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TDMS Study 88032-05 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Battelle Columbus                                        OXYMETHOLONE                                     DATE: 11/24/97       
EXPERIMENT: 88032 TEST: 05                                                                                     TIME: 11:36:10       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1-ES-05295                              ROUTE: GAVAGE                                                  NTP C#: 88032B       
PATHOLOGIST: YARRINGTON, J.                                                                                    CAS: 434-07-01       
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                             CORE STUDY                                                             
                                                                                                                                    

               REASONS FOR REMOVAL:    25018 Dosing Accident                                                                        
                                       25019 Moribund Sacrifice                                                                     
                                       25020 Natural Death                                                                          
                                       25026 Other                                                                                  
                                       25021 Terminal Sacrifice                                                                     
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11    
LAB: Battelle Columbus                                        OXYMETHOLONE                                     DATE: 11/24/97      
EXPERIMENT: 88032 TEST: 05                                                                                     TIME: 11:36:10      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: NO1-ES-05295                              ROUTE: GAVAGE                                                  NTP C#: 88032B      
PATHOLOGIST: YARRINGTON, J.                                                                                    CAS: 434-07-01      
                                   OXYMETHOLONE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 728 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0 MG/KG                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 51     UNCENSORED DEATHS 36     CENSORED DEATHS 0    TERMINAL 15        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      316   366   384   429   464   471   479   486   486   519                 |
 |      524   549   549   553   589   591   596   600   605   611                 |
 |      611   633   646   646   654   654   657   660   666   692                 |
 |      702   706   707   714   716   720                                         |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 3 MG/KG                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 34     CENSORED DEATHS 1    TERMINAL 15        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      202   321   408   424   479   485   485   499   561   563                 |
 |      588   597   598   600   618   622   629   659   675   675                 |
 |      679   692   692   693   703   703   706   706   707   709                 |
 |      709   714   718   720                                                     |
 |  CENSORED DEATHS                                                               |
 |      146                                                                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 30 MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 36     CENSORED DEATHS 0    TERMINAL 14        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      281   353   437   517   527   538   564   577   597   601                 |
 |      605   609   622   629   640   644   644   653   666   666                 |
 |      669   680   681   692   693   696   700   703   703   705                 |
 |      706   707   716   719   720   727                                         |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                                   OXYMETHOLONE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 728 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = 150     MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 27     CENSORED DEATHS 3    TERMINAL 20        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      34    114   115   434   551   561   563   563   577   611                 |
 |      629   636   639   641   644   646   659   660   666   675                 |
 |      675   688   703   708   712   715   724                                   |
 |  CENSORED DEATHS                                                               |
 |      80    116   145                                                           |
 |                                                                                |
 ==================================================================================
                                   OXYMETHOLONE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 728 DAYS

 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   728 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0 MG/KG    |   100.0 100.0 100.0  98.0  94.1  86.3  78.4  62.7  45.1  29.4      |
 |           |                                                                    |
 |           |                                                                    |
 |3 MG/KG    |   100.0 100.0  98.0  95.9  91.8  85.7  83.7  71.4  63.3  30.6      |
 |           |                                                                    |
 |           |                                                                    |
 |30 MG/KG   |   100.0 100.0 100.0  96.0  96.0  94.0  88.0  78.0  64.0  28.0      |
 |           |                                                                    |
 |           |                                                                    |
 |150        |    98.0  93.9  93.9  93.9  93.9  91.8  91.8  81.1  61.9  42.7      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                0 MG/KG      3 MG/KG      30 MG/KG     150      |
 |                                                                       MG/KG    |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       29.4%        30.6%        28.0%        42.7%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.150N     P=0.631N     P=0.670N     P=0.141N |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       582.0        604.1        627.4        575.7    |
 |NATURAL DEATHS (C)      |       (17.8)       (21.7)       (17.0)       (36.1)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       624.9        632.1        655.6        608.9    |
 |(STANDARD ERROR)        |       (15.7)       (19.5)       (13.8)       (28.3)   |
 |                        |                                                       |
 ==================================================================================
                                    

       (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)
                                   OXYMETHOLONE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 728 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0 MG/KG                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 24     CENSORED DEATHS 1    TERMINAL 25        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      478   478   506   533   540   543   548   549   561   562                 |
 |      566   573   574   589   621   625   678   684   693   705                 |
 |      706   707   707   708                                                     |
 |  CENSORED DEATHS                                                               |
 |      573                                                                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 3 MG/KG                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 21     CENSORED DEATHS 0    TERMINAL 29        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      299   501   523   537   556   562   576   579   582   590                 |
 |      639   646   652   652   665   670   691   702   705   711                 |
 |      725                                                                       |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 30 MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 19     CENSORED DEATHS 1    TERMINAL 30        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      229   441   478   478   497   560   561   638   653   659                 |
 |      665   670   671   674   693   693   698   708   713                       |
 |  CENSORED DEATHS                                                               |
 |      118                                                                       |
 |                                                                                |
 ==================================================================================
                                   OXYMETHOLONE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 728 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = 100     MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 18     CENSORED DEATHS 1    TERMINAL 31        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      387   394   490   510   511   539   562   625   659   659                 |
 |      659   663   674   680   695   704   713   725                             |
 |  CENSORED DEATHS                                                               |
 |      177                                                                       |
 |                                                                                |
 ==================================================================================
                                   OXYMETHOLONE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 728 DAYS

 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   728 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0 MG/KG    |   100.0 100.0 100.0 100.0 100.0  96.0  88.0  71.9  67.8  51.4      |
 |           |                                                                    |
 |           |                                                                    |
 |3 MG/KG    |   100.0 100.0 100.0  98.0  98.0  98.0  92.0  80.0  70.0  58.0      |
 |           |                                                                    |
 |           |                                                                    |
 |30 MG/KG   |   100.0 100.0  98.0  98.0  98.0  91.8  89.8  85.7  77.6  61.2      |
 |           |                                                                    |
 |           |                                                                    |
 |100        |   100.0 100.0 100.0 100.0  95.9  95.9  87.8  85.7  75.5  63.3      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                0 MG/KG      3 MG/KG      30 MG/KG     100      |
 |                                                                       MG/KG    |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       51.4%        58.0%        61.2%        63.3%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.365N     P=0.545N     P=0.392N     P=0.296N |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       601.4        607.8        598.9        602.7    |
 |NATURAL DEATHS (C)      |       (16.0)       (21.3)       (28.9)       (25.3)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       664.1        677.5        666.7        671.9    |
 |(STANDARD ERROR)        |       (11.9)       (12.2)       (17.9)       (16.0)   |
 |                        |                                                       |
 ==================================================================================
                                    

       (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)
                                                            OXYMETHOLONE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0 MG/KG          = 1
                                                        3 MG/KG          = 2
                                                        30 MG/KG         = 3
                                                        150     MG/KG    = 4

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

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

      |
      |
  100 + 1     4                         2            3     1
      |       4            4            2            3     1    3 1
      |                    4                               2    3 1  1   2 213           3
      |                                                                    21     1 2    3  3  4
   90 +                                                                           1122      33 4 4
      |                                                                            111       3   3
      |                                                                              2 2         3 3   3
      |                                                                              1 2   1     2 4
P  80 +                                                                                          2 42  334 4
E     |                                                                                    1   1    2  2   44
R     |                                                                                                 3 3344
C     |                                                                                        1      12  23 3
E  70 +
N     |                                                                                               11  22 44
T     |                                                                                                11  2 343 23
      |                                                                                                 11       242
S  60 +                                                                                                  1  1     44
U     |                                                                                                     1 1   3232
R     |                                                                                                            433
V     |                                                                                                       11     4 4
I  50 +                                                                                                              2324
V     |                                                                                                        1 1      44
A     |                                                                                                          11   33 44
L     |                                                                                                           1  1    4
   40 +                                                                                                              1 12
      |
      |                                                                                                                112
      |                                                                                                                 11
   30 +                                                                                                                  11
      |                                                                                                                   3
      |
      |
   20 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 28 obs hidden.
                                                            OXYMETHOLONE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0 MG/KG          = 1
                                                        3 MG/KG          = 2
                                                        30 MG/KG         = 3
                                                        100     MG/KG    = 4

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

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

      |
  100 + 1                                   3          2              4             1
      |
      |                                     3          2              44     3         2
      |                                                                4     3      14 21  2
   95 +
      |                                                                              4  1  2 1
      |                                                                                      11 2
      |                                                                             3 3
   90 +                                                                               3 4    4  22
      |
      |                                                                                      41132 2
      |                                                                                          3         4 3
P  85 +
E     |                                                                                        1 1 22      4 3 3 4
R     |                                                                                             2 2
C     |                                                                                                        3 3
E  80 +                                                                                               2      2
N     |
T     |                                                                                          11          22  33
      |                                                                                                       22
S  75 +                                                                                                          4 4
U     |                                                                                           1   1           334
R     |                                                                                               1   1    2 2
V     |                                                                                                            3434
I  70 +                                                                                                   11     22   44
V     |
A     |                                                                                                    1      21 2344
L     |                                                                                                            112 2
   65 +                                                                                                               3 3 4
      |                                                                                                             11    4
      |                                                                                                                22
      |                                                                                                              1 13 3
   60 +                                                                                                                 2 2
      |
      |                                                                                                                   2
      |
   55 +
      |                                                                                                                11
      |
      |                                                                                                                 1 1
   50 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 14 obs hidden.