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 @ 1:30 PM
Ignite Modification Date: 2025-12-25 @ 12:32 PM
NCT ID: NCT02327195
Description: Continued multi-modal monitoring and vigilance with regard to any suspected adverse effects, including cardiovascular effects will help to fill the informational gap with regards to unknown cardiovascular side effects, emergence delirium incidence and perioperatory awareness.Due to the potential risk of drug related serious side effects, any clinical evidence of a serious adverse event will place the study on clinical hold until a full assessment and decision is made by the responsible parties.
Frequency Threshold: 0
Time Frame: 34 days
Study: NCT02327195
Study Brief: General Anesthesia Emergence Induced by Methylphenidate
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Methylphenidate Quillivant XR - Methylphenidate HCL Extended Release oral suspension - (after reconstruction with water - 5mg/mL) 20 mg (PO) given 2 hours prior to surgery Methylphenidate HCl: Subjects will be randomly assigned to either the Methylphenidate or the Placebo arm, and be given a 20 mg dose (of Methylphenidate or Placebo) in liquid form (4 mL) 0 None 11 27 0 27 View
Placebo 20 mg Placebo (PO) given 2 hours prior to surgery Placebo: 20 mg of placebo (PO) will be given 2 hours prior to surgery 0 None 11 27 0 27 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Mild QTc prolongation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):