TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01130597

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 63 at risk

Adverse event: Sudden cardiac death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 63 at risk

Adverse event: Sudden death
Serious: yes
Organ System: General disorders
Notes: Sudden death occurred during the follow up period, after completing the study.
Frequency: 1 affected / 63 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 63 at risk

Adverse event: Staphylococcal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 63 at risk

Adverse event: Subcutaneous abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 63 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 63 at risk

Adverse event: Azotaemia
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 63 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 63 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 63 at risk
Study: NCT01130883

Adverse event: Tuberculosis pleuritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3128 at risk

Adverse event: Pulmonary tumor
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3128 at risk

Adverse event: Bad taste in mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3128 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3128 at risk

Adverse event: Tongue discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3128 at risk

Adverse event: Bitter taste in mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3128 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 3128 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3128 at risk

Adverse event: Gastrointestinal tract symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3128 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3128 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3128 at risk
Study: NCT01130896

Adverse event: Power on reset
Serious: no
Organ System: Surgical and medical procedures
Frequency: 8 affected / 1509 at risk
Study: NCT01131052

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Notes: Severe Aortic Stenosis
Frequency: 1 affected / 75 at risk

Adverse event: ER visit
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 75 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 75 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 75 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 75 at risk

Adverse event: CV
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 75 at risk

Adverse event: ER visit
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 75 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Cardiac disorders
Frequency: 11 affected / 75 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 75 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 75 at risk

Adverse event: CV
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 75 at risk
Study: NCT01131182

Adverse event: Hunger
Serious: no
Organ System: General disorders
Frequency: 13 affected / 507 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 20 affected / 507 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 25 affected / 507 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 507 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 19 affected / 507 at risk

Adverse event: Pancreatitis acute
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 514 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 514 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 514 at risk

Adverse event: Hunger
Serious: no
Organ System: General disorders
Frequency: 35 affected / 514 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 38 affected / 514 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 44 affected / 514 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 34 affected / 514 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 32 affected / 514 at risk
Study: NCT01131260

Adverse event: Postpartum haemorrhage
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 7 affected / 5532 at risk

Adverse event: Uterine rupture
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 5532 at risk

Adverse event: Congenital malformation
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 11 affected / 5532 at risk

Adverse event: Scalp abscess/pustules (neonatal)
Serious: yes
Organ System: Infections and infestations
Notes: From site of fetal ECG clip
Frequency: 2 affected / 5532 at risk

Adverse event: Neonatal death
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 3 affected / 5532 at risk

Adverse event: Neonatal Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 5532 at risk

Adverse event: Neonatal seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 5532 at risk

Adverse event: Subgaleal hematoma (neonate)
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 5532 at risk

Adverse event: Brachial plexus injury
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 5532 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 5532 at risk

Adverse event: Postpartum haemorrhage
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 5576 at risk

Adverse event: Maternal Infection (bacteremia)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 5576 at risk

Adverse event: Maternal Seizure (eclampsia)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 5576 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Neonatal RDS
Frequency: 1 affected / 5576 at risk

Adverse event: Congenital malformation
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 4 affected / 5576 at risk

Adverse event: Scalp abscess/pustules (neonatal)
Serious: yes
Organ System: Infections and infestations
Notes: From site of fetal ECG clip
Frequency: 2 affected / 5576 at risk

Adverse event: Neonatal death
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 5576 at risk

Adverse event: Neonatal seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 5576 at risk

Adverse event: Subgaleal hematoma (neonate)
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 5576 at risk

Adverse event: Brachial plexus injury
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 5576 at risk

Adverse event: Infection/sepsis (neonate)
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 5576 at risk
Study: NCT01131299

Adverse event: Appendicectomy
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 75 at risk

Adverse event: enrollment in conflicting clinical trial
Serious: yes
Organ System: Social circumstances
Frequency: 1 affected / 75 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 75 at risk

Adverse event: intestinal gas
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 75 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 75 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 75 at risk

Adverse event: Micturition urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 75 at risk

Adverse event: dyspepsia (indigestion)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 75 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 75 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 75 at risk
Study: NCT01131325

Adverse event: Muscle cramps - legs
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3 at risk

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

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

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

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

Adverse event: Pruritus genital
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3 at risk

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

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3 at risk

Adverse event: Mild sweats
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk
Study: NCT01132118

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 1 participants developed a rash when taking HCQ.
Frequency: 1 affected / 15 at risk

Adverse event: Liver Function Test Abnormality
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: 1 patient had abnormal liver function test scores while taking HCQ.
Frequency: 1 affected / 15 at risk
Study: NCT01132482

Adverse event: Distal intestinal obstruction syndrome
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Distal Intestinal Obstruction Syndrome
Frequency: 1 affected / 12 at risk

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

Adverse event: Pain, throat
Serious: no
Organ System: General disorders
Notes: Sore throat
Frequency: 2 affected / 12 at risk

Adverse event: Pain, head
Serious: no
Organ System: General disorders
Notes: Headache
Frequency: 5 affected / 12 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: General disorders
Notes: Runny nose/sinus drainage
Frequency: 2 affected / 12 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: myalgia, achiness
Frequency: 2 affected / 12 at risk

Adverse event: Pain, chest
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Chest heaviness with exertion
Frequency: 2 affected / 12 at risk

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

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 12 at risk

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

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

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 12 at risk

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

Adverse event: Pulmonary exacerbation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Increased sputum clearance
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: General disorders
Notes: Runny nose/sinus drainage
Frequency: 1 affected / 6 at risk

Adverse event: Flushing
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Notes: Dyspepsia
Frequency: 1 affected / 6 at risk

Adverse event: Distension/bloating, abdominal
Serious: no
Organ System: Gastrointestinal disorders
Notes: Distention
Frequency: 1 affected / 6 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: URI
Frequency: 1 affected / 6 at risk
Study: NCT01132495

Adverse event: Non Urgent Revacularization
Serious: yes
Organ System: Vascular disorders
Frequency: 30 affected / 447 at risk

Adverse event: Death or MI
Serious: yes
Organ System: Cardiac disorders
Frequency: 42 affected / 447 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 30 affected / 447 at risk

Adverse event: Unplanned Hospitalization with Urgent Revascularization
Serious: yes
Organ System: Vascular disorders
Frequency: 8 affected / 447 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 16 affected / 447 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: General disorders
Frequency: 10 affected / 447 at risk

Adverse event: Other SAE
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 447 at risk

Adverse event: Non Urgent Revacularization
Serious: yes
Organ System: Vascular disorders
Frequency: 144 affected / 441 at risk

Adverse event: Death or MI
Serious: yes
Organ System: Cardiac disorders
Frequency: 54 affected / 441 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 41 affected / 441 at risk

Adverse event: Unplanned Hospitalization with Urgent Revascularization
Serious: yes
Organ System: Vascular disorders
Frequency: 59 affected / 441 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 17 affected / 441 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 441 at risk

Adverse event: Other SAE
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 441 at risk

Adverse event: Non Urgent Revacularization
Serious: yes
Organ System: Vascular disorders
Frequency: 14 affected / 166 at risk

Adverse event: Death or MI
Serious: yes
Organ System: Cardiac disorders
Frequency: 16 affected / 166 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 11 affected / 166 at risk

Adverse event: Unplanned Hospitalization with Urgent Revascularization
Serious: yes
Organ System: Vascular disorders
Frequency: 6 affected / 166 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 166 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 166 at risk

Adverse event: Non Urgent Revacularization
Serious: yes
Organ System: Vascular disorders
Frequency: 10 affected / 116 at risk

Adverse event: Death or MI
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 116 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 116 at risk

Adverse event: Unplanned Hospitalization with Urgent Revascularization
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 116 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 116 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 116 at risk
Study: NCT01132547

Adverse event: Haemorrhage intracranial
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Platelet count decrease
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 9 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 9 at risk

Adverse event: Neutrophil count decrease
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 9 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 9 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Skin and Subcutaneous tissue disorders other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 9 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 9 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 9 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal 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: Skin and Subcutaneous tissue disorders other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 13 at risk

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

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

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

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

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 13 at risk
Study: NCT01132690

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 6 at risk

Adverse event: Gastrointestinal inflammation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 5 at risk
Study: NCT01133626

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 50 at risk

Adverse event: Nasal discomfort
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 46 at risk

Adverse event: Nasal discomfort
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 46 at risk

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

Adverse event: Blood oestrogen increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 11 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Nasal discomfort
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 11 at risk
Study: NCT01133821

Adverse event: Sedation complication
Serious: no
Organ System: General disorders
Notes: over-sedation variable was created by combining 3 items from the PRISE (sleeping too much, fatigue, and decreased energy).
Frequency: 35 affected / 44 at risk

Adverse event: Early Weight Gain
Serious: no
Organ System: General disorders
Notes: (\>5% in first month)
Frequency: 2 affected / 44 at risk

Adverse event: Sedation complication
Serious: no
Organ System: General disorders
Notes: over-sedation variable was created by combining 3 items from the PRISE (sleeping too much, fatigue, and decreased energy).
Frequency: 42 affected / 44 at risk
Study: NCT01133847

Adverse event: Aggressive behaviors
Serious: no
Organ System: Social circumstances
Frequency: 3 affected / 71 at risk

Adverse event: Aggressive behaviors
Serious: no
Organ System: Social circumstances
Frequency: 1 affected / 74 at risk

Adverse event: Aggressive behaviors
Serious: no
Organ System: Social circumstances
Frequency: 5 affected / 68 at risk
Study: NCT01133860

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: mild and transient headache at the beginning of the treatment, duration 3-4 days, spontaneous remission
Frequency: 2 affected / 12 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Notes: transient sensation o dry mouth at the beginning of the treatment, duration 3-4 days, spontaneous remission
Frequency: 1 affected / 12 at risk
Study: NCT01134016

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: 12 patients, 92.3% \[7 patients in grade 1, 53.8%, and 5 patients in grade 2, 38.5%\]
Frequency: 12 affected / 13 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 13 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 13 at risk