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https://ntp.niehs.nih.gov/go/1139

TDMS Study 05090-01 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: American Biogenics Cor                                     COUMARIN                                       DATE: 10/22/97       
EXPERIMENT: 05090 TEST: 01                                                                                     TIME: 13:56:48       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01ES45039                                ROUTE: GAVAGE                                                  NTP C#: 07103B       
PATHOLOGIST: R. DAHLGREN                                                                                       CAS: 000091645       
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    

               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE 001    VEHICLE CONTROL                                                               
                                       INCLUDE 002    VEHICLE CONTROL                                                               
                                       INCLUDE 003    25 MG/KG                                                                      
                                       INCLUDE 004    25 MG/KG                                                                      
                                       INCLUDE 005    50 MG/KG                                                                      
                                       INCLUDE 006    50 MG/KG                                                                      
                                       INCLUDE 007    100MG/KG                                                                      
                                       INCLUDE 008    100MG/KG                                                                      
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11    
LAB: American Biogenics Cor                                     COUMARIN                                       DATE: 10/22/97      
EXPERIMENT: 05090 TEST: 01                                                                                     TIME: 13:56:48      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01ES45039                                ROUTE: GAVAGE                                                  NTP C#: 07103B      
PATHOLOGIST: R. DAHLGREN                                                                                       CAS: 000091645      
                                     COUMARIN

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = VEHICLE CONTROL                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 20     CENSORED DEATHS 12   TERMINAL 28        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      372   408   420   472   513   573   578   586   601   609                 |
 |      611   622   623   660   671   694   699   704   720   728                 |
 |  CENSORED DEATHS                                                               |
 |      5     335   453   453   453   455   455   455   455   455                 |
 |      455   456                                                                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 25 MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 38     CENSORED DEATHS 13   TERMINAL 9         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      343   482   492   503   518   569   577   583   593   600                 |
 |      600   611   613   615   622   625   625   631   636   639                 |
 |      645   645   652   657   660   661   663   666   671   671                 |
 |      673   675   675   680   692   694   698   719                             |
 |  CENSORED DEATHS                                                               |
 |      90    352   377   453   453   453   453   455   455   455                 |
 |      455   456   456                                                           |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 50 MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 47     CENSORED DEATHS 11   TERMINAL 2         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      408   429   473   496   498   506   506   512   517   525                 |
 |      531   531   533   539   545   546   548   555   556   569                 |
 |      575   580   580   588   594   596   596   601   602   607                 |
 |      615   615   622   622   622   625   628   630   631   643                 |
 |      643   645   657   666   678   679   694                                   |
 |  CENSORED DEATHS                                                               |
 |      63    428   453   453   453   453   455   455   455   455                 |
 |      456                                                                       |
 |                                                                                |
 ==================================================================================
                                     COUMARIN

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 100MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 48     CENSORED DEATHS 12   TERMINAL 0         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      307   380   420   456   477   485   492   496   496   503                 |
 |      510   511   512   517   518   518   525   533   534   551                 |
 |      552   552   560   563   566   567   572   580   580   589                 |
 |      595   601   607   611   611   615   618   618   630   631                 |
 |      636   638   643   646   650   654   660   698                             |
 |  CENSORED DEATHS                                                               |
 |      19    426   453   453   453   453   455   455   455   455                 |
 |      456   456                                                                 |
 |                                                                                |
 ==================================================================================
                                     COUMARIN

                       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  94.8  92.7  90.6  82.2  71.6  59.0      |
 |CONTROL    |                                                                    |
 |           |                                                                    |
 |25 MG/KG   |   100.0 100.0 100.0  98.3  98.3  96.2  89.8  76.9  42.7  19.2      |
 |           |                                                                    |
 |           |                                                                    |
 |50 MG/KG   |   100.0 100.0 100.0 100.0  98.3  94.5  69.9  41.1  12.3   4.1      |
 |           |                                                                    |
 |           |                                                                    |
 |100MG/KG   |   100.0 100.0 100.0  98.3  94.9  88.7  61.2  33.8   2.1   0.0      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                VEHICLE      25 MG/KG     50 MG/KG     100MG/KG |
 |                                CONTROL                                         |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       59.0%        19.2%         4.1%         0.0%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P<0.001      P<0.001      P<0.001      P<0.001  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       593.2        620.4        577.8        558.0    |
 |NATURAL DEATHS (C)      |       (23.8)       (11.9)       ( 9.4)       (11.0)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       619.4        591.6        553.2        529.6    |
 |(STANDARD ERROR)        |       (19.1)       (16.3)       (13.3)       (13.5)   |
 |                        |                                                       |
 ==================================================================================
                                    

       (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 RATS
                       FIRST TERMINAL SACRIFICE AT 729 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = VEHICLE CONTROL                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 19     CENSORED DEATHS 12   TERMINAL 29        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      356   435   491   554   580   607   614   624   649   659                 |
 |      662   665   693   699   700   708   712   714   719                       |
 |  CENSORED DEATHS                                                               |
 |      92    184   455   455   455   455   455   456   456   456                 |
 |      456   456                                                                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 25 MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 11     CENSORED DEATHS 11   TERMINAL 38        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      334   334   439   531   547   654   659   659   662   693                 |
 |      713                                                                       |
 |  CENSORED DEATHS                                                               |
 |      245   455   455   455   456   456   456   456   456   456                 |
 |      456                                                                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 50 MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 9      CENSORED DEATHS 15   TERMINAL 36        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      554   565   601   622   635   637   691   705   709                       |
 |  CENSORED DEATHS                                                               |
 |      13    21    34    67    189   455   455   455   455   456                 |
 |      456   456   456   456   456                                               |
 |                                                                                |
 ==================================================================================
                                     COUMARIN

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 100MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 20     CENSORED DEATHS 10   TERMINAL 30        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      375   463   491   543   551   580   619   629   641   642                 |
 |      651   651   658   665   679   679   686   693   699   699                 |
 |  CENSORED DEATHS                                                               |
 |      455   455   455   456   456   456   456   456   456   456                 |
 |                                                                                |
 ==================================================================================
                                     COUMARIN

                       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  98.3  98.3  96.6  94.5  90.3  75.6  60.9      |
 |CONTROL    |                                                                    |
 |           |                                                                    |
 |25 MG/KG   |   100.0 100.0 100.0  96.6  96.6  94.9  92.9  90.8  82.5  78.4      |
 |           |                                                                    |
 |           |                                                                    |
 |50 MG/KG   |   100.0 100.0 100.0 100.0 100.0 100.0 100.0  93.3  86.7  80.0      |
 |           |                                                                    |
 |           |                                                                    |
 |100MG/KG   |   100.0 100.0 100.0 100.0  98.3  96.3  92.3  88.3  72.2  60.2      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                VEHICLE      25 MG/KG     50 MG/KG     100MG/KG |
 |                                CONTROL                                         |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       60.9%        78.4%        80.0%        60.2%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.616      P=0.133N     P=0.070N     P=0.990  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       623.2        565.9        635.4        614.7    |
 |NATURAL DEATHS (C)      |       (23.3)       (42.4)       (19.1)       (19.8)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       630.2        645.5        614.1        645.4    |
 |(STANDARD ERROR)        |       (18.9)       (17.2)       (25.4)       (14.4)   |
 |                        |                                                       |
 ==================================================================================
                                    

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

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

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

      |
  100 + 1                                               4     2    1     3
      |                                                 4     2    1 4   11 3      32
      |                                                                   1      4 12 22
      |                                                                          4 14 32 1
   90 +                                                                             44 331        1
      |                                                                              44 33        111
      |                                                                                            21  1
      |                                                                               44 3 3        2 211
   80 +                                                                                44  33         2211
      |                                                                                                2 11
      |                                                                                 44  33            1      1
      |                                                                                      33                  11
P  70 +                                                                                                  22       1   1
E     |                                                                                  4 4  33          22
R     |                                                                                    4 4 33          22         11
C     |                                                                                         3 3                    1 1
E  60 +                                                                                      4 4  33        22           11 1
N     |                                                                                                      22
T     |                                                                                        44
      |                                                                                         44 33 3       22
S  50 +                                                                                               33       2 2
U     |                                                                                          44
R     |                                                                                           44
V     |                                                                                                          22
I  40 +                                                                                            4  4333
V     |                                                                                                           22
A     |                                                                                               44433
L     |                                                                                                 44
   30 +                                                                                                   33       22
      |                                                                                                             22
      |                                                                                                  44          22
      |                                                                                                    33         2  2
   20 +                                                                                                   4433           2  2
      |                                                                                                      33
      |                                                                                                     4433
      |                                                                                                        3  3
   10 +                                                                                                      44   33
      |                                                                                                       44
      |                                                                                                        4 4 3  3     3
      |                                                                                                          4    4
    0 +                                                                                                               4
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 28 obs hidden.
                                                              COUMARIN
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        VEHICLE CONTROL  = 1
                                                        25 MG/KG         = 2
                                                        50 MG/KG         = 3
                                                        100MG/KG         = 4

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

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

      |
      |
  100 + 1                                                    2  1  4                            3
      |                                                         1  4         1    4
      |                                                                                         33
      |                                                      2               1    4   1
   95 +                                                                      2        1     2   13     3
      |                                                                               4       4        3  3
      |                                                                                     2 421  1
      |                                                                                        2          3 3  2
P  90 +                                                                                        4   1    1
E     |                                                                                            4    114    2 2
R     |
C     |                                                                                                  1413        3
E  85 +                                                                                                              3 3
N     |                                                                                                    1 41
T     |                                                                                                          2   2 33
      |                                                                                                       1  1
S  80 +                                                                                                      44      2  2   3
U     |                                                                                                                 2   2
R     |
V     |                                                                                                       44
I  75 +                                                                                                          1   1
V     |                                                                                                        4 4   11
A     |                                                                                                          4 4
L     |
   70 +
      |                                                                                                            44 1 1
      |
      |                                                                                                             44
   65 +
      |                                                                                                              44
      |                                                                                                                 11
      |                                                                                                                  1  1
   60 +                                                                                                               4     4
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 10 obs hidden.