Study: NCT03247322

Adverse event: GI Dysfunction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 68 at risk

Adverse event: Musculoskeletal disorder
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 68 at risk

Adverse event: Respiratory disorder
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 68 at risk

Adverse event: Abnormal Vital Signs
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 68 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 59 affected / 68 at risk

Adverse event: Ear disorders
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 68 at risk

Adverse event: Eye disorder
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 68 at risk

Adverse event: Gastrointestinal Disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 30 affected / 68 at risk

Adverse event: Procedural complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 68 at risk

Adverse event: Laboratory Abnormality
Serious: no
Organ System: Investigations
Frequency: 64 affected / 68 at risk

Adverse event: Metabolic acidosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 68 at risk

Adverse event: Musculoskeletal disorder
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 13 affected / 68 at risk

Adverse event: Nervous system disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 23 affected / 68 at risk

Adverse event: Psychiatric Disorders
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 68 at risk

Adverse event: Respiratory disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 68 at risk

Adverse event: Skin disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 68 at risk

Adverse event: GI Dysfunction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 68 at risk

Adverse event: Laboratory abnormality
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 68 at risk

Adverse event: General Disorder
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 68 at risk

Adverse event: Metabolic acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 68 at risk

Adverse event: Musculoskeletal disorder
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 68 at risk

Adverse event: Nervous system disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 68 at risk

Adverse event: Psychiatric Disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 68 at risk

Adverse event: Respiratory disorder
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 68 at risk

Adverse event: Abnormal Vital Signs
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 68 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 63 affected / 68 at risk

Adverse event: Ear disorders
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 68 at risk

Adverse event: Eye disorder
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 68 at risk

Adverse event: Gastrointestinal Disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 29 affected / 68 at risk

Adverse event: Laboratory Abnormality
Serious: no
Organ System: Investigations
Frequency: 64 affected / 68 at risk

Adverse event: Musculoskeletal disorder
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 68 at risk

Adverse event: Nervous system disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 19 affected / 68 at risk

Adverse event: Psychiatric Disorders
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 68 at risk

Adverse event: Respiratory disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 68 at risk

Adverse event: Skin disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 68 at risk