National Toxicology Program

National Toxicology Program
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TDMS Study 05063-02 Pathology Tables

NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11 
LAB: Mason                                                     DATE: 09/08/94   
EXP: 05063                     PHENYLBUTAZONE                  TIME: 21:30:28   
TEST: 02              CAGES FROM 0000 TO LAST CAGE             PAGE:   1        
TEST TYPE: CHRONIC          ROUTE: GAVAGE                      NTP C#: 56531    
CONT: N01ES1803301                                             CAS: 50-33-9     
PATHOLOGIST: R. FLEISCHMAN                                                      
--------------------------------------------------------------------------------
                                                                                
                                                                                
                                                                                


REASONS FOR REMOVAL:                                                            
                                                                                
ALL                                                                             
                                                                                
                                                                                
REMOVAL DATE RANGE:                                                             


ALL                                                                             
                                                                                
TREATMENT GROUPS:                                                               
                                                                                
INCLUDE ALL                                                                     

NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11
LAB: Mason                                                     DATE: 09/08/94  
EXP: 05063                     PHENYLBUTAZONE                  TIME: 21:30:28  
TEST: 02              CAGES FROM 0000 TO LAST CAGE                             
TEST TYPE: CHRONIC          ROUTE: GAVAGE                      NTP C#: 56531   
CONT: N01ES1803301                                             CAS: 50-33-9    
PATHOLOGIST: R. FLEISCHMAN                                                     

                                  PHENYLBUTAZONE


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


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = VEHICLE                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 14     CENSORED DEATHS 0    TERMINAL 36        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      440   558   586   593   606   627   639   661   666   697                 |
 |      698   705   712   712                                                     |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.15G/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 8      CENSORED DEATHS 2    TERMINAL 40        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      612   627   633   647   660   697   698   702                             |
 |  CENSORED DEATHS                                                               |
 |      6     6                                                                   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.3 G/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 14     CENSORED DEATHS 0    TERMINAL 36        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      416   417   500   534   598   599   618   641   661   697                 |
 |      697   700   703   712                                                     |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================

                                  PHENYLBUTAZONE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       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  98.0  92.0  84.0  72.0      |
 |           |                                                                    |
 |           |                                                                    |
 |0.15G/KG   |   100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0  89.6  83.3      |
 |           |                                                                    |
 |           |                                                                    |
 |0.3 G/KG   |   100.0 100.0 100.0 100.0  96.0  96.0  92.0  88.0  82.0  72.0      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                    DOSE                        |
 |                                                                                |
 |                                VEHICLE          0.15G/KG         0.3 G/KG      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       72.0%            83.3%            72.0%         |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=1.000          P=0.254N         P=1.000       |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       635.7            659.5            606.6         |
 |NATURAL DEATHS (C)      |       (20.3)           (12.6)           (27.6)        |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       703.6            689.8            695.5         |
 |(STANDARD ERROR)        |       ( 8.2)           (20.4)           (10.9)        |
 |                        |                                                       |
 ==================================================================================
                                    


       (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)

                                  PHENYLBUTAZONE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 731 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = VEHICLE                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 28     CENSORED DEATHS 0    TERMINAL 22        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      500   568   572   591   596   599   604   610   613   617                 |
 |      631   633   641   652   659   663   669   670   685   688                 |
 |      693   702   710   715   718   726   726   729                             |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.15G/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 21     CENSORED DEATHS 0    TERMINAL 29        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      31    202   244   245   431   445   476   510   557   564                 |
 |      569   579   606   612   613   624   646   647   692   705                 |
 |      712                                                                       |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.3 G/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 17     CENSORED DEATHS 1    TERMINAL 32        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      59    60    60    376   469   492   492   494   513   568                 |
 |      605   638   646   698   702   708   714                                   |
 |  CENSORED DEATHS                                                               |
 |      5                                                                         |
 |                                                                                |
 ==================================================================================

                                  PHENYLBUTAZONE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 731 DAYS


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   731 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |VEHICLE    |   100.0 100.0 100.0 100.0 100.0 100.0  98.0  86.0  68.0  44.0      |
 |           |                                                                    |
 |           |                                                                    |
 |0.15G/KG   |    98.0  98.0  92.0  92.0  92.0  86.0  84.0  76.0  64.0  58.0      |
 |           |                                                                    |
 |           |                                                                    |
 |0.3 G/KG   |    93.9  93.9  93.9  93.9  91.8  89.8  81.6  77.6  73.5  65.3      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                    DOSE                        |
 |                                                                                |
 |                                VEHICLE          0.15G/KG         0.3 G/KG      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       44.0%            58.0%            65.3%         |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.133N         P=0.539N         P=0.132N      |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       649.3            510.0            487.9         |
 |NATURAL DEATHS (C)      |       (10.9)           (40.3)           (54.9)        |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       685.2            638.2            633.8         |
 |(STANDARD ERROR)        |       ( 8.4)           (22.8)           (27.7)        |
 |                        |                                                       |
 ==================================================================================
                                    


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

                                                           PHENYLBUTAZONE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        VEHICLE          = 1
                                                        0.15G/KG         = 2
                                                        0.3 G/KG         = 3

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

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

      |
      |
  100 + 1                                                                 3  1                           2
      |
      |                                                                      1                  1        2 2
      |                                                                   3            3        1   1      22
P  95 +
E     |                                                                                3     3      1 1     2 2
R     |                                                                                      3        131
C     |                                                                                                       2  2
E  90 +                                                                                                 1  1     2    2
N     |
T     |                                                                                                3  31 1
      |                                                                                                   3  1   1
S  85 +                                                                                                               22
U     |                                                                                                      3   11    2    2
R     |                                                                                                          31   1
V     |
I  80 +
V     |
A     |                                                                                                               11
L     |                                                                                                               311
   75 +
      |                                                                                                                33
      |                                                                                                                 1   1
      |
   70 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 8 obs hidden.

                                                           PHENYLBUTAZONE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        VEHICLE          = 1
                                                        0.15G/KG         = 2
                                                        0.3 G/KG         = 3

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

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

      |
      |
  100 + 1     2   3                                                                    1
      |       2                         2                                              1          1
      |           3                     2      2                   3                              1   1
      |                                        2                   3        2     3                   11
P  90 +                                                                     2 2   3   3
E     |                                                                       2    2                   11
R     |                                                                            2    2       2       11
C     |                                                                               3  3      223      11
E  80 +                                                                                          22     3 1 1
N     |                                                                                           22    3    3
T     |                                                                                            2    22  1131
      |                                                                                                       31 1    33
S  70 +                                                                                                  2 2           33
U     |                                                                                                    2  2  11
R     |                                                                                                       2   1 12  3   3
V     |                                                                                                             11 2
I  60 +                                                                                                                22
V     |                                                                                                              1 12   2
A     |                                                                                                                111
L     |
   50 +                                                                                                                  11
      |
      |                                                                                                                   1 1
      |
   40 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 12 obs hidden.
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