TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01084668

Adverse event: Ligament rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 42 at risk

Adverse event: Arthroscopic surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 42 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 42 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 42 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 42 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 42 at risk

Adverse event: Injection site urticaria
Serious: no
Organ System: General disorders
Frequency: 1 affected / 42 at risk

Adverse event: Tooth fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 42 at risk

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

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

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 42 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 42 at risk
Study: NCT01084759

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 16 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Infections and infestations
Notes: Patient died as a result
Frequency: 1 affected / 16 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 16 at risk

Adverse event: Fatigue
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 16 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 16 at risk

Adverse event: Oedema
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 16 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 16 at risk

Adverse event: Priapism
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 16 at risk
Study: NCT01085201

Adverse event: Sickle cell crisis with prolonged hospitalization - Grade 2
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Uncomplicated vaso-occlusive crisis requiring hospitalization - Grade 3
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Uncomplicated vaso-occlusive crisis requiring hospitalization - Grade 3
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Rib pain, leading to hospitalization - Grade 3
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 6 at risk
Study: NCT01085500

Adverse event: Peritoneal tear
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 26 at risk

Adverse event: Epigastric vessel injury
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Haematoma
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 26 at risk

Adverse event: Peritoneal tear
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 24 at risk

Adverse event: Epigastric vessel injury
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 24 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 9 affected / 24 at risk

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

Adverse event: Superficial skin infection
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 24 at risk
Study: NCT01085513

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 75 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 75 at risk
Study: NCT01085760

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: numbness and tingling of extremities
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Vertigo
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 8 at risk

Adverse event: increased itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: headaches
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 8 at risk

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

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

Adverse event: increased fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: increased bilirubin
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 9 at risk

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

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

Adverse event: metallic taste
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 9 at risk

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

Adverse event: increased fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 1 affected / 9 at risk

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

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 9 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 9 at risk

Adverse event: metallic taste
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 9 at risk

Adverse event: numbness and tingling of extremities
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 9 at risk

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

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 9 at risk

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

Adverse event: increased fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 9 at risk
Study: NCT01085786

Adverse event: Dysgeusia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 123 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 123 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 123 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 117 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 117 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 117 at risk
Study: NCT01085903

Adverse event: vasovagal response
Serious: no
Organ System: Vascular disorders
Notes: One normal subject had a vasovagal response during the swallowing evaluation
Frequency: 1 affected / 21 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Notes: One participant had an additional stroke that was unrelated to the study
Frequency: 1 affected / 7 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: one participant broke a hip but this was not related to the study
Frequency: 1 affected / 7 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: headache with or without dizzyness
Frequency: 2 affected / 7 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: rash with or without itchyness
Frequency: 3 affected / 7 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Notes: report of difficulty sleeping
Frequency: 1 affected / 7 at risk
Study: NCT01086215

Adverse event: Bleeding Requiring Transfusion
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 212 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 212 at risk

Adverse event: Bleeding Requiring Transfusion
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 201 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 201 at risk
Study: NCT01086358

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: Sleepiness
Frequency: 8 affected / 45 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 45 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Lightheaded, head pressure and tightness and head rush, diaphoresis
Frequency: 4 affected / 45 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 4 affected / 45 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Frequency: 1 affected / 45 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Loopiness and Dopey
Frequency: 1 affected / 45 at risk

Adverse event: Apraxia
Serious: no
Organ System: Nervous system disorders
Notes: Word finding difficulty
Frequency: 1 affected / 45 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 45 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 1 affected / 45 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Notes: dry mouth and jaw tightness
Frequency: 2 affected / 45 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 45 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: Sleepiness
Frequency: 4 affected / 45 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 45 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Lightheaded, head pressure and tightness and head rush, diaphoresis
Frequency: 1 affected / 45 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 45 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Frequency: 1 affected / 45 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Loopiness and Dopey
Frequency: 1 affected / 45 at risk

Adverse event: Apraxia
Serious: no
Organ System: Nervous system disorders
Notes: Word finding difficulty
Frequency: 1 affected / 45 at risk

Adverse event: Bladder pain
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 45 at risk
Study: NCT01086475

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 9 affected / 34 at risk

Adverse event: Nasal congestion or Cold
Serious: no
Organ System: General disorders
Frequency: 6 affected / 34 at risk

Adverse event: Cough
Serious: no
Organ System: General disorders
Frequency: 7 affected / 34 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 6 affected / 34 at risk

Adverse event: Aggression
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 34 at risk

Adverse event: Increased Motor Activity
Serious: no
Organ System: General disorders
Frequency: 1 affected / 34 at risk

Adverse event: Interrupted Sleep/Other sleep problems
Serious: no
Organ System: General disorders
Frequency: 3 affected / 34 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 16 affected / 34 at risk

Adverse event: Restlessness/Agitation
Serious: no
Organ System: General disorders
Frequency: 4 affected / 34 at risk

Adverse event: Sadness
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 34 at risk

Adverse event: Sedation/Drowsiness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 34 at risk

Adverse event: Suicidal comment
Serious: yes
Organ System: Psychiatric disorders
Notes: One instance of making a suicidal comment at school when angry.
Frequency: 1 affected / 33 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 7 affected / 33 at risk

Adverse event: Nasal congestion or Cold
Serious: no
Organ System: General disorders
Frequency: 8 affected / 33 at risk

Adverse event: Cough
Serious: no
Organ System: General disorders
Frequency: 7 affected / 33 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 2 affected / 33 at risk

Adverse event: Aggression
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 33 at risk

Adverse event: Increased Motor Activity
Serious: no
Organ System: General disorders
Frequency: 5 affected / 33 at risk

Adverse event: Interrupted Sleep/Other sleep problems
Serious: no
Organ System: General disorders
Frequency: 5 affected / 33 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 15 affected / 33 at risk

Adverse event: Restlessness/Agitation
Serious: no
Organ System: General disorders
Frequency: 3 affected / 33 at risk

Adverse event: Sadness
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 33 at risk

Adverse event: Sedation/Drowsiness
Serious: no
Organ System: General disorders
Frequency: 6 affected / 33 at risk
Study: NCT01086852

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 4 at risk

Adverse event: Post procedural discomfort
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4 at risk

Adverse event: Incision site complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 4 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 4 at risk

Adverse event: Procedural pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 4 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 2 affected / 4 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 4 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 4 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 4 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Ecchymosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 4 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 4 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 4 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 4 at risk
Study: NCT01086969

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 11 affected / 100 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 100 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 9 affected / 100 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 13 affected / 100 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 30 affected / 100 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 7 affected / 100 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 10 affected / 100 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 100 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 19 affected / 100 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 13 affected / 100 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 100 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 23 affected / 100 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 100 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 4 affected / 100 at risk

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

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 19 affected / 100 at risk

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

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 100 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 38 affected / 100 at risk
Study: NCT01087489

Adverse event: Death
Serious: yes
Organ System: Gastrointestinal disorders
Notes: death during hospitalization for general surgery
Frequency: 1 affected / 53 at risk

Adverse event: Death
Serious: yes
Organ System: Gastrointestinal disorders
Notes: death during hospitalization for general surgery
Frequency: 1 affected / 53 at risk
Study: NCT01087528

Adverse event: bruising to abdomen
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 51 at risk

Adverse event: Left eye pain
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 51 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 51 at risk
Study: NCT01087541

Adverse event: Drug interactions not serious
Serious: no
Organ System: Investigations
Notes: The assessment for drug interactions was performed by informatic methods. The adverse event was concomitant treatment with gemfibrozil plus glitazones, that is not recommended.
Frequency: 2 affected / 52 at risk

Adverse event: Drug interactions not serious
Serious: no
Organ System: Investigations
Notes: The assessment for drug interactions was performed by informatic methods. The adverse event was concomitant treatment with gemfibrozil plus glitazones, that is not recommended.
Frequency: 1 affected / 87 at risk
Study: NCT01087931

Adverse event: Superficial Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk
Study: NCT01088243

Adverse event: One 5-ASA-treated subject developed dizziness, constipation, stomach pain and chest pain two weeks
Serious: no
Organ System: General disorders
Notes: Dizziness, constipation, stomach pain and chest pain
Frequency: 1 affected / 13 at risk

Adverse event: One 5-ASA-treated subject experienced coughing and low energy after the follow-up bronchoscopy
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Mobitz Type II heart block
Serious: no
Organ System: Cardiac disorders
Notes: In the placebo-treated subjects, we identified a Mobitz Type II heart block during a follow-up bronchoscopy. It was not related to the treatment.
Frequency: 1 affected / 5 at risk

Adverse event: Swelling
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 5 at risk
Study: NCT01088646

Adverse event: capsule failed to deploy in first attempt
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 25 at risk
Study: NCT01088672

Adverse event: Death
Serious: yes
Organ System: Vascular disorders
Frequency: 12 affected / 60 at risk

Adverse event: SICH
Serious: yes
Organ System: Vascular disorders
Notes: Symptomatic intracerebral hemorrhage
Frequency: 5 affected / 60 at risk

Adverse event: Perforation
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 60 at risk

Adverse event: Asymptomatic hemorrhage
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 60 at risk
Study: NCT01088997

Adverse event: Hypoxia requiring ECMO
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 7 at risk

Adverse event: Elevated Liver Function Tests
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 7 at risk

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

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 5 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 5 at risk