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: 2025-12-24 @ 1:18 PM
Ignite Modification Date: 2025-12-25 @ 12:25 PM
NCT ID: NCT05110495
Description: Adverse Event data was collected during trial visits from investigator-led assessments as specified in the protocol.
Frequency Threshold: 0
Time Frame: From consent to end of study visit (up to 19 weeks).
Study: NCT05110495
Study Brief: IGF Inhibition With Xentuzumab Prior to Radical Prostatectomy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Xentuzumab All patients were allocated to receive the study IMP, Xentuzumab. Xentuzumab is a humanised IgG1 monoclonal antibody that neutralises the IGF ligands to inhibit activation of IGF-1R and INSR-A, suppressing IGF-mediated proliferation, invasion and therapy resistance. 0 None 0 27 24 27 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Blood & Lymphatic System Disorders SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.0 View
Eye disorders SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.0 View
Gastrointestinal Disorders SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
General Disorders & Administration Site Conditions SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Infections & Infestations SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Injury; poisoning and procedural complications SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Metabolism & Nutrition Disorders SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Musculoskeletal & Connective Tissue Disorders SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Nervous System Disorders SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Renal and urinary disorders SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
Reproductive system and breast disorders SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 24.0 View
Respiratory, thoracic and mediastinal disorders SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Skin and subcutaneous tissue disorders SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Surgical and medical procedures SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 24.0 View
Vascular disorders SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.0 View