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 @ 12:22 AM
Ignite Modification Date: 2025-12-25 @ 10:26 PM
NCT ID: NCT01543958
Description: AE reporting followed DAIDS reporting level
Frequency Threshold: 5
Time Frame: AEs reported from study enrollment until study completion at week 16
Study: NCT01543958
Study Brief: Sevelamer for Reducing Endotoxemia and Immune Activation
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Sevelamer Carbonate Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks. None None 2 40 32 40 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Joint injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Conjunctivitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Blood bicarbonate decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Blood calcium decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Blood cholesterol increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Blood glucose decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Blood glucose increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Blood phosphorus decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Blood sodium decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Haemoglobin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Low density lipoprotein increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View