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 @ 10:40 PM
Ignite Modification Date: 2025-12-25 @ 8:11 PM
NCT ID: NCT03594435
Description: The study physician (Dr. Miotto) called every participant at the end of the first week on the study medication to discuss any adverse events. Adverse events were also collected at each monthly visit and the study physician was notified of any reported adverse events.
Frequency Threshold: 0
Time Frame: Adverse event data was collected for each participant between randomization to Week 12 visit (final day of study).
Study: NCT03594435
Study Brief: Ibudilast for the Treatment of Alcohol Use 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
Ibudilast 10mg delayed-release capsules, target dose 50mg twice daily (5 x 10mg capsules twice daily) for 12 weeks Ibudilast: targets neurotrophin signaling and neuroimmune function 0 None 1 53 36 53 View
Placebo Oral Capsule matched to experimental drug Placebo oral capsule: matched to active drug, ibudilast 0 None 1 49 27 49 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Left Upper Quadrant Abdominal Pain SYSTEMATIC_ASSESSMENT General disorders None View
Left Ankle Open Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Subdural Hematoma SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dizziness SYSTEMATIC_ASSESSMENT General disorders None View
Libido SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Dysmenorrhea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Abnormal EKG SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Insomnia SYSTEMATIC_ASSESSMENT General disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Flu like symptoms SYSTEMATIC_ASSESSMENT General disorders None View
Body pain SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Gut pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Skin discoloration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Sweating SYSTEMATIC_ASSESSMENT General disorders None View
Flushing SYSTEMATIC_ASSESSMENT General disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Blurry vision SYSTEMATIC_ASSESSMENT Eye disorders None View
Pain and discomfort SYSTEMATIC_ASSESSMENT General disorders None View