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 @ 1:19 AM
Ignite Modification Date: 2025-12-25 @ 11:27 PM
NCT ID: NCT00416793
Description: None
Frequency Threshold: 5
Time Frame: 17 months
Study: NCT00416793
Study Brief: Bortezomib and Carboplatin in Treating Patients With Metastatic Pancreatic 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
Bortezomib + Carboplatin Bortezomib 1.3 mg/m2 by vein (IV) on days 1, 4, 8 + 11; Carboplatin Area Under the Curve (AUC) of 5 IV over 30 minutes None None 0 9 9 9 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Alopecia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Aspartate Aminotransferase increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Bile duct stenosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE (3.0) View
Bilirubin increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Blood Glucose Increase SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Blood uric acid increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Blurred vision SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (3.0) View
Cardiac Pain SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
Chills SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Creatinine increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Depression SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Dizziness SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Erythema multiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Gastrointestinal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Headache SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Increased Alkaline Phosphatase SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Insomnia SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Mucositis (oral) SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Myocardial Ischemia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (3.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Pain(back) SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Peripheral Sensory Neuropathy SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Plate Count decrease SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Renal(loss of feeling of urination) SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (3.0) View
Serum Sodium increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Serum magnesium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Taste Alteration SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (3.0) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View