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 @ 9:24 PM
Ignite Modification Date: 2025-12-25 @ 7:10 PM
NCT ID: NCT01081132
Description: Safety Population defined as all randomized subjects who took at least 1 dose of investigational product. Two subjects did not take investigational product, therefore n = 312 (Placebo = 155, SPD503 = 157).
Frequency Threshold: 5
Time Frame: None
Study: NCT01081132
Study Brief: Dose-optimization in Adolescents Aged 13-17 Diagnosed With Attention-deficit/Hyperactivity Disorder (ADHD) Using Extended-release Guanfacine HCl
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 Orally administered a once-daily dose None None 2 155 120 155 View
SPD503 Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight). None None 4 157 147 157 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Vomiting None Gastrointestinal disorders None View
Cholecystitis chronic None Hepatobiliary disorders None View
Clavicle fracture None Injury, poisoning and procedural complications None View
Concussion None Injury, poisoning and procedural complications None View
Pelvic fracture None Injury, poisoning and procedural complications None View
Loss of consciousness None Nervous system disorders None View
Homicidal ideation None Psychiatric disorders None View
Ovarian cyst ruptured None Reproductive system and breast disorders None View
Withdrawal hypertension None Vascular disorders None View
Abdominal pain None Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain None Gastrointestinal disorders None View
Abdominal pain upper 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
Nasopharyngitis None Infections and infestations None View
Upper respiratory tract infection None Infections and infestations 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
Insomnia None Psychiatric disorders None View
Cough None Respiratory, thoracic and mediastinal disorders None View