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 @ 9:16 PM
Ignite Modification Date: 2025-12-25 @ 7:04 PM
NCT ID: NCT02285504
Description: Safety population included all participants who began infusion with SAGE-547 injection.
Frequency Threshold: 0
Time Frame: AEs: Up to Day 11; SAEs: Up to Day 34
Study: NCT02285504
Study Brief: Evaluate SAGE-547 in Female Participants With Severe Postpartum Depression
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
SAGE-547 Participants received SAGE-547 intravenous injection over 60 hours (including 12-hour titration infusion of 21.5 micrograms/kg/hr \[4 hrs\], 43 micrograms/kg/hr \[4 hrs\] and 64.5 micrograms/kg/hr \[4 hrs\] on Day 1, followed by 13 to 48 hrs \[36 hrs\] maintenance infusion of 86 micrograms/kg/hr from Day 1 to 3, followed by a 12-hr taper infusion of 64.5 micrograms/kg/hr \[49 - 52 hrs\], 43 micrograms/kg/hr \[53 - 56 hrs\] and 21.5 micrograms/kg/hr \[57 - 60 hrs\] on Day 3). 0 None 0 4 4 4 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Blood Thyroid Stimulating Hormone Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (17.0) View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (17.0) View
Infusion Site Discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA (17.0) View
Infusion Site Erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA (17.0) View
Infusion Site Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA (17.0) View
Sedation SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (17.0) View
Oropharyngeal Pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (17.0) View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (17.0) View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (17.0) View