TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01518972

Adverse event: Experienced 1 adverse event
Serious: no
Organ System: General disorders
Notes: This adverse event can be dizziness on standing, headaches, lightheadedness, nausea, lack of energy, drowsiness, and blood pressure drop from sitting to standing.
Frequency: 2 affected / 14 at risk

Adverse event: Experienced 2 adverse events
Serious: no
Organ System: General disorders
Notes: This adverse event can be dizziness on standing, headaches, lightheadedness, nausea, lack of energy, drowsiness, and blood pressure drop from sitting to standing.
Frequency: 5 affected / 14 at risk

Adverse event: Experienced 3 adverse events
Serious: no
Organ System: General disorders
Notes: This adverse event can be dizziness on standing, headaches, lightheadedness, nausea, lack of energy, drowsiness, and blood pressure drop from sitting to standing.
Frequency: 7 affected / 14 at risk

Adverse event: Experienced 2 adverse events
Serious: no
Organ System: General disorders
Notes: This adverse event can be dizziness on standing, headaches, lightheadedness, nausea, lack of energy, drowsiness, and blood pressure drop from sitting to standing.
Frequency: 1 affected / 14 at risk

Adverse event: Experienced 3 adverse events
Serious: no
Organ System: General disorders
Notes: This adverse event can be dizziness on standing, headaches, lightheadedness, nausea, lack of energy, drowsiness, and blood pressure drop from sitting to standing.
Frequency: 9 affected / 14 at risk
Study: NCT01519063

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 47 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 46 at risk
Study: NCT01519167

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

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 89 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 89 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 89 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 89 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 89 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 89 at risk

Adverse event: Blood pressure diastolic decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 89 at risk

Adverse event: Blood pressure systolic decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 89 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 89 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 89 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 89 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 89 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 89 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 89 at risk

Adverse event: Respiratory depression
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 53 affected / 89 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 89 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 89 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 37 affected / 89 at risk
Study: NCT01519271

Adverse event: Blood pressure increased
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 26 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 4 affected / 26 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 26 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 9 affected / 26 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 26 at risk

Adverse event: Decreased Blood Pressure
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 26 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 26 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 26 at risk

Adverse event: Worse Balance
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 26 at risk

Adverse event: Hallucination, visual
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 26 at risk

Adverse event: Increased "off" time
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 26 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 3 affected / 26 at risk

Adverse event: Cognitive disorder
Serious: no
Organ System: General disorders
Frequency: 3 affected / 26 at risk

Adverse event: Depression
Serious: no
Organ System: General disorders
Frequency: 3 affected / 26 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Vascular disorders
Frequency: 8 affected / 28 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 5 affected / 28 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 28 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 11 affected / 28 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 28 at risk

Adverse event: Decreased Blood Pressure
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 28 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 4 affected / 28 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 28 at risk

Adverse event: Worse Balance
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 28 at risk

Adverse event: Hallucination, visual
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 28 at risk

Adverse event: Increased "off" time
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 28 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 1 affected / 28 at risk
Study: NCT01519453

Adverse event: Hospitalization due to asthma [child]
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 199 at risk

Adverse event: Hospitalization due to asthma [consented caregiver]
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 199 at risk

Adverse event: Psychosocial Event [consented caregiver]
Serious: no
Organ System: Social circumstances
Notes: Psychosocial events included call to child protective services due to young child left home unattended and a consented caregiver becoming very emotional and upset during survey due to past events.
Frequency: 2 affected / 199 at risk

Adverse event: Hospitalization due to asthma [child]
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 199 at risk

Adverse event: Non asthma related hospitalization [child]
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 199 at risk

Adverse event: Hospitalization due to asthma [consented caregiver]
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 199 at risk
Study: NCT01519466

Adverse event: Fractured Metacarpus
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 33 at risk

Adverse event: Sensor tip
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 33 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 33 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 33 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 3 affected / 33 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 33 at risk

Adverse event: Middle ear effusion
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 16 at risk

Adverse event: Gingiva abcess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 16 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 16 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 16 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk
Study: NCT01519713

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 60 affected / 194 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 5 affected / 194 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 2 affected / 194 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 30 affected / 194 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 48 affected / 194 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 194 at risk

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

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 2 affected / 2 at risk

Adverse event: Dental caries
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 4 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 3 affected / 4 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 3 affected / 4 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 4 at risk
Study: NCT01519778

Adverse event: Haemoptysis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 200 at risk

Adverse event: Thrombophlebitis septic
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 200 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 200 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 200 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 200 at risk

Adverse event: Abscess
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 200 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 200 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 200 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 200 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 4 affected / 200 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 200 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 200 at risk
Study: NCT01519882

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

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

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

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

Adverse event: Tension headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 1 at risk
Study: NCT01520038

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 2 at risk

Adverse event: Lymphocyte count decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 2 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 2 at risk

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

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2 at risk

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

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

Adverse event: Radiation skin injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2 at risk

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

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2 at risk

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

Adverse event: Anal incontinence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 2 at risk

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

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

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

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 2 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2 at risk

Adverse event: Proctalgia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Vaginal discharge
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 2 at risk

Adverse event: Vaginal haemorrhage
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 2 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 2 at risk
Study: NCT01520207

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Cramps
Frequency: 2 affected / 27 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Notes: HTN
Frequency: 10 affected / 27 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 27 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 27 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 27 at risk

Adverse event: Access issues
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 27 at risk

Adverse event: Oxygen Requirement
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 27 at risk

Adverse event: Confusional state
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 27 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Cramps
Frequency: 1 affected / 25 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Notes: HTN
Frequency: 9 affected / 25 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 25 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 25 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 25 at risk

Adverse event: Access issues
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 25 at risk

Adverse event: Oxygen Requirement
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 25 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 25 at risk

Adverse event: Confusional state
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 25 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 25 at risk
Study: NCT01520324

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Mild nausea for 6 subject s Moderate for 2 subjects
Frequency: 8 affected / 53 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Mild
Frequency: 1 affected / 53 at risk
Study: NCT01520363

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 24 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 24 at risk

Adverse event: Increased alkaline phosphatase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 24 at risk

Adverse event: Platelet count increased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 24 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 26 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 26 at risk

Adverse event: Increased alkaline phosphatase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 26 at risk

Adverse event: Platelet count increased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 26 at risk
Study: NCT01520532

Adverse event: Haemorrhage
Serious: yes
Organ System: Vascular disorders
Notes: Groin bleed requiring intervention (thrombin administration)
Frequency: 1 affected / 60 at risk

Adverse event: Groin Bleed
Serious: no
Organ System: Vascular disorders
Notes: Mild groin bleed at location of sheath insertion
Frequency: 11 affected / 60 at risk
Study: NCT01520688

Adverse event: Colds/viral illnesses
Serious: no
Organ System: General disorders
Frequency: 7 affected / 27 at risk

Adverse event: Headaches
Serious: no
Organ System: General disorders
Frequency: 2 affected / 27 at risk

Adverse event: Respiratory infections
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 27 at risk

Adverse event: Worsening allergies
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 27 at risk

Adverse event: Bodily injuries
Serious: no
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: Asthma exacerbation
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 27 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Colds/viral illnesses
Serious: no
Organ System: General disorders
Frequency: 6 affected / 27 at risk

Adverse event: Headaches
Serious: no
Organ System: General disorders
Frequency: 3 affected / 27 at risk

Adverse event: Respiratory infections
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 27 at risk

Adverse event: Bodily injuries
Serious: no
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: Colds/viral illnesses
Serious: no
Organ System: General disorders
Frequency: 7 affected / 27 at risk

Adverse event: Headaches
Serious: no
Organ System: General disorders
Frequency: 3 affected / 27 at risk

Adverse event: Worsening allergies
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 27 at risk

Adverse event: Ear infection
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 27 at risk

Adverse event: Sinusitis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 27 at risk
Study: NCT01520714

Adverse event: Pre-existing AF-AVNode ABL
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 11 at risk

Adverse event: Enteroccoccal Septicemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 11 at risk

Adverse event: LV lead dislodgement
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 11 at risk
Study: NCT01520727

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

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

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

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 6 at risk

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

Adverse event: Paraplegia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 16 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Orthostatic hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 16 at risk