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TDMS Study 05217-04 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Southern Research Inst                               T-BUTYLHYDROQUINONE                                  DATE: 04/04/96       
EXPERIMENT: 05217 TEST: 04                                                                                     TIME: 08:26:30       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1ES85219                                ROUTE: DOSED FEED                                              NTP C#: C62157       
PATHOLOGIST: J. E. HEATH                                                                                       CAS: 1948330         
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    

               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11    
LAB: Southern Research Inst                               T-BUTYLHYDROQUINONE                                  DATE: 04/04/96      
EXPERIMENT: 05217 TEST: 04                                                                                     TIME: 08:26:30      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: NO1ES85219                                ROUTE: DOSED FEED                                              NTP C#: C62157      
PATHOLOGIST: J. E. HEATH                                                                                       CAS: 1948330        
                                T-BUTYLHYDROQUINONE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 911 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = UNTREATDCONTROL                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 50     CENSORED DEATHS 10   TERMINAL 10        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      484   552   569   578   590   593   603   604   612   626                 |
 |      626   626   632   641   661   670   674   688   691   691                 |
 |      698   707   714   719   730   732   745   752   753   754                 |
 |      759   773   778   780   786   786   786   796   802   808                 |
 |      808   808   822   841   841   841   841   892   898   900                 |
 |  CENSORED DEATHS                                                               |
 |      92    92    92    92    92    92    92    92    92    92                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.5%                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 38     CENSORED DEATHS 10   TERMINAL 22        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      600   630   641   671   677   683   696   712   730   730                 |
 |      731   732   732   732   743   743   745   754   755   759                 |
 |      778   793   796   796   796   807   817   820   828   837                 |
 |      841   845   855   866   890   895   902   910                             |
 |  CENSORED DEATHS                                                               |
 |      92    92    92    92    92    92    92    92    92    92                  |
 |                                                                                |
 ==================================================================================
                                T-BUTYLHYDROQUINONE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 911 DAYS

 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   911 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |UNTREATDCON|ROL100.0 100.0 100.0 100.0 100.0  98.3  98.3  86.7  75.0  16.7      |
 |U          |                                                                    |
 |           |                                                                    |
 |0.5%       |   100.0 100.0 100.0 100.0 100.0 100.0 100.0  98.3  95.0  36.7      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                        DOSE                    |
 |                                                                                |
 |                                UNTREATDCONTROL           0.5%                  |
 |                                U                                               |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       16.7%                     36.7%                 |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.003N                  P=0.003N              |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       721.2                     770.2                 |
 |NATURAL DEATHS (C)      |       (14.0)                    (12.6)                |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       658.4                     717.6                 |
 |(STANDARD ERROR)        |       (30.6)                    (32.4)                |
 |                        |                                                       |
 ==================================================================================
                                    

       (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)
                                T-BUTYLHYDROQUINONE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 911 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = UNTREATDCONTROL                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 42     CENSORED DEATHS 10   TERMINAL 18        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      504   562   575   593   626   638   641   677   688   691                 |
 |      698   710   711   725   730   731   752   771   777   780                 |
 |      786   788   793   808   808   820   822   823   827   828                 |
 |      828   837   837   856   856   862   866   870   870   872                 |
 |      880   892                                                                 |
 |  CENSORED DEATHS                                                               |
 |      92    92    92    92    92    92    92    92    92    92                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.5%                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 70     UNCENSORED DEATHS 36     CENSORED DEATHS 10   TERMINAL 24        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      400   499   540   593   607   649   672   673   688   696                 |
 |      712   741   753   768   773   780   780   788   796   802                 |
 |      823   837   837   841   841   849   852   855   856   856                 |
 |      862   866   872   885   897   909                                         |
 |  CENSORED DEATHS                                                               |
 |      92    92    92    92    92    92    92    92    92    92                  |
 |                                                                                |
 ==================================================================================
                                T-BUTYLHYDROQUINONE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 911 DAYS

 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   911 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |UNTREATDCON|ROL100.0 100.0 100.0 100.0 100.0 100.0  98.3  93.3  88.3  30.0      |
 |U          |                                                                    |
 |           |                                                                    |
 |0.5%       |   100.0 100.0 100.0 100.0  98.3  98.3  95.0  93.3  90.0  40.0      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                        DOSE                    |
 |                                                                                |
 |                                UNTREATDCONTROL           0.5%                  |
 |                                U                                               |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       30.0%                     40.0%                 |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.259N                  P=0.259N              |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       762.1                     762.4                 |
 |NATURAL DEATHS (C)      |       (15.2)                    (20.0)                |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       704.7                     717.6                 |
 |(STANDARD ERROR)        |       (32.3)                    (33.4)                |
 |                        |                                                       |
 ==================================================================================
                                    

       (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)
                                                        T-BUTYLHYDROQUINONE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        UNTREATDCONTROL  = 1
                                                        0.5%             = 2

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

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

             |
             |
         100 +  1                                                    1           2
             |                                                       1     1  1  2  22
             |                                                                1      2  2
             |                                                                1 1       222
          90 +                                                                  11        22
             |                                                                   11        2 2 2
             |                                                                    1 1
             |
          80 +                                                                      1
             |                                                                      11 1       22
       P     |                                                                         11
       E     |                                                                          111     22
       R  70 +
       C     |                                                                            11     22 2
       E     |                                                                             11       2 2
       N     |                                                                              11
       T  60 +                                                                               1 1
             |                                                                                 11     222
       S     |                                                                                  11      22
       U     |                                                                                           22
       R  50 +                                                                                   11       22
       V     |                                                                                    111      22
       I     |                                                                                              22
       V     |                                                                                      11       2  2
       A  40 +                                                                                                  22
       L     |                                                                                       11          22
             |                                                                                        11
             |
          30 +                                                                                         1 1
             |                                                                                           1 1
             |
             |                                                                                             1    1
          20 +                                                                                                  11
             |                                                                                                   11
             |
             |
          10 +
             |
             ---+--------------+--------------+--------------+--------------+--------------+--------------+--------------+--
                0             20             40             60             80             100            120            140

                                                                   WEEK

NOTE: 20 obs hidden.
                                                        T-BUTYLHYDROQUINONE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        UNTREATDCONTROL  = 1
                                                        0.5%             = 2

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

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

             |
             |
         100 +  1                                           2         1
             |                                              2         1    2 11
             |                                                             2  1 1
             |                                                                  12  112
          90 +                                                                        2 2
             |                                                                       1  211
       P     |                                                                            22
       E     |                                                                            11 1  2
       R  80 +                                                                                  22
       C     |                                                                               111 2 2
       E     |                                                                                     22
       N     |                                                                                 1 1 122
       T  70 +                                                                                       22
             |                                                                                     1112  2
       S     |                                                                                           22
       U     |                                                                                       111  22
       R  60 +
       V     |                                                                                         1 1 22
       I     |                                                                                              2
       V     |                                                                                           1
       A  50 +                                                                                              22
       L     |                                                                                           11  22
             |                                                                                            1 1 22
             |                                                                                              11 2 22
          40 +                                                                                                    2
             |                                                                                               11
             |
             |                                                                                                111
          30 +                                                                                                  1 1
             |
             ---+--------------+--------------+--------------+--------------+--------------+--------------+--------------+--
                0             20             40             60             80             100            120            140

                                                                   WEEK

NOTE: 29 obs hidden.