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TDMS Study 05063-01 Pathology Tables

NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11 
LAB: Mason                                                     DATE: 09/08/94   
EXP: 05063                     PHENYLBUTAZONE                  TIME: 19:38:46   
TEST: 01              CAGES FROM 0000 TO LAST CAGE             PAGE:   1        
TEST TYPE: CHRONIC          ROUTE: GAVAGE                      NTP C#: 56531    
CONT: N01-ES-28033                                             CAS: 50-33-9     
PATHOLOGIST: R. FLEISCHMAN                                                      
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NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11
LAB: Mason                                                     DATE: 09/08/94  
EXP: 05063                     PHENYLBUTAZONE                  TIME: 19:38:46  
TEST: 01              CAGES FROM 0000 TO LAST CAGE                             
TEST TYPE: CHRONIC          ROUTE: GAVAGE                      NTP C#: 56531   
CONT: N01-ES-28033                                             CAS: 50-33-9    
PATHOLOGIST: R. FLEISCHMAN                                                     

                                  PHENYLBUTAZONE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 730 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = VEHICLE                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 17     CENSORED DEATHS 0    TERMINAL 33        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      456   519   521   526   589   595   598   599   605   618                 |
 |      639   641   645   672   683   686   701                                   |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.05G/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 29     CENSORED DEATHS 1    TERMINAL 20        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      381   448   472   519   536   542   577   584   593   597                 |
 |      603   607   616   620   622   623   627   630   635   642                 |
 |      646   654   672   680   697   704   717   725   728                       |
 |  CENSORED DEATHS                                                               |
 |      284                                                                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.1 G/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 23     CENSORED DEATHS 0    TERMINAL 27        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      494   505   514   520   548   564   567   575   581   598                 |
 |      632   644   658   689   692   694   703   705   711   715                 |
 |      716   716   721                                                           |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================

                                  PHENYLBUTAZONE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 730 DAYS


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   730 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |VEHICLE    |   100.0 100.0 100.0 100.0 100.0  98.0  92.0  82.0  74.0  66.0      |
 |           |                                                                    |
 |           |                                                                    |
 |0.05G/KG   |   100.0 100.0 100.0 100.0  98.0  93.9  87.8  77.6  55.1  40.8      |
 |           |                                                                    |
 |           |                                                                    |
 |0.1 G/KG   |   100.0 100.0 100.0 100.0 100.0 100.0  92.0  80.0  74.0  54.0      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                    DOSE                        |
 |                                                                                |
 |                                VEHICLE          0.05G/KG         0.1 G/KG      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       66.0%            40.8%            54.0%         |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.374          P=0.025          P=0.385       |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       605.5            610.2            628.8         |
 |NATURAL DEATHS (C)      |       (16.5)           (15.2)           (16.7)        |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       687.7            651.6            683.4         |
 |(STANDARD ERROR)        |       (10.1)           (14.2)           (10.5)        |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                                  PHENYLBUTAZONE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 732 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = VEHICLE                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 19     CENSORED DEATHS 0    TERMINAL 31        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      211   421   485   504   506   533   550   590   619   631                 |
 |      637   651   668   674   680   695   705   714   727                       |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.05G/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 14     CENSORED DEATHS 1    TERMINAL 35        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      299   359   379   557   578   619   655   669   681   683                 |
 |      690   699   704   713                                                     |
 |  CENSORED DEATHS                                                               |
 |      337                                                                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.1 G/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 28     CENSORED DEATHS 0    TERMINAL 22        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      115   417   489   500   504   508   511   520   527   554                 |
 |      563   578   585   585   590   617   619   621   653   659                 |
 |      661   673   673   703   709   718   721   728                             |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================

                                  PHENYLBUTAZONE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 732 DAYS


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   732 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |VEHICLE    |   100.0 100.0  98.0  98.0  96.0  94.0  88.0  84.0  76.0  62.0      |
 |           |                                                                    |
 |           |                                                                    |
 |0.05G/KG   |   100.0 100.0 100.0  96.0  93.9  93.9  93.9  89.8  85.8  71.5      |
 |           |                                                                    |
 |           |                                                                    |
 |0.1 G/KG   |   100.0  98.0  98.0  98.0  96.0  96.0  82.0  70.0  58.0  44.0      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                    DOSE                        |
 |                                                                                |
 |                                VEHICLE          0.05G/KG         0.1 G/KG      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       62.0%            71.5%            44.0%         |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.066          P=0.389N         P=0.091       |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       589.5            591.8            582.2         |
 |NATURAL DEATHS (C)      |       (29.2)           (37.9)           (23.4)        |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       677.9            684.8            648.1         |
 |(STANDARD ERROR)        |       (14.7)           (15.4)           (16.8)        |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                                                           PHENYLBUTAZONE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        VEHICLE          = 1
                                                        0.05G/KG         = 2
                                                        0.1 G/KG         = 3

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

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

      |
      |
  100 + 1                                                            2           1    3
      |                                                              2        2  1    3 3  1
      |                                                                       2    2    33 11
      |                                                                                    212 3      1
P  90 +                                                                                      223 3
E     |                                                                                       2    2  11
R     |                                                                                          3 22  11
C     |                                                                                            32 221 1
E  80 +                                                                                                22 1 31
N     |                                                                                                     33
T     |                                                                                                 22   113  1  3
      |                                                                                                  22       1 1
S  70 +                                                                                                              33
U     |                                                                                                   22        1 31
R     |                                                                                                                13   1
V     |                                                                                                    22           33
I  60 +                                                                                                     222
V     |                                                                                                       22
A     |                                                                                                        2  2      3  3
L     |                                                                                                           2 2
   50 +                                                                                                             2 22
      |                                                                                                                2 2
      |                                                                                                                  22
      |
   40 +                                                                                                                   2 2
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 18 obs hidden.

                                                           PHENYLBUTAZONE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        VEHICLE          = 1
                                                        0.05G/KG         = 2
                                                        0.1 G/KG         = 3

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

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

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

                                                                   WEEK

NOTE: 14 obs hidden.