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 @ 2:11 AM
Ignite Modification Date: 2025-12-26 @ 12:39 AM
NCT ID: NCT05214560
Description: An AE is defined as any untoward medicaloccurrence, unintended disease or injury,or untoward clinical signs (includingabnormal laboratory findings) in subjects,users or other persons, whether or notrelated to the investigational medicaldevice. An adverse device effect is defined asany adverse event that is considered tobe related to the use of an investigationalmedical device.
Frequency Threshold: 0
Time Frame: From the BD Spina needle insertion up to 7 days post procedure
Study: NCT05214560
Study Brief: Prospective Clinical Evaluation of BD Spinal Needles
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
All Participants Participants who require a BD Spinal needle as part of their routine medical care. Spinal needle: Insertion of a spinal needle to perform the neuraxial procedure according to the clinical practice. 0 None 0 144 17 144 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Procedural failure SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.1 View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Injection site irritation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Post lumbar puncture syndrome SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Puncture site pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Paresthesia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.1 View