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 @ 2:47 AM
Ignite Modification Date: 2025-12-26 @ 1:28 AM
NCT ID: NCT00450333
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00450333
Study Brief: Dynepo Infrequent Dosing Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Dynepo (Epoetin Delta)-Naive Once-weekly (QW) Erythropoietin(EPO)-naive subjects receiving Epoetin delta once weekly (QW) None None 15 98 59 98 View
Dynepo-naive Twice-weekly (BIW) EPO-naive subjects receiving Epoetin delta twice weekly (BIW) None None 23 107 50 107 View
Dynepo QW EPO stable subjects receiving Epoetin delta once weekly (QW) None None 20 102 44 102 View
Dynepo Once Every 2 Weeks (Q2W) EPO stable subjects receiving Epoetin delta once every 2 weeks (Q2W) None None 23 100 44 100 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
DIC NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Acute coronary syndrome NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Acute MI NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Colitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrointestinal hemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Peritonitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hemoglobin decreased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Lung neoplasm malignant NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Brain stem hemorrhage NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cerebrovascular accident NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hypoglycemic coma NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Restless legs syndrome NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pulmonary edema NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Angina NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Renal failure NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Cardiac arrest NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Coronary artery disease NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Ischemic cardiomyopathy NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Intercranial hemorrhage NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hemorrhage NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Peripheral ischemia NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Arterial occlusive disease NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Duodenal ulcer hemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Intestinal fistula NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Catheter related complication NON_SYSTEMATIC_ASSESSMENT General disorders None View
Catheter thrombosis NON_SYSTEMATIC_ASSESSMENT General disorders None View
Catheter related infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pyelonephritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Arteriovenous fistula complication NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Fluid overload NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Orthopnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Edema peripheral NON_SYSTEMATIC_ASSESSMENT General disorders None View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hyperkalemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperphosphatemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Iron deficiency NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscle spasms NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View