TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT05439941

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 104 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 104 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 104 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 104 at risk

Adverse event: Hypertension Exacerbation
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 102 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 102 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 102 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 102 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 102 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 79 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 79 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 79 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 79 at risk
Study: NCT05442775

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 71 at risk

Adverse event: Assisted suicide
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 71 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 71 at risk

Adverse event: Gastric ulcer haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 71 at risk

Adverse event: Lower gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 71 at risk

Adverse event: Pneumoperitoneum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 71 at risk

Adverse event: Klebsiella urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 71 at risk

Adverse event: Metapneumovirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 71 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 71 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 71 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 71 at risk

Adverse event: Stress cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 71 at risk

Adverse event: Tibia fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 71 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 71 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 71 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 71 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 71 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 71 at risk
Study: NCT05444543

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 11 at risk

Adverse event: Ulcer of mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 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: 1 affected / 12 at risk
Study: NCT05445427

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

Adverse event: Muscle tightness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 8 at risk
Study: NCT05445557

Adverse event: Oedema
Serious: no
Organ System: General disorders
Notes: GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
Frequency: 11 affected / 12 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
Frequency: 12 affected / 12 at risk

Adverse event: Tenderness
Serious: no
Organ System: General disorders
Notes: GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
Frequency: 4 affected / 12 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 12 at risk

Adverse event: Ecchymosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 12 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 12 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 12 at risk

Adverse event: edema Open Label phase
Serious: no
Organ System: General disorders
Frequency: 9 affected / 9 at risk

Adverse event: pain open label phase
Serious: no
Organ System: General disorders
Frequency: 9 affected / 9 at risk

Adverse event: Tenderness - Open Label phase
Serious: no
Organ System: General disorders
Frequency: 2 affected / 9 at risk

Adverse event: Hypoesthesia Open Label phase
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 9 at risk

Adverse event: Erythema open label phase
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 9 at risk

Adverse event: Pruritus Open Label phase
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 9 at risk

Adverse event: Skin Hyperpigmentation open label phase
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 9 at risk

Adverse event: Skin irritation Open Label phase
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Notes: GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
Frequency: 12 affected / 12 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
Frequency: 12 affected / 12 at risk

Adverse event: Tenderness
Serious: no
Organ System: General disorders
Notes: GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
Frequency: 1 affected / 12 at risk

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

Adverse event: Ecchymosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 12 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 12 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 12 at risk
Study: NCT05445921

Adverse event: Horner syndrome
Serious: no
Organ System: Nervous system disorders
Frequency: 20 affected / 20 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 20 at risk

Adverse event: Globus
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 20 at risk

Adverse event: Brief lightheadedness
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 20 at risk

Adverse event: Numbness of the face
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 20 at risk

Adverse event: Mild shortness of breath
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 20 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: General disorders
Frequency: 3 affected / 20 at risk

Adverse event: Pain at the injection site
Serious: no
Organ System: General disorders
Frequency: 3 affected / 20 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 20 at risk

Adverse event: Cough
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Weakness of the arm
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Weakness of the neck/back
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Tightness of the back
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Arm heaviness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Bruising of the injection site
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Palpitations
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Tightness of the shoulder
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk
Study: NCT05446129

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

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

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

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

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

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

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

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

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

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

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1 at risk
Study: NCT05446168

Adverse event: GI Discomfort
Serious: no
Organ System: Gastrointestinal disorders
Notes: Related, mild, expected AE
Frequency: 7 affected / 14 at risk

Adverse event: Sleep Disruption
Serious: no
Organ System: Nervous system disorders
Notes: Unrelated, mild, unexpected AE
Frequency: 3 affected / 14 at risk

Adverse event: Shakiness/Dyskinesia
Serious: no
Organ System: Nervous system disorders
Notes: Unrelated, mild, unexpected AE
Frequency: 2 affected / 14 at risk

Adverse event: Limb injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated, mild, unexpected AE
Frequency: 1 affected / 14 at risk

Adverse event: Claustrophobia
Serious: no
Organ System: Psychiatric disorders
Notes: Unrelated, mild, unexpected AE
Frequency: 1 affected / 14 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Unrelated, mild, unexpected AE
Frequency: 4 affected / 14 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: Unrelated, mild, unexpected AE
Frequency: 2 affected / 14 at risk

Adverse event: Gait Disturbances
Serious: no
Organ System: Nervous system disorders
Notes: Unrelated, mild, unexpected AE
Frequency: 1 affected / 14 at risk

Adverse event: Leg Swelling
Serious: no
Organ System: Vascular disorders
Notes: Unrelated, mild, unexpected AE
Frequency: 1 affected / 14 at risk

Adverse event: High Blood Glucose
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Unrelated, mild, unexpected AE
Frequency: 1 affected / 14 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated, mild, unexpected AE
Frequency: 1 affected / 14 at risk

Adverse event: Behavioral Disturbance
Serious: no
Organ System: Psychiatric disorders
Notes: Unrelated, mild, unexpected AE
Frequency: 1 affected / 3 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Unrelated, mild, unexpected AE
Frequency: 1 affected / 3 at risk
Study: NCT05448950

Adverse event: pneumonia, requiring hospitalization
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Notes: Hematoma developed at needle puncture site (vascular access) on the AVG, causing damage to the AVG and necrosis in overlying skin. Treatment included excision of the mid-portion of the AVG.
Frequency: 1 affected / 12 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Notes: Subject had out of hospital cardiac arrest. CPR was provided and ROSC was obtained. Subject was transferred for comfort care, followed with subsequent death.
Frequency: 1 affected / 12 at risk

Adverse event: infection of AVG
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 12 at risk

Adverse event: abscess, tooth
Serious: yes
Organ System: Infections and infestations
Notes: abscess of tooth, subject hospitalized for treatment
Frequency: 1 affected / 12 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Notes: Subject had cardiac arrest while receiving hemodialysis. Despite resuscitation efforts, death occurred.
Frequency: 1 affected / 12 at risk

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

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Notes: The study protocol required that subjects with positive COVID-19 test be reported as an AE.
Frequency: 1 affected / 12 at risk

Adverse event: Inflammation
Serious: no
Organ System: General disorders
Notes: inflammation/redness at surgical incision site for AVG placement.
Frequency: 1 affected / 12 at risk

Adverse event: cancer, skin
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 12 at risk

Adverse event: bruising following a fall
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: bleeding, minor
Serious: no
Organ System: General disorders
Notes: minor bleeding at skin (incision) edge following AVG implantation procedure
Frequency: 1 affected / 12 at risk
Study: NCT05451329

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 11 affected / 23 at risk

Adverse event: Ocular hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 23 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 23 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 23 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 23 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 10 affected / 22 at risk

Adverse event: Ocular hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 22 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 22 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 22 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 22 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 23 at risk
Study: NCT05455086

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 20 at risk
Study: NCT05457491

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 56 at risk
Study: NCT05457647

Adverse event: Corneal opacity
Serious: no
Organ System: Eye disorders
Notes: Frequency of corneal haze was maximum at 1 month
Frequency: 6 affected / 50 at risk
Study: NCT05458024

Adverse event: Distressing thoughts related to MVC
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 36 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 36 at risk

Adverse event: Distressing thoughts related to MVC and depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 36 at risk

Adverse event: Distressing thoughts related to MVC
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 35 at risk

Adverse event: Distressing thoughts related to MVC and depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 35 at risk
Study: NCT05458102

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

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 15 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 13 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 13 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 13 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 13 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 13 at risk

Adverse event: Photophobia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 11 at risk

Adverse event: Photopsia
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 11 at risk

Adverse event: Visual impairment
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 11 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 11 at risk

Adverse event: Hallucination
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 11 at risk

Adverse event: Visual impairment
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 11 at risk

Adverse event: Photophobia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 11 at risk

Adverse event: Visual impairment
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 11 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Hallucination
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 11 at risk

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

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

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

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2 at risk

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

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 2 at risk

Adverse event: Cytokine release syndrome
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 2 at risk
Study: NCT05459558

Adverse event: Gingival pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 93 at risk

Adverse event: Gingival swelling
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 93 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 93 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 93 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 93 at risk

Adverse event: Traumatic ulcer
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 93 at risk

Adverse event: Angular cheilitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 92 at risk

Adverse event: Chapped lips
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 92 at risk

Adverse event: Lip dry
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 92 at risk

Adverse event: Lip exfoliation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 92 at risk

Adverse event: Lip pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 92 at risk

Adverse event: Lip ulceration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 92 at risk

Adverse event: Oral mucosal exfoliation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 92 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 92 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 92 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 92 at risk

Adverse event: Skin fissures
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 92 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 94 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 94 at risk