Study: NCT02693691

Adverse event: Blood and lymphatic system disorders
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 239 at risk

Adverse event: Abnormal heart rate or rhythm
Serious: yes
Organ System: Cardiac disorders
Frequency: 43 affected / 239 at risk

Adverse event: Decompensated HF
Serious: yes
Organ System: Cardiac disorders
Frequency: 103 affected / 239 at risk

Adverse event: Other cardiac disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 57 affected / 239 at risk

Adverse event: Endocrine disorders
Serious: yes
Organ System: Endocrine disorders
Frequency: 9 affected / 239 at risk

Adverse event: Gastrointestinal disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 239 at risk

Adverse event: General disorders
Serious: yes
Organ System: General disorders
Frequency: 38 affected / 239 at risk

Adverse event: Hepatobiliary disorders
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 239 at risk

Adverse event: Immune system disorders
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 239 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 51 affected / 239 at risk

Adverse event: Other infections and infestations
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 239 at risk

Adverse event: Injury, poisoning, and procedural complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 19 affected / 239 at risk

Adverse event: Investigations
Serious: yes
Organ System: Investigations
Frequency: 6 affected / 239 at risk

Adverse event: Metabolism and nutrition disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 239 at risk

Adverse event: Neoplasms benign, malignant and unspecified (including cysts and polyps)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 239 at risk

Adverse event: Nervous system disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 239 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 34 affected / 239 at risk

Adverse event: Other renal and urinary disorders
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 239 at risk

Adverse event: Reproductive system and breast disorders
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 239 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 239 at risk

Adverse event: Skin and subcutaneous tissue disorders
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 239 at risk

Adverse event: Surgical and medical procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 239 at risk

Adverse event: Vascular disorders
Serious: yes
Organ System: Vascular disorders
Frequency: 17 affected / 239 at risk

Adverse event: Musculoskeletal and connective tissue disorders
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 239 at risk

Adverse event: Eye disorders
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 239 at risk