Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Drug Use Investigation On Zithromac (Azithromycin) In HIV Patients

This study has been completed.
Sponsor:
Collaborator:
Altmarc Inc.
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01227395
First received: October 7, 2010
Last updated: April 18, 2013
Last verified: April 2013
Results First Received: March 4, 2013  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Retrospective
Condition: HIV Infection
Intervention: Drug: Azithromycin

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This was a phase 4, observational, open-label study conducted in participants who were prescribed azithromycin by their treating physician per usual clinical practice. Study drug was not provided by the Sponsor.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Azithromycin for Prophylaxis Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert.
Azithromycin for Treatment Participants taking Azithromycin for Treatment according to Japanese Package Insert.

Participant Flow:   Overall Study
    Azithromycin for Prophylaxis   Azithromycin for Treatment
STARTED   391   85 
COMPLETED   391   84 
NOT COMPLETED   0   1 
Protocol Violation                0                1 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Azithromycin for Prophylaxis Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert.
Azithromycin for Treatment Participants taking Azithromycin for Treatment according to Japanese Package Insert.
Total Total of all reporting groups

Baseline Measures
   Azithromycin for Prophylaxis   Azithromycin for Treatment   Total 
Overall Participants Analyzed 
[Units: Participants]
 391   84   475 
Age, Customized 
[Units: Participants]
     
<65 years   381   83   464 
>=65 years   10   1   11 
Gender 
[Units: Participants]
     
Female   31   9   40 
Male   360   75   435 


  Outcome Measures
  Hide All Outcome Measures

1.  Primary:   Number of Participants With the Frequency of Treatment Related Adverse Events.   [ Time Frame: 9 years(MAX) ]

Measure Type Primary
Measure Title Number of Participants With the Frequency of Treatment Related Adverse Events.
Measure Description Adverse events mean all unfavorable events that occur in participants after administration of Azithromycin, irrespective of causal relationship to Azithromycin (including clinically problematic abnormal changes in laboratory test values). Treatment related Adverse Events were evaluated in company with the causal relationship to Azithromycin.
Time Frame 9 years(MAX)  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No statistical analysis provided for the frequency of treatment related adverse events.

Reporting Groups
  Description
Azithromycin for Prophylaxis Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert.
Azithromycin for Treatment Participants taking Azithromycin for Treatment according to Japanese Package Insert.

Measured Values
   Azithromycin for Prophylaxis   Azithromycin for Treatment 
Participants Analyzed 
[Units: Participants]
 391   84 
Number of Participants With the Frequency of Treatment Related Adverse Events. 
[Units: Participants]
 73   10 

No statistical analysis provided for Number of Participants With the Frequency of Treatment Related Adverse Events.



2.  Primary:   Number of Unlisted Treatment Related Adverse Events in Japanese Package Insert.   [ Time Frame: 9 years(MAX) ]

Measure Type Primary
Measure Title Number of Unlisted Treatment Related Adverse Events in Japanese Package Insert.
Measure Description Adverse events mean all unfavorable events that occur in participants after administration of Azithromycin, irrespective of causal relationship to Azithromycin (including clinically problematic abnormal changes in laboratory test values). Number of Treatment Related Adverse Events were evaluated in company with the causal relationship to Azithromycin. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction in Japanese package insert.
Time Frame 9 years(MAX)  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No statistical analysis provided for the number of the unlisted treatment related adverse events in Japanese Package Insert.

Reporting Groups
  Description
Azithromycin for Prophylaxis Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert.
Azithromycin for Treatment Participants taking Azithromycin for Treatment according to Japanese Package Insert.

Measured Values
   Azithromycin for Prophylaxis   Azithromycin for Treatment 
Participants Analyzed 
[Units: Participants]
 391   84 
Number of Unlisted Treatment Related Adverse Events in Japanese Package Insert. 
[Units: Events]
 37   9 

No statistical analysis provided for Number of Unlisted Treatment Related Adverse Events in Japanese Package Insert.



3.  Primary:   Risk Factors for the Frequency of Treatment Related Adverse Events -Age (Prophylaxis).   [ Time Frame: 9 years(MAX) ]

Measure Type Primary
Measure Title Risk Factors for the Frequency of Treatment Related Adverse Events -Age (Prophylaxis).
Measure Description Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether <65 years or >=65 years is significant risk factor.
Time Frame 9 years(MAX)  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.

Reporting Groups
  Description
<65 Years Participants with <65 years who taking Azithromycin for Prophylaxis according to Japanese Package Insert.
>=65 Years Participants with >=65 years who taking Azithromycin for Prophylaxis according to Japanese Package Insert.

Measured Values
   <65 Years   >=65 Years 
Participants Analyzed 
[Units: Participants]
 381   10 
Risk Factors for the Frequency of Treatment Related Adverse Events -Age (Prophylaxis). 
[Units: Participants]
 72   1 


Statistical Analysis 1 for Risk Factors for the Frequency of Treatment Related Adverse Events -Age (Prophylaxis).
Groups [1] All groups
Method [2] Fisher Exact
P Value [3] =0.696
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  The risk factor tested was "Age". The null hypothesis is there is no difference between "<65 years and >=65 years " in the frequency of Treatment Related Adverse Events(TRAEs).
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



4.  Primary:   Risk Factors for the Frequency of Treatment Related Adverse Events -Gender (Prophylaxis).   [ Time Frame: 9 years(MAX) ]

Measure Type Primary
Measure Title Risk Factors for the Frequency of Treatment Related Adverse Events -Gender (Prophylaxis).
Measure Description Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin Tablets to determine whether male or female is significant risk factor.
Time Frame 9 years(MAX)  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.

Reporting Groups
  Description
Male Male Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert.
Female Female Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert.

Measured Values
   Male   Female 
Participants Analyzed 
[Units: Participants]
 360   31 
Risk Factors for the Frequency of Treatment Related Adverse Events -Gender (Prophylaxis). 
[Units: Participants]
 65   8 


Statistical Analysis 1 for Risk Factors for the Frequency of Treatment Related Adverse Events -Gender (Prophylaxis).
Groups [1] All groups
Method [2] Fisher Exact
P Value [3] =0.334
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  The risk factor tested was "Gender". The null hypothesis is there is no difference between "Male and Female " in the frequency of Treatment Related Adverse Events(TRAEs).
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



5.  Primary:   Risk Factors for the Frequency of Treatment Related Adverse Events -Concomitant Drugs (Prophylaxis).   [ Time Frame: 9 years(MAX) ]

Measure Type Primary
Measure Title Risk Factors for the Frequency of Treatment Related Adverse Events -Concomitant Drugs (Prophylaxis).
Measure Description Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin Tablets to determine whether with or without concomitant drugs is significant risk factor.
Time Frame 9 years(MAX)  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drugs was confirmed.

Reporting Groups
  Description
Azithromycin With Concomitant Drugs Participants with concomitant drugs who taking Azithromycin for Prophylaxis according to Japanese Package Insert.
Azithromycin Without Concomitant Drugs Participants without concomitant drugs who taking Azithromycin for Prophylaxis according to Japanese Package Insert.

Measured Values
   Azithromycin With Concomitant Drugs   Azithromycin Without Concomitant Drugs 
Participants Analyzed 
[Units: Participants]
 387   4 
Risk Factors for the Frequency of Treatment Related Adverse Events -Concomitant Drugs (Prophylaxis). 
[Units: Participants]
 73   0 


Statistical Analysis 1 for Risk Factors for the Frequency of Treatment Related Adverse Events -Concomitant Drugs (Prophylaxis).
Groups [1] All groups
Method [2] Fisher Exact
P Value [3] =1.000
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  The risk factor tested was "concomitant drugs". The null hypothesis is there is no difference between "with and without concomitant drugs " in the frequency of Treatment Related Adverse Events(TRAEs).
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



6.  Primary:   Risk Factors for the Frequency of Treatment Related Adverse Events -Renal Dysfunction (Prophylaxis).   [ Time Frame: 9 years(MAX) ]

Measure Type Primary
Measure Title Risk Factors for the Frequency of Treatment Related Adverse Events -Renal Dysfunction (Prophylaxis).
Measure Description Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether with or without renal dysfunction is significant risk factor.
Time Frame 9 years(MAX)  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.

Reporting Groups
  Description
Azithromycin With Renal Dysfunction Participants with renal dysfunction who taking Azithromycin for Prophylaxis according to Japanese Package Insert.
Azithromycin Without Renal Dysfunction Participants without renal dysfunction who taking Azithromycin for Prophylaxis according to Japanese Package Insert.

Measured Values
   Azithromycin With Renal Dysfunction   Azithromycin Without Renal Dysfunction 
Participants Analyzed 
[Units: Participants]
 13   378 
Risk Factors for the Frequency of Treatment Related Adverse Events -Renal Dysfunction (Prophylaxis). 
[Units: Participants]
 2   71 


Statistical Analysis 1 for Risk Factors for the Frequency of Treatment Related Adverse Events -Renal Dysfunction (Prophylaxis).
Groups [1] All groups
Method [2] Fisher Exact
P Value [3] =1.000
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  The risk factor tested was "Renal Dysfunction". The null hypothesis is there is no difference between "with and without renal dysfunction " in the frequency of Treatment Related Adverse Events(TRAEs).
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



7.  Primary:   Risk Factors for the Frequency of Treatment Related Adverse Events -Allergies (Prophylaxis).   [ Time Frame: 9 years(MAX) ]

Measure Type Primary
Measure Title Risk Factors for the Frequency of Treatment Related Adverse Events -Allergies (Prophylaxis).
Measure Description Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether with or without allergies is significant risk factor.
Time Frame 9 years(MAX)  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.

Reporting Groups
  Description
Azithromycin With Allergies Participants with allergies who taking Azithromycin for Prophylaxis according to Japanese Package Insert.
Azithromycin Without Allergies Participants without allergies who taking Azithromycin for Prophylaxis according to Japanese Package Insert.

Measured Values
   Azithromycin With Allergies   Azithromycin Without Allergies 
Participants Analyzed 
[Units: Participants]
 108   226 
Risk Factors for the Frequency of Treatment Related Adverse Events -Allergies (Prophylaxis). 
[Units: Participants]
 28   33 


Statistical Analysis 1 for Risk Factors for the Frequency of Treatment Related Adverse Events -Allergies (Prophylaxis).
Groups [1] All groups
Method [2] Fisher Exact
P Value [3] =0.015
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  The risk factor tested was "Allergies". The null hypothesis is there is no difference between "with and without allergies" in the frequency of Treatment Related Adverse Events(TRAEs).
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



8.  Primary:   Risk Factors for the Frequency of Treatment Related Adverse Events -Age (Treatment).   [ Time Frame: 9 years(MAX) ]

Measure Type Primary
Measure Title Risk Factors for the Frequency of Treatment Related Adverse Events -Age (Treatment).
Measure Description Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether <65 years or >=65 years is significant risk factor.
Time Frame 9 years(MAX)  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.

Reporting Groups
  Description
<65 Years Participants with <65 years who taking Azithromycin for Treatment according to Japanese Package Insert.
>=65 Years Participants with >=65 years who taking Azithromycin for Treatment according to Japanese Package Insert.

Measured Values
   <65 Years   >=65 Years 
Participants Analyzed 
[Units: Participants]
 83   1 
Risk Factors for the Frequency of Treatment Related Adverse Events -Age (Treatment). 
[Units: Participants]
 10   0 


Statistical Analysis 1 for Risk Factors for the Frequency of Treatment Related Adverse Events -Age (Treatment).
Groups [1] All groups
Method [2] Fisher Exact
P Value [3] =1.000
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  The risk factor tested was "Age". The null hypothesis is there is no difference between "<65 years and >=65 years " in the frequency of Treatment Related Adverse Events(TRAEs).
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



9.  Primary:   Risk Factors for the Frequency of Treatment Related Adverse Events -Gender (Treatment).   [ Time Frame: 9 years(MAX) ]

Measure Type Primary
Measure Title Risk Factors for the Frequency of Treatment Related Adverse Events -Gender (Treatment).
Measure Description Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin Tablets to determine whether male or female is significant risk factor.
Time Frame 9 years(MAX)  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.

Reporting Groups
  Description
Male Male Participants taking Azithromycin for Treatment according to Japanese Package Insert.
Female Female Participants taking Azithromycin for Treatment according to Japanese Package Insert.

Measured Values
   Male   Female 
Participants Analyzed 
[Units: Participants]
 75   9 
Risk Factors for the Frequency of Treatment Related Adverse Events -Gender (Treatment). 
[Units: Participants]
 8   2 


Statistical Analysis 1 for Risk Factors for the Frequency of Treatment Related Adverse Events -Gender (Treatment).
Groups [1] All groups
Method [2] Fisher Exact
P Value [3] =0.290
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  The risk factor tested was "Gender". The null hypothesis is there is no difference between "Male and Female " in the frequency of Treatment Related Adverse Events(TRAEs).
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



10.  Primary:   Risk Factors for the Frequency of Treatment Related Adverse Events -Renal Dysfunction (Treatment).   [ Time Frame: 9 years(MAX) ]

Measure Type Primary
Measure Title Risk Factors for the Frequency of Treatment Related Adverse Events -Renal Dysfunction (Treatment).
Measure Description Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether with or without renal dysfunction is significant risk factor.
Time Frame 9 years(MAX)  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.

Reporting Groups
  Description
Azithromycin With Renal Dysfunction Participants with renal dysfunction who taking Azithromycin for Treatment according to Japanese Package Insert.
Azithromycin Without Renal Dysfunction Participants without renal dysfunction who taking Azithromycin for Treatment according to Japanese Package Insert.

Measured Values
   Azithromycin With Renal Dysfunction   Azithromycin Without Renal Dysfunction 
Participants Analyzed 
[Units: Participants]
 7   77 
Risk Factors for the Frequency of Treatment Related Adverse Events -Renal Dysfunction (Treatment). 
[Units: Participants]
 4   6 


Statistical Analysis 1 for Risk Factors for the Frequency of Treatment Related Adverse Events -Renal Dysfunction (Treatment).
Groups [1] All groups
Method [2] Fisher Exact
P Value [3] =0.003
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  The risk factor tested was "Renal Dysfunction". The null hypothesis is there is no difference between "with and without renal dysfunction " in the frequency of Treatment Related Adverse Events(TRAEs).
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



11.  Primary:   Risk Factors for the Frequency of Treatment Related Adverse Events -Allergies (Treatment).   [ Time Frame: 9 years(MAX) ]

Measure Type Primary
Measure Title Risk Factors for the Frequency of Treatment Related Adverse Events -Allergies (Treatment).
Measure Description Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether with or without allergies is significant risk factor.
Time Frame 9 years(MAX)  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.

Reporting Groups
  Description
Azithromycin With Allergies Participants with allergies who taking Azithromycin for Treatment according to Japanese Package Insert.
Azithromycin Without Allergies Participants without allergies who taking Azithromycin for Treatment according to Japanese Package Insert.

Measured Values
   Azithromycin With Allergies   Azithromycin Without Allergies 
Participants Analyzed 
[Units: Participants]
 19   56 
Risk Factors for the Frequency of Treatment Related Adverse Events -Allergies (Treatment). 
[Units: Participants]
 3   7 


Statistical Analysis 1 for Risk Factors for the Frequency of Treatment Related Adverse Events -Allergies (Treatment).
Groups [1] All groups
Method [2] Fisher Exact
P Value [3] =0.707
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  The risk factor tested was "Allergies". The null hypothesis is there is no difference between "with and without allergies" in the frequency of Treatment Related Adverse Events(TRAEs).
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



12.  Secondary:   Number of Participants That Responded to Azithromycin Treatment.   [ Time Frame: 9 years(MAX) ]

Measure Type Secondary
Measure Title Number of Participants That Responded to Azithromycin Treatment.
Measure Description The physician performed efficacy evaluations at the end of the observation period (or the time of discontinuing administration), compared with the data before the start of administration of this drug, and entered the results.
Time Frame 9 years(MAX)  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).

Reporting Groups
  Description
Azithromycin for Treatment Participants taking Azithromycin for Treatment according to Japanese Package Insert.

Measured Values
   Azithromycin for Treatment 
Participants Analyzed 
[Units: Participants]
 64 
Number of Participants That Responded to Azithromycin Treatment. 
[Units: Participants]
 51 

No statistical analysis provided for Number of Participants That Responded to Azithromycin Treatment.



13.  Secondary:   Number of Participants Prevented by Azithromycin Treatment.   [ Time Frame: 9 years(MAX) ]

Measure Type Secondary
Measure Title Number of Participants Prevented by Azithromycin Treatment.
Measure Description The physician performed efficacy evaluations at the end of the observation period (or the time of discontinuing administration), compared with the data before the start of administration of this drug, and entered the results.
Time Frame 9 years(MAX)  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).

Reporting Groups
  Description
Azithromycin for Prophylaxis Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert.

Measured Values
   Azithromycin for Prophylaxis 
Participants Analyzed 
[Units: Participants]
 390 
Number of Participants Prevented by Azithromycin Treatment. 
[Units: Participants]
 375 

No statistical analysis provided for Number of Participants Prevented by Azithromycin Treatment.




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information