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 @ 1:06 PM
Ignite Modification Date: 2025-12-25 @ 12:21 PM
NCT ID: NCT00617461
Description: The AEs reported to start or worsen during the treatment phase of the study are presented.
Frequency Threshold: 2
Time Frame: Adverse events (AEs) were collected from the start of the baseline gabapentin treatment period through the post-treatment follow-up visit (up to Week 11).
Study: NCT00617461
Study Brief: A Clinical Study in Subjects With Neuropathic Pain From PHN Who Have Had an Inadequate Response to Gabapentin Treatment
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Baseline Gabapentin 1800 mg Gabapentin 1800 mg daily for 2 weeks before randomization. Only includes participants who were subsequently randomized. None None 0 94 2 94 View
GEn 1200 mg GEn 1200 mg daily either in first intervention period or second intervention period None None 0 91 15 91 View
Crossover GEn 2400 mg GEn 2400 mg daily during 4-day crossover period in between the first intervention period and the second intervention period None None 0 82 3 82 View
GEn 3600 mg GEn 3600 mg daily either in first intervention period or second intervention period None None 0 85 14 85 View
Down-Titration Period Participants down- titrated from GEn 3600 mg/day by taking 2400 mg/day for 2 days, followed by 1200 mg/day for 2 days, followed by 600 mg/day for 2 days before ending the assigned treatment. Participants down- titrated from GEn 1200 mg/day by taking 1200 mg/day for 3 days, followed by 600 mg/day for 3 days before ending the assigned treatment. None None 1 80 2 80 View
Overall GEn All participants receiving GEn in any treatment period None None 1 94 27 94 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hallucination, auditory SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Irritability SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Post herpetic neuralgia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Odema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Blood pressure increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gout SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Rash pruritic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View