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 @ 7:12 PM
Ignite Modification Date: 2025-12-25 @ 4:47 PM
NCT ID: NCT04962503
Description: Patients were advised to report any adverse events to the PI. All adverse events were assessed as unrelated to SCENESSE® (afamelanotide 16 mg).
Frequency Threshold: 5
Time Frame: All adverse events were monitored from baseline until 3 months after the end of treatment, up to 19 weeks.
Study: NCT04962503
Study Brief: A Proof of Concept Study to Evaluate the Safety of Afamelanotide in Patients With Acute Arterial Ischaemic Stroke (AIS)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
SCENESSE® (Afamelanotide 16mg) Six adult patients with clots located in the higher segments of the brain and who are ineligible for alternative treatments will be enrolled in the study and evaluated for six weeks. The study will assess patients' brain injury with computed tomography (CT) scans and magnetic resonance imaging (MRI), as well as using recognised methods of clinical evaluation to measure changes in patients' neurological and cognitive function following treatment. 1 None 1 6 5 6 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Haemorrhagic transformation stroke NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cerebrovascular accident NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Decreased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypervolaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Haemorrhagic transformation stroke NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Delirium NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Troponin increased NON_SYSTEMATIC_ASSESSMENT Investigations None View