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 @ 4:08 PM
Ignite Modification Date: 2025-12-25 @ 2:08 PM
NCT ID: NCT04950166
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were collected for ~2 months. Starting from time of single dose infusion (24-72 hours prior to surgery) through the 28 day visit following hospital discharge.
Study: NCT04950166
Study Brief: A Study to Evaluate ONM100, an Intraoperative Fluor Imaging Agent for the Detection of Peri Mets
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Fluorescence Imaging With Pegsitacianine 1 mg/kg of pegsitacianine administered IV 24-72 hours prior to surgery. pegsitacianine: An intraoperative nanoparticle-based fluorescence imaging agent comprised of micelles covalently conjugated to indocyanine green (ICG). 2 None 17 50 17 50 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (Unspecified) View
Device Dislocation SYSTEMATIC_ASSESSMENT Product Issues MedDRA (Unspecified) View
Abdominal Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (Unspecified) View
Wound Abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (Unspecified) View
Acute Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (Unspecified) View
Pulmonary Embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (Unspecified) View
Aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (Unspecified) View
Gastric Perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (Unspecified) View
Large Intestine Perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (Unspecified) View
Ileal Perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (Unspecified) View
Intra-abdominal Haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (Unspecified) View
Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (Unspecified) View
Cardiac Arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (Unspecified) View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (Unspecified) View
Embolism SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (Unspecified) View
Shock haemorrhagic SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (Unspecified) View
Multiple Organ Dysfunction Syndrome SYSTEMATIC_ASSESSMENT General disorders MedDRA (Unspecified) View
Device Dislocation SYSTEMATIC_ASSESSMENT Product Issues MedDRA (Unspecified) View
Acute Kidney Injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (Unspecified) View
Acute Respiratory Distress Syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (Unspecified) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Infusion Related Reactions SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (Unspecified) View
Alanine Aminotransferase Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (Unspecified) View
Aspartate Aminotransferase Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (Unspecified) View
Blood Lactate Dehydrogenase Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (Unspecified) View