National Toxicology Program

National Toxicology Program
https://ntp.niehs.nih.gov/go/5821

TDMS Study 89006-04 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Southern Research Inst                          AZT/INTERFERON A/INTERFERON AD                            DATE: 07/12/96       
EXPERIMENT: 89006 TEST: 04                                                                                     TIME: 16:19:24       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1-ES-85225                              ROUTE: GAVAGE                                                  NTP C#: C89006       
PATHOLOGIST: R.B. THOMPSON                                                                                     CAS: 30516-871       
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                             CORE STUDY                                                             
                                                                                                                                    

               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: 07/12/96      
EXPERIMENT: 89006 TEST: 04                                                                                     TIME: 16:19:24      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: NO1-ES-85225                              ROUTE: GAVAGE                                                  NTP C#: C89006      
PATHOLOGIST: R.B. THOMPSON                                                                                     CAS: 30516-871      
                          AZT/INTERFERON A/INTERFERON AD

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = VEHICLE CONTROL                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 19     CENSORED DEATHS 0    TERMINAL 31        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      393   462   474   554   576   613   638   670   676   677                 |
 |      690   691   694   697   710   712   714   724   727                       |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 30 MG/KG 5000 U                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 14     CENSORED DEATHS 1    TERMINAL 35        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      363   439   473   528   554   557   557   661   680   683                 |
 |      688   689   715   715                                                     |
 |  CENSORED DEATHS                                                               |
 |      339                                                                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 60 MG/KG 5000 U                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 14     CENSORED DEATHS 1    TERMINAL 35        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      169   215   386   480   488   562   581   605   643   646                 |
 |      652   665   717   726                                                     |
 |  CENSORED DEATHS                                                               |
 |      340                                                                       |
 |                                                                                |
 ==================================================================================
                          AZT/INTERFERON A/INTERFERON AD

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

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = 120MG/KG 5000 U                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 16     CENSORED DEATHS 0    TERMINAL 34        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      413   466   498   517   526   557   562   565   586   600                 |
 |      625   632   697   707   725   726                                         |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 ==================================================================================
                          AZT/INTERFERON A/INTERFERON AD

                       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    |   100.0 100.0 100.0 100.0  98.0  94.0  94.0  90.0  86.0  62.0      |
 |CONTROL    |                                                                    |
 |           |                                                                    |
 |30         |   100.0 100.0 100.0  98.0  98.0  93.9  91.8  85.7  83.7  71.4      |
 |MG/KG 5000 |                                                                    |
 |           |                                                                    |
 |60         |   100.0  98.0  96.0  96.0  94.0  91.9  89.9  83.7  75.6  71.5      |
 |MG/KG 5000 |                                                                    |
 |           |                                                                    |
 |120MG/KG   |   100.0 100.0 100.0 100.0  98.0  96.0  90.0  80.0  76.0  68.0      |
 |5000 U     |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                VEHICLE      30           60           120MG/KG |
 |                                CONTROL      MG/KG 5000 U MG/KG 5000 U 5000 U   |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       62.0%        71.4%        71.5%        68.0%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.836N     P=0.505N     P=0.547N     P=0.782N |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       636.4        593.0        538.2        587.6    |
 |NATURAL DEATHS (C)      |       (22.8)       (30.4)       (46.6)       (23.4)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       693.8        683.1        667.8        683.8    |
 |(STANDARD ERROR)        |       (10.7)       (13.9)       (18.8)       (11.9)   |
 |                        |                                                       |
 ==================================================================================
                                    

       (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 730 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = VEHICLE CONTROL                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 13     CENSORED DEATHS 0    TERMINAL 37        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      480   575   586   589   596   618   625   651   661   672                 |
 |      682   701   710                                                           |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 30 MG/KG 5000 U                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 12     CENSORED DEATHS 0    TERMINAL 38        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      554   557   586   592   598   638   640   656   674   698                 |
 |      712   721                                                                 |
 |  CENSORED DEATHS                                                               |
 |      NONE                                                                      |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                          DOSE = 60 MG/KG 5000 U                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 12     CENSORED DEATHS 2    TERMINAL 36        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      318   344   488   494   581   604   620   648   694   714                 |
 |      722   729                                                                 |
 |  CENSORED DEATHS                                                               |
 |      3     199                                                                 |
 |                                                                                |
 ==================================================================================
                          AZT/INTERFERON A/INTERFERON AD

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 730 DAYS
                                                          

                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                          DOSE = 120MG/KG 5000 U                                |
 |                       ----------------------------                             |
 |                                                                                |
 |  TOTAL 50     UNCENSORED DEATHS 17     CENSORED DEATHS 1    TERMINAL 32        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      501   557   571   593   616   627   628   630   658   661                 |
 |      671   676   680   682   687   713   721                                   |
 |  CENSORED DEATHS                                                               |
 |      26                                                                        |
 |                                                                                |
 ==================================================================================
                          AZT/INTERFERON A/INTERFERON AD

                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE MICE
                       FIRST TERMINAL SACRIFICE AT 730 DAYS

 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   730 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |VEHICLE    |   100.0 100.0 100.0 100.0 100.0  98.0  98.0  90.0  82.0  74.0      |
 |CONTROL    |                                                                    |
 |           |                                                                    |
 |30         |   100.0 100.0 100.0 100.0 100.0 100.0 100.0  90.0  84.0  76.0      |
 |MG/KG 5000 |                                                                    |
 |           |                                                                    |
 |60         |   100.0 100.0 100.0  95.8  95.8  95.8  91.7  87.5  83.3  75.0      |
 |MG/KG 5000 |                                                                    |
 |           |                                                                    |
 |120MG/KG   |   100.0 100.0 100.0 100.0 100.0 100.0  98.0  91.8  79.6  65.3      |
 |5000 U     |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                  DOSE                          |
 |                                                                                |
 |                                VEHICLE      30           60           120MG/KG |
 |                                CONTROL      MG/KG 5000 U MG/KG 5000 U 5000 U   |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       74.0%        76.0%        75.0%        65.3%    |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.339      P=0.959N     P=1.000N     P=0.496  |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       626.6        635.5        579.7        639.5    |
 |NATURAL DEATHS (C)      |       (17.5)       (16.9)       (40.9)       (14.2)   |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       703.1        707.3        668.8        685.2    |
 |(STANDARD ERROR)        |       ( 7.8)       ( 7.0)       (21.3)       (15.5)   |
 |                        |                                                       |
 ==================================================================================
                                    

       (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/INTERFERON A/INTERFERON AD
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        VEHICLE CONTROL  = 1
                                                        30 MG/KG 5000 U  = 2
                                                        60 MG/KG 5000 U  = 3
                                                        120MG/KG 5000 U  = 4

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

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

      |
      |
  100 + 1                           3                            2     1 4
      |
      |                             3     3                      2     1 4   2   14
      |                                   3                           3      2   141   4
   95 +
      |                                                               3            13  4 4  2   1
      |                                                                             33   4  4   1  1
      |                                                                                     2   2
P  90 +                                                                              3      4   43 1     1
E     |
R     |                                                                                         43 3     1   1
C     |                                                                                         2  3    3    1   21
E  85 +
N     |                                                                                          4  4   3    3   2112
T     |                                                                                             4  4
      |                                                                                                      33
S  80 +                                                                                                4   4  33   121
U     |
R     |                                                                                                    44  3 3
V     |                                                                                                     4        11
I  75 +                                                                                                          3   2   2
V     |                                                                                                               44 33
A     |                                                                                                               141 4
L     |                                                                                                                  23 2
   70 +
      |
      |                                                                                                                   4 4
      |                                                                                                                 1 1
   65 +
      |
      |                                                                                                                   1 1
      |
   60 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 10 obs hidden.
                                                   AZT/INTERFERON A/INTERFERON AD
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        VEHICLE CONTROL  = 1
                                                        30 MG/KG 5000 U  = 2
                                                        60 MG/KG 5000 U  = 3
                                                        120MG/KG 5000 U  = 4

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

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

      |
      |
  100 + 1                                                  3                        1  4        2
      |
      |                                                    3   3                    1  4        4  1
      |                                                        3                     3          2 411
   95 +
      |                                                                              33           4 1 1
P     |                                                                                               11
E     |                                                                               3            3  4  4
R  90 +                                                                                            3   13414 2
C     |
E     |                                                                                                 3 11
N     |                                                                                                    1 212
T  85 +                                                                                                   3   3
      |                                                                                                    4  12 1 2  3
S     |                                                                                                          112  2
U     |                                                                                                        4 4    3 3
R  80 +                                                                                                          41 1 2 2
V     |                                                                                                                 3 3
I     |                                                                                                           441  1223 3
V     |                                                                                                                112  2
A  75 +                                                                                                            44       3
L     |                                                                                                                 1   1
      |
      |                                                                                                             44
   70 +                                                                                                              4  4
      |
      |                                                                                                                 44
      |
   65 +                                                                                                                  4  4
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 15 obs hidden.
NTP is located at the National Institute of Environmental Health Sciences, part of the National Institutes of Health.