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 @ 2:00 AM
Ignite Modification Date: 2025-12-26 @ 12:23 AM
NCT ID: NCT02661594
Description: All AE encountered during the study will be reported in detail in the source documents and noted in the AE section of the CRF from the date of subject consent, throughout the clinical conduct and up to the follow-up visit. for a period of 24hours
Frequency Threshold: 5.0
Time Frame: All AE's are to be reported within a timeframe of 24hours.
Study: NCT02661594
Study Brief: Thorough QT Study of Intravenous Amisulpride
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 Intravenous placebo: two infusions in parallel, one over 2 minutes, one over 8 minutes Placebo: Placebo comparator to establish baseline for calculating change in QTcF 0 None 0 38 9 38 View
Amisulpride 5 mg Intravenous amisulpride 5 mg: infusion over 2 minutes; Intravenous placebo infused in parallel over 8 minutes Amisulpride 5 mg: Therapeutic dose of amisulpride 0 None 0 39 5 39 View
Amisulpride 40 mg Intravenous amisulpride 40 mg: infusion over 8 minutes; Intravenous placebo infused in parallel over 2 minutes Amisulpride 40 mg: Supra-therapeutic dose of amisulpride 0 None 0 39 35 39 View
Moxifloxacin Oral moxifloxacin 400 mg tablet administered once (not blinded) Moxifloxacin: Positive control for assay sensitivity 0 None 0 39 5 39 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Infusion-related reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16.0 View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16.0 View
Catheter site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
Application site pruritus SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
Infusion Site Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.0 View
Oropharyngeal Pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16.0 View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16.0 View