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: 2025-12-24 @ 11:02 PM
Ignite Modification Date: 2025-12-25 @ 8:33 PM
NCT ID: NCT01470469
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01470469
Study Brief: SPD503 in Subjects Aged 6-17 Years With Generalized Anxiety Disorder (GAD), Separation Anxiety Disorder (SAD), or Social Phobia (SoP)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
PLACEBO Once-daily oral dosing in the evening for 12 weeks. None None 0 21 10 21 View
SPD503 Once-daily oral dosing of SPD503 in the evening ranging from 1-6 mg for 12 weeks. None None 0 62 48 62 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Cough None Respiratory, thoracic and mediastinal disorders None View
Abdominal pain upper None Gastrointestinal disorders None View
Constipation None Gastrointestinal disorders None View
Diarrhoea None Gastrointestinal disorders None View
Dry mouth None Gastrointestinal disorders None View
Nausea None Gastrointestinal disorders None View
Vomiting None Gastrointestinal disorders None View
Fatigue None General disorders None View
Irritability None General disorders None View
Pharyngitis streptococcal None Infections and infestations None View
Upper respiratory tract infection None Infections and infestations None View
Joint sprain None Injury, poisoning and procedural complications None View
Decreased appetite None Metabolism and nutrition disorders None View
Increased appetite None Metabolism and nutrition disorders None View
Dizziness None Nervous system disorders None View
Dizziness postural None Nervous system disorders None View
Headache None Nervous system disorders None View
Sedation None Nervous system disorders None View
Somnolence None Nervous system disorders None View
Initial insomnia None Psychiatric disorders None View