANTHRAQUINONE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA

                                     MALE MICE

                       FIRST TERMINAL SACRIFICE AT 729 DAYS


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

 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |

 |                                                                                |

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

 |    DOSE                               TIME (DAYS)                              |

 |                 90   180   270   365   425   485   545   605   665   729 (A)   |

 |                                                                                |

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

 |           |                                                                    |

 |0 PPM      |    98.0  98.0  98.0  98.0  98.0  98.0  98.0  96.0  94.0  90.0      |

 |           |                                                                    |

 |           |                                                                    |

 |833 PPM    |   100.0 100.0 100.0 100.0 100.0  96.0  96.0  94.0  88.0  82.0      |

 |           |                                                                    |

 |           |                                                                    |

 |2500 PPM   |   100.0 100.0 100.0 100.0 100.0  96.0  94.0  94.0  92.0  86.0      |

 |           |                                                                    |

 |           |                                                                    |

 |7500 PPM   |   100.0 100.0 100.0 100.0 100.0  98.0  92.0  80.0  58.0  46.0      |

 |           |                                                                    |

 |           |                                                                    |

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

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

 |                           SURVIVAL SUMMARY STATISTICS                          |

 |                                                                                |

 |                                                                                |

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

 |                                                  DOSE                          |

 |                                                                                |

 |                                0 PPM        833 PPM      2500 PPM     7500 PPM |

 |                                                                                |

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

 |SURVIVAL AT END OF STUDY|       90.0%        82.0%        86.0%        46.0%    |

 |(KAPLAN-MEIER)          |                                                       |

 |                        |                                                       |

 |SIGNIFICANCE (B)        |       P<0.001      P=0.374      P=0.751      P<0.001  |

 |(LIFE TABLE)            |                                                       |

 |                        |                                                       |

 |MEAN DAY OF             |       527.8        616.8        601.4        615.2    |

 |NATURAL DEATHS (C)      |       ( 131)       (31.1)       (45.6)       (13.2)   |

 |(STANDARD ERROR)        |                                                       |

 |                        |                                                       |

 |MEAN LIFE SPAN (D)      |       708.9        708.8        711.1        667.6    |

 |(STANDARD ERROR)        |       (14.7)       ( 8.1)       ( 8.7)       (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)
                                   ANTHRAQUINONE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA

                                    FEMALE MICE

                       FIRST TERMINAL SACRIFICE AT 730 DAYS

                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)

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

 |                                DOSE = 0 PPM                                    |

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

 |                                                                                |

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

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      242   519   554   554   569   613   617   627   652   690                 |

 |      701   715   717   717   717                                               |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

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

 |                                DOSE = 833 PPM                                  |

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

 |                                                                                |

 |  TOTAL 50     UNCENSORED DEATHS 8      CENSORED DEATHS 0    TERMINAL 42        |

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      499   519   549   575   611   648   694   703                             |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

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

 |                                DOSE = 2500 PPM                                 |

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

 |                                                                                |

 |  TOTAL 50     UNCENSORED DEATHS 12     CENSORED DEATHS 3    TERMINAL 35        |

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      491   505   568   589   599   624   626   627   631   700                 |

 |      700   711                                                                 |

 |  CENSORED DEATHS                                                               |

 |      675   675   676                                                           |

 |                                                                                |

 ==================================================================================
                                   ANTHRAQUINONE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA

                                    FEMALE MICE

                       FIRST TERMINAL SACRIFICE AT 730 DAYS

                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)

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

 |                                DOSE = 7500 PPM                                 |

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

 |                                                                                |

 |  TOTAL 50     UNCENSORED DEATHS 7      CENSORED DEATHS 1    TERMINAL 42        |

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      172   186   477   549   625   681   711                                   |

 |  CENSORED DEATHS                                                               |

 |      680                                                                       |

 |                                                                                |

 ==================================================================================
                                   ANTHRAQUINONE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA

                                    FEMALE 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 PPM      |   100.0 100.0  98.0  98.0  98.0  98.0  96.0  90.0  82.0  70.0      |

 |           |                                                                    |

 |           |                                                                    |

 |833 PPM    |   100.0 100.0 100.0 100.0 100.0 100.0  96.0  92.0  88.0  84.0      |

 |           |                                                                    |

 |           |                                                                    |

 |2500 PPM   |   100.0 100.0 100.0 100.0 100.0 100.0  96.0  90.0  82.0  75.5      |

 |           |                                                                    |

 |           |                                                                    |

 |7500 PPM   |   100.0  98.0  96.0  96.0  96.0  94.0  94.0  92.0  90.0  85.9      |

 |           |                                                                    |

 |           |                                                                    |

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

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

 |                           SURVIVAL SUMMARY STATISTICS                          |

 |                                                                                |

 |                                                                                |

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

 |                                                  DOSE                          |

 |                                                                                |

 |                                0 PPM        833 PPM      2500 PPM     7500 PPM |

 |                                                                                |

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

 |SURVIVAL AT END OF STUDY|       70.0%        84.0%        75.5%        85.9%    |

 |(KAPLAN-MEIER)          |                                                       |

 |                        |                                                       |

 |SIGNIFICANCE (B)        |       P=0.227N     P=0.175N     P=0.737N     P=0.117N |

 |(LIFE TABLE)            |                                                       |

 |                        |                                                       |

 |MEAN DAY OF             |       613.6        599.8        614.3        485.9    |

 |NATURAL DEATHS (C)      |       (31.9)       (27.3)       (20.4)       (84.6)   |

 |(STANDARD ERROR)        |                                                       |

 |                        |                                                       |

 |MEAN LIFE SPAN (D)      |       695.1        709.2        698.9        694.8    |

 |(STANDARD ERROR)        |       (12.1)       ( 8.0)       ( 8.5)       (16.4)   |

 |                        |                                                       |

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

                                    


       (A)  FIRST TERMINAL SACRIFICE

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

            SUBSEQUENT ENTRIES ARE THE RESULTS OF PAIRWISE TESTS

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

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

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

                                                    KAPLAN-MEIER SURVIVAL CURVES

                                                        0 PPM            = 1

                                                        833 PPM          = 2

                                                        2500 PPM         = 3

                                                        7500 PPM         = 4



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



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



      |

      |

  100 + 1  1                                                                    32

      |    1                                                                    322 34         1

      |                                                                           2 343       41       2       2 1     1

      |                                                                                       4 4                3  3  11

P  90 +                                                                                                        2 2  3   1   1

E     |                                                                                         4 4              22     3 3

R     |                                                                                           4 4             22    2 3 3

C     |                                                                                             4 4                 2   2

E  80 +                                                                                               4   4

N     |

T     |

      |                                                                                                   4  4

S  70 +

U     |

R     |                                                                                                      44

V     |                                                                                                       44

I  60 +                                                                                                        4 4

V     |                                                                                                          4   4

A     |

L     |                                                                                                              4 4

   50 +

      |                                                                                                                44

      |                                                                                                                 4   4

      |

   40 +

      |

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

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



                                                                   WEEK



NOTE: 13 obs hidden.
                                                           ANTHRAQUINONE

                                                    KAPLAN-MEIER SURVIVAL CURVES

                                                        0 PPM            = 1

                                                        833 PPM          = 2

                                                        2500 PPM         = 3

                                                        7500 PPM         = 4



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



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



      |

      |

  100 + 1                           4          1                                      32

      |

      |                             4 4        1                                      323  1

      |                               4                                             4   3  1   21 3

P  95 +

E     |                                                                             4          2  32  3

R     |                                                                                        41 12  33 2 4

C     |

E  90 +                                                                                           1    3 1 3  2     4

N     |

T     |                                                                                                  11   2     4 2 4

      |                                                                                                   11          224   4

S  85 +

U     |                                                                                                    13  1       2    2

R     |                                                                                                     3  1     13

V     |

I  80 +                                                                                                              1 1

V     |

A     |                                                                                                               3131

L     |

   75 +                                                                                                                 3   3

      |

      |

      |

   70 +                                                                                                                  1  1

      |

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

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



                                                                   WEEK



NOTE: 9 obs hidden.