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 @ 1:05 AM
Ignite Modification Date: 2025-12-25 @ 11:17 PM
NCT ID: NCT05290493
Description: Treatment-emergent AEs are defined as those AEs with onset after the first dose of IP or existing events that worsened after the first dose during the study. Any AE that occurred between the date of ICF signature and the date/time of first IP administration was considered a pre-treatment-emergent AE. At each level of summarization (any event, system organ class, and preferred term), subjects reporting more than one AE are counted only once.
Frequency Threshold: 5
Time Frame: Approximately 21 weeks: Adverse Events (AEs) were collected from the time of signing the Informed Consent Form (ICF) to the End of Trial Visit (Day 119).
Study: NCT05290493
Study Brief: NB-001 in Children and Adolescents With 22q11 Deletion Syndrome
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
NB-001 Active drug product, NB-001: Two (2) 100 mg capsules administered orally BID with liquids or, if the subject is unable to swallow a capsule whole, capsules may be opened, and the contents sprinkled on applesauce; total daily dose: 400 mg. NB-001: NB-001 is a non-stimulant modulator of multiple metabotropic glutamate receptors (mGluRs). 0 None 0 33 18 33 View
Placebo Placebo: Two (2) capsules (matching NB-001) administered orally BID with liquids or, if the subject is unable to swallow a capsule whole, capsules may be opened, and the contents sprinkled on applesauce. Placebo: Matching, inactive placebo 0 None 0 34 24 34 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, 24.1 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA, 24.1 View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA, 24.1 View
Irritability NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA, 24.1 View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA, 24.1 View
Panic attack NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA, 24.1 View
Abdominal pain upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA, 24.1 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA, 24.1 View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA, 24.1 View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA, 24.1 View
Nasal congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA, 24.1 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA, 24.1 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA, 24.1 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA, 24.1 View