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 @ 11:24 PM
Ignite Modification Date: 2025-12-25 @ 9:10 PM
NCT ID: NCT02398656
Description: AE and SAE definitions are as per GCP requirements.
Frequency Threshold: 1
Time Frame: Adverse events were collected from randomization to Day 5 or discharge ( whichever was sooner). SAE's were collected to the Day 90 assessment completion. AEs and SAE's were collected from the beginning of the trial until the last Day 90 assessment was completed.
Study: NCT02398656
Study Brief: A Randomized Controlled Trial of TNK-tPA Versus Standard of Care for Minor Ischemic Stroke With Proven Occlusion
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 (tNK) Experimental: TNK-tPA (0.25mg/kg) given as a single, intravenous bolus immediately upon randomization. Experimental treatment will be administered as a single intravenous bolus over 1-2 minutes as per the standard manufacturers' instructions for use. Tenecteplase, a genetically engineered mutant tissue plasminogen activator, has a longer half-life, is more fibrin specific, produces less systemic depletion of circulating fibrinogen, and is more resistant to plasminogen activator inhibitor than alteplase. Tenecteplase: TNK will be administered as a single intravenous bolus over 1-2 minutes within 90 minutes of the CT scan. 20 None 16 432 35 435 View
Control (Antiplatelet Agents) Control: Patients will be treated with standard of care based antiplatelet treatment - choice at the discretion of the investigator. Low dose aspirin (single agent) will be the choice of most physicians, some will chose to use the combination of aspirin and clopidogrel. As this is a multi-centre, international trial where local practices will vary, rather than mandating a specific antiplatelet agent, we will allow the local investigator to chose which antithrombotic regime should be used. Standard of care medication(s) should be given immediately upon randomization. Antiplatelet treatment: Low dose aspirin (single agent) will be the choice of most physicians, some Investigators will chose to use the combination of aspirin and clopidogrel. 5 None 2 452 33 452 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Symptomatic Intracerebral hemorrhage NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (10.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Stroke Progression NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (10.0) View