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: 2025-12-25 @ 2:02 AM
Ignite Modification Date: 2025-12-26 @ 12:26 AM
NCT ID: NCT01657760
Description: Adverse events were collected on all study days, both upon initial participant contact, during the study procedures, and upon completing each day's study procedures.
Frequency Threshold: 0
Time Frame: two weeks of study procedures per participant
Study: NCT01657760
Study Brief: Citalopram Effects on Craving and Dopamine Receptor Availability in Alcoholics
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 Intravenous saline control, in a double-blind, crossover study, with infusion days at least 2 weeks apart. citalopram: citalopram, 40 mg IV, vs. saline control, each to be administered in a double-blinded, within-subjects design. 0 None 0 20 7 20 View
Citalopram Infusion 40 mg citalopram in 250 ml saline infused over 1 hour, in a double-blind, crossover study, with infusion days at least 2 weeks apart. citalopram: citalopram, 40 mg IV, vs. saline control, each to be administered in a double-blinded, within-subjects design. 0 None 0 20 12 20 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
anxiety SYSTEMATIC_ASSESSMENT Nervous system disorders None View
dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
fatigue SYSTEMATIC_ASSESSMENT Nervous system disorders None View
muscle tension SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
insomnia SYSTEMATIC_ASSESSMENT Nervous system disorders None View