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 @ 1:33 AM
Ignite Modification Date: 2025-12-25 @ 11:46 PM
NCT ID: NCT01603394
Description: The same event may appear as both an adverse event (AE) and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Frequency Threshold: 0
Time Frame: AEs: The time the participant had taken at least one dose of study treatment through last participant visit. SAEs: The time the participant provides informed consent through and including 28 calendar days after the last administration of study treatment.
Study: NCT01603394
Study Brief: Pilot Study Of Pregabalin And Prediction Of Treatment Response In Patients With Postherpetic Neuralgia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose) During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4). None None 0 9 8 9 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Edema peripheral NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
Muscle rigidity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16.0 View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.0 View
Dry mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.0 View
Sedation NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.0 View