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 @ 9:33 PM
Ignite Modification Date: 2025-12-25 @ 7:17 PM
NCT ID: NCT01893632
Description: None
Frequency Threshold: 0
Time Frame: 12 weeks of trial
Study: NCT01893632
Study Brief: Gabapentin Treatment of Benzodiazepine Dependence
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 All study medication will be over-capsulated with riboflavin to assess compliance using quantitative fluoroscopy. All participants will take three capsules three times per day throughout the study period. During week 1, GBP will be titrated over a five-day period to the dose target (GBP 1200 mg three times daily) or the maximum tolerated dose. Medication dosing will continue at GBP 1200 mg three times daily or placebo through the end of the study period (week 12). Dose reductions will be made for tolerability if necessary. gabapentin 0 None 0 1 1 1 View
Placebo Capsules filled with riboflavin. Placebo 0 None 0 1 1 1 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
anxiety SYSTEMATIC_ASSESSMENT General disorders None View
appetite change SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
unsteady gait SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
chest tightness SYSTEMATIC_ASSESSMENT General disorders None View
confusion SYSTEMATIC_ASSESSMENT General disorders None View
coordination issues SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
sensory overstimulation SYSTEMATIC_ASSESSMENT General disorders None View