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

Trial of Clindamycin / Benzoyl Peroxide Gel in Subjects With Acne

This study has been completed.
Sponsor:
Collaborators:
Rho, Inc.
Quintiles, Inc.
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Stiefel, a GSK Company )
ClinicalTrials.gov Identifier:
NCT00776919
First received: October 21, 2008
Last updated: October 11, 2016
Last verified: October 2016
Results First Received: December 21, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Acne Vulgaris
Interventions: Drug: clindamycin / benzoyl peroxide gel
Drug: clindamycin gel
Drug: BPO gel
Drug: vehicle gel

  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
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Reporting Groups
  Description
Duac Low-dose (LD) Gel Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
Clindamycin Gel Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
BPO Gel Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
Vehicle Gel Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks

Participant Flow:   Overall Study
    Duac Low-dose (LD) Gel   Clindamycin Gel   BPO Gel   Vehicle Gel
STARTED   327   328   328   332 
COMPLETED   300   295   296   293 
NOT COMPLETED   27   33   32   39 
Withdrawal by Subject                16                14                15                26 
Lost to Follow-up                8                12                11                8 
Adverse Event                1                0                2                2 
Protocol Violation                1                2                0                1 
Other: Lack of Efficacy/Lost Medication                1                5                4                2 



  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.
No text entered.

Reporting Groups
  Description
Duac Low-dose (LD) Gel Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
Clindamycin Gel Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
BPO Gel Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
Vehicle Gel Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
Total Total of all reporting groups

Baseline Measures
   Duac Low-dose (LD) Gel   Clindamycin Gel   BPO Gel   Vehicle Gel   Total 
Overall Participants Analyzed 
[Units: Participants]
 327   328   328   332   1315 
Age 
[Units: Years]
Mean (Standard Deviation)
 20.0  (7.0)   20.2  (6.9)   20.6  (7.1)   20.7  (7.4)   20.4  (7.1) 
Gender 
[Units: Participants]
         
Female   202   180   203   210   795 
Male   125   148   125   122   520 
Race/Ethnicity, Customized 
[Units: Participants]
         
White   259   274   251   258   1042 
Black   47   37   54   54   192 
Asian   13   9   17   16   55 
Multiracial   5   7   7   4   23 
American Indian or Alaska Native   3   1   0   0   4 


  Outcome Measures
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1.  Primary:   Number of Participants With Improvement of at Least 2 Grades in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12   [ Time Frame: Baseline (Day 1) and Week 12 ]

2.  Primary:   Mean Change From Baseline (BL) to Week 12 in Inflammatory Lesion Counts   [ Time Frame: Baseline (Day 1) and Week 12 ]

3.  Primary:   Mean Change From Baseline to Week 12 in Non-inflammatory Lesion Counts   [ Time Frame: Baseline (Day 1) and Week 12 ]

4.  Primary:   Mean Change From Baseline to Week 12 in Total Lesion Counts   [ Time Frame: Baseline (Day 1) and Week 12 ]

5.  Secondary:   Mean Percent Change From Baseline to Week 12 in Lesion Counts (Total, Inflammatory, and Non-inflammatory)   [ Time Frame: Baseline (Day 1) and Week 12 ]

6.  Secondary:   Number of Participants Who Had a Subject Global Assessment (SGA) Score of 0 or 1 at Week 12   [ Time Frame: Week 12 ]

7.  Secondary:   Number of Participants Who Had an ISGA Score of 0 or 1 at Week 12   [ Time Frame: Week 12 ]

8.  Secondary:   Mean Change From Baseline to Week 12 in Systolic and Diastolic Blood Pressure   [ Time Frame: Baseline (Day 1) and Week 12 ]

9.  Secondary:   Mean Change From Baseline to Week 12 in Temperature   [ Time Frame: Baseline (Day 1) and Week 12 ]

10.  Secondary:   Mean Change From Baseline to Week 12 in Pulse Rate   [ Time Frame: Baseline (Day 1) and Week 12 ]

11.  Secondary:   Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling   [ Time Frame: Baseline; Weeks 2, 4, 8, and 12 ]

12.  Secondary:   Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Itching and Burning/Stinging   [ Time Frame: Baseline; Weeks 2, 4, 8, and 12 ]

13.  Secondary:   Mean Duration of Study Product Use   [ Time Frame: Baseline (Day 1) through Week 12 ]

14.  Secondary:   Number of Participants Reporting the Indicated Treatment-emergent Adverse Events (AEs) Resulting in Study Product Discontinuation   [ Time Frame: Baseline (Day 1) through Week 12 ]


  Serious Adverse Events


  Other Adverse Events
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Time Frame No text entered.
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Frequency Threshold
Threshold above which other adverse events are reported   0  

Reporting Groups
  Description
Duac Low-dose (LD) Gel Duac LD gel (combination of 1% clindamycin phosphate and 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
Clindamycin Gel Clindamycin gel (containing 1% clindamycin phosphate) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
BPO Gel Benzoyl peroxide (BPO) gel (containing 3% benzoyl peroxide) applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks
Vehicle Gel Matching vehicle gel without the active ingredients clinidamycin phosphate and benzoyl peroxide, applied once daily (in the morning or evening, but at approximately the same time each day) to the entire face for 12 weeks

Other Adverse Events
    Duac Low-dose (LD) Gel   Clindamycin Gel   BPO Gel   Vehicle Gel
Total, other (not including serious) adverse events         
# participants affected / at risk   72/327 (22.02%)   83/328 (25.30%)   102/328 (31.10%)   87/332 (26.20%) 
Blood and lymphatic system disorders         
Iron Deficiency Anemia † 1         
# participants affected / at risk   1/327 (0.31%)   0/328 (0.00%)   0/328 (0.00%)   0/332 (0.00%) 
Lymphadenopathy † 1         
# participants affected / at risk   0/327 (0.00%)   1/328 (0.30%)   0/328 (0.00%)   1/332 (0.30%) 
Ear and labyrinth disorders         
Ear Congestion † 1         
# participants affected / at risk   1/327 (0.31%)   0/328 (0.00%)   0/328 (0.00%)   0/332 (0.00%) 
Ear Pain † 1         
# participants affected / at risk   0/327 (0.00%)   0/328 (0.00%)   0/328 (0.00%)   1/332 (0.30%) 
Eye disorders         
Blepharospasm † 1         
# participants affected / at risk   0/327 (0.00%)   0/328 (0.00%)   0/328 (0.00%)   1/332 (0.30%) 
Conjunctivitis † 1         
# participants affected / at risk   1/327 (0.31%)   0/328 (0.00%)   0/328 (0.00%)   0/332 (0.00%) 
Keratoconus † 1         
# participants affected / at risk   0/327 (0.00%)   0/328 (0.00%)   0/328 (0.00%)   1/332 (0.30%) 
Gastrointestinal disorders         
Abdominal Discomfort † 1         
# participants affected / at risk   0/327 (0.00%)   0/328 (0.00%)   0/328 (0.00%)   1/332 (0.30%) 
Abdominal Hernia † 1         
# participants affected / at risk   0/327 (0.00%)   0/328 (0.00%)   0/328 (0.00%)   1/332 (0.30%) 
Abdominal Pain Upper † 1         
# participants affected / at risk   1/327 (0.31%)   2/328 (0.61%)   1/328 (0.30%)   1/332 (0.30%) 
Cheilitis † 1         
# participants affected / at risk   0/327 (0.00%)   0/328 (0.00%)   0/328 (0.00%)   1/332 (0.30%) 
Dental Caries † 1         
# participants affected / at risk   1/327 (0.31%)   0/328 (0.00%)   0/328 (0.00%)   1/332 (0.30%) 
Diarrhea † 1         
# participants affected / at risk   0/327 (0.00%)   2/328 (0.61%)   0/328 (0.00%)   0/332 (0.00%) 
Dyspepsia † 1         
# participants affected / at risk   1/327 (0.31%)   0/328 (0.00%)   0/328 (0.00%)   1/332 (0.30%) 
Gastritis † 1         
# participants affected / at risk   1/327 (0.31%)   0/328 (0.00%)   1/328 (0.30%)   0/332 (0.00%) 
Gastroesophageal Reflux Disease † 1         
# participants affected / at risk   0/327 (0.00%)   0/328 (0.00%)   0/328 (0.00%)   1/332 (0.30%) 
Hiatus Hernia † 1         
# participants affected / at risk   0/327 (0.00%)   0/328 (0.00%)   0/328 (0.00%)   1/332 (0.30%) 
Nausea † 1         
# participants affected / at risk   0/327 (0.00%)   2/328 (0.61%)   0/328 (0.00%)   0/332 (0.00%) 
Stomach Discomfort † 1         
# participants affected / at risk   2/327 (0.61%)   0/328 (0.00%)   0/328 (0.00%)   0/332 (0.00%) 
Toothache † 1         
# participants affected / at risk   1/327 (0.31%)   1/328 (0.30%)   1/328 (0.30%)   1/332 (0.30%) 
Vomiting † 1         
# participants affected / at risk   0/327 (0.00%)   1/328 (0.30%)   0/328 (0.00%)   1/332 (0.30%) 
Gastrointestinal Infection † 1         
# participants affected / at risk   1/327 (0.31%)   1/328 (0.30%)   2/328 (0.61%)   0/332 (0.00%) 
General disorders         
Application Site Dermatitis † 1         
# participants affected / at risk   2/327 (0.61%)   0/328 (0.00%)   0/328 (0.00%)   0/332 (0.00%) 
Application Site Dryness † 1         
# participants affected / at risk   0/327 (0.00%)   0/328 (0.00%)   1/328 (0.30%)   1/332 (0.30%) 
Application Site Eczema † 1         
# participants affected / at risk   0/327 (0.00%)   0/328 (0.00%)   1/328 (0.30%)   0/332 (0.00%) 
Application Site Erythema † 1         
# participants affected / at risk   0/327 (0.00%)   0/328 (0.00%)   1/328 (0.30%)   0/332 (0.00%) 
Application Site Hypersensitivity † 1         
# participants affected / at risk   0/327 (0.00%)   0/328 (0.00%)   1/328 (0.30%)   0/332 (0.00%) 
Application Site Irritation † 1         
# participants affected / at risk   1/327 (0.31%)   0/328 (0.00%)   2/328 (0.61%)   0/332 (0.00%) 
Application Site Pain † 1         
# participants affected / at risk   0/327 (0.00%)   1/328 (0.30%)   0/328 (0.00%)   0/332 (0.00%) 
Application Site Photosensitivity Reaction † 1         
# participants affected / at risk   2/327 (0.61%)   1/328 (0.30%)   1/328 (0.30%)   2/332 (0.60%) 
Application Site Pruritus † 1         
# participants affected / at risk   0/327 (0.00%)   1/328 (0.30%)   1/328 (0.30%)   1/332 (0.30%) 
Application Site Rash † 1         
# participants affected / at risk   0/327 (0.00%)   0/328 (0.00%)   1/328 (0.30%)   0/332 (0.00%) 
Drug Intolerance † 1         
# participants affected / at risk   0/327 (0.00%)   0/328 (0.00%)   1/328 (0.30%)   0/332 (0.00%) 
Influenza Like Illness † 1         
# participants affected / at risk   0/327 (0.00%)   1/328 (0.30%)   0/328 (0.00%)   1/332 (0.30%) 
Mass † 1         
# participants affected / at risk   1/327 (0.31%)   0/328 (0.00%)   0/328 (0.00%)   0/332 (0.00%) 
Pyrexia † 1         
# participants affected / at risk   1/327 (0.31%)   1/328 (0.30%)   0/328 (0.00%)   2/332 (0.60%) 
Hepatobiliary disorders         
Hepatic Cyst † 1         
# participants affected / at risk   0/327 (0.00%)   0/328 (0.00%)   0/328 (0.00%)   1/332 (0.30%) 
Immune system disorders         
Seasonal Allergy † 1         
# participants affected / at risk   0/327 (0.00%)   0/328 (0.00%)   2/328 (0.61%)   0/332 (0.00%) 
Infections and infestations         
Acarodermatitis † 1         
# participants affected / at risk   0/327 (0.00%)   0/328 (0.00%)   0/328 (0.00%)   1/332 (0.30%) 
Alveolar Osteitis † 1         
# participants affected / at risk   1/327 (0.31%)   0/328 (0.00%)   0/328 (0.00%)   0/332 (0.00%) 
Arthritis Infective † 1         
# participants affected / at risk   0/327 (0.00%)   1/328 (0.30%)   0/328 (0.00%)   0/332 (0.00%) 
Body Tinea † 1         
# participants affected / at risk   0/327 (0.00%)   0/328 (0.00%)   0/328 (0.00%)   1/332 (0.30%) 
Bronchitis † 1         
# participants affected / at risk   0/327 (0.00%)   2/328 (0.61%)   1/328 (0.30%)   1/332 (0.30%) 
Cellulitis † 1         
# participants affected / at risk   0/327 (0.00%)   1/328 (0.30%)   0/328 (0.00%)   0/332 (0.00%) 
Conjunctivitis Infective † 1         
# participants affected / at risk   0/327 (0.00%)   0/328 (0.00%)   0/328 (0.00%)   1/332 (0.30%) 
Ear Infection † 1         
# participants affected / at risk   1/327 (0.31%)   0/328 (0.00%)   2/328 (0.61%)   0/332 (0.00%) 
Folliculitis † 1         
# participants affected / at risk   1/327 (0.31%)   0/328 (0.00%)   0/328 (0.00%)   0/332 (0.00%) 
Fungal Infection † 1         
# participants affected / at risk   0/327 (0.00%)   0/328 (0.00%)   1/328 (0.30%)   0/332 (0.00%) 
Furuncle † 1         
# participants affected / at risk   0/327 (0.00%)   0/328 (0.00%)   1/328 (0.30%)   0/332 (0.00%) 
Gastroenteritis † 1         
# participants affected / at risk   1/327 (0.31%)   0/328 (0.00%)   0/328 (0.00%)   1/332 (0.30%) 
Gastroenteritis Viral † 1         
# participants affected / at risk   0/327 (0.00%)   0/328 (0.00%)   1/328 (0.30%)   2/332 (0.60%) 
Gingival Infection † 1         
# participants affected / at risk   0/327 (0.00%)   1/328 (0.30%)   0/328 (0.00%)   1/332 (0.30%) 
Herpes Zoster † 1         
# participants affected / at risk   1/327 (0.31%)   0/328 (0.00%)   0/328 (0.00%)   0/332 (0.00%) 
Impetigo † 1         
# participants affected / at risk   0/327 (0.00%)   1/328 (0.30%)   0/328 (0.00%)   0/332 (0.00%) 
Infectious Mononucleosis † 1         
# participants affected / at risk   0/327 (0.00%)   0/328 (0.00%)   0/328 (0.00%)   1/332 (0.30%) 
Influenza † 1         
# participants affected / at risk   3/327 (0.92%)   5/328 (1.52%)   1/328 (0.30%)   4/332 (1.20%) 
Laryngitis † 1         
# participants affected / at risk   0/327 (0.00%)   0/328 (0.00%)   1/328 (0.30%)   0/332 (0.00%) 
Lower Respiratory Tract Infection † 1         
# participants affected / at risk   0/327 (0.00%)   0/328 (0.00%)   1/328 (0.30%)   0/332 (0.00%) 
Nasopharyngitis † 1         
# participants affected / at risk   27/327 (8.26%)   23/328 (7.01%)   32/328 (9.76%)   19/332 (5.72%) 
Oral Candidiasis † 1         
# participants affected / at risk   1/327 (0.31%)   0/328 (0.00%)   0/328 (0.00%)   0/332 (0.00%) 
Otitis Externa † 1         
# participants affected / at risk   1/327 (0.31%)   0/328 (0.00%)   1/328 (0.30%)   0/332 (0.00%) 
Pharyngitis † 1         
# participants affected / at risk   0/327 (0.00%)   1/328 (0.30%)   2/328 (0.61%)   0/332 (0.00%) 
Pharyngitis Streptococcal † 1         
# participants affected / at risk   0/327 (0.00%)   1/328 (0.30%)   0/328 (0.00%)   2/332 (0.60%) 
Pneumonia † 1         
# participants affected / at risk   0/327 (0.00%)   0/328 (0.00%)   0/328 (0.00%)   1/332 (0.30%) 
Respiratory Tract Infection † 1         
# participants affected / at risk   0/327 (0.00%)   0/328 (0.00%)   0/328 (0.00%)   1/332 (0.30%) 
Rhinitis † 1         
# participants affected / at risk   0/327 (0.00%)   2/328 (0.61%)   0/328 (0.00%)   1/332 (0.30%) 
Sinusitis † 1         
# participants affected / at risk   2/327 (0.61%)   2/328 (0.61%)   2/328 (0.61%)   2/332 (0.60%) 
Staphylococcal Infection † 1         
# participants affected / at risk   1/327 (0.31%)   0/328 (0.00%)   0/328 (0.00%)   0/332 (0.00%) 
Tinea Infection † 1         
# participants affected / at risk   0/327 (0.00%)   0/328 (0.00%)   0/328 (0.00%)   1/332 (0.30%) 
Tonsillitis † 1         
# participants affected / at risk   0/327 (0.00%)   0/328 (0.00%)   0/328 (0.00%)   1/332 (0.30%) 
Tooth Abscess † 1         
# participants affected / at risk   1/327 (0.31%)   0/328 (0.00%)   0/328 (0.00%)   1/332 (0.30%) 
Tooth Infection † 1         
# participants affected / at risk   1/327 (0.31%)   0/328 (0.00%)   1/328 (0.30%)   0/332 (0.00%) 
Upper Respiratory Tract Infection † 1         
# participants affected / at risk   11/327 (3.36%)   13/328 (3.96%)   13/328 (3.96%)   13/332 (3.92%) 
Urinary Tract Infection † 1         
# participants affected / at risk   1/327 (0.31%)   2/328 (0.61%)   1/328 (0.30%)   2/332 (0.60%) 
Vaginal Infection † 1         
# participants affected / at risk   0/327 (0.00%)   1/328 (0.30%)   0/328 (0.00%)   1/332 (0.30%) 
Varicella † 1         
# participants affected / at risk   0/327 (0.00%)   0/328 (0.00%)   0/328 (0.00%)   1/332 (0.30%) 
Viral Infection † 1         
# participants affected / at risk   1/327 (0.31%)   0/328 (0.00%)   0/328 (0.00%)   1/332 (0.30%) 
Viral Upper Respiratory Tract Infection † 1         
# participants affected / at risk   0/327 (0.00%)   0/328 (0.00%)   0/328 (0.00%)   1/332 (0.30%) 
Vulvovaginal Mycotic Infection † 1         
# participants affected / at risk   0/327 (0.00%)   1/328 (0.30%)   0/328 (0.00%)   0/332 (0.00%) 
Injury, poisoning and procedural complications         
Arthropod Bite † 1         
# participants affected / at risk   0/327 (0.00%)   0/328 (0.00%)   0/328 (0.00%)   0/332 (0.00%) 
Excoriation † 1         
# participants affected / at risk   1/327 (0.31%)   1/328 (0.30%)   2/328 (0.61%)   1/332 (0.30%) 
Fractured Coccyx † 1         
# participants affected / at risk   0/327 (0.00%)   1/328 (0.30%)   0/328 (0.00%)   0/332 (0.00%) 
Head Injury † 1         
# participants affected / at risk   0/327 (0.00%)   1/328 (0.30%)   0/328 (0.00%)   0/332 (0.00%) 
Injury † 1         
# participants affected / at risk   0/327 (0.00%)   0/328 (0.00%)   0/328 (0.00%)   0/332 (0.00%) 
Joint Sprain † 1         
# participants affected / at risk   0/327 (0.00%)   2/328 (0.61%)   5/328 (1.52%)   0/332 (0.00%) 
Limb Crushing Injury † 1         
# participants affected / at risk   1/327 (0.31%)   0/328 (0.00%)   0/328 (0.00%)   0/332 (0.00%) 
Muscle Strain † 1         
# participants affected / at risk   0/327 (0.00%)   1/328 (0.30%)   0/328 (0.00%)   1/332 (0.30%) 
Neck Injury † 1         
# participants affected / at risk   0/327 (0.00%)   0/328 (0.00%)   1/328 (0.30%)   0/332 (0.00%) 
Post-Traumatic Pain † 1         
# participants affected / at risk   1/327 (0.31%)   0/328 (0.00%)   0/328 (0.00%)   0/332 (0.00%) 
Procedural Pain † 1         
# participants affected / at risk   2/327 (0.61%)   1/328 (0.30%)   0/328 (0.00%)   2/332 (0.60%) 
Radius Fracture † 1         
# participants affected / at risk   1/327 (0.31%)   0/328 (0.00%)   0/328 (0.00%)   0/332 (0.00%) 
Skin Laceration † 1         
# participants affected / at risk   0/327 (0.00%)   2/328 (0.61%)   1/328 (0.30%)   1/332 (0.30%) 
Sunburn † 1         
# participants affected / at risk   2/327 (0.61%)   5/328 (1.52%)   1/328 (0.30%)   2/332 (0.60%) 
Thermal Burn † 1         
# participants affected / at risk   1/327 (0.31%)   0/328 (0.00%)   0/328 (0.00%)   0/332 (0.00%) 
Upper Limb Fracture † 1         
# participants affected / at risk   0/327 (0.00%)   0/328 (0.00%)   2/328 (0.61%)   0/332 (0.00%) 
Wrist Fracture † 1         
# participants affected / at risk   0/327 (0.00%)   0/328 (0.00%)   1/328 (0.30%)   0/332 (0.00%) 
Investigations         
Blood Testosterone Increased † 1         
# participants affected / at risk   0/327 (0.00%)   0/328 (0.00%)   1/328 (0.30%)   0/332 (0.00%) 
Musculoskeletal and connective tissue disorders         
Arthralgia † 1         
# participants affected / at risk   1/327 (0.31%)   0/328 (0.00%)   0/328 (0.00%)   0/332 (0.00%) 
Back Pain † 1         
# participants affected / at risk   2/327 (0.61%)   1/328 (0.30%)   0/328 (0.00%)   0/332 (0.00%) 
Musculoskeletal Stiffness † 1         
# participants affected / at risk   0/327 (0.00%)   0/328 (0.00%)   1/328 (0.30%)   0/332 (0.00%) 
Neck Pain † 1         
# participants affected / at risk   1/327 (0.31%)   0/328 (0.00%)   0/328 (0.00%)   0/332 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Melanocytic Naevus † 1         
# participants affected / at risk   0/327 (0.00%)   1/328 (0.30%)   0/328 (0.00%)   0/332 (0.00%) 
Skin Papilloma † 1         
# participants affected / at risk   1/327 (0.31%)   0/328 (0.00%)   1/328 (0.30%)   0/332 (0.00%) 
Nervous system disorders         
Convulsion † 1         
# participants affected / at risk   0/327 (0.00%)   0/328 (0.00%)   0/328 (0.00%)   1/332 (0.30%) 
Dizziness † 1         
# participants affected / at risk   0/327 (0.00%)   1/328 (0.30%)   0/328 (0.00%)   0/332 (0.00%) 
Headache † 1         
# participants affected / at risk   4/327 (1.22%)   8/328 (2.44%)   9/328 (2.74%)   7/332 (2.11%) 
Migraine † 1         
# participants affected / at risk   1/327 (0.31%)   0/328 (0.00%)   0/328 (0.00%)   0/332 (0.00%) 
Paraesthesia † 1         
# participants affected / at risk   0/327 (0.00%)   0/328 (0.00%)   1/328 (0.30%)   0/332 (0.00%) 
Sinus Headache † 1         
# participants affected / at risk   0/327 (0.00%)   1/328 (0.30%)   0/328 (0.00%)   0/332 (0.00%) 
Syncope † 1         
# participants affected / at risk   0/327 (0.00%)   0/328 (0.00%)   1/328 (0.30%)   0/332 (0.00%) 
Tremor † 1         
# participants affected / at risk   0/327 (0.00%)   0/328 (0.00%)   0/328 (0.00%)   1/332 (0.30%) 
Psychiatric disorders         
Anxiety † 1         
# participants affected / at risk   0/327 (0.00%)   0/328 (0.00%)   1/328 (0.30%)   0/332 (0.00%) 
Attention Deficit/Hyperactivity Disorder † 1         
# participants affected / at risk   0/327 (0.00%)   0/328 (0.00%)   0/328 (0.00%)   1/332 (0.30%) 
Depression † 1         
# participants affected / at risk   1/327 (0.31%)   0/328 (0.00%)   1/328 (0.30%)   0/332 (0.00%) 
Nephrolithiasis † 1         
# participants affected / at risk   0/327 (0.00%)   0/328 (0.00%)   1/328 (0.30%)   0/332 (0.00%) 
Renal and urinary disorders         
Nephrolithiasis † 1         
# participants affected / at risk   0/327 (0.00%)   1/328 (0.30%)   0/328 (0.00%)   0/332 (0.00%) 
Reproductive system and breast disorders         
Adnexa Uteri Pain † 1         
# participants affected / at risk   0/327 (0.00%)   0/328 (0.00%)   0/328 (0.00%)   1/332 (0.30%) 
Breast Cyst † 1         
# participants affected / at risk   0/327 (0.00%)   1/328 (0.30%)   0/328 (0.00%)   0/332 (0.00%) 
Dysmenorrhoea † 1         
# participants affected / at risk   1/327 (0.31%)   0/328 (0.00%)   1/328 (0.30%)   2/332 (0.60%) 
Endometriosis † 1         
# participants affected / at risk   0/327 (0.00%)   1/328 (0.30%)   0/328 (0.00%)   0/332 (0.00%) 
Ovarian Cyst Ruptured † 1         
# participants affected / at risk   0/327 (0.00%)   0/328 (0.00%)   1/328 (0.30%)   0/332 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Cough † 1         
# participants affected / at risk   2/327 (0.61%)   0/328 (0.00%)   1/328 (0.30%)   2/332 (0.60%) 
Epistaxis † 1         
# participants affected / at risk   0/327 (0.00%)   1/328 (0.30%)   0/328 (0.00%)   0/332 (0.00%) 
Nasal Congestion † 1         
# participants affected / at risk   1/327 (0.31%)   1/328 (0.30%)   2/328 (0.61%)   0/332 (0.00%) 
Pharyngolaryngeal Pain † 1         
# participants affected / at risk   3/327 (0.92%)   0/328 (0.00%)   2/328 (0.61%)   2/332 (0.60%) 
Respiratory Tract Congestion † 1         
# participants affected / at risk   0/327 (0.00%)   0/328 (0.00%)   1/328 (0.30%)   0/332 (0.00%) 
Rhinitis Allergic † 1         
# participants affected / at risk   0/327 (0.00%)   0/328 (0.00%)   0/328 (0.00%)   1/332 (0.30%) 
Rhinorrhea † 1         
# participants affected / at risk   0/327 (0.00%)   0/328 (0.00%)   0/328 (0.00%)   1/332 (0.30%) 
Sinus Congestion † 1         
# participants affected / at risk   1/327 (0.31%)   0/328 (0.00%)   1/328 (0.30%)   1/332 (0.30%) 
Skin and subcutaneous tissue disorders         
Acne † 1         
# participants affected / at risk   0/327 (0.00%)   1/328 (0.30%)   1/328 (0.30%)   1/332 (0.30%) 
Chloasma † 1         
# participants affected / at risk   0/327 (0.00%)   0/328 (0.00%)   1/328 (0.30%)   0/332 (0.00%) 
Dermatitis Atopic † 1         
# participants affected / at risk   0/327 (0.00%)   1/328 (0.30%)   0/328 (0.00%)   0/332 (0.00%) 
Dermatitis Contact † 1         
# participants affected / at risk   1/327 (0.31%)   1/328 (0.30%)   0/328 (0.00%)   1/332 (0.30%) 
Ingrowing Nail † 1         
# participants affected / at risk   0/327 (0.00%)   0/328 (0.00%)   0/328 (0.00%)   1/332 (0.30%) 
Pruritus † 1         
# participants affected / at risk   0/327 (0.00%)   0/328 (0.00%)   1/328 (0.30%)   1/332 (0.30%) 
Rash † 1         
# participants affected / at risk   0/327 (0.00%)   1/328 (0.30%)   0/328 (0.00%)   0/332 (0.00%) 
Urticaria † 1         
# participants affected / at risk   0/327 (0.00%)   0/328 (0.00%)   2/328 (0.61%)   0/332 (0.00%) 
Surgical and medical procedures         
Elective Surgery † 1         
# participants affected / at risk   0/327 (0.00%)   0/328 (0.00%)   1/328 (0.30%)   0/332 (0.00%) 
Mole Excision † 1         
# participants affected / at risk   1/327 (0.31%)   0/328 (0.00%)   0/328 (0.00%)   0/332 (0.00%) 
Tooth Extraction † 1         
# participants affected / at risk   0/327 (0.00%)   0/328 (0.00%)   0/328 (0.00%)   1/332 (0.30%) 
Wisdom Teeth Removal † 1         
# participants affected / at risk   1/327 (0.31%)   0/328 (0.00%)   2/328 (0.61%)   2/332 (0.60%) 
Vascular disorders         
Hypertension † 1         
# participants affected / at risk   0/327 (0.00%)   0/328 (0.00%)   1/328 (0.30%)   0/332 (0.00%) 
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA



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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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