Study: NCT01012622

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 66 affected / 136 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 51 affected / 136 at risk

Adverse event: Decreased interest
Serious: no
Organ System: Psychiatric disorders
Frequency: 41 affected / 136 at risk

Adverse event: Communication disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 37 affected / 136 at risk

Adverse event: Onychophagia
Serious: no
Organ System: Psychiatric disorders
Frequency: 37 affected / 136 at risk

Adverse event: Daydreaming
Serious: no
Organ System: Psychiatric disorders
Frequency: 31 affected / 136 at risk

Adverse event: Nightmare
Serious: no
Organ System: Psychiatric disorders
Frequency: 21 affected / 136 at risk

Adverse event: Depressed mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 18 affected / 136 at risk

Adverse event: Tic
Serious: no
Organ System: Psychiatric disorders
Frequency: 11 affected / 136 at risk

Adverse event: Nervousness
Serious: no
Organ System: Psychiatric disorders
Frequency: 9 affected / 136 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 136 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 136 at risk

Adverse event: Hostility
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 136 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 136 at risk

Adverse event: Euphoric mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 136 at risk

Adverse event: Acute stress disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 136 at risk

Adverse event: Logorrhoea
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 136 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 82 affected / 136 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 43 affected / 136 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 136 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 136 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 136 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 136 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 136 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 41 affected / 136 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 32 affected / 136 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 19 affected / 136 at risk

Adverse event: Movement disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 136 at risk

Adverse event: Hypersomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 136 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 136 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 136 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 136 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 136 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 136 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 136 at risk

Adverse event: Otitis media chronic
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 136 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 136 at risk

Adverse event: Varicella
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 136 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 136 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 136 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 136 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 136 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 136 at risk

Adverse event: Excessive eye blinking
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 136 at risk

Adverse event: Eye pain
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 136 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 136 at risk

Adverse event: Crying
Serious: no
Organ System: General disorders
Frequency: 1 affected / 136 at risk

Adverse event: Inflammation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 136 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 1 affected / 136 at risk

Adverse event: Ear malformation
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 136 at risk

Adverse event: Ventricular septal defect
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 136 at risk

Adverse event: Enuresis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 136 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 136 at risk

Adverse event: Sneezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 136 at risk

Adverse event: Deafness neurosensory
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 136 at risk

Adverse event: Scratch
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 136 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 136 at risk

Adverse event: Depilation
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 136 at risk