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 @ 4:15 AM
Ignite Modification Date: 2025-12-26 @ 3:14 AM
NCT ID: NCT01999920
Description: None
Frequency Threshold: 5
Time Frame: Baseline to week 12
Study: NCT01999920
Study Brief: Vilazodone for Separation Anxiety Disorder
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Vilazodone Vilazodone treatment. Dosage will begin at 10mg/day and will be increased to 20mg/day after 1 week, and 40mg/day after two weeks (optional). Dosage can be held steady or lowered at any time during the study as clinically indicated in the event of adverse effects. Twelve weeks of treatment, total. Vilazodone: 10mg to 40mg per day for 12 weeks 0 None 0 13 13 13 View
Placebo Pill placebo. Placebo: One to two pills per day for 12 weeks 0 None 0 11 11 11 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Heartburn SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Decreased Appetite SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Increased Appetite SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dry Mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea/Gas SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Excessive Sweating SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin Problems SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Bruising Easily SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Restlessness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Impaired Coordination SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Insomnia SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Decreased Libido (men) SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Decreased Libido (women) SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Sexual Dysfunction (men) SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Sexual Dysfunction (women) SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Blurry Vision SYSTEMATIC_ASSESSMENT Eye disorders None View
Lightheadedness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Forgetfulness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Impaired Concentration SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Apathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Nervousness SYSTEMATIC_ASSESSMENT Nervous system disorders None View