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 @ 4:36 PM
Ignite Modification Date: 2025-12-25 @ 2:27 PM
NCT ID: NCT03383666
Description: Modified intent to treat (mITT) analysis set: all enrolled Participants in whom treatment with PulseRider device was attempted. Adverse event data was adjudicated by independent Clinical Events Committee (CEC).
Frequency Threshold: 0
Time Frame: From enrollment up to 1 year post procedure.
Study: NCT03383666
Study Brief: A Study Evaluating the Safety and Effectiveness of the PulseRider® Aneurysm Neck Reconstruction Device Used in Conjunction With Endovascular Coil Embolization in the Treatment of Wide-Neck Bifurcation Intracranial Aneurysm
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
PulseRider Aneurysm Neck Reconstruction Device Participants with wide-neck bifurcation intracranial aneurysms were implanted with PulseRider device. 0 None 5 21 13 21 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sickle cell anaemia with crisis NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Toxicity to various agents NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hyponatraemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Cerebral haemorrhage NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Suicide attempt NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Migraine NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neuralgia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Tremor NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Corneal abrasion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Vascular access site haematoma NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Vascular access site haemorrhage NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Diplopia NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Eye haemorrhage NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Muscular weakness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Confusional state NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Hallucination, visual NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Asthenia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Menorrhagia NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View