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 @ 12:05 AM
Ignite Modification Date: 2025-12-25 @ 10:04 PM
NCT ID: NCT01280058
Description: The National Cancer Institutes (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for adverse event grading and reporting.
Frequency Threshold: 5
Time Frame: None
Study: NCT01280058
Study Brief: Carboplatin and Paclitaxel With or Without Viral Therapy in Treating Patients With Recurrent or 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
Arm A (Wild-type Reovirus, Carboplatin, Paclitaxel) Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and wild-type reovirus IV over 60 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Carboplatin and Paclitaxel were given IV. Wild-type Reovirus: Given IV None None 36 36 36 36 View
Arm B (Carboplatin, Paclitaxel) Patients receive paclitaxel and carboplatin as in Arm I. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may crossover to Arm I. Carboplatin and Paclitaxel were given IV None None 37 37 37 37 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE version 4.0 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE version 4.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE version 4.0 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE version 4.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE version 4.0 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE version 4.0 View
Bloating SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE version 4.0 View
Gastric hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE version 4.0 View
Gastric ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE version 4.0 View
Lower gastrointestional hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE version 4.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE version 4.0 View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE version 4.0 View
Rectal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE version 4.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE version 4.0 View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders CTCAE version 4.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE version 4.0 View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE version 4.0 View
Infusion related reaction SYSTEMATIC_ASSESSMENT General disorders CTCAE version 4.0 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders CTCAE version 4.0 View
Bile duct stenosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE version 4.0 View
Device related infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE version 4.0 View
Infections SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE version 4.0 View
Lung Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE version 4.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE version 4.0 View
Skin Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE version 4.0 View
Upper Respiratory Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE version 4.0 View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE version 4.0 View
Injury, poisoning and procedural complications SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE version 4.0 View
Postoperative hemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE version 4.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE version 4.0 View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE version 4.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE version 4.0 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations CTCAE version 4.0 View
Cardiac troponin I increaesd SYSTEMATIC_ASSESSMENT Investigations CTCAE version 4.0 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE version 4.0 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE version 4.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE version 4.0 View
White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE version 4.0 View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE version 4.0 View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE version 4.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE version 4.0 View
Peripheral sensory SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE version 4.0 View
Transient ischemic attacks SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE version 4.0 View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE version 4.0 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE version 4.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE version 4.0 View
Hypostension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE version 4.0 View
Thromboembolic event SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE version 4.0 View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE version 4.0 View
Febrile Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE version 4.0 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE version 4.0 View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE version 4.0 View
Chest pain-cardiac SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE version 4.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders CTCAE version 4.0 View
Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE version 4.0 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE version 4.0 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE version 4.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE version 4.0 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE version 4.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE version 4.0 View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE version 4.0 View
Febrile Neutropenia SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE version 4.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE version 4.0 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE version 4.0 View