Adverse Events Module

Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module


Ignite Creation Date: 2025-12-24 @ 2:17 PM
Ignite Modification Date: 2025-12-25 @ 12:54 PM
NCT ID: NCT03625895
Description: At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Frequency Threshold: 5
Time Frame: From start of study drug administration up to 12 months
Study: NCT03625895
Study Brief: Agrylin Drug Use-Result Survey
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Anagrelide Hydrochloride Participants who received treatment with Anagrelide hydrochloride will be evaluated for this study. Participants will receive interventions as part of routine medical care. 47 None 234 1241 477 1241 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Diverticulum intestinal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA/J Ver. 22.0 View
Duodenal ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA/J Ver. 22.0 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA/J Ver. 22.0 View
Enterocolitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA/J Ver. 22.0 View
Gastric ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA/J Ver. 22.0 View
Gastric ulcer haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA/J Ver. 22.0 View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA/J Ver. 22.0 View
Gastrointestinal perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA/J Ver. 22.0 View
Gingival bleeding SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA/J Ver. 22.0 View
Haemorrhoidal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA/J Ver. 22.0 View
Intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA/J Ver. 22.0 View
Mallory-Weiss syndrome SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA/J Ver. 22.0 View
Melaena SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA/J Ver. 22.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA/J Ver. 22.0 View
Oesophageal ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA/J Ver. 22.0 View
Pancreatitis acute SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA/J Ver. 22.0 View
Peritoneal haematoma SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA/J Ver. 22.0 View
Rectal ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA/J Ver. 22.0 View
Retroperitoneal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA/J Ver. 22.0 View
Small intestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA/J Ver. 22.0 View
Upper gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA/J Ver. 22.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA/J Ver. 22.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA/J Ver. 22.0 View
Condition aggravated SYSTEMATIC_ASSESSMENT General disorders MedDRA/J Ver. 22.0 View
Cerebrovascular stenosis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA/J Ver. 22.0 View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA/J Ver. 22.0 View
Oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA/J Ver. 22.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA/J Ver. 22.0 View
Bile duct obstruction SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA/J Ver. 22.0 View
Bile duct stone SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA/J Ver. 22.0 View
Cholangitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA/J Ver. 22.0 View
Cholangitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA/J Ver. 22.0 View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA/J Ver. 22.0 View
Hepatic function abnormal SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA/J Ver. 22.0 View
Liver disorder SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA/J Ver. 22.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA/J Ver. 22.0 View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA/J Ver. 22.0 View
Diverticulitis intestinal haemorrhagic SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA/J Ver. 22.0 View
Fungal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA/J Ver. 22.0 View
Hepatitis E SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA/J Ver. 22.0 View
Osteomyelitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA/J Ver. 22.0 View
Pneumonia bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA/J Ver. 22.0 View
Pseudomembranous colitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA/J Ver. 22.0 View
Pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA/J Ver. 22.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA/J Ver. 22.0 View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA/J Ver. 22.0 View
Vascular device infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA/J Ver. 22.0 View
Facial bones fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA/J Ver. 22.0 View
Forearm fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA/J Ver. 22.0 View
Joint dislocation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA/J Ver. 22.0 View
Spinal compression fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA/J Ver. 22.0 View
Subdural haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA/J Ver. 22.0 View
Tendon rupture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA/J Ver. 22.0 View
Traumatic haemothorax SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA/J Ver. 22.0 View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA/J Ver. 22.0 View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA/J Ver. 22.0 View
Cardiac failure acute SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA/J Ver. 22.0 View
Cardiac failure chronic SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA/J Ver. 22.0 View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA/J Ver. 22.0 View
Cardiac failure high output SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA/J Ver. 22.0 View
Cardio-respiratory arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA/J Ver. 22.0 View
Coronary artery stenosis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA/J Ver. 22.0 View
Left ventricular failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA/J Ver. 22.0 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA/J Ver. 22.0 View
Myocardial ischaemia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA/J Ver. 22.0 View
Haemorrhage SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA/J Ver. 22.0 View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA/J Ver. 22.0 View
Right ventricular failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA/J Ver. 22.0 View
Stress cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA/J Ver. 22.0 View
Torsade de pointes SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA/J Ver. 22.0 View
Hypertrophic cardiomyopathy SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA/J Ver. 22.0 View
Sudden hearing loss SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA/J Ver. 22.0 View
Autoimmune thyroiditis SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA/J Ver. 22.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA/J Ver. 22.0 View
Nephrogenic anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA/J Ver. 22.0 View
Pancytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA/J Ver. 22.0 View
Acute coronary syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA/J Ver. 22.0 View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA/J Ver. 22.0 View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA/J Ver. 22.0 View
Angina unstable SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA/J Ver. 22.0 View
Aortic valve incompetence SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA/J Ver. 22.0 View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA/J Ver. 22.0 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA/J Ver. 22.0 View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA/J Ver. 22.0 View
Bundle branch block bilateral SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA/J Ver. 22.0 View
Cardiac aneurysm SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA/J Ver. 22.0 View
Basedow's disease SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA/J Ver. 22.0 View
Hyperthyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA/J Ver. 22.0 View
Angle closure glaucoma SYSTEMATIC_ASSESSMENT Eye disorders MedDRA/J Ver. 22.0 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA/J Ver. 22.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA/J Ver. 22.0 View
Upper limb fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA/J Ver. 22.0 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA/J Ver. 22.0 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA/J Ver. 22.0 View
Electrocardiogram QT prolonged SYSTEMATIC_ASSESSMENT Investigations MedDRA/J Ver. 22.0 View
Electrocardiogram T wave inversion SYSTEMATIC_ASSESSMENT Investigations MedDRA/J Ver. 22.0 View
Pancreatic enzymes increased SYSTEMATIC_ASSESSMENT Investigations MedDRA/J Ver. 22.0 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA/J Ver. 22.0 View
Diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA/J Ver. 22.0 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA/J Ver. 22.0 View
Marasmus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA/J Ver. 22.0 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA/J Ver. 22.0 View
Rheumatoid arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA/J Ver. 22.0 View
Acute myeloid leukaemia SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA/J Ver. 22.0 View
Bladder cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA/J Ver. 22.0 View
Colon cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA/J Ver. 22.0 View
Gastric cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA/J Ver. 22.0 View
Haemangioma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA/J Ver. 22.0 View
Hepatic cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA/J Ver. 22.0 View
Hepatocellular carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA/J Ver. 22.0 View
Leukaemia SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA/J Ver. 22.0 View
Lung neoplasm malignant SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA/J Ver. 22.0 View
Myelodysplastic syndrome SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA/J Ver. 22.0 View
Myelofibrosis SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA/J Ver. 22.0 View
Myeloproliferative neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA/J Ver. 22.0 View
Nasopharyngeal cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA/J Ver. 22.0 View
Non-Hodgkin's lymphoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA/J Ver. 22.0 View
Ovarian neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA/J Ver. 22.0 View
Pancreatic carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA/J Ver. 22.0 View
Schwannoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA/J Ver. 22.0 View
Tumour rupture SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA/J Ver. 22.0 View
Altered state of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA/J Ver. 22.0 View
Brain stem infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA/J Ver. 22.0 View
Cerebral artery stenosis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA/J Ver. 22.0 View
Cerebral haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA/J Ver. 22.0 View
Cerebral infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA/J Ver. 22.0 View
Dementia Alzheimer's type SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA/J Ver. 22.0 View
Dementia with Lewy bodies SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA/J Ver. 22.0 View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA/J Ver. 22.0 View
Lacunar infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA/J Ver. 22.0 View
Loss of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA/J Ver. 22.0 View
Posterior reversible encephalopathy syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA/J Ver. 22.0 View
Putamen haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA/J Ver. 22.0 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA/J Ver. 22.0 View
Subarachnoid haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA/J Ver. 22.0 View
Thrombotic cerebral infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA/J Ver. 22.0 View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA/J Ver. 22.0 View
Bipolar I disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA/J Ver. 22.0 View
Delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA/J Ver. 22.0 View
Chronic kidney disease SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA/J Ver. 22.0 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA/J Ver. 22.0 View
Nephrotic syndrome SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA/J Ver. 22.0 View
Renal disorder SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA/J Ver. 22.0 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA/J Ver. 22.0 View
Renal impairment SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA/J Ver. 22.0 View
Emphysema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA/J Ver. 22.0 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA/J Ver. 22.0 View
Interstitial lung disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA/J Ver. 22.0 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA/J Ver. 22.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA/J Ver. 22.0 View
Pneumonia aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA/J Ver. 22.0 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA/J Ver. 22.0 View
Pulmonary hypertension SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA/J Ver. 22.0 View
Pulmonary oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA/J Ver. 22.0 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA/J Ver. 22.0 View
Dermatitis bullous SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA/J Ver. 22.0 View
Haemorrhage subcutaneous SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA/J Ver. 22.0 View
Dialysis SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA/J Ver. 22.0 View
Aortic dissection SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA/J Ver. 22.0 View
Aortic thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA/J Ver. 22.0 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA/J Ver. 22.0 View
Extremity necrosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA/J Ver. 22.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA/J Ver. 22.0 View
Internal haemorrhage SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA/J Ver. 22.0 View
Polyarteritis nodosa SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA/J Ver. 22.0 View
Prinzmetal angina SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA/J Ver. 22.0 View
Raynaud's phenomenon SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA/J Ver. 22.0 View
Shock haemorrhagic SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA/J Ver. 22.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA/J Ver. 22.0 View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA/J Ver. 22.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA/J Ver. 22.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA/J Ver. 22.0 View