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TDMS Study 05099-98 Pathology Tables

NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11 
LAB: SOUTHERN RESEARCH INST                                    DATE: 05/09/95   
EXP: 05099                 SALICYLAZOSULFAPYRIDINE             TIME: 15:27:06   
TEST: 98              CAGES FROM 0000 TO LAST CAGE             PAGE:   1        
TEST TYPE: CHRONIC          ROUTE: GAVAGE                      NTP C#: 61552B   
CONT: N01-ES-85233                                             CAS: 599-79-1    
PATHOLOGIST: DR J. HEATH                                                        
--------------------------------------------------------------------------------
                                                                                
                       05099/07 -VS- 05099/09 COMPARISON                        
                                                                                

REASONS FOR REMOVAL:                                                            
                                                                                
25004 Dead                                                                      
25018 Dosing Accident                                                           
25014 Gavage Death                                                              
25005 Interval Sacrifice                                                        
25003 Moribund                                                                  
25019 Moribund Sacrifice                                                        
25020 Natural Death                                                             
25017 Scheduled Sacrifice                                                       
25021 Terminal Sacrifice                                                        
                                                                                
                                                                                
REMOVAL DATE RANGE:                                                             

ALL                                                                             
                                                                                
TREATMENT GROUPS:                                                               
                                                                                
INCLUDE 001    0 MG/KG AD LIB                                                   
INCLUDE 004    0 MG/KG RTD                                                      
NTP           STATISTICAL ANALYSIS OF SURVIVAL DATA            REPORT: PEIRPT11
LAB: SOUTHERN RESEARCH INST                                    DATE: 05/09/95  
EXP: 05099                 SALICYLAZOSULFAPYRIDINE             TIME: 15:27:06  
TEST: 98              CAGES FROM 0000 TO LAST CAGE                             
TEST TYPE: CHRONIC          ROUTE: GAVAGE                      NTP C#: 61552B  
CONT: N01-ES-85233                                             CAS: 599-79-1   
PATHOLOGIST: DR J. HEATH                                                       
                              SALICYLAZOSULFAPYRIDINE

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = 0 MG/KG AD LIB                                 |
 |                       ----------------------------                             |
 |                                                                                |
 |  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 RTD                              |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 15     CENSORED DEATHS 12   TERMINAL 33        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      437   520   597   627   631   645   645   667   680   682                 |
 |      690   698   700   703   722                                               |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   456   456   456                 |
 |      478   639                                                                 |
 |                                                                                |
 ==================================================================================
                              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          |   100.0 100.0 100.0 100.0 100.0  95.9  91.8  87.8  83.7  71.4      |
 |MG/KG AD LI|                                                                    |
 |           |                                                                    |
 |0 MG/KG RTD|   100.0 100.0 100.0 100.0 100.0  98.3  96.3  94.2  85.9  69.2      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                        DOSE                    |
 |                                                                                |
 |                                0                         0 MG/KG RTD           |
 |                                MG/KG AD LIB                                    |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       71.4%                     69.2%                 |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |        -----                     -----                |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       617.3                     642.9                 |
 |NATURAL DEATHS (C)      |       (25.4)                    (19.7)                |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       581.5                     656.3                 |
 |(STANDARD ERROR)        |       (24.2)                    (14.0)                |
 |                        |                                                       |
 ==================================================================================
                                    

       (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
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0 MG/KG AD LIB   = 1
                                                        0 MG/KG RTD      = 2

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

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

      |
      |
  100 + 1                                                                    2     1
      |                                                                      2             2
      |                                                                            11
      |                                                                             1  1   2           2
   95 +
      |                                                                                1   1           2   2
P     |                                                                                                    22
E     |                                                                                    1   1
R  90 +                                                                                        1        1   2 2
C     |
E     |                                                                                                 1   1
N     |                                                                                                     1 21  2
T  85 +
      |                                                                                                        1  212
S     |
U     |                                                                                                            11
R  80 +                                                                                                             12  1
V     |
I     |                                                                                                              22 11
V     |
A  75 +
L     |                                                                                                               22 11
      |
      |                                                                                                                2  1 1
   70 +
      |                                                                                                                   2 2
      |
      |
   65 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 3 obs hidden.