TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01566526

Adverse event: Lenticular opacities
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 26 at risk

Adverse event: Ocular hypertension
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 26 at risk

Adverse event: Intraocular pressure increased
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 26 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 26 at risk

Adverse event: Cataract operation
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 26 at risk

Adverse event: Eye laser surgery
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 26 at risk

Adverse event: Macular fibrosis
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 26 at risk

Adverse event: Visual impairment
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 26 at risk
Study: NCT01566539

Adverse event: high blood pressure or heart rate post-drug administration
Serious: no
Organ System: Vascular disorders
Notes: Subjects experience high blood pressure (above 140/90) or heart rate (above 100 bpm) post drug administration. Per protocol, subjects rested for 5-10 minutes and blood pressure and heart rate was retaken. They returned normal. Study proceeded.
Frequency: 3 affected / 101 at risk

Adverse event: Epistaxis
Serious: no
Organ System: General disorders
Notes: subject experience nose bleed prior to drug administration, probably due to dry weather.
Frequency: 1 affected / 101 at risk

Adverse event: high blood pressure or heart rate post-drug administration
Serious: no
Organ System: Vascular disorders
Notes: Subjects experience high blood pressure (above 140/90) or heart rate (above 100 bpm) post drug administration. Per protocol, subjects rested for 5-10 minutes and blood pressure and heart rate was retaken. They returned normal. Study proceeded.
Frequency: 3 affected / 100 at risk

Adverse event: felt faint after blood draw
Serious: no
Organ System: General disorders
Notes: subject felt faint after first blood draw. After resting, subject recovered and the study continued.
Frequency: 1 affected / 100 at risk

Adverse event: Claustrophobia
Serious: no
Organ System: Psychiatric disorders
Notes: participants have claustrophobia and cannot enter a MRI scanner
Frequency: 1 affected / 104 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Participant came in with a fever and was scheduled for later date. No procedures were done to the participant.
Frequency: 1 affected / 104 at risk

Adverse event: high blood pressure or heart rate post-drug administration
Serious: no
Organ System: Vascular disorders
Notes: Subjects experience high blood pressure (above 140/90) or heart rate (above 100 bpm) post drug administration. Per protocol, subjects rested for 5-10 minutes and blood pressure and heart rate was retaken. They returned normal. Study proceeded.
Frequency: 9 affected / 104 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Notes: Subject experience nausea after drug administration.The subject believed it was due to hunger. Study physician was contacted and subject was provided some food. Once fed, the nausea subsided. He reported no side-effects.
Frequency: 1 affected / 104 at risk

Adverse event: high blood pressure or heart rate post-drug administration
Serious: no
Organ System: Vascular disorders
Notes: Subjects experience high blood pressure (above 140/90) or heart rate (above 100 bpm) post drug administration. Per protocol, subjects rested for 5-10 minutes and blood pressure and heart rate was retaken. They returned normal. Study proceeded.
Frequency: 1 affected / 43 at risk
Study: NCT01566682

Adverse event: Discomfort at Device Measurement Location
Serious: no
Organ System: Product Issues
Notes: 3 subjects complained of discomfort at the device measurement location on the skin. All patients who experienced an adverse event stated that they would agree to undergo measurement again.
Frequency: 3 affected / 420 at risk
Study: NCT01566773

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 64 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 64 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 64 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 62 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 64 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 64 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 57 at risk

Adverse event: Prostatitis
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 59 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 59 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 62 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 62 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 62 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 62 at risk
Study: NCT01566890

Adverse event: Vaso Occlusive Crisis
Serious: yes
Organ System: Vascular disorders
Notes: Vaso-Occlusive Crisis consistent with Sickle Cell Pain Crisis
Frequency: 4 affected / 32 at risk

Adverse event: Severe Pain
Serious: yes
Organ System: Vascular disorders
Notes: Severe Diffuse or Targeted Pain that begins after CEU Procedure consistent with description in package insert
Frequency: 1 affected / 32 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Pain
Frequency: 13 affected / 32 at risk

Adverse event: Nausea and/or Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 32 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 32 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: joint stifness
Frequency: 3 affected / 32 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Pain
Frequency: 1 affected / 10 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 10 at risk

Adverse event: Hot flash
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Severe Pain
Serious: yes
Organ System: Vascular disorders
Notes: Severe Diffuse or Targeted Pain that begins after CEU Procedure consistent with description in package insert
Frequency: 3 affected / 21 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Pain
Frequency: 3 affected / 21 at risk

Adverse event: Cheilitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 21 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 21 at risk

Adverse event: Dysguesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 21 at risk
Study: NCT01567462

Adverse event: Post procedural haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 45 at risk

Adverse event: Bladder perforation
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 5 affected / 45 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Continuous Bladder Irrigation
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Need for continuous bladder irrigation.
Frequency: 11 affected / 45 at risk

Adverse event: Post procedural haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 45 at risk

Adverse event: Continuous Bladder Irrigation
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Need for continuous bladder irrigation.
Frequency: 4 affected / 45 at risk
Study: NCT01567826

Adverse event: Hospitalisation
Serious: yes
Organ System: Cardiac disorders
Notes: Hospitalization for Chest Pain
Frequency: 2 affected / 43 at risk

Adverse event: Unplanned revascularization
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 43 at risk

Adverse event: Periprocedural complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 43 at risk

Adverse event: Any bleeding
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 43 at risk

Adverse event: Creatine kinase-MB > 5x ULN
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 43 at risk

Adverse event: Creatine kinase-MB >10x ULN
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 43 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Cardiac disorders
Notes: Hospitalization for Chest Pain
Frequency: 3 affected / 44 at risk

Adverse event: Periprocedural complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 44 at risk

Adverse event: Creatine kinase-MB > 5x ULN
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 44 at risk

Adverse event: Statin dose reduction
Serious: no
Organ System: General disorders
Frequency: 3 affected / 44 at risk
Study: NCT01567852

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 35 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 35 at risk

Adverse event: Dysphoria
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 35 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 2 affected / 35 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 3 affected / 35 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 35 at risk

Adverse event: Lethargy
Serious: no
Organ System: General disorders
Frequency: 2 affected / 35 at risk

Adverse event: Hallucination
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 35 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 34 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 34 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 34 at risk

Adverse event: Anesthesia Awareness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 34 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 34 at risk

Adverse event: Lethargy
Serious: no
Organ System: General disorders
Frequency: 2 affected / 34 at risk
Study: NCT01568008

Adverse event: Ocular hyperaemia
Serious: yes
Organ System: Eye disorders
Frequency: 3 affected / 933 at risk

Adverse event: Vein disorder
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 933 at risk

Adverse event: Eye irritation
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 933 at risk

Adverse event: Dry eye
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 933 at risk

Adverse event: Nightmare
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 933 at risk

Adverse event: Ocular hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 53 affected / 933 at risk
Study: NCT01568021

Adverse event: Endophthalmitis
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 99 at risk

Adverse event: Ocular hypertension
Serious: no
Organ System: Eye disorders
Frequency: 26 affected / 99 at risk
Study: NCT01568047

Adverse event: Blood creatine
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: PHOSPHOKINASE INCREASED BLOOD LACTATE
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: DEHYDROGENASE INCREASED BLOOD PRESSURE INCREASED
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 10 at risk

Adverse event: Seborrhoeic dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 10 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 10 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Therapeutic product effect decreased
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Parkinson's disease
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Bradyphrenia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 10 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 10 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Dyskinesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk
Study: NCT01568112

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 44 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 44 at risk

Adverse event: Ovarian germ cell teratoma stage I
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 43 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 43 at risk

Adverse event: Eosinophilia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 43 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 43 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 43 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 43 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 43 at risk

Adverse event: Eosinophilia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 43 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 43 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 43 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 43 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 43 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 42 at risk

Adverse event: Eosinophilia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 42 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 42 at risk
Study: NCT01568424

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 13 affected / 25 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 16 affected / 25 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 25 at risk

Adverse event: Arrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 13 affected / 25 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 25 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 11 affected / 25 at risk

Adverse event: Neurologic Dysfunction (Stroke)
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 25 at risk

Adverse event: Thrombotic Vascular
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 25 at risk

Adverse event: Pericardial Fluid Collection
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 25 at risk

Adverse event: Right ventricular failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 25 at risk

Adverse event: Haemolysis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 25 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 25 at risk

Adverse event: Psychiatric Episode
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 25 at risk

Adverse event: Arterial non-CNS
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 25 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 25 at risk
Study: NCT01568593

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 48 at risk
Study: NCT01568918

Adverse event: Lower Extremity Edema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 51 at risk
Study: NCT01569022

Adverse event: mask discomfort
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 35 at risk

Adverse event: Claustrophobia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 35 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 10 affected / 35 at risk

Adverse event: Pain in jaw
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 35 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 6 affected / 35 at risk
Study: NCT01569152

Adverse event: Pneumonia pneumococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 41 at risk

Adverse event: Pneumonia viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 41 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 41 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 41 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 41 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 41 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 41 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 41 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 41 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 41 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 41 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 41 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 41 at risk

Adverse event: Hepatitis toxic
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 55 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 55 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 55 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 55 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 55 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 55 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 55 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 55 at risk