TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01732458

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

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 57 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 57 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 57 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 55 at risk

Adverse event: Post procedural haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 55 at risk

Adverse event: Bladder perforation
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 55 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 55 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 55 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 55 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 55 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 55 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 56 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 56 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 56 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 56 at risk

Adverse event: Accidental overdose
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 56 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 56 at risk

Adverse event: Procedural complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 52 at risk

Adverse event: Male genital tract fistula
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 52 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 52 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 52 at risk

Adverse event: Accidental overdose
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 52 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 52 at risk
Study: NCT01732471

Adverse event: Upper limb fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 90 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 90 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 90 at risk

Adverse event: Faeces pale
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Genital labial adhesions
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 90 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 90 at risk

Adverse event: Heat stroke
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 90 at risk

Adverse event: Iodine deficiency
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 90 at risk

Adverse event: Leukocyturia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 90 at risk

Adverse event: Myopia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 90 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 90 at risk

Adverse event: Phenylketonuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 90 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 90 at risk

Adverse event: Respiratory tract infection viral
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 90 at risk

Adverse event: Retinal vascular disorder
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 90 at risk

Adverse event: Skin odour abnormal
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 90 at risk

Adverse event: Syncope
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 90 at risk
Study: NCT01732536

Adverse event: Chronic Sinusitits
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 53 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 53 at risk

Adverse event: Acute sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 53 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 53 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 53 at risk

Adverse event: Presyncope
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 53 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 53 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 53 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 47 at risk

Adverse event: Chronic Sinusitits
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 47 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 47 at risk

Adverse event: Acute sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 47 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 47 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 47 at risk

Adverse event: Presyncope
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 47 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 47 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 47 at risk
Study: NCT01732588

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

Adverse event: increased alanine aminotransferase
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: increased aspartate aminotransferase
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: abnormal urine analysis
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: abnormal electrocardiogram
Serious: no
Organ System: Investigations
Frequency: 1 affected / 11 at risk

Adverse event: Vessel puncture site haematoma
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

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

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 10 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk
Study: NCT01732627

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 23 affected / 199 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 61 affected / 199 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 15 affected / 199 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 44 affected / 199 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 70 affected / 199 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: 1 Headache event which occurred 7 days post-vaccination was considered as an unsolicited AE.
Frequency: 47 affected / 199 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 5 affected / 100 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 32 affected / 100 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 2 affected / 100 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 15 affected / 100 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 26 affected / 100 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: 1 Headache event which occurred 7 days post-vaccination was considered as an unsolicited AE.
Frequency: 29 affected / 100 at risk
Study: NCT01732640

Adverse event: Gr. 4 Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Gr. 3 Elevated ALT
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Gr. 3 Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 3 at risk

Adverse event: Gr. 3 Abdominal Pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3 at risk

Adverse event: Gr. 3 Diarrhea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Gr. 3 Pancytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 3 at risk

Adverse event: Gr. 3 Urinary Tract Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3 at risk

Adverse event: Gr. 4 Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3 at risk
Study: NCT01732718

Adverse event: Pain
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 13 at risk

Adverse event: Headaches/Head Pressure
Serious: no
Organ System: General disorders
Frequency: 2 affected / 13 at risk

Adverse event: Pain Crisis Treated at Home
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 13 at risk

Adverse event: Edema of Lower Extremity
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 13 at risk

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

Adverse event: Low O2 Saturation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: General disorders
Frequency: 2 affected / 13 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 13 at risk

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

Adverse event: Pain
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 13 at risk

Adverse event: Heart Palpitations and Fainting
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 13 at risk

Adverse event: Influenza B
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 13 at risk

Adverse event: Pain Crisis Treated at Home
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 13 at risk

Adverse event: Dry skin
Serious: no
Organ System: General disorders
Frequency: 2 affected / 13 at risk

Adverse event: Edema of Lower Extremity
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 13 at risk

Adverse event: Skin ulcer
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 13 at risk

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

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 13 at risk

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

Adverse event: Low ANC
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 13 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 13 at risk
Study: NCT01732809

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Erythema after injection procedure
Frequency: 1 affected / 19 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Minimal bleeding after injection procedure
Frequency: 2 affected / 19 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Erythema after injection procedure
Frequency: 1 affected / 19 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Minimal bleeding after injection procedure
Frequency: 1 affected / 19 at risk
Study: NCT01733121

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 49 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 49 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 49 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 49 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 49 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 49 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 49 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 49 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 49 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 51 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 51 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 51 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 51 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 5 affected / 51 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 51 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 51 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 51 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 51 at risk
Study: NCT01733147

Adverse event: Mild nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 30 at risk
Study: NCT01733472

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Notes: atrial fibrillation
Frequency: 1 affected / 60 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Notes: atrial fibrillation
Frequency: 1 affected / 60 at risk
Study: NCT01733732

Adverse event: Metastasis to central nervous system
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 27 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 27 at risk
Study: NCT01733745

Adverse event: Infectious mononucleosis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 13 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 13 at risk
Study: NCT01734161

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

Adverse event: Incision site haemorrhage
Serious: no
Organ System: Surgical and medical procedures
Notes: incision site bleeding
Frequency: 1 affected / 55 at risk

Adverse event: low body temperature
Serious: no
Organ System: General disorders
Notes: low body temperature
Frequency: 2 affected / 55 at risk

Adverse event: post-op shivering
Serious: no
Organ System: General disorders
Notes: post-op shivering
Frequency: 1 affected / 55 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: Tachycardia
Frequency: 1 affected / 55 at risk

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

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: Hypertension
Frequency: 3 affected / 53 at risk
Study: NCT01734239

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 14 affected / 102 at risk
Study: NCT01734395

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1882 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1882 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1882 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 1882 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1882 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1882 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1882 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1882 at risk
Study: NCT01734655

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: A participant reported that she had experienced some abdominal pain. This was determined to be non-serious and unrelated to the study by the medical investigator.
Frequency: 1 affected / 40 at risk

Adverse event: Vaginal Spotting
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: A participant reported that she had experienced some vaginal spotting. She visited her OB/GYN and it was determined to be harmless. This was determined to be non-serious and unrelated to the study by the medical investigator.
Frequency: 1 affected / 40 at risk
Study: NCT01734694

Adverse event: Nephropathy toxic
Serious: yes
Organ System: Renal and urinary disorders
Notes: Increase in SCr of at least 0.5 mg/dL or 50% (whichever is greater) on at least 2 consecutive measurements while on the study drug.
Frequency: 5 affected / 51 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Notes: An abrupt change in renal function signified by an increase in SCr of at least 0.3 mg/dL, a reduction in creatinine clearance (CrCl) of at least 50%, or a change in urine output to \<0.5 mL/kg/h for at least 6 hours.
Frequency: 16 affected / 51 at risk

Adverse event: Nephropathy toxic
Serious: yes
Organ System: Renal and urinary disorders
Notes: Increase in SCr of at least 0.5 mg/dL or 50% (whichever is greater) on at least 2 consecutive measurements while on the study drug.
Frequency: 3 affected / 49 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Notes: An abrupt change in renal function signified by an increase in SCr of at least 0.3 mg/dL, a reduction in creatinine clearance (CrCl) of at least 50%, or a change in urine output to \<0.5 mL/kg/h for at least 6 hours.
Frequency: 16 affected / 49 at risk
Study: NCT01734772

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 24 at risk
Study: NCT01734811

Adverse event: Epilectic seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 58 at risk
Study: NCT01734889

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 18 at risk

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

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

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

Adverse event: Mouth haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk
Study: NCT01734902

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 30 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 28 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 28 at risk