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 @ 12:01 AM
Ignite Modification Date: 2025-12-25 @ 9:59 PM
NCT ID: NCT00526058
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00526058
Study Brief: (H.E.L.P.)Apheresis Therapy to Compare the Reduction of LDL (Low Density Lipoprotein) Cholesterol
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Secura Randomized first to the approved Plasmat® Secura apheresis system then Plasmat® Futura apheresis system. None None 4 18 15 18 View
Futura Randomized first to the approved Plasmat® Futura apheresis system then Plasmat® Secura apheresis system. None None 1 18 17 18 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anemia None Blood and lymphatic system disorders None View
Bacteremia None Blood and lymphatic system disorders None View
Hyperkalemia None Endocrine disorders None View
Atrial Flutter None Cardiac disorders None View
Myocardial Ischemia None Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia None Blood and lymphatic system disorders None View
Atrial Flutter None Cardiac disorders None View
Myocardial Ischaemia None Cardiac disorders None View
abdominal tenderness None Gastrointestinal disorders None View
diverticulum None Gastrointestinal disorders None View
epigastric discomfort None Gastrointestinal disorders None View
gastritis None Gastrointestinal disorders None View
melaena None Gastrointestinal disorders None View
nausea None Gastrointestinal disorders None View
stomach discomfort None Gastrointestinal disorders None View
fatigue None General disorders None View
malaise None General disorders None View
bacteraemia None Infections and infestations None View
bacterial infection None Infections and infestations None View
bronchitis None Infections and infestations None View
sinusitis None Infections and infestations None View
urinary tract infection None Infections and infestations None View
arteriovenous fistula occlusion None Injury, poisoning and procedural complications None View
arteriovenous fistula site complication None Injury, poisoning and procedural complications None View
arteriovenous fistula site haemorrhage None Injury, poisoning and procedural complications None View
device breakage None Injury, poisoning and procedural complications None View
device failure None Injury, poisoning and procedural complications None View
device malfunction None Injury, poisoning and procedural complications None View
device occlusion None Injury, poisoning and procedural complications None View
medical device complication None Injury, poisoning and procedural complications None View
road traffic accident None Injury, poisoning and procedural complications None View
breath sounds abnormal None Investigations None View
serum ferritin decreased None Investigations None View
hyperkalaemia None Metabolism and nutrition disorders None View
joint swelling None Musculoskeletal and connective tissue disorders None View
musculoskeletal pain None Musculoskeletal and connective tissue disorders None View
myalgia None Musculoskeletal and connective tissue disorders None View
pain in extremity None Musculoskeletal and connective tissue disorders None View
skin cancer None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
dizziness None Nervous system disorders None View
sciatica None Nervous system disorders None View
cough None Respiratory, thoracic and mediastinal disorders None View
nasal mucosal disorder None Respiratory, thoracic and mediastinal disorders None View
nasal oedema None Respiratory, thoracic and mediastinal disorders None View
pharyngolaryngeal pain None Respiratory, thoracic and mediastinal disorders None View
throat tightness None Respiratory, thoracic and mediastinal disorders None View
wheezing None Respiratory, thoracic and mediastinal disorders None View
hyperhidrosis None Skin and subcutaneous tissue disorders None View
rash None Skin and subcutaneous tissue disorders None View
hypotension None Vascular disorders None View