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: 2025-12-25 @ 3:01 AM
Ignite Modification Date: 2025-12-26 @ 1:41 AM
NCT ID: NCT00395733
Description: None
Frequency Threshold: 1
Time Frame: None
Study: NCT00395733
Study Brief: Efficacy and Safety Study to Evaluate Gadavist (Gadobutrol) as Contrast Agent in Magnetic Resonance Imaging (MRI) of Vascular Diseases in Chinese Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Gadobutrol (Gadavist, BAY86-4875) Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW) None None 0 78 7 78 View
Gadopentate Dimeglumine (Magnevist, BAY86-4882) Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW) None None 0 81 7 81 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA, version 10.0 View
Vertigo NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA, version 10.0 View
Rash papular NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA, version 10.0 View
Blood pressure increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA, version 10.0 View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA, version 10.0 View
Palpitations NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA, version 10.0 View
C-reactive protein increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA, version 10.0 View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA, version 10.0 View
Feeling hot NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA, version 10.0 View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA, version 10.0 View
Oedema peripheral NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA, version 10.0 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA, version 10.0 View
Injection site swelling NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA, version 10.0 View
Protein urine present NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA, version 10.0 View
Atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA, version 10.0 View