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 @ 3:07 PM
Ignite Modification Date: 2025-12-25 @ 1:28 PM
NCT ID: NCT00150592
Description: None
Frequency Threshold: 2
Time Frame: None
Study: NCT00150592
Study Brief: Safety, Tolerability and Efficacy of SPD503 in Treating ADHD in Children 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 Subjects received either 1, 2, or 3 mg once-daily of SPD503 (Guanfacine hydrochloride) for 6 weeks. None None 2 121 96 121 View
Placebo None None None 0 57 32 57 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Asthma exacerbation NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Moderate loss of consciousness NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Ear pain NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dry mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Non-cardiac chest pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Sedation NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Irritability NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Dysmenorrhea NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View