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TDMS Study 89006-02 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Southern Research Inst                          AZT/INTERFERON A/INTERFERON AD                            DATE: 08/21/96       
EXPERIMENT: 89006 TEST: 02                                                                                     TIME: 11:12:21       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1-ES-85225                              ROUTE: GAVAGE                                                  NTP C#: C89006       
PATHOLOGIST: JAMES E. HEATH                                                                                    CAS: 30516-871       
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               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/INTERFERON A/INTERFERON AD                            DATE: 08/21/96      
EXPERIMENT: 89006 TEST: 02                                                                                     TIME: 11:12:21      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: NO1-ES-85225                              ROUTE: GAVAGE                                                  NTP C#: C89006      
PATHOLOGIST: JAMES E. HEATH                                                                                    CAS: 30516-871      
                          AZT/INTERFERON A/INTERFERON AD

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = VEHICLE CONTROL                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 14     CENSORED DEATHS 0    TERMINAL 36        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      358   374   477   531   542   600   618   660   675   690                 |
 |      703   716   716   726                                                     |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 30 MG/KG 500 U                                 |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 21     CENSORED DEATHS 2    TERMINAL 27        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      131   296   376   501   518   542   554   556   570   579                 |
 |      604   624   656   658   663   674   705   708   717   720                 |
 |      723                                                                       |
 |  CENSORED DEATHS                                                               |
 |      3     15                                                                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 60 MG/KG 500 U                                 |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 9      CENSORED DEATHS 3    TERMINAL 38        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      303   563   598   624   631   636   685   699   722                       |
 |  CENSORED DEATHS                                                               |
 |      15    15    722                                                           |
 |                                                                                |
 ==================================================================================
                          AZT/INTERFERON A/INTERFERON AD

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = 120MG/KG 500 U                                 |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 15     CENSORED DEATHS 0    TERMINAL 35        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      522   527   546   562   575   632   638   663   672   682                 |
 |      682   696   699   703   727                                               |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                          AZT/INTERFERON A/INTERFERON AD

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE 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  98.0  96.0  94.0  90.0  88.0  84.0  72.0      |
 |CONTROL    |                                                                    |
 |           |                                                                    |
 |30         |   100.0  97.9  97.9  95.8  93.8  93.8  87.5  77.1  68.8  56.3      |
 |MG/KG 500 U|                                                                    |
 |           |                                                                    |
 |60         |   100.0 100.0 100.0  97.9  97.9  97.9  97.9  93.8  87.5  81.3      |
 |MG/KG 500 U|                                                                    |
 |           |                                                                    |
 |120MG/KG   |   100.0 100.0 100.0 100.0 100.0 100.0  96.0  90.0  84.0  70.0      |
 |500 U      |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                VEHICLE      30           60           120MG/KG |
 |                                CONTROL      MG/KG 500 U  MG/KG 500 U  500 U    |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       72.0%        56.3%        81.3%        70.0%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.816      P=0.136      P=0.393N     P=0.998  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       599.0        575.0        606.8        635.1    |
 |NATURAL DEATHS (C)      |       (33.5)       (33.0)       (41.5)       (18.1)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       694.0        636.6        679.8        702.2    |
 |(STANDARD ERROR)        |       (12.4)       (25.3)       (21.7)       ( 8.2)   |
 |                        |                                                       |
 ==================================================================================
                                    

       (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)
                          AZT/INTERFERON A/INTERFERON AD

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = VEHICLE CONTROL                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 14     CENSORED DEATHS 3    TERMINAL 33        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      467   530   568   593   610   649   675   688   690   705                 |
 |      705   707   710   715                                                     |
 |  CENSORED DEATHS                                                               |
 |      3     17    26                                                            |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 30 MG/KG 500 U                                 |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 14     CENSORED DEATHS 4    TERMINAL 32        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      441   467   480   526   527   534   561   603   610   628                 |
 |      631   638   667   702                                                     |
 |  CENSORED DEATHS                                                               |
 |      2     24    57    541                                                     |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 60 MG/KG 500 U                                 |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 16     CENSORED DEATHS 2    TERMINAL 32        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      436   445   514   594   597   598   614   614   634   647                 |
 |      656   660   682   689   707   713                                         |
 |  CENSORED DEATHS                                                               |
 |      14    20                                                                  |
 |                                                                                |
 ==================================================================================
                          AZT/INTERFERON A/INTERFERON AD

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = 120MG/KG 500 U                                 |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 21     CENSORED DEATHS 5    TERMINAL 24        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      32    376   491   577   589   597   603   604   610   617                 |
 |      631   631   662   673   695   699   705   722   725   726                 |
 |      726                                                                       |
 |  CENSORED DEATHS                                                               |
 |      14    25    25    430   669                                               |
 |                                                                                |
 ==================================================================================
                          AZT/INTERFERON A/INTERFERON AD

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE 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    |   100.0 100.0 100.0 100.0 100.0  97.9  95.7  91.5  87.2  70.2      |
 |CONTROL    |                                                                    |
 |           |                                                                    |
 |30         |   100.0 100.0 100.0 100.0 100.0  93.6  87.2  82.9  74.1  69.8      |
 |MG/KG 500 U|                                                                    |
 |           |                                                                    |
 |60         |   100.0 100.0 100.0 100.0 100.0  95.8  93.8  87.5  75.0  66.7      |
 |MG/KG 500 U|                                                                    |
 |           |                                                                    |
 |120MG/KG   |    97.9  97.9  97.9  97.9  95.7  95.7  93.6  82.7  71.8  53.9      |
 |500 U      |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                VEHICLE      30           60           120MG/KG |
 |                                CONTROL      MG/KG 500 U  MG/KG 500 U  500 U    |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       70.2%        69.8%        66.7%        53.9%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.402      P=0.906      P=0.752      P=0.138  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       643.7        572.5        612.5        604.3    |
 |NATURAL DEATHS (C)      |       (20.9)       (21.2)       (20.9)       (34.1)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       662.3        639.3        663.2        627.0    |
 |(STANDARD ERROR)        |       (24.6)       (25.0)       (21.4)       (27.8)   |
 |                        |                                                       |
 ==================================================================================
                                    

       (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/INTERFERON A/INTERFERON AD
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        VEHICLE CONTROL  = 1
                                                        30 MG/KG 500 U   = 2
                                                        60 MG/KG 500 U   = 3
                                                        120MG/KG 500 U   = 4

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

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

      |
      |
  100 + 1                    2                          3        1                         4
      |
      |                      2                         23        1 1                       44    3
      |                                                2           1                1       4 4  3     3
   95 +
      |                                                            2                1  2    1 4  4     3   3
      |                                                                                     1 1  4 4
      |                                                                                2 2                 33
   90 +                                                                                  2    1    4   1    4
      |
P     |                                                                                       2 2      1  1 34      3
E     |                                                                                                   1  4   1
R  85 +                                                                                                             3 3
C     |                                                                                         2 2              141  3   3
E     |                                                                                                           4141
N     |                                                                                           22                      3 3
T  80 +                                                                                                              1 1
      |                                                                                            2    2
S     |                                                                                                 2  2        4 41 1
U     |
R  75 +                                                                                                    2   2
V     |                                                                                                               44 11
I     |                                                                                                                4  1 1
V     |                                                                                                        2 2
A  70 +                                                                                                                   4 4
L     |                                                                                                          2 2
      |
      |                                                                                                            2   2
   65 +                                                                                                                22
      |
      |                                                                                                                 22
      |
   60 +
      |                                                                                                                  22
      |
      |                                                                                                                   2 2
   55 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 9 obs hidden.
                                                   AZT/INTERFERON A/INTERFERON AD
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        VEHICLE CONTROL  = 1
                                                        30 MG/KG 500 U   = 2
                                                        60 MG/KG 500 U   = 3
                                                        120MG/KG 500 U   = 4

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

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

      |
  100 + 1     4                                                              2    1
      |
      |       4                                                    4         23   1         1
      |                                                            4          3   2 2 4  3  1     1
   95 +
      |                                                                             2 4  3  2     14  1
      |
      |                                                                                            4  13 1
   90 +
      |                                                                                     22        44 1    1
      |                                                                                      2   2     343    1    1
      |
P  85 +                                                                                          2      2          1 1
E     |                                                                                                  3  3
R     |                                                                                                 22
C     |                                                                                                  2 23 3      1 1
E  80 +                                                                                                  44
N     |                                                                                                   422 33
T     |                                                                                                        3 3
      |                                                                                                     22
S  75 +                                                                                                          3  3  11
U     |                                                                                                     42   42
R     |                                                                                                           2 33 211
V     |                                                                                                          4 4 3 3
I  70 +                                                                                                            4  42 1  1
V     |                                                                                                                33
A     |
L     |                                                                                                                 3   3
   65 +                                                                                                               44
      |
      |                                                                                                                4  4
      |
   60 +
      |
      |
      |
   55 +
      |                                                                                                                   4 4
      |
      |
   50 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 14 obs hidden.