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 @ 2:14 AM
Ignite Modification Date: 2025-12-26 @ 12:43 AM
NCT ID: NCT03131960
Description: None
Frequency Threshold: 5
Time Frame: Adverse events were collected over the course of the randomized study (enrollment, 4-week baseline, implant, 2-week recover, 6-week therapy, 90-day follow-up) and reported here.
Study: NCT03131960
Study Brief: Pivotal Study of VNS During Rehab After Stroke (VNS-REHAB)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
VNS + Rehabilitation (1) Study treatment is vagus nerve stimulation (VNS) delivered during rehabilitation. Paired Vagus Nerve Stimulation: Stimulation of the vagus nerve that is paired with upper limb rehabilitation movements. Rehabilitation: Rehabilitation movements to improve upper limb function after stroke 0 None 5 53 43 53 View
Control VNS Active control treatment is rehabilitation (standard-of-care treatment) with only a minimal amount of VNS at the start of each session intended to support blinding. Rehabilitation: Rehabilitation movements to improve upper limb function after stroke 0 None 3 55 42 55 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Seizure NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (22.0) View
Acute Kidney Injury (AKI)/ chronic kidney disease (CKD) NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (22.0) View
Urinary Tract Infection (UTI) NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (22.0) View
Dysphonia NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (22.0) View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (22.0) View
Colinic Diverticular Abscess NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (22.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Coughing/Hoarseness NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (22.0) View
Local Throat Irritation NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (22.0) View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (22.0) View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (22.0) View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (22.0) View
Low Mood NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (22.0) View
Bruise NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (22.0) View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (22.0) View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (22.0) View
Headache NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (22.0) View