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 @ 1:16 AM
Ignite Modification Date: 2025-12-25 @ 11:25 PM
NCT ID: NCT03080493
Description: Only adverse events collected were specific to the intervention: dizziness and tiredness
Frequency Threshold: 0
Time Frame: One day (from treatment initiation until procedure the following day
Study: NCT03080493
Study Brief: Gabapentin for Pain Control After Osmotic Dilator Insertion and Prior to D&E Procedure: a Randomized Controlled Trial
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Gabapentin Gabapentin 600 mg PO - first dose in clinic prior to osmotic dilator placement, second dose 8 hours later (at home) Will receive standard regimen of acetaminophen/codeine and ibuprofen to take as needed for pain overnight Gabapentin 600mg: Gabapentin 600 mg PO (two total doses, thereby lasting duration while osmotic dilators are in place) acetaminophen/codeine and ibuprofen: Over the counter analgesic medications 0 None 0 60 57 60 View
Placebo Oral Capsule Matched placebo Will receive standard regimen of acetaminophen/codeine and ibuprofen to take as needed for pain overnight Placebo oral capsule: Packaged identical to gabapentin dosing acetaminophen/codeine and ibuprofen: Over the counter analgesic medications 0 None 0 58 51 58 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dizziness at baseline NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness at 5 minutes after dilator placement NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizzines at 2 hours after dilator placement NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness at 4 hours after dilator placement NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness at 8 hours after dilator placement NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness at 18-24 hours after dilator placement NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Tiredness at baseline NON_SYSTEMATIC_ASSESSMENT General disorders None View
Tiredness at 5 minutes after dilator placement NON_SYSTEMATIC_ASSESSMENT General disorders None View
Tiredness at 2 hours after dilator placement NON_SYSTEMATIC_ASSESSMENT General disorders None View
Tiredness at 4 hours after dilator placement NON_SYSTEMATIC_ASSESSMENT General disorders None View
Tiredness at 8 hours after dilator placement NON_SYSTEMATIC_ASSESSMENT General disorders None View
Tiredness at 18-24 hours after dilator placment NON_SYSTEMATIC_ASSESSMENT General disorders None View