Study: NCT03822871

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Notes: Number of patients that experienced Grade 1 or 2
Frequency: 1 affected / 1 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Number of patients that experienced Grade 1 or 2
Frequency: 1 affected / 1 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Notes: Number of patients that experienced Grade 1 or 2
Frequency: 1 affected / 1 at risk

Adverse event: Dry heave
Serious: no
Organ System: Gastrointestinal disorders
Notes: Number of patients that experienced Grade 1 or 2
Frequency: 1 affected / 3 at risk

Adverse event: Abdominal malaise
Serious: no
Organ System: General disorders
Notes: Number of patients that experienced Grade 1 or 2
Frequency: 1 affected / 3 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Number of patients that experienced Grade 1 or 2
Frequency: 1 affected / 3 at risk

Adverse event: Decreased apetite
Serious: no
Organ System: Gastrointestinal disorders
Notes: Number of patients that experienced Grade 1 or 2
Frequency: 2 affected / 3 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Number of patients that experienced Grade 1 or 2
Frequency: 1 affected / 3 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Number of patients that experienced Grade 1 or 2
Frequency: 1 affected / 3 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Number of patients that experienced Grade 1 or 2
Frequency: 1 affected / 3 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Notes: Number of patients that experienced Grade 1 or 2
Frequency: 1 affected / 3 at risk

Adverse event: Grade 3 Syncope
Serious: yes
Organ System: General disorders
Notes: Unrelated to study drug. Met reporting criteria per protocol due to hospitalization.
Frequency: 1 affected / 4 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Number of patients that experienced Grade 1 or 2
Frequency: 1 affected / 4 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Number of patients that experienced Grade 1 or 2
Frequency: 1 affected / 4 at risk

Adverse event: Decreased apetite
Serious: no
Organ System: Gastrointestinal disorders
Notes: Number of patients that experienced Grade 1 or 2
Frequency: 1 affected / 4 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Number of patients that experienced Grade 1 or 2
Frequency: 1 affected / 4 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Number of patients that experienced Grade 1 or 2
Frequency: 1 affected / 4 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Number of patients that experienced Grade 1 or 2
Frequency: 1 affected / 4 at risk

Adverse event: Flank pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Number of patients that experienced Grade 1 or 2
Frequency: 1 affected / 4 at risk

Adverse event: Taste changes
Serious: no
Organ System: Gastrointestinal disorders
Notes: Number of patients that experienced Grade 1 or 2
Frequency: 1 affected / 4 at risk

Adverse event: Periorbital swelling
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Number of patients that experienced Grade 1 or 2
Frequency: 1 affected / 4 at risk

Adverse event: Intermittent bloating
Serious: no
Organ System: Gastrointestinal disorders
Notes: Number of patients that experienced Grade 1 or 2
Frequency: 1 affected / 4 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Number of patients that experienced Grade 1 or 2
Frequency: 1 affected / 4 at risk

Adverse event: Grade 3 Atrial Fibrillation with Rapid Ventricular Response
Serious: yes
Organ System: Cardiac disorders
Notes: Unrelated to study drug. Met reporting criteria per protocol due to hospitalization.
Frequency: 1 affected / 3 at risk

Adverse event: Grade 3 Pulmonary Edema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated to study drug. Met reporting criteria per protocol due to hospitalization.
Frequency: 1 affected / 3 at risk

Adverse event: Grade 3 Hyponatremia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Unrelated to study drug. Met reporting criteria per protocol due to hospitalization.
Frequency: 1 affected / 3 at risk

Adverse event: Grade 3 Cerebrovascular Accident
Serious: yes
Organ System: Nervous system disorders
Notes: Unrelated to study drug. Met reporting criteria per protocol due to hospitalization.
Frequency: 1 affected / 3 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Number of patients that experienced Grade 1 or 2
Frequency: 1 affected / 3 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Number of patients that experienced Grade 1 or 2
Frequency: 1 affected / 3 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Number of patients that experienced Grade 1 or 2
Frequency: 1 affected / 3 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Number of patients that experienced Grade 1 or 2
Frequency: 1 affected / 3 at risk

Adverse event: Blood urine present
Serious: no
Organ System: Renal and urinary disorders
Notes: Number of patients that experienced Grade 1 or 2
Frequency: 1 affected / 3 at risk

Adverse event: Vomitting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Number of patients that experienced Grade 1 or 2
Frequency: 1 affected / 3 at risk

Adverse event: Grade 3 Fall
Serious: yes
Organ System: General disorders
Notes: Unrelated to study drug. Met reporting criteria per protocol due to hospitalization.
Frequency: 1 affected / 3 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Notes: Number of patients that experienced Grade 1 or 2
Frequency: 1 affected / 3 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Number of patients that experienced Grade 1 or 2
Frequency: 1 affected / 3 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Number of patients that experienced Grade 1 or 2
Frequency: 1 affected / 1 at risk