Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 3:35 PM
Ignite Modification Date: 2025-12-25 @ 1:47 PM
NCT ID: NCT02655692
Description: None
Frequency Threshold: 0
Time Frame: The study duration was 5 years; time Veterans participated was ~2 months total.
Study: NCT02655692
Study Brief: CAP-Ketamine for Antidepressant Resistant PTSD
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 Saline dose Placebo: This is a saline placebo/non-active solution. 0 None 0 55 25 55 View
Low Dose Ketamine Low Dose Ketamine (.20 mg/kg) Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects. 0 None 0 55 42 55 View
High Dose Ketamine High Dose Ketamine (.50 mg/kg) Ketamine: FDA approved anesthetic medication with rapid acting antidepressant effects. 0 None 0 53 38 53 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
agitation SYSTEMATIC_ASSESSMENT Social circumstances None View
anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
fatigue SYSTEMATIC_ASSESSMENT General disorders None View
headache SYSTEMATIC_ASSESSMENT General disorders None View
irritability SYSTEMATIC_ASSESSMENT Social circumstances None View
nausea/GI disturb SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
nightmares SYSTEMATIC_ASSESSMENT General disorders None View
depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
suicidality SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
sweating SYSTEMATIC_ASSESSMENT General disorders None View
diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
soreness/bruising at INJ site SYSTEMATIC_ASSESSMENT General disorders None View