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TDMS Study 05205-08 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     

LAB: Southern Research Inst                                  P-NITROTOLUENE                                    DATE: 02/08/00       

EXPERIMENT: 05205 TEST: 08                                                                                     TIME: 09:36:03       

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

CONT: N01-ES-55393                              ROUTE: DOSED FEED                                              NTP C#: 62537D       

PATHOLOGIST: FARNELL, D.                                                                                       CAS: 99-99-0         

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                                                   FINAL#1 CHRONIC STUDY FOR MICE                                                   

                                                                                                                                    


               REASONS FOR REMOVAL:    ALL                                                                                          

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

               REMOVAL DATE RANGE:     ALL                                                                                          

                                                                                                                                    

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

LAB: Southern Research Inst                                  P-NITROTOLUENE                                    DATE: 02/08/00      

EXPERIMENT: 05205 TEST: 08                                                                                     TIME: 09:36:03      

TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       

CONT: N01-ES-55393                              ROUTE: DOSED FEED                                              NTP C#: 62537D      

PATHOLOGIST: FARNELL, D.                                                                                       CAS: 99-99-0        
                                  P-NITROTOLUENE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA

                                     MALE MICE

                       FIRST TERMINAL SACRIFICE AT 729 DAYS

                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)

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

 |                                DOSE = 0       PPM                              |

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

 |                                                                                |

 |  TOTAL 50     UNCENSORED DEATHS 4      CENSORED DEATHS 0    TERMINAL 46        |

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      453   665   717   721                                                     |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

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

 |                                DOSE = 1250    PPM                              |

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

 |                                                                                |

 |  TOTAL 50     UNCENSORED DEATHS 4      CENSORED DEATHS 0    TERMINAL 46        |

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      280   689   711   715                                                     |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

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

 |                                DOSE = 2500    PPM                              |

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

 |                                                                                |

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

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      597   597   625   689   693                                               |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

 ==================================================================================
                                  P-NITROTOLUENE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA

                                     MALE MICE

                       FIRST TERMINAL SACRIFICE AT 729 DAYS

                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)

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

 |                                DOSE = 5000    PPM                              |

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

 |                                                                                |

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

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      505   585   597   625   681   689   714   721                             |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

 ==================================================================================
                                  P-NITROTOLUENE


                       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|   100.0 100.0 100.0 100.0 100.0  98.0  98.0  98.0  96.0  92.0      |

 |           |                                                                    |

 |           |                                                                    |

 |1250    PPM|   100.0 100.0 100.0  98.0  98.0  98.0  98.0  98.0  98.0  92.0      |

 |           |                                                                    |

 |           |                                                                    |

 |2500    PPM|   100.0 100.0 100.0 100.0 100.0 100.0 100.0  96.0  94.0  90.0      |

 |           |                                                                    |

 |           |                                                                    |

 |5000    PPM|   100.0 100.0 100.0 100.0 100.0 100.0  98.0  94.0  92.0  84.0      |

 |           |                                                                    |

 |           |                                                                    |

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

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

 |                           SURVIVAL SUMMARY STATISTICS                          |

 |                                                                                |

 |                                                                                |

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

 |                                                  DOSE                          |

 |                                                                                |

 |                                0       PPM  1250    PPM  2500    PPM  5000    P|M

 |                                                                                |

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

 |SURVIVAL AT END OF STUDY|       92.0%        92.0%        90.0%        84.0%    |

 |(KAPLAN-MEIER)          |                                                       |

 |                        |                                                       |

 |SIGNIFICANCE (B)        |       P=0.187      P=1.000      P=0.974      P=0.341  |

 |(LIFE TABLE)            |                                                       |

 |                        |                                                       |

 |MEAN DAY OF             |       639.0        598.8        640.2        639.6    |

 |NATURAL DEATHS (C)      |       (63.3)       ( 106)       (21.4)       (26.5)   |

 |(STANDARD ERROR)        |                                                       |

 |                        |                                                       |

 |MEAN LIFE SPAN (D)      |       721.8        718.6        720.1        714.7    |

 |(STANDARD ERROR)        |       ( 5.6)       ( 9.0)       ( 4.3)       ( 6.2)   |

 |                        |                                                       |

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

                                    


       (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)
                                  P-NITROTOLUENE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA

                                    FEMALE MICE

                       FIRST TERMINAL SACRIFICE AT 729 DAYS

                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)

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

 |                                DOSE = 0       PPM                              |

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

 |                                                                                |

 |  TOTAL 50     UNCENSORED DEATHS 4      CENSORED DEATHS 0    TERMINAL 46        |

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      629   654   682   707                                                     |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

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

 |                                DOSE = 1250    PPM                              |

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

 |                                                                                |

 |  TOTAL 50     UNCENSORED DEATHS 3      CENSORED DEATHS 0    TERMINAL 47        |

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      487   664   680                                                           |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

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

 |                                DOSE = 2500    PPM                              |

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

 |                                                                                |

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

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      456   534   625   669   682   714   716                                   |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

 ==================================================================================
                                  P-NITROTOLUENE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA

                                    FEMALE MICE

                       FIRST TERMINAL SACRIFICE AT 729 DAYS

                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)

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

 |                                DOSE = 5000    PPM                              |

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

 |                                                                                |

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

 |                                                                                |

 |  UNCENSORED DEATHS                                                             |

 |      276                                                                       |

 |  CENSORED DEATHS                                                               |

 |      NONE                                                                      |

 |                                                                                |

 ==================================================================================
                                  P-NITROTOLUENE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA

                                    FEMALE 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|   100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0  96.0  92.0      |

 |           |                                                                    |

 |           |                                                                    |

 |1250    PPM|   100.0 100.0 100.0 100.0 100.0 100.0  98.0  98.0  96.0  94.0      |

 |           |                                                                    |

 |           |                                                                    |

 |2500    PPM|   100.0 100.0 100.0 100.0 100.0  98.0  96.0  96.0  94.0  86.0      |

 |           |                                                                    |

 |           |                                                                    |

 |5000    PPM|   100.0 100.0 100.0  98.0  98.0  98.0  98.0  98.0  98.0  98.0      |

 |           |                                                                    |

 |           |                                                                    |

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

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

 |                           SURVIVAL SUMMARY STATISTICS                          |

 |                                                                                |

 |                                                                                |

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

 |                                                  DOSE                          |

 |                                                                                |

 |                                0       PPM  1250    PPM  2500    PPM  5000    P|M

 |                                                                                |

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

 |SURVIVAL AT END OF STUDY|       92.0%        94.0%        86.0%        98.0%    |

 |(KAPLAN-MEIER)          |                                                       |

 |                        |                                                       |

 |SIGNIFICANCE (B)        |       P=0.452N     P=1.000N     P=0.509      P=0.366N |

 |(LIFE TABLE)            |                                                       |

 |                        |                                                       |

 |MEAN DAY OF             |       668.0        610.3        628.0        276.0    |

 |NATURAL DEATHS (C)      |       (16.9)       (61.8)       (37.2)       (  . )   |

 |(STANDARD ERROR)        |                                                       |

 |                        |                                                       |

 |MEAN LIFE SPAN (D)      |       724.1        721.9        714.9        719.9    |

 |(STANDARD ERROR)        |       ( 2.6)       ( 5.1)       ( 7.0)       ( 9.1)   |

 |                        |                                                       |

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

                                    


       (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)
                                                           P-NITROTOLUENE

                                                    KAPLAN-MEIER SURVIVAL CURVES

                                                        0       PPM      = 1

                                                        1250    PPM      = 2

                                                        2500    PPM      = 3

                                                        5000    PPM      = 4



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



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



      |

      |

  100 + 1                                           2                           1       4              3

      |

      |

      |

   98 +                                             2                           1       4           4            1   2

      |

      |

      |

P  96 +                                                                                             4  3   3     1   2  21

E     |

R     |

C     |

E  94 +                                                                                                4   3         3  22

N     |

T     |

      |

S  92 +                                                                                                    4        4    1  1

U     |

R     |

V     |

I  90 +                                                                                                             43      3

V     |

A     |

L     |

   88 +                                                                                                              4  4

      |

      |

      |

   86 +                                                                                                                 44

      |

      |

      |

   84 +                                                                                                                  4  4

      |

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

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



                                                                   WEEK



NOTE: 8 obs hidden.
                                                           P-NITROTOLUENE

                                                    KAPLAN-MEIER SURVIVAL CURVES

                                                        0       PPM      = 1

                                                        1250    PPM      = 2

                                                        2500    PPM      = 3

                                                        5000    PPM      = 4



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



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



      |

      |

  100 + 1                                           4                            3   2                     1

      |

      |

      |

   98 +                                             4                            3   2       3             1   1 2          4

      |

P     |

E     |

R  96 +                                                                                      3             3   1 2  1

C     |

E     |

N     |

T  94 +                                                                                                    3      3 1  1    2

      |

S     |

U     |

R  92 +                                                                                                           3 3  1    1

V     |

I     |

V     |

A  90 +                                                                                                             3   3

L     |

      |

      |

   88 +                                                                                                                 33

      |

      |

      |

   86 +                                                                                                                  3  3

      |

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

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



                                                                   WEEK



NOTE: 5 obs hidden.

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