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 @ 6:38 PM
Ignite Modification Date: 2025-12-25 @ 4:09 PM
NCT ID: NCT02707757
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT02707757
Study Brief: Treatment Response in Dialysis Anaemia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Iron Sucrose Iron sucrose 200mg for 5 doses Iron sucrose: 1gram of iron sucrose (5 200mg aliquots) administered if participant's haemoglobin is less than 9.5g/dl 3 None 17 88 2 88 View
Neorecormon Incremental increase in dose along following parameters: 1000-2000-3000-4000-6000-8000-12000 Erythopoietin stimulating agent: Incremental increase in dose of erythropoeitin stimulating agent being administered as per a pre-defined criteria 2 None 21 96 1 96 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute coronary syndrome None Cardiac disorders None View
Cardiac arrhythmia None Cardiac disorders None View
Bacteraemia None Infections and infestations None View
Soft tissue infection None Skin and subcutaneous tissue disorders None View
Cervical discitis None Musculoskeletal and connective tissue disorders None View
Dyspepsia None Gastrointestinal disorders None View
Hip fracture None Musculoskeletal and connective tissue disorders None View
Chronic obstructive pulmonary disease None Respiratory, thoracic and mediastinal disorders None View
Catheter related infection None Infections and infestations None View
Pleural effusion None Respiratory, thoracic and mediastinal disorders None View
Pneumonia None Respiratory, thoracic and mediastinal disorders None View
Psoas abscess None Infections and infestations None View
Vasculitis None Immune system disorders None View
Stroke None Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Transfusion None Blood and lymphatic system disorders None View