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TDMS Study 05044-01 Pathology Tables

NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11 
LAB: Battelle Columbus                                         DATE: 09/06/94   
EXP: 05044             4-VINYL-1-CYCLOHEXENE DIEPOXIDE         TIME: 11:49:18   
TEST: 01              CAGES FROM 0000 TO LAST CAGE             PAGE:   1        
TEST TYPE: CHRONIC          ROUTE: DERMAL,SOLUTION             NTP C#: 60139A   
CONT: N01-CP-95653                                             CAS: 106-87-6    
PATHOLOGIST: S. GRUMBEIN                     S. EUSTIS                          
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REASONS FOR REMOVAL:                                                            
                                                                                
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REMOVAL DATE RANGE:                                                             


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TREATMENT GROUPS:                                                               
                                                                                
INCLUDE ALL                                                                     

NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11
LAB: Battelle Columbus                                         DATE: 09/06/94  
EXP: 05044             4-VINYL-1-CYCLOHEXENE DIEPOXIDE         TIME: 11:49:18  
TEST: 01              CAGES FROM 0000 TO LAST CAGE                             
TEST TYPE: CHRONIC          ROUTE: DERMAL,SOLUTION             NTP C#: 60139A  
CONT: N01-CP-95653                                             CAS: 106-87-6   
PATHOLOGIST: S. GRUMBEIN                     S. EUSTIS                         

                          4-VINYL-1-CYCLOHEXENE DIEPOXIDE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 743 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0 MG/ML                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 43     CENSORED DEATHS 10   TERMINAL 7         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      379   458   458   470   504   509   509   525   536   542                 |
 |      548   548   550   571   582   584   585   591   596   602                 |
 |      602   607   607   608   619   619   620   647   667   669                 |
 |      669   673   673   682   682   682   685   690   696   707                 |
 |      712   730   736                                                           |
 |  CENSORED DEATHS                                                               |
 |      458   458   458   458   458   459   459   459   459   459                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 50 MG/ML                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 42     CENSORED DEATHS 10   TERMINAL 8         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      79    373   387   389   404   427   467   489   538   538                 |
 |      542   569   571   576   596   609   611   613   626   638                 |
 |      642   642   647   662   668   674   674   675   676   676                 |
 |      688   689   689   689   695   704   712   718   722   730                 |
 |      736   736                                                                 |
 |  CENSORED DEATHS                                                               |
 |      458   458   458   458   458   458   459   459   459   459                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 100 MG/ ML                               |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 45     CENSORED DEATHS 11   TERMINAL 4         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      242   350   394   441   478   543   548   550   550   558                 |
 |      568   568   577   590   591   591   593   595   609   609                 |
 |      612   612   612   613   618   628   629   635   638   642                 |
 |      659   662   665   668   668   668   684   685   686   687                 |
 |      691   691   718   725   740                                               |
 |  CENSORED DEATHS                                                               |
 |      458   458   458   458   458   459   459   459   459   459                 |
 |      503                                                                       |
 |                                                                                |
 ==================================================================================

                          4-VINYL-1-CYCLOHEXENE DIEPOXIDE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 743 DAYS


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   743 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0 MG/ML    |   100.0 100.0 100.0 100.0  98.3  93.0  80.9  58.6  44.5  14.1      |
 |           |                                                                    |
 |           |                                                                    |
 |50 MG/ML   |    98.3  98.3  98.3  98.3  91.7  88.0  79.8  71.6  53.2  16.4      |
 |           |                                                                    |
 |           |                                                                    |
 |100 MG/ ML |   100.0 100.0  98.3  96.7  95.0  91.3  89.2  64.3  33.2   8.3      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                    DOSE                        |
 |                                                                                |
 |                                0 MG/ML          50 MG/ML         100 MG/ ML    |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       14.1%            16.4%             8.3%         |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.524          P=0.487N         P=0.590       |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       603.0            599.7            601.8         |
 |NATURAL DEATHS (C)      |       (12.6)           (20.4)           (14.5)        |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       595.3            595.2            585.7         |
 |(STANDARD ERROR)        |       (13.3)           (17.5)           (14.0)        |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                          4-VINYL-1-CYCLOHEXENE DIEPOXIDE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 743 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0 MG/ML                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 23     CENSORED DEATHS 10   TERMINAL 27        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      226   383   425   586   602   604   609   609   626   635                 |
 |      646   662   677   698   698   714   715   719   721   725                 |
 |      725   729   736                                                           |
 |  CENSORED DEATHS                                                               |
 |      458   458   458   458   458   459   459   459   459   459                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 50 MG/ML                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 27     CENSORED DEATHS 10   TERMINAL 23        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      166   410   471   487   534   542   571   572   584   591                 |
 |      600   602   608   609   612   613   618   619   625   637                 |
 |      638   656   661   670   676   718   739                                   |
 |  CENSORED DEATHS                                                               |
 |      458   458   458   458   459   459   459   459   459   459                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 100 MG/ ML                               |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 35     CENSORED DEATHS 10   TERMINAL 15        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      396   403   404   410   460   494   508   519   524   542                 |
 |      562   564   601   612   619   620   620   635   640   648                 |
 |      648   654   661   670   675   676   681   684   689   689                 |
 |      690   694   695   696   698                                               |
 |  CENSORED DEATHS                                                               |
 |      458   458   458   458   458   459   459   459   459   459                 |
 |                                                                                |
 ==================================================================================

                          4-VINYL-1-CYCLOHEXENE DIEPOXIDE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 743 DAYS


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   743 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0 MG/ML    |   100.0 100.0  98.3  98.3  95.0  95.0  95.0  88.9  76.8  54.6      |
 |           |                                                                    |
 |           |                                                                    |
 |50 MG/ML   |   100.0  98.3  98.3  98.3  96.7  94.7  88.6  76.5  54.4  46.3      |
 |           |                                                                    |
 |           |                                                                    |
 |100 MG/ ML |   100.0 100.0 100.0 100.0  93.3  91.3  81.2  75.1  54.8  30.4      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                    DOSE                        |
 |                                                                                |
 |                                0 MG/ML          50 MG/ML         100 MG/ ML    |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       54.6%            46.3%            30.4%         |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.007          P=0.262          P=0.005       |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       629.1            586.3            599.5         |
 |NATURAL DEATHS (C)      |       (26.4)           (21.1)           (16.4)        |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       651.9            625.1            611.9         |
 |(STANDARD ERROR)        |       (16.5)           (16.4)           (15.2)        |
 |                        |                                                       |
 ==================================================================================
                                    


       (A)  FIRST TERMINAL SACRIFICE
       (B)  THE FIRST ENTRY IS THE TREND TEST (TARONE, 1975) RESULT.
            SUBSEQUENT ENTRIES ARE THE RESULTS OF PAIRWISE TESTS
            (COX,1972).  NEGATIVE TRENDS ARE INDICATED BY "N".
       (C)  MEAN OF ALL UNCENSORED DEATHS PRIOR TO TERMINAL SACRIFICE
       (D)  MEAN OF ALL DEATHS (UNCENSORED, CENSORED, TERMINAL SACRIFICE)

                                                  4-VINYL-1-CYCLOHEXENE DIEPOXIDE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0 MG/ML          = 1
                                                        50 MG/ML         = 2
                                                        100 MG/ ML       = 3

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

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

      |
      |
  100 + 1            2                         3                     1
      |              2                         3               3   2 123         1
      |                                                                3     3   1 1
      |                                                               2 2  2 3     13  1      3
   90 +                                                                    2      2    11     33
      |                                                                           2  2  1  1
      |                                                                              2     1 1
      |                                                                                      1133
   80 +                                                                                       113 2
      |                                                                                           33
      |                                                                                        1  12  3
      |                                                                                           121  22
P  70 +                                                                                                 22
E     |                                                                                             1 1
R     |                                                                                               1132 2
C     |                                                                                                    2 2
E  60 +                                                                                                 33
N     |                                                                                                11    22
T     |                                                                                                       2  2
      |                                                                                                 131      22
S  50 +                                                                                                   33      22
U     |                                                                                                   1   1
R     |                                                                                                    33 1   1
V     |                                                                                                     33
I  40 +                                                                                                      3   3 2 2
V     |                                                                                                           11
A     |                                                                                                            11
L     |                                                                                                          33  22
   30 +                                                                                                               22
      |                                                                                                           3 11 222
      |                                                                                                              11  22
      |                                                                                                               11  2 2
   20 +                                                                                                             33 11   22
      |                                                                                                                 1   122
      |                                                                                                              3   3  111
      |                                                                                                                  33
   10 +                                                                                                                   3  3
      |                                                                                                                      33
      |
      |
    0 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 19 obs hidden.

                                                  4-VINYL-1-CYCLOHEXENE DIEPOXIDE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0 MG/ML          = 1
                                                        50 MG/ML         = 2
                                                        100 MG/ ML       = 3

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

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

      |
      |
  100 + 1                         2         1                          3
      |                           2         1                        1 332 1       2
      |                                                                 33 1       2 2              1
      |                                                                  3       3   23      2      1  1
   90 +                                                                               3 3    22        11
      |                                                                                 3  3  2   2
P     |                                                                                           2 2   1  1
E     |                                                                                    3  3     2 2    11
R  80 +                                                                                       3  3    22    1 1  1
C     |                                                                                          3     22        1 1
E     |                                                                                                3 3         1  1
N     |                                                                                                 223
T  70 +                                                                                                               1 1
      |                                                                                                  22 3           11
S     |                                                                                                   2233
U     |                                                                                                    2233          11
R  60 +                                                                                                     2233
V     |                                                                                                      2 2 2        1 11
I     |                                                                                                          22          11
V     |                                                                                                           22
A  50 +                                                                                                            2     2
L     |                                                                                                            33    2   22
      |                                                                                                             33
      |
   40 +
      |                                                                                                              33
      |
      |
   30 +                                                                                                               3       3
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 18 obs hidden.

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