TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01560377

Adverse event: Anastomotic leak
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 139 at risk

Adverse event: Pelvic abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 139 at risk

Adverse event: Abdominal wall infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 139 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 139 at risk

Adverse event: Transfusion
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 139 at risk

Adverse event: C. difficile colitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 139 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 139 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 139 at risk

Adverse event: Ileus requiring nasogastric tube
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 139 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 139 at risk

Adverse event: Incisional hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 139 at risk

Adverse event: Thrombosed left renal artery
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 139 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 139 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 139 at risk

Adverse event: Wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 139 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 139 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 139 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 139 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 139 at risk
Study: NCT01560585

Adverse event: Neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Rapid ccognitive decline; found to have glioblastoma
Frequency: 1 affected / 3 at risk

Adverse event: Loss of consciousness
Serious: no
Organ System: Nervous system disorders
Notes: Transient lossw of consciousness in one participant
Frequency: 1 affected / 3 at risk
Study: NCT01560780

Adverse event: Severe GUSTO bleeding
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 42 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 42 at risk

Adverse event: Acute coronary syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 42 at risk

Adverse event: Percutaneous coronary intervention
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 42 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 42 at risk

Adverse event: Acute coronary syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 42 at risk

Adverse event: Percutaneous coronary intervention
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 42 at risk
Study: NCT01560819

Adverse event: Bloating/flatulance
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 10 at risk

Adverse event: Abdominal pain/cramping
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 10 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 10 at risk

Adverse event: Haematochezia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 10 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 10 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 10 at risk
Study: NCT01560871

Adverse event: Hospitalisation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: worsening of chronic obstructive pulmonary disease; pneumonia
Frequency: 2 affected / 9 at risk

Adverse event: transportation issue, relocation, loss to follow up
Serious: no
Organ System: Cardiac disorders
Notes: Reasons for dropout: transportation issues (2), relocation (1), loss to follow up (1), hospital readmission (2 due to COPD or pneumonia)
Frequency: 6 affected / 9 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Cardiac disorders
Notes: worsening of heart failure symptoms such as shortness of breath and weight gain.
Frequency: 1 affected / 7 at risk

Adverse event: transportation issue, relocation, loss to follow up
Serious: no
Organ System: Cardiac disorders
Notes: Reasons for dropout: transportation issues (2), relocation (1), loss to follow up (1), hospital readmission (2 due to COPD or pneumonia)
Frequency: 2 affected / 7 at risk
Study: NCT01560988

Adverse event: Asthma deterioration
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Increased use of rescue inhaler or decreased lung function
Frequency: 3 affected / 42 at risk

Adverse event: Gastrointestinal distress
Serious: no
Organ System: Gastrointestinal disorders
Notes: Constipation, gassiness, heatburt
Frequency: 6 affected / 42 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 42 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 42 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 42 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Asthma deterioration
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Increased use of rescue inhaler or decreased lung function
Frequency: 1 affected / 38 at risk

Adverse event: Gastrointestinal distress
Serious: no
Organ System: Gastrointestinal disorders
Notes: Constipation, gassiness, heatburt
Frequency: 2 affected / 38 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Hepatic enzyme increased
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 38 at risk
Study: NCT01561079

Adverse event: Severe adverse event
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: One infant born to a buprenorphine maintained mother in the protocol had polydactyly The infant had a family history of polydactyly
Frequency: 1 affected / 49 at risk

Adverse event: congenital heart disease
Serious: yes
Organ System: Cardiac disorders
Notes: One infant born to a buprenorphine maintained mother was born with a congenital heart disease. The infant had a family history of congenital heart disease.
Frequency: 1 affected / 49 at risk

Adverse event: Cholestasis of pregnancy
Serious: no
Organ System: Hepatobiliary disorders
Notes: Three participants developed cholestasis of pregnancy. All three had concurrent Hepatitis C infection and were therefore at increased risk for this condition.
Frequency: 3 affected / 49 at risk

Adverse event: Bacterial vaginosis
Serious: no
Organ System: Infections and infestations
Notes: One subject developed bacterial vaginosis
Frequency: 1 affected / 49 at risk

Adverse event: choroid plexus cysts
Serious: no
Organ System: Nervous system disorders
Notes: One fetal subject had choroid plexus cysts on fetal sonogram
Frequency: 1 affected / 49 at risk

Adverse event: Cardiomegaly
Serious: no
Organ System: Cardiac disorders
Notes: 2 fetal subjects had mild cardiomegaly on fetal sonogram
Frequency: 2 affected / 49 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Notes: One infant was born with congenital pneumonia
Frequency: 1 affected / 49 at risk

Adverse event: Foetal growth restriction
Serious: no
Organ System: General disorders
Notes: One fetus was diagnosed with fetal growth restriction (but was average for gestational age at delivery)
Frequency: 1 affected / 49 at risk

Adverse event: Amniotic cavity infection
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Two maternal subjects had chorioamnionitis at delivery
Frequency: 2 affected / 49 at risk

Adverse event: Fetal stress at delivery
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Two fetuses exhibited fetal stress at the time of delivery
Frequency: 2 affected / 49 at risk

Adverse event: psychiatric concern
Serious: no
Organ System: General disorders
Notes: One maternal subject developed a psychiatric concern warranting hospitalization
Frequency: 1 affected / 49 at risk

Adverse event: fetal arrythmia
Serious: no
Organ System: Cardiac disorders
Notes: One fetus had a cardiac arrhythmia
Frequency: 1 affected / 49 at risk

Adverse event: maternal dehydration
Serious: no
Organ System: General disorders
Notes: One maternal subject developed decreased fetal HRV and fetal tachycardia, was dx with dehydration
Frequency: 1 affected / 49 at risk

Adverse event: nonreactive fetal tracing, fetal hear rate deceleration
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 49 at risk
Study: NCT01561300

Adverse event: Increased ferquency of stool
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: Upper restiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: During tea drinking
Frequency: 1 affected / 29 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Notes: Subject developed hypertension after being included
Frequency: 1 affected / 30 at risk

Adverse event: Upper restiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: During tea drinking
Frequency: 1 affected / 30 at risk

Adverse event: Blood urine present
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 30 at risk
Study: NCT01561313

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 63 at risk

Adverse event: Rash erythematous
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 63 at risk

Adverse event: Protein urine present
Serious: no
Organ System: Investigations
Frequency: 1 affected / 62 at risk
Study: NCT01561755

Adverse event: Mild headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk
Study: NCT01561976

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 24 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 24 at risk
Study: NCT01562041

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 14 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 14 at risk

Adverse event: Night sweats
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 14 at risk
Study: NCT01562132

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 1
Frequency: 2 affected / 3 at risk

Adverse event: Abnormal loss of weight
Serious: no
Organ System: General disorders
Notes: Grade 2
Frequency: 1 affected / 3 at risk

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

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

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2
Frequency: 1 affected / 3 at risk
Study: NCT01562327

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

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 50 at risk
Study: NCT01562548

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 25 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 25 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 25 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 25 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 25 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: Anthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 25 at risk

Adverse event: Sinus operation
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 25 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 24 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 24 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 24 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 24 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 24 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 24 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 24 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 14 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 14 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 14 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 14 at risk
Study: NCT01562613

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 533 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 533 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 533 at risk

Adverse event: Dizziness
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 533 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 533 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 533 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 533 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 533 at risk

Adverse event: Prostatitis
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 533 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 533 at risk
Study: NCT01562678

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 28 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 28 at risk
Study: NCT01562782

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Mild nausea after ingestion of beverage in one subject.
Frequency: 1 affected / 15 at risk
Study: NCT01562873

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 21 at risk

Adverse event: Aspartate aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 21 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 21 at risk

Adverse event: Neutrophil count decreased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 21 at risk

Adverse event: BL101
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 5 at risk

Adverse event: GI108
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: GI123
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: GI179
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: GI216
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 5 at risk

Adverse event: CN101
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: CN105
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: CN108
Serious: no
Organ System: General disorders
Frequency: 3 affected / 5 at risk

Adverse event: CN109
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: IN999
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk

Adverse event: IV129
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: IV137
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: MU112
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: MU999
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: NE145
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 5 at risk

Adverse event: PU113
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: PU114
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: DE999
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 5 at risk
Study: NCT01562886

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 13 at risk
Study: NCT01563081

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

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

Adverse event: Pharyngeal erythema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 30 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 30 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 30 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 30 at risk

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

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 60 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 60 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 60 at risk

Adverse event: Pharyngeal erythema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 60 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 60 at risk
Study: NCT01563107

Adverse event: Mass
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Participant notified the PI that a mass had been discovered on her pineal gland during a brain MRI for another research study. We do not believe that the mass is related to any study procedures undertaken as part of this research protocol.
Frequency: 1 affected / 13 at risk
Study: NCT01563341

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 5 at risk

Adverse event: Sleep difficulty
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 5 at risk

Adverse event: Dystonia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 5 at risk
Study: NCT01563913

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 15 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 15 at risk

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

Adverse event: Gynaecomastia
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 15 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: New diagnosis of prostate cancer.
Frequency: 1 affected / 15 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Notes: Syncope during IV infusion leading to discontinuing infusion, ER visit with overnight Hospitalization with no findings.
Frequency: 1 affected / 15 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 15 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 15 at risk

Adverse event: Urinary Track Infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 15 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 15 at risk
Study: NCT01563978

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 68 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 67 at risk