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 @ 7:12 PM
Ignite Modification Date: 2025-12-25 @ 4:47 PM
NCT ID: NCT02097303
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were collected from enrollment through 6 monthly cycles, and 30 days after the end of treatment, for a total of 7 months.
Study: NCT02097303
Study Brief: Open Label Phase Two Trial of Radium Ra 223 Dichloride With Concurrent Administration of Abiraterone Acetate Plus Prednisone in Symptomatic Castration-Resistant (Hormone-Refractory) Prostate Cancer Subjects With Bone Metastasis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Radium 223 With Concomitant Abiraterone Acetate and Prednisone Name of active ingredient Radium Ra 223 dichloride Dose 50 kBq/kg body weight Route of Administration Intravenous Duration of Treatment One injection every 4 weeks X 6 injections maximum. Name of active ingredient Abiraterone Acetate plus Prednisone Dose 1000 mg/day and 5 mg BID Route of Administration Oral Duration of Treatment 26 weeks minimum duration. There is no maximum duration. 1 None 5 36 30 36 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abdominal Pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cardiopulmonary Arrest NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Urinary Tract Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Syncope SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Small Bowel Obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Congestive Heart Failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Leukopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Pancytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Stomach Pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal Pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Decreased Appetitie NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dysguesia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Edema Limbs NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Increased Liver Function Tests NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Decreased Red Blood Count NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Increased ALT NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Increased ALT NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Increased ALP NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Hypocalcemia NON_SYSTEMATIC_ASSESSMENT Investigations None View
Hyponatremia NON_SYSTEMATIC_ASSESSMENT Investigations None View
Hyponatremia NON_SYSTEMATIC_ASSESSMENT Investigations None View
Hypochloremia NON_SYSTEMATIC_ASSESSMENT Investigations None View
Bone Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Headaches NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Paresthesia NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Gynecomastia NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View