Study: NCT04069156

Adverse event: Haemorrhage
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Site reported event terms were used for protocol defined adverse events.
Frequency: 68 affected / 296 at risk

Adverse event: Haemolysis
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Site reported event terms were used for protocol defined adverse events.
Frequency: 1 affected / 296 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Notes: Site reported event terms were used for protocol defined adverse events.
Frequency: 44 affected / 296 at risk

Adverse event: Right ventricular failure
Serious: yes
Organ System: Cardiac disorders
Notes: Site reported event terms were used for protocol defined adverse events.
Frequency: 12 affected / 296 at risk

Adverse event: Hepatic Dysfunction
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Site reported event terms were used for protocol defined adverse events.
Frequency: 6 affected / 296 at risk

Adverse event: Major Infection
Serious: yes
Organ System: Infections and infestations
Notes: Site reported event terms were used for protocol defined adverse events.
Frequency: 99 affected / 296 at risk

Adverse event: Neurologic Dysfunction
Serious: yes
Organ System: Nervous system disorders
Notes: Site reported event terms were used for protocol defined adverse events.
Frequency: 25 affected / 296 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Site reported event terms were used for protocol defined adverse events.
Frequency: 15 affected / 296 at risk

Adverse event: Renal Dysfunction
Serious: yes
Organ System: Renal and urinary disorders
Notes: Site reported event terms were used for protocol defined adverse events.
Frequency: 15 affected / 296 at risk

Adverse event: Embolism venous
Serious: yes
Organ System: Vascular disorders
Notes: Site reported event terms were used for protocol defined adverse events.
Frequency: 2 affected / 296 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Notes: Site reported event terms were used for protocol defined adverse events.
Frequency: 9 affected / 296 at risk

Adverse event: Blood And Lymphatic System Disorders
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Other events reported by MedDRA system organ classification.
Frequency: 3 affected / 296 at risk

Adverse event: Cardiac Disorders
Serious: yes
Organ System: Cardiac disorders
Notes: Other events reported by MedDRA system organ classification.
Frequency: 33 affected / 296 at risk

Adverse event: Ear And Labyrinth Disorders
Serious: yes
Organ System: Ear and labyrinth disorders
Notes: Other events reported by MedDRA system organ classification.
Frequency: 1 affected / 296 at risk

Adverse event: Endocrine Disorders
Serious: yes
Organ System: Endocrine disorders
Notes: Other events reported by MedDRA system organ classification.
Frequency: 3 affected / 296 at risk

Adverse event: Eye Disorders
Serious: yes
Organ System: Eye disorders
Notes: Other events reported by MedDRA system organ classification.
Frequency: 1 affected / 296 at risk

Adverse event: Gastrointestinal Disorders
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Other events reported by MedDRA system organ classification.
Frequency: 24 affected / 296 at risk

Adverse event: General Disorders And Administration Site Conditions
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Other events reported by MedDRA system organ classification.
Frequency: 31 affected / 296 at risk

Adverse event: Hepatobiliary Disorders
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Other events reported by MedDRA system organ classification.
Frequency: 1 affected / 296 at risk

Adverse event: Infections And Infestations
Serious: yes
Organ System: Infections and infestations
Notes: Other events reported by MedDRA system organ classification.
Frequency: 2 affected / 296 at risk

Adverse event: Injury, Poisoning And Procedural Complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Other events reported by MedDRA system organ classification.
Frequency: 15 affected / 296 at risk

Adverse event: Investigations
Serious: yes
Organ System: Investigations
Notes: Other events reported by MedDRA system organ classification.
Frequency: 14 affected / 296 at risk

Adverse event: Metabolism And Nutrition Disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Other events reported by MedDRA system organ classification.
Frequency: 32 affected / 296 at risk

Adverse event: Musculoskeletal And Connective Tissue Disorders
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Other events reported by MedDRA system organ classification.
Frequency: 4 affected / 296 at risk

Adverse event: Neoplasms Benign, Malignant And Unspecified (Incl Cysts And Polyps)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Other events reported by MedDRA system organ classification.
Frequency: 2 affected / 296 at risk

Adverse event: Nervous System Disorders
Serious: yes
Organ System: Nervous system disorders
Notes: Other events reported by MedDRA system organ classification.
Frequency: 22 affected / 296 at risk

Adverse event: Pregnancy, Puerperium And Perinatal Conditions
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Other events reported by MedDRA system organ classification.
Frequency: 1 affected / 296 at risk

Adverse event: Psychiatric Disorders
Serious: yes
Organ System: Psychiatric disorders
Notes: Other events reported by MedDRA system organ classification.
Frequency: 5 affected / 296 at risk

Adverse event: Renal And Urinary Disorders
Serious: yes
Organ System: Renal and urinary disorders
Notes: Other events reported by MedDRA system organ classification.
Frequency: 11 affected / 296 at risk

Adverse event: Respiratory, Thoracic And Mediastinal Disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Other events reported by MedDRA system organ classification.
Frequency: 25 affected / 296 at risk

Adverse event: Skin And Subcutaneous Tissue Disorders
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Other events reported by MedDRA system organ classification.
Frequency: 2 affected / 296 at risk

Adverse event: Surgical And Medical Procedures
Serious: yes
Organ System: Surgical and medical procedures
Notes: Other events reported by MedDRA system organ classification.
Frequency: 1 affected / 296 at risk

Adverse event: Vascular Disorders
Serious: yes
Organ System: Vascular disorders
Notes: Other events reported by MedDRA system organ classification.
Frequency: 22 affected / 296 at risk

Adverse event: Major Infection
Serious: no
Organ System: Infections and infestations
Notes: Site reported event terms were used for protocol defined adverse events.
Frequency: 94 affected / 296 at risk

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Notes: Site reported event terms were used for protocol defined adverse events.
Frequency: 8 affected / 296 at risk

Adverse event: Hepatic Dysfunction
Serious: no
Organ System: Hepatobiliary disorders
Notes: Site reported event terms were used for protocol defined adverse events.
Frequency: 5 affected / 296 at risk

Adverse event: Embolism venous
Serious: no
Organ System: Vascular disorders
Notes: Site reported event terms were used for protocol defined adverse events.
Frequency: 4 affected / 296 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Site reported event terms were used for protocol defined adverse events.
Frequency: 3 affected / 296 at risk

Adverse event: Renal Dysfunction
Serious: no
Organ System: Renal and urinary disorders
Notes: Site reported event terms were used for protocol defined adverse events.
Frequency: 3 affected / 296 at risk

Adverse event: Blood And Lymphatic System Disorders
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Other events reported by MedDRA system organ classification.
Frequency: 14 affected / 296 at risk

Adverse event: Cardiac Disorders
Serious: no
Organ System: Cardiac disorders
Notes: Other events reported by MedDRA system organ classification.
Frequency: 42 affected / 296 at risk

Adverse event: Eye Disorders
Serious: no
Organ System: Eye disorders
Notes: Other events reported by MedDRA system organ classification.
Frequency: 14 affected / 296 at risk

Adverse event: Gastrointestinal Disorders
Serious: no
Organ System: Gastrointestinal disorders
Notes: Other events reported by MedDRA system organ classification.
Frequency: 21 affected / 296 at risk

Adverse event: General Disorders And Administration Site Conditions
Serious: no
Organ System: General disorders
Notes: Other events reported by MedDRA system organ classification.
Frequency: 34 affected / 296 at risk

Adverse event: Hepatobiliary Disorders
Serious: no
Organ System: Hepatobiliary disorders
Notes: Other events reported by MedDRA system organ classification.
Frequency: 6 affected / 296 at risk

Adverse event: Infections And Infestations
Serious: no
Organ System: Infections and infestations
Notes: Other events reported by MedDRA system organ classification.
Frequency: 5 affected / 296 at risk

Adverse event: Injury, Poisoning And Procedural Complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Other events reported by MedDRA system organ classification.
Frequency: 20 affected / 296 at risk

Adverse event: Investigations
Serious: no
Organ System: Investigations
Notes: Other events reported by MedDRA system organ classification.
Frequency: 25 affected / 296 at risk

Adverse event: Metabolism And Nutrition Disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Other events reported by MedDRA system organ classification.
Frequency: 43 affected / 296 at risk

Adverse event: Musculoskeletal And Connective Tissue Disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Other events reported by MedDRA system organ classification.
Frequency: 19 affected / 296 at risk

Adverse event: Nervous System Disorders
Serious: no
Organ System: Nervous system disorders
Notes: Other events reported by MedDRA system organ classification.
Frequency: 40 affected / 296 at risk

Adverse event: Psychiatric Disorders
Serious: no
Organ System: Psychiatric disorders
Notes: Other events reported by MedDRA system organ classification.
Frequency: 16 affected / 296 at risk

Adverse event: Renal And Urinary Disorders
Serious: no
Organ System: Renal and urinary disorders
Notes: Other events reported by MedDRA system organ classification.
Frequency: 19 affected / 296 at risk

Adverse event: Reproductive System And Breast Disorders
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Other events reported by MedDRA system organ classification.
Frequency: 5 affected / 296 at risk

Adverse event: Respiratory, Thoracic And Mediastinal Disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Other events reported by MedDRA system organ classification.
Frequency: 25 affected / 296 at risk

Adverse event: Skin And Subcutaneous Tissue Disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Other events reported by MedDRA system organ classification.
Frequency: 15 affected / 296 at risk

Adverse event: Vascular Disorders
Serious: no
Organ System: Vascular disorders
Notes: Other events reported by MedDRA system organ classification.
Frequency: 36 affected / 296 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Site reported event terms were used for protocol defined adverse events.
Frequency: 100 affected / 293 at risk

Adverse event: Haemolysis
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Site reported event terms were used for protocol defined adverse events.
Frequency: 1 affected / 293 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Notes: Site reported event terms were used for protocol defined adverse events.
Frequency: 41 affected / 293 at risk

Adverse event: Right ventricular failure
Serious: yes
Organ System: Cardiac disorders
Notes: Site reported event terms were used for protocol defined adverse events.
Frequency: 6 affected / 293 at risk

Adverse event: Hepatic Dysfunction
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Site reported event terms were used for protocol defined adverse events.
Frequency: 4 affected / 293 at risk

Adverse event: Major Infection
Serious: yes
Organ System: Infections and infestations
Notes: Site reported event terms were used for protocol defined adverse events.
Frequency: 116 affected / 293 at risk

Adverse event: Neurologic Dysfunction
Serious: yes
Organ System: Nervous system disorders
Notes: Site reported event terms were used for protocol defined adverse events.
Frequency: 21 affected / 293 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Site reported event terms were used for protocol defined adverse events.
Frequency: 14 affected / 293 at risk

Adverse event: Renal Dysfunction
Serious: yes
Organ System: Renal and urinary disorders
Notes: Site reported event terms were used for protocol defined adverse events.
Frequency: 2 affected / 293 at risk

Adverse event: Embolism venous
Serious: yes
Organ System: Vascular disorders
Notes: Site reported event terms were used for protocol defined adverse events.
Frequency: 3 affected / 293 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Notes: Site reported event terms were used for protocol defined adverse events.
Frequency: 7 affected / 293 at risk

Adverse event: Blood And Lymphatic System Disorders
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Other events reported by MedDRA system organ classification.
Frequency: 4 affected / 293 at risk

Adverse event: Cardiac Disorders
Serious: yes
Organ System: Cardiac disorders
Notes: Other events reported by MedDRA system organ classification.
Frequency: 35 affected / 293 at risk

Adverse event: Endocrine Disorders
Serious: yes
Organ System: Endocrine disorders
Notes: Other events reported by MedDRA system organ classification.
Frequency: 2 affected / 293 at risk

Adverse event: Eye Disorders
Serious: yes
Organ System: Eye disorders
Notes: Other events reported by MedDRA system organ classification.
Frequency: 1 affected / 293 at risk

Adverse event: Gastrointestinal Disorders
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Other events reported by MedDRA system organ classification.
Frequency: 13 affected / 293 at risk

Adverse event: General Disorders And Administration Site Conditions
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Other events reported by MedDRA system organ classification.
Frequency: 24 affected / 293 at risk

Adverse event: Immune System Disorders
Serious: yes
Organ System: Immune system disorders
Notes: Other events reported by MedDRA system organ classification.
Frequency: 1 affected / 293 at risk

Adverse event: Infections And Infestations
Serious: yes
Organ System: Infections and infestations
Notes: Other events reported by MedDRA system organ classification.
Frequency: 3 affected / 293 at risk

Adverse event: Injury, Poisoning And Procedural Complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Other events reported by MedDRA system organ classification.
Frequency: 17 affected / 293 at risk

Adverse event: Investigations
Serious: yes
Organ System: Investigations
Notes: Other events reported by MedDRA system organ classification.
Frequency: 17 affected / 293 at risk

Adverse event: Metabolism And Nutrition Disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Other events reported by MedDRA system organ classification.
Frequency: 33 affected / 293 at risk

Adverse event: Musculoskeletal And Connective Tissue Disorders
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Other events reported by MedDRA system organ classification.
Frequency: 4 affected / 293 at risk

Adverse event: Neoplasms Benign, Malignant And Unspecified (Incl Cysts And Polyps)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Other events reported by MedDRA system organ classification.
Frequency: 4 affected / 293 at risk

Adverse event: Nervous System Disorders
Serious: yes
Organ System: Nervous system disorders
Notes: Other events reported by MedDRA system organ classification.
Frequency: 26 affected / 293 at risk

Adverse event: Psychiatric Disorders
Serious: yes
Organ System: Psychiatric disorders
Notes: Other events reported by MedDRA system organ classification.
Frequency: 2 affected / 293 at risk

Adverse event: Renal And Urinary Disorders
Serious: yes
Organ System: Renal and urinary disorders
Notes: Other events reported by MedDRA system organ classification.
Frequency: 8 affected / 293 at risk

Adverse event: Respiratory, Thoracic And Mediastinal Disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Other events reported by MedDRA system organ classification.
Frequency: 24 affected / 293 at risk

Adverse event: Skin And Subcutaneous Tissue Disorders
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Other events reported by MedDRA system organ classification.
Frequency: 1 affected / 293 at risk

Adverse event: Social Circumstances
Serious: yes
Organ System: Social circumstances
Notes: Other events reported by MedDRA system organ classification.
Frequency: 1 affected / 293 at risk

Adverse event: Surgical And Medical Procedures
Serious: yes
Organ System: Surgical and medical procedures
Notes: Other events reported by MedDRA system organ classification.
Frequency: 1 affected / 293 at risk

Adverse event: Vascular Disorders
Serious: yes
Organ System: Vascular disorders
Notes: Other events reported by MedDRA system organ classification.
Frequency: 20 affected / 293 at risk

Adverse event: Major Infection
Serious: no
Organ System: Infections and infestations
Notes: Site reported event terms were used for protocol defined adverse events.
Frequency: 92 affected / 293 at risk

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Notes: Site reported event terms were used for protocol defined adverse events.
Frequency: 11 affected / 293 at risk

Adverse event: Hepatic Dysfunction
Serious: no
Organ System: Hepatobiliary disorders
Notes: Site reported event terms were used for protocol defined adverse events.
Frequency: 6 affected / 293 at risk

Adverse event: Embolism venous
Serious: no
Organ System: Vascular disorders
Notes: Site reported event terms were used for protocol defined adverse events.
Frequency: 4 affected / 293 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Site reported event terms were used for protocol defined adverse events.
Frequency: 1 affected / 293 at risk

Adverse event: Blood And Lymphatic System Disorders
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Other events reported by MedDRA system organ classification.
Frequency: 10 affected / 293 at risk

Adverse event: Cardiac Disorders
Serious: no
Organ System: Cardiac disorders
Notes: Other events reported by MedDRA system organ classification.
Frequency: 23 affected / 293 at risk

Adverse event: Eye Disorders
Serious: no
Organ System: Eye disorders
Notes: Other events reported by MedDRA system organ classification.
Frequency: 2 affected / 293 at risk

Adverse event: Gastrointestinal Disorders
Serious: no
Organ System: Gastrointestinal disorders
Notes: Other events reported by MedDRA system organ classification.
Frequency: 18 affected / 293 at risk

Adverse event: General Disorders And Administration Site Conditions
Serious: no
Organ System: General disorders
Notes: Other events reported by MedDRA system organ classification.
Frequency: 21 affected / 293 at risk

Adverse event: Hepatobiliary Disorders
Serious: no
Organ System: Hepatobiliary disorders
Notes: Other events reported by MedDRA system organ classification.
Frequency: 1 affected / 293 at risk

Adverse event: Infections And Infestations
Serious: no
Organ System: Infections and infestations
Notes: Other events reported by MedDRA system organ classification.
Frequency: 3 affected / 293 at risk

Adverse event: Injury, Poisoning And Procedural Complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Other events reported by MedDRA system organ classification.
Frequency: 24 affected / 293 at risk

Adverse event: Investigations
Serious: no
Organ System: Investigations
Notes: Other events reported by MedDRA system organ classification.
Frequency: 29 affected / 293 at risk

Adverse event: Metabolism And Nutrition Disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Other events reported by MedDRA system organ classification.
Frequency: 33 affected / 293 at risk

Adverse event: Musculoskeletal And Connective Tissue Disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Other events reported by MedDRA system organ classification.
Frequency: 15 affected / 293 at risk

Adverse event: Nervous System Disorders
Serious: no
Organ System: Nervous system disorders
Notes: Other events reported by MedDRA system organ classification.
Frequency: 26 affected / 293 at risk

Adverse event: Psychiatric Disorders
Serious: no
Organ System: Psychiatric disorders
Notes: Other events reported by MedDRA system organ classification.
Frequency: 9 affected / 293 at risk

Adverse event: Renal And Urinary Disorders
Serious: no
Organ System: Renal and urinary disorders
Notes: Other events reported by MedDRA system organ classification.
Frequency: 8 affected / 293 at risk

Adverse event: Reproductive System And Breast Disorders
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Other events reported by MedDRA system organ classification.
Frequency: 1 affected / 293 at risk

Adverse event: Respiratory, Thoracic And Mediastinal Disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Other events reported by MedDRA system organ classification.
Frequency: 27 affected / 293 at risk

Adverse event: Skin And Subcutaneous Tissue Disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Other events reported by MedDRA system organ classification.
Frequency: 9 affected / 293 at risk

Adverse event: Vascular Disorders
Serious: no
Organ System: Vascular disorders
Notes: Other events reported by MedDRA system organ classification.
Frequency: 39 affected / 293 at risk