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: 2025-12-24 @ 10:54 PM
Ignite Modification Date: 2025-12-25 @ 8:23 PM
NCT ID: NCT03079869
Description: Adverse event (AE's) were included for all patient who received study drug for at least 1 day (n=54). After the baseline visit adverse events are collected on a weekly basis for the hemodialysis patients, and on a bi-monthly basis from the dialysis patients, and again 30days after the termination of the study.
Frequency Threshold: 0
Time Frame: 7 months
Study: NCT03079869
Study Brief: Transition to Ferric Citrate Among Hemodialysis and Peritoneal Dialysis Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Ferric Citrate - Hemodialysis Auryxia, 210 mg ferric iron tablets equivalent to 1 g of ferric citrate are supplied as 200 tablets in 400-cc high-density polyethylene bottles. Ferric Citrate: One to two tablets of Ferric Citrate phosphorus binder administered by mouth before every meal to prevent dietary phosphorus absorption. 0 None 7 27 23 27 View
Ferric Citrate - Peritoneal Dialysis Auryxia, 210 mg ferric iron tablets equivalent to 1 g of ferric citrate are supplied as 200 tablets in 400-cc high-density polyethylene bottles. Ferric Citrate: One to two tablets of Ferric Citrate phosphorus binder administered by mouth before every meal to prevent dietary phosphorus absorption. 0 None 10 27 27 27 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Congestive heart failure exacerbation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Gastrointestinal Hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hematochezia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal swelling SYSTEMATIC_ASSESSMENT General disorders None View
Chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Chronic back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Intertrochanteric fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Right hip osteoporotic Fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Laparoscopic right nephrectomy SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Placement of catheter for HD SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Right sided pleuroperitoneal leak SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Left heel ulcers SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Critical limb ischemia SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hemorrhagic cerebrovascular accident SYSTEMATIC_ASSESSMENT Vascular disorders None View
Peripheral vascular disease SYSTEMATIC_ASSESSMENT Vascular disorders None View
Arteriovenous fistula SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
gallstone pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Peritonitis SYSTEMATIC_ASSESSMENT General disorders None View
Right foot infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Left foot pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Black stool SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Bloating/Gas SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea, vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Itching/rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Upper Respiratory Infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Abscess SYSTEMATIC_ASSESSMENT Infections and infestations None View
Peritonitis SYSTEMATIC_ASSESSMENT General disorders None View
Chest Pain/Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View