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 @ 5:18 PM
Ignite Modification Date: 2025-12-25 @ 2:55 PM
NCT ID: NCT03669250
Description: TEAEs and SAEs has been presented for Safety Population. Safety Population consisted of all participants who were randomized and received study drug.
Frequency Threshold: 0
Time Frame: 58 days from screen through study duration
Study: NCT03669250
Study Brief: CVN058 Effect on Mismatch Negativity in Schizophrenics
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 were randomized to receive placebo in each treatment period. 0 None 0 20 1 20 View
15mg CVN058 Participants were randomized to receive CVN058 15 mg in each treatment period. 0 None 0 13 1 13 View
75mg CVN058 Participants were randomized to receive CVN058 75 mg in each treatment period. 0 None 0 8 1 8 View
150 mg CVN058 Participants were randomized to receive CVN058 150 mg in each treatment period. 0 None 0 19 4 19 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (21.0) View
dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (21.0) View
Blood glucose abnormal NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (21.0) View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.0) View
Blood sodium abnormal NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (21.0) View
Throat irritation NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (21.0) View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (21.0) View