Study: NCT01903005

Adverse event: Heroin toxicity
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Condition led to death; non-treatment-emergent; not related to study drug.
Frequency: 1 affected / 665 at risk

Adverse event: Hypertensive and atherosclerotic cardiovascular disease
Serious: yes
Organ System: Cardiac disorders
Notes: Condition led to death; non-treatment-emergent, not related to study drug.
Frequency: 1 affected / 665 at risk

Adverse event: Non-small cell lung cancer
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Moderate, treatment-emergent; not related to study drug.
Frequency: 1 affected / 665 at risk

Adverse event: Respiratory syncytial virus bronchitis
Serious: yes
Organ System: Infections and infestations
Notes: Moderate, treatment-emergent; not related to study drug.
Frequency: 1 affected / 665 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Notes: Mild, treatment-emergent; not related to study drug in one patient; severe, treatment-emergent; possibly related to study drug in another patient.
Frequency: 2 affected / 665 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Moderate, treatment-emergent; not related to study drug.
Frequency: 1 affected / 665 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Moderate, treatment-emergent; not related to study drug.
Frequency: 1 affected / 665 at risk

Adverse event: Anal abscess
Serious: yes
Organ System: Infections and infestations
Notes: Severe, treatment-emergent; unlikely related to study drug.
Frequency: 1 affected / 665 at risk

Adverse event: Arthropod bite
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Moderate, treatment-emergent; not related to study drug.
Frequency: 1 affected / 665 at risk

Adverse event: Overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Severe, treatment-emergent; not related to study drug.
Frequency: 1 affected / 665 at risk

Adverse event: Metabolic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Notes: Severe, treatment-emergent; not related to study drug.
Frequency: 1 affected / 665 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Notes: Severe, treatment-emergent; not related to study drug.
Frequency: 1 affected / 665 at risk

Adverse event: Multiple fractures
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Severe, treatment-emergent; not related to study drug.
Frequency: 1 affected / 665 at risk

Adverse event: Intentional overdose
Serious: yes
Organ System: Social circumstances
Notes: Severe, non-treatment-emergent; not related to study drug.
Frequency: 1 affected / 665 at risk

Adverse event: Worsening of opioid dependence
Serious: yes
Organ System: Psychiatric disorders
Notes: Moderate, non-treatment-emergent; not related to study drug in two patients.
Frequency: 2 affected / 665 at risk

Adverse event: Bipolar disorder
Serious: yes
Organ System: Psychiatric disorders
Notes: Severe, non-treatment-emergent; unlikely related to study drug.
Frequency: 1 affected / 665 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Treatment-emergent.
Frequency: 20 affected / 665 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Treatment-emergent.
Frequency: 21 affected / 665 at risk