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 @ 10:30 PM
Ignite Modification Date: 2025-12-25 @ 8:03 PM
NCT ID: NCT01112735
Description: An AE was defined as any untoward medical occurrence in a subject administered IP that does not necessarily have a causal relationship with the treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IP, whether or not related to the IP. An AE included any event, regardless of the presumed causality between the event and the IP.
Frequency Threshold: 5
Time Frame: 90 days
Study: NCT01112735
Study Brief: Efficacy and Safety of ARTISS for Flap Adherence in Abdominoplasty
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
ARTISS ARTISS will be used as an adjuvant to standard of care. FS VH S/D 4 s-apr (= two-component fibrin sealant, double virus inactivated, made from pooled human plasma): Dosage form: spray (aerosolized sealant), Dosage frequency: once (1 layer). ARTISS will be applied onto the fascia or the wound bed. 0 None 1 20 10 20 View
Standard of Care Standard of care Standard of care: Standard of care 0 None 0 20 7 20 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Incision Site Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Abdominal Abscess SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Seroma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Wound Dehiscence SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Staphylococcus Test Positive SYSTEMATIC_ASSESSMENT Investigations None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Atelectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pruritus Generalized SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Incision Site Complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Skin Necrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View