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 @ 1:22 AM
Ignite Modification Date: 2025-12-25 @ 11:31 PM
NCT ID: NCT00501293
Description: Safety population defined as all subjects who received at least one dose of MTS.
Frequency Threshold: 5
Time Frame: None
Study: NCT00501293
Study Brief: Evaluate the Safety and Efficacy of Methylphenidate Transdermal System (MTS) in Adolescents Aged 13-17 Years With ADHD
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Antecedent Methylphenidate Transdermal System (MTS) Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment. None None 3 109 36 109 View
Antecedent Placebo Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment. None None 1 53 32 53 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Seizure None Nervous system disorders None View
Syncope None Nervous system disorders None View
Hallucinations None Psychiatric disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis None Infections and infestations None View
Upper respiratory tract infection None Infections and infestations None View
Decreased appetite None Metabolism and nutrition disorders None View
Headache None Nervous system disorders None View
Irritability None Psychiatric disorders None View