TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02143843

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 75 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 75 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 15 affected / 75 at risk

Adverse event: Punctate keratitis
Serious: no
Organ System: Eye disorders
Frequency: 12 affected / 75 at risk

Adverse event: Eye discharge
Serious: no
Organ System: Eye disorders
Frequency: 11 affected / 75 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 9 affected / 75 at risk

Adverse event: Eye pruritus
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 75 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 75 at risk

Adverse event: Foreign body sensation in eyes
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 75 at risk

Adverse event: Ocular discomfort
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 75 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 75 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Frequency: 9 affected / 75 at risk
Study: NCT02144233

Adverse event: Dental hypersensitivity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Dental hypersensitivity, treated using topic fluorides
Frequency: 3 affected / 39 at risk
Study: NCT02144714

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 63 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 63 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 63 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 63 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 63 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 63 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 63 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 63 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 63 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 63 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 63 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 63 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 63 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 63 at risk
Study: NCT02145260

Adverse event: NSTEMI non-ST segment elevation myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: NSTEMI non-ST segment elevation myocardial infarction
Frequency: 1 affected / 69 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 9 affected / 69 at risk

Adverse event: Hypertension (>180 mmHg)
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 69 at risk

Adverse event: Chest pain/myocardial infarction
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 69 at risk

Adverse event: Cramping
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 69 at risk

Adverse event: Other pain
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 69 at risk

Adverse event: post-operative bleed
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Post-operative bleed
Frequency: 1 affected / 70 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 70 at risk

Adverse event: Hypertension (>180 mmHg)
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 70 at risk

Adverse event: Chest pain/myocardial infarction
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 70 at risk

Adverse event: Cramping
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 70 at risk

Adverse event: Other pain
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 70 at risk
Study: NCT02145351

Adverse event: Chest discomfort/palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 29 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 29 at risk

Adverse event: Worsening fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 29 at risk

Adverse event: Non pacemaker infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 29 at risk

Adverse event: Chest discomfort/palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 29 at risk

Adverse event: Worsening fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 29 at risk

Adverse event: Non pacemaker infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 29 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 32 at risk

Adverse event: Pacing lead induced tricuspid regurgitation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 32 at risk

Adverse event: Upper extremity deep venous thrombosis
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 32 at risk

Adverse event: Incision site reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 32 at risk
Study: NCT02145390

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

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

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

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

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1 at risk

Adverse event: Mucositis/stomatitis (functional/symptomatic)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1 at risk
Study: NCT02145429

Adverse event: Medical or Surgical Hospitalization
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 19 affected / 91 at risk

Adverse event: Medical or Surgical Hospitalization
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 5 affected / 90 at risk
Study: NCT02145507

Adverse event: Vasvagal reaction to blood donation (vascular access)
Serious: no
Organ System: Psychiatric disorders
Notes: Verbatim terms that fit into this category are: "Mild pallor \& complaining of 'getting warm'", "Lightheadedness", "After needle inserted, donor stated they 'felt weird'", "Vasovagal syncope", "Donor was light-headed and nauseous during donation".
Frequency: 1 affected / 82 at risk

Adverse event: Vasvagal reaction to blood donation (vascular access)
Serious: no
Organ System: Psychiatric disorders
Notes: Verbatim terms that fit into this category are: "Mild pallor \& complaining of 'getting warm'", "Lightheadedness", "After needle inserted, donor stated they 'felt weird'", "Vasovagal syncope", "Donor was light-headed and nauseous during donation".
Frequency: 4 affected / 88 at risk

Adverse event: Vasvagal reaction to blood donation (vascular access)
Serious: no
Organ System: Psychiatric disorders
Notes: Verbatim terms that fit into this category are: "Mild pallor \& complaining of 'getting warm'", "Lightheadedness", "After needle inserted, donor stated they 'felt weird'", "Vasovagal syncope", "Donor was light-headed and nauseous during donation".
Frequency: 1 affected / 82 at risk

Adverse event: Haematoma
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Refers in both cases to mild hematoma at the site of vascular access
Frequency: 2 affected / 82 at risk

Adverse event: Vasvagal reaction to blood donation (vascular access)
Serious: no
Organ System: Psychiatric disorders
Notes: Verbatim terms that fit into this category are: "Mild pallor \& complaining of 'getting warm'", "Lightheadedness", "After needle inserted, donor stated they 'felt weird'", "Vasovagal syncope", "Donor was light-headed and nauseous during donation".
Frequency: 1 affected / 88 at risk
Study: NCT02145949

Adverse event: Nausea
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 31 at risk

Adverse event: Nausea
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 36 at risk
Study: NCT02146105

Adverse event: Joint injury
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Painful ankle during the intervention period. Physician consultation revealed no fracture.
Frequency: 1 affected / 45 at risk
Study: NCT02146131

Adverse event: Adverse event
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Patient diagnosed with a pneumothorax orexcessive bleeding as a result of a standard of care bronchoscopy.
Frequency: 6 affected / 109 at risk

Adverse event: Adverse event
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Patient diagnosed with a pneumothorax orexcessive bleeding as a result of a standard of care bronchoscopy.
Frequency: 5 affected / 113 at risk
Study: NCT02146248

Adverse event: Pelvic pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 10 at risk
Study: NCT02146352

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 30 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Biliary Stricture
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 30 at risk

Adverse event: Bleeding post-AXIOS stent removal
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 30 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Chest pain/shortness of breath
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 30 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 30 at risk

Adverse event: Ascites
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Bleeding post-AXIOS stent removal
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 30 at risk

Adverse event: Blood urine present
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 30 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 30 at risk

Adverse event: Concussion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 30 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Lightheadedness/ dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pancreatic duct leak
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 30 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Spontaneous stent migration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Ulcer
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk
Study: NCT02146365

Adverse event: Malnutrition
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 50 at risk

Adverse event: Cerebral malaria
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 50 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 50 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 50 at risk

Adverse event: Malaria
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 50 at risk

Adverse event: Malaria
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 49 at risk

Adverse event: Malaria
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 50 at risk
Study: NCT02147132

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 7 at risk

Adverse event: Sneezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 7 at risk

Adverse event: Sinus congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: hot / cold flashes
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 6 at risk

Adverse event: difficulty hearing in right ear
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 6 at risk

Adverse event: bloodshot eyes
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 6 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 6 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 6 at risk
Study: NCT02147184

Adverse event: Multiple blood draws required
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 127 at risk

Adverse event: Dizziness
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 127 at risk

Adverse event: Syncope
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 127 at risk

Adverse event: Syncope
Serious: yes
Organ System: Cardiac disorders
Notes: Fainting during blood draw with convulsion. Neurology consult determined that it was a vasovagal reaction
Frequency: 1 affected / 137 at risk

Adverse event: Multiple blood draws required
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 17 affected / 137 at risk

Adverse event: Dizziness
Serious: no
Organ System: Cardiac disorders
Frequency: 9 affected / 137 at risk

Adverse event: Syncope
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 137 at risk
Study: NCT02147197

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 56 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 56 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 56 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 56 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 53 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 53 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 53 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 53 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Haemorrhoids
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 48 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 48 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 48 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 48 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 48 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 48 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 48 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 48 at risk
Study: NCT02147288

Adverse event: post-operative hematoma
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 22 at risk

Adverse event: Seroma
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 22 at risk

Adverse event: Wound dehiscence
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 22 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 22 at risk

Adverse event: post-operative hematoma
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 24 at risk

Adverse event: abcess with infected mesh
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 24 at risk

Adverse event: Seroma
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 24 at risk

Adverse event: Wound dehiscence
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 24 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 24 at risk

Adverse event: stitch absess
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 24 at risk
Study: NCT02147301

Adverse event: Hepatic failure
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 17 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 17 at risk

Adverse event: Oedema peripheral
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 17 at risk

Adverse event: Hyperbilirubinaemia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 17 at risk

Adverse event: AST elevation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 17 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 17 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 17 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 17 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 6 affected / 17 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 17 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 17 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 17 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 8 affected / 17 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 17 at risk

Adverse event: Hiccoughs
Serious: no
Organ System: General disorders
Frequency: 1 affected / 17 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 17 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 17 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 17 at risk

Adverse event: ALT elevation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 17 at risk

Adverse event: Creatinine elevation
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 17 at risk
Study: NCT02147353

Adverse event: local site reactions
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Local site reactions is any experienced mild to moderate local site reactions (erythema, edema, scaling, crusting, and erosion). these were not separated out.
Frequency: 21 affected / 21 at risk

Adverse event: local site reactions
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Local site reactions is any experienced mild to moderate local site reactions (erythema, edema, scaling, crusting, and erosion). these were not separated out.
Frequency: 21 affected / 21 at risk
Study: NCT02147522

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 178 at risk

Adverse event: Resided in a nursing home
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 178 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: revealed by family member who did not specify the cause
Frequency: 1 affected / 170 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 170 at risk
Study: NCT02147561

Adverse event: Haemoptysis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 279 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 279 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 279 at risk

Adverse event: Migraine
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 279 at risk

Adverse event: Nasopharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 279 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 24 affected / 279 at risk

Adverse event: Eyelid ptosis
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 279 at risk