Study: NCT02332291

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Gastrointestinal bleeding requiring medical hospitalization
Frequency: 1 affected / 63 at risk

Adverse event: Dehydration
Serious: yes
Organ System: General disorders
Notes: Dehydration requiring hospital admission
Frequency: 1 affected / 63 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 63 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 63 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 63 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 63 at risk

Adverse event: Dizziness / Lightheaded
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 63 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 63 at risk

Adverse event: Anxiety / Tension
Serious: no
Organ System: Psychiatric disorders
Notes: New onset or worsening anxiety
Frequency: 2 affected / 63 at risk

Adverse event: Increased dreaming
Serious: no
Organ System: Psychiatric disorders
Notes: Lifelike or vivid dreams
Frequency: 3 affected / 63 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 2 affected / 63 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 8 affected / 63 at risk

Adverse event: Hot flush
Serious: no
Organ System: General disorders
Frequency: 1 affected / 63 at risk

Adverse event: Sexual dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 7 affected / 63 at risk

Adverse event: Appetite loss
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 63 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 63 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 63 at risk

Adverse event: Arthralgia / Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 63 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 63 at risk

Adverse event: Diplopia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 63 at risk

Adverse event: Stroke, ischemic
Serious: yes
Organ System: Nervous system disorders
Notes: Ischemic stroke, leading to medical hospitalization
Frequency: 1 affected / 32 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 1 affected / 32 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 32 at risk

Adverse event: Minor Environmental Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Minor injury reported not requiring medical care, such as superficial laceration
Frequency: 1 affected / 32 at risk

Adverse event: Dizziness / Lightheaded
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 32 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 32 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 32 at risk

Adverse event: Anxiety / Tension
Serious: no
Organ System: Psychiatric disorders
Notes: New onset or worsening anxiety
Frequency: 1 affected / 32 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 32 at risk

Adverse event: Edema, peripheral
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 32 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 32 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 32 at risk

Adverse event: Arthralgia / Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 32 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Notes: Development of pyelonephritis requiring medical hospital admission for intravenous antibiotics.
Frequency: 1 affected / 41 at risk

Adverse event: Irregular Heartbeat
Serious: no
Organ System: Cardiac disorders
Notes: Subjective irregular heartbeat
Frequency: 1 affected / 41 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 1 affected / 41 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 41 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 41 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 41 at risk

Adverse event: Minor Environmental Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Minor injury reported not requiring medical care, such as superficial laceration
Frequency: 1 affected / 41 at risk

Adverse event: Dizziness / Lightheaded
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 41 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 41 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 41 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 41 at risk

Adverse event: Anxiety / Tension
Serious: no
Organ System: Psychiatric disorders
Notes: New onset or worsening anxiety
Frequency: 8 affected / 41 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 41 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 41 at risk

Adverse event: Increased dreaming
Serious: no
Organ System: Psychiatric disorders
Notes: Lifelike or vivid dreams
Frequency: 3 affected / 41 at risk