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 @ 11:39 PM
Ignite Modification Date: 2025-12-25 @ 9:30 PM
NCT ID: NCT01117051
Description: None
Frequency Threshold: 2
Time Frame: None
Study: NCT01117051
Study Brief: Prucalopride Effects on Subjects With Chronic Non-cancer Pain Suffering From Opioid Induced Constipation
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo once daily before breakfast for up to 12 weeks None None 2 83 30 83 View
Prucalopride 1 or 2 mg prucalopride once daily before breakfast for up to 12 weeks None None 2 86 30 86 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Breast cancer None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Pulmonary embolism None Respiratory, thoracic and mediastinal disorders None View
Intestinal obstruction None Gastrointestinal disorders None View
Hepatitis A None Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea None Gastrointestinal disorders None View
Flatulence None Gastrointestinal disorders None View
Abdominal pain upper None Gastrointestinal disorders None View
Diarrhea None Gastrointestinal disorders None View
Abdominal pain None Gastrointestinal disorders None View
Vomiting None Gastrointestinal disorders None View
Back pain None Musculoskeletal and connective tissue disorders None View
Influenza None Infections and infestations None View
Headache None Nervous system disorders None View
Fall None Injury, poisoning and procedural complications None View
Rash None Skin and subcutaneous tissue disorders None View
Nasopharyngitis None Infections and infestations None View
Pain in extremity None Musculoskeletal and connective tissue disorders None View
Hypertension None Vascular disorders None View
Rectal hemorrhage None Gastrointestinal disorders None View