Study: NCT01393392

Adverse event: cough up blood
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: General disorders
Frequency: 2 affected / 44 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 2 affected / 44 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 44 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 44 at risk

Adverse event: increased alcohol use
Serious: no
Organ System: General disorders
Frequency: 1 affected / 44 at risk

Adverse event: itching/irritation at patch site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 44 at risk

Adverse event: jittery/agitated/irritable
Serious: no
Organ System: General disorders
Frequency: 4 affected / 44 at risk

Adverse event: Tooth infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 44 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 3 affected / 44 at risk

Adverse event: Abnormal dreams
Serious: no
Organ System: General disorders
Frequency: 2 affected / 44 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: General disorders
Frequency: 1 affected / 44 at risk

Adverse event: chest discomfort/pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 44 at risk

Adverse event: Increased appetite
Serious: no
Organ System: General disorders
Frequency: 1 affected / 44 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 44 at risk

Adverse event: Extremely high expired carbon monoxide level
Serious: no
Organ System: General disorders
Frequency: 1 affected / 44 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: sores on tongue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 44 at risk

Adverse event: Suicidal ideation
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 44 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: insomnia/restless sleep
Serious: no
Organ System: General disorders
Frequency: 2 affected / 44 at risk

Adverse event: Vertigo
Serious: no
Organ System: General disorders
Frequency: 2 affected / 44 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 44 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 44 at risk

Adverse event: Cough
Serious: no
Organ System: General disorders
Frequency: 1 affected / 44 at risk

Adverse event: Death
Serious: yes
Organ System: Renal and urinary disorders
Notes: Death related to pre-existing kidney disease.
Frequency: 1 affected / 43 at risk

Adverse event: Appendicitis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 43 at risk