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TDMS Study 05068-09 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Microbiological Assoc.                                     CODEINE                                        DATE: 04/02/96       
EXPERIMENT: 05068 TEST: 09                                                                                     TIME: 20:09:10       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-75178                              ROUTE: DOSED FEED                                              NTP C#: 61541B       
PATHOLOGIST: L. BRENNECKE                                                                                      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: 04/02/96      
EXPERIMENT: 05068 TEST: 09                                                                                     TIME: 20:09:10      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01-ES-75178                              ROUTE: DOSED FEED                                              NTP C#: 61541B      
PATHOLOGIST: L. BRENNECKE                                                                                      CAS: 76-57-3        
                                      CODEINE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 732 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0 PPM                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 21     CENSORED DEATHS 10   TERMINAL 29        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      203   334   446   449   495   500   525   554   567   599                 |
 |      601   636   643   652   657   662   670   681   684   700                 |
 |      720                                                                       |
 |  CENSORED DEATHS                                                               |
 |      455   455   455   455   455   455   455   455   455   455                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 400  PPM                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 30     CENSORED DEATHS 10   TERMINAL 20        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      336   404   426   549   574   586   608   615   615   624                 |
 |      627   632   641   651   651   657   658   678   678   679                 |
 |      684   684   693   695   701   706   707   711   720   729                 |
 |  CENSORED DEATHS                                                               |
 |      455   455   455   455   455   455   455   455   455   455                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 800 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 29     CENSORED DEATHS 10   TERMINAL 21        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      519   526   546   550   559   567   574   580   608   634                 |
 |      635   638   638   638   655   658   658   665   687   687                 |
 |      695   706   707   712   720   720   722   726   726                       |
 |  CENSORED DEATHS                                                               |
 |      455   455   455   455   455   455   455   455   455   455                 |
 |                                                                                |
 ==================================================================================
                                      CODEINE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 732 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 1600    PPM                              |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 30     CENSORED DEATHS 10   TERMINAL 20        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      355   383   484   530   537   543   544   550   559   571                 |
 |      582   585   594   603   621   659   659   670   670   683                 |
 |      687   700   701   705   705   708   715   729   730   731                 |
 |  CENSORED DEATHS                                                               |
 |      455   455   455   455   455   455   455   455   455   455                 |
 |                                                                                |
 ==================================================================================
                                      CODEINE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 732 DAYS

 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   732 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0 PPM      |   100.0 100.0  98.3  96.7  96.7  93.3  87.2  79.1  69.0  58.8      |
 |           |                                                                    |
 |           |                                                                    |
 |400  PPM   |   100.0 100.0 100.0  98.3  96.7  95.0  95.0  88.9  66.7  40.4      |
 |           |                                                                    |
 |           |                                                                    |
 |800 PPM    |   100.0 100.0 100.0 100.0 100.0 100.0  96.0  84.0  64.0  42.0      |
 |           |                                                                    |
 |           |                                                                    |
 |1600    PPM|   100.0 100.0 100.0  98.3  96.7  94.7  86.6  72.5  66.5  40.3      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                0 PPM        400  PPM     800 PPM      1600    P|M
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       58.8%        40.4%        42.0%        40.3%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.244      P=0.216      P=0.319      P=0.193  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       570.4        630.6        643.3        616.4    |
 |NATURAL DEATHS (C)      |       (28.5)       (17.2)       (12.3)       (18.0)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       629.3        635.2        643.0        628.1    |
 |(STANDARD ERROR)        |       (17.0)       (14.7)       (13.5)       (15.1)   |
 |                        |                                                       |
 ==================================================================================
                                    

       (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 RATS
                       FIRST TERMINAL SACRIFICE AT 733 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0 PPM                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 22     CENSORED DEATHS 10   TERMINAL 28        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      313   432   475   475   490   495   532   547   548   575                 |
 |      581   581   586   587   591   631   663   673   677   689                 |
 |      712   725                                                                 |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   456   456   456                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 400 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 12     CENSORED DEATHS 10   TERMINAL 38        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      400   479   540   546   606   681   689   689   705   707                 |
 |      712   731                                                                 |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   456   456   456                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 800 PPM                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 22     CENSORED DEATHS 9    TERMINAL 29        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      365   427   584   606   635   641   641   643   659   662                 |
 |      670   673   677   684   686   686   687   694   700   707                 |
 |      707   721                                                                 |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   456   456                       |
 |                                                                                |
 ==================================================================================
                                      CODEINE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 733 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 1600    PPM                              |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 19     CENSORED DEATHS 9    TERMINAL 32        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      383   444   473   617   624   631   638   645   664   684                 |
 |      691   698   701   702   714   718   719   720   725                       |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   456   456                       |
 |                                                                                |
 ==================================================================================
                                      CODEINE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 733 DAYS

 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   733 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0 PPM      |   100.0 100.0 100.0  98.3  98.3  92.6  86.6  70.5  66.5  56.4      |
 |           |                                                                    |
 |           |                                                                    |
 |400 PPM    |   100.0 100.0 100.0 100.0  98.3  96.3  94.3  92.3  90.3  76.3      |
 |           |                                                                    |
 |           |                                                                    |
 |800 PPM    |   100.0 100.0 100.0  98.3  98.3  96.7  96.7  94.7  80.9  57.2      |
 |           |                                                                    |
 |           |                                                                    |
 |1600    PPM|   100.0 100.0 100.0 100.0  98.3  94.7  94.7  94.7  82.9  63.1      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                0 PPM        400 PPM      800 PPM      1600    P|M
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       56.4%        76.3%        57.2%        63.1%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.782N     P=0.035N     P=0.718N     P=0.369N |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       571.7        623.8        643.4        641.6    |
 |NATURAL DEATHS (C)      |       (21.4)       (31.3)       (18.6)       (23.0)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       627.7        665.0        658.6        662.5    |
 |(STANDARD ERROR)        |       (15.8)       (14.7)       (14.0)       (14.4)   |
 |                        |                                                       |
 ==================================================================================
                                    

       (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)
                                                              CODEINE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0 PPM            = 1
                                                        400  PPM         = 2
                                                        800 PPM          = 3
                                                        1600    PPM      = 4

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

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

      |
      |
  100 + 1                               1                    2  4                          3
      |                                 1                    1  4    4  2  2  1      4     33
      |                                                                    2  1 1    4      3 32
      |                                                                         1     11    44 23 2
P  90 +                                                                                1   1 44 332 2   2
E     |                                                                                    1  44133     22
R     |                                                                                        41133    3
C     |                                                                                         414    132 23
E  80 +                                                                                           4 4  1   21
N     |                                                                                             4 4     11
T     |                                                                                               4 4    121
      |                                                                                                 4 4  3 3
S  70 +                                                                                                   4   21 11
U     |                                                                                                        2 4121
R     |                                                                                                        3 3   3
V     |                                                                                                           4 1 1
I  60 +                                                                                                            2231  1  1
V     |                                                                                                             2233
A     |                                                                                                              2233
L     |                                                                                                               2233
   50 +                                                                                                                44
      |                                                                                                                2233 4
      |                                                                                                                 22
      |                                                                                                                  23 2
   40 +                                                                                                                     2
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 40 obs hidden.
                                                              CODEINE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0 PPM            = 1
                                                        400 PPM          = 2
                                                        800 PPM          = 3
                                                        1600    PPM      = 4

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

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

      |
      |
  100 + 1                                                 1       3  4  2
      |                                                   1       3  4  2  31 4     2
      |
      |                                                                    31 4    12         2     3
   95 +                                                                            4                3   3 4
      |
      |                                                                            1 1        2         2 443
      |                                                                              11                    433
   90 +                                                                                                 2           2
      |                                                                               1     1               44      22
P     |
E     |                                                                                     1  1             44
R  85 +                                                                                                      34  3
C     |                                                                                                              2 2
E     |                                                                                        1   1             4  4
N     |                                                                                                          33 44
T  80 +                                                                                                                22
      |                                                                                                           33 44 2   2
S     |                                                                                                               44
U     |                                                                                            11                       2
R  75 +                                                                                                            33
V     |
I     |                                                                                             1 1                44
V     |                                                                                                                 44
A  70 +                                                                                               1     1
L     |                                                                                                     1    1  33
      |                                                                                                              33
      |                                                                                                          1 1
   65 +                                                                                                                  44
      |                                                                                                               33  4 4
      |                                                                                                            1 1
      |
   60 +                                                                                                              1  1
      |                                                                                                                3131
      |                                                                                                                  3  3
      |                                                                                                                   1 1
   55 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 7 obs hidden.