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TDMS Study 05142-03 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Southern Research Inst                                  T-BUTYL ALCOHOL                                   DATE: 05/20/95       
EXPERIMENT: 05142 TEST: 03                                                                                     TIME: 07:57:41       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1-ES-55121                              ROUTE: DOSED WATER                                             NTP C#: 55367B       
PATHOLOGIST: DR J. HEATH                     S. EUSTIS                                                         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: 03                                                                                     TIME: 07:57:41      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: NO1-ES-55121                              ROUTE: DOSED WATER                                             NTP C#: 55367B      
PATHOLOGIST: DR J. HEATH                     S. EUSTIS                                                         CAS: 75-65-0        

                                  T-BUTYL ALCOHOL


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = VEHICLE CONTROL                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 40     CENSORED DEATHS 10   TERMINAL 10        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      20    288   505   526   526   553   553   553   553   562                 |
 |      563   572   573   586   588   589   594   594   595   603                 |
 |      604   614   617   617   622   623   630   636   637   645                 |
 |      646   657   669   672   678   692   694   698   720   720                 |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   456   456   456                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.125%                                   |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 44     CENSORED DEATHS 10   TERMINAL 6         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      307   348   395   512   520   553   557   562   569   575                 |
 |      575   575   584   591   596   602   603   603   605   619                 |
 |      624   624   626   629   630   639   646   651   651   656                 |
 |      666   666   672   673   679   679   692   693   694   699                 |
 |      708   708   720   720                                                     |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   456   456   456                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.25%                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 46     CENSORED DEATHS 10   TERMINAL 4         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      343   355   398   449   484   510   512   525   528   542                 |
 |      545   547   551   553   556   569   577   580   582   589                 |
 |      589   595   595   603   605   607   623   624   630   637                 |
 |      637   637   638   643   643   645   650   651   653   666                 |
 |      673   673   678   679   685   703                                         |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   456   456   456                 |
 |                                                                                |
 ==================================================================================

                                  T-BUTYL ALCOHOL


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0.50%                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 49     CENSORED DEATHS 10   TERMINAL 1         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      262   274   506   508   526   553   555   555   562   566                 |
 |      569   569   575   575   575   577   583   587   588   589                 |
 |      594   594   594   594   595   596   598   598   604   604                 |
 |      604   604   624   624   636   639   646   650   651   653                 |
 |      666   667   669   672   672   679   679   679   708                       |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   456   456   456                 |
 |                                                                                |
 ==================================================================================

                                  T-BUTYL ALCOHOL


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       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  98.3  96.7  96.7  96.7  90.6  58.4  36.3  20.1      |
 |CONTROL    |                                                                    |
 |           |                                                                    |
 |0.125%     |   100.0 100.0 100.0  96.7  95.0  95.0  91.0  62.7  40.4  12.1      |
 |           |                                                                    |
 |           |                                                                    |
 |0.25%      |   100.0 100.0 100.0  96.7  95.0  91.3  79.1  50.7  22.3   8.1      |
 |           |                                                                    |
 |           |                                                                    |
 |0.50%      |   100.0 100.0  98.3  96.7  96.7  96.7  90.6  36.3  20.1   2.0      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                VEHICLE      0.125%       0.25%        0.50%    |
 |                                CONTROL                                         |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       20.1%        12.1%         8.1%         2.0%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.001      P=0.853      P=0.091      P=0.010  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       589.7        611.3        586.0        592.8    |
 |NATURAL DEATHS (C)      |       (18.7)       (13.5)       (12.1)       (11.7)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       590.6        597.2        573.9        572.3    |
 |(STANDARD ERROR)        |       (16.1)       (13.6)       (12.4)       (11.9)   |
 |                        |                                                       |
 ==================================================================================
                                    


       (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 RATS
                       FIRST TERMINAL SACRIFICE AT 729 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = VEHICLE CONTROL                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 22     CENSORED DEATHS 10   TERMINAL 28        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      226   428   524   547   554   576   580   589   591   594                 |
 |      603   604   625   627   637   645   646   650   674   680                 |
 |      695   723                                                                 |
 |  CENSORED DEATHS                                                               |
 |      457   457   457   457   457   457   457   457   457   457                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.25%                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 26     CENSORED DEATHS 10   TERMINAL 24        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      232   324   424   430   502   533   542   552   552   589                 |
 |      590   591   593   610   611   612   618   624   625   645                 |
 |      646   674   703   703   723   727                                         |
 |  CENSORED DEATHS                                                               |
 |      457   457   457   457   457   457   457   457   457   457                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.50%                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 28     CENSORED DEATHS 10   TERMINAL 22        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      255   321   332   377   384   459   468   534   562   563                 |
 |      565   573   575   598   637   639   645   651   652   667                 |
 |      694   694   699   701   703   703   708   724                             |
 |  CENSORED DEATHS                                                               |
 |      457   457   457   457   457   457   457   457   457   457                 |
 |                                                                                |
 ==================================================================================

                                  T-BUTYL ALCOHOL


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 1.00%                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 38     CENSORED DEATHS 10   TERMINAL 12        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      206   476   511   551   555   576   590   591   591   597                 |
 |      597   597   605   610   610   610   617   617   624   624                 |
 |      625   625   625   631   636   643   666   666   667   674                 |
 |      685   685   693   703   703   703   708   727                             |
 |  CENSORED DEATHS                                                               |
 |      457   457   457   457   457   457   457   457   457   457                 |
 |                                                                                |
 ==================================================================================

                                  T-BUTYL ALCOHOL


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       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    |   100.0 100.0  98.3  98.3  98.3  96.7  94.7  76.5  64.4  56.4      |
 |CONTROL    |                                                                    |
 |           |                                                                    |
 |0.25%      |   100.0 100.0  98.3  96.7  95.0  93.3  87.2  75.1  58.8  48.7      |
 |           |                                                                    |
 |           |                                                                    |
 |0.50%      |   100.0 100.0  98.3  95.0  91.7  87.6  85.6  73.3  63.1  44.8      |
 |           |                                                                    |
 |           |                                                                    |
 |1.00%      |   100.0 100.0  98.3  98.3  98.3  96.3  94.3  74.3  48.2  24.1      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                VEHICLE      0.25%        0.50%        1.00%    |
 |                                CONTROL                                         |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       56.4%        48.7%        44.8%        24.1%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.004      P=0.476      P=0.335      P=0.006  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       591.7        576.0        574.4        616.3    |
 |NATURAL DEATHS (C)      |       (22.1)       (23.0)       (25.6)       (14.2)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       633.3        617.4        611.5        612.3    |
 |(STANDARD ERROR)        |       (15.3)       (16.3)       (17.4)       (13.9)   |
 |                        |                                                       |
 ==================================================================================
                                    


       (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
                                                        0.125%           = 2
                                                        0.25%            = 3
                                                        0.50%            = 4

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

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

      |
  100 + 1  1                                      4     2     3
      |    1                                      4 4 1 2     323      2                1
      |                                                                2        3       12  1
      |                                                                         3    3  32 24
   90 +                                                                                 33 21  12
      |                                                                                  3 3   422
      |                                                                                    33   422
      |                                                                                     3 31 122
   80 +                                                                                       33 44
      |                                                                                          1122
      |                                                                                           1 1 2
      |                                                                                        33     22
P  70 +                                                                                         3 331 1
E     |                                                                                            44  22
R     |                                                                                            33
C     |                                                                                             3 1 1 2
E  60 +                                                                                                   22
N     |                                                                                                 111
T     |                                                                                               3 3
      |
S  50 +                                                                                               44   2 2
U     |                                                                                                 3 11122
R     |                                                                                                44
V     |                                                                                                    31 12
I  40 +                                                                                                        2  2
V     |                                                                                                 4  43311  1
A     |                                                                                                           22
L     |                                                                                                    44     11
   30 +                                                                                                     433    1 1
      |                                                                                                      44    2 11
      |                                                                                                       33     21  1
      |                                                                                                       43  3
   20 +                                                                                                        4  33  2 21  1
      |
      |                                                                                                                 22
      |                                                                                                            33    2  2
   10 +                                                                                                           443  3
      |                                                                                                                3    3
      |                                                                                                            4    4
      |                                                                                                                 4   4
    0 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 39 obs hidden.

                                                          T-BUTYL ALCOHOL
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        VEHICLE CONTROL  = 1
                                                        0.25%            = 2
                                                        0.50%            = 3
                                                        1.00%            = 4

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

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

      |
      |
  100 + 1                                4  12   3
      |                                  4  12   3         323             21      4    4  1
      |                                                      3     3       22           4  1   1
      |                                                            3 3      2    3     2     2 11
   90 +                                                                          33          22 1  1
      |                                                                           3          322   1  1
      |                                                                                      3   3
      |                                                                                        2      24
P  80 +                                                                                          33   1 1
E     |                                                                                           33   41  1
R     |                                                                                            3  2342
C     |                                                                                                3   113
E  70 +                                                                                                  22 131
N     |                                                                                                  422
T     |                                                                                                   44  13   1
      |                                                                                                    2  23  311
S  60 +                                                                                                       2   321 1
U     |                                                                                                            2  12  1 1
R     |                                                                                                    44         33
V     |                                                                                                                2  2
I  50 +                                                                                                     44         33
V     |                                                                                                      4    4     3 2 2
A     |                                                                                                                   3 3
L     |                                                                                                           44
   40 +                                                                                                            44
      |
      |                                                                                                             44 4
      |
   30 +
      |                                                                                                                44
      |                                                                                                                 4 4 4
      |
   20 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 29 obs hidden.