TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01858194

Adverse event: AF with urosepsis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: Worsening heart failure/Total artifical heart implant
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 9 at risk

Adverse event: Pseudoaneurysm at septal aspect of LV apex
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 9 at risk

Adverse event: LUE Cephalic vein thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 9 at risk

Adverse event: Hypotension with pleuritic chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 9 at risk

Adverse event: Kidney pain with near syncope
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 9 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 9 at risk

Adverse event: Bradycardia associated with dyspnea on exertion
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 9 at risk

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

Adverse event: VT recurrence
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 8 at risk

Adverse event: Non-sustained VT
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 8 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Macrohematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 8 at risk

Adverse event: VT recurrence
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 8 at risk

Adverse event: Dissection of left external iliac artery
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 8 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8 at risk
Study: NCT01858545

Adverse event: Enteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 27 at risk

Adverse event: Localised infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 27 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 27 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 27 at risk

Adverse event: Flank pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 27 at risk

Adverse event: Cerebrovascular Accident (Death)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 27 at risk

Adverse event: Wound infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 27 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 29 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 29 at risk

Adverse event: Wound
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 29 at risk

Adverse event: Wound infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 29 at risk
Study: NCT01858636

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 211 at risk

Adverse event: VASC bleeding
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 211 at risk

Adverse event: VASC pseudoaneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 211 at risk

Adverse event: Vascular Hematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 211 at risk

Adverse event: Aortic valve stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 211 at risk

Adverse event: Bacterial infection
Serious: yes
Organ System: Infections and infestations
Notes: Vascular Access Site Complication (VASC) Infections
Frequency: 3 affected / 211 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 211 at risk

Adverse event: Aortic aneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 211 at risk

Adverse event: Vascular Disection
Serious: yes
Organ System: Vascular disorders
Notes: Coronary Site - Not Access Site
Frequency: 1 affected / 211 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 211 at risk

Adverse event: Cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 211 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 211 at risk

Adverse event: Decreased Left Ventricular Function
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 211 at risk

Adverse event: Elective Cardiac Surgery
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 211 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 211 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 211 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 211 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 211 at risk

Adverse event: Sinus node dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 211 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 211 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 211 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 211 at risk

Adverse event: VASC bruise
Serious: no
Organ System: Vascular disorders
Frequency: 17 affected / 211 at risk

Adverse event: VASC hematoma
Serious: no
Organ System: Vascular disorders
Frequency: 8 affected / 211 at risk

Adverse event: VASC bleeding
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 211 at risk

Adverse event: VASC pain
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 211 at risk
Study: NCT01858688

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 97 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 97 at risk

Adverse event: Prostate infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 97 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 97 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 97 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 97 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 97 at risk
Study: NCT01858753

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

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 5 at risk
Study: NCT01859078

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 28 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 28 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 28 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 28 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 28 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 28 at risk
Study: NCT01859130

Adverse event: Cardiovascular
Serious: yes
Organ System: Cardiac disorders
Notes: Chest pain Chest pressure Congestive Heart Failure Atrial Fibrillation
Frequency: 11 affected / 299 at risk

Adverse event: Generic Cardiovascular Reports
Serious: yes
Organ System: Cardiac disorders
Notes: Cerebral Ischemic Stroke Blockage in Artery DX of SVT
Frequency: 3 affected / 299 at risk

Adverse event: Dermatological Disorders
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Hives and rashes Cellulitis left shin
Frequency: 3 affected / 299 at risk

Adverse event: Adrenal insufficiency
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 299 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Appendicitis Gall Bladder Bleeding ulcers Colon resection
Frequency: 5 affected / 299 at risk

Adverse event: Genitourinary / Renal
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 5 affected / 299 at risk

Adverse event: Hematological
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 299 at risk

Adverse event: Infection (non-knee)
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 299 at risk

Adverse event: Musculoskeletal
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 26 affected / 299 at risk

Adverse event: Neurological
Serious: yes
Organ System: Nervous system disorders
Frequency: 7 affected / 299 at risk

Adverse event: Oncological
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 299 at risk

Adverse event: Pulmonary / Respiratory
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 299 at risk

Adverse event: Wound Drainage / Device Loosening
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 299 at risk

Adverse event: Other General Adverse Events
Serious: yes
Organ System: General disorders
Frequency: 10 affected / 299 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 41 affected / 299 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 145 affected / 299 at risk

Adverse event: Other General Adverse Events
Serious: no
Organ System: General disorders
Frequency: 118 affected / 299 at risk
Study: NCT01859143

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 241 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 241 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 241 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 241 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 241 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 241 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 241 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 241 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 241 at risk

Adverse event: Sinus congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 241 at risk

Adverse event: Sneezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 241 at risk

Adverse event: Night sweats
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 241 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 59 at risk

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

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 59 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 59 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 59 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 59 at risk

Adverse event: Nasal discharge discolouration
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 59 at risk

Adverse event: Night sweats
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 59 at risk
Study: NCT01859312

Adverse event: Skin erythema with pruritis at the infusion set site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 8 at risk

Adverse event: Local skin infection at the infusion set site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 8 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 8 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 8 at risk

Adverse event: Asthenia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 8 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 7 affected / 8 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 8 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 8 at risk

Adverse event: Carpal tunnel
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Knee pain when walking
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Tinnutus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 8 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 8 at risk

Adverse event: Increased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 8 at risk

Adverse event: Difficulty falling asleep or frequent wakening
Serious: no
Organ System: General disorders
Frequency: 5 affected / 8 at risk

Adverse event: Early morning wakening
Serious: no
Organ System: General disorders
Frequency: 3 affected / 8 at risk

Adverse event: Increased acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 8 at risk

Adverse event: Weight increased
Serious: no
Organ System: General disorders
Frequency: 5 affected / 8 at risk
Study: NCT01859494

Adverse event: Hypoglycaemia
Serious: no
Organ System: Endocrine disorders
Notes: Subjects' hypoglycemia events were resolved at the visit.
Frequency: 8 affected / 219 at risk
Study: NCT01859598

Adverse event: nephroma
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 65 affected / 18995 at risk

Adverse event: Cardio-cerebrovascular disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 258 affected / 18995 at risk

Adverse event: pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 103 affected / 18995 at risk

Adverse event: nerve system
Serious: yes
Organ System: Nervous system disorders
Frequency: 50 affected / 18995 at risk

Adverse event: eye disease
Serious: yes
Organ System: Eye disorders
Frequency: 23 affected / 18995 at risk

Adverse event: Gastrointestinal disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 91 affected / 18995 at risk

Adverse event: Hepatobiliary disease
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 45 affected / 18995 at risk
Study: NCT01859702

Adverse event: Hypertensive crisis
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 36 at risk
Study: NCT01859793

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 1 subject developed a minor rash along the subjects belt line during the study and was withdrawn from the study. The subject was on placebo at the time as discovered following unblinding
Frequency: 1 affected / 36 at risk
Study: NCT01860040

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

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1 at risk
Study: NCT01860079

Adverse event: All cause mortality and readmission
Serious: yes
Organ System: Cardiac disorders
Frequency: 16 affected / 370 at risk

Adverse event: All cause mortality and readmission
Serious: yes
Organ System: Cardiac disorders
Frequency: 28 affected / 363 at risk
Study: NCT01860170

Adverse event: Vagotomy
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3 at risk

Adverse event: Syncope related to anemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3 at risk

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

Adverse event: Pyrexia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3 at risk

Adverse event: Vagotomy
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3 at risk

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

Adverse event: Epstein-Barr virus
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3 at risk

Adverse event: Respiratory syncytial virus
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3 at risk

Adverse event: Progressive multifocal leukoencephalopathy
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 22 at risk

Adverse event: Hypovolaemic shock
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 22 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 22 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 22 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Cytomegalovirus
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 22 at risk

Adverse event: Epstein-Barr virus
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 22 at risk

Adverse event: Respiratory syncytial virus
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 22 at risk

Adverse event: BK virus
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 22 at risk
Study: NCT01860404

Adverse event: Mild (not interfering with daily life) or Moderate (limitation to daily activity)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 8 at risk

Adverse event: Mild (not interfering with daily life) or Moderate (limitation to daily activity)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 8 at risk

Adverse event: Mild (not interfering with daily life) or Moderate (limitation to daily activity)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Mild (not interfering with daily life) or Moderate (limitation to daily activity)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk
Study: NCT01860417

Adverse event: Device failure
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 12 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 12 at risk
Study: NCT01860521

Adverse event: Haemorrhage
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 52 at risk

Adverse event: Uterine perforation
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 35 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 52 at risk

Adverse event: Hypotension
Serious: no
Organ System: General disorders
Frequency: 2 affected / 52 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 52 at risk

Adverse event: Pruritus
Serious: no
Organ System: General disorders
Frequency: 14 affected / 52 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 11 affected / 52 at risk

Adverse event: Sedation
Serious: no
Organ System: General disorders
Frequency: 3 affected / 52 at risk

Adverse event: Respiratory depression
Serious: no
Organ System: General disorders
Frequency: 2 affected / 52 at risk

Adverse event: Failure of induction
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 52 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 52 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 52 at risk

Adverse event: Hypotension
Serious: no
Organ System: General disorders
Frequency: 4 affected / 52 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 52 at risk

Adverse event: Pruritus
Serious: no
Organ System: General disorders
Frequency: 17 affected / 52 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 9 affected / 52 at risk

Adverse event: Failure of induction
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 52 at risk