Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 2:02 AM
Ignite Modification Date: 2025-12-26 @ 12:26 AM
NCT ID: NCT00758160
Description: Adverse events(AEs) data was reported for each visit as total data for AEs were not analyzed. In addition to the AEs reported in the below table, a category of AEs titled "Other" was reported as no dictionary was used and events under this category were not further specified. Total # affected by other AEs is minimum number of participants affected.
Frequency Threshold: 0
Time Frame: None
Study: NCT00758160
Study Brief: The Impact of Osmotic Release Oral Delivery System Methylphenidate (OROS MPH) Upon Family of Children and Adolescents With Attention Deficit Hyperactivity Disorder (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
OROS MPH-Week 8 Participants received Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects. None None 0 296 95 296 View
OROS MPH-Week 4 Participants received Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects. None None 0 296 90 296 View
OROS MPH-Baseline Participants received Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects. None None 0 296 80 296 View
OROS MPH-Week 2 Participants received Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose was adjusted for each participant based on clinical responses and/or side effects. None None 0 296 100 296 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Insomnia NON_SYSTEMATIC_ASSESSMENT General disorders No dictionary used View
Stomachache NON_SYSTEMATIC_ASSESSMENT General disorders No dictionary used View
Appetite decreased NON_SYSTEMATIC_ASSESSMENT General disorders No dictionary used View
Nausea NON_SYSTEMATIC_ASSESSMENT General disorders No dictionary used View
Headache NON_SYSTEMATIC_ASSESSMENT General disorders No dictionary used View
Dizziness NON_SYSTEMATIC_ASSESSMENT General disorders No dictionary used View
Somnolence NON_SYSTEMATIC_ASSESSMENT General disorders No dictionary used View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT General disorders No dictionary used View
Other NON_SYSTEMATIC_ASSESSMENT General disorders Other View