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 @ 9:19 PM
Ignite Modification Date: 2025-12-25 @ 7:07 PM
NCT ID: NCT02942004
Description: The Safety Set included all randomized participants who started the study drug infusion.
Frequency Threshold: 5
Time Frame: Up to approximately 37 days.
Study: NCT02942004
Study Brief: A Study to Evaluate Efficacy and Safety of SAGE-547 in Participants With Severe Postpartum Depression (547-PPD-202B)
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 received infusion rates equivalent to either the 60 μg/kg/h or 90 μg/kg/h group. 0 None 0 43 9 43 View
SAGE-547 60 μg/kg/h Participants received a 4-hour titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 56 hours), followed by a taper to 30 μg/kg/h (56 to 60 hours). 0 None 1 38 17 38 View
SAGE-547 90 μg/kg/h Participants received a 4-hour dose titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 24 hours), then 90 μg/kg/h (24 to 52 hours), followed by a taper to 60 μg/kg/h (52 to 56 hours), and 30 μg/kg/h (56 to 60 hours). 0 None 0 41 13 41 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Intentional overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v19.1 View
Suicidal ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v19.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v19.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v19.1 View
Infusion site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA v19.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v19.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v19.1 View
Loss of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v19.1 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v19.1 View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v19.1 View