A Study Of Different Doses Of UK-453, 061 Plus Truvada Compared To Efavirenz Plus Truvada In Patients Who Have Not Been Previously Treated For HIV-1

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00824421
First received: January 15, 2009
Last updated: December 9, 2013
Last verified: November 2011
Results First Received: December 9, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: HIV-1
Interventions: Drug: UK-453, 061
Drug: EFV +TVA

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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
Lersivirine 500 mg Two lersivirine 250 milligram (mg) tablets (equivalent to lersivirine 500 mg), a placebo tablet matched to lersivirine and a placebo tablet matched to efavirenz orally once daily along with tenofovir disoproxil fumarate (DF) 300 mg tablet and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in pharmacokinetic (PK) substudy switched to lersivirine morning dosing regimen, received 2 Lersivirine 250 mg tablets, a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
Lersivirine 750 mg Three Lersivirine 250 mg tablets (equivalent to lersivirine 750 mg) and a placebo tablet matched to efavirenz orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
Efavirenz 600 mg Three placebo tablets matched to lersivirine, efavirenz 600 mg tablet orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 placebo tablets matched to lersivirine and efavirenz 600 mg tablet orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. Efavirenz 600 mg tablet, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.

Participant Flow:   Overall Study
    Lersivirine 500 mg     Lersivirine 750 mg     Efavirenz 600 mg  
STARTED     66     66     63  
Treated     65     65     63  
COMPLETED     49     44     49  
NOT COMPLETED     17     22     14  
Adverse Event                 6                 6                 6  
Death                 0                 1                 0  
Lack of Efficacy                 5                 7                 4  
Lost to Follow-up                 2                 3                 0  
Pregnancy                 1                 0                 1  
Withdrawal by Subject                 2                 3                 3  
Randomized but not Treated                 1                 1                 0  
Unspecified                 0                 1                 0  



  Baseline Characteristics
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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.
Intent-to-treat (ITT) population included all randomized participants who had received at least 1 dose of study medication.

Reporting Groups
  Description
Lersivirine 500 mg Two lersivirine 250 milligram (mg) tablets (equivalent to lersivirine 500 mg), a placebo tablet matched to lersivirine and a placebo tablet matched to efavirenz orally once daily along with tenofovir disoproxil fumarate (DF) 300 mg tablet and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in pharmacokinetic (PK) substudy switched to lersivirine morning dosing regimen, received 2 Lersivirine 250 mg tablets, a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
Lersivirine 750 mg Three Lersivirine 250 mg tablets (equivalent to lersivirine 750 mg) and a placebo tablet matched to efavirenz orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
Efavirenz 600 mg Three placebo tablets matched to lersivirine, efavirenz 600 mg tablet orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 placebo tablets matched to lersivirine and efavirenz 600 mg tablet orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. Efavirenz 600 mg tablet, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
Total Total of all reporting groups

Baseline Measures
    Lersivirine 500 mg     Lersivirine 750 mg     Efavirenz 600 mg     Total  
Number of Participants  
[units: participants]
  65     65     63     193  
Age  
[units: years]
Mean ± Standard Deviation
  36.5  ± 8.0     35.7  ± 8.2     36.3  ± 8.7     36.2  ± 8.2  
Gender  
[units: participants]
       
Female     16     19     17     52  
Male     49     46     46     141  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With Less Than 50 Copies Per Milliliter (Copies/mL) of Human Immunodeficiency Virus Type 1 Ribonucleic Acid (HIV-1 RNA) at Week 48   [ Time Frame: Week 48 ]

2.  Secondary:   Percentage of Participants With Less Than 50 Copies/mL of HIV-1 RNA at Week 24 and 96   [ Time Frame: Week 24, 96 ]

3.  Secondary:   Percentage of Participants With Less Than 400 Copies/mL of HIV-1 RNA at Week 24, 48 and 96   [ Time Frame: Week 24, 48, 96 ]

4.  Secondary:   Change From Baseline in Log 10 Transformed HIV-1 RNA Levels at Week 24, 48 and 96   [ Time Frame: Baseline, Week 24, 48, 96 ]

5.  Secondary:   Time-Averaged Difference (TAD) in Log 10 Transformed HIV-1 RNA Levels at Week 24, 48 and 96   [ Time Frame: Baseline up to Week 24, 48, 96 ]

6.  Secondary:   Percentage of Participants With Response as Determined Using the Time-to Loss of Virologic Response (TLOVR50) Algorithm at Week 24, 48 and 96   [ Time Frame: Week 24, 48, 96 ]

7.  Secondary:   Change From Baseline in Cluster of Differentiation (CD4+) Absolute Cell Count at Week 24, 48 and 96   [ Time Frame: Baseline, Week 24, 48, 96 ]

8.  Secondary:   Change From Baseline in Cluster of Differentiation (CD4+) Percentage Cell Count at Week 24, 48 and 96   [ Time Frame: Baseline, Week 24, 48, 96 ]

9.  Secondary:   Number of Participants With NRTI and NNRTI Resistance-Associated Mutations (RAMs) at Time of Treatment Failure Through Week 24, 48 and 96   [ Time Frame: Day 1 (pre-dose) through Week 24, 48, 96 ]

10.  Secondary:   Number of Participants With Laboratory Test Abnormalities   [ Time Frame: Baseline up to Week 96 or early termination ]

11.  Secondary:   Lersivirine Success Percentage With Reference to Median Minimum Observed Plasma Concentration (Cmin)   [ Time Frame: Week 2, 4, 8, 12, 16, 24, 32, 40, 48 ]

12.  Secondary:   Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC[0-24]) of Lersivirine   [ Time Frame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 24 hours (hrs) post-dose on Week 4 ]

13.  Secondary:   Maximum Observed Plasma Concentration (Cmax) of Lersivirine   [ Time Frame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 24 hrs post-dose on Week 4 ]

14.  Secondary:   Time to Reach Maximum Observed Plasma Concentration (Tmax) of Lersivirine   [ Time Frame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 24 hrs post-dose on Week 4 ]

15.  Secondary:   Plasma Concentration of Lersivirine at 24 Hour   [ Time Frame: 24 hrs post-dose on Week 4 ]

16.  Secondary:   Population Pharmacokinetic (PK) of Lersivirine   [ Time Frame: Week 2, 4, 8, 12, 16, 24, 32, 40, 48 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events
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Time Frame No text entered.
Additional Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.

Frequency Threshold
Threshold above which other adverse events are reported   0%  

Reporting Groups
  Description
Lersivirine 500 mg Two lersivirine 250 milligram (mg) tablets (equivalent to lersivirine 500 mg), a placebo tablet matched to lersivirine and a placebo tablet matched to efavirenz orally once daily along with tenofovir disoproxil fumarate (DF) 300 mg tablet and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in pharmacokinetic (PK) substudy switched to lersivirine morning dosing regimen, received 2 Lersivirine 250 mg tablets, a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
Lersivirine 750 mg Three Lersivirine 250 mg tablets (equivalent to lersivirine 750 mg) and a placebo tablet matched to efavirenz orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
Efavirenz 600 mg Three placebo tablets matched to lersivirine, efavirenz 600 mg tablet orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 placebo tablets matched to lersivirine and efavirenz 600 mg tablet orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. Efavirenz 600 mg tablet, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.

Other Adverse Events
    Lersivirine 500 mg     Lersivirine 750 mg     Efavirenz 600 mg  
Total, other (not including serious) adverse events        
# participants affected / at risk     51/65     58/65     59/63  
Blood and lymphatic system disorders        
Anaemia * 1      
# participants affected / at risk     1/65 (1.54%)     0/65 (0.00%)     0/63 (0.00%)  
Lymphadenopathy * 1      
# participants affected / at risk     2/65 (3.08%)     2/65 (3.08%)     2/63 (3.17%)  
Neutropenia * 1      
# participants affected / at risk     0/65 (0.00%)     1/65 (1.54%)     0/63 (0.00%)  
Cardiac disorders        
Atrioventricular block first degree * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     1/63 (1.59%)  
Bradycardia * 1      
# participants affected / at risk     1/65 (1.54%)     0/65 (0.00%)     1/63 (1.59%)  
Tachycardia * 1      
# participants affected / at risk     1/65 (1.54%)     0/65 (0.00%)     0/63 (0.00%)  
Ventricular extrasystoles * 1      
# participants affected / at risk     0/65 (0.00%)     1/65 (1.54%)     0/63 (0.00%)  
Congenital, familial and genetic disorders        
Hydrocele * 1      
# participants affected / at risk     0/65 (0.00%)     1/65 (1.54%)     0/63 (0.00%)  
Ear and labyrinth disorders        
Ear pain * 1      
# participants affected / at risk     1/65 (1.54%)     0/65 (0.00%)     0/63 (0.00%)  
Hypoacusis * 1      
# participants affected / at risk     0/65 (0.00%)     1/65 (1.54%)     0/63 (0.00%)  
Vertigo * 1      
# participants affected / at risk     4/65 (6.15%)     1/65 (1.54%)     5/63 (7.94%)  
Eye disorders        
Chalazion * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     2/63 (3.17%)  
Conjunctivitis * 1      
# participants affected / at risk     3/65 (4.62%)     5/65 (7.69%)     2/63 (3.17%)  
Conjunctivitis allergic * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     2/63 (3.17%)  
Dry eye * 1      
# participants affected / at risk     1/65 (1.54%)     0/65 (0.00%)     0/63 (0.00%)  
Pterygium * 1      
# participants affected / at risk     0/65 (0.00%)     1/65 (1.54%)     0/63 (0.00%)  
Pupils unequal * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     1/63 (1.59%)  
Visual acuity reduced * 1      
# participants affected / at risk     1/65 (1.54%)     0/65 (0.00%)     0/63 (0.00%)  
Gastrointestinal disorders        
Abdominal discomfort * 1      
# participants affected / at risk     1/65 (1.54%)     3/65 (4.62%)     0/63 (0.00%)  
Abdominal distension * 1      
# participants affected / at risk     2/65 (3.08%)     4/65 (6.15%)     3/63 (4.76%)  
Abdominal pain * 1      
# participants affected / at risk     2/65 (3.08%)     8/65 (12.31%)     8/63 (12.70%)  
Abdominal pain lower * 1      
# participants affected / at risk     0/65 (0.00%)     2/65 (3.08%)     0/63 (0.00%)  
Abdominal pain upper * 1      
# participants affected / at risk     3/65 (4.62%)     3/65 (4.62%)     1/63 (1.59%)  
Abdominal rigidity * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     1/63 (1.59%)  
Abdominal tenderness * 1      
# participants affected / at risk     0/65 (0.00%)     1/65 (1.54%)     0/63 (0.00%)  
Anal fissure * 1      
# participants affected / at risk     1/65 (1.54%)     1/65 (1.54%)     0/63 (0.00%)  
Anal haemorrhage * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     2/63 (3.17%)  
Anal ulcer * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     1/63 (1.59%)  
Anogenital dysplasia * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     2/63 (3.17%)  
Aphthous stomatitis * 1      
# participants affected / at risk     0/65 (0.00%)     2/65 (3.08%)     1/63 (1.59%)  
Breath odour * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     1/63 (1.59%)  
Cheilitis * 1      
# participants affected / at risk     2/65 (3.08%)     1/65 (1.54%)     1/63 (1.59%)  
Colitis * 1      
# participants affected / at risk     0/65 (0.00%)     2/65 (3.08%)     1/63 (1.59%)  
Constipation * 1      
# participants affected / at risk     2/65 (3.08%)     0/65 (0.00%)     2/63 (3.17%)  
Dental caries * 1      
# participants affected / at risk     1/65 (1.54%)     0/65 (0.00%)     0/63 (0.00%)  
Diarrhoea * 1      
# participants affected / at risk     12/65 (18.46%)     12/65 (18.46%)     14/63 (22.22%)  
Dry mouth * 1      
# participants affected / at risk     1/65 (1.54%)     0/65 (0.00%)     1/63 (1.59%)  
Dyspepsia * 1      
# participants affected / at risk     1/65 (1.54%)     2/65 (3.08%)     2/63 (3.17%)  
Dysphagia * 1      
# participants affected / at risk     0/65 (0.00%)     1/65 (1.54%)     0/63 (0.00%)  
Enteritis * 1      
# participants affected / at risk     0/65 (0.00%)     1/65 (1.54%)     0/63 (0.00%)  
Eructation * 1      
# participants affected / at risk     0/65 (0.00%)     1/65 (1.54%)     0/63 (0.00%)  
Flatulence * 1      
# participants affected / at risk     1/65 (1.54%)     1/65 (1.54%)     2/63 (3.17%)  
Food poisoning * 1      
# participants affected / at risk     0/65 (0.00%)     1/65 (1.54%)     1/63 (1.59%)  
Frequent bowel movements * 1      
# participants affected / at risk     0/65 (0.00%)     1/65 (1.54%)     0/63 (0.00%)  
Gastritis * 1      
# participants affected / at risk     1/65 (1.54%)     2/65 (3.08%)     1/63 (1.59%)  
Gastrointestinal pain * 1      
# participants affected / at risk     1/65 (1.54%)     0/65 (0.00%)     0/63 (0.00%)  
Gastrointestinal toxicity * 1      
# participants affected / at risk     0/65 (0.00%)     1/65 (1.54%)     0/63 (0.00%)  
Gastrooesophageal reflux disease * 1      
# participants affected / at risk     2/65 (3.08%)     3/65 (4.62%)     1/63 (1.59%)  
Gingival bleeding * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     1/63 (1.59%)  
Gingival pain * 1      
# participants affected / at risk     0/65 (0.00%)     1/65 (1.54%)     0/63 (0.00%)  
Gingivitis * 1      
# participants affected / at risk     2/65 (3.08%)     0/65 (0.00%)     0/63 (0.00%)  
Haemorrhoids * 1      
# participants affected / at risk     0/65 (0.00%)     3/65 (4.62%)     2/63 (3.17%)  
Inflammatory bowel disease * 1      
# participants affected / at risk     1/65 (1.54%)     0/65 (0.00%)     0/63 (0.00%)  
Lip disorder * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     1/63 (1.59%)  
Lip dry * 1      
# participants affected / at risk     1/65 (1.54%)     0/65 (0.00%)     0/63 (0.00%)  
Mouth ulceration * 1      
# participants affected / at risk     1/65 (1.54%)     0/65 (0.00%)     0/63 (0.00%)  
Nausea * 1      
# participants affected / at risk     16/65 (24.62%)     28/65 (43.08%)     8/63 (12.70%)  
Oral disorder * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     1/63 (1.59%)  
Palatal disorder * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     1/63 (1.59%)  
Palatal oedema * 1      
# participants affected / at risk     1/65 (1.54%)     0/65 (0.00%)     0/63 (0.00%)  
Periodontal disease * 1      
# participants affected / at risk     1/65 (1.54%)     0/65 (0.00%)     0/63 (0.00%)  
Poor dental condition * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     1/63 (1.59%)  
Proctalgia * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     3/63 (4.76%)  
Rectal haemorrhage * 1      
# participants affected / at risk     1/65 (1.54%)     0/65 (0.00%)     0/63 (0.00%)  
Rectal polyp * 1      
# participants affected / at risk     1/65 (1.54%)     0/65 (0.00%)     0/63 (0.00%)  
Salivary gland enlargement * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     1/63 (1.59%)  
Tongue coated * 1      
# participants affected / at risk     1/65 (1.54%)     0/65 (0.00%)     0/63 (0.00%)  
Tongue ulceration * 1      
# participants affected / at risk     0/65 (0.00%)     1/65 (1.54%)     0/63 (0.00%)  
Toothache * 1      
# participants affected / at risk     2/65 (3.08%)     2/65 (3.08%)     1/63 (1.59%)  
Vomiting * 1      
# participants affected / at risk     3/65 (4.62%)     12/65 (18.46%)     11/63 (17.46%)  
General disorders        
Asthenia * 1      
# participants affected / at risk     2/65 (3.08%)     2/65 (3.08%)     4/63 (6.35%)  
Chest pain * 1      
# participants affected / at risk     0/65 (0.00%)     3/65 (4.62%)     3/63 (4.76%)  
Cyst * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     1/63 (1.59%)  
Drug withdrawal syndrome * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     1/63 (1.59%)  
Fatigue * 1      
# participants affected / at risk     2/65 (3.08%)     4/65 (6.15%)     3/63 (4.76%)  
Feeling abnormal * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     2/63 (3.17%)  
Feeling drunk * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     1/63 (1.59%)  
Influenza like illness * 1      
# participants affected / at risk     3/65 (4.62%)     5/65 (7.69%)     2/63 (3.17%)  
Irritability * 1      
# participants affected / at risk     2/65 (3.08%)     1/65 (1.54%)     1/63 (1.59%)  
Malaise * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     1/63 (1.59%)  
Oedema peripheral * 1      
# participants affected / at risk     0/65 (0.00%)     1/65 (1.54%)     1/63 (1.59%)  
Pain * 1      
# participants affected / at risk     0/65 (0.00%)     1/65 (1.54%)     0/63 (0.00%)  
Pelvic mass * 1      
# participants affected / at risk     0/65 (0.00%)     1/65 (1.54%)     0/63 (0.00%)  
Pyrexia * 1      
# participants affected / at risk     1/65 (1.54%)     1/65 (1.54%)     0/63 (0.00%)  
Hepatobiliary disorders        
Hepatic lesion * 1      
# participants affected / at risk     0/65 (0.00%)     1/65 (1.54%)     0/63 (0.00%)  
Immune system disorders        
House dust allergy * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     1/63 (1.59%)  
Immune reconstitution syndrome * 1      
# participants affected / at risk     0/65 (0.00%)     1/65 (1.54%)     0/63 (0.00%)  
Seasonal allergy * 1      
# participants affected / at risk     1/65 (1.54%)     2/65 (3.08%)     0/63 (0.00%)  
Infections and infestations        
Abdominal abscess * 1      
# participants affected / at risk     1/65 (1.54%)     0/65 (0.00%)     0/63 (0.00%)  
Abscess oral * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     1/63 (1.59%)  
Acarodermatitis * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     1/63 (1.59%)  
Acute sinusitis * 1      
# participants affected / at risk     0/65 (0.00%)     1/65 (1.54%)     0/63 (0.00%)  
Balanitis candida * 1      
# participants affected / at risk     1/65 (1.54%)     0/65 (0.00%)     0/63 (0.00%)  
Body tinea * 1      
# participants affected / at risk     0/65 (0.00%)     2/65 (3.08%)     1/63 (1.59%)  
Borrelia infection * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     2/63 (3.17%)  
Bronchitis * 1      
# participants affected / at risk     4/65 (6.15%)     9/65 (13.85%)     5/63 (7.94%)  
Bronchopneumonia * 1      
# participants affected / at risk     1/65 (1.54%)     0/65 (0.00%)     0/63 (0.00%)  
Chlamydial infection * 1      
# participants affected / at risk     2/65 (3.08%)     1/65 (1.54%)     1/63 (1.59%)  
Conjunctivitis viral * 1      
# participants affected / at risk     1/65 (1.54%)     0/65 (0.00%)     0/63 (0.00%)  
Dysentery * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     1/63 (1.59%)  
Eyelid infection * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     1/63 (1.59%)  
Folliculitis * 1      
# participants affected / at risk     2/65 (3.08%)     2/65 (3.08%)     2/63 (3.17%)  
Fungal skin infection * 1      
# participants affected / at risk     0/65 (0.00%)     1/65 (1.54%)     1/63 (1.59%)  
Furuncle * 1      
# participants affected / at risk     1/65 (1.54%)     1/65 (1.54%)     1/63 (1.59%)  
Gastroenteritis * 1      
# participants affected / at risk     5/65 (7.69%)     5/65 (7.69%)     5/63 (7.94%)  
Gastroenteritis bacterial * 1      
# participants affected / at risk     1/65 (1.54%)     0/65 (0.00%)     0/63 (0.00%)  
Genital herpes * 1      
# participants affected / at risk     1/65 (1.54%)     0/65 (0.00%)     2/63 (3.17%)  
Gonorrhoea * 1      
# participants affected / at risk     0/65 (0.00%)     1/65 (1.54%)     0/63 (0.00%)  
H1N1 influenza * 1      
# participants affected / at risk     0/65 (0.00%)     1/65 (1.54%)     0/63 (0.00%)  
Helicobacter infection * 1      
# participants affected / at risk     0/65 (0.00%)     1/65 (1.54%)     0/63 (0.00%)  
Hepatitis A * 1      
# participants affected / at risk     1/65 (1.54%)     0/65 (0.00%)     0/63 (0.00%)  
Hepatitis C * 1      
# participants affected / at risk     1/65 (1.54%)     0/65 (0.00%)     0/63 (0.00%)  
Herpes dermatitis * 1      
# participants affected / at risk     0/65 (0.00%)     1/65 (1.54%)     0/63 (0.00%)  
Herpes zoster * 1      
# participants affected / at risk     1/65 (1.54%)     4/65 (6.15%)     0/63 (0.00%)  
Herpes zoster ophthalmic * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     1/63 (1.59%)  
Impetigo * 1      
# participants affected / at risk     1/65 (1.54%)     0/65 (0.00%)     0/63 (0.00%)  
Infected bites * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     1/63 (1.59%)  
Influenza * 1      
# participants affected / at risk     5/65 (7.69%)     7/65 (10.77%)     8/63 (12.70%)  
Kaposi's varicelliform eruption * 1      
# participants affected / at risk     0/65 (0.00%)     1/65 (1.54%)     0/63 (0.00%)  
Lower respiratory tract infection * 1      
# participants affected / at risk     2/65 (3.08%)     3/65 (4.62%)     3/63 (4.76%)  
Molluscum contagiosum * 1      
# participants affected / at risk     2/65 (3.08%)     0/65 (0.00%)     1/63 (1.59%)  
Nasopharyngitis * 1      
# participants affected / at risk     8/65 (12.31%)     3/65 (4.62%)     4/63 (6.35%)  
Onychomycosis * 1      
# participants affected / at risk     1/65 (1.54%)     0/65 (0.00%)     0/63 (0.00%)  
Oral candidiasis * 1      
# participants affected / at risk     1/65 (1.54%)     2/65 (3.08%)     2/63 (3.17%)  
Oral hairy leukoplakia * 1      
# participants affected / at risk     1/65 (1.54%)     0/65 (0.00%)     0/63 (0.00%)  
Oral herpes * 1      
# participants affected / at risk     1/65 (1.54%)     2/65 (3.08%)     2/63 (3.17%)  
Orchitis * 1      
# participants affected / at risk     0/65 (0.00%)     1/65 (1.54%)     1/63 (1.59%)  
Otitis externa * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     2/63 (3.17%)  
Otitis media * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     1/63 (1.59%)  
Otitis media acute * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     1/63 (1.59%)  
Parasitic gastroenteritis * 1      
# participants affected / at risk     0/65 (0.00%)     1/65 (1.54%)     0/63 (0.00%)  
Paronychia * 1      
# participants affected / at risk     1/65 (1.54%)     0/65 (0.00%)     0/63 (0.00%)  
Pelvic inflammatory disease * 1      
# participants affected / at risk     0/65 (0.00%)     1/65 (1.54%)     1/63 (1.59%)  
Penile abscess * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     1/63 (1.59%)  
Pharyngitis * 1      
# participants affected / at risk     2/65 (3.08%)     2/65 (3.08%)     8/63 (12.70%)  
Respiratory tract infection * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     1/63 (1.59%)  
Respiratory tract infection viral * 1      
# participants affected / at risk     0/65 (0.00%)     2/65 (3.08%)     1/63 (1.59%)  
Rhinitis * 1      
# participants affected / at risk     3/65 (4.62%)     1/65 (1.54%)     2/63 (3.17%)  
Sinusitis * 1      
# participants affected / at risk     4/65 (6.15%)     2/65 (3.08%)     1/63 (1.59%)  
Skin candida * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     1/63 (1.59%)  
Skin infection * 1      
# participants affected / at risk     0/65 (0.00%)     1/65 (1.54%)     0/63 (0.00%)  
Subcutaneous abscess * 1      
# participants affected / at risk     1/65 (1.54%)     1/65 (1.54%)     0/63 (0.00%)  
Syphilis * 1      
# participants affected / at risk     6/65 (9.23%)     1/65 (1.54%)     3/63 (4.76%)  
Tinea cruris * 1      
# participants affected / at risk     1/65 (1.54%)     0/65 (0.00%)     0/63 (0.00%)  
Tinea infection * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     1/63 (1.59%)  
Tinea pedis * 1      
# participants affected / at risk     4/65 (6.15%)     1/65 (1.54%)     0/63 (0.00%)  
Tonsillitis * 1      
# participants affected / at risk     1/65 (1.54%)     2/65 (3.08%)     1/63 (1.59%)  
Tooth infection * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     1/63 (1.59%)  
Tracheitis * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     1/63 (1.59%)  
Upper respiratory tract infection * 1      
# participants affected / at risk     10/65 (15.38%)     13/65 (20.00%)     14/63 (22.22%)  
Urethritis * 1      
# participants affected / at risk     0/65 (0.00%)     1/65 (1.54%)     2/63 (3.17%)  
Urethritis chlamydial * 1      
# participants affected / at risk     1/65 (1.54%)     0/65 (0.00%)     0/63 (0.00%)  
Urethritis gonococcal * 1      
# participants affected / at risk     0/65 (0.00%)     1/65 (1.54%)     0/63 (0.00%)  
Urinary tract infection * 1      
# participants affected / at risk     1/65 (1.54%)     2/65 (3.08%)     3/63 (4.76%)  
Vaginal infection * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     1/63 (1.59%)  
Viral pharyngitis * 1      
# participants affected / at risk     0/65 (0.00%)     1/65 (1.54%)     1/63 (1.59%)  
Viral upper respiratory tract infection * 1      
# participants affected / at risk     1/65 (1.54%)     2/65 (3.08%)     1/63 (1.59%)  
Vulvovaginal candidiasis * 1      
# participants affected / at risk     0/65 (0.00%)     1/65 (1.54%)     1/63 (1.59%)  
Vulvovaginal mycotic infection * 1      
# participants affected / at risk     0/65 (0.00%)     1/65 (1.54%)     1/63 (1.59%)  
Injury, poisoning and procedural complications        
Alcohol poisoning * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     1/63 (1.59%)  
Ankle fracture * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     1/63 (1.59%)  
Arthropod bite * 1      
# participants affected / at risk     0/65 (0.00%)     1/65 (1.54%)     0/63 (0.00%)  
Contusion * 1      
# participants affected / at risk     1/65 (1.54%)     0/65 (0.00%)     1/63 (1.59%)  
Epicondylitis * 1      
# participants affected / at risk     0/65 (0.00%)     1/65 (1.54%)     0/63 (0.00%)  
Excoriation * 1      
# participants affected / at risk     1/65 (1.54%)     1/65 (1.54%)     1/63 (1.59%)  
Face injury * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     1/63 (1.59%)  
Fall * 1      
# participants affected / at risk     0/65 (0.00%)     1/65 (1.54%)     0/63 (0.00%)  
Foot fracture * 1      
# participants affected / at risk     1/65 (1.54%)     0/65 (0.00%)     1/63 (1.59%)  
Forearm fracture * 1      
# participants affected / at risk     1/65 (1.54%)     0/65 (0.00%)     0/63 (0.00%)  
Fractured coccyx * 1      
# participants affected / at risk     0/65 (0.00%)     1/65 (1.54%)     0/63 (0.00%)  
Head injury * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     2/63 (3.17%)  
Joint dislocation * 1      
# participants affected / at risk     1/65 (1.54%)     0/65 (0.00%)     0/63 (0.00%)  
Joint injury * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     1/63 (1.59%)  
Laceration * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     2/63 (3.17%)  
Ligament sprain * 1      
# participants affected / at risk     1/65 (1.54%)     0/65 (0.00%)     0/63 (0.00%)  
Limb injury * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     1/63 (1.59%)  
Muscle strain * 1      
# participants affected / at risk     1/65 (1.54%)     0/65 (0.00%)     0/63 (0.00%)  
Post procedural haemorrhage * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     1/63 (1.59%)  
Procedural pain * 1      
# participants affected / at risk     1/65 (1.54%)     0/65 (0.00%)     0/63 (0.00%)  
Scratch * 1      
# participants affected / at risk     0/65 (0.00%)     1/65 (1.54%)     1/63 (1.59%)  
Skeletal injury * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     1/63 (1.59%)  
Stab wound * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     1/63 (1.59%)  
Thermal burn * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     1/63 (1.59%)  
Wound * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     1/63 (1.59%)  
Investigations        
Alanine aminotransferase increased * 1      
# participants affected / at risk     1/65 (1.54%)     1/65 (1.54%)     4/63 (6.35%)  
Aspartate aminotransferase increased * 1      
# participants affected / at risk     1/65 (1.54%)     1/65 (1.54%)     4/63 (6.35%)  
Blood amylase increased * 1      
# participants affected / at risk     1/65 (1.54%)     0/65 (0.00%)     1/63 (1.59%)  
Blood bilirubin increased * 1      
# participants affected / at risk     1/65 (1.54%)     0/65 (0.00%)     0/63 (0.00%)  
Blood cholesterol increased * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     2/63 (3.17%)  
Blood creatine phosphokinase increased * 1      
# participants affected / at risk     2/65 (3.08%)     1/65 (1.54%)     4/63 (6.35%)  
Blood creatinine increased * 1      
# participants affected / at risk     2/65 (3.08%)     0/65 (0.00%)     0/63 (0.00%)  
Blood glucose increased * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     2/63 (3.17%)  
Blood lactate dehydrogenase increased * 1      
# participants affected / at risk     0/65 (0.00%)     1/65 (1.54%)     0/63 (0.00%)  
Blood pressure increased * 1      
# participants affected / at risk     0/65 (0.00%)     1/65 (1.54%)     1/63 (1.59%)  
Blood uric acid increased * 1      
# participants affected / at risk     1/65 (1.54%)     0/65 (0.00%)     0/63 (0.00%)  
Blood urine present * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     1/63 (1.59%)  
Body temperature increased * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     2/63 (3.17%)  
Electrocardiogram QT prolonged * 1      
# participants affected / at risk     2/65 (3.08%)     0/65 (0.00%)     0/63 (0.00%)  
Gamma-glutamyltransferase increased * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     1/63 (1.59%)  
Lipase increased * 1      
# participants affected / at risk     2/65 (3.08%)     0/65 (0.00%)     0/63 (0.00%)  
Liver function test abnormal * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     1/63 (1.59%)  
Low density lipoprotein increased * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     2/63 (3.17%)  
Protein urine present * 1      
# participants affected / at risk     1/65 (1.54%)     0/65 (0.00%)     1/63 (1.59%)  
Serum ferritin decreased * 1      
# participants affected / at risk     0/65 (0.00%)     1/65 (1.54%)     0/63 (0.00%)  
Vestibular function test * 1      
# participants affected / at risk     0/65 (0.00%)     1/65 (1.54%)     0/63 (0.00%)  
Vitamin D decreased * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     1/63 (1.59%)  
Weight decreased * 1      
# participants affected / at risk     2/65 (3.08%)     1/65 (1.54%)     5/63 (7.94%)  
Weight increased * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     1/63 (1.59%)  
White blood cell count decreased * 1      
# participants affected / at risk     1/65 (1.54%)     0/65 (0.00%)     0/63 (0.00%)  
White blood cells urine * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     1/63 (1.59%)  
Metabolism and nutrition disorders        
Decreased appetite * 1      
# participants affected / at risk     2/65 (3.08%)     0/65 (0.00%)     3/63 (4.76%)  
Hypoglycaemia * 1      
# participants affected / at risk     1/65 (1.54%)     0/65 (0.00%)     0/63 (0.00%)  
Vitamin D deficiency * 1      
# participants affected / at risk     1/65 (1.54%)     1/65 (1.54%)     0/63 (0.00%)  
Musculoskeletal and connective tissue disorders        
Arthralgia * 1      
# participants affected / at risk     5/65 (7.69%)     3/65 (4.62%)     3/63 (4.76%)  
Arthritis * 1      
# participants affected / at risk     0/65 (0.00%)     1/65 (1.54%)     0/63 (0.00%)  
Arthropathy * 1      
# participants affected / at risk     1/65 (1.54%)     0/65 (0.00%)     0/63 (0.00%)  
Back pain * 1      
# participants affected / at risk     5/65 (7.69%)     4/65 (6.15%)     6/63 (9.52%)  
Bursitis * 1      
# participants affected / at risk     1/65 (1.54%)     0/65 (0.00%)     0/63 (0.00%)  
Chondrocalcinosis * 1      
# participants affected / at risk     0/65 (0.00%)     1/65 (1.54%)     0/63 (0.00%)  
Costochondritis * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     1/63 (1.59%)  
Groin pain * 1      
# participants affected / at risk     2/65 (3.08%)     1/65 (1.54%)     0/63 (0.00%)  
Hand deformity * 1      
# participants affected / at risk     0/65 (0.00%)     1/65 (1.54%)     0/63 (0.00%)  
Inguinal mass * 1      
# participants affected / at risk     0/65 (0.00%)     1/65 (1.54%)     0/63 (0.00%)  
Joint range of motion decreased * 1      
# participants affected / at risk     1/65 (1.54%)     0/65 (0.00%)     0/63 (0.00%)  
Joint swelling * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     1/63 (1.59%)  
Muscle spasms * 1      
# participants affected / at risk     2/65 (3.08%)     0/65 (0.00%)     0/63 (0.00%)  
Musculoskeletal chest pain * 1      
# participants affected / at risk     0/65 (0.00%)     1/65 (1.54%)     0/63 (0.00%)  
Musculoskeletal pain * 1      
# participants affected / at risk     2/65 (3.08%)     2/65 (3.08%)     2/63 (3.17%)  
Myalgia * 1      
# participants affected / at risk     1/65 (1.54%)     4/65 (6.15%)     2/63 (3.17%)  
Neck pain * 1      
# participants affected / at risk     1/65 (1.54%)     0/65 (0.00%)     0/63 (0.00%)  
Pain in extremity * 1      
# participants affected / at risk     3/65 (4.62%)     0/65 (0.00%)     2/63 (3.17%)  
Periarthritis * 1      
# participants affected / at risk     0/65 (0.00%)     1/65 (1.54%)     0/63 (0.00%)  
Tendonitis * 1      
# participants affected / at risk     2/65 (3.08%)     0/65 (0.00%)     1/63 (1.59%)  
Tenosynovitis * 1      
# participants affected / at risk     0/65 (0.00%)     1/65 (1.54%)     0/63 (0.00%)  
Tenosynovitis stenosans * 1      
# participants affected / at risk     0/65 (0.00%)     1/65 (1.54%)     0/63 (0.00%)  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)        
Anogenital warts * 1      
# participants affected / at risk     0/65 (0.00%)     3/65 (4.62%)     1/63 (1.59%)  
Basal cell carcinoma * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     1/63 (1.59%)  
Blepharal papilloma * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     1/63 (1.59%)  
Neoplasm * 1      
# participants affected / at risk     0/65 (0.00%)     1/65 (1.54%)     0/63 (0.00%)  
Oral papilloma * 1      
# participants affected / at risk     1/65 (1.54%)     0/65 (0.00%)     0/63 (0.00%)  
Skin papilloma * 1      
# participants affected / at risk     3/65 (4.62%)     5/65 (7.69%)     0/63 (0.00%)  
Testicular neoplasm * 1      
# participants affected / at risk     1/65 (1.54%)     0/65 (0.00%)     0/63 (0.00%)  
Nervous system disorders        
Areflexia * 1      
# participants affected / at risk     0/65 (0.00%)     1/65 (1.54%)     1/63 (1.59%)  
Carpal tunnel syndrome * 1      
# participants affected / at risk     0/65 (0.00%)     2/65 (3.08%)     0/63 (0.00%)  
Cerebrovascular accident * 1      
# participants affected / at risk     1/65 (1.54%)     0/65 (0.00%)     0/63 (0.00%)  
Disturbance in attention * 1      
# participants affected / at risk     1/65 (1.54%)     2/65 (3.08%)     3/63 (4.76%)  
Dizziness * 1      
# participants affected / at risk     5/65 (7.69%)     5/65 (7.69%)     15/63 (23.81%)  
Dysarthria * 1      
# participants affected / at risk     0/65 (0.00%)     1/65 (1.54%)     0/63 (0.00%)  
Dysgeusia * 1      
# participants affected / at risk     1/65 (1.54%)     3/65 (4.62%)     1/63 (1.59%)  
Headache * 1      
# participants affected / at risk     19/65 (29.23%)     14/65 (21.54%)     11/63 (17.46%)  
Hyperaesthesia * 1      
# participants affected / at risk     0/65 (0.00%)     1/65 (1.54%)     0/63 (0.00%)  
Lethargy * 1      
# participants affected / at risk     0/65 (0.00%)     1/65 (1.54%)     1/63 (1.59%)  
Memory impairment * 1      
# participants affected / at risk     1/65 (1.54%)     0/65 (0.00%)     0/63 (0.00%)  
Migraine * 1      
# participants affected / at risk     1/65 (1.54%)     1/65 (1.54%)     0/63 (0.00%)  
Nervous system disorder * 1      
# participants affected / at risk     0/65 (0.00%)     1/65 (1.54%)     0/63 (0.00%)  
Neuropathy peripheral * 1      
# participants affected / at risk     1/65 (1.54%)     0/65 (0.00%)     1/63 (1.59%)  
Nystagmus * 1      
# participants affected / at risk     0/65 (0.00%)     1/65 (1.54%)     0/63 (0.00%)  
Paraesthesia * 1      
# participants affected / at risk     1/65 (1.54%)     1/65 (1.54%)     1/63 (1.59%)  
Post herpetic neuralgia * 1      
# participants affected / at risk     0/65 (0.00%)     1/65 (1.54%)     0/63 (0.00%)  
Presyncope * 1      
# participants affected / at risk     0/65 (0.00%)     1/65 (1.54%)     0/63 (0.00%)  
Sciatica * 1      
# participants affected / at risk     1/65 (1.54%)     1/65 (1.54%)     1/63 (1.59%)  
Somnolence * 1      
# participants affected / at risk     3/65 (4.62%)     1/65 (1.54%)     1/63 (1.59%)  
Syncope * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     1/63 (1.59%)  
Tension headache * 1      
# participants affected / at risk     0/65 (0.00%)     2/65 (3.08%)     1/63 (1.59%)  
Psychiatric disorders        
Abnormal dreams * 1      
# participants affected / at risk     5/65 (7.69%)     5/65 (7.69%)     12/63 (19.05%)  
Agitation * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     1/63 (1.59%)  
Anxiety * 1      
# participants affected / at risk     0/65 (0.00%)     5/65 (7.69%)     5/63 (7.94%)  
Attention deficit/hyperactivity disorder * 1      
# participants affected / at risk     1/65 (1.54%)     0/65 (0.00%)     0/63 (0.00%)  
Depressed mood * 1      
# participants affected / at risk     1/65 (1.54%)     2/65 (3.08%)     1/63 (1.59%)  
Depression * 1      
# participants affected / at risk     3/65 (4.62%)     2/65 (3.08%)     3/63 (4.76%)  
Disturbance in sexual arousal * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     1/63 (1.59%)  
Dysphoria * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     1/63 (1.59%)  
Grief reaction * 1      
# participants affected / at risk     1/65 (1.54%)     0/65 (0.00%)     0/63 (0.00%)  
Hallucination * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     1/63 (1.59%)  
Initial insomnia * 1      
# participants affected / at risk     1/65 (1.54%)     0/65 (0.00%)     1/63 (1.59%)  
Insomnia * 1      
# participants affected / at risk     7/65 (10.77%)     9/65 (13.85%)     8/63 (12.70%)  
Libido decreased * 1      
# participants affected / at risk     3/65 (4.62%)     0/65 (0.00%)     0/63 (0.00%)  
Libido increased * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     1/63 (1.59%)  
Major depression * 1      
# participants affected / at risk     0/65 (0.00%)     1/65 (1.54%)     0/63 (0.00%)  
Mental disorder * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     1/63 (1.59%)  
Negative thoughts * 1      
# participants affected / at risk     1/65 (1.54%)     0/65 (0.00%)     0/63 (0.00%)  
Nightmare * 1      
# participants affected / at risk     3/65 (4.62%)     1/65 (1.54%)     3/63 (4.76%)  
Sleep disorder * 1      
# participants affected / at risk     1/65 (1.54%)     1/65 (1.54%)     1/63 (1.59%)  
Suicidal ideation * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     2/63 (3.17%)  
Renal and urinary disorders        
Dysuria * 1      
# participants affected / at risk     1/65 (1.54%)     0/65 (0.00%)     0/63 (0.00%)  
Haematuria * 1      
# participants affected / at risk     1/65 (1.54%)     0/65 (0.00%)     0/63 (0.00%)  
Leukocyturia * 1      
# participants affected / at risk     1/65 (1.54%)     0/65 (0.00%)     0/63 (0.00%)  
Nocturia * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     1/63 (1.59%)  
Polyuria * 1      
# participants affected / at risk     2/65 (3.08%)     0/65 (0.00%)     1/63 (1.59%)  
Proteinuria * 1      
# participants affected / at risk     4/65 (6.15%)     2/65 (3.08%)     1/63 (1.59%)  
Urinary incontinence * 1      
# participants affected / at risk     1/65 (1.54%)     0/65 (0.00%)     0/63 (0.00%)  
Urine odour abnormal * 1      
# participants affected / at risk     0/65 (0.00%)     1/65 (1.54%)     0/63 (0.00%)  
Reproductive system and breast disorders        
Balanitis * 1      
# participants affected / at risk     2/65 (3.08%)     0/65 (0.00%)     0/63 (0.00%)  
Cervical dysplasia * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     1/63 (1.59%)  
Dysmenorrhoea * 1      
# participants affected / at risk     1/65 (1.54%)     1/65 (1.54%)     0/63 (0.00%)  
Epididymitis * 1      
# participants affected / at risk     1/65 (1.54%)     0/65 (0.00%)     0/63 (0.00%)  
Erectile dysfunction * 1      
# participants affected / at risk     5/65 (7.69%)     1/65 (1.54%)     2/63 (3.17%)  
Genital rash * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     1/63 (1.59%)  
Menopausal symptoms * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     1/63 (1.59%)  
Menorrhagia * 1      
# participants affected / at risk     0/65 (0.00%)     2/65 (3.08%)     0/63 (0.00%)  
Metrorrhagia * 1      
# participants affected / at risk     0/65 (0.00%)     1/65 (1.54%)     0/63 (0.00%)  
Perineal ulceration * 1      
# participants affected / at risk     0/65 (0.00%)     1/65 (1.54%)     0/63 (0.00%)  
Prostatism * 1      
# participants affected / at risk     1/65 (1.54%)     0/65 (0.00%)     0/63 (0.00%)  
Prostatitis * 1      
# participants affected / at risk     1/65 (1.54%)     0/65 (0.00%)     0/63 (0.00%)  
Testicular pain * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     1/63 (1.59%)  
Vaginal discharge * 1      
# participants affected / at risk     0/65 (0.00%)     2/65 (3.08%)     0/63 (0.00%)  
Vaginal disorder * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     1/63 (1.59%)  
Vaginal haemorrhage * 1      
# participants affected / at risk     1/65 (1.54%)     0/65 (0.00%)     0/63 (0.00%)  
Vulvovaginal pruritus * 1      
# participants affected / at risk     0/65 (0.00%)     1/65 (1.54%)     0/63 (0.00%)  
Respiratory, thoracic and mediastinal disorders        
Asthma * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     1/63 (1.59%)  
Bronchiectasis * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     1/63 (1.59%)  
Bronchospasm * 1      
# participants affected / at risk     0/65 (0.00%)     2/65 (3.08%)     0/63 (0.00%)  
Cough * 1      
# participants affected / at risk     5/65 (7.69%)     4/65 (6.15%)     3/63 (4.76%)  
Dysphonia * 1      
# participants affected / at risk     1/65 (1.54%)     1/65 (1.54%)     1/63 (1.59%)  
Dyspnoea * 1      
# participants affected / at risk     1/65 (1.54%)     0/65 (0.00%)     0/63 (0.00%)  
Epistaxis * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     1/63 (1.59%)  
Hyperventilation * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     1/63 (1.59%)  
Nasal congestion * 1      
# participants affected / at risk     0/65 (0.00%)     1/65 (1.54%)     1/63 (1.59%)  
Nasal inflammation * 1      
# participants affected / at risk     0/65 (0.00%)     1/65 (1.54%)     0/63 (0.00%)  
Oropharyngeal pain * 1      
# participants affected / at risk     1/65 (1.54%)     2/65 (3.08%)     4/63 (6.35%)  
Pharyngeal disorder * 1      
# participants affected / at risk     1/65 (1.54%)     0/65 (0.00%)     0/63 (0.00%)  
Pleuritic pain * 1      
# participants affected / at risk     2/65 (3.08%)     0/65 (0.00%)     0/63 (0.00%)  
Productive cough * 1      
# participants affected / at risk     0/65 (0.00%)     2/65 (3.08%)     0/63 (0.00%)  
Pulmonary oedema * 1      
# participants affected / at risk     1/65 (1.54%)     0/65 (0.00%)     0/63 (0.00%)  
Rhinitis allergic * 1      
# participants affected / at risk     1/65 (1.54%)     2/65 (3.08%)     1/63 (1.59%)  
Rhinorrhoea * 1      
# participants affected / at risk     2/65 (3.08%)     1/65 (1.54%)     0/63 (0.00%)  
Sleep apnoea syndrome * 1      
# participants affected / at risk     1/65 (1.54%)     0/65 (0.00%)     0/63 (0.00%)  
Upper-airway cough syndrome * 1      
# participants affected / at risk     0/65 (0.00%)     1/65 (1.54%)     0/63 (0.00%)  
Skin and subcutaneous tissue disorders        
Acne * 1      
# participants affected / at risk     4/65 (6.15%)     2/65 (3.08%)     0/63 (0.00%)  
Actinic keratosis * 1      
# participants affected / at risk     0/65 (0.00%)     1/65 (1.54%)     0/63 (0.00%)  
Alopecia * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     2/63 (3.17%)  
Dermatitis * 1      
# participants affected / at risk     2/65 (3.08%)     2/65 (3.08%)     2/63 (3.17%)  
Dermatitis allergic * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     1/63 (1.59%)  
Dermatitis contact * 1      
# participants affected / at risk     1/65 (1.54%)     0/65 (0.00%)     0/63 (0.00%)  
Dermatosis * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     1/63 (1.59%)  
Drug eruption * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     1/63 (1.59%)  
Dry skin * 1      
# participants affected / at risk     3/65 (4.62%)     0/65 (0.00%)     1/63 (1.59%)  
Eczema * 1      
# participants affected / at risk     0/65 (0.00%)     2/65 (3.08%)     1/63 (1.59%)  
Erythema * 1      
# participants affected / at risk     2/65 (3.08%)     0/65 (0.00%)     0/63 (0.00%)  
Facial wasting * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     1/63 (1.59%)  
Heat rash * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     1/63 (1.59%)  
Night sweats * 1      
# participants affected / at risk     1/65 (1.54%)     0/65 (0.00%)     4/63 (6.35%)  
Papule * 1      
# participants affected / at risk     0/65 (0.00%)     1/65 (1.54%)     0/63 (0.00%)  
Pityriasis * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     1/63 (1.59%)  
Pruritus * 1      
# participants affected / at risk     0/65 (0.00%)     1/65 (1.54%)     3/63 (4.76%)  
Rash * 1      
# participants affected / at risk     2/65 (3.08%)     1/65 (1.54%)     5/63 (7.94%)  
Rash erythematous * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     2/63 (3.17%)  
Rash macular * 1      
# participants affected / at risk     0/65 (0.00%)     1/65 (1.54%)     1/63 (1.59%)  
Rash maculo-papular * 1      
# participants affected / at risk     1/65 (1.54%)     0/65 (0.00%)     1/63 (1.59%)  
Rash pruritic * 1      
# participants affected / at risk     1/65 (1.54%)     0/65 (0.00%)     0/63 (0.00%)  
Rosacea * 1      
# participants affected / at risk     0/65 (0.00%)     1/65 (1.54%)     0/63 (0.00%)  
Seborrhoea * 1      
# participants affected / at risk     0/65 (0.00%)     1/65 (1.54%)     1/63 (1.59%)  
Skin exfoliation * 1      
# participants affected / at risk     0/65 (0.00%)     2/65 (3.08%)     0/63 (0.00%)  
Skin lesion * 1      
# participants affected / at risk     0/65 (0.00%)     1/65 (1.54%)     0/63 (0.00%)  
Surgical and medical procedures        
Lymphadenectomy * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     1/63 (1.59%)  
Vascular disorders        
Deep vein thrombosis * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     1/63 (1.59%)  
Hyperaemia * 1      
# participants affected / at risk     0/65 (0.00%)     1/65 (1.54%)     0/63 (0.00%)  
Hypertension * 1      
# participants affected / at risk     1/65 (1.54%)     0/65 (0.00%)     2/63 (3.17%)  
Hypotension * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     1/63 (1.59%)  
Labile hypertension * 1      
# participants affected / at risk     1/65 (1.54%)     0/65 (0.00%)     0/63 (0.00%)  
Thrombophlebitis * 1      
# participants affected / at risk     0/65 (0.00%)     0/65 (0.00%)     1/63 (1.59%)  
* Events were collected by non-systematic assessment
1 Term from vocabulary, MedDRA (14.1)



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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
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