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 @ 10:08 PM
Ignite Modification Date: 2025-12-25 @ 7:44 PM
NCT ID: NCT05168735
Description: Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument and the Clinician-Administered Dissociative States Scale (CADSS). Open-ended questions were also used to inquire about any additional adverse events not captured on the PRISE. Adverse events were tallied for all symptoms that were reported as new or worsening from pre-infusion baseline with onset during the infusion and/or within the subsequent 24hr period.
Frequency Threshold: 0
Time Frame: 24 hours
Study: NCT05168735
Study Brief: Ketamine + Mindfulness for 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
Intravenous Ketamine + Mindfulness Exercises Intravenous Ketamine: Single infusion of intravenous racemic ketamine (0.5mg/kg over 40min) Brief Mindfulness Exercises: 30min guided training in mindfulness meditation immediately prior to infusion 0 None 0 22 22 22 View
Intravenous Ketamine + Academic Exercises Intravenous Ketamine: Single infusion of intravenous racemic ketamine (0.5mg/kg over 40min) Academic Exercises: 30min of mental math and other academic cognitive puzzles completed silently/mentally 0 None 0 21 21 21 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
decreased energy SYSTEMATIC_ASSESSMENT General disorders None View
diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
difficulty sleeping: too little SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
difficulty sleeping: too much SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
dissociative symptoms SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
elevated blood pressure SYSTEMATIC_ASSESSMENT Vascular disorders None View
emotional indifference SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
increased appetite SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
increased weight SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
loss of sexual desire SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders None View
restlessness SYSTEMATIC_ASSESSMENT General disorders None View
sweating SYSTEMATIC_ASSESSMENT General disorders None View
tremors SYSTEMATIC_ASSESSMENT Nervous system disorders None View
trouble achieving orgasm SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View