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 @ 12:01 AM
Ignite Modification Date: 2025-12-25 @ 9:58 PM
NCT ID: NCT00302458
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00302458
Study Brief: A Study of Repeat Dosing of OROS® Methylphenidate Hydrochloride (CONCERTA®) and Immediate Release Methylphenidate Hydrochloride in Healthy Adults
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Healthy Volunteers Healthy volunteers each received IR MPH, Oros MPH, and matched placebo (at four separate study visits) in a four way crossover design. None None 0 29 29 29 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Dry Mouth SYSTEMATIC_ASSESSMENT General disorders None View
Fogginess in head SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Stomach discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Sweaty SYSTEMATIC_ASSESSMENT General disorders None View
Tingling SYSTEMATIC_ASSESSMENT General disorders None View
Tingling in hands SYSTEMATIC_ASSESSMENT General disorders None View
Tingling in Head SYSTEMATIC_ASSESSMENT General disorders None View
Tired SYSTEMATIC_ASSESSMENT General disorders None View
Unfocused SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Head Pressure SYSTEMATIC_ASSESSMENT General disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Appetite Loss SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Aware of heartbeat SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Restlessness SYSTEMATIC_ASSESSMENT General disorders None View
Chest Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Flushing SYSTEMATIC_ASSESSMENT General disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Heart Racing SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Stomach Ache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Heavy limbs SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Heavy head SYSTEMATIC_ASSESSMENT General disorders None View
Insomnia SYSTEMATIC_ASSESSMENT General disorders None View
Jaw Clenching SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Jittery SYSTEMATIC_ASSESSMENT General disorders None View
Lightheaded SYSTEMATIC_ASSESSMENT General disorders None View
Limb Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View