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Study Evaluating Desvenlafaxine Succinate Sustained-release (DVS SR) in Adult Outpatients With Pain Associated With Diabetic Peripheral Neuropathy

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ClinicalTrials.gov Identifier: NCT00283842
Recruitment Status : Terminated (business reasons)
First Posted : January 30, 2006
Results First Posted : August 13, 2009
Last Update Posted : October 24, 2011
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Diabetic Neuropathies
Pain
Interventions Drug: DVS SR
Drug: Placebo
Enrollment 408

Recruitment Details Participants were recruited January 2006 to February 2008
Pre-assignment Details Participants were screened during a 7- to 28-day period, a treatment period.
Arm/Group Title Desvenlafaxine Succinate Sustained-release (DVS SR) 50mg Desvenlafaxine Succinate Sustained-release (DVS SR) 100mg Desvenlafaxine Succinate Sustained-release (DVS SR) 200mg Desvenlafaxine Succinate Sustained-release (DVS SR) 400mg Placebo
Hide Arm/Group Description 50mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally 100mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally 200mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally 400mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally [Not Specified]
Period Title: Overall Study
Started 63 87 99 69 90
Completed 51 69 68 42 75
Not Completed 12 18 31 27 15
Reason Not Completed
Adverse Event             8             7             21             21             5
Protocol Violation             1             5             4             0             0
Protocol deviation             0             0             0             0             2
Withdrawal by Subject             2             1             1             5             4
Lack of Efficacy             1             3             1             0             3
Lost to Follow-up             0             2             4             1             1
Arm/Group Title Desvenlafaxine Succinate Sustained-release (DVS SR) 50mg Desvenlafaxine Succinate Sustained-release (DVS SR) 100mg Desvenlafaxine Succinate Sustained-release (DVS SR) 200mg Desvenlafaxine Succinate Sustained-release (DVS SR) 400mg Placebo Total
Hide Arm/Group Description 50mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally 100mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally 200mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally 400mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 63 87 99 69 90 408
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 63 participants 87 participants 99 participants 69 participants 90 participants 408 participants
61.62  (8.59) 60.66  (9.23) 59.80  (9.38) 61.14  (10.03) 58.98  (8.51) 60.31  (9.16)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants 87 participants 99 participants 69 participants 90 participants 408 participants
Female
16
  25.4%
20
  23.0%
30
  30.3%
17
  24.6%
25
  27.8%
108
  26.5%
Male
47
  74.6%
67
  77.0%
69
  69.7%
52
  75.4%
65
  72.2%
300
  73.5%
1.Primary Outcome
Title Change in Mean Pain Severity Score From Baseline to 13 Weeks
Hide Description Pain severity measured on a Numeric Rating Scale (NRS). Range: 0 (no pain) to 10 (worst possible pain). Change: score at 13 weeks minus score at baseline.
Time Frame Baseline and 13 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population was the intent to treat.
Arm/Group Title Desvenlafaxine Succinate Sustained-release (DVS SR) 50mg Desvenlafaxine Succinate Sustained-release (DVS SR) 100mg Desvenlafaxine Succinate Sustained-release (DVS SR) 200mg Desvenlafaxine Succinate Sustained-release (DVS SR) 400mg Placebo
Hide Arm/Group Description:
50mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
100mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
200mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
400mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
[Not Specified]
Overall Number of Participants Analyzed 49 65 70 40 72
Mean (Standard Error)
Unit of Measure: units on scale
-2.41  (0.26) -2.42  (0.23) -2.93  (0.22) -2.74  (0.27) -1.83  (0.22)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Desvenlafaxine Succinate Sustained-release (DVS SR) 50mg, Desvenlafaxine Succinate Sustained-release (DVS SR) 100mg, Desvenlafaxine Succinate Sustained-release (DVS SR) 200mg, Desvenlafaxine Succinate Sustained-release (DVS SR) 400mg
Comments Statistical analysis provided for 50mg.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.084
Comments [Not Specified]
Method Hochberg
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Desvenlafaxine Succinate Sustained-release (DVS SR) 50mg, Desvenlafaxine Succinate Sustained-release (DVS SR) 100mg, Desvenlafaxine Succinate Sustained-release (DVS SR) 200mg, Desvenlafaxine Succinate Sustained-release (DVS SR) 400mg
Comments Statistical analysis provided for 100mg.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.084
Comments [Not Specified]
Method Hochberg
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Desvenlafaxine Succinate Sustained-release (DVS SR) 50mg, Desvenlafaxine Succinate Sustained-release (DVS SR) 100mg, Desvenlafaxine Succinate Sustained-release (DVS SR) 200mg, Desvenlafaxine Succinate Sustained-release (DVS SR) 400mg
Comments Statistical analysis provided for 200mg.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Hochberg
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Desvenlafaxine Succinate Sustained-release (DVS SR) 50mg, Desvenlafaxine Succinate Sustained-release (DVS SR) 100mg, Desvenlafaxine Succinate Sustained-release (DVS SR) 200mg, Desvenlafaxine Succinate Sustained-release (DVS SR) 400mg
Comments Statistical analysis provided for 400mg.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.027
Comments [Not Specified]
Method Hochberg
Comments [Not Specified]
2.Secondary Outcome
Title Number of Patients With ≥50% Reduction in Mean Pain Severity Score.
Hide Description Pain severity measured on a Numeric Rating Scale (NRS). Range: 0 (no pain) to 10 (worst possible pain). Assessment of reduction based on change in score at 13 weeks compared to baseline.
Time Frame Baseline and 13 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population is the intent to treat.
Arm/Group Title Desvenlafaxine Succinate Sustained-release (DVS SR) 50mg Desvenlafaxine Succinate Sustained-release (DVS SR) 100mg Desvenlafaxine Succinate Sustained-release (DVS SR) 200mg Desvenlafaxine Succinate Sustained-release (DVS SR) 400mg Placebo
Hide Arm/Group Description:
50mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
100mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
200mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
400mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
[Not Specified]
Overall Number of Participants Analyzed 63 86 99 68 89
Measure Type: Number
Unit of Measure: patients
22 32 36 22 23
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Desvenlafaxine Succinate Sustained-release (DVS SR) 50mg, Desvenlafaxine Succinate Sustained-release (DVS SR) 100mg, Desvenlafaxine Succinate Sustained-release (DVS SR) 200mg, Desvenlafaxine Succinate Sustained-release (DVS SR) 400mg
Comments Statistical analysis provided for 50mg.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.375
Comments [Not Specified]
Method Hochberg
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Desvenlafaxine Succinate Sustained-release (DVS SR) 50mg, Desvenlafaxine Succinate Sustained-release (DVS SR) 100mg, Desvenlafaxine Succinate Sustained-release (DVS SR) 200mg, Desvenlafaxine Succinate Sustained-release (DVS SR) 400mg
Comments Statistical analysis provided for 100mg.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.342
Comments [Not Specified]
Method Hochberg
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Desvenlafaxine Succinate Sustained-release (DVS SR) 50mg, Desvenlafaxine Succinate Sustained-release (DVS SR) 100mg, Desvenlafaxine Succinate Sustained-release (DVS SR) 200mg, Desvenlafaxine Succinate Sustained-release (DVS SR) 400mg
Comments Statistical analysis provided for 200mg.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.342
Comments [Not Specified]
Method Hochberg
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Desvenlafaxine Succinate Sustained-release (DVS SR) 50mg, Desvenlafaxine Succinate Sustained-release (DVS SR) 100mg, Desvenlafaxine Succinate Sustained-release (DVS SR) 200mg, Desvenlafaxine Succinate Sustained-release (DVS SR) 400mg
Comments Statistical analysis provided for 400mg.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.375
Comments [Not Specified]
Method Hochberg
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Desvenlafaxine Succinate Sustained-release (DVS SR) 50mg Desvenlafaxine Succinate Sustained-release (DVS SR) 100mg Desvenlafaxine Succinate Sustained-release (DVS SR) 200mg Desvenlafaxine Succinate Sustained-release (DVS SR) 400mg Placebo
Hide Arm/Group Description 50mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally 100mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally 200mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally 400mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally [Not Specified]
All-Cause Mortality
Desvenlafaxine Succinate Sustained-release (DVS SR) 50mg Desvenlafaxine Succinate Sustained-release (DVS SR) 100mg Desvenlafaxine Succinate Sustained-release (DVS SR) 200mg Desvenlafaxine Succinate Sustained-release (DVS SR) 400mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Desvenlafaxine Succinate Sustained-release (DVS SR) 50mg Desvenlafaxine Succinate Sustained-release (DVS SR) 100mg Desvenlafaxine Succinate Sustained-release (DVS SR) 200mg Desvenlafaxine Succinate Sustained-release (DVS SR) 400mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1   1   1   3   6 
Cardiac disorders           
Angina pectoris *  0/63 (0.00%)  0/87 (0.00%)  0/99 (0.00%)  0/69 (0.00%)  1/90 (1.11%) 
Ventricular tachycardia *  0/63 (0.00%)  0/87 (0.00%)  1/99 (1.01%)  0/69 (0.00%)  0/90 (0.00%) 
Gastrointestinal disorders           
Gastrointestinal hemorrhage *  0/63 (0.00%)  0/87 (0.00%)  1/99 (1.01%)  0/69 (0.00%)  0/90 (0.00%) 
Infections and infestations           
Pneumonia *  0/63 (0.00%)  1/87 (1.15%)  0/99 (0.00%)  0/69 (0.00%)  1/90 (1.11%) 
Injury, poisoning and procedural complications           
Ankle fracture *  0/63 (0.00%)  0/87 (0.00%)  0/99 (0.00%)  0/69 (0.00%)  1/90 (1.11%) 
Overdose *  0/63 (0.00%)  0/87 (0.00%)  0/99 (0.00%)  0/69 (0.00%)  1/90 (1.11%) 
Stress fracture *  0/63 (0.00%)  0/87 (0.00%)  0/99 (0.00%)  0/69 (0.00%)  1/90 (1.11%) 
Investigations           
Blood glucose increased *  0/63 (0.00%)  0/87 (0.00%)  0/99 (0.00%)  0/69 (0.00%)  1/90 (1.11%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Anaplastic thyroid cancer *  0/63 (0.00%)  0/87 (0.00%)  0/99 (0.00%)  1/69 (1.45%)  0/90 (0.00%) 
Colon cancer *  0/63 (0.00%)  0/87 (0.00%)  1/99 (1.01%)  0/69 (0.00%)  0/90 (0.00%) 
Esophageal cancer *  1/63 (1.59%)  0/87 (0.00%)  0/99 (0.00%)  0/69 (0.00%)  0/90 (0.00%) 
Psychiatric disorders           
Mental status changes *  0/63 (0.00%)  0/87 (0.00%)  1/99 (1.01%)  0/69 (0.00%)  0/90 (0.00%) 
Renal and urinary disorders           
Urinary retention *  0/63 (0.00%)  0/87 (0.00%)  0/99 (0.00%)  1/69 (1.45%)  0/90 (0.00%) 
Vascular disorders           
Orthostatic hypotension *  0/63 (0.00%)  0/87 (0.00%)  0/99 (0.00%)  1/69 (1.45%)  0/90 (0.00%) 
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Desvenlafaxine Succinate Sustained-release (DVS SR) 50mg Desvenlafaxine Succinate Sustained-release (DVS SR) 100mg Desvenlafaxine Succinate Sustained-release (DVS SR) 200mg Desvenlafaxine Succinate Sustained-release (DVS SR) 400mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   47   65   82   63   68 
Blood and lymphatic system disorders           
Anemia *  0/63 (0.00%)  0/87 (0.00%)  0/99 (0.00%)  0/69 (0.00%)  1/90 (1.11%) 
Ecchymosis *  0/63 (0.00%)  0/87 (0.00%)  1/99 (1.01%)  1/69 (1.45%)  0/90 (0.00%) 
Leukopenia *  0/63 (0.00%)  0/87 (0.00%)  0/99 (0.00%)  0/69 (0.00%)  1/90 (1.11%) 
Lymphadenopathy *  0/63 (0.00%)  1/87 (1.15%)  0/99 (0.00%)  0/69 (0.00%)  0/90 (0.00%) 
Cardiac disorders           
Angina pectoris *  1/63 (1.59%)  0/87 (0.00%)  0/99 (0.00%)  0/69 (0.00%)  1/90 (1.11%) 
Arrhythmia *  1/63 (1.59%)  0/87 (0.00%)  0/99 (0.00%)  0/69 (0.00%)  0/90 (0.00%) 
Atrial flutter *  0/63 (0.00%)  0/87 (0.00%)  0/99 (0.00%)  0/69 (0.00%)  1/90 (1.11%) 
AV block first degree *  0/63 (0.00%)  0/87 (0.00%)  0/99 (0.00%)  0/69 (0.00%)  1/90 (1.11%) 
Bundle branck block *  0/63 (0.00%)  0/87 (0.00%)  0/99 (0.00%)  0/69 (0.00%)  1/90 (1.11%) 
Cardiovascular physical finding *  0/63 (0.00%)  0/87 (0.00%)  1/99 (1.01%)  0/69 (0.00%)  0/90 (0.00%) 
Coronary artery disorder *  0/63 (0.00%)  0/87 (0.00%)  0/99 (0.00%)  1/69 (1.45%)  0/90 (0.00%) 
Electrocardiogram abnormal *  1/63 (1.59%)  0/87 (0.00%)  2/99 (2.02%)  0/69 (0.00%)  0/90 (0.00%) 
Palpitation *  0/63 (0.00%)  0/87 (0.00%)  1/99 (1.01%)  0/69 (0.00%)  1/90 (1.11%) 
QRS prolongation *  0/63 (0.00%)  0/87 (0.00%)  0/99 (0.00%)  0/69 (0.00%)  1/90 (1.11%) 
QT interval prolonged *  0/63 (0.00%)  0/87 (0.00%)  0/99 (0.00%)  0/69 (0.00%)  2/90 (2.22%) 
Sinus bradycardia *  0/63 (0.00%)  1/87 (1.15%)  0/99 (0.00%)  0/69 (0.00%)  0/90 (0.00%) 
Syncope *  0/63 (0.00%)  0/87 (0.00%)  1/99 (1.01%)  1/69 (1.45%)  0/90 (0.00%) 
Tachycardia *  1/63 (1.59%)  1/87 (1.15%)  0/99 (0.00%)  5/69 (7.25%)  0/90 (0.00%) 
Ventricular extrasystoles *  0/63 (0.00%)  0/87 (0.00%)  0/99 (0.00%)  0/69 (0.00%)  1/90 (1.11%) 
Ventricular tachycardia *  0/63 (0.00%)  0/87 (0.00%)  1/99 (1.01%)  0/69 (0.00%)  0/90 (0.00%) 
Ear and labyrinth disorders           
Ear disorder *  1/63 (1.59%)  0/87 (0.00%)  1/99 (1.01%)  1/69 (1.45%)  0/90 (0.00%) 
Ear pain *  0/63 (0.00%)  0/87 (0.00%)  1/99 (1.01%)  0/69 (0.00%)  0/90 (0.00%) 
Otitis media *  1/63 (1.59%)  0/87 (0.00%)  0/99 (0.00%)  0/69 (0.00%)  0/90 (0.00%) 
Taste perversion *  0/63 (0.00%)  1/87 (1.15%)  0/99 (0.00%)  0/69 (0.00%)  0/90 (0.00%) 
Tinnitus *  1/63 (1.59%)  0/87 (0.00%)  1/99 (1.01%)  3/69 (4.35%)  0/90 (0.00%) 
Endocrine disorders           
Thyroid carcinoma *  0/63 (0.00%)  0/87 (0.00%)  0/99 (0.00%)  1/69 (1.45%)  0/90 (0.00%) 
Thyroid disorder *  0/63 (0.00%)  0/87 (0.00%)  0/99 (0.00%)  0/69 (0.00%)  1/90 (1.11%) 
Eye disorders           
Abnormal vision *  0/63 (0.00%)  1/87 (1.15%)  1/99 (1.01%)  2/69 (2.90%)  0/90 (0.00%) 
Conjunctivitis *  0/63 (0.00%)  0/87 (0.00%)  0/99 (0.00%)  0/69 (0.00%)  1/90 (1.11%) 
Eye pain *  0/63 (0.00%)  0/87 (0.00%)  0/99 (0.00%)  0/69 (0.00%)  1/90 (1.11%) 
Mydriasis *  0/63 (0.00%)  0/87 (0.00%)  0/99 (0.00%)  2/69 (2.90%)  0/90 (0.00%) 
Refraction disorder *  0/63 (0.00%)  0/87 (0.00%)  1/99 (1.01%)  0/69 (0.00%)  0/90 (0.00%) 
Retinal disorder *  0/63 (0.00%)  1/87 (1.15%)  0/99 (0.00%)  0/69 (0.00%)  0/90 (0.00%) 
Gastrointestinal disorders           
Abdominal distension *  0/63 (0.00%)  0/87 (0.00%)  1/99 (1.01%)  0/69 (0.00%)  1/90 (1.11%) 
Anorexia *  2/63 (3.17%)  3/87 (3.45%)  5/99 (5.05%)  3/69 (4.35%)  2/90 (2.22%) 
Colitis *  0/63 (0.00%)  0/87 (0.00%)  1/99 (1.01%)  0/69 (0.00%)  0/90 (0.00%) 
Constipation *  3/63 (4.76%)  4/87 (4.60%)  6/99 (6.06%)  6/69 (8.70%)  0/90 (0.00%) 
Diarrhea *  5/63 (7.94%)  6/87 (6.90%)  7/99 (7.07%)  6/69 (8.70%)  9/90 (10.00%) 
Dry mouth *  2/63 (3.17%)  4/87 (4.60%)  5/99 (5.05%)  9/69 (13.04%)  2/90 (2.22%) 
Dyspepsia *  1/63 (1.59%)  3/87 (3.45%)  3/99 (3.03%)  1/69 (1.45%)  3/90 (3.33%) 
Dysphagia *  0/63 (0.00%)  0/87 (0.00%)  1/99 (1.01%)  1/69 (1.45%)  0/90 (0.00%) 
Eructation *  0/63 (0.00%)  0/87 (0.00%)  0/99 (0.00%)  0/69 (0.00%)  2/90 (2.22%) 
Flatulence *  2/63 (3.17%)  2/87 (2.30%)  0/99 (0.00%)  0/69 (0.00%)  0/90 (0.00%) 
Gastroenteritis *  1/63 (1.59%)  1/87 (1.15%)  2/99 (2.02%)  2/69 (2.90%)  1/90 (1.11%) 
Gastroesophageal reflux disease *  0/63 (0.00%)  1/87 (1.15%)  0/99 (0.00%)  0/69 (0.00%)  1/90 (1.11%) 
Gastrointestinal carcinoma *  1/63 (1.59%)  0/87 (0.00%)  1/99 (1.01%)  0/69 (0.00%)  0/90 (0.00%) 
Gastrointestinal disorder *  1/63 (1.59%)  0/87 (0.00%)  0/99 (0.00%)  0/69 (0.00%)  0/90 (0.00%) 
Gastrointestinal hemorrhage *  0/63 (0.00%)  0/87 (0.00%)  1/99 (1.01%)  0/69 (0.00%)  0/90 (0.00%) 
Hiatal hernia *  1/63 (1.59%)  0/87 (0.00%)  0/99 (0.00%)  0/69 (0.00%)  0/90 (0.00%) 
Increased appetite *  0/63 (0.00%)  1/87 (1.15%)  0/99 (0.00%)  0/69 (0.00%)  1/90 (1.11%) 
Nausea *  9/63 (14.29%)  11/87 (12.64%)  27/99 (27.27%)  12/69 (17.39%)  2/90 (2.22%) 
Periodontal abscess *  0/63 (0.00%)  2/87 (2.30%)  0/99 (0.00%)  0/69 (0.00%)  1/90 (1.11%) 
Retching *  0/63 (0.00%)  1/87 (1.15%)  0/99 (0.00%)  1/69 (1.45%)  0/90 (0.00%) 
Tenesmus *  1/63 (1.59%)  0/87 (0.00%)  0/99 (0.00%)  0/69 (0.00%)  0/90 (0.00%) 
Tooth disorder *  0/63 (0.00%)  0/87 (0.00%)  1/99 (1.01%)  0/69 (0.00%)  0/90 (0.00%) 
Vomiting *  3/63 (4.76%)  3/87 (3.45%)  10/99 (10.10%)  2/69 (2.90%)  2/90 (2.22%) 
General disorders           
Abdominal pain *  3/63 (4.76%)  2/87 (2.30%)  1/99 (1.01%)  1/69 (1.45%)  1/90 (1.11%) 
Abscess *  0/63 (0.00%)  1/87 (1.15%)  0/99 (0.00%)  0/69 (0.00%)  0/90 (0.00%) 
Accidental injury *  3/63 (4.76%)  5/87 (5.75%)  7/99 (7.07%)  8/69 (11.59%)  6/90 (6.67%) 
Allergic reaction *  0/63 (0.00%)  0/87 (0.00%)  0/99 (0.00%)  0/69 (0.00%)  1/90 (1.11%) 
Asthenia *  4/63 (6.35%)  8/87 (9.20%)  9/99 (9.09%)  10/69 (14.49%)  4/90 (4.44%) 
Back pain *  2/63 (3.17%)  0/87 (0.00%)  3/99 (3.03%)  1/69 (1.45%)  5/90 (5.56%) 
Cellulitis *  1/63 (1.59%)  1/87 (1.15%)  0/99 (0.00%)  0/69 (0.00%)  0/90 (0.00%) 
Chest pain *  0/63 (0.00%)  2/87 (2.30%)  0/99 (0.00%)  0/69 (0.00%)  1/90 (1.11%) 
Chills *  1/63 (1.59%)  0/87 (0.00%)  3/99 (3.03%)  0/69 (0.00%)  0/90 (0.00%) 
Cyst *  0/63 (0.00%)  0/87 (0.00%)  0/99 (0.00%)  0/69 (0.00%)  1/90 (1.11%) 
Face edema *  0/63 (0.00%)  0/87 (0.00%)  1/99 (1.01%)  0/69 (0.00%)  1/90 (1.11%) 
Fever *  0/63 (0.00%)  1/87 (1.15%)  1/99 (1.01%)  1/69 (1.45%)  0/90 (0.00%) 
Flu syndrome *  1/63 (1.59%)  3/87 (3.45%)  1/99 (1.01%)  0/69 (0.00%)  0/90 (0.00%) 
Generalized edema *  1/63 (1.59%)  0/87 (0.00%)  0/99 (0.00%)  0/69 (0.00%)  0/90 (0.00%) 
Headache *  5/63 (7.94%)  7/87 (8.05%)  9/99 (9.09%)  5/69 (7.25%)  9/90 (10.00%) 
Infection *  3/63 (4.76%)  7/87 (8.05%)  7/99 (7.07%)  3/69 (4.35%)  1/90 (1.11%) 
Malaise *  0/63 (0.00%)  0/87 (0.00%)  1/99 (1.01%)  0/69 (0.00%)  0/90 (0.00%) 
Medication error *  0/63 (0.00%)  0/87 (0.00%)  1/99 (1.01%)  0/69 (0.00%)  0/90 (0.00%) 
Mucous membrane disorder *  0/63 (0.00%)  0/87 (0.00%)  1/99 (1.01%)  0/69 (0.00%)  0/90 (0.00%) 
Neck pain *  0/63 (0.00%)  1/87 (1.15%)  0/99 (0.00%)  2/69 (2.90%)  0/90 (0.00%) 
Neoplasm *  0/63 (0.00%)  1/87 (1.15%)  0/99 (0.00%)  0/69 (0.00%)  2/90 (2.22%) 
Overdose *  0/63 (0.00%)  0/87 (0.00%)  0/99 (0.00%)  0/69 (0.00%)  1/90 (1.11%) 
Pain *  5/63 (7.94%)  3/87 (3.45%)  4/99 (4.04%)  3/69 (4.35%)  2/90 (2.22%) 
Photosensitivity reaction *  0/63 (0.00%)  0/87 (0.00%)  0/99 (0.00%)  2/69 (2.90%)  0/90 (0.00%) 
Withdrawal syndrome *  0/63 (0.00%)  0/87 (0.00%)  1/99 (1.01%)  1/69 (1.45%)  0/90 (0.00%) 
Allergic reaction other than drug *  0/63 (0.00%)  0/87 (0.00%)  0/99 (0.00%)  1/69 (1.45%)  0/90 (0.00%) 
Local reaction to procedure *  0/63 (0.00%)  1/87 (1.15%)  0/99 (0.00%)  0/69 (0.00%)  1/90 (1.11%) 
Positive event *  0/63 (0.00%)  1/87 (1.15%)  0/99 (0.00%)  0/69 (0.00%)  0/90 (0.00%) 
Metabolism and nutrition disorders           
Creatinine increased *  0/63 (0.00%)  0/87 (0.00%)  0/99 (0.00%)  1/69 (1.45%)  0/90 (0.00%) 
Gout *  0/63 (0.00%)  1/87 (1.15%)  0/99 (0.00%)  1/69 (1.45%)  1/90 (1.11%) 
Healing abnormal *  0/63 (0.00%)  0/87 (0.00%)  0/99 (0.00%)  1/69 (1.45%)  0/90 (0.00%) 
Hypercholesteremia *  2/63 (3.17%)  3/87 (3.45%)  3/99 (3.03%)  0/69 (0.00%)  1/90 (1.11%) 
Hyperglycemia *  2/63 (3.17%)  1/87 (1.15%)  1/99 (1.01%)  0/69 (0.00%)  2/90 (2.22%) 
Hyperkalemia *  0/63 (0.00%)  0/87 (0.00%)  0/99 (0.00%)  0/69 (0.00%)  1/90 (1.11%) 
Hyperlipemia *  4/63 (6.35%)  6/87 (6.90%)  7/99 (7.07%)  5/69 (7.25%)  8/90 (8.89%) 
Hyperuricemia *  0/63 (0.00%)  0/87 (0.00%)  1/99 (1.01%)  0/69 (0.00%)  0/90 (0.00%) 
Hypoglycemia *  1/63 (1.59%)  0/87 (0.00%)  0/99 (0.00%)  3/69 (4.35%)  0/90 (0.00%) 
Hypokalemia *  1/63 (1.59%)  0/87 (0.00%)  0/99 (0.00%)  0/69 (0.00%)  0/90 (0.00%) 
Hyponatremia *  0/63 (0.00%)  0/87 (0.00%)  1/99 (1.01%)  0/69 (0.00%)  0/90 (0.00%) 
Peripheral edema *  2/63 (3.17%)  2/87 (2.30%)  0/99 (0.00%)  0/69 (0.00%)  2/90 (2.22%) 
Weight gain *  0/63 (0.00%)  1/87 (1.15%)  0/99 (0.00%)  0/69 (0.00%)  0/90 (0.00%) 
Weight loss *  0/63 (0.00%)  0/87 (0.00%)  1/99 (1.01%)  4/69 (5.80%)  0/90 (0.00%) 
Musculoskeletal and connective tissue disorders           
Arthralgia *  1/63 (1.59%)  2/87 (2.30%)  2/99 (2.02%)  2/69 (2.90%)  6/90 (6.67%) 
Arthritis *  0/63 (0.00%)  0/87 (0.00%)  0/99 (0.00%)  0/69 (0.00%)  1/90 (1.11%) 
Joint disorder *  0/63 (0.00%)  1/87 (1.15%)  0/99 (0.00%)  0/69 (0.00%)  1/90 (1.11%) 
Leg cramps *  4/63 (6.35%)  3/87 (3.45%)  3/99 (3.03%)  2/69 (2.90%)  2/90 (2.22%) 
Muscle cramp *  1/63 (1.59%)  0/87 (0.00%)  0/99 (0.00%)  2/69 (2.90%)  1/90 (1.11%) 
Muscle spasms *  1/63 (1.59%)  1/87 (1.15%)  1/99 (1.01%)  0/69 (0.00%)  1/90 (1.11%) 
Musculoskeletal stiffness *  1/63 (1.59%)  0/87 (0.00%)  0/99 (0.00%)  0/69 (0.00%)  0/90 (0.00%) 
Myalgia *  1/63 (1.59%)  2/87 (2.30%)  1/99 (1.01%)  1/69 (1.45%)  1/90 (1.11%) 
Myasthenia *  1/63 (1.59%)  0/87 (0.00%)  1/99 (1.01%)  0/69 (0.00%)  0/90 (0.00%) 
Tendon disorder *  0/63 (0.00%)  0/87 (0.00%)  0/99 (0.00%)  1/69 (1.45%)  0/90 (0.00%) 
Nervous system disorders           
Abnormal dreams *  1/63 (1.59%)  2/87 (2.30%)  3/99 (3.03%)  1/69 (1.45%)  0/90 (0.00%) 
Anxiety *  3/63 (4.76%)  0/87 (0.00%)  3/99 (3.03%)  0/69 (0.00%)  1/90 (1.11%) 
Apathy *  1/63 (1.59%)  0/87 (0.00%)  0/99 (0.00%)  0/69 (0.00%)  0/90 (0.00%) 
Ataxia *  0/63 (0.00%)  1/87 (1.15%)  0/99 (0.00%)  0/69 (0.00%)  0/90 (0.00%) 
Carpal tunnel syndrome *  0/63 (0.00%)  0/87 (0.00%)  1/99 (1.01%)  0/69 (0.00%)  0/90 (0.00%) 
Confusion *  0/63 (0.00%)  0/87 (0.00%)  0/99 (0.00%)  1/69 (1.45%)  0/90 (0.00%) 
Depersonalization *  0/63 (0.00%)  0/87 (0.00%)  2/99 (2.02%)  0/69 (0.00%)  0/90 (0.00%) 
Depression *  0/63 (0.00%)  2/87 (2.30%)  0/99 (0.00%)  1/69 (1.45%)  1/90 (1.11%) 
Dizziness *  1/63 (1.59%)  7/87 (8.05%)  18/99 (18.18%)  18/69 (26.09%)  9/90 (10.00%) 
Emotional liability *  0/63 (0.00%)  0/87 (0.00%)  0/99 (0.00%)  0/69 (0.00%)  3/90 (3.33%) 
Euphoria *  0/63 (0.00%)  0/87 (0.00%)  0/99 (0.00%)  1/69 (1.45%)  0/90 (0.00%) 
Hostility *  2/63 (3.17%)  0/87 (0.00%)  1/99 (1.01%)  0/69 (0.00%)  0/90 (0.00%) 
Hyperkinesia *  0/63 (0.00%)  0/87 (0.00%)  1/99 (1.01%)  0/69 (0.00%)  0/90 (0.00%) 
Hypertonia *  1/63 (1.59%)  0/87 (0.00%)  0/99 (0.00%)  1/69 (1.45%)  0/90 (0.00%) 
Hypesthesia *  0/63 (0.00%)  1/87 (1.15%)  3/99 (3.03%)  0/69 (0.00%)  2/90 (2.22%) 
Incoordination *  0/63 (0.00%)  0/87 (0.00%)  0/99 (0.00%)  0/69 (0.00%)  1/90 (1.11%) 
Insomnia *  3/63 (4.76%)  1/87 (1.15%)  4/99 (4.04%)  7/69 (10.14%)  1/90 (1.11%) 
Libido decreased *  0/63 (0.00%)  1/87 (1.15%)  3/99 (3.03%)  1/69 (1.45%)  0/90 (0.00%) 
Memory impairment *  0/63 (0.00%)  0/87 (0.00%)  0/99 (0.00%)  1/69 (1.45%)  0/90 (0.00%) 
Mental status changes *  0/63 (0.00%)  0/87 (0.00%)  1/99 (1.01%)  0/69 (0.00%)  0/90 (0.00%) 
Motion sickness *  0/63 (0.00%)  0/87 (0.00%)  0/99 (0.00%)  1/69 (1.45%)  0/90 (0.00%) 
Movement disorder *  0/63 (0.00%)  0/87 (0.00%)  0/99 (0.00%)  1/69 (1.45%)  0/90 (0.00%) 
Nervousness *  1/63 (1.59%)  1/87 (1.15%)  3/99 (3.03%)  2/69 (2.90%)  0/90 (0.00%) 
Neuralgia *  0/63 (0.00%)  0/87 (0.00%)  0/99 (0.00%)  0/69 (0.00%)  1/90 (1.11%) 
Paresthesia *  0/63 (0.00%)  0/87 (0.00%)  2/99 (2.02%)  0/69 (0.00%)  0/90 (0.00%) 
Reflexes decreased *  2/63 (3.17%)  0/87 (0.00%)  0/99 (0.00%)  2/69 (2.90%)  2/90 (2.22%) 
Reflexes increased *  0/63 (0.00%)  0/87 (0.00%)  0/99 (0.00%)  1/69 (1.45%)  0/90 (0.00%) 
Restless legs syndrome *  0/63 (0.00%)  0/87 (0.00%)  1/99 (1.01%)  0/69 (0.00%)  1/90 (1.11%) 
Somnolence *  3/63 (4.76%)  9/87 (10.34%)  9/99 (9.09%)  7/69 (10.14%)  2/90 (2.22%) 
Thinking abnormal *  0/63 (0.00%)  0/87 (0.00%)  1/99 (1.01%)  2/69 (2.90%)  0/90 (0.00%) 
Tremor *  1/63 (1.59%)  0/87 (0.00%)  2/99 (2.02%)  1/69 (1.45%)  0/90 (0.00%) 
Twitching *  0/63 (0.00%)  0/87 (0.00%)  0/99 (0.00%)  0/69 (0.00%)  1/90 (1.11%) 
Vertigo *  1/63 (1.59%)  2/87 (2.30%)  2/99 (2.02%)  0/69 (0.00%)  0/90 (0.00%) 
Renal and urinary disorders           
Creatine clearance decreased *  0/63 (0.00%)  1/87 (1.15%)  0/99 (0.00%)  0/69 (0.00%)  1/90 (1.11%) 
Cystitis *  0/63 (0.00%)  0/87 (0.00%)  1/99 (1.01%)  0/69 (0.00%)  0/90 (0.00%) 
Dysuria *  1/63 (1.59%)  1/87 (1.15%)  2/99 (2.02%)  0/69 (0.00%)  0/90 (0.00%) 
Hematuria *  3/63 (4.76%)  0/87 (0.00%)  1/99 (1.01%)  1/69 (1.45%)  1/90 (1.11%) 
Impotence *  1/63 (1.59%)  4/87 (4.60%)  2/99 (2.02%)  3/69 (4.35%)  1/90 (1.11%) 
Kidney function abnormal *  0/63 (0.00%)  0/87 (0.00%)  1/99 (1.01%)  1/69 (1.45%)  0/90 (0.00%) 
Nocturia *  0/63 (0.00%)  1/87 (1.15%)  1/99 (1.01%)  1/69 (1.45%)  0/90 (0.00%) 
Pyuria *  1/63 (1.59%)  0/87 (0.00%)  0/99 (0.00%)  0/69 (0.00%)  0/90 (0.00%) 
Urinary frequency *  2/63 (3.17%)  0/87 (0.00%)  2/99 (2.02%)  1/69 (1.45%)  1/90 (1.11%) 
Urinary hesitation *  0/63 (0.00%)  1/87 (1.15%)  1/99 (1.01%)  2/69 (2.90%)  0/90 (0.00%) 
Urinary incontinence *  0/63 (0.00%)  1/87 (1.15%)  1/99 (1.01%)  1/69 (1.45%)  0/90 (0.00%) 
Urinary retention *  0/63 (0.00%)  0/87 (0.00%)  0/99 (0.00%)  1/69 (1.45%)  0/90 (0.00%) 
Urinary tract infection *  1/63 (1.59%)  2/87 (2.30%)  1/99 (1.01%)  0/69 (0.00%)  3/90 (3.33%) 
Urination impaired *  0/63 (0.00%)  0/87 (0.00%)  1/99 (1.01%)  3/69 (4.35%)  0/90 (0.00%) 
Urine abnormality *  1/63 (1.59%)  0/87 (0.00%)  1/99 (1.01%)  0/69 (0.00%)  0/90 (0.00%) 
Albuminuria *  1/63 (1.59%)  0/87 (0.00%)  0/99 (0.00%)  1/69 (1.45%)  0/90 (0.00%) 
Reproductive system and breast disorders           
Abnormal ejaculation/orgasm *  0/63 (0.00%)  0/87 (0.00%)  2/99 (2.02%)  1/69 (1.45%)  0/90 (0.00%) 
Anorgasmia *  0/63 (0.00%)  1/87 (1.15%)  2/99 (2.02%)  1/69 (1.45%)  0/90 (0.00%) 
Breast disorder *  0/63 (0.00%)  0/87 (0.00%)  0/99 (0.00%)  1/69 (1.45%)  0/90 (0.00%) 
Cervix disorder *  0/63 (0.00%)  0/87 (0.00%)  0/99 (0.00%)  1/69 (1.45%)  0/90 (0.00%) 
Prostatic disorder *  0/63 (0.00%)  3/87 (3.45%)  2/99 (2.02%)  4/69 (5.80%)  1/90 (1.11%) 
Prostatic specific antigen increase *  0/63 (0.00%)  0/87 (0.00%)  1/99 (1.01%)  0/69 (0.00%)  0/90 (0.00%) 
Sexual function abnormal *  0/63 (0.00%)  2/87 (2.30%)  1/99 (1.01%)  1/69 (1.45%)  0/90 (0.00%) 
Testis disorder *  0/63 (0.00%)  0/87 (0.00%)  1/99 (1.01%)  0/69 (0.00%)  0/90 (0.00%) 
Vulvovaginal disorder *  0/63 (0.00%)  0/87 (0.00%)  0/99 (0.00%)  1/69 (1.45%)  0/90 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Bronchitis *  1/63 (1.59%)  0/87 (0.00%)  0/99 (0.00%)  3/69 (4.35%)  0/90 (0.00%) 
Chronic obstructive airways disease *  0/63 (0.00%)  0/87 (0.00%)  0/99 (0.00%)  0/69 (0.00%)  1/90 (1.11%) 
Cough increased *  1/63 (1.59%)  4/87 (4.60%)  1/99 (1.01%)  2/69 (2.90%)  6/90 (6.67%) 
Dyspnea *  0/63 (0.00%)  2/87 (2.30%)  1/99 (1.01%)  0/69 (0.00%)  1/90 (1.11%) 
Epistaxis *  0/63 (0.00%)  0/87 (0.00%)  1/99 (1.01%)  0/69 (0.00%)  0/90 (0.00%) 
Lung disorder *  0/63 (0.00%)  1/87 (1.15%)  1/99 (1.01%)  0/69 (0.00%)  0/90 (0.00%) 
Nose dryness *  0/63 (0.00%)  0/87 (0.00%)  1/99 (1.01%)  0/69 (0.00%)  0/90 (0.00%) 
Pharyngitis *  0/63 (0.00%)  0/87 (0.00%)  2/99 (2.02%)  1/69 (1.45%)  3/90 (3.33%) 
Pneumonia *  0/63 (0.00%)  1/87 (1.15%)  0/99 (0.00%)  0/69 (0.00%)  1/90 (1.11%) 
Pulmonary physical finding *  0/63 (0.00%)  1/87 (1.15%)  0/99 (0.00%)  0/69 (0.00%)  0/90 (0.00%) 
Rhinitis *  0/63 (0.00%)  2/87 (2.30%)  3/99 (3.03%)  1/69 (1.45%)  1/90 (1.11%) 
Sinusittis *  0/63 (0.00%)  3/87 (3.45%)  4/99 (4.04%)  1/69 (1.45%)  1/90 (1.11%) 
Upper respiratory infection *  2/63 (3.17%)  3/87 (3.45%)  2/99 (2.02%)  1/69 (1.45%)  7/90 (7.78%) 
Voice alteration *  0/63 (0.00%)  0/87 (0.00%)  0/99 (0.00%)  1/69 (1.45%)  0/90 (0.00%) 
Yawn *  0/63 (0.00%)  0/87 (0.00%)  0/99 (0.00%)  1/69 (1.45%)  0/90 (0.00%) 
Skin and subcutaneous tissue disorders           
Acne *  0/63 (0.00%)  0/87 (0.00%)  0/99 (0.00%)  0/69 (0.00%)  3/90 (3.33%) 
Alopecia *  1/63 (1.59%)  0/87 (0.00%)  0/99 (0.00%)  0/69 (0.00%)  0/90 (0.00%) 
Contact dermatitis *  1/63 (1.59%)  0/87 (0.00%)  0/99 (0.00%)  0/69 (0.00%)  0/90 (0.00%) 
Dry skin *  0/63 (0.00%)  1/87 (1.15%)  0/99 (0.00%)  1/69 (1.45%)  0/90 (0.00%) 
Eczema *  0/63 (0.00%)  0/87 (0.00%)  0/99 (0.00%)  1/69 (1.45%)  0/90 (0.00%) 
Exfoliative dermatitis *  0/63 (0.00%)  1/87 (1.15%)  0/99 (0.00%)  0/69 (0.00%)  0/90 (0.00%) 
Folliculitis *  0/63 (0.00%)  0/87 (0.00%)  0/99 (0.00%)  0/69 (0.00%)  1/90 (1.11%) 
Fungal dermatitis *  0/63 (0.00%)  0/87 (0.00%)  0/99 (0.00%)  2/69 (2.90%)  0/90 (0.00%) 
Furunculosis *  0/63 (0.00%)  0/87 (0.00%)  1/99 (1.01%)  0/69 (0.00%)  0/90 (0.00%) 
Herpes simplex *  2/63 (3.17%)  0/87 (0.00%)  0/99 (0.00%)  0/69 (0.00%)  1/90 (1.11%) 
Herpes zoster *  0/63 (0.00%)  0/87 (0.00%)  0/99 (0.00%)  0/69 (0.00%)  1/90 (1.11%) 
Maculopapular rash *  0/63 (0.00%)  1/87 (1.15%)  0/99 (0.00%)  0/69 (0.00%)  0/90 (0.00%) 
Nail disorder *  0/63 (0.00%)  1/87 (1.15%)  0/99 (0.00%)  1/69 (1.45%)  0/90 (0.00%) 
Night sweats *  1/63 (1.59%)  1/87 (1.15%)  1/99 (1.01%)  0/69 (0.00%)  0/90 (0.00%) 
Pruritus *  0/63 (0.00%)  0/87 (0.00%)  3/99 (3.03%)  3/69 (4.35%)  2/90 (2.22%) 
Rash *  1/63 (1.59%)  0/87 (0.00%)  0/99 (0.00%)  4/69 (5.80%)  3/90 (3.33%) 
Seborrhea *  0/63 (0.00%)  0/87 (0.00%)  0/99 (0.00%)  0/69 (0.00%)  1/90 (1.11%) 
Skin benign neoplasm *  1/63 (1.59%)  0/87 (0.00%)  0/99 (0.00%)  0/69 (0.00%)  0/90 (0.00%) 
Skin discoloration *  0/63 (0.00%)  0/87 (0.00%)  0/99 (0.00%)  1/69 (1.45%)  0/90 (0.00%) 
Skin disorder *  2/63 (3.17%)  0/87 (0.00%)  2/99 (2.02%)  0/69 (0.00%)  0/90 (0.00%) 
Skin hypertrophy *  0/63 (0.00%)  0/87 (0.00%)  0/99 (0.00%)  0/69 (0.00%)  2/90 (2.22%) 
Sweating *  3/63 (4.76%)  2/87 (2.30%)  7/99 (7.07%)  5/69 (7.25%)  1/90 (1.11%) 
Urticaria *  0/63 (0.00%)  0/87 (0.00%)  0/99 (0.00%)  1/69 (1.45%)  0/90 (0.00%) 
Vesiculobullous rash *  0/63 (0.00%)  1/87 (1.15%)  0/99 (0.00%)  0/69 (0.00%)  1/90 (1.11%) 
Vascular disorders           
Hemorrhage *  0/63 (0.00%)  1/87 (1.15%)  0/99 (0.00%)  0/69 (0.00%)  0/90 (0.00%) 
Hypertension *  2/63 (3.17%)  6/87 (6.90%)  11/99 (11.11%)  9/69 (13.04%)  7/90 (7.78%) 
Hypotension *  1/63 (1.59%)  0/87 (0.00%)  0/99 (0.00%)  1/69 (1.45%)  1/90 (1.11%) 
Peripheral vascular disorder *  1/63 (1.59%)  0/87 (0.00%)  2/99 (2.02%)  2/69 (2.90%)  0/90 (0.00%) 
Postural hypotension *  1/63 (1.59%)  2/87 (2.30%)  5/99 (5.05%)  4/69 (5.80%)  1/90 (1.11%) 
Vasodilatation *  1/63 (1.59%)  1/87 (1.15%)  4/99 (4.04%)  2/69 (2.90%)  0/90 (0.00%) 
*
Indicates events were collected by non-systematic assessment
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.
The PIs agreed to allow the sponsor 60 days to review and require changes to presentations or publications but only to protect confidential information and intellectual property, and for the sponsor to file a patent application, as applicable. The PIs also agreed for data to be presented first as a joint, multi-center publication
Results Point of Contact
Name/Title: U.S. Contact Center
Organization: Wyeth
Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT00283842     History of Changes
Other Study ID Numbers: 3151A5-322
First Submitted: January 26, 2006
First Posted: January 30, 2006
Results First Submitted: June 30, 2009
Results First Posted: August 13, 2009
Last Update Posted: October 24, 2011