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TDMS Study 89006-06 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Southern Research Inst                                       AZT                                          DATE: 05/31/96       
EXPERIMENT: 89006 TEST: 06                                                                                     TIME: 13:43:08       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1-ES-85225                              ROUTE: GAVAGE                                                  NTP C#: C88072       
PATHOLOGIST: R.B. THOMPSON                                                                                     CAS: 30516-87-1      
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                          TWO-YEAR CHRONIC                                                          
                                                                                                                                    

               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11    
LAB: Southern Research Inst                                       AZT                                          DATE: 05/31/96      
EXPERIMENT: 89006 TEST: 06                                                                                     TIME: 13:43:08      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: NO1-ES-85225                              ROUTE: GAVAGE                                                  NTP C#: C88072      
PATHOLOGIST: R.B. THOMPSON                                                                                     CAS: 30516-87-1     
                                        AZT

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = VEHICLE CONTROL                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 18     CENSORED DEATHS 0    TERMINAL 32        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      325   425   458   565   570   576   590   596   606   632                 |
 |      638   646   684   698   701   703   710   722                             |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 30 MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 15     CENSORED DEATHS 0    TERMINAL 35        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      257   348   350   458   484   568   582   624   634   652                 |
 |      665   671   711   722   722                                               |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 60 MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 18     CENSORED DEATHS 3    TERMINAL 29        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      310   422   473   501   505   547   564   584   596   638                 |
 |      639   647   663   667   677   691   722   722                             |
 |  CENSORED DEATHS                                                               |
 |      4     256   382                                                           |
 |                                                                                |
 ==================================================================================
                                        AZT

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = 120     MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 8      CENSORED DEATHS 0    TERMINAL 42        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      513   540   547   584   612   680   694   695                             |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                                        AZT

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE MICE
                       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)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |VEHICLE    |   100.0 100.0 100.0  98.0  96.0  94.0  94.0  84.0  76.0  64.0      |
 |CONTROL    |                                                                    |
 |           |                                                                    |
 |30 MG/KG   |   100.0 100.0  98.0  94.0  94.0  90.0  90.0  86.0  78.0  70.0      |
 |           |                                                                    |
 |           |                                                                    |
 |60 MG/KG   |   100.0 100.0 100.0  97.9  95.8  93.7  89.4  80.9  72.4  61.7      |
 |           |                                                                    |
 |           |                                                                    |
 |120        |   100.0 100.0 100.0 100.0 100.0 100.0  96.0  92.0  90.0  84.0      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                VEHICLE      30 MG/KG     60 MG/KG     120      |
 |                                CONTROL                                MG/KG    |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       64.0%        70.0%        61.7%        84.0%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.054N     P=0.674N     P=0.905      P=0.044N |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       602.5        563.2        587.1        608.1    |
 |NATURAL DEATHS (C)      |       (25.4)       (38.7)       (26.2)       (26.1)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       683.5        679.3        647.0        709.7    |
 |(STANDARD ERROR)        |       (12.5)       (15.7)       (21.2)       ( 7.5)   |
 |                        |                                                       |
 ==================================================================================
                                    

       (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)
                                        AZT

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 731 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = VEHICLE CONTROL                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 16     CENSORED DEATHS 0    TERMINAL 34        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      379   410   470   513   523   603   607   610   647   654                 |
 |      665   683   691   706   723   723                                         |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 30 MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 11     CENSORED DEATHS 0    TERMINAL 39        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      525   527   589   602   617   636   648   654   674   680                 |
 |      690                                                                       |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 60 MG/KG                                 |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 16     CENSORED DEATHS 3    TERMINAL 31        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      219   296   493   523   556   582   612   620   620   662                 |
 |      674   689   690   699   713   722                                         |
 |  CENSORED DEATHS                                                               |
 |      3     87    288                                                           |
 |                                                                                |
 ==================================================================================
                                        AZT

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 731 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = 120     MG/KG                                  |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 18     CENSORED DEATHS 1    TERMINAL 31        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      467   497   556   601   604   612   625   666   679   695                 |
 |      695   703   709   710   710   714   721   722                             |
 |  CENSORED DEATHS                                                               |
 |      2                                                                         |
 |                                                                                |
 ==================================================================================
                                        AZT

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 731 DAYS

 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   731 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |VEHICLE    |   100.0 100.0 100.0 100.0  96.0  94.0  90.0  88.0  78.0  68.0      |
 |CONTROL    |                                                                    |
 |           |                                                                    |
 |30 MG/KG   |   100.0 100.0 100.0 100.0 100.0 100.0  96.0  92.0  84.0  78.0      |
 |           |                                                                    |
 |           |                                                                    |
 |60 MG/KG   |   100.0 100.0  97.9  95.8  95.8  95.8  91.5  87.3  78.8  66.0      |
 |           |                                                                    |
 |           |                                                                    |
 |120        |   100.0 100.0 100.0 100.0 100.0  98.0  95.9  89.8  85.7  63.3      |
 |MG/KG      |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                VEHICLE      30 MG/KG     60 MG/KG     120      |
 |                                CONTROL                                MG/KG    |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       68.0%        78.0%        66.0%        63.3%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.499      P=0.360N     P=0.971      P=0.874  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       600.4        622.0        585.6        649.2    |
 |NATURAL DEATHS (C)      |       (27.5)       (17.2)       (36.4)       (18.5)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       689.2        707.0        648.2        687.0    |
 |(STANDARD ERROR)        |       (12.2)       ( 7.4)       (24.4)       (16.4)   |
 |                        |                                                       |
 ==================================================================================
                                    

       (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)
                                                                AZT
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        VEHICLE CONTROL  = 1
                                                        30 MG/KG         = 2
                                                        60 MG/KG         = 3
                                                        120     MG/KG    = 4

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

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

      |
      |
  100 + 1                                        2        3 1                            4
      |
      |                                          2        3 1  2           1             4    4
      |                                                                    1     1 3          44
   95 +
      |                                                        2                 1 3   3       4 1  4
      |                                                                          2   2           11 4    4
      |                                                                                33
P  90 +                                                                              2  3      3  11     4          4
E     |
R     |                                                                                        3 3212 1             4 4
C     |                                                                                             2 11   2
E  85 +                                                                                          3  3
N     |                                                                                                11  22         4     4
T     |                                                                                             3  31   1  2
      |                                                                                                3     3
S  80 +                                                                                                     11 2 2
U     |
R     |                                                                                                      11  22
V     |                                                                                                      31   2 1   2
I  75 +                                                                                                       3  3
V     |                                                                                                             1 1 2 2
A     |                                                                                                          33   11
L     |
   70 +                                                                                                           33      2 2
      |
      |                                                                                                            3 3 11
      |                                                                                                              3  1 1
   65 +
      |                                                                                                                   1 1
      |
      |                                                                                                                   3 3
   60 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 10 obs hidden.
                                                                AZT
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        VEHICLE CONTROL  = 1
                                                        30 MG/KG         = 2
                                                        60 MG/KG         = 3
                                                        120     MG/KG    = 4

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

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

      |
      |
  100 + 1                                  3                         1            4        2
      |
      |                                    3           3             1   1        4   4    22
      |                                                3                 1         1  3     2   4     2
   95 +
      |                                                                            1  3  1 3    4     22
      |                                                                                  1 1           2  2
      |                                                                                    3    3      44
P  90 +                                                                                    1    3   3   142 2
E     |
R     |                                                                                             3    3 42 2
C     |                                                                                                 11 4  22  4
E  85 +                                                                                                  33
N     |                                                                                                  1    12  42
T     |                                                                                                       11   22
      |                                                                                                   3      3 4  4
S  80 +                                                                                                        1 1  22
U     |                                                                                                          3 3
R     |                                                                                                          1  1244    2
V     |                                                                                                            311
I  75 +                                                                                                                44
V     |                                                                                                              1 1
A     |                                                                                                              331  1
L     |
   70 +                                                                                                               3 3
      |
      |                                                                                                                 341 1
      |                                                                                                                   3 3
   65 +                                                                                                                  44
      |                                                                                                                   4 4
      |
      |
   60 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 11 obs hidden.