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 @ 2:00 AM
Ignite Modification Date: 2025-12-26 @ 12:23 AM
NCT ID: NCT00642694
Description: None
Frequency Threshold: 0
Time Frame: During 12 weeks of active treatment, plus time between consent and treatment and 2-weeks post-treatment
Study: NCT00642694
Study Brief: Time to Remission of Depressive Symptoms With Combined SSRI and Ramelteon
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Escitalopram + Placebo Placebo augmentation None None 0 15 15 15 View
Escitalopram + Ramelteon active augmentation None None 0 14 13 14 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
vivid dreams NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
pain and discomfort in genital area NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
sinus headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
palpitations NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
tiredness NON_SYSTEMATIC_ASSESSMENT General disorders None View
insomnia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
heartburn/indigestion/dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
dry mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
weight gain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
metallic taste NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
altered taste NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
lightheadedness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
toothache NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
tingling NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
head fullness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
fidgetiness/restlesness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
increased urination NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
stomach cramps NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
increased perspiration NON_SYSTEMATIC_ASSESSMENT General disorders None View
dizziness NON_SYSTEMATIC_ASSESSMENT General disorders None View
rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
decreased libido NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
pulled back muscle NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
hot flashes NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
blurred vision NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
heart pounding NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
increased anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
sore throat NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
stomach pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
muscle and joint aches and pains NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
increased appetite NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
swollen lymph node NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
increased yawning NON_SYSTEMATIC_ASSESSMENT General disorders None View
erectile dysfunction NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
sinus infection/allergy NON_SYSTEMATIC_ASSESSMENT General disorders None View
chills NON_SYSTEMATIC_ASSESSMENT General disorders None View
fever NON_SYSTEMATIC_ASSESSMENT General disorders None View