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TDMS Study 05099-08 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Southern Research Inst                             SALICYLAZOSULFAPYRIDINE                                DATE: 04/03/96       
EXPERIMENT: 05099 TEST: 08                                                                                     TIME: 20:46:43       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-85233                              ROUTE: GAVAGE                                                  NTP C#: 61552B       
PATHOLOGIST: R.B. THOMPSON                                                                                     CAS: 599-79-1        
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    

               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11    
LAB: Southern Research Inst                             SALICYLAZOSULFAPYRIDINE                                DATE: 04/03/96      
EXPERIMENT: 05099 TEST: 08                                                                                     TIME: 20:46:43      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01-ES-85233                              ROUTE: GAVAGE                                                  NTP C#: 61552B      
PATHOLOGIST: R.B. THOMPSON                                                                                     CAS: 599-79-1       
                              SALICYLAZOSULFAPYRIDINE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 728 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0 MG/KG                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 8      CENSORED DEATHS 12   TERMINAL 40        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      420   420   610   611   658   662   666   689                             |
 |  CENSORED DEATHS                                                               |
 |      150   351   456   456   456   456   456   456   456   456                 |
 |      456   456                                                                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 0 MG/KG FEED RTD                               |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 4      CENSORED DEATHS 11   TERMINAL 45        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      574   601   610   633                                                     |
 |  CENSORED DEATHS                                                               |
 |      151   456   456   456   456   456   456   456   456   456                 |
 |      456                                                                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 675     MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 9      CENSORED DEATHS 10   TERMINAL 41        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      75    288   567   588   611   652   665   666   700                       |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   456   456   456                 |
 |                                                                                |
 ==================================================================================
                              SALICYLAZOSULFAPYRIDINE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 728 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = 1350    MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 9      CENSORED DEATHS 10   TERMINAL 41        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      402   504   505   611   648   678   681   681   702                       |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   456   456   456                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 2700    MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 4      CENSORED DEATHS 10   TERMINAL 46        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      6     7     497   647                                                     |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   456   456   456                 |
 |                                                                                |
 ==================================================================================
                              SALICYLAZOSULFAPYRIDINE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 728 DAYS

 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   728 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0 MG/KG    |   100.0 100.0 100.0 100.0  96.6  96.6  96.6  96.6  88.2  84.0      |
 |           |                                                                    |
 |           |                                                                    |
 |0          |   100.0 100.0 100.0 100.0 100.0 100.0 100.0  95.9  91.8  91.8      |
 |MG/KG FEED |TD                                                                  |
 |           |                                                                    |
 |675        |    98.3  98.3  98.3  96.7  96.7  96.7  96.7  92.6  86.6  82.6      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 |1350       |   100.0 100.0 100.0 100.0  98.3  98.3  94.3  94.3  90.3  82.3      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 |2700       |    96.7  96.7  96.7  96.7  96.7  96.7  94.7  94.7  92.6  92.6      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 ==================================================================================
                              SALICYLAZOSULFAPYRIDINE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 728 DAYS

 ===============================================================================================================================
 |                                               SURVIVAL SUMMARY STATISTICS                                                   |
 |                                                                                                                             |
 |                                                                                                                             |
 |-----------------------------------------------------------------------------------------------------------------------------|
 |                                                                           DOSE                                              |
 |                                                                                                                             |
 |                                0 MG/KG            0                  675                1350               2700             |
 |                                                   MG/KG FEED RTD     MG/KG              MG/KG              MG/KG            |
 |-----------------------------------------------------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       84.0%              91.8%              82.6%              82.3%              92.6%            |
 |(KAPLAN-MEIER)          |                                                                                                    |
 |                        |                                                                                                    |
 |SIGNIFICANCE (B)        |       P=0.638N            -----             P=1.000            P=1.000            P=0.350N         |
 |(LIFE TABLE)            |                                                                                                    |
 |                        |                                                                                                    |
 |MEAN DAY OF             |       592.0              604.5              534.7              601.3              289.3            |
 |NATURAL DEATHS (C)      |       (38.7)             (12.2)             (70.4)             (35.2)             ( 166)           |
 |(STANDARD ERROR)        |                                                                                                    |
 |                        |                                                                                                    |
 |MEAN LIFE SPAN (D)      |       648.6              664.8              653.7              663.7              653.4            |
 |(STANDARD ERROR)        |       (17.4)             (15.9)             (17.6)             (14.3)             (20.6)           |
 |                        |                                                                                                    |
 ===============================================================================================================================
                                    

       (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)
                              SALICYLAZOSULFAPYRIDINE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 735 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0 MG/KG                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 7      CENSORED DEATHS 12   TERMINAL 41        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      324   429   476   518   595   708   723                                   |
 |  CENSORED DEATHS                                                               |
 |      14    74    457   457   457   457   457   457   457   457                 |
 |      457   457                                                                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 675     MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 9      CENSORED DEATHS 10   TERMINAL 41        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      224   297   471   493   539   551   620   723   732                       |
 |  CENSORED DEATHS                                                               |
 |      457   457   457   457   457   457   457   457   457   457                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 1350    MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 12     CENSORED DEATHS 11   TERMINAL 37        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      9     171   316   420   588   618   660   661   663   686                 |
 |      693   732                                                                 |
 |  CENSORED DEATHS                                                               |
 |      457   457   457   457   457   457   457   457   457   457                 |
 |      465                                                                       |
 |                                                                                |
 ==================================================================================
                              SALICYLAZOSULFAPYRIDINE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 735 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = 2700    MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 10     CENSORED DEATHS 12   TERMINAL 38        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      67    70    583   603   604   610   655   659   660   695                 |
 |  CENSORED DEATHS                                                               |
 |      2     72    457   457   457   457   457   457   457   457                 |
 |      457   457                                                                 |
 |                                                                                |
 ==================================================================================
                              SALICYLAZOSULFAPYRIDINE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 735 DAYS

 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   735 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0 MG/KG    |   100.0 100.0 100.0  98.3  98.3  94.5  92.4  90.3  90.3  86.1      |
 |           |                                                                    |
 |           |                                                                    |
 |675        |   100.0 100.0  98.3  96.7  96.7  94.7  90.6  88.6  86.6  82.6      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 |1350       |    98.3  96.7  96.7  95.0  93.3  93.3  93.3  91.3  83.0  76.7      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 |2700       |    96.6  96.6  96.6  96.6  96.6  96.6  96.6  90.3  81.9  79.8      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                0 MG/KG      675          1350         2700     |
 |                                             MG/KG        MG/KG        MG/KG    |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       86.1%        82.6%        76.7%        79.8%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.487      P=0.837      P=0.327      P=0.595  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       539.0        516.7        518.1        520.6    |
 |NATURAL DEATHS (C)      |       (55.3)       (57.5)       (68.0)       (76.1)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       642.8        655.9        640.8        629.7    |
 |(STANDARD ERROR)        |       (21.4)       (17.3)       (20.5)       (24.2)   |
 |                        |                                                       |
 ==================================================================================
                                    

       (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)
                                                      SALICYLAZOSULFAPYRIDINE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0 MG/KG          = 1
                                                        0 MG/KG FEED RTD = 2
                                                        675     MG/KG    = 3
                                                        1350    MG/KG    = 4
                                                        2700    MG/KG    = 5

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

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

      |
      |
  100 + 15          3                                                   4 1                       2
      |
      |
      |             3                                 3                 4              4
   98 +                                                                                           2    2
      |
      |
      |  5                                            3                   1           544        3       1
   96 +                                                                                                2 2
      |
P     |
E     |                                                                               5 4        3  3    4    5
R  94 +                                                                                                  2  2
C     |
E     |
N     |                                                                                             3    1    41          5
T  92 +                                                                                                     2             2
      |
S     |
U     |                                                                                                  3    41 1 4
R  90 +
V     |
I     |
V     |                                                                                                        3 3 44
A  88 +                                                                                                          11
L     |
      |
      |                                                                                                          33
   86 +                                                                                                           1  1
      |
      |
      |                                                                                                           3 4 34
   84 +                                                                                                              1    1
      |
      |
      |                                                                                                               34  3
   82 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 9 obs hidden.
                                                      SALICYLAZOSULFAPYRIDINE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0 MG/KG          = 1
                                                        675     MG/KG    = 2
                                                        1350    MG/KG    = 3
                                                        2700    MG/KG    = 4

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

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

        |
  100.0 +1 3        4                       2                1
        |
        |
        |  3                         3      2           2    1               1
   97.5 +
        |           4                3                  2   3                       2                4
        |                                                                    1      1
        |
   95.0 +                                                   3              3
        |                                                                           1  2  1          4   4
        |
        |                                                                  3                         3
P  92.5 +                                                                              2  1   2        1
E       |
R       |                                                                                            3     3
C       |                                                                                     2 2
E  90.0 +                                                                                              1 44              1
N       |                                                                                                  3      3
T       |                                                                                       2          2
        |                                                                                                 4     4        1 1
S  87.5 +
U       |                                                                                                  2               2
R       |                                                                                                       4 4        1 1
V       |
I  85.0 +
V       |                                                                                                                  2 2
A       |
L       |                                                                                                         3  3
   82.5 +                                                                                                                    2
        |                                                                                                         4    4
        |
        |                                                                                                            33
   80.0 +                                                                                                              4     4
        |
        |                                                                                                             3      3
        |
   77.5 +
        |                                                                                                                    3
        |
        |
   75.0 +
        |
        -+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-
         0         10         20         30         40         50         60         70         80         90         100        110

                                                                    WEEK

NOTE: 4 obs hidden.