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TDMS Study 05090-02 Pathology Tables


NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11 
LAB: American Biogenics                                        DATE: 09/12/94   
EXP: 05090                        COUMARIN                     TIME: 06:36:33   
TEST: 02              CAGES FROM 0000 TO LAST CAGE             PAGE:   1        
TEST TYPE: CHRONIC          ROUTE: GAVAGE                      NTP C#: 07103B   
CONT: NO1-ES-45039                                             CAS: 91-64-5     
PATHOLOGIST: R. DAHLGREN                                                        
--------------------------------------------------------------------------------
                                                                                
                                                                                
                                                                                


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: 05090                        COUMARIN                     TIME: 06:36:33  
TEST: 02              CAGES FROM 0000 TO LAST CAGE                             
TEST TYPE: CHRONIC          ROUTE: GAVAGE                      NTP C#: 07103B  
CONT: NO1-ES-45039                                             CAS: 91-64-5    
PATHOLOGIST: R. DAHLGREN                                                       

                                     COUMARIN


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = VEHICLE CONTROL                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 6      CENSORED DEATHS 21   TERMINAL 43        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      541   653   670   680   716   726                                         |
 |  CENSORED DEATHS                                                               |
 |      455   455   455   455   455   456   456   456   456   456                 |
 |      456   460   460   460   460   460   460   460   460   460                 |
 |      460                                                                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 50 MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 3      CENSORED DEATHS 20   TERMINAL 47        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      532   607   701                                                           |
 |  CENSORED DEATHS                                                               |
 |      455   455   455   455   455   456   456   456   456   456                 |
 |      460   460   460   460   460   460   460   460   460   460                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 100MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 7      CENSORED DEATHS 21   TERMINAL 42        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      1     64    419   567   567   636   723                                   |
 |  CENSORED DEATHS                                                               |
 |      455   455   455   455   455   456   456   456   456   456                 |
 |      460   460   460   460   460   460   460   460   460   460                 |
 |      525                                                                       |
 |                                                                                |
 ==================================================================================

                                     COUMARIN


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 200MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 14     CENSORED DEATHS 19   TERMINAL 37        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      177   323   412   476   498   541   558   608   659   661                 |
 |      674   687   692   712                                                     |
 |  CENSORED DEATHS                                                               |
 |      455   455   455   455   455   456   456   456   456   460                 |
 |      460   460   460   460   460   460   460   460   460                       |
 |                                                                                |
 ==================================================================================

                                     COUMARIN


                       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    |   100.0 100.0 100.0 100.0 100.0 100.0  98.0  98.0  95.9  87.8      |
 |CONTROL    |                                                                    |
 |           |                                                                    |
 |50 MG/KG   |   100.0 100.0 100.0 100.0 100.0 100.0  98.0  98.0  96.0  94.0      |
 |           |                                                                    |
 |           |                                                                    |
 |100MG/KG   |    97.1  97.1  97.1  97.1  95.7  95.7  95.7  91.6  89.5  87.4      |
 |           |                                                                    |
 |           |                                                                    |
 |200MG/KG   |   100.0  98.6  98.6  97.1  95.7  93.7  89.7  87.7  81.8  73.8      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                VEHICLE      50 MG/KG     100MG/KG     200MG/KG |
 |                                CONTROL                                         |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       87.8%        94.0%        87.4%        73.8%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.008      P=0.476N     P=0.927      P=0.075  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       664.3        613.3        425.3        548.4    |
 |NATURAL DEATHS (C)      |       (27.1)       (48.9)       ( 107)       (42.3)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       642.1        646.5        618.2        619.3    |
 |(STANDARD ERROR)        |       (14.8)       (14.7)       (19.2)       (16.6)   |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                                     COUMARIN


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = VEHICLE CONTROL                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 15     CENSORED DEATHS 22   TERMINAL 33        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      12    159   367   474   550   557   589   589   623   673                 |
 |      683   683   694   708   714                                               |
 |  CENSORED DEATHS                                                               |
 |      2     2     4     4     455   455   455   456   456   456                 |
 |      456   456   460   460   460   460   460   460   460   460                 |
 |      460   460                                                                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 50 MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 10     CENSORED DEATHS 20   TERMINAL 40        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      495   593   622   635   635   670   673   683   715   722                 |
 |  CENSORED DEATHS                                                               |
 |      455   455   456   456   456   456   456   456   456   456                 |
 |      460   460   460   460   460   460   460   460   460   460                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 100MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 8      CENSORED DEATHS 20   TERMINAL 42        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      4     70    564   586   672   679   689   694                             |
 |  CENSORED DEATHS                                                               |
 |      3     455   455   455   456   456   456   456   456   456                 |
 |      456   460   460   460   460   460   460   460   460   460                 |
 |                                                                                |
 ==================================================================================

                                     COUMARIN


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 200MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 21     CENSORED DEATHS 21   TERMINAL 28        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      139   225   253   257   260   288   358   426   496   508                 |
 |      611   615   615   637   655   678   684   684   700   700                 |
 |      716                                                                       |
 |  CENSORED DEATHS                                                               |
 |      48    455   455   456   456   456   456   456   456   456                 |
 |      460   460   460   460   460   460   460   460   460   460                 |
 |      718                                                                       |
 |                                                                                |
 ==================================================================================

                                     COUMARIN


                       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    |    98.5  97.0  97.0  97.0  95.5  93.3  93.3  84.8  82.7  70.0      |
 |CONTROL    |                                                                    |
 |           |                                                                    |
 |50 MG/KG   |   100.0 100.0 100.0 100.0 100.0 100.0  98.0  96.0  90.0  80.0      |
 |           |                                                                    |
 |           |                                                                    |
 |100MG/KG   |    97.1  97.1  97.1  97.1  97.1  97.1  97.1  93.1  93.1  85.0      |
 |           |                                                                    |
 |           |                                                                    |
 |200MG/KG   |   100.0  98.6  92.8  89.9  89.9  88.4  84.2  84.2  73.7  61.0      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                VEHICLE      50 MG/KG     100MG/KG     200MG/KG |
 |                                CONTROL                                         |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       70.0%        80.0%        85.0%        61.0%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.105      P=0.240N     P=0.124N     P=0.330  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       538.3        644.3        494.8        500.2    |
 |NATURAL DEATHS (C)      |       (53.9)       (21.0)       ( 102)       (42.6)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       577.0        639.4        618.2        576.9    |
 |(STANDARD ERROR)        |       (24.8)       (14.5)       (20.8)       (20.9)   |
 |                        |                                                       |
 ==================================================================================
                                    


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

                                                              COUMARIN
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        VEHICLE CONTROL  = 1
                                                        50 MG/KG         = 2
                                                        100MG/KG         = 3
                                                        200MG/KG         = 4

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

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

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

                                                                   WEEK

NOTE: 6 obs hidden.

                                                              COUMARIN
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        VEHICLE CONTROL  = 1
                                                        50 MG/KG         = 2
                                                        100MG/KG         = 3
                                                        200MG/KG         = 4

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

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

      |
      |
  100 + 131                   4                                                       2
      |  31        3          4  1          4
      |            3             1          4    4                1                   2          3    2
      |                                                                                               2   2
   95 +                                                           1                1             3  3
      |                                          44                                1           1          2 2
      |                                           4   4                                             3             3
      |                                               4          4                             11                 33
P  90 +                                                          4         4                                2     2
E     |                                                                    4          4         1     1            3 3
R     |                                                                                                           22 33
C     |                                                                               4 4                          22
E  85 +                                                                                               1   1           3     3
N     |                                                                                 4                4          2    2
T     |                                                                                                   1        1     22
      |
S  80 +                                                                                                            11     2 2
U     |
R     |                                                                                                  4  4
V     |                                                                                                     4  4    1 1
I  75 +
V     |                                                                                                        4   4  1 1
A     |
L     |                                                                                                            44
   70 +                                                                                                                 1   1
      |
      |                                                                                                             4 4
      |
   65 +
      |                                                                                                               4  4
      |
      |                                                                                                                  4  4
   60 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 3 obs hidden.