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 @ 1:33 AM
Ignite Modification Date: 2025-12-25 @ 11:46 PM
NCT ID: NCT02268994
Description: None
Frequency Threshold: 5
Time Frame: 16 Week Randomized Period
Study: NCT02268994
Study Brief: KRX-0502 (Ferric Citrate) for the Treatment of IDA in Adult Subjects With NDD-CKD
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
KRX-0502 (Ferric Citrate) 1 g of KRX-0502 (ferric citrate) containing approximately 210 mg of ferric iron ferric citrate: 1 g ferric citrate containing approximately 210 mg of ferric iron 2 None 14 117 61 117 View
Placebo Matching Placebo Placebo: Matching placebo 0 None 13 116 41 116 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Iron Deficiency Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Cardiac Arrest SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardio-Respiratory Arrest SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Sick Sinus Syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac Failure Congestive SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Acute Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac Failure Acute SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Colitis Ischaemic SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Necrosis SYSTEMATIC_ASSESSMENT General disorders None View
Cholangitis Acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Clostridium Difficle Colitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Abscess Limb SYSTEMATIC_ASSESSMENT Infections and infestations None View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Septic Shock SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary Tract Infection Fungal SYSTEMATIC_ASSESSMENT Infections and infestations None View
Celluitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Osteomyelitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pyelonephritis Acute SYSTEMATIC_ASSESSMENT Infections and infestations None View
Abdominal Wound Dehiscence SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Procedural Haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Procedural Nausea SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Procedural Vomiting SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Blood Glucose Increased SYSTEMATIC_ASSESSMENT Investigations None View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Diabetic Ketoacidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Fluid Overload SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Gout SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Metabolic Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Status Epilepticus SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Renal Failure Acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Renal Failure Chronic SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hydronephrosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Renal Impairment SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary Retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Acute Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Chronic Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumonia Aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary Fibrosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Chronic Obstructive Pulmonary Disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Toe Amputation SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Faeces Discoloured SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View