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TDMS Study 05035-02 Pathology Tables

NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11 
LAB: Mason                                                     DATE: 09/04/94   
EXP: 05035                  4-HYDROXYACETANILIDE               TIME: 22:38:36   
TEST: 02              CAGES FROM 0000 TO LAST CAGE             PAGE:   1        
TEST TYPE: CHRONIC          ROUTE: DOSED FEED                  NTP C#: 55801    
CONT: N01CP9561902                                             CAS: 103-90-2    
PATHOLOGIST: A. RUSSFIELD                    S. EUSTIS                          
--------------------------------------------------------------------------------
                                                                                
                                                                                
                                                                                


REASONS FOR REMOVAL:                                                            
                                                                                
ALL                                                                             
                                                                                
                                                                                
REMOVAL DATE RANGE:                                                             


ALL                                                                             
                                                                                
TREATMENT GROUPS:                                                               
                                                                                
INCLUDE ALL                                                                     

NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11
LAB: Mason                                                     DATE: 09/04/94  
EXP: 05035                  4-HYDROXYACETANILIDE               TIME: 22:38:36  
TEST: 02              CAGES FROM 0000 TO LAST CAGE                             
TEST TYPE: CHRONIC          ROUTE: DOSED FEED                  NTP C#: 55801   
CONT: N01CP9561902                                             CAS: 103-90-2   
PATHOLOGIST: A. RUSSFIELD                    S. EUSTIS                         

                               4-HYDROXYACETANILIDE


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = CONTROL UM                               |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 18     CENSORED DEATHS 10   TERMINAL 32        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      176   267   293   419   463   479   541   561   563   578                 |
 |      618   651   654   654   671   689   703   718                             |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   457   457   457   457   457   457   457                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.06%                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 10     CENSORED DEATHS 10   TERMINAL 40        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      78    87    111   122   424   442   502   651   671   671                 |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   457   457   457   457   457   457                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.3%                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 19     CENSORED DEATHS 10   TERMINAL 31        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      461   510   512   563   608   644   647   650   654   655                 |
 |      657   657   661   666   680   687   695   709   715                       |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   456   456   456                 |
 |                                                                                |
 ==================================================================================

                               4-HYDROXYACETANILIDE


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0.6%                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 19     CENSORED DEATHS 10   TERMINAL 31        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      7     84    169   301   398   414   512   523   563   570                 |
 |      605   632   637   650   654   676   715   715   717                       |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   457   457   457   457   457                 |
 |                                                                                |
 ==================================================================================

                               4-HYDROXYACETANILIDE


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


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   729 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |CONTROL UM |   100.0  98.3  96.7  95.0  93.3  89.3  87.2  81.2  73.0  64.9      |
 |           |                                                                    |
 |           |                                                                    |
 |0.06%      |    96.7  93.3  93.3  93.3  91.7  90.0  88.0  88.0  85.9  81.8      |
 |           |                                                                    |
 |           |                                                                    |
 |0.3%       |   100.0 100.0 100.0 100.0 100.0  98.0  94.0  92.0  74.0  62.0      |
 |           |                                                                    |
 |           |                                                                    |
 |0.6%       |    96.7  95.0  95.0  93.3  90.0  90.0  85.9  79.8  71.6  63.4      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                CONTROL UM   0.06%        0.3%         0.6%     |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       64.9%        81.8%        62.0%        63.4%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.292      P=0.152N     P=1.000N     P=0.942  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       538.8        375.9        633.2        502.2    |
 |NATURAL DEATHS (C)      |       (37.8)       (80.2)       (16.3)       (50.0)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       626.6        624.8        653.2        611.8    |
 |(STANDARD ERROR)        |       (18.4)       (23.3)       (13.7)       (22.2)   |
 |                        |                                                       |
 ==================================================================================
                                    


       (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-HYDROXYACETANILIDE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 730 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = CONTROL UF                               |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 23     CENSORED DEATHS 10   TERMINAL 27        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      397   491   506   534   534   536   555   564   611   634                 |
 |      635   642   642   647   653   660   684   701   702   715                 |
 |      719   722   726                                                           |
 |  CENSORED DEATHS                                                               |
 |      457   457   457   457   457   458   458   458   458   458                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.06%                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 18     CENSORED DEATHS 10   TERMINAL 32        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      436   449   516   547   549   551   599   614   633   634                 |
 |      638   638   661   661   667   678   680   691                             |
 |  CENSORED DEATHS                                                               |
 |      457   457   457   457   457   457   458   458   458   458                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.3%                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 21     CENSORED DEATHS 14   TERMINAL 25        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      414   480   488   516   534   540   549   551   551   607                 |
 |      610   639   642   659   659   684   684   701   705   716                 |
 |      726                                                                       |
 |  CENSORED DEATHS                                                               |
 |      8     8     8     9     457   457   457   457   457   457                 |
 |      458   458   458   458                                                     |
 |                                                                                |
 ==================================================================================

                               4-HYDROXYACETANILIDE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 730 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0.6%                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 12     CENSORED DEATHS 10   TERMINAL 38        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      251   522   536   579   593   596   620   631   632   635                 |
 |      642   661                                                                 |
 |  CENSORED DEATHS                                                               |
 |      457   457   457   458   458   458   458   458   458   458                 |
 |                                                                                |
 ==================================================================================

                               4-HYDROXYACETANILIDE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 730 DAYS


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   730 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |CONTROL UF |   100.0 100.0 100.0 100.0  98.3  98.3  88.3  84.3  68.2  54.2      |
 |           |                                                                    |
 |           |                                                                    |
 |0.06%      |   100.0 100.0 100.0 100.0 100.0  96.7  94.7  86.6  72.5  64.4      |
 |           |                                                                    |
 |           |                                                                    |
 |0.3%       |   100.0 100.0 100.0 100.0  98.2  96.0  87.3  80.8  67.7  54.6      |
 |           |                                                                    |
 |           |                                                                    |
 |0.6%       |   100.0 100.0  98.3  98.3  98.3  98.3  94.3  88.3  76.3  76.3      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                CONTROL UF   0.06%        0.3%         0.6%     |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       54.2%        64.4%        54.6%        76.3%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.105N     P=0.477N     P=1.000      P=0.053N |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       617.8        602.3        602.6        574.8    |
 |NATURAL DEATHS (C)      |       (18.4)       (18.3)       (19.4)       (31.9)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       641.6        646.3        591.9        653.6    |
 |(STANDARD ERROR)        |       (14.4)       (14.2)       (24.8)       (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-HYDROXYACETANILIDE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        CONTROL UM       = 1
                                                        0.06%            = 2
                                                        0.3%             = 3
                                                        0.6%             = 4

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

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

      |
      |
  100 + 14           2               1                                           3
      |  4           22              1             1
      |                                                                          3      3
      |              42   2         4              1  1                                 33
   95 +                   2 2       4                 14                  1
      |                     2                          4               4  12      1      3       3
      |                                                                                          3      3
      |                                                                4  42  2   1 1
P  90 +                                                                   4   2        2 4              3    3
E     |                                                                             1         1
R     |                                                                                2 4 4  1  1           32
C     |                                                                                    4     4            2   2
E  85 +
N     |                                                                                          141          33
T     |
      |                                                                                           41    4 1       2         2
S  80 +                                                                                                 4   4
U     |                                                                                                   1   1
R     |                                                                                                       11
V     |                                                                                                     4 43 3
I  75 +
V     |                                                                                                       44 33
A     |                                                                                                        1  1 3
L     |                                                                                                        4  14 1
   70 +                                                                                                            433   4
      |                                                                                                              1 1
      |                                                                                                              331 1
      |                                                                                                               3 3
   65 +                                                                                                                  1  1
      |                                                                                                                 33  4
      |                                                                                                                  3  3
      |
   60 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 8 obs hidden.

                                                        4-HYDROXYACETANILIDE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        CONTROL UF       = 1
                                                        0.06%            = 2
                                                        0.3%             = 3
                                                        0.6%             = 4

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

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

      |
  100 + 1                                       4                      1  3  2
      |                                         4                      1  3  2  2   3 1    4
      |
      |                                                                         2   331 12 4 4
   95 +                                                                                  2     2
      |                                                                              3  13   1     4
      |                                                                                            4  4
      |                                                                                  3   3
   90 +                                                                                      33       44
      |                                                                                      1 21      2  4
      |                                                                                       33
      |                                                                                         11     2 24 4
P  85 +                                                                                                  2  2
E     |                                                                                          1       1
R     |                                                                                                  1  1
C     |                                                                                        3        3
E  80 +                                                                                                     22
N     |                                                                                                 33  11   4
T     |
      |                                                                                                  3   2   2          4
S  75 +
U     |                                                                                                      11
R     |                                                                                                      311 22
V     |
I  70 +                                                                                                        1 122
V     |                                                                                                          1 21
A     |                                                                                                          3  3
L     |                                                                                                             12 1
   65 +                                                                                                              2      2
      |                                                                                                             3  3
      |                                                                                                                1 1
      |
   60 +
      |                                                                                                                3 11
      |
      |                                                                                                                  33
   55 +                                                                                                                   3 3
      |                                                                                                                   1 1
      |
      |
   50 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 14 obs hidden.

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