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 @ 2:04 AM
Ignite Modification Date: 2025-12-26 @ 12:30 AM
NCT ID: NCT01907360
Description: None
Frequency Threshold: 0
Time Frame: Baseline to 48 hours after the HLD200 dose
Study: NCT01907360
Study Brief: Pharmacokinetics of HLD200 in Children and Adolescents 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
Adolescents (13-17yrs) Drug: B-HLD200 54mg capsules (Methylphenidate Modified Release B Formulation) or Drug: C-HLD200 54mg capsules (Methylphenidate Modified Release C Formulation) 0 None 0 18 10 18 View
Children (6-12 Yrs) Drug: B-HLD200 54mg capsules (Methylphenidate Modified Release B Formulation) or Drug: C-HLD200 54mg capsules (Methylphenidate Modified Release C Formulation) 0 None 0 11 6 11 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Musculoskeletal And Connective Tissue Disorders NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cerumen Impaction NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Abdominal Pain Upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Flatulence NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper Respiratory Tract Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Myalgia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness Postural NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View