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 @ 11:30 PM
Ignite Modification Date: 2025-12-25 @ 9:18 PM
NCT ID: NCT03614156
Description: Adverse event data for non-randomized participants in the OLTP also include AEs that occurred during the safety follow period. Adverse event data for randomized participants in the DBTP were collected for up to 54 weeks which included the 2 week safety follow up period.
Frequency Threshold: 5
Time Frame: The study consisted of an 8 to 16 week OLTP; followed by a randomized DBTP of up to 52 weeks; followed by a 2 week safety period.
Study: NCT03614156
Study Brief: Study of Monotherapy Rapastinel in the Prevention of Relapse in Patients With Major Depressive Disorder (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
Open-Label Treatment Period Rapastinel 225 milligrams (mg) or 450 mg intravenous (IV) once a week during OLTP. 0 None 4 363 44 363 View
DBTP Placebo Weekly Placebo (prefilled syringe, weekly IV administration) 0 None 1 40 17 40 View
DBTP Rapastinel Clinically Driven Schedule Rapastinel 450 mg or 225 mg (prefilled syringe, clinically driven schedule IV administration, variable interval, placebo on intervening weeks) 0 None 1 42 9 42 View
DBTP Rapastinel Weekly Rapastinel 450 mg or 225 mg (prefilled syringe, weekly intravenous IV administration) 0 None 0 55 13 55 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Partial seizures SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 21.2 View
Suicidal ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Version 21.2 View
Suicide attempt SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Version 21.2 View
Angioedema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA Version 21.2 View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 21.2 View
Alcoholism SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Version 21.2 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 21.2 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 21.2 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 21.2 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 21.2 View
Seasonal allergy SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA Version 21.2 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 21.2 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 21.2 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Version 21.2 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 21.2 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 21.2 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 21.2 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 21.2 View