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 @ 4:52 PM
Ignite Modification Date: 2025-12-25 @ 2:35 PM
NCT ID: NCT03914950
Description: None
Frequency Threshold: 0
Time Frame: 1 day
Study: NCT03914950
Study Brief: TOF-18F-FDG-PET/CT in Patients With Suspected Pancreatic Cancer
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
PET/CT Results With TOF/ Without TOF 101 participants received diagnostic CT of the abdomen/upper abdomen with contrast medium within the PET/CT examination and 19 participants had diagnostic CT of the abdomen or upper abdomen without contrast medium due to elevated creatine or decreased GFR (glomerular filtration rate) or TSH (thyroid-stimulating hormone) levels. 0 None 0 101 0 101 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hypotensive shock SYSTEMATIC_ASSESSMENT Cardiac disorders ESUR guidelines View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders ESUR guidelines View
Respiratory arrest SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders ESUR guidelines View
Convulsion SYSTEMATIC_ASSESSMENT Nervous system disorders ESUR guidelines View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Severe vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders ESUR guidelines View
Nausea, mild vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders ESUR guidelines View
Marked urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders ESUR guidelines View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders ESUR guidelines View
Itching SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders ESUR guidelines View
Facial edema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders ESUR guidelines View
Bronchospasm SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders ESUR guidelines View
Laryngeal edema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders ESUR guidelines View
Vasovagal attack SYSTEMATIC_ASSESSMENT Nervous system disorders ESUR guidelines View