Study: NCT00181883

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Notes: 1 subject was terminated due to a serious adverse event possibly related to study medication. The subject had an increase in underlying symptoms of bipolar disorder, experiencing passive suicidal ideation (also present before participation).
Frequency: 1 affected / 30 at risk

Adverse event: chin/elbow abrasions
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 30 at risk

Adverse event: injury (fall)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 30 at risk

Adverse event: Agitation
Serious: no
Organ System: General disorders
Frequency: 2 affected / 30 at risk

Adverse event: anxious/figety
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Vision blurred
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: General disorders
Frequency: 2 affected / 30 at risk

Adverse event: congested
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 30 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 30 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 3 affected / 30 at risk

Adverse event: Depressed mood
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: enlarged gland, right side of neck
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Enuresis
Serious: no
Organ System: General disorders
Frequency: 4 affected / 30 at risk

Adverse event: epistasis (nose bleeding)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 30 at risk

Adverse event: Influenza
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 4 affected / 30 at risk

Adverse event: Increased appetite
Serious: no
Organ System: General disorders
Frequency: 4 affected / 30 at risk

Adverse event: insect bite
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Lethargy
Serious: no
Organ System: General disorders
Frequency: 2 affected / 30 at risk

Adverse event: minor burn on arm
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: Pallor
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Perseveration
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Sedation
Serious: no
Organ System: General disorders
Frequency: 2 affected / 30 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 30 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 8 affected / 30 at risk

Adverse event: Dysarthria
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 30 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 30 at risk

Adverse event: Sunburn
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: teary
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: thirsty/dry mouth
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 6 affected / 30 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 30 at risk