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TDMS Study 05217-05 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Southern Research Inst                               T-BUTYLHYDROQUINONE                                  DATE: 04/04/96       
EXPERIMENT: 05217 TEST: 05                                                                                     TIME: 09:19:27       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1-ES-85219                              ROUTE: DOSED FEED                                              NTP C#: C62157       
PATHOLOGIST: D.R. FARNELL                                                                                      CAS: 1948-33-0       
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    

               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: 05                                                                                     TIME: 09:19:27      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: NO1-ES-85219                              ROUTE: DOSED FEED                                              NTP C#: C62157      
PATHOLOGIST: D.R. FARNELL                                                                                      CAS: 1948-33-0      
                                T-BUTYLHYDROQUINONE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 727 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = UNTREATDCONTROL                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 10     CENSORED DEATHS 11   TERMINAL 39        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      539   595   619   647   651   673   680   705   712   723                 |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   456   456   456                 |
 |      651                                                                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.125%                                   |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 4      CENSORED DEATHS 10   TERMINAL 46        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      619   630   654   710                                                     |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   456   456   456                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.25%                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 13     CENSORED DEATHS 9    TERMINAL 38        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      409   520   549   550   619   654   657   666   669   673                 |
 |      680   710   724                                                           |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   456   456                       |
 |                                                                                |
 ==================================================================================
                                T-BUTYLHYDROQUINONE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 727 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0.5%                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 9      CENSORED DEATHS 9    TERMINAL 42        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      171   589   595   614   615   628   630   680   688                       |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   456   456                       |
 |                                                                                |
 ==================================================================================
                                T-BUTYLHYDROQUINONE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       FIRST TERMINAL SACRIFICE AT 727 DAYS

 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   727 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |UNTREATDCON|ROL100.0 100.0 100.0 100.0 100.0 100.0  98.0  96.0  90.0  79.8      |
 |U          |                                                                    |
 |           |                                                                    |
 |0.125%     |   100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0  94.0  92.0      |
 |           |                                                                    |
 |           |                                                                    |
 |0.25%      |   100.0 100.0 100.0 100.0  98.3  98.3  96.4  92.4  86.5  74.7      |
 |           |                                                                    |
 |           |                                                                    |
 |0.5%       |   100.0  98.3  98.3  98.3  98.3  98.3  98.3  94.4  86.5  82.6      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                UNTREATDCONTR0.125%       0.25%        0.5%     |
 |                                U                                               |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       79.8%        92.0%        74.7%        82.6%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.778      P=0.143N     P=0.643      P=1.000N |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       654.4        653.3        621.5        578.9    |
 |NATURAL DEATHS (C)      |       (18.2)       (20.3)       (24.9)       (52.2)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       668.5        676.9        663.5        664.1    |
 |(STANDARD ERROR)        |       (13.2)       (13.1)       (13.7)       (15.2)   |
 |                        |                                                       |
 ==================================================================================
                                    

       (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)
                                T-BUTYLHYDROQUINONE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 734 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = UNTREATDCONTROL                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 13     CENSORED DEATHS 9    TERMINAL 38        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      364   461   550   567   582   617   618   619   622   667                 |
 |      673   677   723                                                           |
 |  CENSORED DEATHS                                                               |
 |      457   457   457   457   457   457   457   457   457                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.125%                                   |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 17     CENSORED DEATHS 8    TERMINAL 35        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      365   399   469   494   503   562   598   612   623   623                 |
 |      654   668   697   706   710   725   729                                   |
 |  CENSORED DEATHS                                                               |
 |      457   457   457   457   457   457   457   457                             |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 0.25%                                    |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 11     CENSORED DEATHS 9    TERMINAL 40        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      288   456   548   555   618   651   664   676   718   723                 |
 |      724                                                                       |
 |  CENSORED DEATHS                                                               |
 |      457   457   457   457   457   457   457   457   457                       |
 |                                                                                |
 ==================================================================================
                                T-BUTYLHYDROQUINONE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 734 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0.5%                                     |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 11     CENSORED DEATHS 6    TERMINAL 43        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      82    296   418   429   538   629   701   703   722   723                 |
 |      728                                                                       |
 |  CENSORED DEATHS                                                               |
 |      457   457   457   457   457   457                                         |
 |                                                                                |
 ==================================================================================
                                T-BUTYLHYDROQUINONE

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 734 DAYS

 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   734 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |UNTREATDCON|ROL100.0 100.0 100.0  98.3  98.3  96.4  96.4  90.5  82.6  74.7      |
 |U          |                                                                    |
 |           |                                                                    |
 |0.125%     |   100.0 100.0 100.0  98.3  96.7  94.7  90.9  87.0  79.3  67.7      |
 |           |                                                                    |
 |           |                                                                    |
 |0.25%      |   100.0 100.0 100.0  98.3  98.3  96.7  96.7  92.7  86.8  78.9      |
 |           |                                                                    |
 |           |                                                                    |
 |0.5%       |    98.3  98.3  98.3  96.7  95.0  93.3  91.5  91.5  89.6  80.3      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                UNTREATDCONTR0.125%       0.25%        0.5%     |
 |                                U                                               |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       74.7%        67.7%        78.9%        80.3%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.360N     P=0.567      P=0.766N     P=0.684N |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       595.4        596.3        601.9        542.6    |
 |NATURAL DEATHS (C)      |       (26.7)       (27.7)       (40.5)       (64.6)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       662.4        658.1        668.2        671.2    |
 |(STANDARD ERROR)        |       (14.5)       (15.0)       (15.1)       (17.5)   |
 |                        |                                                       |
 ==================================================================================
                                    

       (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
                                                        0.125%           = 2
                                                        0.25%            = 3
                                                        0.5%             = 4

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

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

        |
  100.0 +1                           4                                    3                   1            2
        |
        |
        |                            4                                    3                 3 1        1   22
   97.5 +
        |
        |                                                                                   3   3      1   12   2
        |
   95.0 +
        |                                                                                              4  4
        |                                                                                                  1   12        2
        |
P  92.5 +                                                                                       3          3
E       |                                                                                                                2 2
R       |
C       |                                                                                                 434   3
E  90.0 +                                                                                                      1    1
N       |
T       |
        |                                                                                                           11
S  87.5 +
U       |
R       |                                                                                                   4   3  3 4
V       |                                                                                                            1  1
I  85.0 +
V       |                                                                                                            44
A       |                                                                                                               11
L       |
   82.5 +                                                                                                          33 4    4
        |                                                                                                                1 1
        |
        |                                                                                                           33
   80.0 +                                                                                                                  1
        |
        |                                                                                                            3   3
        |
   77.5 +
        |                                                                                                                3 3
        |
        |
   75.0 +                                                                                                                  3
        |
        -+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+-
         0         10         20         30         40         50         60         70         80         90         100        110

                                                                    WEEK

NOTE: 4 obs hidden.
                                                        T-BUTYLHYDROQUINONE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        UNTREATDCONTROL  = 1
                                                        0.125%           = 2
                                                        0.25%            = 3
                                                        0.5%             = 4

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

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

      |
      |
  100 + 1            4                                3          12
      |              4                                34         12    2         1
      |
      |                                                4               2  4      12            1
   95 +                                                                   4 4     2   2        131
      |                                                                     4                4
P     |                                                                               22        31  1     3
E     |                                                                                2     4   2        34  3
R  90 +                                                                                             1     14           4
C     |                                                                                          2     2      3  3
E     |                                                                                                2 2
N     |                                                                                                          3 3   4  4
T  85 +                                                                                                  22        3     3
      |
S     |                                                                                                   1       1      33
U     |                                                                                                   2    2  11
R  80 +                                                                                                                   4 4
V     |                                                                                                        2  2       3 3
I     |                                                                                                           2   2
V     |                                                                                                            1      1
A  75 +                                                                                                               22  1 1
L     |                                                                                                                22
      |
      |                                                                                                                 2 2
   70 +                                                                                                                   2 2
      |
      |                                                                                                                     2
      |
   65 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 7 obs hidden.