Study: NCT03278067

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Notes: No MedDRA coding applied to this event
Frequency: 1 affected / 16433 at risk

Adverse event: Accidental fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: No MedDRA coding applied to this event
Frequency: 5 affected / 16433 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: No MedDRA coding applied to this event
Frequency: 1 affected / 16433 at risk

Adverse event: Transfusion
Serious: yes
Organ System: Surgical and medical procedures
Notes: No MedDRA coding applied to this event
Frequency: 1 affected / 16433 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: No MedDRA coding applied to this event
Frequency: 1 affected / 16433 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Notes: No MedDRA coding applied to this event
Frequency: 3 affected / 16433 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: No MedDRA coding applied to this event
Frequency: 1 affected / 16433 at risk

Adverse event: Fracture of bone
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: No MedDRA coding applied to this event
Frequency: 1 affected / 16433 at risk

Adverse event: Frail
Serious: yes
Organ System: General disorders
Notes: No MedDRA coding applied to this event
Frequency: 1 affected / 16433 at risk

Adverse event: Gynaecological
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: No MedDRA coding applied to this event
Frequency: 1 affected / 16433 at risk

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: No MedDRA coding applied to this event
Frequency: 1 affected / 16433 at risk

Adverse event: Infection of Chronic Wound
Serious: yes
Organ System: Infections and infestations
Notes: No MedDRA coding applied to this event
Frequency: 1 affected / 16433 at risk

Adverse event: Sensitivity Reaction
Serious: yes
Organ System: Immune system disorders
Notes: No MedDRA coding applied to this event
Frequency: 1 affected / 16433 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Notes: No MedDRA coding applied to this event
Frequency: 1 affected / 16433 at risk

Adverse event: Unknown, non-causal
Serious: yes
Organ System: General disorders
Notes: No MedDRA coding applied to this event
Frequency: 5 affected / 16433 at risk

Adverse event: Fever/pyrexia
Serious: no
Organ System: General disorders
Notes: No MedDRA coding applied to this event
Frequency: 70 affected / 16433 at risk

Adverse event: Local symptoms (i.e. local erythema)
Serious: no
Organ System: General disorders
Notes: No MedDRA coding applied to this event
Frequency: 264 affected / 16433 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: No MedDRA coding applied to this event
Frequency: 107 affected / 16433 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: No MedDRA coding applied to this event
Frequency: 249 affected / 16433 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: No MedDRA coding applied to this event
Frequency: 271 affected / 16433 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: No MedDRA coding applied to this event
Frequency: 41 affected / 16433 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: No MedDRA coding applied to this event
Frequency: 3 affected / 16433 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: No MedDRA coding applied to this event
Frequency: 53 affected / 16433 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: No MedDRA coding applied to this event
Frequency: 172 affected / 16433 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: No MedDRA coding applied to this event
Frequency: 318 affected / 16433 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: No MedDRA coding applied to this event
Frequency: 14 affected / 16433 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: No MedDRA coding applied to this event
Frequency: 104 affected / 16433 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: No MedDRA coding applied to this event
Frequency: 139 affected / 16433 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: No MedDRA coding applied to this event
Frequency: 219 affected / 16433 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: No MedDRA coding applied to this event
Frequency: 366 affected / 16433 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: No MedDRA coding applied to this event
Frequency: 81 affected / 16433 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Notes: No MedDRA coding applied to this event
Frequency: 73 affected / 16433 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: No MedDRA coding applied to this event
Frequency: 112 affected / 16433 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: No MedDRA coding applied to this event
Frequency: 118 affected / 16433 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: No MedDRA coding applied to this event
Frequency: 30 affected / 16433 at risk

Adverse event: Anaphylactic reactions
Serious: no
Organ System: Immune system disorders
Notes: No MedDRA coding applied to this event
Frequency: 45 affected / 16433 at risk

Adverse event: Facial oedema
Serious: no
Organ System: Immune system disorders
Notes: No MedDRA coding applied to this event
Frequency: 8 affected / 16433 at risk

Adverse event: Hypersensitivity reactions
Serious: no
Organ System: Immune system disorders
Notes: No MedDRA coding applied to this event
Frequency: 18 affected / 16433 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: No MedDRA coding applied to this event
Frequency: 74 affected / 16433 at risk

Adverse event: Arthropathy
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: No MedDRA coding applied to this event
Frequency: 143 affected / 16433 at risk

Adverse event: Muscle aches / myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: No MedDRA coding applied to this event
Frequency: 454 affected / 16433 at risk

Adverse event: Bell's palsy
Serious: no
Organ System: Nervous system disorders
Notes: No MedDRA coding applied to this event
Frequency: 1 affected / 16433 at risk

Adverse event: Peripheral tremor
Serious: no
Organ System: Nervous system disorders
Notes: No MedDRA coding applied to this event
Frequency: 26 affected / 16433 at risk

Adverse event: Seizure / Febrile convulsions
Serious: no
Organ System: Nervous system disorders
Notes: No MedDRA coding applied to this event
Frequency: 1 affected / 16433 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Notes: No MedDRA coding applied to this event
Frequency: 1 affected / 3310 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: No MedDRA coding applied to this event
Frequency: 1 affected / 3310 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Notes: No MedDRA coding applied to this event
Frequency: 1 affected / 3310 at risk

Adverse event: Fever/pyrexia
Serious: no
Organ System: General disorders
Notes: No MedDRA coding applied to this event
Frequency: 11 affected / 3310 at risk

Adverse event: Local symptoms (i.e. local erythema)
Serious: no
Organ System: General disorders
Notes: No MedDRA coding applied to this event
Frequency: 17 affected / 3310 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: No MedDRA coding applied to this event
Frequency: 7 affected / 3310 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: No MedDRA coding applied to this event
Frequency: 10 affected / 3310 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: No MedDRA coding applied to this event
Frequency: 23 affected / 3310 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: No MedDRA coding applied to this event
Frequency: 4 affected / 3310 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: No MedDRA coding applied to this event
Frequency: 3 affected / 3310 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: No MedDRA coding applied to this event
Frequency: 3 affected / 3310 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: No MedDRA coding applied to this event
Frequency: 12 affected / 3310 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: No MedDRA coding applied to this event
Frequency: 43 affected / 3310 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: No MedDRA coding applied to this event
Frequency: 5 affected / 3310 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: No MedDRA coding applied to this event
Frequency: 10 affected / 3310 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: No MedDRA coding applied to this event
Frequency: 12 affected / 3310 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: No MedDRA coding applied to this event
Frequency: 28 affected / 3310 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: No MedDRA coding applied to this event
Frequency: 13 affected / 3310 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Notes: No MedDRA coding applied to this event
Frequency: 6 affected / 3310 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: No MedDRA coding applied to this event
Frequency: 2 affected / 3310 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: No MedDRA coding applied to this event
Frequency: 4 affected / 3310 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: No MedDRA coding applied to this event
Frequency: 2 affected / 3310 at risk

Adverse event: Anaphylactic reactions
Serious: no
Organ System: Immune system disorders
Notes: No MedDRA coding applied to this event
Frequency: 7 affected / 3310 at risk

Adverse event: Hypersensitivity reactions
Serious: no
Organ System: Immune system disorders
Notes: No MedDRA coding applied to this event
Frequency: 2 affected / 3310 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: No MedDRA coding applied to this event
Frequency: 9 affected / 3310 at risk

Adverse event: Arthropathy
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: No MedDRA coding applied to this event
Frequency: 7 affected / 3310 at risk

Adverse event: Muscle aches / myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: No MedDRA coding applied to this event
Frequency: 18 affected / 3310 at risk

Adverse event: Peripheral tremor
Serious: no
Organ System: Nervous system disorders
Notes: No MedDRA coding applied to this event
Frequency: 2 affected / 3310 at risk

Adverse event: Seizure / Febrile convulsions
Serious: no
Organ System: Nervous system disorders
Notes: No MedDRA coding applied to this event
Frequency: 1 affected / 3310 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Notes: No MedDRA coding applied to this event
Frequency: 1 affected / 4196 at risk

Adverse event: Accidental fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: No MedDRA coding applied to this event
Frequency: 1 affected / 4196 at risk

Adverse event: Chronic Ear Infection
Serious: yes
Organ System: Infections and infestations
Notes: No MedDRA coding applied to this event
Frequency: 1 affected / 4196 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: No MedDRA coding applied to this event
Frequency: 1 affected / 4196 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: No MedDRA coding applied to this event
Frequency: 1 affected / 4196 at risk

Adverse event: Infection of Chronic Wound
Serious: yes
Organ System: Infections and infestations
Notes: No MedDRA coding applied to this event
Frequency: 1 affected / 4196 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: No MedDRA coding applied to this event
Frequency: 1 affected / 4196 at risk

Adverse event: Self Harm
Serious: yes
Organ System: Psychiatric disorders
Notes: No MedDRA coding applied to this event
Frequency: 1 affected / 4196 at risk

Adverse event: Unknown, non-causal
Serious: yes
Organ System: General disorders
Notes: No MedDRA coding applied to this event
Frequency: 1 affected / 4196 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Notes: No MedDRA coding applied to this event
Frequency: 1 affected / 4196 at risk

Adverse event: Fever/pyrexia
Serious: no
Organ System: General disorders
Notes: No MedDRA coding applied to this event
Frequency: 2 affected / 4196 at risk

Adverse event: Local symptoms (i.e. local erythema)
Serious: no
Organ System: General disorders
Notes: No MedDRA coding applied to this event
Frequency: 1 affected / 4196 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: No MedDRA coding applied to this event
Frequency: 3 affected / 4196 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: No MedDRA coding applied to this event
Frequency: 6 affected / 4196 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: No MedDRA coding applied to this event
Frequency: 5 affected / 4196 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: No MedDRA coding applied to this event
Frequency: 2 affected / 4196 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: No MedDRA coding applied to this event
Frequency: 22 affected / 4196 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: No MedDRA coding applied to this event
Frequency: 1 affected / 4196 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: No MedDRA coding applied to this event
Frequency: 3 affected / 4196 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: No MedDRA coding applied to this event
Frequency: 7 affected / 4196 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: No MedDRA coding applied to this event
Frequency: 3 affected / 4196 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: No MedDRA coding applied to this event
Frequency: 4 affected / 4196 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: No MedDRA coding applied to this event
Frequency: 1 affected / 4196 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: No MedDRA coding applied to this event
Frequency: 2 affected / 4196 at risk

Adverse event: Anaphylactic reactions
Serious: no
Organ System: Immune system disorders
Notes: No MedDRA coding applied to this event
Frequency: 1 affected / 4196 at risk

Adverse event: Hypersensitivity reactions
Serious: no
Organ System: Immune system disorders
Notes: No MedDRA coding applied to this event
Frequency: 1 affected / 4196 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: No MedDRA coding applied to this event
Frequency: 3 affected / 4196 at risk

Adverse event: Arthropathy
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: No MedDRA coding applied to this event
Frequency: 1 affected / 4196 at risk

Adverse event: Muscle aches / myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: No MedDRA coding applied to this event
Frequency: 15 affected / 4196 at risk

Adverse event: Seizure / Febrile convulsions
Serious: no
Organ System: Nervous system disorders
Notes: No MedDRA coding applied to this event
Frequency: 1 affected / 4196 at risk