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 @ 11:57 PM
Ignite Modification Date: 2025-12-25 @ 9:54 PM
NCT ID: NCT01156051
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01156051
Study Brief: Effect of Guanfacine Extended-Release on Attention Deficit Hyperactivity Disorder (ADHD)-Associated Insomnia
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 Comparator Placebo control Placebo comparator: Placebo tablets identical to the experimental arm guanfacine extended-release tablets 1mg, 2mg, 3mg, 4mg, but without the active ingredient (guanfacine). None None 0 17 11 17 View
Guanfacine Extended-Release Tablets Guanfacine Extended-Release Tablets 1mg, 2mg, 3mg, and 4mg Guanfacine extended-release tablets: Guanfacine extended-release tablets will be started at 1mg and then increased at weekly intervals to 2mg, 3mg, or 4mg as needed and as tolerated None None 0 12 9 12 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
somnolence / sedation NON_SYSTEMATIC_ASSESSMENT Nervous system disorders sedation View
headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders headache View
stomachache / abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders abdominal pain View
acute gastroenteritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders gastroenteritis View
decreased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders appetite decrease View
inguinal hernia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders inguinal hernia View
febrile illness NON_SYSTEMATIC_ASSESSMENT Infections and infestations fever View
upper respiratory infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations infectious rhinitis View
exacerbation of allergic rhinitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders allergic rhinitis View
exacerbation of asthma NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders asthma View
cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders cough View
enuresis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders enuresis View
dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders dizziness View
musculoskeletal chest pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders costochondritis View
oral pain due to loose teeth NON_SYSTEMATIC_ASSESSMENT General disorders oral pain View
dermatitis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders rash View
stuttering NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders stuttering View