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TDMS Study 88050-06 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     

LAB: Battelle Columbus                                     METHACRYLONITRILE                                   DATE: 10/19/99       

EXPERIMENT: 88050 TEST: 06                                                                                     TIME: 12:52:11       

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

CONT: NO1-ES-55388                              ROUTE: GAVAGE                                                  NTP C#: 88050B       

PATHOLOGIST: TOFT, JOHN                                                                                        CAS: 126-98-7        

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

                                                                                                                                    

                                                      CORE STUDY MICE FINAL#1                                                       

                                                                                                                                    


               REASONS FOR REMOVAL:    ALL                                                                                          

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

               REMOVAL DATE RANGE:     ALL                                                                                          

                                                                                                                                    

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

LAB: Battelle Columbus                                     METHACRYLONITRILE                                   DATE: 10/19/99      

EXPERIMENT: 88050 TEST: 06                                                                                     TIME: 12:52:11      

TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       

CONT: NO1-ES-55388                              ROUTE: GAVAGE                                                  NTP C#: 88050B      

PATHOLOGIST: TOFT, JOHN                                                                                        CAS: 126-98-7       
                                 METHACRYLONITRILE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA

                                     MALE MICE

                       FIRST TERMINAL SACRIFICE AT 729 DAYS

                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)

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

 |                                DOSE = 0 MG/KG                                  |

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

 |                                                                                |

 |  TOTAL 50     UNCENSORED DEATHS 14     CENSORED DEATHS 1    TERMINAL 35        |

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      501   513   583   600   638   650   663   670   677   694                 |

 |      694   694   709   712                                                     |

 |  CENSORED DEATHS                                                               |

 |      73                                                                        |

 |                                                                                |

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

 |                          DOSE = 1.5     MG/KG                                  |

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

 |                                                                                |

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

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      563   605   625   625   629   644   714                                   |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

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

 |                                DOSE = 3 MG/KG                                  |

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

 |                                                                                |

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

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      429   439   502   612   655   694   703                                   |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

 ==================================================================================
                                 METHACRYLONITRILE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA

                                     MALE MICE

                       FIRST TERMINAL SACRIFICE AT 729 DAYS

                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)

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

 |                                DOSE = 6 MG/KG                                  |

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

 |                                                                                |

 |  TOTAL 50     UNCENSORED DEATHS 3      CENSORED DEATHS 25   TERMINAL 22        |

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      621   623   710                                                           |

 |  CENSORED DEATHS                                                               |

 |      3     481   481   481   481   481   481   481   481   481                 |

 |      481   481   481   481   481   481   481   481   481   481                 |

 |      481   481   481   481   481                                               |

 |                                                                                |

 ==================================================================================
                                 METHACRYLONITRILE


                       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 MG/KG    |   100.0 100.0 100.0 100.0 100.0 100.0  95.9  91.8  85.7  71.4      |

 |           |                                                                    |

 |           |                                                                    |

 |1.5        |   100.0 100.0 100.0 100.0 100.0 100.0 100.0  96.0  88.0  86.0      |

 |MG/KG      |                                                                    |

 |           |                                                                    |

 |3 MG/KG    |   100.0 100.0 100.0 100.0 100.0  96.0  94.0  94.0  90.0  86.0      |

 |           |                                                                    |

 |           |                                                                    |

 |6 MG/KG    |   100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0  92.0  88.0      |

 |           |                                                                    |

 |           |                                                                    |

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

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

 |                           SURVIVAL SUMMARY STATISTICS                          |

 |                                                                                |

 |                                                                                |

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

 |                                                  DOSE                          |

 |                                                                                |

 |                                0 MG/KG      1.5          3 MG/KG      6 MG/KG  |

 |                                             MG/KG                              |

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

 |SURVIVAL AT END OF STUDY|       71.4%        86.0%        86.0%        88.0%    |

 |(KAPLAN-MEIER)          |                                                       |

 |                        |                                                       |

 |SIGNIFICANCE (B)        |       P=0.099N     P=0.139N     P=0.143N     P=0.191N |

 |(LIFE TABLE)            |                                                       |

 |                        |                                                       |

 |MEAN DAY OF             |       642.7        629.3        576.3        651.3    |

 |NATURAL DEATHS (C)      |       (18.4)       (17.2)       (44.6)       (29.3)   |

 |(STANDARD ERROR)        |                                                       |

 |                        |                                                       |

 |MEAN LIFE SPAN (D)      |       691.7        715.0        707.6        590.8    |

 |(STANDARD ERROR)        |       (14.7)       ( 5.4)       ( 9.6)       (20.9)   |

 |                        |                                                       |

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

                                    


       (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)
                                 METHACRYLONITRILE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA

                                    FEMALE MICE

                       FIRST TERMINAL SACRIFICE AT 730 DAYS

                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)

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

 |                                DOSE = 0 MG/KG                                  |

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

 |                                                                                |

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

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      362   492   593   607   623   625   645   653   662   668                 |

 |      671   687   704   709   727                                               |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

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

 |                          DOSE = 1.5     MG/KG                                  |

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

 |                                                                                |

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

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      289   374   405   422   476   521   556   568   638   644                 |

 |      667   709   711   721   722                                               |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

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

 |                                DOSE = 3 MG/KG                                  |

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

 |                                                                                |

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

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      533   589   589   602   653   701   716                                   |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

 ==================================================================================
                                 METHACRYLONITRILE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA

                                    FEMALE MICE

                       FIRST TERMINAL SACRIFICE AT 730 DAYS

                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)

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

 |                                DOSE = 6 MG/KG                                  |

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

 |                                                                                |

 |  TOTAL 50     UNCENSORED DEATHS 10     CENSORED DEATHS 15   TERMINAL 25        |

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      212   308   343   581   641   641   673   694   703   714                 |

 |  CENSORED DEATHS                                                               |

 |      480   480   480   480   480   480   480   480   480   480                 |

 |      480   480   480   480   480                                               |

 |                                                                                |

 ==================================================================================
                                 METHACRYLONITRILE


                       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 MG/KG    |   100.0 100.0 100.0  98.0  98.0  98.0  96.0  94.0  82.0  70.0      |

 |           |                                                                    |

 |           |                                                                    |

 |1.5        |   100.0 100.0 100.0  98.0  92.0  90.0  88.0  84.0  80.0  70.0      |

 |MG/KG      |                                                                    |

 |           |                                                                    |

 |3 MG/KG    |   100.0 100.0 100.0 100.0 100.0 100.0  98.0  92.0  90.0  86.0      |

 |           |                                                                    |

 |           |                                                                    |

 |6 MG/KG    |   100.0 100.0  98.0  94.0  94.0  94.0  94.0  91.1  85.2  73.4      |

 |           |                                                                    |

 |           |                                                                    |

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

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

 |                           SURVIVAL SUMMARY STATISTICS                          |

 |                                                                                |

 |                                                                                |

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

 |                                                  DOSE                          |

 |                                                                                |

 |                                0 MG/KG      1.5          3 MG/KG      6 MG/KG  |

 |                                             MG/KG                              |

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

 |SURVIVAL AT END OF STUDY|       70.0%        70.0%        86.0%        73.4%    |

 |(KAPLAN-MEIER)          |                                                       |

 |                        |                                                       |

 |SIGNIFICANCE (B)        |       P=0.563N     P=1.000      P=0.097N     P=0.978N |

 |(LIFE TABLE)            |                                                       |

 |                        |                                                       |

 |MEAN DAY OF             |       628.5        561.5        626.1        551.0    |

 |NATURAL DEATHS (C)      |       (24.1)       (36.6)       (25.1)       (59.6)   |

 |(STANDARD ERROR)        |                                                       |

 |                        |                                                       |

 |MEAN LIFE SPAN (D)      |       699.6        679.5        715.5        619.2    |

 |(STANDARD ERROR)        |       ( 9.7)       (15.4)       ( 6.1)       (19.8)   |

 |                        |                                                       |

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

                                    


       (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)
                                                         METHACRYLONITRILE

                                                    KAPLAN-MEIER SURVIVAL CURVES

                                                        0 MG/KG          = 1

                                                        1.5     MG/KG    = 2

                                                        3 MG/KG          = 3

                                                        6 MG/KG          = 4



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



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



      |

      |

  100 + 1                                                                   3          1         2        4

      |

      |                                                                     33         1 1       2      2

      |                                                                      3         3 1          1   2  2

P  95 +

E     |                                                                                3            1  1 3

R     |                                                                                                  34    3        4

C     |                                                                                                1     1

E  90 +                                                                                                    2 113      3

N     |

T     |                                                                                                      21  1    332   4

      |                                                                                                          11    32   2

S  85 +

U     |                                                                                                           11

R     |

V     |                                                                                                            1  1

I  80 +

V     |

A     |

L     |

   75 +                                                                                                               1 1

      |

      |

      |                                                                                                                 1   1

   70 +

      |

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

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



                                                                   WEEK



NOTE: 6 obs hidden.
                                                         METHACRYLONITRILE

                                                    KAPLAN-MEIER SURVIVAL CURVES

                                                        0 MG/KG          = 1

                                                        1.5     MG/KG    = 2

                                                        3 MG/KG          = 3

                                                        6 MG/KG          = 4



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



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



      |

      |

  100 + 1                                 4           2          1                           3

      |

      |                                   4           2 4        1 2                  1      3        3

      |                                                 4     4    2    2             1               1

P  95 +

E     |                                                       4         2  2                       4  131

R     |                                                                    2       2                   31 1    3

C     |                                                                                            4         4

E  90 +                                                                            2       2              11   3       3

N     |

T     |                                                                                    2    2          1  1        3 3

      |                                                                                         2 2           11         3  3

S  85 +                                                                                                      4     4

U     |                                                                                           2          2 1 1

R     |                                                                                                          114  4

V     |

I  80 +                                                                                                      2    2

V     |                                                                                                               44

A     |                                                                                                           1  1  2

L     |                                                                                                              1 14

   75 +

      |                                                                                                                112  4

      |                                                                                                                 121

      |

   70 +                                                                                                                   1 1

      |

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

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



                                                                   WEEK



NOTE: 11 obs hidden.