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 @ 1:33 AM
Ignite Modification Date: 2025-12-25 @ 11:46 PM
NCT ID: NCT03325894
Description: Safety set consisted of all participants who had taken at least 1 dose of investigational product in this current study.
Frequency Threshold: 5
Time Frame: From start of study drug administration up to follow-up (approximately up to 367 days)
Study: NCT03325894
Study Brief: Safety and Tolerability Study of SHP465 in Children Aged 4 to 12 Years Diagnosed 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
Group A (Antecedent Studies) Participants who completed antecedent studies SHP465-112 (NCT03327402) or SHP465-309 (NCT03325881) were in group A and received 6.25 milligram (mg) SHP465 capsule orally once daily for up to 330 days. 0 None 0 63 12 63 View
Group B (Direct Enrollment) Participants who directly enrolled in this study were in group B and received 6.25 mg SHP465 capsule orally once daily for up to 330 days. 0 None 1 77 20 77 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Rhabdomyolysis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 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
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Irritability NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.0 View