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 @ 3:17 PM
Ignite Modification Date: 2025-12-25 @ 1:38 PM
NCT ID: NCT04505592
Description: None
Frequency Threshold: 0
Time Frame: 28 days
Study: NCT04505592
Study Brief: Tenecteplase in Patients 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
Tenecteplase Tenecteplase 0.25 mg/kg (maximum dose of 25 mg) And received concomitant heparin to maintain activated partial thromboplastin time between 2.0 and 2.5 upper limit of normal. 2 None 4 8 3 8 View
Placebo Patients received placebo with concomitant heparin to maintain activated partial thromboplastin time between 2.0 and 2.5 upper limit of normal. 1 None 4 5 2 5 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cardiogenic shock SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (Unspecified) View
ST Elevation Myocardial Infarction (STEMI) SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (Unspecified) View
Large retroperitoneal hematoma with hgb drop SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (Unspecified) View
Intubation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (Unspecified) View
Hemorrhagic shock SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (Unspecified) View
Compartment syndrome SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (Unspecified) View
Worsening respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (Unspecified) View
Death SYSTEMATIC_ASSESSMENT General disorders CTCAE (Unspecified) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Mild oral bleeding SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (Unspecified) View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (Unspecified) View
Decreased hemoglobin SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (Unspecified) View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (Unspecified) View
Bleeding from mouth and wrist SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (Unspecified) View