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 @ 5:05 AM
Ignite Modification Date: 2025-12-26 @ 4:08 AM
NCT ID: NCT03652818
Description: An adverse event (AE) is defined as any untoward medical occurrence and does not necessarily have to have causal relationship with the study medication. An AE can therefore be an unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease, which is a change from baseline and is temporally associated with the use of the study medication, whether or not it is considered related to the study medication.
Frequency Threshold: 0
Time Frame: Up to Day 15 (± 1 day)
Study: NCT03652818
Study Brief: Dental Pain Study of Analgesics in Patients Undergoing Molar Removal
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Group A/ Placebo Group Pre-surgery placebo and post-surgery placebo 1 and placebo 2 0 None 0 24 2 24 View
Group B/ APAP Group Pre-surgery placebo 1 and post-surgery placebo 1 and acetaminophen (APAP) 0 None 0 23 3 23 View
Group C/ PGB Group Pre-surgery placebo 1 and post-surgery placebo 2 and pregabalin (PGB) 0 None 0 22 14 22 View
Group D/ Combination Co-dosing Group Pre-surgery placebo 1 and post-surgery APAP and PGB 0 None 0 23 15 23 View
Group E/ Combination Split-dosing Group Pre-surgery PGB and post-surgery placebo 1 and APAP 0 None 0 23 12 23 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 21.0 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 21.0 View
Retching SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 21.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 21.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 21.0 View
Body temperature increased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 21.0 View
Muscle twitching SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 21.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 21.0 View
Dizziness postural SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 21.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 21.0 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 21.0 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 21.0 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 21.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 21.0 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA Version 21.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA Version 21.0 View