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 @ 12:37 AM
Ignite Modification Date: 2025-12-25 @ 10:47 PM
NCT ID: NCT04540367
Description: It was a muscle strain as the volunteer had an untrained arm. It was treated with ibuprofen, the subject was completely fine and able to finish the study.
Frequency Threshold: 0
Time Frame: The AE was a single episode of a muscle strain. The subject was monitored from the time of the event through study completion, an average of 8 weeks.
Study: NCT04540367
Study Brief: Blood Flow Restriction Training for The Shoulder
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
No Intervention: Control (Pitchers) Participants in this group performed the exercises without the blood flow restriction therapy cuff. Additionally, these participants are considered the pitchers. 0 None 0 13 0 13 View
No Intervention: Control (General Population) Participants in this group performed the exercises without the blood flow restriction therapy cuff. Additionally, these participants are considered part of the general population. 0 None 0 16 0 16 View
Experimental: BFR (Pitchers) Participants in this group performed the exercises with the blood flow restriction therapy cuff Blood flow restriction therapy: The study group underwent the same exercises as the control group modified by the use of a tourniquet for blood flow restriction during those exercises. Additionally, these participants are considered the pitchers. 0 None 0 15 0 15 View
Experimental: BFR (General Population) Participants in this group performed the exercises with the blood flow restriction therapy cuff Blood flow restriction therapy: The study group underwent the same exercises as the control group modified by the use of a tourniquet for blood flow restriction during those exercises. Additionally, these participants are considered part of the general population. 0 None 1 16 0 16 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Other SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications Other View
Other Events(If Any):