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 @ 4:36 AM
Ignite Modification Date: 2025-12-26 @ 3:38 AM
NCT ID: NCT00150618
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00150618
Study Brief: Safety and Efficacy of SPD503 in Treating ADHD in Children and Adolescents Aged 6-17
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
SPD503 (1 mg) Guanfacine HCl once daily None None 0 61 49 61 View
SPD503 (2 mg) Guanfacine HCl once daily None None 0 65 40 65 View
SPD503 (3 mg) Guanfacine HCl once daily None None 1 65 45 65 View
SPD503 (4 mg) Guanfacine HCl once daily None None 0 65 55 65 View
Placebo once daily None None 1 66 45 66 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Concussion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Convulsion NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Lower limb fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Upper abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dry mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Irritability NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Lethargy NON_SYSTEMATIC_ASSESSMENT General disorders None View
Sedation NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View