TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01856114

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 11 at risk

Adverse event: Drowsy
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 11 at risk

Adverse event: Itchiness
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 11 at risk
Study: NCT01856140

Adverse event: Swelling at injection site
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Although mild swelling was seen at the injection site in six participants (three in group 1 and three in group 2) within 48 hours after injection, the regional swelling subsided spontaneously (without any treatment) within 2 weeks.
Frequency: 3 affected / 6 at risk

Adverse event: Swelling at injection site
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Although mild swelling was seen at the injection site in six participants (three in group 1 and three in group 2) within 48 hours after injection, the regional swelling subsided spontaneously (without any treatment) within 2 weeks.
Frequency: 3 affected / 6 at risk
Study: NCT01856270

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

Adverse event: Increased QTc
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 24 at risk

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

Adverse event: decreased libido
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 24 at risk

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

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

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

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 26 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 26 at risk

Adverse event: possible metabolic encephalopathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 26 at risk
Study: NCT01856530

Adverse event: Jitteriness/restlessness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 27 at risk

Adverse event: Anxiety
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 27 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 27 at risk

Adverse event: Jitteriness/restlessness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 27 at risk

Adverse event: Anxiety
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 27 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 27 at risk
Study: NCT01856543

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 73 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 73 at risk

Adverse event: Myocarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 73 at risk

Adverse event: Pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 73 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 73 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 13 affected / 73 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 73 at risk

Adverse event: Radiation skin injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 73 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 73 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 73 at risk

Adverse event: Radiation skin injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 70 at risk

Adverse event: Skin infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 70 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 10 affected / 70 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 70 at risk

Adverse event: Radiation skin injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 70 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 70 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 70 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 70 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 70 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 70 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 70 at risk
Study: NCT01856582

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 23 at risk

Adverse event: Chronic sinusitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 23 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 23 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Hepatic failure
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 23 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 23 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 23 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 23 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 23 at risk

Adverse event: Haemolysis
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 23 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 23 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 23 at risk
Study: NCT01856712

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 23 at risk
Study: NCT01856764

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

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 20 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 20 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 20 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

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

Adverse event: Red blood cells urine
Serious: no
Organ System: Investigations
Frequency: 1 affected / 20 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 20 at risk
Study: NCT01856790

Adverse event: gastrointestinal distress
Serious: no
Organ System: Gastrointestinal disorders
Notes: nausea, decreased appetite, constipation, bloating, and/or diarrhea
Frequency: 6 affected / 11 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: headache
Frequency: 6 affected / 11 at risk
Study: NCT01856855

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 26 at risk

Adverse event: Haematochezia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 26 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 7 affected / 26 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 26 at risk

Adverse event: Micturition urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 26 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 26 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 10 affected / 26 at risk
Study: NCT01856868

Adverse event: Bruising at the biopsy site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 6 at risk

Adverse event: Non-biopsy-related flulike symptoms
Serious: no
Organ System: General disorders
Frequency: 2 affected / 6 at risk

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

Adverse event: suspected varicella (shingles)
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk
Study: NCT01856907

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 12 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 12 at risk
Study: NCT01857063

Adverse event: Protein urine present
Serious: no
Organ System: Investigations
Frequency: 10 affected / 216 at risk

Adverse event: Protein urine present
Serious: no
Organ System: Investigations
Frequency: 17 affected / 218 at risk
Study: NCT01857245

Adverse event: Virologic Failure (HCV)
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 51 at risk

Adverse event: Virologic Failure (HCV)
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 48 at risk

Adverse event: Virologic Failure (HCV)
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 5 affected / 51 at risk
Study: NCT01857271

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

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3 at risk
Study: NCT01857297

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 35 affected / 60 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 14 affected / 60 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 6 affected / 60 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: unsolicited adverse event
Frequency: 15 affected / 60 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: unsolicited adverse event
Frequency: 6 affected / 60 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: unsolicited adverse event
Frequency: 4 affected / 60 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 8 affected / 60 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 4 affected / 60 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 4 affected / 60 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: unsolicited adverse event
Frequency: 6 affected / 60 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: unsolicited adverse event
Frequency: 1 affected / 60 at risk
Study: NCT01857310

Adverse event: Eosinophilic oesophagitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1185 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1185 at risk

Adverse event: Clostridium difficile infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1185 at risk

Adverse event: Staphylococcal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1185 at risk

Adverse event: Rhabdomyolysis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1185 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1185 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1185 at risk

Adverse event: Abdominal discomfort or pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 66 affected / 1185 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 66 affected / 1185 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 57 affected / 1185 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1185 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1185 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1185 at risk

Adverse event: Gun shot wound
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1185 at risk

Adverse event: Variococele repair
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1185 at risk

Adverse event: Abdominal discomfort or pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 40 affected / 1185 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 62 affected / 1185 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 60 affected / 1185 at risk
Study: NCT01857323

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 316 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 316 at risk

Adverse event: Drug eruption
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 316 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 316 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 316 at risk
Study: NCT01857362

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

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 12 at risk

Adverse event: Increased appetite
Serious: no
Organ System: Metabolism and nutrition 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: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Catheter site related reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

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

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

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 12 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 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: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 12 at risk
Study: NCT01857531

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 16 at risk

Adverse event: Fatigue
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 16 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 16 at risk

Adverse event: Balance disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 16 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 16 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 16 at risk

Adverse event: Irritability
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 16 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 16 at risk

Adverse event: Nightmare
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 16 at risk

Adverse event: Abnormal dreams
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 16 at risk

Adverse event: Muscle / joint pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 16 at risk

Adverse event: Thirst
Serious: no
Organ System: General disorders
Frequency: 3 affected / 16 at risk

Adverse event: Stomatitis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Itching at patch site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 16 at risk

Adverse event: Rash at patch site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 16 at risk
Study: NCT01857713

Adverse event: Reza Band Comfort
Serious: no
Organ System: Social circumstances
Notes: Woke up because Reza Band was too uncomfortable
Frequency: 1 affected / 95 at risk

Adverse event: Post Nasal Drip
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Patient reported post nasal drip while wearing Reza Band
Frequency: 1 affected / 95 at risk

Adverse event: Temporomandibular pain and dysfunction syndrome
Serious: no
Organ System: General disorders
Notes: TMJ was noted following a dental procedure. Determined by the investigator to not be related to the device.
Frequency: 1 affected / 95 at risk

Adverse event: Bruised neck
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Patient reported sleeping on stomach which resulted in bruising of the neck from the device.
Frequency: 1 affected / 95 at risk

Adverse event: Biopsies due to Colonoscopy
Serious: no
Organ System: Gastrointestinal disorders
Notes: Two biopsies taken as a result of colonoscopy. Determined by the investigator not to be related to the device.
Frequency: 1 affected / 95 at risk

Adverse event: Fell Down
Serious: no
Organ System: General disorders
Notes: Fell down in garage and injured foot. Determined by the investigator not to be related to the device.
Frequency: 1 affected / 95 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Infection that was ongoing and treated by the investigator with antibiotics. Determined by the investigator not to be related to the device.
Frequency: 1 affected / 95 at risk
Study: NCT01857973

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 78 at risk

Adverse event: Left arm pain due to IV placement
Serious: no
Organ System: General disorders
Frequency: 1 affected / 78 at risk

Adverse event: Right arm pain due to IV placement
Serious: no
Organ System: General disorders
Frequency: 1 affected / 78 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 78 at risk

Adverse event: Facial petechiae of the eyes
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 78 at risk

Adverse event: Costochondritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 78 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 78 at risk

Adverse event: Severe hyperglycemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 78 at risk

Adverse event: Sunburn
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 78 at risk
Study: NCT01857986

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 39 at risk

Adverse event: Atrial Fibrilation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 39 at risk

Adverse event: Infection of surgery wound
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 39 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 39 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 39 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 33 at risk

Adverse event: Haemodynamic instability
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: Atrial Fibrilation
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 33 at risk

Adverse event: Infection of surgery wound
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 33 at risk

Adverse event: Melaena
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 33 at risk

Adverse event: Massive bleeding after surgery
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 33 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 33 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 33 at risk

Adverse event: Pulmonary oedema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 33 at risk