TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01683383

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Note: These deaths were all attributed to disease complications and were not attributable to the study intervention.
Frequency: 6 affected / 49 at risk

Adverse event: Pulmonary haemorrhage
Serious: yes
Organ System: Vascular disorders
Notes: Note: Pulmonary hemorrhage was present prior to randomization and was not attributable to the study intervention.
Frequency: 1 affected / 51 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Note: These deaths were all attributed to disease complications and were not attributable to the study intervention.
Frequency: 9 affected / 51 at risk

Adverse event: Equipment alarms
Serious: no
Organ System: General disorders
Notes: Brief equipment alarms when non-physiologic changes in temperature were registered by the device
Frequency: 2 affected / 51 at risk
Study: NCT01683422

Adverse event: serious
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: metastatic disease
Frequency: 9 affected / 9 at risk
Study: NCT01683565

Adverse event: Gastrointestinal Symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 15 at risk

Adverse event: Ear Nose Throat Symptoms
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 6 affected / 15 at risk

Adverse event: Respiratory symptoms
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 15 at risk

Adverse event: Skin and Limb Symptoms
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 15 at risk

Adverse event: Behavioral Symptoms
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 15 at risk

Adverse event: Cold/Fever
Serious: no
Organ System: Infections and infestations
Notes: Multi-symptom illnesses reported by caregivers which typically included more than 1 body system and/or fever
Frequency: 2 affected / 15 at risk

Adverse event: Gastrointestinal Symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 16 at risk

Adverse event: Ear Nose Throat Symptoms
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 9 affected / 16 at risk

Adverse event: Respiratory symptoms
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 16 at risk

Adverse event: Skin and Limb Symptoms
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 16 at risk

Adverse event: Behavioral Symptoms
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 16 at risk

Adverse event: Cold/Fever
Serious: no
Organ System: Infections and infestations
Notes: Multi-symptom illnesses reported by caregivers which typically included more than 1 body system and/or fever
Frequency: 5 affected / 16 at risk
Study: NCT01683604

Adverse event: Mycoplasma infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 37 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 37 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 37 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 37 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 37 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 37 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 37 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 37 at risk

Adverse event: Infusion related reaction
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 37 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 37 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 37 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 37 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 37 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 37 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 37 at risk
Study: NCT01684007

Adverse event: Sjogren's syndrome
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 53 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 50 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 50 at risk

Adverse event: Sjogren's syndrome
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 50 at risk
Study: NCT01684020

Adverse event: Ecchymosis
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: A discoloration of the skin resulting from bleeding underneath, typically caused by bruising
Frequency: 1 affected / 5 at risk

Adverse event: Ecchymosis
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: A discoloration of the skin resulting from bleeding underneath, typically caused by bruising
Frequency: 1 affected / 4 at risk
Study: NCT01684566

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 57 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 57 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 57 at risk

Adverse event: Pulmonay haemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 57 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 57 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 57 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 57 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 57 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 57 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 57 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 8 affected / 57 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 57 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 52 at risk

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

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 52 at risk

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

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 52 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 52 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 52 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 6 affected / 52 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 52 at risk
Study: NCT01684592

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Five participants miscarried prior to randomization at week 26 but following study enrollment.
Frequency: 5 affected / 64 at risk
Study: NCT01684826

Adverse event: Ventricle Fibrillations (VF)
Serious: yes
Organ System: Cardiac disorders
Notes: defibrillation is done with 150 J
Frequency: 1 affected / 49 at risk

Adverse event: Type 2 Aorta dissection
Serious: yes
Organ System: Cardiac disorders
Notes: patient has atypical complaints. Suspected ACS. Troponin negative. Bloodpressure declines. Remaining contrast extra vasal (contrast injection in false lumen). Emergency CT scan made. Confirmed Aorta Dissection. Patient underwent emergency surgery.
Frequency: 1 affected / 49 at risk
Study: NCT01684930

Adverse event: hypotensive episode with exercise
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 12 at risk
Study: NCT01685073

Adverse event: Stroke, cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 62 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 62 at risk

Adverse event: Toothache
Serious: no
Organ System: General disorders
Frequency: 5 affected / 62 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 4 affected / 62 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: General disorders
Frequency: 6 affected / 62 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 62 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 62 at risk

Adverse event: Sleep Difficulties
Serious: no
Organ System: General disorders
Frequency: 2 affected / 62 at risk

Adverse event: Toothache
Serious: no
Organ System: General disorders
Frequency: 3 affected / 65 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 5 affected / 65 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: General disorders
Frequency: 9 affected / 65 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 65 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 65 at risk

Adverse event: Sleep Difficulties
Serious: no
Organ System: General disorders
Frequency: 5 affected / 65 at risk
Study: NCT01685229

Adverse event: GI Bleeding
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 146 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 146 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 146 at risk

Adverse event: Neuropenic Shock
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 146 at risk

Adverse event: Cancer, Glioblastoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 146 at risk

Adverse event: Bells Palsy, TIA
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 146 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 146 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 146 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 30 affected / 146 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 146 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 52 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 52 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 52 at risk
Study: NCT01685242

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 50 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Pharyngeal oedema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 50 at risk

Adverse event: Rheumatoid arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 50 at risk

Adverse event: Visual acuity reduced
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 50 at risk

Adverse event: Punctate keratitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 50 at risk

Adverse event: Lower respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 50 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 50 at risk
Study: NCT01685372

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Subject developed acute gastroenteritis 27 days after vaccination. Subject required hospitalization for rehydration and monitoring of immunosuppression levels.
Frequency: 1 affected / 7 at risk

Adverse event: Injection site reaction - pain
Serious: no
Organ System: General disorders
Notes: Pain at site of injection - Grade 1
Frequency: 6 affected / 7 at risk

Adverse event: Injection site reaction - induration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Induration at site of injection - Grade 2
Frequency: 1 affected / 7 at risk

Adverse event: Injection site reaction - bruising
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Bruising at site of injection - Grade 1
Frequency: 1 affected / 7 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Headache within 14 days of vaccination - Grade 1, possibly related
Frequency: 1 affected / 7 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Abdominal pain on day after vaccination - Grade 1, possibly related
Frequency: 1 affected / 7 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Notes: Subject developed dialysis catheter insertion site infection 15 days after vaccination. Subject was admitted for IV antibiotics. No long-term sequelae. SAE was determined to be not related to the vaccine by study DSMB.
Frequency: 1 affected / 9 at risk

Adverse event: Injection site reaction - pain
Serious: no
Organ System: General disorders
Notes: Pain at site of injection - Grade 1
Frequency: 7 affected / 9 at risk

Adverse event: Injection site reaction - induration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Induration at site of injection - Grade 1
Frequency: 1 affected / 9 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Fatigue starting a few days after injection - Grade 1, possibly related
Frequency: 1 affected / 9 at risk
Study: NCT01685411

Adverse event: Veno-occlusive disease (VOD)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Adrenal insufficiency
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 5 at risk

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

Adverse event: Bacterial infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 5 at risk

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

Adverse event: Cardiac dysfunction
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 5 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 5 at risk

Adverse event: CSA induced hypertension
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 5 at risk

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

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

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

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 5 at risk

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

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

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

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

Adverse event: Pericardial effusion
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 5 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 5 at risk

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

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

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

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

Adverse event: Transplant-associated thrombotic microangiopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 5 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 5 at risk
Study: NCT01685437

Adverse event: Acoustic neuroma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 189 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 189 at risk

Adverse event: Ureterolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 189 at risk

Adverse event: Penile haematoma
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 114 affected / 189 at risk

Adverse event: Penile pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 64 affected / 189 at risk

Adverse event: Penile swelling
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 57 affected / 189 at risk

Adverse event: Penile oedema
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 46 affected / 189 at risk

Adverse event: Penile haemorrhage
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 39 affected / 189 at risk

Adverse event: Injection site haematoma
Serious: no
Organ System: General disorders
Frequency: 35 affected / 189 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 32 affected / 189 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 21 affected / 189 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 20 affected / 189 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 17 affected / 189 at risk
Study: NCT01685697

Adverse event: Death during Admissions
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 28 at risk

Adverse event: Death during Admissions
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 28 at risk
Study: NCT01685840

Adverse event: Symptomatic Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 448 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 448 at risk

Adverse event: Worsening renal function
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 9 affected / 448 at risk

Adverse event: Other Adverse Events
Serious: yes
Organ System: Investigations
Notes: Other Adverse Events
Frequency: 19 affected / 448 at risk

Adverse event: Symptomatic Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 30 affected / 448 at risk

Adverse event: Symptomatic Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 448 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 22 affected / 448 at risk

Adverse event: Worsening renal function
Serious: no
Organ System: Renal and urinary disorders
Frequency: 83 affected / 448 at risk

Adverse event: Other Adverse Events
Serious: no
Organ System: Investigations
Notes: Other Adverse Events
Frequency: 19 affected / 448 at risk

Adverse event: Symptomatic Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 446 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 446 at risk

Adverse event: Worsening renal function
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 16 affected / 446 at risk

Adverse event: Other Adverse Events
Serious: yes
Organ System: Investigations
Notes: Other Adverse Events
Frequency: 17 affected / 446 at risk

Adverse event: Symptomatic Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 37 affected / 446 at risk

Adverse event: Symptomatic Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 446 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 30 affected / 446 at risk

Adverse event: Worsening renal function
Serious: no
Organ System: Renal and urinary disorders
Frequency: 91 affected / 446 at risk

Adverse event: Other Adverse Events
Serious: no
Organ System: Investigations
Notes: Other Adverse Events
Frequency: 18 affected / 446 at risk