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 @ 11:44 PM
Ignite Modification Date: 2025-12-25 @ 9:37 PM
NCT ID: NCT01874951
Description: None
Frequency Threshold: 5
Time Frame: 3 weeks
Study: NCT01874951
Study Brief: Low-Dose Naltrexone (LDN) for Depression Relapse and Recurrence
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 In this arm, patients will receive placebo for 3 weeks. Placebo identical in appearance to naltrexone will be given twice daily to all patients assigned to placebo. None None 0 6 6 6 View
Naltrexone In this arm, patients will receive active naltrexone for 3 weeks. 1 mg of naltrexone will be given twice daily to all patients assigned to active drug. None None 0 6 6 6 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Irritable SYSTEMATIC_ASSESSMENT Psychiatric disorders SAFTEE View
Menstrual irregularities SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders SAFTEE View
Fluid retention or swelling SYSTEMATIC_ASSESSMENT Vascular disorders SAFTEE View
Trouble sleeping SYSTEMATIC_ASSESSMENT Nervous system disorders SAFTEE View
Nightmares SYSTEMATIC_ASSESSMENT Nervous system disorders SAFTEE View
Hearing or seeing things SYSTEMATIC_ASSESSMENT Psychiatric disorders SAFTEE View
Numbness or tingling SYSTEMATIC_ASSESSMENT Nervous system disorders SAFTEE View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders SAFTEE View
Drooling or increased salivation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders SAFTEE View
Muscle cramps or stiffness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders SAFTEE View
Tremor or shakiness SYSTEMATIC_ASSESSMENT Nervous system disorders SAFTEE View
Poor coordination or unsteadiness SYSTEMATIC_ASSESSMENT Nervous system disorders SAFTEE View
Trouble catching breath or hyperventilation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders SAFTEE View
Loss of sexual interest SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders SAFTEE View
Problems with sexual arousal SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders SAFTEE View
Delayed or absent orgasm SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders SAFTEE View
Sweating excessively SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders SAFTEE View
Weight gain SYSTEMATIC_ASSESSMENT General disorders SAFTEE View
Strange taste in mouth SYSTEMATIC_ASSESSMENT Nervous system disorders SAFTEE View