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 @ 1:37 PM
Ignite Modification Date: 2025-12-25 @ 12:36 PM
NCT ID: NCT03538795
Description: Selected, anticipated medical problems in the target population, i.e, stroke, were assessed either as part of the outcome testing or trainers and testers regularly asked about the presence of symptoms of interest.
Frequency Threshold: 0
Time Frame: 42 days
Study: NCT03538795
Study Brief: Brain Stimulation and Rehabilitation for Adults With Chronic, Severe Arm Motor Impairment After Stroke
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
iTBS&eCIMT Participants will first receive baseline testing followed by a no-treatment control period. Participants will then be tested again, receive the combination therapy, i.e., iTBS\&eCIMT, and then receive post-treatment testing. iTBS\&eCIMT: All will receive eCIMT+iTBS on an outpatient basis for 4 hours/day for 15 consecutive weekdays. eCIMT will include training of the more-affected arm following shaping principles, restraint of the less-affected arm, and the Transfer Package in combination with NDT techniques to reduce tone so that shaping of movement can be carried out. The Transfer Package is a set of behavioral techniques designed to transfer therapeutic gains from the treatment setting to everyday life. iTBS will be added to prime the areas of the brain that control movement of the more-affected arm so that the responsiveness of that tissue to motor training is enhanced. Treatment sessions will alternate between 10 minute periods of iTBS and 1-hour periods of eCIMT. 0 None 0 3 2 3 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pain SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Depressive symptoms SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Lethargy NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Elevated blood pressure SYSTEMATIC_ASSESSMENT Vascular disorders None View