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 @ 5:04 AM
Ignite Modification Date: 2025-12-26 @ 4:06 AM
NCT ID: NCT01711918
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01711918
Study Brief: Domperidone for the Treatment of Chronic Nausea and Vomiting Secondary to Gastroparesis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Domperidone Participants will received domperidone at a dose of 10mg given up to three times per day Domperidone: oral tablet; dose is 10mg per tablet given up to 3 times daily. None None 0 7 5 7 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Allergic Reaction None Skin and subcutaneous tissue disorders None View
Partial Bowel Obstruction None Gastrointestinal disorders None View
Abdominal Pain None Gastrointestinal disorders None View
Heartburn None Gastrointestinal disorders None View
Hypophosphatemia None Blood and lymphatic system disorders None View
Upper Respiratory Tract Infection None Respiratory, thoracic and mediastinal disorders None View
Ruptured Right Ovarian Cyst None Reproductive system and breast disorders None View
Migraine None Nervous system disorders None View
Back Pain None Musculoskeletal and connective tissue disorders None View
Dizziness None Ear and labyrinth disorders None View
Shaking None Musculoskeletal and connective tissue disorders None View
Headache None Nervous system disorders None View
Chest Pain None Musculoskeletal and connective tissue disorders None View
Hand Tingling None Nervous system disorders None View
Shoulder Pain None Musculoskeletal and connective tissue disorders None View
Dry Mouth None General disorders None View
Shortness of Breath None Respiratory, thoracic and mediastinal disorders None View
Chest Palpitations None Cardiac disorders None View
Elevated ALT None Hepatobiliary disorders None View
Elevated AST None Hepatobiliary disorders None View