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 @ 9:07 PM
Ignite Modification Date: 2025-12-25 @ 6:58 PM
NCT ID: NCT04322604
Description: None
Frequency Threshold: 5
Time Frame: Baseline up to Day 225
Study: NCT04322604
Study Brief: A Study to Assess AK002 in Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
3 mg/kg of Lirentelimab (AK002) Subjects in this arm will receive 6 monthly doses of lirentelimab (AK002): a first dose of 1 mg/kg followed by 5 monthly doses of 3 mg/kg. lirentelimab (AK002): Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8. 0 None 7 91 41 91 View
Placebo Placebo Placebo: Placebo 0 None 5 89 31 89 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cholecystitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE 5.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 5.0 View
Mental status changes SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE 5.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE 5.0 View
Biliary dyskinesia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE 5.0 View
Osteomyelitis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 5.0 View
Femur fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE 5.0 View
Diabetic ketoacidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 5.0 View
Lumbar radiculopathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 5.0 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 5.0 View
Pharyngeal haemorrhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 5.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE 5.0 View
Corona virus infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 5.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 5.0 View
Infusion related reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE 5.0 View
Coronavirus test positive SYSTEMATIC_ASSESSMENT Investigations CTCAE 5.0 View