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 @ 1:41 AM
Ignite Modification Date: 2025-12-25 @ 11:57 PM
NCT ID: NCT01521494
Description: None
Frequency Threshold: 5
Time Frame: 6 weeks
Study: NCT01521494
Study Brief: PA21 Phase II Clinical Study 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 750 mg/Day PA21 0 None 1 39 13 39 View
PA21 1500 mg/Day PA21 0 None 2 36 11 36 View
PA21 2250 mg/Day PA21 0 None 2 35 19 35 View
PA21 3000 mg/Day PA21 0 None 1 36 20 36 View
Placebo Placebo 0 None 1 37 11 37 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Liver abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cerebral infarction NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cardiac failure congestive NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Peripheral arterial occlusive disease NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Prostate cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Brain stem infarction NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Intracranial aneurysm NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Angina pectoris NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Upper respiratory tract inflammation NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Flatulence NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Haemorrhoids NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Contusion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View