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TDMS Study 05068-10 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Microbiological Assoc.                                     CODEINE                                        DATE: 04/03/96       
EXPERIMENT: 05068 TEST: 10                                                                                     TIME: 02:01:06       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-75178                              ROUTE: DOSED FEED                                              NTP C#: 61541B       
PATHOLOGIST: MISSING                                                                                           CAS: 76-57-3         
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               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11    
LAB: Microbiological Assoc.                                     CODEINE                                        DATE: 04/03/96      
EXPERIMENT: 05068 TEST: 10                                                                                     TIME: 02:01:06      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01-ES-75178                              ROUTE: DOSED FEED                                              NTP C#: 61541B      
PATHOLOGIST: MISSING                                                                                           CAS: 76-57-3        
                                      CODEINE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 729 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0 PPM                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 9      CENSORED DEATHS 10   TERMINAL 41        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      227   450   497   546   579   609   629   689   693                       |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   456   456   456                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 750 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 11     CENSORED DEATHS 11   TERMINAL 38        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      8     396   474   559   566   603   622   633   697   716                 |
 |      725                                                                       |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   456   456   456                 |
 |      724                                                                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 1500 PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 5      CENSORED DEATHS 10   TERMINAL 45        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      9     635   667   718   727                                               |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   456   456   456                 |
 |                                                                                |
 ==================================================================================
                                      CODEINE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 729 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 3000 PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 7      CENSORED DEATHS 10   TERMINAL 43        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      9     401   500   537   652   697   726                                   |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   456   456   456                 |
 |                                                                                |
 ==================================================================================
                                      CODEINE

                       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  98.3  98.3  98.3  96.7  94.7  90.6  86.6  82.6      |
 |           |                                                                    |
 |           |                                                                    |
 |750 PPM    |    98.3  98.3  98.3  98.3  96.7  94.7  94.7  88.6  84.6  78.5      |
 |           |                                                                    |
 |           |                                                                    |
 |1500 PPM   |    98.3  98.3  98.3  98.3  98.3  98.3  98.3  98.3  96.3  90.3      |
 |           |                                                                    |
 |           |                                                                    |
 |3000 PPM   |    98.3  98.3  98.3  98.3  96.7  96.7  92.6  92.6  90.6  86.6      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                0 PPM        750 PPM      1500 PPM     3000 PPM |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       82.6%        78.5%        90.3%        86.6%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.417N     P=0.810      P=0.350N     P=0.766N |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       546.6        545.4        551.2        503.1    |
 |NATURAL DEATHS (C)      |       (48.2)       (61.6)       ( 137)       (93.2)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       656.1        649.8        668.7        657.2    |
 |(STANDARD ERROR)        |       (15.9)       (18.1)       (17.3)       (18.1)   |
 |                        |                                                       |
 ==================================================================================
                                    

       (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)
                                      CODEINE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 731 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0 PPM                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 14     CENSORED DEATHS 10   TERMINAL 36        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      9     272   497   530   544   565   570   582   591   651                 |
 |      659   695   713   722                                                     |
 |  CENSORED DEATHS                                                               |
 |      457   457   457   457   457   457   457   457   457   457                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 750 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 15     CENSORED DEATHS 9    TERMINAL 36        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      8     8     348   359   388   479   512   539   616   625                 |
 |      633   647   664   672   677                                               |
 |  CENSORED DEATHS                                                               |
 |      457   457   457   457   457   457   457   457   457                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 1500 PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 8      CENSORED DEATHS 9    TERMINAL 43        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      8     323   329   643   703   724   727   727                             |
 |  CENSORED DEATHS                                                               |
 |      457   457   457   457   457   457   457   457   457                       |
 |                                                                                |
 ==================================================================================
                                      CODEINE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 731 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 3000 PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 15     CENSORED DEATHS 10   TERMINAL 35        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      8     8     397   506   556   598   619   631   680   711                 |
 |      711   720   722   727   728                                               |
 |  CENSORED DEATHS                                                               |
 |      430   457   457   457   457   457   457   457   457   457                 |
 |                                                                                |
 ==================================================================================
                                      CODEINE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 731 DAYS

 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   731 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0 PPM      |    98.3  98.3  98.3  96.7  96.7  96.7  90.6  82.6  78.5  72.5      |
 |           |                                                                    |
 |           |                                                                    |
 |750 PPM    |    96.7  96.7  96.7  93.3  91.7  89.7  85.7  85.7  75.7  71.7      |
 |           |                                                                    |
 |           |                                                                    |
 |1500 PPM   |    98.3  98.3  98.3  95.0  95.0  95.0  95.0  95.0  93.0  85.1      |
 |           |                                                                    |
 |           |                                                                    |
 |3000 PPM   |    96.7  96.7  96.7  96.7  95.0  95.0  93.0  88.9  84.9  70.7      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                0 PPM        750 PPM      1500 PPM     3000 PPM |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       72.5%        71.7%        85.1%        70.7%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.979N     P=0.945      P=0.185N     P=1.000  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       542.9        478.3        523.0        554.8    |
 |NATURAL DEATHS (C)      |       (51.1)       (57.4)       (95.7)       (62.4)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       641.4        626.7        662.2        640.8    |
 |(STANDARD ERROR)        |       (18.7)       (21.7)       (18.8)       (21.0)   |
 |                        |                                                       |
 ==================================================================================
                                    

       (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)
                                                              CODEINE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0 PPM            = 1
                                                        750 PPM          = 2
                                                        1500 PPM         = 3
                                                        3000 PPM         = 4

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

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

        |
        |
  100.0 +1 2                                 1
        |
        |
        |  2                                 1                          24       1                           3
   97.5 +
        |                                                               24       1  2  14
        |                                                                                                    3     3
        |
   95.0 +
        |                                                                           2  14     41 2                 3      3
P       |
E       |
R  92.5 +                                                                                     41 22 1           4         33
C       |
E       |
N       |                                                                                         2 1    1      4      4
T  90.0 +                                                                                                                  3 3
        |
S       |                                                                                                1 21          4   4
U       |
R  87.5 +
V       |                                                                                                  212        1    4 4
I       |
V       |
A  85.0 +
L       |                                                                                                    2         2
        |
        |
   82.5 +                                                                                                             12  2  1
        |
        |
        |                                                                                                                 22
   80.0 +
        |
        |                                                                                                                  2 2
        |
   77.5 +
        |
        -+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-
         0         10         20         30         40         50         60         70         80         90         100        110

                                                                    WEEK

NOTE: 9 obs hidden.
                                                              CODEINE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0 PPM            = 1
                                                        750 PPM          = 2
                                                        1500 PPM         = 3
                                                        3000 PPM         = 4

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

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

      |
      |
  100 + 1 1
      |   1                                        1        3
      |
      |   2                                        1           2       4              1
P  95 +                                                     3  2 2     4              1 4   1                3
E     |                                                          2    2
R     |                                                                                 4   1 1 4            3         3
C     |                                                               2             2         1 41     4               3  3
E  90 +                                                                             2    2
N     |                                                                                          11    4  4
T     |                                                                                  2   2            4 4
      |                                                                                      2    1 1    2
S  85 +                                                                                             1 1     4       4     3 3
U     |                                                                                                  2 2
R     |                                                                                               1       1     4   4
V     |                                                                                                    22
I  80 +                                                                                                     2 1  1
V     |                                                                                                          1    1 44
A     |                                                                                                       2  2
L     |                                                                                                          22   1 144
   75 +                                                                                                                 1 1
      |                                                                                                           22
      |                                                                                                                   1 1
      |                                                                                                            2      4 2
   70 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 10 obs hidden.