Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 4:53 AM
Ignite Modification Date: 2025-12-26 @ 3:54 AM
NCT ID: NCT03560518
Description: The Safety Population consists of all randomized patients who received at least 1 dose of randomized IP.
Frequency Threshold: 5
Time Frame: The study consisted of a 6 week double-blind treatment period, followed by a 2-week safety follow-up period.
Study: NCT03560518
Study Brief: Study of Rapastinel as Monotherapy in Patients With MDD
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Rapastinel 900mg Rapastinel 900 mg (prefilled syringe, weekly intravenous IV administration) 0 None 1 147 21 147 View
Placebo Placebo (prefilled syringe, weekly IV administration) 0 None 2 147 15 147 View
Rapastinel 450mg Rapastinel 450 mg (prefilled syringe, weekly intravenous IV administration) 1 None 2 145 28 145 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abortion induced SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA Version 22.0 View
Asphyxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 22.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Version 22.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA Version 22.0 View
Haemorrhoidal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 22.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 22.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 22.0 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 22.0 View