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 @ 4:44 PM
Ignite Modification Date: 2025-12-25 @ 2:32 PM
NCT ID: NCT04154150
Description: Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument. 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: NCT04154150
Study Brief: Ketamine + Cognitive Training for Suicidality in the Medical Setting: Pilot
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 + Cognitive Training Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg) Cognitive training: 8 sessions of computer-based cognitive training 0 None 0 7 7 7 View
Ketamine + Sham Training Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg) Sham Training: 8 sessions of computer-based sham training 0 None 0 9 9 9 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
decreased energy SYSTEMATIC_ASSESSMENT General disorders None View
difficulty sleeping: too little SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
difficulty sleeping: too much SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
feeling 'high' SYSTEMATIC_ASSESSMENT Nervous system disorders None View
headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
increased appetite SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
restlessness SYSTEMATIC_ASSESSMENT General disorders None View
tremors SYSTEMATIC_ASSESSMENT Nervous system disorders None View
diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
emotional indifference SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
loss of sexual desire SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
sweating SYSTEMATIC_ASSESSMENT General disorders None View
trouble achieving orgasm SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View