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 @ 10:09 PM
Ignite Modification Date: 2025-12-25 @ 7:45 PM
NCT ID: NCT02685735
Description: Adverse events related to known effects of gabapentin (sedation, dizziness, nausea) were assessed daily via the daily digital diaries beginning two weeks prior to surgery (the time study drug began) and continuing for 3 weeks after surgery, when study drug was discontinued. Adverse events during hospitalization were captured via the electronic medical health record. Other adverse events were captured daily via digital diaries until 2 months after surgery, then at 6- and 12- month phone calls.
Frequency Threshold: 3
Time Frame: through study completion, an average of 1 year per participant
Study: NCT02685735
Study Brief: Predicting, Understanding and Speeding Recovery After TKA
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Subjects will receive placebo pills and the number of pills will be the same as gabapentin in the active treatment arm. Treatment will begin 2 weeks prior to surgery and continue 3 weeks afterwards. 1 None 0 139 2 139 View
Gabapentin Subjects will receive gabapentin, 900 mg/day for the first week, 1800 mg/day for the next 3 weeks, and 900 mg/day for the last week. Treatment will begin 2 weeks prior to surgery and continue 3 weeks afterwards. 1 None 1 135 17 135 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Death SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (10.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (10.0) View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (10.0) View