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 @ 5:37 PM
Ignite Modification Date: 2025-12-25 @ 3:08 PM
NCT ID: NCT00764868
Description: Safety population is defined as all subjects who take at least 1 dose of investigational product. In the Serious Adverse Events, the same subject reported multiple adverse events.
Frequency Threshold: 5
Time Frame: None
Study: NCT00764868
Study Brief: Vyvanse Adolescent Open-Label Safety and Efficacy Extension Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Lisdexamfetamine Dimesylate (LDX) Subjects who received either Lisdexamfetamine Dimesylate (LDX) or placebo during antecedent study 489-305 were eligible for 489-306. All subjects were titrated to their optimal dose of LDX (30, 50 or 70 mg per day). None None 10 265 230 265 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hydrocele None Congenital, familial and genetic disorders None View
Pneumonia None Infections and infestations None View
Joint Sprain None Injury, poisoning and procedural complications None View
Pelvic Fracture None Injury, poisoning and procedural complications None View
Traumatic Liver Injury None Injury, poisoning and procedural complications None View
Wrist Fracture None Injury, poisoning and procedural complications None View
Syncope None Nervous system disorders None View
Syncope Vasovagal None Nervous system disorders None View
Ectopic Pregnancy None Pregnancy, puerperium and perinatal conditions None View
Aggression None Psychiatric disorders None View
Testicular Torsion None Reproductive system and breast disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dry Mouth None Gastrointestinal disorders None View
Irritability None General disorders None View
Upper Respiratory Tract Infection None Infections and infestations None View
Weight Decreased None Investigations None View
Dizziness None Nervous system disorders None View
Headache None Nervous system disorders None View
Influenza None Infections and infestations None View
Nasopharyngitis None Infections and infestations None View
Decreased Appetite None Metabolism and nutrition disorders None View
Insomnia None Psychiatric disorders None View