Study: NCT01432262

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 162 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 162 at risk

Adverse event: Fever Any
Serious: no
Organ System: General disorders
Frequency: 3 affected / 126 at risk

Adverse event: Fever Mild
Serious: no
Organ System: General disorders
Frequency: 2 affected / 126 at risk

Adverse event: Fever Moderate
Serious: no
Organ System: General disorders
Frequency: 1 affected / 125 at risk

Adverse event: Fever Severe
Serious: no
Organ System: General disorders
Frequency: 1 affected / 124 at risk

Adverse event: Fatigue Any
Serious: no
Organ System: General disorders
Frequency: 68 affected / 144 at risk

Adverse event: Fatigue Mild
Serious: no
Organ System: General disorders
Frequency: 56 affected / 142 at risk

Adverse event: Fatigue Moderate
Serious: no
Organ System: General disorders
Frequency: 36 affected / 134 at risk

Adverse event: Fatigue Severe
Serious: no
Organ System: General disorders
Frequency: 8 affected / 126 at risk

Adverse event: Headache Any
Serious: no
Organ System: General disorders
Frequency: 62 affected / 140 at risk

Adverse event: Headache Mild
Serious: no
Organ System: General disorders
Frequency: 55 affected / 140 at risk

Adverse event: Headache Moderate
Serious: no
Organ System: General disorders
Frequency: 24 affected / 129 at risk

Adverse event: Headache Severe
Serious: no
Organ System: General disorders
Frequency: 5 affected / 126 at risk

Adverse event: Vomiting Any
Serious: no
Organ System: General disorders
Frequency: 5 affected / 125 at risk

Adverse event: Vomiting Mild
Serious: no
Organ System: General disorders
Frequency: 4 affected / 125 at risk

Adverse event: Vomiting Moderate
Serious: no
Organ System: General disorders
Frequency: 2 affected / 124 at risk

Adverse event: Diarrhea Any
Serious: no
Organ System: General disorders
Frequency: 35 affected / 134 at risk

Adverse event: Diarrhea Mild
Serious: no
Organ System: General disorders
Frequency: 30 affected / 129 at risk

Adverse event: Diarrhea Moderate
Serious: no
Organ System: General disorders
Frequency: 8 affected / 129 at risk

Adverse event: Diarrhea Severe
Serious: no
Organ System: General disorders
Frequency: 1 affected / 125 at risk

Adverse event: Muscle pain Any
Serious: no
Organ System: General disorders
Frequency: 89 affected / 147 at risk

Adverse event: Muscle pain Mild
Serious: no
Organ System: General disorders
Frequency: 87 affected / 146 at risk

Adverse event: Muscle pain Moderate
Serious: no
Organ System: General disorders
Frequency: 31 affected / 132 at risk

Adverse event: Muscle pain Severe
Serious: no
Organ System: General disorders
Frequency: 7 affected / 125 at risk

Adverse event: Joint pain Any
Serious: no
Organ System: General disorders
Frequency: 49 affected / 139 at risk

Adverse event: Joint pain Mild
Serious: no
Organ System: General disorders
Frequency: 42 affected / 137 at risk

Adverse event: Joint pain Moderate
Serious: no
Organ System: General disorders
Frequency: 17 affected / 130 at risk

Adverse event: Joint pain Severe
Serious: no
Organ System: General disorders
Frequency: 5 affected / 125 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 162 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 162 at risk

Adverse event: Laryngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 162 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 162 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 162 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 162 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 162 at risk

Adverse event: Limb injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 162 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 162 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 162 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 162 at risk

Adverse event: Libido decreased
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 162 at risk

Adverse event: Vaginal haemorrhage
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 162 at risk

Adverse event: Redness Any
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 18 affected / 125 at risk

Adverse event: Redness Mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 124 at risk

Adverse event: Redness Moderate
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 125 at risk

Adverse event: Redness Severe
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 125 at risk

Adverse event: Swelling Any
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 28 affected / 130 at risk

Adverse event: Swelling Mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 23 affected / 127 at risk

Adverse event: Swelling Moderate
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 127 at risk

Adverse event: Swelling Severe
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 125 at risk

Adverse event: Pain at injection site Any
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 114 affected / 151 at risk

Adverse event: Pain at injection site Mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 112 affected / 151 at risk

Adverse event: Pain at injection site Moderate
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 28 affected / 130 at risk

Adverse event: Pain at injection site Severe
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 125 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 162 at risk

Adverse event: Gastric ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 161 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 161 at risk

Adverse event: Benign prostatic hyperplasia
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 161 at risk

Adverse event: Aphthous ulcer
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 161 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 161 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 161 at risk

Adverse event: Fever Any
Serious: no
Organ System: General disorders
Frequency: 12 affected / 118 at risk

Adverse event: Fever Mild
Serious: no
Organ System: General disorders
Frequency: 4 affected / 113 at risk

Adverse event: Fever Moderate
Serious: no
Organ System: General disorders
Frequency: 2 affected / 113 at risk

Adverse event: Fever Severe
Serious: no
Organ System: General disorders
Frequency: 2 affected / 113 at risk

Adverse event: Fever Potentially life threatening
Serious: no
Organ System: General disorders
Notes: All 'Fever Potentially life threatening' events were confirmed as data entry errors.
Frequency: 5 affected / 116 at risk

Adverse event: Fatigue Any
Serious: no
Organ System: General disorders
Frequency: 51 affected / 132 at risk

Adverse event: Fatigue Mild
Serious: no
Organ System: General disorders
Frequency: 47 affected / 130 at risk

Adverse event: Fatigue Moderate
Serious: no
Organ System: General disorders
Frequency: 25 affected / 125 at risk

Adverse event: Fatigue Severe
Serious: no
Organ System: General disorders
Frequency: 6 affected / 113 at risk

Adverse event: Headache Any
Serious: no
Organ System: General disorders
Frequency: 42 affected / 129 at risk

Adverse event: Headache Mild
Serious: no
Organ System: General disorders
Frequency: 39 affected / 129 at risk

Adverse event: Headache Moderate
Serious: no
Organ System: General disorders
Frequency: 19 affected / 119 at risk

Adverse event: Headache Severe
Serious: no
Organ System: General disorders
Frequency: 6 affected / 115 at risk

Adverse event: Vomiting Any
Serious: no
Organ System: General disorders
Frequency: 2 affected / 113 at risk

Adverse event: Vomiting Mild
Serious: no
Organ System: General disorders
Frequency: 2 affected / 113 at risk

Adverse event: Vomiting Moderate
Serious: no
Organ System: General disorders
Frequency: 1 affected / 113 at risk

Adverse event: Diarrhea Any
Serious: no
Organ System: General disorders
Frequency: 18 affected / 120 at risk

Adverse event: Diarrhea Mild
Serious: no
Organ System: General disorders
Frequency: 17 affected / 120 at risk

Adverse event: Diarrhea Moderate
Serious: no
Organ System: General disorders
Frequency: 2 affected / 113 at risk

Adverse event: Diarrhea Severe
Serious: no
Organ System: General disorders
Frequency: 1 affected / 112 at risk

Adverse event: Muscle pain Any
Serious: no
Organ System: General disorders
Frequency: 58 affected / 132 at risk

Adverse event: Muscle pain Mild
Serious: no
Organ System: General disorders
Frequency: 52 affected / 129 at risk

Adverse event: Muscle pain Moderate
Serious: no
Organ System: General disorders
Frequency: 24 affected / 123 at risk

Adverse event: Muscle pain Severe
Serious: no
Organ System: General disorders
Frequency: 7 affected / 116 at risk

Adverse event: Joint pain Any
Serious: no
Organ System: General disorders
Frequency: 43 affected / 129 at risk

Adverse event: Joint pain Mild
Serious: no
Organ System: General disorders
Frequency: 38 affected / 127 at risk

Adverse event: Joint pain Moderate
Serious: no
Organ System: General disorders
Frequency: 21 affected / 123 at risk

Adverse event: Joint pain Severe
Serious: no
Organ System: General disorders
Frequency: 6 affected / 116 at risk

Adverse event: Gastrointestinal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 161 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 161 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 161 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 161 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 161 at risk

Adverse event: Urethral pain
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 161 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 161 at risk

Adverse event: Redness Any
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 19 affected / 120 at risk

Adverse event: Redness Mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 16 affected / 120 at risk

Adverse event: Redness Moderate
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 115 at risk

Adverse event: Swelling Any
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 16 affected / 120 at risk

Adverse event: Swelling Mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 120 at risk

Adverse event: Swelling Moderate
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 114 at risk

Adverse event: Swelling Severe
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 113 at risk

Adverse event: Pain at injection site Any
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 83 affected / 137 at risk

Adverse event: Pain at injection site Mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 82 affected / 136 at risk

Adverse event: Pain at injection site Moderate
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 117 at risk

Adverse event: Pain at injection site Severe
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 113 at risk