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 @ 2:00 AM
Ignite Modification Date: 2025-12-26 @ 12:24 AM
NCT ID: NCT01711294
Description: Reported on all Serious Adverse Events and procedure-related non-serious Adverse Events.
Frequency Threshold: 0
Time Frame: Adverse event data collected from the time the participant signed to informed consent and was randomized to the study, until completion of the post-EUS FNA procedure 30-day follow-up visit (window of 25-35 days post EUS FNA procedure).
Study: NCT01711294
Study Brief: Evaluation of PCLs Using Three EUS-FNA 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
19G Flex Needle Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G Flex) 19G Flex Needle: Fine Needle Aspiration of PCL with a 19G Flex needle. If unsuccessful, a salvage procedure will be done with 19G or 22G needle. 1 None 3 121 1 121 View
22G Needle Device: Expect™ Endoscopic Ultrasound Aspiration Needle (22G) 22G Needle: Fine Needle Aspiration of PCL with a 22G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle. 1 None 2 65 1 65 View
19G Needle Device: Expect™ Endoscopic Ultrasound Aspiration Needle (19G) 19G Needle: Fine Needle Aspiration of PCL with a 19G needle. If unsuccessful, a salvage procedure will be done with 19G Flex needle. 0 None 0 64 1 64 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pancreatitis acute SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (15.0) View
Pneumonia aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (15.0) View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (15.0) View
Endometrial cancer metastatic SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (15.0) View
Neuroendocrine carcinoma metastatic SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (15.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Haemorrhagic cyst SYSTEMATIC_ASSESSMENT General disorders MedDRA (15.0) View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (15.0) View
Pancreatitis acute SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (15.0) View