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Statistical Analysis Of Survival Data

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Battelle Columbus                            OLEIC ACID DIETHANOLAMINE CONDENSATE                         DATE: 11/14/97       
EXPERIMENT: 91014 TEST: 03                                                                                     TIME: 13:49:29       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1-ES-15314                              ROUTE: SKIN APPLICATION                                        NTP C#: C91014       
PATHOLOGIST: YARRINGTON, J.                                                                                    CAS: 93-83-4         
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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: Battelle Columbus                            OLEIC ACID DIETHANOLAMINE CONDENSATE                         DATE: 11/14/97      
EXPERIMENT: 91014 TEST: 03                                                                                     TIME: 13:49:29      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: NO1-ES-15314                              ROUTE: SKIN APPLICATION                                        NTP C#: C91014      
PATHOLOGIST: YARRINGTON, J.                                                                                    CAS: 93-83-4        
                       OLEIC ACID DIETHANOLAMINE CONDENSATE

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0 MG/KG                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 42     CENSORED DEATHS 0    TERMINAL 8         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      293   440   440   469   473   495   506   517   530   542                 |
 |      549   571   574   580   598   603   608   613   614   618                 |
 |      623   634   637   638   638   638   647   653   653   654                 |
 |      654   654   659   674   678   694   699   700   700   706                 |
 |      707   712                                                                 |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 50 MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 40     CENSORED DEATHS 0    TERMINAL 10        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      224   331   440   483   497   528   549   551   554   567                 |
 |      580   580   580   591   603   603   607   611   611   611                 |
 |      612   615   621   623   630   636   637   638   638   653                 |
 |      653   654   659   668   674   696   699   706   707   727                 |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 100MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 36     CENSORED DEATHS 0    TERMINAL 14        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      482   497   502   526   529   532   535   549   554   576                 |
 |      580   580   591   611   618   628   631   636   638   638                 |
 |      638   638   644   647   661   674   676   676   677   696                 |
 |      703   703   710   713   723   727                                         |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                       OLEIC ACID DIETHANOLAMINE CONDENSATE

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

 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   728 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0 MG/KG    |   100.0 100.0 100.0  98.0  98.0  90.0  80.0  68.0  34.0  16.0      |
 |           |                                                                    |
 |           |                                                                    |
 |50 MG/KG   |   100.0 100.0  98.0  96.0  96.0  92.0  88.0  68.0  34.0  20.0      |
 |           |                                                                    |
 |           |                                                                    |
 |100MG/KG   |   100.0 100.0 100.0 100.0 100.0  98.0  86.0  74.0  50.0  28.0      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                    DOSE                        |
 |                                                                                |
 |                                0 MG/KG          50 MG/KG         100MG/KG      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       16.0%            20.0%            28.0%         |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.125N         P=0.949N         P=0.127N      |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       602.0            596.2            620.5         |
 |NATURAL DEATHS (C)      |       (13.9)           (15.3)           (11.7)        |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       622.2            622.5            650.6         |
 |(STANDARD ERROR)        |       (13.4)           (14.4)           (10.8)        |
 |                        |                                                       |
 ==================================================================================
                                    

       (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)
                       OLEIC ACID DIETHANOLAMINE CONDENSATE

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0 MG/KG                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 35     CENSORED DEATHS 0    TERMINAL 15        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      296   423   429   437   447   462   462   497   513   524                 |
 |      529   545   560   571   579   586   602   610   614   635                 |
 |      635   635   641   641   653   668   676   679   692   694                 |
 |      695   696   698   706   718                                               |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 50 MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 32     CENSORED DEATHS 0    TERMINAL 18        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      244   270   284   289   371   397   429   508   524   528                 |
 |      541   541   544   545   546   547   567   579   622   623                 |
 |      630   635   658   662   667   674   685   685   693   702                 |
 |      719   722                                                                 |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 100MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 36     CENSORED DEATHS 0    TERMINAL 14        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      169   170   302   305   313   331   355   356   394   419                 |
 |      434   459   463   501   518   518   519   526   535   535                 |
 |      549   560   561   563   568   574   595   621   637   644                 |
 |      673   681   692   695   709   726                                         |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                       OLEIC ACID DIETHANOLAMINE CONDENSATE

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

 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   728 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0 MG/KG    |   100.0 100.0 100.0  98.0  96.0  86.0  76.0  66.0  50.0  30.0      |
 |           |                                                                    |
 |           |                                                                    |
 |50 MG/KG   |   100.0 100.0  96.0  92.0  88.0  86.0  72.0  64.0  52.0  36.0      |
 |           |                                                                    |
 |           |                                                                    |
 |100MG/KG   |   100.0  96.0  96.0  84.0  80.0  74.0  60.0  46.0  40.0  28.0      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                    DOSE                        |
 |                                                                                |
 |                                0 MG/KG          50 MG/KG         100MG/KG      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       30.0%            36.0%            28.0%         |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.380          P=0.802N         P=0.400       |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       584.2            551.0            504.7         |
 |NATURAL DEATHS (C)      |       (17.5)           (24.6)           (24.4)        |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       627.4            614.7            567.2         |
 |(STANDARD ERROR)        |       (15.4)           (19.8)           (22.6)        |
 |                        |                                                       |
 ==================================================================================
                                    

       (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)
                                                OLEIC ACID DIETHANOLAMINE CONDENSATE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0 MG/KG          = 1
                                                        50 MG/KG         = 2
                                                        100MG/KG         = 3

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

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

      |
      |
  100 + 1                                  2          1                             3
      |                                    2          1      2               1      3 3
      |                                                      2               1    1 2 33    3
      |                                                                           112 2
   90 +                                                                            1  1     2
      |                                                                               1 1   23 2
      |                                                                                 11  13 22
      |                                                                                     1 1 22 3
   80 +                                                                                       11 2 2
      |                                                                                        1  1
P     |                                                                                           11  2  3
E     |                                                                                            1  21233
R  70 +                                                                                                11 33
C     |                                                                                                    33
E     |                                                                                                 11  33
N     |                                                                                                  11
T  60 +
      |                                                                                                   1 1
S     |                                                                                                  22 113
U     |                                                                                                   22  3  3
R  50 +                                                                                                    22    3 3
V     |                                                                                                      11
I     |                                                                                                     2211
V     |                                                                                                      2 2   3  3
A  40 +                                                                                                               33
L     |
      |                                                                                                        1 121   33
      |                                                                                                           22    3 3
   30 +                                                                                                            1  1
      |                                                                                                                   3
      |                                                                                                               22
      |                                                                                                               11  2
   20 +                                                                                                                   2
      |                                                                                                                11
      |                                                                                                                 1 1
      |
   10 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 26 obs hidden.
                                                OLEIC ACID DIETHANOLAMINE CONDENSATE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0 MG/KG          = 1
                                                        50 MG/KG         = 2
                                                        100MG/KG         = 3

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

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

      |
      |
  104 +
      |
      | 1                           3          2       1
      |                                        2   2   1                   1
   96 +                             3              2 2  3                  11
      |                                              22                     11
      |                                               2 3 3       2          11
      |                                                   3  3    2    2      1  1
   88 +                                                      3  3      2    2
      |                                                                     2    1    1 2
      |                                                         3      3              1 21 2
      |                                                                3  3              1 12
P  80 +                                                                   3 3              11 2
E     |                                                                     3    3          1 1
R     |                                                                          33           1 1
C     |                                                                           3    3        1 1
E  72 +                                                                                3 3        11
N     |                                                                                       22   11
T     |                                                                                  3 3   2 2  1  1
      |                                                                                    33    2 2   1 1
S  64 +                                                                                     33     2      2
U     |                                                                                                  1  1
R     |                                                                                      3 3          22
V     |                                                                                        33          22
I  56 +                                                                                         33          11 2
V     |                                                                                                        2 2
A     |                                                                                          33          1 1 22
L     |                                                                                                        1  12
   48 +                                                                                           3   3           112
      |                                                                                               3   3
      |                                                                                                   3 3      121
      |                                                                                                     33       112
   40 +                                                                                                      3     3   2 2
      |                                                                                                            33    22
      |                                                                                                             33    2
      |                                                                                                              311
   32 +                                                                                                               3131
      |                                                                                                                 311
      |                                                                                                                   3
      |
   24 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 11 obs hidden.