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 @ 12:44 AM
Ignite Modification Date: 2025-12-25 @ 10:57 PM
NCT ID: NCT00295867
Description: None
Frequency Threshold: 0
Time Frame: Two years
Study: NCT00295867
Study Brief: Zoledronate in Treating Bone Marrow Micrometastases in Women With Stage I, Stage II, or Stage III Breast Cancer
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Zoledronic Acid Patients who had greater than 4 disseminated tumor cells (DTCs)/mL present following neoadjuvant or adjuvant chemotherapy for early stage breast cancer were treated with 4mg zoledronic acid each month for 24 months. 2 None 1 45 33 45 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
appendicitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Flu like symptoms SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
grinding teeth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Hip pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Jaw pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Lightheadedness SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Soreness at infusion site SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE (3.0) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View