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: 2025-12-26 @ 11:46 AM
Ignite Modification Date: 2025-12-26 @ 11:46 AM
NCT ID: NCT02973516
Description: Post-injection adverse events are reported below.
Frequency Threshold: 0
Time Frame: Adverse events were recorded from informed consent signature up to 13 weeks after gadopiclenol administration
Study: NCT02973516
Study Brief: Proof of Concept Study Concerning Efficacy of P03277 MR Imaging in HCC Diagnosis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cohort 1 Gadopiclenol administered at 0.1 mmol/kg BW (corresponding to 0.2 mL/kg BW) by intravenous (IV) bolus injection at 2 mL/s rate without dilution, followed by a 0.9% saline flush. 0 None 0 30 8 30 View
Cohort 2 Gadopiclenol administered at 0.05 mmol/kg BW (corresponding to 0.1 mL/kg BW) by intravenous (IV) bolus injection at 2 mL/s rate without dilution, followed by a 0.9% saline flush. 0 None 1 10 0 10 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
gastric perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.1 View
procedural complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Feeling hot SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.1 View
Injection site coldness SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.1 View
Injection site haematoma SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.1 View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.1 View
Blood pressure increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.1 View
Muscle tightness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.1 View