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 @ 10:48 PM
Ignite Modification Date: 2025-12-25 @ 8:18 PM
NCT ID: NCT02137369
Description: None
Frequency Threshold: 0
Time Frame: 12 weeks
Study: NCT02137369
Study Brief: The ISLAND Study: InSuLa Assessed Needs 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
SSRI Escitalopram, pill form, 20mg-40mg, daily, for 12 weeks OR Sertraline, pill form, 50-150 mg, daily, for 12 weeks 0 None 1 49 44 49 View
Cognitive Behavioral Therapy Cognitive Behavioral Therapy (CBT) Cognitive Behavioral Therapy: Cognitive Behavioral Therapy, standardized, 16 1-hour sessions over 12 weeks. 0 None 0 11 5 11 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hospitalization for suicidal ideation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache NON_SYSTEMATIC_ASSESSMENT General disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Insomnia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Diarea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Musculoskeletal pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Sedation NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Reduced Concentration NON_SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Libido reduced NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Restlessness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Paresthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Sweating NON_SYSTEMATIC_ASSESSMENT General disorders None View
Yawning NON_SYSTEMATIC_ASSESSMENT General disorders None View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Abnormal Dreams NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Reduced Appetite NON_SYSTEMATIC_ASSESSMENT General disorders None View
Erectile dysfunction NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Blurred vision NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Palpitations NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Feeling hot NON_SYSTEMATIC_ASSESSMENT General disorders None View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dry mouth NON_SYSTEMATIC_ASSESSMENT General disorders None View
Ovarian Cyst NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Myoclonic jerks NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Emotional blunting NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Plantar fascitis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Fungal infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Orgasm abnormal NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Laceration NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Epistaxis NON_SYSTEMATIC_ASSESSMENT General disorders None View
Cervical dysplasia NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Tinnitus NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Panic Attack NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Iritis NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Mouth Sores NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bacterial vaginosis NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Difficulty swallowing NON_SYSTEMATIC_ASSESSMENT General disorders None View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Worsening depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Increased Urination NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cognitive slowing NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Increased Appetite NON_SYSTEMATIC_ASSESSMENT General disorders None View
Weight gain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Renal calculus NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Jaw tightness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View