Study: NCT04818229

Adverse event: Catheter site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 55 at risk

Adverse event: Catheter site bruise
Serious: no
Organ System: General disorders
Frequency: 1 affected / 55 at risk

Adverse event: Medical device site pruritus
Serious: no
Organ System: General disorders
Frequency: 2 affected / 55 at risk

Adverse event: Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 55 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 55 at risk

Adverse event: Medical device site dermatitis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 55 at risk

Adverse event: Medical device site irritation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 55 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 55 at risk

Adverse event: Medical device site erythema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 55 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 55 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Oropharyngeal discomfort
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 55 at risk

Adverse event: Catheter site irritation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 55 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 55 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 55 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 55 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 55 at risk

Adverse event: Electrocardiogram PR prolongation
Serious: no
Organ System: Investigations
Frequency: 1 affected / 55 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 55 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 55 at risk

Adverse event: Ear discomfort
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 55 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 55 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 55 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 50 at risk

Adverse event: Catheter site bruise
Serious: no
Organ System: General disorders
Frequency: 1 affected / 50 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 50 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Frequency: 1 affected / 50 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 50 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 50 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 50 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Sinus arrest
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 50 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 50 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 50 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 50 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 50 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 50 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 55 at risk

Adverse event: Catheter site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 55 at risk

Adverse event: Catheter site bruise
Serious: no
Organ System: General disorders
Frequency: 2 affected / 55 at risk

Adverse event: Medical device site dermatitis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 55 at risk

Adverse event: Catheter site irritation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 55 at risk

Adverse event: Medical device site irritation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 55 at risk

Adverse event: Medical device site pruritus
Serious: no
Organ System: General disorders
Frequency: 2 affected / 55 at risk

Adverse event: Medical device site reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 55 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 55 at risk

Adverse event: Application site vesicles
Serious: no
Organ System: General disorders
Frequency: 1 affected / 55 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 55 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Frequency: 1 affected / 55 at risk

Adverse event: Medical device site erythema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 55 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 55 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 55 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 55 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 55 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 55 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Oropharyngeal discomfort
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 55 at risk

Adverse event: Sinus arrest
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 55 at risk

Adverse event: Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 55 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 55 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 55 at risk

Adverse event: Hepatic enzyme increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 55 at risk

Adverse event: Electrocardiogram PR prolongation
Serious: no
Organ System: Investigations
Frequency: 1 affected / 55 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 55 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 55 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 55 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 55 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 55 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 55 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 55 at risk

Adverse event: Ear discomfort
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 55 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 55 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 55 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 55 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 55 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 57 at risk

Adverse event: Catheter site pain
Serious: no
Organ System: General disorders
Frequency: 4 affected / 57 at risk

Adverse event: Catheter site bruise
Serious: no
Organ System: General disorders
Frequency: 1 affected / 57 at risk

Adverse event: Medical device site dermatitis
Serious: no
Organ System: General disorders
Frequency: 2 affected / 57 at risk

Adverse event: Catheter site irritation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 57 at risk

Adverse event: Medical device site irritation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 57 at risk

Adverse event: Medical device site reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 57 at risk

Adverse event: Catheter site erythema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 57 at risk

Adverse event: Catheter site pruritus
Serious: no
Organ System: General disorders
Frequency: 1 affected / 57 at risk

Adverse event: Catheter site swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 57 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 57 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 57 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 57 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 57 at risk

Adverse event: Lethargy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 57 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 57 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 57 at risk

Adverse event: Sneezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 57 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 57 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 57 at risk

Adverse event: Ventricular arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 57 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 57 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 57 at risk

Adverse event: Abdominal pain lower
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 57 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 57 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 57 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 57 at risk

Adverse event: Joint stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 57 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 57 at risk

Adverse event: Hepatic enzyme increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 57 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 57 at risk

Adverse event: Onychoclasis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 57 at risk

Adverse event: Ear haemorrhage
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 57 at risk

Adverse event: Hyperacusis
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 57 at risk

Adverse event: Photophobia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 57 at risk

Adverse event: Disorientation
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 57 at risk