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 @ 2:00 AM
Ignite Modification Date: 2025-12-26 @ 12:23 AM
NCT ID: NCT01833494
Description: None
Frequency Threshold: 5
Time Frame: 52 weeks
Study: NCT01833494
Study Brief: A Long-term Study of PA21 in Hemodialysis Patients With Hyperphosphatemia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
PA21 PA21 3 None 29 161 133 161 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pyelonephritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Renal cyst infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Lung neoplasm malignant NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Altered state of consciousness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Subarachnoid haemorrhage NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Transient ischaemic attack NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
VIIth nerve paralysis NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cataract NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Retinal haemorrhage NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Vitreous haemorrhage NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Macular fibrosis NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Angina pectoris NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Arteriosclerosis coronary artery NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac failure congestive NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Ventricular fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Haematoma NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Venous stenosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Gastrointestinal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Ileus NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Jaw cyst NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Renal cyst haemorrhage NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Shunt occlusion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Contusion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Shunt stenosis NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Shunt malfunction NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Shunt aneurysm NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dental caries NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Eczema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Excoriation NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Contusion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Wound NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Procedural hypotension NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View