TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT03378076

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

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

Adverse event: Vessel puncture site haematoma
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 12 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 12 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 12 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 12 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 12 at risk

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

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 12 at risk

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

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

Adverse event: Food allergy
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 12 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 12 at risk

Adverse event: Fibromyalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Joint swelling
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 12 at risk
Study: NCT03378921

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

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

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

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk
Study: NCT03379233

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 6 at risk
Study: NCT03379376

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Notes: Led to death
Frequency: 1 affected / 10 at risk
Study: NCT03379675

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 24 at risk

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

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 24 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 24 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 24 at risk

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

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

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

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 24 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 24 at risk

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

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 24 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 24 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 24 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 24 at risk
Study: NCT03379740

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

Adverse event: Catheter site hypoaesthesia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Catheter site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

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

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

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

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

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

Adverse event: Catheter site inflammation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

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

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

Adverse event: Phlebitis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 15 at risk
Study: NCT03379792

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 6 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 9 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 9 at risk

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

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

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

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk
Study: NCT03379870

Adverse event: Pain
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Subject reported a headache and pain with loud sound.
Frequency: 1 affected / 16 at risk
Study: NCT03380026

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 16 affected / 28 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 28 at risk
Study: NCT03380390

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 46 at risk

Adverse event: Rash papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 46 at risk

Adverse event: Rash pustular
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 46 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 46 at risk

Adverse event: Face oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 46 at risk
Study: NCT03380572

Adverse event: Wound infection
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Wound infection
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 20 at risk

Adverse event: Bile leak
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 20 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk
Study: NCT03381989

Adverse event: Cardiac pacemaker insertion
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 30 at risk

Adverse event: Hemodynamic instability from lacertation requiring vasopressors
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 30 at risk

Adverse event: Secondary myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 30 at risk

Adverse event: Life threatening bleeding
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: not related to BASILICA
Frequency: 2 affected / 30 at risk

Adverse event: Major vascular complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: not related to BASILICA
Frequency: 6 affected / 30 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Notes: Disabling 1 subject Non-disabling 2 subjects
Frequency: 3 affected / 30 at risk

Adverse event: AKI - Acute Kidney Injury Stage 2/3
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 30 at risk
Study: NCT03382041

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

Adverse event: Fracture-left proximal tibial plateau
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 3 at risk

Adverse event: Sepsis secondary to hardware infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3 at risk
Study: NCT03382639

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 87 at risk

Adverse event: Rhabdomyolysis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 87 at risk

Adverse event: COVID-19
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 87 at risk

Adverse event: Tooth abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 87 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 87 at risk

Adverse event: Schizophrenia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 56 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 56 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 55 at risk
Study: NCT03382665

Adverse event: General SAE
Serious: yes
Organ System: General disorders
Notes: Serious Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 38 affected / 70 at risk

Adverse event: General AE
Serious: no
Organ System: General disorders
Notes: Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Frequency: 33 affected / 70 at risk
Study: NCT03382782

Adverse event: Difficulty walking to interview, back pain
Serious: yes
Organ System: General disorders
Notes: Researcher observed participant in hallway. Co-Investigator was consulted \& present. 2 public safety officers assisted until participant was picked up by caseworker.
Frequency: 1 affected / 69 at risk

Adverse event: High blood pressure observed at interview
Serious: yes
Organ System: General disorders
Notes: Participant's blood pressure was observed to be very high during data collection (1st reading: 160+/109) (2nd reading: 150+/109). Research interviewer notified medical team at clinic. Caseworker waited until transfer to hospital for evaluation.
Frequency: 1 affected / 74 at risk
Study: NCT03382834

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 21 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 21 at risk

Adverse event: Thirst
Serious: no
Organ System: General disorders
Frequency: 1 affected / 21 at risk

Adverse event: Metastatic squamous cell carcinoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 21 at risk
Study: NCT03382847

Adverse event: Pancreatitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 25 at risk
Study: NCT03382873

Adverse event: Colon abscess
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 86 at risk

Adverse event: Hand surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 86 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 86 at risk

Adverse event: Knee or hip pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 86 at risk

Adverse event: Hamstring tear
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 122 at risk

Adverse event: Hip arthroplasty
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 122 at risk

Adverse event: Arrythmia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 122 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 122 at risk

Adverse event: Knee or hip pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 122 at risk
Study: NCT03382925

Adverse event: Procedure AE
Serious: yes
Organ System: Cardiac disorders
Notes: AE for cardiac and unrelated to procedure.
Frequency: 1 affected / 10 at risk
Study: NCT03383523

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

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

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

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

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

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

Adverse event: Pigmentation disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 11 at risk

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

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

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

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Visual impairment
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 10 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 10 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: 1 affected / 12 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 11 at risk

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

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

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

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

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

Adverse event: Visual impairment
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 10 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk

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

Adverse event: Feeling of relaxation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk
Study: NCT03383588

Adverse event: Postpartum readmission to hospital (OBGYN related)
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Patient was admitted one week postoperatively for severe postpartum preeclampsia
Frequency: 1 affected / 8 at risk

Adverse event: Postpartum re-admission to hospital (not OBGYN related)
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Patient was admitted to general surgery service 1 month postpartum for acute cholecystitis requiring a cholecystectomy
Frequency: 1 affected / 9 at risk

Adverse event: Large intraoperative blood loss
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Patient had a placenta previa that was adhered to the lower intrauterine segment intraoperatively, had a large intraoperative blood loss not requiring transfusion, and had a uterine tamponade balloon placed intraoperatively
Frequency: 1 affected / 9 at risk

Adverse event: Large intraoperative blood loss
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Patient had preoperative anemia and a large intraoperative blood loss secondary to dense intraabdominal adhesions requiring 2 units pRBC's
Frequency: 1 affected / 9 at risk

Adverse event: Large intraoperative blood loss
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Patient had a placenta previa that was adhered to the lower intrauterine segment intraoperatively, had a large intraoperative blood loss not requiring transfusion, and had a uterine tamponade balloon placed intraoperatively
Frequency: 1 affected / 9 at risk
Study: NCT03383887

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk
Study: NCT03384693

Adverse event: Haemorrhage
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 25 at risk
Study: NCT03384784

Adverse event: Bone fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 52 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 52 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 52 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 49 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 4 affected / 49 at risk

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

Adverse event: Low Hemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 48 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 48 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 48 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 47 at risk

Adverse event: Muscle strain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 47 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 47 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 47 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 47 at risk
Study: NCT03385304

Adverse event: Study Fracture Related Complication
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 178 affected / 828 at risk

Adverse event: Non-Study Fracture Related Complication
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 23 affected / 828 at risk

Adverse event: Neurological
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 828 at risk

Adverse event: Renal
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 10 affected / 828 at risk

Adverse event: Cardiac
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 828 at risk

Adverse event: Vascular
Serious: yes
Organ System: Vascular disorders
Frequency: 11 affected / 828 at risk

Adverse event: Gastro-Intestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 828 at risk

Adverse event: Pulmonary
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 26 affected / 828 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Frequency: 95 affected / 828 at risk

Adverse event: Study Fracture Related Complication
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 192 affected / 810 at risk

Adverse event: Non-Study Fracture Related Complication
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 31 affected / 810 at risk

Adverse event: Neurological
Serious: yes
Organ System: Nervous system disorders
Frequency: 8 affected / 810 at risk

Adverse event: Renal
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 10 affected / 810 at risk

Adverse event: Cardiac
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 810 at risk

Adverse event: Vascular
Serious: yes
Organ System: Vascular disorders
Frequency: 12 affected / 810 at risk

Adverse event: Gastro-Intestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 810 at risk

Adverse event: Pulmonary
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 25 affected / 810 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Frequency: 69 affected / 810 at risk
Study: NCT03386032

Adverse event: Atopic /Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 36 at risk

Adverse event: Atopic /Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 18 at risk