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TDMS Study 05142-04 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Southern Research Inst                                  T-BUTYL ALCOHOL                                   DATE: 05/20/95       
EXPERIMENT: 05142 TEST: 04                                                                                     TIME: 08:43:20       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1-ES-55121                              ROUTE: DOSED WATER                                             NTP C#: 55367B       
PATHOLOGIST: DR. FARNELL                                                                                       CAS: 75-65-0         
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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: Southern Research Inst                                  T-BUTYL ALCOHOL                                   DATE: 05/20/95      
EXPERIMENT: 05142 TEST: 04                                                                                     TIME: 08:43:20      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: NO1-ES-55121                              ROUTE: DOSED WATER                                             NTP C#: 55367B      
PATHOLOGIST: DR. FARNELL                                                                                       CAS: 75-65-0        

                                  T-BUTYL ALCOHOL


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = VEHICLE CONTROL                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 33     CENSORED DEATHS 0    TERMINAL 27        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      362   461   486   496   498   560   589   616   631   633                 |
 |      636   638   643   647   647   652   652   653   653   673                 |
 |      673   675   675   689   692   702   707   707   707   707                 |
 |      708   709   727                                                           |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.5%                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 22     CENSORED DEATHS 2    TERMINAL 36        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      210   312   469   531   531   597   615   621   630   640                 |
 |      645   647   702   705   706   707   709   710   724   727                 |
 |      727   727                                                                 |
 |  CENSORED DEATHS                                                               |
 |      49    73                                                                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 1.0%                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 25     CENSORED DEATHS 1    TERMINAL 34        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      434   486   526   562   580   580   589   611   612   616                 |
 |      622   646   646   647   647   674   675   695   707   707                 |
 |      709   721   727   727   727                                               |
 |  CENSORED DEATHS                                                               |
 |      76                                                                        |
 |                                                                                |
 ==================================================================================

                                  T-BUTYL ALCOHOL


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 2.0%                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 43     CENSORED DEATHS 0    TERMINAL 17        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      93    94    106   112   118   125   139   146   174   189                 |
 |      269   318   360   370   386   396   460   486   486   489                 |
 |      511   529   531   552   567   577   580   602   611   614                 |
 |      625   628   630   671   684   684   687   707   708   709                 |
 |      709   726   727                                                           |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================

                                  T-BUTYL ALCOHOL


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       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)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |VEHICLE    |   100.0 100.0 100.0  98.3  98.3  96.7  91.7  88.3  68.3  45.0      |
 |CONTROL    |                                                                    |
 |           |                                                                    |
 |0.5%       |   100.0 100.0  98.3  96.6  96.6  94.8  91.4  89.7  79.3  62.1      |
 |           |                                                                    |
 |           |                                                                    |
 |1.0%       |   100.0 100.0 100.0 100.0 100.0  98.3  94.9  88.1  74.6  57.6      |
 |           |                                                                    |
 |           |                                                                    |
 |2.0%       |   100.0  85.0  81.7  78.3  73.3  71.7  61.7  53.3  45.0  28.3      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                VEHICLE      0.5%         1.0%         2.0%     |
 |                                CONTROL                                         |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       45.0%        62.1%        57.6%        28.3%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P<0.001      P=0.077N     P=0.228N     P=0.007  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       633.5        617.8        634.9        462.4    |
 |NATURAL DEATHS (C)      |       (14.8)       (29.2)       (15.6)       (33.1)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       676.0        665.4        678.4        537.7    |
 |(STANDARD ERROR)        |       (10.1)       (19.3)       (13.4)       (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)

                                  T-BUTYL ALCOHOL


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = VEHICLE CONTROL                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 23     CENSORED DEATHS 1    TERMINAL 36        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      16    258   330   331   469   472   555   568   583   584                 |
 |      590   601   647   653   659   659   702   707   709   714                 |
 |      723   727   727                                                           |
 |  CENSORED DEATHS                                                               |
 |      170                                                                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.5%                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 22     CENSORED DEATHS 3    TERMINAL 35        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      504   550   570   576   577   610   616   628   633   635                 |
 |      674   684   696   696   704   707   709   710   715   724                 |
 |      727   727                                                                 |
 |  CENSORED DEATHS                                                               |
 |      72    310   365                                                           |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 1.0%                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 17     CENSORED DEATHS 2    TERMINAL 41        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      79    140   488   591   607   625   645   646   646   647                 |
 |      702   702   707   707   710   727   728                                   |
 |  CENSORED DEATHS                                                               |
 |      440   506                                                                 |
 |                                                                                |
 ==================================================================================

                                  T-BUTYL ALCOHOL


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 2.0%                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 16     CENSORED DEATHS 2    TERMINAL 42        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      224   472   595   632   646   651   651   668   675   687                 |
 |      695   702   707   726   727   727                                         |
 |  CENSORED DEATHS                                                               |
 |      64    74                                                                  |
 |                                                                                |
 ==================================================================================

                                  T-BUTYL ALCOHOL


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE 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)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |VEHICLE    |    98.3  98.3  96.6  93.2  93.2  89.9  89.9  79.7  72.9  61.0      |
 |CONTROL    |                                                                    |
 |           |                                                                    |
 |0.5%       |   100.0 100.0 100.0 100.0 100.0 100.0  98.2  91.2  82.5  61.4      |
 |           |                                                                    |
 |           |                                                                    |
 |1.0%       |    98.3  96.7  96.7  96.7  96.7  96.7  95.0  93.2  82.9  70.8      |
 |           |                                                                    |
 |           |                                                                    |
 |2.0%       |   100.0 100.0  98.3  98.3  98.3  96.6  96.6  94.8  87.9  72.4      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                VEHICLE      0.5%         1.0%         2.0%     |
 |                                CONTROL                                         |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       61.0%        61.4%        70.8%        72.4%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.121N     P=0.924N     P=0.298N     P=0.198N |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       564.5        653.3        593.9        636.6    |
 |NATURAL DEATHS (C)      |       (37.7)       (14.2)       (46.7)       (31.7)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       656.6        677.2        682.2        682.4    |
 |(STANDARD ERROR)        |       (19.4)       (15.0)       (16.0)       (17.8)   |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                                                          T-BUTYL ALCOHOL
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        VEHICLE CONTROL  = 1
                                                        0.5%             = 2
                                                        1.0%             = 3
                                                        2.0%             = 4

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

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

      |
      |
  100 + 1              4                 2                       1          3
      |                4  4              2                2      1          3    12  1      3
      |                                                                           2  11     2    3
      |                   444                                                         11    2   13 3   2
   90 +                     4 4                                                                 1  3  12 2
      |                       44    4                                                                 1  12 1
      |                             4 4                                                                   22 2
      |                               4            4       4                                             33 112
P  80 +                                                    4     4                                            2        2
E     |                                                          44   4                                      11
R     |                                                               44                                      11   3
C     |                                                                4         4   4                                 22
E  70 +                                                                                                            3  332 2
N     |                                                                              4  4                      1   1
T     |                                                                                 4   4                          333
      |                                                                                     4  4                   1 1   32
S  60 +                                                                                        4 4
U     |                                                                                          4 4                 1 1  3
R     |                                                                                            4   4
V     |                                                                                                4 4
I  50 +                                                                                                  4 4           11
V     |                                                                                                                 1 1
A     |                                                                                                    4      4       1
L     |                                                                                                           4 4
   40 +                                                                                                             44
      |                                                                                                              4 44
      |
      |                                                                                                                 4 4
   30 +
      |                                                                                                                   4
      |
      |
   20 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 28 obs hidden.

                                                          T-BUTYL ALCOHOL
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        VEHICLE CONTROL  = 1
                                                        0.5%             = 2
                                                        1.0%             = 3
                                                        2.0%             = 4

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

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

      |
      |
  100 + 1  1         3                     4                                           2
      |    1         3        3            4     1                                 4   2       2
      |
      |                       3                  1           1                     4 3         2  2   4
   95 +                                                                              3            22  3     4
      |                                                      1                    1                   3 3
      |                                                                                                     4 4
      |                                                                           11               2    32 3
P  90 +                                                                            1            1          3  3
E     |                                                                                         1 1
R     |                                                                                                  2 2  4   4
C     |                                                                                           1 1      22     44
E  85 +                                                                                                            4 4
N     |
T     |                                                                                             1 1     2 3    2 443
      |                                                                                               11           22 44
S  80 +                                                                                                1      1
U     |                                                                                                             2 2
R     |                                                                                                       11       4  4
V     |                                                                                                        1 1     33
I  75 +                                                                                                               22
V     |                                                                                                                 3 3
A     |                                                                                                          1     12 4 4
L     |                                                                                                                   3 3
   70 +                                                                                                                11
      |                                                                                                                 22
      |
      |                                                                                                                 121
   65 +
      |
      |
      |                                                                                                                   1 1
   60 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 8 obs hidden.