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 @ 4:50 AM
Ignite Modification Date: 2025-12-26 @ 3:51 AM
NCT ID: NCT04027218
Description: Because in this clinical trial using dry heat and high pressure were only expected local erythema and transient paresthesia as adverse events. The treatment for those adverse events, if applicable, were not consider a requirement of medical or surgical intervention. A supervision (for local erythema) and release the pressure (for transient paresthesia) were considered sufficient as treatment.
Frequency Threshold: 0
Time Frame: Adverse events were collected during the study completion, an average of 30 days.
Study: NCT04027218
Study Brief: Clinical Trial to Assess the Effectiveness of Applying Dry Local Heat and/ or High Tourniquet Pressure for Venipuncture.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Dry Heat Dry heat: The application is made with two sacks of carob seeds during 7 minutes. The sacks are placed on antebrachial anatomical zone, together, and previously heated in the microwave for 0.30 seconds at 850 W of power. 0 None 0 21 7 21 View
High Pressure High pressure: It will be carried out with the use of the manual aneroid sphygmomanometer fixed at 100 millimeters of mercury. Brand (QUIRUMED) with European Conformity (CE) marking 0197. A pressure lower than the systolic blood pressure, and in each subject will be monitored the radial pulse. 0 None 0 18 1 21 View
Combination Combination of dry heat and high pressure: The application is made with two sacks of carob seeds during 7 minutes, then application of high pressure as described is carried out. 0 None 0 20 6 20 View
Current Clinical Practice The standardized and approved Clinical and Laboratory Standards Institute (CLSI) GP41-A6 venipuncture guide has been established for clinical current practice so far. According to vein cannulation procedure CLSI GP41-A6, an elastic compressor will be applied (Synthetic rubber-latex compressor tape, UNIDIX®, Madrid, Spain) provided by the hospital. 0 None 0 59 0 59 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Local erythema NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Transient paresthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View