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 @ 12:10 AM
Ignite Modification Date: 2025-12-25 @ 10:11 PM
NCT ID: NCT04085458
Description: None
Frequency Threshold: 5
Time Frame: Timeframe for TEAEs: After the first study intervention up to 7 days after the end of study intervention, with an average of 475 days. Timeframe for the all-cause mortality: All deaths that occurred at any time during the study before the last contact, with an average of 476 days.
Study: NCT04085458
Study Brief: Study to Gain More Information on How Safe and Effective Jivi Works in Patients With Severe Hemophilia A (Post-marketing Investigation)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Severe Hemophilia A Patients With Damoctocog Alfa Pegol (Jivi, BAY94-9027) Treatment Prophylaxis regimens with every 5 days treatment (45-60 IU/kg), or every 7 days (60 IU/kg) or twice per week (40 IU/kg). 0 None 2 32 15 32 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (25.0) View
Osteoarthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (25.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (25.0) View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (25.0) View
Limb injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (25.0) View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (25.0) View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (25.0) View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (25.0) View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (25.0) View
Tooth extraction NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (25.0) View