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TDMS Study 05091-01 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: American Biogenics Cor                               3,4-DIHYDROCOUMARIN                                  DATE: 10/22/97       
EXPERIMENT: 05091 TEST: 01                                                                                     TIME: 13:41:26       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1-ES-45039                              ROUTE: GAVAGE                                                  NTP C#: 55890B       
PATHOLOGIST: R. DAHLGREN                     S. EUSTIS                                                         CAS: 119-84-6        
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    

               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE 001    VEHICLE CONTROL                                                               
                                       INCLUDE 002    VEHICLE CONTROL                                                               
                                       INCLUDE 003    150MG/KG                                                                      
                                       INCLUDE 004    150MG/KG                                                                      
                                       INCLUDE 005    300MG/KG                                                                      
                                       INCLUDE 006    300MG/KG                                                                      
                                       INCLUDE 007    600MG/KG                                                                      
                                       INCLUDE 008    600MG/KG                                                                      
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11    
LAB: American Biogenics Cor                               3,4-DIHYDROCOUMARIN                                  DATE: 10/22/97      
EXPERIMENT: 05091 TEST: 01                                                                                     TIME: 13:41:26      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: NO1-ES-45039                              ROUTE: GAVAGE                                                  NTP C#: 55890B      
PATHOLOGIST: R. DAHLGREN                     S. EUSTIS                                                         CAS: 119-84-6       
                                3,4-DIHYDROCOUMARIN

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = VEHICLE CONTROL                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 21     CENSORED DEATHS 11   TERMINAL 28        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      379   526   534   540   596   619   634   637   639   648                 |
 |      654   654   655   656   670   678   690   704   705   711                 |
 |      717                                                                       |
 |  CENSORED DEATHS                                                               |
 |      45    458   458   458   458   459   459   459   459   459                 |
 |      541                                                                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 150MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 36     CENSORED DEATHS 11   TERMINAL 13        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      238   455   462   472   548   549   550   556   557   567                 |
 |      576   584   584   588   599   599   623   634   645   657                 |
 |      662   668   668   673   673   677   681   681   685   694                 |
 |      695   695   718   721   721   723                                         |
 |  CENSORED DEATHS                                                               |
 |      458   458   458   458   458   458   458   459   459   459                 |
 |      543                                                                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 300MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 41     CENSORED DEATHS 11   TERMINAL 8         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      494   522   527   554   592   596   603   605   613   615                 |
 |      633   634   634   654   662   662   665   666   670   674                 |
 |      675   678   679   681   684   690   691   694   694   695                 |
 |      697   697   701   708   709   709   709   716   720   723                 |
 |      725                                                                       |
 |  CENSORED DEATHS                                                               |
 |      458   458   458   458   459   459   459   459   459   459                 |
 |      619                                                                       |
 |                                                                                |
 ==================================================================================
                                3,4-DIHYDROCOUMARIN

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 600MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 46     CENSORED DEATHS 12   TERMINAL 2         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      365   444   483   501   528   537   552   554   569   577                 |
 |      584   593   598   605   605   605   606   607   616   618                 |
 |      625   627   640   640   651   659   662   663   668   668                 |
 |      672   672   673   673   677   681   687   688   690   690                 |
 |      694   696   710   711   712   720                                         |
 |  CENSORED DEATHS                                                               |
 |      44    45    458   458   458   458   458   459   459   459                 |
 |      459   459                                                                 |
 |                                                                                |
 ==================================================================================
                                3,4-DIHYDROCOUMARIN

                       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    |   100.0 100.0 100.0 100.0  98.3  98.3  92.3  90.2  71.8  57.4      |
 |CONTROL    |                                                                    |
 |           |                                                                    |
 |150MG/KG   |   100.0 100.0  98.3  98.3  98.3  92.6  92.6  67.9  57.6  26.8      |
 |           |                                                                    |
 |           |                                                                    |
 |300MG/KG   |   100.0 100.0 100.0 100.0 100.0 100.0  94.0  84.0  65.6  16.4      |
 |           |                                                                    |
 |           |                                                                    |
 |600MG/KG   |   100.0 100.0 100.0  98.3  98.3  94.5  88.2  67.2  42.0   4.2      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                VEHICLE      150MG/KG     300MG/KG     600MG/KG |
 |                                CONTROL                                         |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       57.4%        26.8%        16.4%         4.2%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P<0.001      P=0.004      P<0.001      P<0.001  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       630.8        613.3        657.3        623.8    |
 |NATURAL DEATHS (C)      |       (17.5)       (16.4)       ( 9.0)       (11.1)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       639.5        611.4        633.1        580.5    |
 |(STANDARD ERROR)        |       (16.9)       (14.6)       (12.3)       (17.7)   |
 |                        |                                                       |
 ==================================================================================
                                    

       (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)
                                3,4-DIHYDROCOUMARIN

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = VEHICLE CONTROL                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 17     CENSORED DEATHS 12   TERMINAL 31        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      385   466   506   580   589   598   631   651   652   665                 |
 |      680   680   696   703   709   716   717                                   |
 |  CENSORED DEATHS                                                               |
 |      461   461   461   461   461   461   461   462   462   462                 |
 |      533   542                                                                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 150MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 25     CENSORED DEATHS 14   TERMINAL 21        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      357   455   471   508   513   537   588   590   591   612                 |
 |      618   644   657   664   667   682   701   710   710   710                 |
 |      710   715   716   716   717                                               |
 |  CENSORED DEATHS                                                               |
 |      6     49    73    300   461   461   461   461   462   462                 |
 |      462   462   462   542                                                     |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 300MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 24     CENSORED DEATHS 10   TERMINAL 26        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      387   538   552   580   595   611   618   622   624   631                 |
 |      633   667   672   678   680   689   692   695   696   700                 |
 |      710   717   717   724                                                     |
 |  CENSORED DEATHS                                                               |
 |      461   461   461   461   461   461   462   462   462   462                 |
 |                                                                                |
 ==================================================================================
                                3,4-DIHYDROCOUMARIN

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 600MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 24     CENSORED DEATHS 13   TERMINAL 23        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      331   455   504   506   531   533   535   553   570   591                 |
 |      596   602   618   618   631   639   639   678   680   708                 |
 |      710   710   711   717                                                     |
 |  CENSORED DEATHS                                                               |
 |      41    90    461   461   461   462   462   462   462   462                 |
 |      462   521   638                                                           |
 |                                                                                |
 ==================================================================================
                                3,4-DIHYDROCOUMARIN

                       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    |   100.0 100.0 100.0 100.0  98.3  96.3  94.3  88.0  79.6  65.0      |
 |CONTROL    |                                                                    |
 |           |                                                                    |
 |150MG/KG   |   100.0 100.0 100.0  98.2  98.2  94.3  87.9  81.3  70.3  46.1      |
 |           |                                                                    |
 |           |                                                                    |
 |300MG/KG   |   100.0 100.0 100.0 100.0  98.3  98.3  96.3  90.3  78.3  52.2      |
 |           |                                                                    |
 |           |                                                                    |
 |600MG/KG   |   100.0 100.0 100.0  98.3  98.3  96.6  86.1  75.6  65.0  49.8      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                VEHICLE      150MG/KG     300MG/KG     600MG/KG |
 |                                CONTROL                                         |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       65.0%        46.1%        52.2%        49.8%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.213      P=0.106      P=0.300      P=0.134  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       624.9        622.4        642.8        598.6    |
 |NATURAL DEATHS (C)      |       (23.1)       (19.9)       (15.5)       (19.4)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       648.5        599.9        649.9        609.6    |
 |(STANDARD ERROR)        |       (14.4)       (22.5)       (13.6)       (19.4)   |
 |                        |                                                       |
 ==================================================================================
                                    

       (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)
                                                        3,4-DIHYDROCOUMARIN
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        VEHICLE CONTROL  = 1
                                                        150MG/KG         = 2
                                                        300MG/KG         = 3
                                                        600MG/KG         = 4

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

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

      |
  100 + 1                                    2                    4  1                3
      |                                      2                    4  1        4 22  4 3    311
      |                                                                          2 24  4   3311 3
      |                                                                            2   4    4 123     31
   90 +                                                                                     44        31  1
      |                                                                                      4 22      33 1 1
      |                                                                                        44 4     33  11
      |                                                                                         2244         11
   80 +                                                                                          2 24    3  3 11
      |                                                                                            22 4
      |                                                                                               44    3  3
      |                                                                                             2  24      1 31
P  70 +                                                                                                           11
E     |                                                                                                2  2        1 1
R     |                                                                                                   2 2 2  33  1 1
C     |                                                                                                 44    22  33   11
E  60 +                                                                                                  444   2 2      11
N     |                                                                                                          22      1  1
T     |                                                                                                    4 4
      |                                                                                                           223
S  50 +                                                                                                      44     33
U     |                                                                                                       4  4 22
R     |                                                                                                              33
V     |                                                                                                          44
I  40 +                                                                                                             2 2
V     |
A     |                                                                                                               23 2
L     |                                                                                                           44   33
   30 +                                                                                                                  22
      |                                                                                                            44     2 2
      |                                                                                                             44  33
      |
   20 +                                                                                                                  33
      |                                                                                                              44   3 3
      |
      |                                                                                                               4 4
   10 +
      |                                                                                                                 44
      |                                                                                                                  4  4
      |
    0 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 18 obs hidden.
                                                        3,4-DIHYDROCOUMARIN
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        VEHICLE CONTROL  = 1
                                                        150MG/KG         = 2
                                                        300MG/KG         = 3
                                                        600MG/KG         = 4

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

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

      |
      |
  100 + 1                                                    4  2    13
      |                                                      4  2    13         2 12   41    3 3
      |                                                                            2   41      3   1
      |                                                                                 22  4      1  1
P  90 +                                                                                  2  42        11 3
E     |                                                                                      2      2  1 33 1
R     |                                                                                      4 4  4 2 2   331 11
C     |                                                                                           4   2  2 33  1 1
E  80 +                                                                                               44 22      1  1
N     |                                                                                                   2 32    3
T     |                                                                                                4  4  2 2  331 1
      |                                                                                                   4 4  2 2 33 111
S  70 +                                                                                                     44   22 33  11
U     |                                                                                                           2 2
R     |                                                                                                      4     42332 1  1
V     |                                                                                                            44  22
I  60 +                                                                                                             4 3 3
V     |                                                                                                                 33
A     |                                                                                                                 223
L     |                                                                                                                 443 3
   50 +                                                                                                                  4  4
      |
      |                                                                                                                  2  2
      |
   40 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 22 obs hidden.