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 @ 2:17 AM
Ignite Modification Date: 2025-12-26 @ 12:47 AM
NCT ID: NCT01675960
Description: Adverse events are collection on all participants who received at least one dose of intervention, regardless of arm.
Frequency Threshold: 0
Time Frame: Adverse events were collected during each contact with the subject after initial drug administration. Patient contacts were scheduled at day 6, 13, 24, 28, 34-37, 38, 44, 51, 62, and 76. SAE still ongoing at end of study period will be followed up on to determine final outcome.
Study: NCT01675960
Study Brief: Effectiveness of Gabapentin on Chronic Irritability in Neurologically Impaired Children
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 Neurotin Gabapentin: The active drug is in a flavored glycerin based solution. The drug will be given orally or through a gastrointestinal tube. Titration up to a stable dose will take 22 days. The total stable dose is 40mg/kg/day. Once 7 days on this dose are finished, children will take 6 days to reduce their dose and begin their 3 day washout period. 0 None 0 2 1 2 View
Placebo Glycerin based clear solution that is flavored similar to the commercial product placebo 0 None 0 2 0 2 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Increased sleepiness NON_SYSTEMATIC_ASSESSMENT General disorders None View