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: 2025-12-25 @ 3:28 AM
Ignite Modification Date: 2025-12-26 @ 2:09 AM
NCT ID: NCT03260205
Description: None
Frequency Threshold: 5
Time Frame: From start of the study drug administration up to follow up (Week 7)
Study: NCT03260205
Study Brief: Safety and Efficacy Study in Preschool Children Aged 4-5 Years With Attention-deficit/Hyperactivity Disorder (ADHD)
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 Participants received placebo matched to SPD489 capsule orally once daily for 6 weeks. 0 None 0 45 4 45 View
SPD489 5 mg Participants received SPD489 capsule orally at a dose of 5 milligram (mg) once daily for 6 weeks. 0 None 0 39 8 39 View
SPD489 10 mg Participants received SPD489 capsule orally at a dose of 10 mg once daily for 6 weeks. 0 None 0 35 11 35 View
SPD489 20 mg Participants received SPD489 capsule orally at a dose of 20 mg once daily for 6 weeks. 0 None 0 34 14 34 View
SPD489 30 mg Participants received SPD489 capsule orally at a dose of 30 mg once daily for 6 weeks. 0 None 0 38 18 38 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.0 View
Weight decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.0 View
Decreased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.0 View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Affect lability NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.0 View
Aggression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.0 View
Initial insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.0 View
Irritability NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.0 View
Middle insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.0 View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.0 View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Dry mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.0 View