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TDMS Study 05091-02 Pathology Tables


NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11 
LAB: American Biogenics                                        DATE: 09/12/94   
EXP: 05091                     DIHYDROCOUMARIN                 TIME: 13:18:28   
TEST: 02              CAGES FROM 0000 TO LAST CAGE             PAGE:   1        
TEST TYPE: CHRONIC          ROUTE: GAVAGE                      NTP C#: 55890B   
CONT: NO1-ES-45039                                             CAS: 119-84-6    
PATHOLOGIST: R. DAHLGREN                     S. EUSTIS                          
--------------------------------------------------------------------------------
                                                                                
                                                                                
                                                                                


REASONS FOR REMOVAL:                                                            
                                                                                
ALL                                                                             
                                                                                
                                                                                
REMOVAL DATE RANGE:                                                             


ALL                                                                             
                                                                                
TREATMENT GROUPS:                                                               
                                                                                
INCLUDE ALL                                                                     

NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11
LAB: American Biogenics                                        DATE: 09/12/94  
EXP: 05091                     DIHYDROCOUMARIN                 TIME: 13:18:28  
TEST: 02              CAGES FROM 0000 TO LAST CAGE                             
TEST TYPE: CHRONIC          ROUTE: GAVAGE                      NTP C#: 55890B  
CONT: NO1-ES-45039                                             CAS: 119-84-6   
PATHOLOGIST: R. DAHLGREN                     S. EUSTIS                         

                                  DIHYDROCOUMARIN


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = VEHICLE CONTROL                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 7      CENSORED DEATHS 21   TERMINAL 42        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      449   456   528   591   658   690   696                                   |
 |  CENSORED DEATHS                                                               |
 |      11    455   455   455   455   456   456   456   456   456                 |
 |      456   458   458   458   458   458   458   458   458   458                 |
 |      458                                                                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 200MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 11     CENSORED DEATHS 20   TERMINAL 39        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      423   438   449   553   558   568   643   666   673   718                 |
 |      723                                                                       |
 |  CENSORED DEATHS                                                               |
 |      107   455   455   455   455   455   455   456   456   456                 |
 |      458   458   458   458   458   458   458   458   458   458                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 400MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 16     CENSORED DEATHS 20   TERMINAL 34        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      393   410   555   583   599   618   639   640   655   659                 |
 |      675   679   715   718   718   722                                         |
 |  CENSORED DEATHS                                                               |
 |      14    455   455   455   455   455   456   456   456   456                 |
 |      458   458   458   458   458   458   458   458   458   458                 |
 |                                                                                |
 ==================================================================================

                                  DIHYDROCOUMARIN


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 800MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 12     CENSORED DEATHS 20   TERMINAL 38        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      417   438   477   489   527   561   613   634   645   652                 |
 |      716   722                                                                 |
 |  CENSORED DEATHS                                                               |
 |      455   455   455   455   455   456   456   456   456   456                 |
 |      458   458   458   458   458   458   458   458   458   458                 |
 |                                                                                |
 ==================================================================================

                                  DIHYDROCOUMARIN


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


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   729 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |VEHICLE    |   100.0 100.0 100.0 100.0 100.0  97.0  94.9  92.9  90.8  86.7      |
 |CONTROL    |                                                                    |
 |           |                                                                    |
 |200MG/KG   |   100.0 100.0 100.0 100.0  98.6  95.7  95.7  89.5  87.5  79.4      |
 |           |                                                                    |
 |           |                                                                    |
 |400MG/KG   |   100.0 100.0 100.0 100.0  97.1  97.1  97.1  91.0  80.9  68.8      |
 |           |                                                                    |
 |           |                                                                    |
 |800MG/KG   |   100.0 100.0 100.0 100.0  98.6  95.1  91.1  89.0  81.0  76.9      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                VEHICLE      200MG/KG     400MG/KG     800MG/KG |
 |                                CONTROL                                         |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       86.7%        79.4%        68.8%        76.9%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.287      P=0.443      P=0.071      P=0.315  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       581.1        582.9        623.6        574.3    |
 |NATURAL DEATHS (C)      |       (39.9)       (33.4)       (25.0)       (30.2)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       626.2        623.3        620.8        624.7    |
 |(STANDARD ERROR)        |       (17.5)       (16.8)       (17.2)       (15.3)   |
 |                        |                                                       |
 ==================================================================================
                                    


       (A)  FIRST TERMINAL SACRIFICE
       (B)  THE FIRST ENTRY IS THE TREND TEST (TARONE, 1975) RESULT.
            SUBSEQUENT ENTRIES ARE THE RESULTS OF PAIRWISE TESTS
            (COX,1972).  NEGATIVE TRENDS ARE INDICATED BY "N".
       (C)  MEAN OF ALL UNCENSORED DEATHS PRIOR TO TERMINAL SACRIFICE
       (D)  MEAN OF ALL DEATHS (UNCENSORED, CENSORED, TERMINAL SACRIFICE)

                                  DIHYDROCOUMARIN


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = VEHICLE CONTROL                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 13     CENSORED DEATHS 21   TERMINAL 36        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      117   545   587   597   605   639   643   668   674   674                 |
 |      680   704   707                                                           |
 |  CENSORED DEATHS                                                               |
 |      15    24    455   455   455   455   456   456   456   456                 |
 |      456   458   458   458   458   458   458   458   458   458                 |
 |      458                                                                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 200MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 11     CENSORED DEATHS 20   TERMINAL 39        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      437   590   594   615   632   671   685   703   717   720                 |
 |      721                                                                       |
 |  CENSORED DEATHS                                                               |
 |      455   455   456   456   456   456   456   456   456   456                 |
 |      458   458   458   458   458   458   458   458   458   458                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 400MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 9      CENSORED DEATHS 20   TERMINAL 41        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      444   515   538   665   687   694   694   700   717                       |
 |  CENSORED DEATHS                                                               |
 |      455   455   456   456   456   456   456   456   456   458                 |
 |      458   458   458   458   458   458   458   458   458   521                 |
 |                                                                                |
 ==================================================================================

                                  DIHYDROCOUMARIN


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 800MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 23     CENSORED DEATHS 18   TERMINAL 29        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      9     419   420   422   462   504   526   529   540   545                 |
 |      554   583   592   595   637   646   654   689   692   701                 |
 |      703   703   704                                                           |
 |  CENSORED DEATHS                                                               |
 |      455   455   456   456   456   456   456   456   456   458                 |
 |      458   458   458   458   458   458   458   458                             |
 |                                                                                |
 ==================================================================================

                                  DIHYDROCOUMARIN


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


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   729 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |VEHICLE    |   100.0  98.5  98.5  98.5  98.5  98.5  96.5  90.3  86.2  73.9      |
 |CONTROL    |                                                                    |
 |           |                                                                    |
 |200MG/KG   |   100.0 100.0 100.0 100.0 100.0  98.6  98.6  94.5  90.5  78.5      |
 |           |                                                                    |
 |           |                                                                    |
 |400MG/KG   |   100.0 100.0 100.0 100.0 100.0  98.6  94.6  94.6  92.6  82.5      |
 |           |                                                                    |
 |           |                                                                    |
 |800MG/KG   |    98.6  98.6  98.6  98.6  94.3  92.3  82.5  74.6  68.8  57.0      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                VEHICLE      200MG/KG     400MG/KG     800MG/KG |
 |                                CONTROL                                         |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       73.9%        78.5%        82.5%        57.0%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.014      P=0.698N     P=0.396N     P=0.063  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       603.1        644.1        628.2        557.8    |
 |NATURAL DEATHS (C)      |       (42.7)       (25.6)       (33.6)       (32.0)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       611.5        637.9        639.2        602.8    |
 |(STANDARD ERROR)        |       (20.0)       (14.8)       (14.8)       (17.1)   |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                                                          DIHYDROCOUMARIN
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        VEHICLE CONTROL  = 1
                                                        200MG/KG         = 2
                                                        400MG/KG         = 3
                                                        800MG/KG         = 4

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

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

      |
      |
  100 + 1                                                              3  42    1
      |                                                                3 342 2  11
      |                                                                  3   2  21  4       1   3
      |                                                                         2              2
   95 +                                                                             44      1   3   3 1
      |                                                                                        22
P     |                                                                              4      4       3 13       1
E     |                                                                                     4   242    3  3    1     1
R  90 +                                                                                           2          2
C     |                                                                                          4       43  3       11
E     |                                                                                                  4  42    2
N     |                                                                                                               1     1
T  85 +                                                                                                     4343  22
      |                                                                                                            2     2
S     |                                                                                                       43 3
U     |                                                                                                        4 3 3     22
R  80 +
V     |                                                                                                                  42 2
I     |                                                                                                                   4 4
V     |                                                                                                            3     3
A  75 +
L     |
      |
      |                                                                                                                  33
   70 +
      |                                                                                                                   3 3
      |
      |
   65 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 8 obs hidden.

                                                          DIHYDROCOUMARIN
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        VEHICLE CONTROL  = 1
                                                        200MG/KG         = 2
                                                        400MG/KG         = 3
                                                        800MG/KG         = 4

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

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

      |
      |
  100 + 1 4                1                                                 23
      |   4                1                                              4  23          3    1       2
      |
      |                                                                   44             3   31     1
   95 +                                                                                      3      1 21 2       3
      |                                                                    4     4
      |                                                                          4     4               112  2    3   3
      |
   90 +                                                                                4    4           1   21    2  33
      |                                                                                                           2 2
P     |
E     |                                                                                     4 4              1    1 2  2
R  85 +                                                                                                               32 2
C     |                                                                                                           11
E     |                                                                                       4 4                        3  3
N     |
T  80 +                                                                                         4   4              11
      |                                                                                             4 4                  2  2
S     |                                                                                                             1  1
U     |
R  75 +                                                                                               4     4
V     |                                                                                                                1    1
I     |                                                                                                     4 4
V     |                                                                                                       44
A  70 +
L     |                                                                                                        4     4
      |
      |
   65 +                                                                                                              4 4
      |
      |
      |
   60 +
      |
      |                                                                                                                4    4
      |
   55 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 4 obs hidden.