TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02263326

Adverse event: Grade 4 viral syndrome
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 44 at risk

Adverse event: Grade 4 myocardial infarctions
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 45 at risk

Adverse event: Grade 3 bilirubinemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 45 at risk
Study: NCT02263547

Adverse event: Anticipated Adverse events
Serious: no
Organ System: Gastrointestinal disorders
Notes: nausea, diarrhea, abdominal discomfort, heartburn
Frequency: 11 affected / 14 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 14 at risk
Study: NCT02263729

Adverse event: Hamstring reinjury
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 3 at risk
Study: NCT02263833

Adverse event: Atrioventricular block
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 742 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 742 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 742 at risk
Study: NCT02263885

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Notes: A subject experienced a stroke 2 years post-treatment. The DSMB adjudicated the stroke as unrelated to the device or procedure.
Frequency: 1 affected / 20 at risk

Adverse event: Contusion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Bruise unrelated to device or procedure
Frequency: 2 affected / 20 at risk

Adverse event: Facial Edema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Edema related to stereotactic frame
Frequency: 3 affected / 20 at risk

Adverse event: Drooling
Serious: no
Organ System: General disorders
Notes: Drooling related to Parkinson's Disease
Frequency: 2 affected / 20 at risk

Adverse event: Dyskinesia
Serious: no
Organ System: Nervous system disorders
Notes: Dyskinesia related to Parkinson's Disease
Frequency: 2 affected / 20 at risk

Adverse event: Nausea/Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Tranient nausea/vomiting, resolving within 72 hours of treatment
Frequency: 3 affected / 20 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: Transient headache, resolving within 72 hours of treatment
Frequency: 3 affected / 20 at risk

Adverse event: Sonication Related Head Pain
Serious: no
Organ System: General disorders
Notes: Transient sonication related head pain, resolving within 72 hours of treatment.
Frequency: 7 affected / 20 at risk

Adverse event: Fine Motor Problems
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 20 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: Procedure related headache
Frequency: 5 affected / 20 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: Procedure related anxiety
Frequency: 2 affected / 20 at risk

Adverse event: Dysarthria
Serious: no
Organ System: Nervous system disorders
Notes: Pallidotomy related dysarthria
Frequency: 4 affected / 20 at risk
Study: NCT02264210

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 63 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 63 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 63 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 25 affected / 63 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 63 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 7 affected / 63 at risk

Adverse event: Elevated ALT
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 63 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 5 affected / 63 at risk
Study: NCT02264353

Adverse event: Heart Burn
Serious: no
Organ System: Investigations
Notes: Subject reported "heart burn" and decided to quit after taking placebo.
Frequency: 1 affected / 41 at risk

Adverse event: Difficulty Falling Asleep
Serious: no
Organ System: Investigations
Notes: Subject reported difficulty falling asleep in laboratory after taking placebo.
Frequency: 1 affected / 41 at risk
Study: NCT02264821

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 22 affected / 63 at risk

Adverse event: Nausea and/or vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 63 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 31 affected / 63 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 23 affected / 61 at risk

Adverse event: Nausea and/or vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 61 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 35 affected / 61 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 30 affected / 58 at risk

Adverse event: Nausea and/or vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 58 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 21 affected / 58 at risk
Study: NCT02265224

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 48 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 48 at risk

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

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

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

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 48 at risk
Study: NCT02265367

Adverse event: Sleep / Energy Changes
Serious: no
Organ System: General disorders
Frequency: 16 affected / 52 at risk

Adverse event: Gastrointestinal Symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 52 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 9 affected / 52 at risk

Adverse event: Changes in Mood, Anxiety or Irritability Level
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 52 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 52 at risk

Adverse event: Excessive Sweating
Serious: no
Organ System: General disorders
Frequency: 3 affected / 52 at risk

Adverse event: Body aches / pains
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 52 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 3 affected / 52 at risk

Adverse event: Change in Appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 52 at risk

Adverse event: Cold / Seasonal Allergy Symptoms
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 52 at risk

Adverse event: Sleep / Energy Changes
Serious: no
Organ System: General disorders
Frequency: 12 affected / 51 at risk

Adverse event: Gastrointestinal Symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 51 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 8 affected / 51 at risk

Adverse event: Changes in Mood, Anxiety or Irritability Level
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 51 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 5 affected / 51 at risk

Adverse event: Excessive Sweating
Serious: no
Organ System: General disorders
Frequency: 3 affected / 51 at risk

Adverse event: Body aches / pains
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 51 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 2 affected / 51 at risk

Adverse event: Change in Appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 51 at risk

Adverse event: Cold / Seasonal Allergy Symptoms
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 51 at risk
Study: NCT02265913

Adverse event: Colon cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1357 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1357 at risk

Adverse event: Thyroid cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1357 at risk

Adverse event: Worsening Of Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1361 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1361 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1361 at risk

Adverse event: Right Forearm Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1361 at risk
Study: NCT02266004

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 9 at risk

Adverse event: fall at home
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: Fatigue
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 9 at risk
Study: NCT02266134

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 5 affected / 141 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 7 affected / 87 at risk

Adverse event: Death
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 87 at risk

Adverse event: Inappropriate Behavior Toward Staff
Serious: no
Organ System: Psychiatric disorders
Notes: e.g., threatening behavior/language
Frequency: 1 affected / 87 at risk
Study: NCT02266225

Adverse event: Infection in big toe secondary to diabetes
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Resulted in hospitalization
Frequency: 1 affected / 48 at risk

Adverse event: Worsening of COPD symptoms
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Resulted in hospitalization
Frequency: 1 affected / 48 at risk

Adverse event: Severe chest/abdominal pain
Serious: yes
Organ System: Cardiac disorders
Notes: Resulted in hospitalization
Frequency: 1 affected / 48 at risk

Adverse event: Diabetic episode
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Resulted in hospitalization
Frequency: 1 affected / 48 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Vascular disorders
Notes: Resulted in death
Frequency: 1 affected / 48 at risk

Adverse event: Heel pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Possibly related to the intervention
Frequency: 1 affected / 48 at risk

Adverse event: Hamstring strain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Possibly related to the intervention
Frequency: 1 affected / 48 at risk

Adverse event: Pneumonia/flu
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 48 at risk

Adverse event: Chronic leg pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 48 at risk

Adverse event: Fall-related injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 48 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 48 at risk

Adverse event: Racing heart rate
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 48 at risk

Adverse event: Strained rotator cuff
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 48 at risk

Adverse event: Hip tendonitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 48 at risk

Adverse event: Dementia diagnosis
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 48 at risk

Adverse event: Heel spur
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 48 at risk
Study: NCT02266342

Adverse event: Cardiac
Serious: yes
Organ System: Cardiac disorders
Frequency: 13 affected / 154 at risk

Adverse event: Neurological
Serious: yes
Organ System: Nervous system disorders
Frequency: 12 affected / 154 at risk

Adverse event: Pulmonary
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 154 at risk

Adverse event: Renal
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 6 affected / 154 at risk

Adverse event: Vascular
Serious: yes
Organ System: Vascular disorders
Frequency: 40 affected / 154 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Frequency: 24 affected / 154 at risk

Adverse event: Vascular
Serious: no
Organ System: Vascular disorders
Frequency: 24 affected / 154 at risk

Adverse event: Cardiac
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 154 at risk

Adverse event: Neurological
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 154 at risk

Adverse event: Renal
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 154 at risk

Adverse event: Pulmonary
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 154 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 5 affected / 154 at risk
Study: NCT02266381

Adverse event: Perioperative complications
Serious: no
Organ System: Surgical and medical procedures
Frequency: 17 affected / 147 at risk

Adverse event: Perioperative complications
Serious: no
Organ System: Surgical and medical procedures
Frequency: 31 affected / 145 at risk

Adverse event: Perioperative complications
Serious: no
Organ System: Surgical and medical procedures
Frequency: 20 affected / 146 at risk
Study: NCT02266433

Adverse event: Skin discolouration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: minor skin discoloration at the site of injection
Frequency: 1 affected / 127 at risk

Adverse event: Redness and itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: developed redness and an itch in an adjacent finger several minutes after injection which resolved without further issue
Frequency: 1 affected / 127 at risk
Study: NCT02266472

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 30 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 30 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk
Study: NCT02266706

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk

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

Adverse event: Infective pulmonary exacerbation of cystic fibrosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 3 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 3 at risk

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

Adverse event: Device related sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 5 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Skin exfoliation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 5 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 5 at risk

Adverse event: Device dislocation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Device leakage
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 7 at risk

Adverse event: Periorbital oedema
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 7 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 7 at risk

Adverse event: Weaning failure
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 7 at risk

Adverse event: Waist circumference increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 2 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 2 at risk

Adverse event: Hypokinesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 2 at risk

Adverse event: Metabolic acidosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 2 at risk
Study: NCT02266810

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Notes: not device related
Frequency: 1 affected / 80 at risk

Adverse event: Respiratory tract infection fungal
Serious: yes
Organ System: Infections and infestations
Notes: not device related
Frequency: 1 affected / 80 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Notes: not device related
Frequency: 1 affected / 80 at risk

Adverse event: Acute sinusitis
Serious: no
Organ System: Infections and infestations
Notes: not device related
Frequency: 12 affected / 80 at risk

Adverse event: Chronic sinusitis
Serious: no
Organ System: Infections and infestations
Notes: not device related
Frequency: 9 affected / 80 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: not device related
Frequency: 5 affected / 80 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: not device related
Frequency: 9 affected / 80 at risk

Adverse event: Presyncope
Serious: no
Organ System: Nervous system disorders
Notes: not device related
Frequency: 4 affected / 80 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: not device related
Frequency: 4 affected / 80 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Notes: not device-related
Frequency: 1 affected / 80 at risk

Adverse event: Acute sinusitis
Serious: no
Organ System: Infections and infestations
Notes: not device related
Frequency: 16 affected / 80 at risk

Adverse event: Chronic sinusitis
Serious: no
Organ System: Infections and infestations
Notes: not device related
Frequency: 4 affected / 80 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: not device related
Frequency: 4 affected / 80 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: not device related
Frequency: 5 affected / 80 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: not device related
Frequency: 1 affected / 80 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 80 at risk
Study: NCT02267135

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 51 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 51 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 51 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 51 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 51 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 51 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 51 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 46 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 46 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 46 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 46 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 96 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 96 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 96 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 96 at risk
Study: NCT02267187

Adverse event: Contusion
Serious: no
Organ System: Surgical and medical procedures
Frequency: 10 affected / 10 at risk