Study: NCT04113694

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 132 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 132 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 132 at risk

Adverse event: Complication of device removal
Serious: no
Organ System: General disorders
Frequency: 1 affected / 132 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 132 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 132 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 132 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 132 at risk

Adverse event: Diabetic ketosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 132 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 132 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 132 at risk

Adverse event: Foot fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 132 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 132 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 23 affected / 132 at risk

Adverse event: Incision site complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 132 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 132 at risk

Adverse event: Infusion site cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 132 at risk

Adverse event: Infusion site dermatitis
Serious: no
Organ System: General disorders
Frequency: 2 affected / 132 at risk

Adverse event: Infusion site discomfort
Serious: no
Organ System: General disorders
Frequency: 8 affected / 132 at risk

Adverse event: Infusion site erythema
Serious: no
Organ System: General disorders
Frequency: 2 affected / 132 at risk

Adverse event: Infusion site hypersensitivity
Serious: no
Organ System: General disorders
Frequency: 1 affected / 132 at risk

Adverse event: Infusion site infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 132 at risk

Adverse event: Infusion site nodule
Serious: no
Organ System: General disorders
Frequency: 1 affected / 132 at risk

Adverse event: Infusion site pain
Serious: no
Organ System: General disorders
Frequency: 4 affected / 132 at risk

Adverse event: Infusion site reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 132 at risk

Adverse event: Infusion site swelling
Serious: no
Organ System: General disorders
Frequency: 3 affected / 132 at risk

Adverse event: Infusion site vesicles
Serious: no
Organ System: General disorders
Frequency: 1 affected / 132 at risk

Adverse event: Medical device site discomfort
Serious: no
Organ System: General disorders
Frequency: 2 affected / 132 at risk

Adverse event: Medical device site erythema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 132 at risk

Adverse event: Medical device site nodule
Serious: no
Organ System: General disorders
Frequency: 1 affected / 132 at risk

Adverse event: Medical device site swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 132 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 132 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 132 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 132 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 132 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 132 at risk

Adverse event: Stress
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 132 at risk

Adverse event: Suspected COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 132 at risk

Adverse event: Tourette's disorder
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 132 at risk

Adverse event: Vertigo positional
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 132 at risk

Adverse event: Vulvovaginal mycotic infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 132 at risk

Adverse event: Tendon rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 127 at risk

Adverse event: Acute sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 127 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 127 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 127 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 127 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 127 at risk

Adverse event: Facial paralysis
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 127 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 127 at risk

Adverse event: Gingivitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 127 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 127 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 28 affected / 127 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 127 at risk

Adverse event: Infusion site bruising
Serious: no
Organ System: General disorders
Frequency: 2 affected / 127 at risk

Adverse event: Infusion site cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 127 at risk

Adverse event: Infusion site dermatitis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 127 at risk

Adverse event: Infusion site discomfort
Serious: no
Organ System: General disorders
Frequency: 6 affected / 127 at risk

Adverse event: Infusion site erythema
Serious: no
Organ System: General disorders
Frequency: 3 affected / 127 at risk

Adverse event: Infusion site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 1 affected / 127 at risk

Adverse event: Infusion site infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 127 at risk

Adverse event: Infusion site irritation
Serious: no
Organ System: General disorders
Frequency: 2 affected / 127 at risk

Adverse event: Infusion site nodule
Serious: no
Organ System: General disorders
Frequency: 2 affected / 127 at risk

Adverse event: Infusion site pain
Serious: no
Organ System: General disorders
Frequency: 4 affected / 127 at risk

Adverse event: Infusion site swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 127 at risk

Adverse event: Intervertebral disc protrusion
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 127 at risk

Adverse event: Limb injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 127 at risk

Adverse event: Medical device site cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 127 at risk

Adverse event: Medical device site discomfort
Serious: no
Organ System: General disorders
Frequency: 1 affected / 127 at risk

Adverse event: Medical device site erythema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 127 at risk

Adverse event: Medical device site irritation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 127 at risk

Adverse event: Medical device site oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 127 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 127 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 127 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 127 at risk

Adverse event: Onychomycosis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 127 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 127 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 127 at risk

Adverse event: Otitis externa
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 127 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 127 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 127 at risk

Adverse event: Pharyngitis streptococcal
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 127 at risk

Adverse event: Postoperative wound infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 127 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 127 at risk

Adverse event: Stress
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 127 at risk

Adverse event: Sunburn
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 127 at risk

Adverse event: Tooth abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 127 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 127 at risk

Adverse event: Varicose vein
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 127 at risk