Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 7:36 PM
Ignite Modification Date: 2025-12-25 @ 5:17 PM
NCT ID: NCT04712903
Description: None
Frequency Threshold: 5
Time Frame: During study treatment, until disease progression (median 6 months)
Study: NCT04712903
Study Brief: Durvalumab Plus Chemotherapy in Untreated Patients With Extensive-Stage Small Cell Lung Cancer
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Experimental Arm Received study intervention 76 None 57 101 100 101 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Febrile neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Pancytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Atrial flutter NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardio-respiratory arrest NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Inappropriate antidiuretic hormone secretion NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Diplopia NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Haematemesis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Bile duct stone NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Hepatitis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
COVID-19 NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
COVID-19 pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Herpes zoster reactivation NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Staphylococcal infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Radial head dislocation NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Neutrophil count decreased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Transaminases increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Hypoglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyponatraemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Bone pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Bladder neoplasm NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Rectal neoplasm NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Cerebellar syndrome NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Haemorrhage intracranial NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Immune-mediated neurological disorder NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Multiple sclerosis NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neurological decompensation NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Seizure NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Spinal cord compression NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Confusional state NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Acute kidney injury NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Nephritis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Renal tubular disorder NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Haemoptysis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Obstructive airways disorder NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumonitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory failure NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Skin reaction NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Peripheral ischaemia NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Superior vena cava syndrome NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Asthenia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Alopecia NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Decreased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hypothyroidism NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Platelet count decreased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Mucosal inflammation NON_SYSTEMATIC_ASSESSMENT General disorders None View
Respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hypomagnesaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyponatraemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Oedema peripheral NON_SYSTEMATIC_ASSESSMENT General disorders None View
Neutrophil count decreased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Haemoptysis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hyperthyroidism NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Amylase increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Acute kidney injury NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Illness NON_SYSTEMATIC_ASSESSMENT General disorders None View
COVID-19 NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Gamma-glutamyltransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Lymphocyte count decreased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Dysgeusia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View