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 @ 4:18 AM
Ignite Modification Date: 2025-12-26 @ 3:18 AM
NCT ID: NCT03002220
Description: None
Frequency Threshold: 5
Time Frame: Baseline up to 2 years after last dose.
Study: NCT03002220
Study Brief: Trial of Rad-223 Activity in Asymptomatic Patients With mCRPC While on Abiraterone or Enzalutamide Besides AR-V7 Status
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Open-label Patient will be treated with radium-223 at a dose of 55 kBq (after 2015 NIST implementation) per kilogram body weight, given at four-week intervals for six intravenous injections. radium-223: Radium-223 at a dose of 55 kBq 3 None 11 52 30 52 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (20.0) View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (20.0) View
Fever SYSTEMATIC_ASSESSMENT General disorders MedDRA (20.0) View
Fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (20.0) View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (20.0) View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (20.0) View
Congestive heart failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (20.0) View
Flank pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (20.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (20.0) View
Respiratory infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (20.0) View
Uncontrolled pain SYSTEMATIC_ASSESSMENT General disorders MedDRA (20.0) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (20.0) View
Worsening general condition SYSTEMATIC_ASSESSMENT General disorders MedDRA (20.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA (20.0) View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (20.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (20.0) View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (20.0) View
Athralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (20.0) View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (20.0) View