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 @ 9:41 PM
Ignite Modification Date: 2025-12-25 @ 7:23 PM
NCT ID: NCT02414932
Description: Tolerability of the trial agents was assessed at multiple points before, during and after treatment sessions over the 8 week treatment period using a battery of assessments(CADSS, BPRS, PRISE and YMRS) as well as assessment of physical health parameters before, during and after assessments. In addition, follow up assessments were performed at set intervals over the six-month follow-up period.
Frequency Threshold: 0
Time Frame: 8 months (8 week treatment period and 6-month follow-up assessment period)
Study: NCT02414932
Study Brief: Ketamine for Depression Relapse Prevention Following ECT
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Ketamine Ketamine (ketamine hydrochloride 0.5 mg/kg; Pfizer Healthcare Ireland)) will be made up as a 50 ml colourless saline solution and administered as a slow infusion over 40 minutes using an intravenous infusion pump. A course of up to four once-weekly infusions will be administered. Infusions will be discontinued by the Anaesthetist if there are persisting haemodynamic changes (i.e. heart rate \>110/minute or systolic/diastolic blood pressure (BP) \>180/100 or \>20% increase above pre-infusion BP for more than 15 minutes) that do not respond to beta-blocker therapy. Ketamine: Ketamine hydrochloride 0.5 mg/kg; Pfizer Healthcare Ireland 0 None 0 3 2 3 View
Midazolam Midazolam (0.045 mg/kg; Roche Products Ireland Ltd) will be made up as a 50 ml colourless saline solution and administered as a slow infusion over 40 minutes using an intravenous infusion pump. A course of up to four once-weekly infusions will be administered. Midazolam: Midazolam 0.045 mg/kg; Roche Products Ireland Ltd 0 None 0 3 0 3 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dissociation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.0 View