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 @ 2:16 PM
Ignite Modification Date: 2025-12-25 @ 12:53 PM
NCT ID: NCT03413995
Description: None
Frequency Threshold: 0
Time Frame: Baseline to End of Treatment approximately 4 years 8 months
Study: NCT03413995
Study Brief: Trial of Rucaparib in Patients With Metastatic Hormone-Sensitive Prostate Cancer Harboring Germline DNA Repair Gene Mutations
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Rucaparib 600 mg BID Subjects will be administered Rucaparib 600mg by mouth twice daily, continuous dosing in 28 day cycles. Drug should be taken as close as possible to 12 hours apart and preferably at the same times every day, with water. Rucaparib tablets must be swallowed whole and may be taken with or without food. Rucaparib: Rucaparib will be dispensed to patients on Day 1 and every 28 days thereafter until the patient completes the study, withdraws from the study or closure of the study. 0 None 3 12 8 12 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Small Bowel Obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Atrial Fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Aspartate Aminotransferase-increased NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Alanine Aminotransferase-Increased NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Creatinine-Increased NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Edema NON_SYSTEMATIC_ASSESSMENT General disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Palmar-Plantar Erythrodyesia Syndrome NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Skin Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dysguesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View