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Drug Use Investigation On Zithromac (Azithromycin) In HIV Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01227395
Recruitment Status : Completed
First Posted : October 25, 2010
Results First Posted : April 16, 2013
Last Update Posted : April 26, 2013
Sponsor:
Collaborator:
Altmarc Inc.
Information provided by (Responsible Party):
Pfizer

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Retrospective
Condition HIV Infection
Intervention Drug: Azithromycin
Enrollment 476
Recruitment Details 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  
Arm/Group Title Azithromycin for Prophylaxis Azithromycin for Treatment
Hide Arm/Group Description Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert. Participants taking Azithromycin for Treatment according to Japanese Package Insert.
Period Title: Overall Study
Started 391 85
Completed 391 84
Not Completed 0 1
Reason Not Completed
Protocol Violation             0             1
Arm/Group Title Azithromycin for Prophylaxis Azithromycin for Treatment Total
Hide Arm/Group Description Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert. Participants taking Azithromycin for Treatment according to Japanese Package Insert. Total of all reporting groups
Overall Number of Baseline Participants 391 84 475
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 391 participants 84 participants 475 participants
<65 years 381 83 464
>=65 years 10 1 11
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 391 participants 84 participants 475 participants
Female
31
   7.9%
9
  10.7%
40
   8.4%
Male
360
  92.1%
75
  89.3%
435
  91.6%
1.Primary Outcome
Title Number of Participants With the Frequency of Treatment Related Adverse Events.
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
No statistical analysis provided for the frequency of treatment related adverse events.
Arm/Group Title Azithromycin for Prophylaxis Azithromycin for Treatment
Hide Arm/Group Description:
Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert.
Participants taking Azithromycin for Treatment according to Japanese Package Insert.
Overall Number of Participants Analyzed 391 84
Measure Type: Number
Unit of Measure: participants
73 10
2.Primary Outcome
Title Number of Unlisted Treatment Related Adverse Events in Japanese Package Insert.
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
No statistical analysis provided for the number of the unlisted treatment related adverse events in Japanese Package Insert.
Arm/Group Title Azithromycin for Prophylaxis Azithromycin for Treatment
Hide Arm/Group Description:
Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert.
Participants taking Azithromycin for Treatment according to Japanese Package Insert.
Overall Number of Participants Analyzed 391 84
Measure Type: Number
Unit of Measure: Events
37 9
3.Primary Outcome
Title Risk Factors for the Frequency of Treatment Related Adverse Events -Age (Prophylaxis).
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.
Arm/Group Title <65 Years >=65 Years
Hide Arm/Group Description:
Participants with <65 years who taking Azithromycin for Prophylaxis according to Japanese Package Insert.
Participants with >=65 years who taking Azithromycin for Prophylaxis according to Japanese Package Insert.
Overall Number of Participants Analyzed 381 10
Measure Type: Number
Unit of Measure: participants
72 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection <65 Years, >=65 Years
Comments 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).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.696
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
4.Primary Outcome
Title Risk Factors for the Frequency of Treatment Related Adverse Events -Gender (Prophylaxis).
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.
Arm/Group Title Male Female
Hide Arm/Group Description:
Male Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert.
Female Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert.
Overall Number of Participants Analyzed 360 31
Measure Type: Number
Unit of Measure: participants
65 8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Male, Female
Comments 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).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.334
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
5.Primary Outcome
Title Risk Factors for the Frequency of Treatment Related Adverse Events -Concomitant Drugs (Prophylaxis).
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drugs was confirmed.
Arm/Group Title Azithromycin With Concomitant Drugs Azithromycin Without Concomitant Drugs
Hide Arm/Group Description:
Participants with concomitant drugs who taking Azithromycin for Prophylaxis according to Japanese Package Insert.
Participants without concomitant drugs who taking Azithromycin for Prophylaxis according to Japanese Package Insert.
Overall Number of Participants Analyzed 387 4
Measure Type: Number
Unit of Measure: participants
73 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azithromycin With Concomitant Drugs, Azithromycin Without Concomitant Drugs
Comments 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).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =1.000
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
6.Primary Outcome
Title Risk Factors for the Frequency of Treatment Related Adverse Events -Renal Dysfunction (Prophylaxis).
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.
Arm/Group Title Azithromycin With Renal Dysfunction Azithromycin Without Renal Dysfunction
Hide Arm/Group Description:
Participants with renal dysfunction who taking Azithromycin for Prophylaxis according to Japanese Package Insert.
Participants without renal dysfunction who taking Azithromycin for Prophylaxis according to Japanese Package Insert.
Overall Number of Participants Analyzed 13 378
Measure Type: Number
Unit of Measure: participants
2 71
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azithromycin With Renal Dysfunction, Azithromycin Without Renal Dysfunction
Comments 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).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =1.000
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
7.Primary Outcome
Title Risk Factors for the Frequency of Treatment Related Adverse Events -Allergies (Prophylaxis).
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.
Arm/Group Title Azithromycin With Allergies Azithromycin Without Allergies
Hide Arm/Group Description:
Participants with allergies who taking Azithromycin for Prophylaxis according to Japanese Package Insert.
Participants without allergies who taking Azithromycin for Prophylaxis according to Japanese Package Insert.
Overall Number of Participants Analyzed 108 226
Measure Type: Number
Unit of Measure: participants
28 33
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azithromycin With Allergies, Azithromycin Without Allergies
Comments 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).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.015
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
8.Primary Outcome
Title Risk Factors for the Frequency of Treatment Related Adverse Events -Age (Treatment).
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.
Arm/Group Title <65 Years >=65 Years
Hide Arm/Group Description:
Participants with <65 years who taking Azithromycin for Treatment according to Japanese Package Insert.
Participants with >=65 years who taking Azithromycin for Treatment according to Japanese Package Insert.
Overall Number of Participants Analyzed 83 1
Measure Type: Number
Unit of Measure: participants
10 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection <65 Years, >=65 Years
Comments 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).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =1.000
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
9.Primary Outcome
Title Risk Factors for the Frequency of Treatment Related Adverse Events -Gender (Treatment).
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.
Arm/Group Title Male Female
Hide Arm/Group Description:
Male Participants taking Azithromycin for Treatment according to Japanese Package Insert.
Female Participants taking Azithromycin for Treatment according to Japanese Package Insert.
Overall Number of Participants Analyzed 75 9
Measure Type: Number
Unit of Measure: participants
8 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Male, Female
Comments 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).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.290
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
10.Primary Outcome
Title Risk Factors for the Frequency of Treatment Related Adverse Events -Renal Dysfunction (Treatment).
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.
Arm/Group Title Azithromycin With Renal Dysfunction Azithromycin Without Renal Dysfunction
Hide Arm/Group Description:
Participants with renal dysfunction who taking Azithromycin for Treatment according to Japanese Package Insert.
Participants without renal dysfunction who taking Azithromycin for Treatment according to Japanese Package Insert.
Overall Number of Participants Analyzed 7 77
Measure Type: Number
Unit of Measure: participants
4 6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azithromycin With Renal Dysfunction, Azithromycin Without Renal Dysfunction
Comments 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).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.003
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
11.Primary Outcome
Title Risk Factors for the Frequency of Treatment Related Adverse Events -Allergies (Treatment).
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.
Arm/Group Title Azithromycin With Allergies Azithromycin Without Allergies
Hide Arm/Group Description:
Participants with allergies who taking Azithromycin for Treatment according to Japanese Package Insert.
Participants without allergies who taking Azithromycin for Treatment according to Japanese Package Insert.
Overall Number of Participants Analyzed 19 56
Measure Type: Number
Unit of Measure: participants
3 7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Azithromycin With Allergies, Azithromycin Without Allergies
Comments 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).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.707
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
12.Secondary Outcome
Title Number of Participants That Responded to Azithromycin Treatment.
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Azithromycin for Treatment
Hide Arm/Group Description:
Participants taking Azithromycin for Treatment according to Japanese Package Insert.
Overall Number of Participants Analyzed 64
Measure Type: Number
Unit of Measure: participants
51
13.Secondary Outcome
Title Number of Participants Prevented by Azithromycin Treatment.
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Azithromycin for Prophylaxis
Hide Arm/Group Description:
Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert.
Overall Number of Participants Analyzed 390
Measure Type: Number
Unit of Measure: participants
375
Time Frame [Not Specified]
Adverse Event Reporting Description The frequency of treatment related advers events during the study.
 
Arm/Group Title Azithromycin for Prophylaxis Azithromycin for Treatment
Hide Arm/Group Description Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert. Participants taking Azithromycin for Treatment according to Japanese Package Insert.
All-Cause Mortality
Azithromycin for Prophylaxis Azithromycin for Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Azithromycin for Prophylaxis Azithromycin for Treatment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/391 (2.81%)      4/84 (4.76%)    
Blood and lymphatic system disorders     
Idiopathic thrombocytopenic purpura  1  1/391 (0.26%)  1 0/84 (0.00%)  0
Pancytopenia  1  1/391 (0.26%)  1 0/84 (0.00%)  0
Anaemia  1  2/391 (0.51%)  2 1/84 (1.19%)  1
Gastrointestinal disorders     
Duodenal stenosis  1  1/391 (0.26%)  1 0/84 (0.00%)  0
Hepatobiliary disorders     
Hepatic function abnormal  1  3/391 (0.77%)  3 0/84 (0.00%)  0
Liver disorder  1  1/391 (0.26%)  1 0/84 (0.00%)  0
Infections and infestations     
Progressive multifocal leukoencephalopathy  1  0/391 (0.00%)  0 1/84 (1.19%)  1
Investigations     
White blood cell count decreased  1  1/391 (0.26%)  1 0/84 (0.00%)  0
Metabolism and nutrition disorders     
Hypokalaemia  1  1/391 (0.26%)  1 0/84 (0.00%)  0
Hyponatraemia  1  1/391 (0.26%)  1 0/84 (0.00%)  0
Renal and urinary disorders     
Renal impairment  1  1/391 (0.26%)  1 0/84 (0.00%)  0
Renal failure acute  1  0/391 (0.00%)  0 1/84 (1.19%)  1
Renal disorder  1  0/391 (0.00%)  0 1/84 (1.19%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA-J 14.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Azithromycin for Prophylaxis Azithromycin for Treatment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   62/391 (15.86%)      6/84 (7.14%)    
Blood and lymphatic system disorders     
Lymphadenopathy  1  1/391 (0.26%)  1 0/84 (0.00%)  0
Anaemia  1  1/391 (0.26%)  1 0/84 (0.00%)  0
Cardiac disorders     
Bradycardia  1  1/391 (0.26%)  1 0/84 (0.00%)  0
Ear and labyrinth disorders     
Hypoacusis  1  0/391 (0.00%)  0 1/84 (1.19%)  1
Deafness  1  0/391 (0.00%)  0 1/84 (1.19%)  1
Endocrine disorders     
Hyperthyroidism  1  1/391 (0.26%)  1 1/84 (1.19%)  1
Gastrointestinal disorders     
Nausea  1  5/391 (1.28%)  5 0/84 (0.00%)  0
Gastric ulcer  1  1/391 (0.26%)  1 0/84 (0.00%)  0
Diarrhoea  1  10/391 (2.56%)  10 1/84 (1.19%)  1
Abdominal discomfort  1  2/391 (0.51%)  2 0/84 (0.00%)  0
Vomiting  1  3/391 (0.77%)  3 0/84 (0.00%)  0
Gastrooesophageal reflux disease  1  0/391 (0.00%)  0 1/84 (1.19%)  1
General disorders     
Duodenal ulcer  1  1/391 (0.26%)  1 0/84 (0.00%)  0
Pyrexia  1  3/391 (0.77%)  3 0/84 (0.00%)  0
Hepatobiliary disorders     
Hepatic function abnormal  1  5/391 (1.28%)  5 1/84 (1.19%)  1
Liver disorder  1  3/391 (0.77%)  3 0/84 (0.00%)  0
Hyperbilirubinaemia  1  5/391 (1.28%)  5 0/84 (0.00%)  0
Immune system disorders     
Hypersensitivity  1  1/391 (0.26%)  1 0/84 (0.00%)  0
Infections and infestations     
Hepatitis C  1  1/391 (0.26%)  1 0/84 (0.00%)  0
Oral candidiasis  1  1/391 (0.26%)  1 0/84 (0.00%)  0
Investigations     
C-reactive protein increased  1  1/391 (0.26%)  1 0/84 (0.00%)  0
Haemoglobin decreased  1  1/391 (0.26%)  1 0/84 (0.00%)  0
Gamma-glutamyltransferase increased  1  4/391 (1.02%)  4 1/84 (1.19%)  1
Platelet count decreased  1  2/391 (0.51%)  2 0/84 (0.00%)  0
Blood alkaline phosphatase increased  1  1/391 (0.26%)  1 0/84 (0.00%)  0
Blood creatinine increased  1  1/391 (0.26%)  1 0/84 (0.00%)  0
Blood cholesterol increased  1  1/391 (0.26%)  1 0/84 (0.00%)  0
Blood triglycerides increased  1  3/391 (0.77%)  3 0/84 (0.00%)  0
Blood bilirubin increased  1  2/391 (0.51%)  2 1/84 (1.19%)  1
Blood uric acid increased  1  1/391 (0.26%)  1 0/84 (0.00%)  0
Red blood cell count decreased  1  1/391 (0.26%)  1 0/84 (0.00%)  0
Beta 2 microglobulin urine increased  1  1/391 (0.26%)  1 0/84 (0.00%)  0
White blood cell count decreased  1  3/391 (0.77%)  3 0/84 (0.00%)  0
Metabolism and nutrition disorders     
Hypercalcaemia  1  1/391 (0.26%)  1 0/84 (0.00%)  0
Hypercholesterolaemia  1  1/391 (0.26%)  1 0/84 (0.00%)  0
Hypertriglyceridaemia  1  4/391 (1.02%)  4 0/84 (0.00%)  0
Hyperlipidaemia  1  5/391 (1.28%)  5 1/84 (1.19%)  1
Diabetes mellitus  1  1/391 (0.26%)  1 0/84 (0.00%)  0
Nervous system disorders     
Headache  1  1/391 (0.26%)  1 0/84 (0.00%)  0
Neuropathy peripheral  1  1/391 (0.26%)  1 0/84 (0.00%)  0
Psychiatric disorders     
Depression  1  1/391 (0.26%)  1 0/84 (0.00%)  0
Abnormal dreams  1  1/391 (0.26%)  1 0/84 (0.00%)  0
Renal and urinary disorders     
Renal impairment  1  1/391 (0.26%)  1 1/84 (1.19%)  1
Reproductive system and breast disorders     
Sexual dysfunction  1  0/391 (0.00%)  0 1/84 (1.19%)  1
Skin and subcutaneous tissue disorders     
Pruritus  1  2/391 (0.51%)  2 0/84 (0.00%)  0
Rash  1  2/391 (0.51%)  2 1/84 (1.19%)  1
Drug eruption  1  2/391 (0.51%)  2 0/84 (0.00%)  0
Lipodystrophy acquired  1  0/391 (0.00%)  0 1/84 (1.19%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA-J 14.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01227395     History of Changes
Other Study ID Numbers: A0661097
First Submitted: October 7, 2010
First Posted: October 25, 2010
Results First Submitted: March 4, 2013
Results First Posted: April 16, 2013
Last Update Posted: April 26, 2013