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 @ 3:51 PM
Ignite Modification Date: 2025-12-25 @ 1:57 PM
NCT ID: NCT04951492
Description: None
Frequency Threshold: 0
Time Frame: Within 30 days of end of treatment, up to 16.6 weeks
Study: NCT04951492
Study Brief: Olaparib for the Treatment of Castration Resistant Prostate Adenocarcinoma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treatment (Olaparib) Patients receive olaparib orally (PO) twice daily (BID). Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Olaparib: Given PO 0 None 1 2 2 2 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pulmonary Embolism SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Bone Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Left Forearm Tear SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Lightheadedness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
White Blood Cell Count Decreased SYSTEMATIC_ASSESSMENT Investigations None View
Neutrophil Count Decreased SYSTEMATIC_ASSESSMENT Investigations None View
Supraventricular Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Lymphocyte Count Decreased SYSTEMATIC_ASSESSMENT Investigations None View