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 @ 11:09 PM
Ignite Modification Date: 2025-12-25 @ 8:43 PM
NCT ID: NCT05321069
Description: Treated Set (TS): This patient set includes all randomized patients who received at least one dose of study drug.
Frequency Threshold: 5
Time Frame: AE collection and All-cause mortality From first trial drug administration (Placebo or Nerandomilast) up to 22.9 months.
Study: NCT05321069
Study Brief: A Study to Find Out Whether BI 1015550 Improves Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Participants received placebo matching 9 mg or 18 mg nerandomilast film-coated tablets orally twice daily, with doses given at least 12 hours apart and each taken with 250 mL of water. 42 None 181 393 316 393 View
Nera 9 mg BID Participants received 9 mg film-coated nerandomilast tablets orally twice daily, with doses administered at least 12 hours apart, each taken with 250 mL of water. 36 None 159 392 319 392 View
Nera 18 mg BID Participants received 18 mg film-coated nerandomilast tablets orally twice daily, with doses administered at least 12 hours apart, each taken with 250 mL of water. 26 None 165 392 337 392 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Atrioventricular block second degree SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.1 View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.1 View
Bundle branch block right SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.1 View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.1 View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.1 View
Cardiac failure acute SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.1 View
Cardiac failure chronic SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.1 View
Cardiac valve disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.1 View
Cardio-respiratory arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.1 View
Cardiogenic shock SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.1 View
Cor pulmonale SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.1 View
Cor pulmonale chronic SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.1 View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.1 View
Coronary artery dissection SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.1 View
Coronary artery occlusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.1 View
Coronary artery stenosis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.1 View
Heart failure with preserved ejection fraction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.1 View
Heart failure with reduced ejection fraction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.1 View
Ischaemic cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.1 View
Left ventricular failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.1 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.1 View
Myocardial ischaemia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.1 View
Pericarditis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.1 View
Right ventricular failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.1 View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.1 View
Ventricular fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.1 View
Ventricular hypertrophy SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.1 View
Hypertrophic cardiomyopathy SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 27.1 View
Retinopathy congenital SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 27.1 View
Presbyacusis SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 27.1 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 27.1 View
Hyperparathyroidism primary SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 27.1 View
Amaurosis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 27.1 View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 27.1 View
Dry age-related macular degeneration SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 27.1 View
Glaucoma SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 27.1 View
Hypotony of eye SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 27.1 View
Retinal infarction SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 27.1 View
Retinal tear SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 27.1 View
Retinal vein occlusion SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 27.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Abdominal wall haematoma SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Enteritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Enterocolitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Haematochezia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Hiatus hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Inguinal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Intestinal mass SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Intestinal perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Large intestine perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Large intestine polyp SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Mechanical ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Obstructive pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Oesophageal rupture SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Oesophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Oronasal fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Pancreatitis acute SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Tongue ulceration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Upper gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Varices oesophageal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Volvulus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.1 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.1 View
Condition aggravated SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.1 View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.1 View
Disease progression SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.1 View
Gait disturbance SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.1 View
General physical health deterioration SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.1 View
Illness SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.1 View
Inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.1 View
Sudden death SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.1 View
Vascular stent stenosis SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.1 View
Bile duct stone SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 27.1 View
Biliary colic SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 27.1 View
Biliary dilatation SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 27.1 View
Biliary obstruction SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 27.1 View
Cholangitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 27.1 View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 27.1 View
Cholecystitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 27.1 View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 27.1 View
Drug-induced liver injury SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 27.1 View
Hepatic cirrhosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 27.1 View
Hepatic failure SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 27.1 View
Hepatic function abnormal SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 27.1 View
Hepatitis toxic SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 27.1 View
Liver injury SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 27.1 View
Portal vein thrombosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 27.1 View
Suspected drug-induced liver injury SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 27.1 View
Anaphylactic shock SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 27.1 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 27.1 View
Appendiceal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Aspergillus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Atypical mycobacterial infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Atypical pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Biliary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
COVID-19 pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Cholecystitis infective SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Coronavirus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Cytomegalovirus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Endocarditis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Febrile infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Gastroenteritis norovirus SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Gastroenteritis salmonella SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Gastrointestinal bacterial infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
HCoV-OC43 infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Hepatitis E SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Laryngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Latent tuberculosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Norovirus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Pleurisy bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Pneumocystis jirovecii pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Pneumonia aspiration SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Pneumonia bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Pneumonia fungal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Pneumonia haemophilus SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Pneumonia influenzal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Pneumonia mycoplasmal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Pneumonia pseudomonal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Pneumonia viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Pyelonephritis acute SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Salmonellosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Tuberculosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Urosepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Cervical vertebral fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.1 View
Clavicle fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.1 View
Compression fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.1 View
Coronary artery restenosis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.1 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.1 View
Femur fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.1 View
Fractured sacrum SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.1 View
Hip fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.1 View
Humerus fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.1 View
Lower limb fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.1 View
Pelvic fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.1 View
Procedural pneumothorax SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.1 View
Rib fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.1 View
Road traffic accident SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.1 View
Skin laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.1 View
Venomous bite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.1 View
Wrist fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.1 View
Amylase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
C-reactive protein increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
Clostridium test positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
False positive investigation result SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
Haemoglobin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
Heart rate irregular SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
Influenza A virus test positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
Interferon gamma release assay positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
Lipase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
Oxygen saturation decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
Troponin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.1 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.1 View
Diabetes mellitus inadequate control SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.1 View
Fluid retention SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.1 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.1 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.1 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.1 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.1 View
Malnutrition SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.1 View
Arthropathy SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.1 View
Chondropathy SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.1 View
Gouty arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.1 View
Intervertebral disc protrusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.1 View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.1 View
Osteonecrosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.1 View
Polymyalgia rheumatica SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.1 View
Polymyositis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.1 View
Rhabdomyolysis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.1 View
Rotator cuff syndrome SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.1 View
Spinal osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.1 View
Spinal stenosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.1 View
Systemic scleroderma SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.1 View
Acute leukaemia SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.1 View
Adenocarcinoma of colon SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.1 View
Atypical fibroxanthoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.1 View
Basal cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.1 View
Bladder cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.1 View
Bladder cancer stage 0, with cancer in situ SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.1 View
Bladder papilloma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.1 View
Bowen's disease SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.1 View
Cholangiocarcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.1 View
Chronic myeloid leukaemia SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.1 View
Clear cell renal cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.1 View
Colon cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.1 View
Ductal adenocarcinoma of pancreas SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.1 View
Extranodal marginal zone B-cell lymphoma (MALT type) SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.1 View
Hepatocellular carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.1 View
Hodgkin's disease SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.1 View
Laryngeal neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.1 View
Lip squamous cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.1 View
Lung adenocarcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.1 View
Lung cancer metastatic SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.1 View
Lung neoplasm malignant SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.1 View
Metastases to bone SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.1 View
Metastases to liver SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.1 View
Metastases to lung SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.1 View
Metastatic neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.1 View
Neuroendocrine carcinoma of the skin SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.1 View
Oesophageal neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.1 View
Prostate cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.1 View
Queyrat erythroplasia SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.1 View
Rectal adenocarcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.1 View
Rectal cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.1 View
Sarcomatoid carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.1 View
Skin cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.1 View
Squamous cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.1 View
Squamous cell carcinoma of lung SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.1 View
Squamous cell carcinoma of skin SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.1 View
Sweat gland tumour SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.1 View
Transitional cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.1 View
Carotid artery dissection SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Carotid artery stenosis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Central nervous system haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Cerebral haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Cerebral infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Dementia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Epilepsy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Focal dyscognitive seizures SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Haemorrhagic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Ischaemic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Lacunar infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Loss of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Mental impairment SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Metabolic encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Middle cerebral artery stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Monoplegia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Myelopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Partial seizures SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Spinal claudication SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Subdural hygroma SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Alcohol abuse SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 27.1 View
Delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 27.1 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 27.1 View
Depressive symptom SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 27.1 View
Hallucinations, mixed SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 27.1 View
Major depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 27.1 View
Mental status changes SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 27.1 View
Suicidal ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 27.1 View
Tobacco abuse SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 27.1 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 27.1 View
Nephritis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 27.1 View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 27.1 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 27.1 View
Renal impairment SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 27.1 View
Urethral stenosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 27.1 View
Benign prostatic hyperplasia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 27.1 View
Genital prolapse SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 27.1 View
Prostatitis SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 27.1 View
Prostatomegaly SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 27.1 View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.1 View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.1 View
Chronic respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.1 View
Dyspnoea exertional SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.1 View
Emphysema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.1 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.1 View
Haemothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.1 View
Hepatopulmonary syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.1 View
Hypercapnia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.1 View
Hypersensitivity pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.1 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.1 View
Idiopathic pulmonary fibrosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.1 View
Interstitial lung disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.1 View
Painful respiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.1 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.1 View
Pneumomediastinum SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.1 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.1 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.1 View
Pneumothorax spontaneous SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.1 View
Pulmonary arterial hypertension SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.1 View
Pulmonary artery dilatation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.1 View
Pulmonary artery thrombosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.1 View
Pulmonary congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.1 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.1 View
Pulmonary fibrosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.1 View
Pulmonary hypertension SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.1 View
Pulmonary venous hypertension SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.1 View
Respiratory distress SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.1 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.1 View
Vocal cord leukoplakia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.1 View
Assisted suicide SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 27.1 View
Aneurysm SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 27.1 View
Aortic aneurysm SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 27.1 View
Aortic dilatation SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 27.1 View
Aortic dissection SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 27.1 View
Aortic stenosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 27.1 View
Arteriosclerosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 27.1 View
Circulatory collapse SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 27.1 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 27.1 View
Granulomatosis with polyangiitis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 27.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 27.1 View
Hypertensive urgency SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 27.1 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 27.1 View
Hypovolaemic shock SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 27.1 View
Iliac artery stenosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 27.1 View
Microscopic polyangiitis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 27.1 View
Peripheral artery occlusion SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 27.1 View
Vasculitis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 27.1 View
Venous thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 27.1 View
Acquired factor VIII deficiency SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27.1 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27.1 View
Autoimmune haemolytic anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27.1 View
Blood loss anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27.1 View
Pancytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27.1 View
Acute coronary syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.1 View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.1 View
Acute right ventricular failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.1 View
Angina unstable SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.1 View
Aortic valve incompetence SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.1 View
Aortic valve stenosis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.1 View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.1 View
Arteriosclerosis coronary artery SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.1 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.1 View
Atrial flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.1 View
Atrioventricular block SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Condition aggravated SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.1 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 27.1 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 27.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.1 View