National Toxicology Program

National Toxicology Program
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TDMS Study 05145-01 Pathology Tables


NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11 
LAB: Mason                                                     DATE: 09/17/94   
EXP: 05145                       TRICAPRYLIN                   TIME: 20:57:59   
TEST: 01              CAGES FROM 0000 TO LAST CAGE             PAGE:   1        
TEST TYPE: CHRONIC          ROUTE: GAVAGE                      NTP C#: 62215    
CONT: N01-ES-55123                                             CAS: 538-23-8    
PATHOLOGIST: K. MURTHY                       S. EUSTIS                          
--------------------------------------------------------------------------------
                                                                                
                                                                                
                                                                                


REASONS FOR REMOVAL:                                                            
                                                                                
ALL                                                                             
                                                                                
                                                                                
REMOVAL DATE RANGE:                                                             


ALL                                                                             
                                                                                
TREATMENT GROUPS:                                                               
                                                                                
INCLUDE ALL                                                                     

NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11
LAB: Mason                                                     DATE: 09/17/94  
EXP: 05145                       TRICAPRYLIN                   TIME: 20:57:59  
TEST: 01              CAGES FROM 0000 TO LAST CAGE                             
TEST TYPE: CHRONIC          ROUTE: GAVAGE                      NTP C#: 62215   
CONT: N01-ES-55123                                             CAS: 538-23-8   
PATHOLOGIST: K. MURTHY                       S. EUSTIS                         

                                    TRICAPRYLIN


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0 ML/KG                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 19     CENSORED DEATHS 10   TERMINAL 31        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      306   390   541   576   593   604   623   625   663   673                 |
 |      678   682   687   687   691   699   704   705   707                       |
 |  CENSORED DEATHS                                                               |
 |      463   463   463   463   463   464   464   464   464   464                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 2.5 MLKG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 20     CENSORED DEATHS 10   TERMINAL 30        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      127   379   386   391   524   579   592   593   632   659                 |
 |      663   666   678   687   690   691   718   721   723   726                 |
 |  CENSORED DEATHS                                                               |
 |      463   463   463   463   463   463   463   464   464   464                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 5.0 MLKG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 19     CENSORED DEATHS 10   TERMINAL 31        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      83    454   457   518   587   587   597   601   608   623                 |
 |      628   670   678   686   687   687   688   698   721                       |
 |  CENSORED DEATHS                                                               |
 |      463   463   463   463   463   464   464   464   464   464                 |
 |                                                                                |
 ==================================================================================

                                    TRICAPRYLIN


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = 10.0    ML/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 30     CENSORED DEATHS 7    TERMINAL 23        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      233   282   288   292   292   322   322   322   324   324                 |
 |      324   328   328   356   415   426   446   447   483   483                 |
 |      485   485   569   590   608   623   645   674   715   726                 |
 |  CENSORED DEATHS                                                               |
 |      463   463   463   464   464   464   464                                   |
 |                                                                                |
 ==================================================================================

                                    TRICAPRYLIN


                       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)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0 ML/KG    |   100.0 100.0 100.0  98.3  96.7  96.7  94.7  88.6  82.6  62.4      |
 |           |                                                                    |
 |           |                                                                    |
 |2.5 MLKG   |   100.0  98.3  98.3  98.3  93.3  93.3  91.3  85.2  79.1  60.9      |
 |           |                                                                    |
 |           |                                                                    |
 |5.0 MLKG   |    98.3  98.3  98.3  98.3  98.3  95.0  93.0  84.9  78.8  62.7      |
 |           |                                                                    |
 |           |                                                                    |
 |10.0       |   100.0 100.0  98.3  76.7  75.0  62.0  62.0  58.0  52.0  46.0      |
 |ML/KG      |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                0 ML/KG      2.5 MLKG     5.0 MLKG     10.0     |
 |                                                                       ML/KG    |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       62.4%        60.9%        62.7%        46.0%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.286      P=0.944      P=1.000      P=0.014  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       622.8        591.3        592.5        438.6    |
 |NATURAL DEATHS (C)      |       (25.0)       (35.1)       (33.4)       (26.5)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       651.1        638.8        641.5        552.8    |
 |(STANDARD ERROR)        |       (14.7)       (17.4)       (16.7)       (22.4)   |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                                                            TRICAPRYLIN
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0 ML/KG          = 1
                                                        2.5 MLKG         = 2
                                                        5.0 MLKG         = 3
                                                        10.0    ML/KG    = 4

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

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

      |
      |
  104 +
      |
      | 1            3       2               4          1
      |              3       2               4       4  1            21         3
   96 +                                              44              21         33       3    1
      |                                                               2                    2  1    1
      |                                               4    4                             3 2       13 1
      |                                                                                            2  1 1
P  88 +                                                                                             3  31 1
E     |                                                    44                                         2   112
R     |                                                                                                33  12    1
C     |                                                                                                 3 3      1 1
E  80 +                                                                                                   33     22
N     |                                                     4   4                                          3      211
T     |                                                         4         44                                      3211
      |                                                                    4  4                                    33
S  72 +                                                                                                             33
U     |                                                                       4     4                                11
R     |                                                                                                              211 2
V     |                                                                             44                               33
I  64 +                                                                                                               3  22
V     |                                                                              4            4                    1 3  1
A     |                                                                                           4   4                   2 2
L     |                                                                                               4 4
   56 +                                                                                                 4 4
      |                                                                                                   4   4
      |                                                                                                       4    4
      |                                                                                                            4     4
   48 +                                                                                                                  44
      |                                                                                                                   4 4
      |
      |
   40 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 15 obs hidden.
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