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https://ntp.niehs.nih.gov/go/3357

TDMS Study 05099-07 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Southern Research Inst                             SALICYLAZOSULFAPYRIDINE                                DATE: 04/03/96       
EXPERIMENT: 05099 TEST: 07                                                                                     TIME: 19:39:42       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-85233                              ROUTE: GAVAGE                                                  NTP C#: 61552B       
PATHOLOGIST: DR J. HEATH                                                                                       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: 07                                                                                     TIME: 19:39:42      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: N01-ES-85233                              ROUTE: GAVAGE                                                  NTP C#: 61552B      
PATHOLOGIST: DR J. HEATH                                                                                       CAS: 599-79-1       
                              SALICYLAZOSULFAPYRIDINE

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0 MG/KG                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 14     CENSORED DEATHS 21   TERMINAL 35        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      473   477   500   523   551   605   632   653   676   684                 |
 |      708   717   717   726                                                     |
 |  CENSORED DEATHS                                                               |
 |      150   183   183   183   183   183   183   183   183   183                 |
 |      183   456   456   456   456   456   457   457   457   457                 |
 |      457                                                                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 0 MG/KG FEED RTD                               |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 17     CENSORED DEATHS 12   TERMINAL 31        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      484   521   526   542   578   591   620   627   646   689                 |
 |      689   692   697   703   704   709   726                                   |
 |  CENSORED DEATHS                                                               |
 |      66    456   456   456   456   456   457   457   457   457                 |
 |      457   458                                                                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 84 MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 13     CENSORED DEATHS 14   TERMINAL 33        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      414   424   515   605   625   654   659   662   680   691                 |
 |      692   709   726                                                           |
 |  CENSORED DEATHS                                                               |
 |      85    234   243   456   456   456   456   456   457   457                 |
 |      457   457   457   460                                                     |
 |                                                                                |
 ==================================================================================
                              SALICYLAZOSULFAPYRIDINE

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = 168     MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 18     CENSORED DEATHS 11   TERMINAL 31        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      396   414   435   437   502   515   536   549   578   611                 |
 |      611   639   680   695   696   702   704   704                             |
 |  CENSORED DEATHS                                                               |
 |      233   456   456   456   456   456   457   457   457   457                 |
 |      457                                                                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 337.5   MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 25     CENSORED DEATHS 12   TERMINAL 23        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      428   436   473   565   581   585   613   635   645   653                 |
 |      658   659   659   672   684   687   696   704   704   704                 |
 |      705   708   718   723   726                                               |
 |  CENSORED DEATHS                                                               |
 |      122   240   456   456   456   456   456   457   457   457                 |
 |      457   457                                                                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 337.5   STOP                                   |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 17     CENSORED DEATHS 23   TERMINAL 30        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      130   361   383   423   430   466   506   542   547   568                 |
 |      585   644   648   662   684   696   704                                   |
 |  CENSORED DEATHS                                                               |
 |      85    120   183   183   183   183   183   183   183   183                 |
 |      183   183   240   456   456   456   456   456   457   457                 |
 |      457   457   457                                                           |
 |                                                                                |
 ==================================================================================
                              SALICYLAZOSULFAPYRIDINE

                       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)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0 MG/KG    |   100.0 100.0 100.0 100.0 100.0  95.9  91.8  87.8  83.7  71.4      |
 |           |                                                                    |
 |           |                                                                    |
 |0          |   100.0 100.0 100.0 100.0 100.0  97.9  91.7  87.5  81.3  64.6      |
 |MG/KG FEED |TD                                                                  |
 |           |                                                                    |
 |84 MG/KG   |   100.0 100.0 100.0 100.0  96.5  96.5  94.3  92.1  83.3  72.4      |
 |           |                                                                    |
 |           |                                                                    |
 |168        |   100.0 100.0 100.0 100.0  96.6  93.2  87.0  82.9  76.6  64.2      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 |337.5      |   100.0 100.0 100.0 100.0 100.0  94.5  94.5  88.2  73.5  48.3      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 |337.5      |   100.0  98.5  98.5  96.8  93.3  89.3  85.0  78.4  71.9  65.4      |
 |STOP       |                                                                    |
 |           |                                                                    |
 ==================================================================================
                              SALICYLAZOSULFAPYRIDINE

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

 ===============================================================================================================================
 |                                               SURVIVAL SUMMARY STATISTICS                                                   |
 |                                                                                                                             |
 |                                                                                                                             |
 |-----------------------------------------------------------------------------------------------------------------------------|
 |                                                                          DOSE                                               |
 |                                                                                                                             |
 |                                0 MG/KG         0               84 MG/KG        168             337.5           337.5        |
 |                                                MG/KG FEED RTD                  MG/KG           MG/KG           STOP         |
 |-----------------------------------------------------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       71.4%           64.6%           72.4%           64.2%           48.3%           65.4%        |
 |(KAPLAN-MEIER)          |                                                                                                    |
 |                        |                                                                                                    |
 |SIGNIFICANCE (B)        |       P=0.043          -----          P=1.000N        P=0.424         P=0.036         P=0.416      |
 |(LIFE TABLE)            |                                                                                                    |
 |                        |                                                                                                    |
 |MEAN DAY OF             |       617.3           632.0           619.7           578.0           640.8           528.2        |
 |NATURAL DEATHS (C)      |       (25.4)          (19.0)          (28.8)          (25.8)          (17.2)          (36.7)       |
 |(STANDARD ERROR)        |                                                                                                    |
 |                        |                                                                                                    |
 |MEAN LIFE SPAN (D)      |       581.5           640.5           628.3           630.0           628.6           538.4        |
 |(STANDARD ERROR)        |       (24.2)          (17.2)          (19.8)          (16.9)          (17.8)          (26.0)       |
 |                        |                                                                                                    |
 ===============================================================================================================================
                                    

       (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 RATS
                       FIRST TERMINAL SACRIFICE AT 737 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0 MG/KG                                  |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 14     CENSORED DEATHS 11   TERMINAL 35        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      260   507   592   598   622   635   649   663   663   684                 |
 |      691   692   703   709                                                     |
 |  CENSORED DEATHS                                                               |
 |      332   458   458   458   458   458   459   459   459   459                 |
 |      459                                                                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 84 MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 15     CENSORED DEATHS 11   TERMINAL 34        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      218   395   396   432   472   501   544   583   632   648                 |
 |      684   693   703   717   724                                               |
 |  CENSORED DEATHS                                                               |
 |      280   458   458   458   458   458   459   459   459   459                 |
 |      459                                                                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 168     MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 19     CENSORED DEATHS 10   TERMINAL 31        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      544   619   621   624   625   667   687   691   691   692                 |
 |      695   695   696   708   708   725   733   733   733                       |
 |  CENSORED DEATHS                                                               |
 |      458   458   458   458   458   459   459   459   459   459                 |
 |                                                                                |
 ==================================================================================
                              SALICYLAZOSULFAPYRIDINE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 737 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = 337.5   MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 15     CENSORED DEATHS 19   TERMINAL 26        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      358   375   405   416   495   495   568   603   607   693                 |
 |      696   703   704   709   733                                               |
 |  CENSORED DEATHS                                                               |
 |      122   214   349   393   398   458   458   458   458   458                 |
 |      459   459   459   459   459   508   508   508   508                       |
 |                                                                                |
 ==================================================================================
                              SALICYLAZOSULFAPYRIDINE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 737 DAYS

 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   737 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0 MG/KG    |   100.0 100.0  98.3  98.3  98.3  98.3  96.3  92.2  81.9  71.7      |
 |           |                                                                    |
 |           |                                                                    |
 |84 MG/KG   |   100.0 100.0  98.3  98.3  94.9  91.2  87.0  85.0  80.8  70.5      |
 |           |                                                                    |
 |           |                                                                    |
 |168        |   100.0 100.0 100.0 100.0 100.0 100.0  98.0  98.0  90.0  62.0      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 |337.5      |   100.0 100.0 100.0  98.2  92.9  92.9  88.3  83.3  80.8  65.6      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                0 MG/KG      84 MG/KG     168          337.5    |
 |                                                          MG/KG        MG/KG    |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       71.7%        70.5%        62.0%        65.6%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.458      P=0.898      P=0.577      P=0.568  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       619.1        556.1        678.3        570.7    |
 |NATURAL DEATHS (C)      |       (31.2)       (38.9)       (11.5)       (35.2)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       656.3        637.8        672.0        596.9    |
 |(STANDARD ERROR)        |       (16.1)       (18.4)       (13.4)       (20.7)   |
 |                        |                                                       |
 ==================================================================================
                                    

       (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)
                                                      SALICYLAZOSULFAPYRIDINE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0 MG/KG          = 1
                                                        0 MG/KG FEED RTD = 2
                                                        84 MG/KG         = 3
                                                        168     MG/KG    = 4
                                                        337.5   MG/KG    = 5
                                                        337.5   STOP     = 6

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

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

      |
      |
  100 + 1                    6                                         4  3 5      1 2
      |                      6                                   6   6 4  3354     112   3 2
      |                                                              6     6       51  1 3 12 2  5      3
      |                                                                    664    6    4   1  21 5 2    3  3
P  90 +                                                                           6    464   4 1   25 2 1  3   3
E     |                                                                                 6    464    5 2 152 1  3 3
R     |                                                                                       64   4     5221 51
C     |                                                                                        6  64     4 2  21 3 112
E  80 +                                                                                           6 6               13  1
N     |                                                                                             6    4   4 5 5  43  11
T     |                                                                                                      66  6  422 3 3
      |                                                                                                          55 5 22 11 1
S  70 +                                                                                                             55422
U     |                                                                                                              5562 2
R     |                                                                                                               54  2 2
V     |
I  60 +
V     |                                                                                                                55
A     |                                                                                                                 55
L     |                                                                                                                  55
   50 +
      |                                                                                                                   5 5
      |
      |
   40 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 47 obs hidden.
                                                      SALICYLAZOSULFAPYRIDINE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0 MG/KG          = 1
                                                        84 MG/KG         = 2
                                                        168     MG/KG    = 3
                                                        337.5   MG/KG    = 4

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

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

      |
      |
  100 + 1                                  2      1              4                            3
      |                                    2      1              4 4   2                1
      |                                                                                       3           3
      |                                                            4    4               1             1
   95 +                                                                24 4 2
      |                                                                     2      2                  11  33
      |                                                                   4           4                1  1
      |                                                                            2   2
P  90 +                                                                                                   131     3
E     |                                                                               42      2   4
R     |                                                                                       2     2       1 1   3  3
C     |                                                                                           4     4     1  1
E  85 +                                                                                             2       2
N     |
T     |                                                                                                     2 2  1  1
      |                                                                                                 4     2     24
S  80 +                                                                                                             113
U     |                                                                                                             224
R     |
V     |                                                                                                              141
I  75 +                                                                                                                2 2
V     |                                                                                                               311
A     |                                                                                                                  22
L     |                                                                                                                41    1
   70 +                                                                                                                 3 2  2
      |                                                                                                                 4   4
      |                                                                                                                   3 3
      |
   65 +                                                                                                                     44
      |
      |                                                                                                                     33
      |
   60 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 11 obs hidden.