Study: NCT02420015

Adverse event: Hospitalisation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 21 at risk

Adverse event: Suicidal ideation
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 21 at risk

Adverse event: Mouth and/or throat irritation
Serious: no
Organ System: General disorders
Notes: study-related
Frequency: 3 affected / 21 at risk

Adverse event: Jitteriness, shakiness
Serious: no
Organ System: Nervous system disorders
Notes: Related to bupropion use
Frequency: 2 affected / 21 at risk

Adverse event: Sleep problems and/or nightmares
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 21 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Related to nicotine patch use
Frequency: 2 affected / 21 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Related to quitting smoking
Frequency: 1 affected / 21 at risk

Adverse event: Family violence
Serious: no
Organ System: Social circumstances
Notes: Not related to study participation
Frequency: 2 affected / 21 at risk

Adverse event: Increased psychiatric symptoms
Serious: no
Organ System: Psychiatric disorders
Notes: Not related to study procedures, includes increased hallucinations and/or depressed mood
Frequency: 1 affected / 21 at risk

Adverse event: Nausea, upset stomach
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 21 at risk

Adverse event: Influenza
Serious: no
Organ System: General disorders
Notes: Not study related
Frequency: 2 affected / 21 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 21 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Car accident
Serious: no
Organ System: Social circumstances
Frequency: 1 affected / 21 at risk

Adverse event: Increased foot pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Related to pre-existing medical conditions
Frequency: 1 affected / 21 at risk

Adverse event: Benign tumor removed from lung
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Pre-existing medical condition
Frequency: 1 affected / 21 at risk

Adverse event: Dental surgery
Serious: no
Organ System: Surgical and medical procedures
Notes: Related to pre-existing medical condition
Frequency: 1 affected / 21 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Related to pre-existing medical condition
Frequency: 1 affected / 21 at risk

Adverse event: Increased seizures
Serious: no
Organ System: Nervous system disorders
Notes: Related to pre-existing medical condition
Frequency: 1 affected / 21 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 13 at risk

Adverse event: Suicidal ideation
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 13 at risk

Adverse event: Mouth and/or throat irritation
Serious: no
Organ System: General disorders
Notes: study-related
Frequency: 2 affected / 13 at risk

Adverse event: Altercation with police
Serious: no
Organ System: Social circumstances
Frequency: 1 affected / 13 at risk

Adverse event: Jitteriness, shakiness
Serious: no
Organ System: Nervous system disorders
Notes: Related to bupropion use
Frequency: 1 affected / 13 at risk

Adverse event: Sleep problems and/or nightmares
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 13 at risk

Adverse event: Sexual abuse
Serious: no
Organ System: Social circumstances
Notes: Not related to study participation
Frequency: 1 affected / 13 at risk

Adverse event: Increased psychiatric symptoms
Serious: no
Organ System: Psychiatric disorders
Notes: Not related to study procedures, includes increased hallucinations and/or depressed mood
Frequency: 1 affected / 13 at risk

Adverse event: Nausea, upset stomach
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 13 at risk

Adverse event: Influenza
Serious: no
Organ System: General disorders
Notes: Not study related
Frequency: 1 affected / 13 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 13 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 13 at risk

Adverse event: Death in family
Serious: no
Organ System: Social circumstances
Frequency: 1 affected / 13 at risk

Adverse event: Eye infection
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 13 at risk

Adverse event: Increased foot pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Related to pre-existing medical conditions
Frequency: 1 affected / 13 at risk

Adverse event: Swelling in leg
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Related to pre-existing medical condition
Frequency: 1 affected / 13 at risk