Study: NCT01908842

Adverse event: Worsening of pre-existing condition (foreign body in neck)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Serious adverse event reported during blinded induction phase.
Frequency: 1 affected / 383 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Serious adverse event reported during open-label maintenance phase.
Frequency: 1 affected / 383 at risk

Adverse event: Elevated Transaminases
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Serious adverse event reported during open-label maintenance phase.
Frequency: 1 affected / 383 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Adverse events reported during the blinded induction phase.
Frequency: 20 affected / 383 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adverse events reported during the blinded induction phase.
Frequency: 12 affected / 383 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adverse events reported during the blinded induction phase.
Frequency: 8 affected / 383 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adverse events reported during the blinded induction phase.
Frequency: 8 affected / 383 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: Adverse events reported during the blinded induction phase.
Frequency: 5 affected / 383 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: Adverse events reported during the blinded induction phase.
Frequency: 6 affected / 383 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adverse events reported during the blinded induction phase.
Frequency: 4 affected / 383 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Notes: Serious adverse event reported during blinded induction phase.
Frequency: 1 affected / 375 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Adverse events reported during the blinded induction phase.
Frequency: 19 affected / 375 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adverse events reported during the blinded induction phase.
Frequency: 11 affected / 375 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adverse events reported during the blinded induction phase.
Frequency: 15 affected / 375 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adverse events reported during the blinded induction phase.
Frequency: 2 affected / 375 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: Adverse events reported during the blinded induction phase.
Frequency: 4 affected / 375 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: Adverse events reported during the blinded induction phase.
Frequency: 2 affected / 375 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adverse events reported during the blinded induction phase.
Frequency: 3 affected / 375 at risk