Study: NCT01811940

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: One patient was hospitalized for 48 hours due to an exacerbation of preexisting asthma. Upon receiving treatment, the symptoms subsided. Hospitalization was not considered related to study procedures.
Frequency: 1 affected / 64 at risk

Adverse event: inpatient rehabilitation
Serious: yes
Organ System: General disorders
Notes: patient voluntarily entered an inpatient rehabilitation program.
Frequency: 1 affected / 64 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 9 affected / 64 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 12 affected / 64 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 64 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Cardiac disorders
Frequency: 10 affected / 64 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 64 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 10 affected / 64 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 7 affected / 64 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 64 at risk

Adverse event: muscle aches
Serious: no
Organ System: General disorders
Frequency: 5 affected / 64 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: General disorders
Frequency: 6 affected / 64 at risk

Adverse event: Anxiety
Serious: no
Organ System: General disorders
Frequency: 6 affected / 64 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 7 affected / 64 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 3 affected / 64 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 64 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 64 at risk

Adverse event: increased heart rate
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 64 at risk

Adverse event: inpatient rehabilitation
Serious: yes
Organ System: General disorders
Notes: patient voluntarily entered an inpatient rehabilitation program.
Frequency: 1 affected / 63 at risk

Adverse event: leg swelling/pain
Serious: yes
Organ System: General disorders
Notes: One participant presented to the ER with pain and swelling in both legs. He was admitted for 48 hours for observation in the hospital and treated with antibiotics.
Frequency: 1 affected / 63 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 10 affected / 63 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 6 affected / 63 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 63 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 63 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 63 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 3 affected / 63 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 6 affected / 63 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 63 at risk

Adverse event: muscle aches
Serious: no
Organ System: General disorders
Frequency: 7 affected / 63 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 63 at risk

Adverse event: Anxiety
Serious: no
Organ System: General disorders
Frequency: 4 affected / 63 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 3 affected / 63 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 7 affected / 63 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 63 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 63 at risk

Adverse event: increased heart rate
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 63 at risk