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: 2025-12-25 @ 4:32 AM
Ignite Modification Date: 2025-12-26 @ 3:34 AM
NCT ID: NCT04860518
Description: All adverse events up to day 28 are reported, adverse events occurring after D28 only if the investigator considers there is a causal relationship with the study drug and all deaths up to D90.
Frequency Threshold: 0
Time Frame: Adverse events are collected from the signing of consent up to Day 28. AEs occurring after D28 were to be reported only if the Investigator considers there is a causal relationship with the study drug. All AEs up to D90, which lead to death, are reported as SAEs.
Study: NCT04860518
Study Brief: Human Intravenous Interferon Beta-Ia Safety and Preliminary Efficacy in Hospitalized Subjects With COVID-19
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
IV IFN Beta-1a Patients receiving active drug: will receive two separate bolus injections one containing IFN-beta -1a and another injection containing Saline. IFN beta-1a: Treated daily with IFN beta-1a 10 μg as an IV bolus for 6 days while hospitalised 0 None 0 2 1 2 View
IV Dexamethasone Patients receiving active comparator: will receive two separate bolus injections one containing saline and another injection containing Dexamethasone. Dexamethasone: Treated daily with dexamethasone 6 mg as an IV bolus for 6 days while hospitalised 0 None 2 3 2 3 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
head injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (24.0) View
dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (24.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (24.0) View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (24.0) View
Hypnoatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (24.0) View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (24.0) View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (24.0) View
Subdural hematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (24.0) View