Study: NCT01188421

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 9 affected / 31 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 1 affected / 31 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 17 affected / 31 at risk

Adverse event: Lethargy
Serious: no
Organ System: General disorders
Notes: stupor or coma from disease
Frequency: 2 affected / 31 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: uneasiness or indisposition
Frequency: 2 affected / 31 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: High heart rate
Frequency: 6 affected / 31 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 31 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 31 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 31 at risk

Adverse event: Flatulance
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 31 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 31 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 31 at risk

Adverse event: Vomitting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 31 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: pain in joint
Frequency: 5 affected / 31 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 31 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 31 at risk

Adverse event: Pain Lower Extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 31 at risk

Adverse event: Agitation
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 31 at risk

Adverse event: Anxiety
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 31 at risk

Adverse event: Fatigue
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 31 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 31 at risk

Adverse event: Irritability
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 31 at risk

Adverse event: Restlessness
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 31 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 31 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: General disorders
Frequency: 5 affected / 31 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: General disorders
Frequency: 13 affected / 31 at risk

Adverse event: Yawning
Serious: no
Organ System: General disorders
Notes: Excessively
Frequency: 8 affected / 31 at risk

Adverse event: Piloerection
Serious: no
Organ System: General disorders
Frequency: 5 affected / 31 at risk

Adverse event: Sweat Increased
Serious: no
Organ System: General disorders
Frequency: 6 affected / 31 at risk

Adverse event: Hot flush
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 31 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 31 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 13 affected / 36 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 14 affected / 36 at risk

Adverse event: Lethargy
Serious: no
Organ System: General disorders
Notes: stupor or coma from disease
Frequency: 1 affected / 36 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: uneasiness or indisposition
Frequency: 1 affected / 36 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 36 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: High heart rate
Frequency: 8 affected / 36 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 36 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 36 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 36 at risk

Adverse event: Flatulance
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 36 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 36 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 36 at risk

Adverse event: Vomitting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: pain in joint
Frequency: 4 affected / 36 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 36 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 36 at risk

Adverse event: Pain Lower Extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 36 at risk

Adverse event: Agitation
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 36 at risk

Adverse event: Anxiety
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 36 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 36 at risk

Adverse event: Fatigue
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 36 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 36 at risk

Adverse event: Irritability
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 36 at risk

Adverse event: Restlessness
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 36 at risk

Adverse event: Shaky
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 36 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 36 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: General disorders
Frequency: 5 affected / 36 at risk

Adverse event: Rhinitis
Serious: no
Organ System: General disorders
Frequency: 4 affected / 36 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: General disorders
Frequency: 10 affected / 36 at risk

Adverse event: Yawning
Serious: no
Organ System: General disorders
Notes: Excessively
Frequency: 4 affected / 36 at risk

Adverse event: Piloerection
Serious: no
Organ System: General disorders
Frequency: 4 affected / 36 at risk

Adverse event: Sweat Increased
Serious: no
Organ System: General disorders
Frequency: 5 affected / 36 at risk

Adverse event: Hot flush
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 36 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Frequency: 8 affected / 36 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 17 affected / 36 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 4 affected / 36 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 10 affected / 36 at risk

Adverse event: Lethargy
Serious: no
Organ System: General disorders
Notes: stupor or coma from disease
Frequency: 3 affected / 36 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: uneasiness or indisposition
Frequency: 2 affected / 36 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 36 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 36 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: High heart rate
Frequency: 9 affected / 36 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 36 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 36 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 36 at risk

Adverse event: Flatulance
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 36 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 36 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 36 at risk

Adverse event: Vomitting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 36 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: pain in joint
Frequency: 5 affected / 36 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 36 at risk

Adverse event: Cramp Lower Extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 36 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 36 at risk

Adverse event: Pain Lower Extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 36 at risk

Adverse event: Agitation
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 36 at risk

Adverse event: Anxiety
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 36 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 36 at risk

Adverse event: Fatigue
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 36 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 36 at risk

Adverse event: Irritability
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 36 at risk

Adverse event: Restlessness
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 36 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 36 at risk

Adverse event: Cough
Serious: no
Organ System: General disorders
Notes: non-productive
Frequency: 2 affected / 36 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: General disorders
Frequency: 6 affected / 36 at risk

Adverse event: Rhinitis
Serious: no
Organ System: General disorders
Frequency: 2 affected / 36 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: General disorders
Frequency: 10 affected / 36 at risk

Adverse event: Yawning
Serious: no
Organ System: General disorders
Notes: Excessively
Frequency: 6 affected / 36 at risk

Adverse event: Piloerection
Serious: no
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: Sweat Increased
Serious: no
Organ System: General disorders
Frequency: 6 affected / 36 at risk

Adverse event: Hot flush
Serious: no
Organ System: Eye disorders
Frequency: 8 affected / 36 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 36 at risk