TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00319982

Adverse event: Dyspnoea
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 18 at risk

Adverse event: Lightheadeness
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 18 at risk

Adverse event: Nausea/GI distress
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 18 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 20 at risk

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

Adverse event: Nausea/GI distress
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 20 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 20 at risk

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

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 20 at risk
Study: NCT00320112

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Cause of death was unknown to study team
Frequency: 2 affected / 125 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Cause of death was unknown to study team
Frequency: 1 affected / 119 at risk
Study: NCT00320424

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 48 at risk

Adverse event: Femur fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 48 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 48 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 48 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 4 affected / 48 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 48 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 48 at risk

Adverse event: Restlessness
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 48 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 48 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 48 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 48 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 48 at risk

Adverse event: C reactive protein increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 48 at risk

Adverse event: Platelet count increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 48 at risk

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

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 48 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 48 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 48 at risk
Study: NCT00320671

Adverse event: Hospitalisation
Serious: yes
Organ System: Psychiatric disorders
Notes: subjects were admitted to the hospital
Frequency: 7 affected / 102 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Psychiatric disorders
Notes: subjects were admitted to the hospital
Frequency: 12 affected / 96 at risk
Study: NCT00320749

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 21 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 21 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 21 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 10 affected / 21 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 18 affected / 21 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 21 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 21 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 21 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 21 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 21 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 21 at risk

Adverse event: Hypertransaminasaemia
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 21 at risk
Study: NCT00321698

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 3 at risk

Adverse event: Hemoglobin (L)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Difficulty with ADLs
Serious: yes
Organ System: General disorders
Notes: Difficulty with activities of daily living (ADLs)
Frequency: 1 affected / 3 at risk

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

Adverse event: Pain
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 3 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3 at risk

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

Adverse event: Hemoglobin (L)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 13 at risk

Adverse event: Hypophosphataemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 13 at risk

Adverse event: Lymphapenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 13 at risk
Study: NCT00321789

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 128 at risk
Study: NCT00321828

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 89 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 89 at risk

Adverse event: Anaphylactic reaction
Serious: no
Organ System: Immune system disorders
Frequency: 9 affected / 89 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 89 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 89 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 89 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 89 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 89 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 14 affected / 89 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 89 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 29 affected / 89 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 89 at risk

Adverse event: Embolism
Serious: no
Organ System: Vascular disorders
Frequency: 10 affected / 89 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 89 at risk
Study: NCT00321932

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 29 at risk

Adverse event: Idiopathic pulmonary syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 29 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 15 affected / 32 at risk

Adverse event: Graft-versus-host disease
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 32 at risk

Adverse event: Infection with unknown absolute neutrophil count
Serious: yes
Organ System: Infections and infestations
Notes: Pneumonia
Frequency: 2 affected / 32 at risk

Adverse event: New Malignancy
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 32 at risk

Adverse event: Pseudomonas sepsis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 32 at risk
Study: NCT00321984

Adverse event: Coronary Artery Disorders Not Elsewhere Classified (NEC)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 317 at risk

Adverse event: Diarrhoea (Excluding Infective)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 317 at risk

Adverse event: Headaches NEC
Serious: no
Organ System: Nervous system disorders
Frequency: 19 affected / 317 at risk

Adverse event: Nausea and Vomiting Symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 317 at risk

Adverse event: Ischaemic Coronary Artery Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 315 at risk

Adverse event: Heart Failures NEC
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 315 at risk

Adverse event: Sepsis, Bacteraemia, Viraemia and Fungaemia NEC
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 315 at risk

Adverse event: Central Nervous System Haemorrhage & Cerebrovascular Accidents
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 315 at risk

Adverse event: Diarrhoea (Excluding Infective)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 315 at risk

Adverse event: Headaches NEC
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 315 at risk

Adverse event: Nausea and Vomiting Symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 315 at risk

Adverse event: Gastrointestinal & Abdominal Pains (Excluding Oral and Throat)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 315 at risk

Adverse event: Non-site Specific Gastrointestinal Haemorrhages
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 315 at risk

Adverse event: Diarrhoea (Excluding Infective)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 315 at risk

Adverse event: Headaches NEC
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 315 at risk

Adverse event: Nausea and Vomiting Symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 315 at risk
Study: NCT00322023

Adverse event: Proteinuria
Serious: yes
Organ System: Renal and urinary disorders
Notes: 2+ proteinuria without glycosuria during the final week of treatment with no significant change in creatinine that resolved following dserine discontinuation.
Frequency: 1 affected / 16 at risk

Adverse event: asymptomatic transaminitis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 16 at risk
Study: NCT00322101

Adverse event: severe diarrhea due to gut GVHD
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 12 at risk

Adverse event: tachycardia and hypotenstion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 12 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 12 at risk

Adverse event: severe diarrhea due to gut GVHD
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 11 at risk

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

Adverse event: Mucosal inflammation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 11 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 11 at risk
Study: NCT00322218

Adverse event: Cytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 34 at risk

Adverse event: Infections and manifestations
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 34 at risk

Adverse event: Cytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 34 at risk

Adverse event: Infections and manifestations
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 34 at risk
Study: NCT00322231

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 33 affected / 98 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 36 affected / 98 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Frequency: 5 affected / 98 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 26 affected / 98 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 3 affected / 96 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 96 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 2 affected / 96 at risk
Study: NCT00322309

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

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

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

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

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 13 at risk
Study: NCT00322868

Adverse event: hypoglycemic event
Serious: no
Organ System: Endocrine disorders
Notes: Non serious, unexpected, possibly study related
Frequency: 1 affected / 20 at risk
Study: NCT00323115

Adverse event: Pain, neck, unilateral, Grade 2
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk
Study: NCT00323284

Adverse event: Best Corrected Visual Acuity loss greater than 1 line at or after the 3 month visit
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 116 at risk

Adverse event: Early post-op corneal edema
Serious: no
Organ System: Eye disorders
Frequency: 9 affected / 116 at risk

Adverse event: Posterior capsular opacification
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 116 at risk

Adverse event: Any BCVA loss greater than 1 line of vision at or after the 3 month visit
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 116 at risk

Adverse event: Blurry vision or visual disturbance
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 116 at risk

Adverse event: Best Corrected Visual Acuity loss greater than 1 line at or after the 3 month visit
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 123 at risk

Adverse event: Early post-op corneal edema
Serious: no
Organ System: Eye disorders
Frequency: 11 affected / 123 at risk

Adverse event: Posterior capsular opacification
Serious: no
Organ System: Eye disorders
Frequency: 12 affected / 123 at risk

Adverse event: Any BCVA loss greater than 1 line of vision at or after the 3 month visit
Serious: no
Organ System: Eye disorders
Frequency: 11 affected / 123 at risk

Adverse event: Blurry vision or visual disturbance
Serious: no
Organ System: Eye disorders
Frequency: 8 affected / 123 at risk
Study: NCT00323310

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

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

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 92 at risk

Adverse event: Eyelid oedema
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 92 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 92 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 92 at risk

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

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 92 at risk
Study: NCT00323414

Adverse event: No tissue
Serious: no
Organ System: Surgical and medical procedures
Notes: Liver biopsy did not yield tissue
Frequency: 1 affected / 18 at risk

Adverse event: Post liver biopsy pain
Serious: yes
Organ System: Surgical and medical procedures
Notes: End of treatment, post liver biopsy bleeding requiring blood transfusion in one and none in the other. Both patients showed evidence of perihepatic hematoma and were discharged home uneventfully
Frequency: 1 affected / 19 at risk

Adverse event: Post liver biopsy bleeding
Serious: yes
Organ System: Surgical and medical procedures
Notes: Needed 2 units blood transfusion. Discharged uneventfully and is being followed in the clinic subsequently
Frequency: 1 affected / 19 at risk
Study: NCT00323453

Adverse event: Wound infection
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Wound Infection
Frequency: 1 affected / 61 at risk

Adverse event: Wound infection
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Wound Infection
Frequency: 7 affected / 48 at risk
Study: NCT00323557

Adverse event: Pain and redness at injection site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 25 at risk

Adverse event: Palmar erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 25 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 25 at risk

Adverse event: Pain and redness at injection site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 7 at risk
Study: NCT00323635

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Dropout patient explained she had to go to hospital because of pneumonia. However, tt remained unclear whether she in fact had pneumonia.
Frequency: 1 affected / 9 at risk
Study: NCT00323856

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Device malfunction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 50 at risk

Adverse event: Post procedural discharge
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 50 at risk

Adverse event: Joint swelling
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 50 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 50 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 50 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 50 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 50 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 50 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 50 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 50 at risk

Adverse event: Joint injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 50 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 50 at risk

Adverse event: Limb injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 50 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 50 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 50 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 50 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 4 affected / 50 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 50 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 50 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 50 at risk

Adverse event: Headche
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 50 at risk