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 @ 12:44 AM
Ignite Modification Date: 2025-12-25 @ 10:56 PM
NCT ID: NCT01677767
Description: An Adverse Event is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Frequency Threshold: 2
Time Frame: Up to Week 24
Study: NCT01677767
Study Brief: An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Chronic Kidney Disease Patients on Dialysis With Renal Anemia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
C.E.R.A. Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks. None None 6 124 21 124 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Peritonitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Asthenia SYSTEMATIC_ASSESSMENT General disorders None View
Death SYSTEMATIC_ASSESSMENT General disorders None View
Chronic renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Peritonitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Chills SYSTEMATIC_ASSESSMENT General disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders None View