Adverse Events Module

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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 @ 11:53 PM
Ignite Modification Date: 2025-12-25 @ 9:49 PM
NCT ID: NCT05876351
Description: Safety Set: Included all participants who received at least 1 dose of study intervention.
Frequency Threshold: 5
Time Frame: Up to Week 34
Study: NCT05876351
Study Brief: Eculizumab in Pediatric and Adult Participants With Atypical Hemolytic Uremic Syndrome (aHUS) in China
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Eculizumab Participants received eculizumab as an IV infusion at a dose and schedule according to body weight for 26 weeks. 0 None 8 25 24 25 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Rotavirus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Retching SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Upper gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Hepatic function abnormal SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 27.1 View
Synovial cyst SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.1 View
Bacterial infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Clostridium difficile infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Infection 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
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27.1 View
Electrolyte imbalance SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.1 View
Hyperphosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.1 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Hepatic function abnormal SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 27.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.1 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 27.1 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27.1 View