Study: NCT02082678

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 35 at risk

Adverse event: Bacterial parasite in gut
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 35 at risk

Adverse event: Leg swelling
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 35 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 35 at risk

Adverse event: Detoxification
Serious: yes
Organ System: Social circumstances
Frequency: 1 affected / 35 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Social circumstances
Notes: Overdose
Frequency: 1 affected / 35 at risk

Adverse event: Mania
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 35 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 35 at risk

Adverse event: Ulcerative keratitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 35 at risk

Adverse event: Spinal disk degeneration
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 35 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 35 at risk

Adverse event: Suicide ideation
Serious: yes
Organ System: Social circumstances
Frequency: 1 affected / 35 at risk

Adverse event: Prolonged QTc interval
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 35 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 35 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 35 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 35 at risk

Adverse event: Hot flush
Serious: no
Organ System: General disorders
Frequency: 1 affected / 35 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 35 at risk

Adverse event: Swollen feet
Serious: no
Organ System: General disorders
Frequency: 1 affected / 35 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 35 at risk

Adverse event: Cramping
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 35 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 35 at risk

Adverse event: Glaucoma
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 35 at risk

Adverse event: Suicidal ideation
Serious: no
Organ System: Social circumstances
Frequency: 1 affected / 35 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Social circumstances
Notes: Overdose
Frequency: 1 affected / 35 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 35 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 35 at risk

Adverse event: Suicide ideation
Serious: yes
Organ System: Social circumstances
Frequency: 1 affected / 35 at risk

Adverse event: Pain in finger and foot
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 35 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 1 affected / 35 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 35 at risk

Adverse event: Sedation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 35 at risk

Adverse event: Hallucination, auditory
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 35 at risk

Adverse event: Swollen feet
Serious: no
Organ System: General disorders
Frequency: 1 affected / 35 at risk

Adverse event: Dehydration
Serious: no
Organ System: General disorders
Frequency: 1 affected / 35 at risk

Adverse event: Suicidal ideation
Serious: no
Organ System: Social circumstances
Frequency: 1 affected / 35 at risk