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 @ 2:01 AM
Ignite Modification Date: 2025-12-26 @ 12:25 AM
NCT ID: NCT01239160
Description: Systematic assessment included investigator and study personnel asking subjects at each study visit if they had experienced any AEs since their previous visit. Results presented include 130 subjects who had completed the 12 week follow up (or who withdrew within 12 weeks) prior to the 26Oct2011 dataset.
Frequency Threshold: 5
Time Frame: Adverse events reported below were collected from Baseline through 24 week visit.
Study: NCT01239160
Study Brief: Two Pneumatic Compression Devices in the Treatment of Lower Extremity Lymphedema
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Advanced PCD The use of an advanced PCD device to reduce and maintain limb volume Flexitouch System: A segmental, programmable, gradient pneumatic compression device. It consists of a controller and garment set. The garments are constructed of nylon and have 27-32 chambers, depending upon garment size. The pressure setting is variable between "normal" and "increased." The device is intended to be used for 60 minutes per day 0 None 3 64 25 64 View
Simple PCD The use of the Simple PCD is to reduce and maintain limb volume Hydroven FPR: The FH is an intermittent sequential external pneumatic compression system. The garment contains 3 compression chambers. The pressure range of the compressor device is 30-100 mmHg. It is intended to be used for 60 minutes per day. 0 None 3 66 15 66 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Edema SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Pain SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Cancer SYSTEMATIC_ASSESSMENT General disorders None View
Fractured legs SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Discoloration of toes SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Breathlessness SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Vomiting/Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pain/Itching SYSTEMATIC_ASSESSMENT General disorders None View
Worsened swelling/Edema SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Cellulitis/Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View