TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01957553

Adverse event: pain in chest
Serious: yes
Organ System: Cardiac disorders
Notes: not related to device
Frequency: 1 affected / 124 at risk

Adverse event: rectal bleeding/inflammtion of the intestine
Serious: yes
Organ System: Gastrointestinal disorders
Notes: unlikely related to device
Frequency: 1 affected / 124 at risk

Adverse event: Sclerosing angiomatoid nodlar tranformation
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not related to device
Frequency: 1 affected / 124 at risk

Adverse event: A cystic lesion in operation area
Serious: yes
Organ System: Surgical and medical procedures
Notes: Not related to device
Frequency: 1 affected / 124 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Notes: Not related to device
Frequency: 1 affected / 124 at risk

Adverse event: peristomal skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The adverse events are related to the device. Related adverse events includes the adverse events in the categories 'unlikely related', possibly related', 'probably related' and 'definitely related'.
Frequency: 27 affected / 124 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not related to device
Frequency: 1 affected / 120 at risk

Adverse event: peristomal skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: The adverse events are related to the device. Related adverse events includes the adverse events in the categories 'unlikely related', possibly related', 'probably related' and 'definitely related'.
Frequency: 22 affected / 120 at risk
Study: NCT01957657

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 4 at risk
Study: NCT01957709

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Notes: Grade 1: all events
Frequency: 5 affected / 8 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Grade 1: 4 events Grade 2: 1 event
Frequency: 5 affected / 8 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: Grade 1: all events
Frequency: 4 affected / 8 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Grade 1: all events
Frequency: 4 affected / 8 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Grade 1: all events
Frequency: 2 affected / 8 at risk

Adverse event: Body Aches
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 1: all events
Frequency: 2 affected / 8 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Notes: Grade 1: all events
Frequency: 2 affected / 8 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Grade 1
Frequency: 1 affected / 8 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: Grade 1
Frequency: 1 affected / 8 at risk

Adverse event: Night sweats
Serious: no
Organ System: General disorders
Notes: Grade 1
Frequency: 1 affected / 8 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 1
Frequency: 1 affected / 8 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Grade 1
Frequency: 1 affected / 8 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Notes: Grade 1
Frequency: 1 affected / 8 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 1
Frequency: 1 affected / 8 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 1
Frequency: 1 affected / 8 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Notes: Grade 1
Frequency: 1 affected / 8 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1
Frequency: 1 affected / 8 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Grade 2
Frequency: 1 affected / 8 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: Grade 3
Frequency: 1 affected / 8 at risk

Adverse event: Biopsy site pain
Serious: no
Organ System: General disorders
Notes: Grade 2
Frequency: 1 affected / 8 at risk
Study: NCT01958112

Adverse event: Embolism
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 14 at risk

Adverse event: Large intestine perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Hypophosphataemia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 14 at risk

Adverse event: Retinal pigment epithelial detachment
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 14 at risk

Adverse event: Dermatitis acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 14 at risk
Study: NCT01958164

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 6 at risk
Study: NCT01958294

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Notes: SAEs were not reviewed by the independent Clinical Events Committee (CEC) because no MI Stroke or Death. Neither of these events was deemed to be related to the study device.
Frequency: 2 affected / 12 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 12 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 12 at risk

Adverse event: Myocardial infarction
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 12 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Procedural Complication (Transient Intolerance)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 12 at risk

Adverse event: Vascular procedure complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 12 at risk

Adverse event: Blood Troponin, CK or CK-MB Increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 12 at risk

Adverse event: Full blood count abnormal
Serious: no
Organ System: Investigations
Frequency: 2 affected / 12 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 12 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Right Arm Drift
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Transient ischaemic attack
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 12 at risk

Adverse event: Hemorrhage/Oozing
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 12 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 12 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 12 at risk
Study: NCT01958320

Adverse event: Necrotising colitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: NEC
Frequency: 17 affected / 104 at risk

Adverse event: Necrotising colitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: NEC
Frequency: 19 affected / 98 at risk
Study: NCT01958346

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 39 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 39 at risk
Study: NCT01958476

Adverse event: Hypothermia, apnea and lethargy
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 58 at risk

Adverse event: Medication Administration Error
Serious: yes
Organ System: Surgical and medical procedures
Notes: Includes "medication error by Registered Nurse (RN)", "missed dose by RN", "incorrect dose supplied by pharmacy", and "Delayed escalation doses by RN";
Frequency: 4 affected / 58 at risk

Adverse event: Apnea and shallow breathing episodes
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 58 at risk

Adverse event: Excessive sleepiness/somnolence
Serious: no
Organ System: Investigations
Frequency: 4 affected / 58 at risk

Adverse event: Hypothermia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 58 at risk

Adverse event: Stridor/desaturation/shalllow breathing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 58 at risk

Adverse event: Bradychardia
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 58 at risk

Adverse event: Medication Administration Error
Serious: yes
Organ System: Surgical and medical procedures
Notes: Includes "medication error by Registered Nurse (RN)", "missed dose by RN", "incorrect dose supplied by pharmacy", and "Delayed escalation doses by RN";
Frequency: 3 affected / 58 at risk

Adverse event: Excessive sleepiness/somnolence
Serious: no
Organ System: Investigations
Frequency: 2 affected / 58 at risk

Adverse event: Lethargy
Serious: no
Organ System: Investigations
Frequency: 1 affected / 58 at risk

Adverse event: Bradychardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 58 at risk

Adverse event: Feeding disorder
Serious: no
Organ System: Investigations
Frequency: 1 affected / 58 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 58 at risk
Study: NCT01958580

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 3
Frequency: 1 affected / 3 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Episodic. Grade 1-2
Frequency: 1 affected / 3 at risk

Adverse event: Skin hyperpigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 1
Frequency: 1 affected / 3 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Notes: Grade 1-2. Bilateral lower extremities
Frequency: 1 affected / 3 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 1
Frequency: 1 affected / 3 at risk

Adverse event: Nephropathy toxic
Serious: no
Organ System: Renal and urinary disorders
Notes: Grade 1
Frequency: 1 affected / 3 at risk

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

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 1
Frequency: 1 affected / 3 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 1
Frequency: 1 affected / 3 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Notes: Grade 1
Frequency: 1 affected / 3 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Grade 1
Frequency: 1 affected / 3 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 1
Frequency: 1 affected / 3 at risk
Study: NCT01958593

Adverse event: Emotional distress
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 2 at risk

Adverse event: Dissociation
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 2 at risk

Adverse event: Intentional self-injury
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 2 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Muscle tightness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 4 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 4 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 4 at risk

Adverse event: Depressed Moods
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 4 at risk

Adverse event: Emotional distress
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 4 at risk

Adverse event: Bruxism
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 4 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 4 at risk

Adverse event: Restlessness
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 4 at risk

Adverse event: Intentional self-injury
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 2 at risk

Adverse event: Concussion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2 at risk
Study: NCT01958606

Adverse event: Joint/muscle soreness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 13 at risk

Adverse event: Fatigue
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 13 at risk

Adverse event: Light-headedness
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 13 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 13 at risk

Adverse event: Fall
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 13 at risk

Adverse event: Other injury
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 13 at risk

Adverse event: Joint/muscle soreness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 5 at risk

Adverse event: Fall
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 5 at risk
Study: NCT01958619

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 15 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 15 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 14 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 14 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 14 at risk

Adverse event: Psoriasis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 14 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 14 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 14 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 14 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 14 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Feeling hot
Serious: no
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 12 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 12 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk
Study: NCT01958645

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 4 at risk

Adverse event: Fibrin D-dimer increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 4 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: Muscle contractions involuntary
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 4 at risk

Adverse event: Hypoaesthesia oral
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 4 at risk

Adverse event: Increased upper airway secretion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4 at risk
Study: NCT01959035

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 88 at risk

Adverse event: Alcoholism
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 88 at risk

Adverse event: Dysphoria
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 88 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 88 at risk
Study: NCT01959048

Adverse event: Death
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Five days post FMT patient fell from bed and sustained fracture of femur. Was not operated and died 11 days later.
Frequency: 1 affected / 3 at risk
Study: NCT01959204

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 97 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 97 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 97 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 97 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Frequency: 1 affected / 97 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 97 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 97 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 97 at risk

Adverse event: Drug Hypersenstivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 97 at risk

Adverse event: Alanine amniotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 97 at risk

Adverse event: Blood phosphorus decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 97 at risk

Adverse event: Haematocrit decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 97 at risk

Adverse event: Liver function test increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 97 at risk

Adverse event: Oxygen saturation decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 97 at risk

Adverse event: Red blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 97 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 97 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 97 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 97 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 97 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 97 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 97 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 97 at risk