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 @ 7:22 PM
Ignite Modification Date: 2025-12-25 @ 5:01 PM
NCT ID: NCT01208103
Description: None
Frequency Threshold: 3.3
Time Frame: Assessed up to 67 months
Study: NCT01208103
Study Brief: Bevacizumab, Capecitabine, and Oxaliplatin in Treating Advanced Small Intestinal or Ampulla of Vater Adenocarcinoma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Bevacizumab + Capecitabine + Oxaliplatin Capecitabine 750mg/m2 oral twice daily, Days 1 - 14 and Panitumumab 9 mg/kg IV over 60 minutes on Day 1 and Oxaliplatin 130 mg/m2 IV over 2 hours Day 1 of 21-day cycle. 30 None 4 30 30 30 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Upper gastrointestinal hemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
Non-cardiac chest pain NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE 4.0 View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Aspartate NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Blood bilirubin increased NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 4.0 View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE 4.0 View
Hyponatremia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Pancreatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Peripheral sensor neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 4.0 View
Portal hypertension NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE 4.0 View
Proteinuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE 4.0 View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 4.0 View
Thromboembolic event NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE 4.0 View
Weight loss NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE 4.0 View
Platelet count decreased NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Neutrophil count decreased NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Alkaline phosphatase increased NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Anorexia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
Ascites NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Colitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Creatinine increased NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE 4.0 View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 4.0 View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View
Dysesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 4.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE 4.0 View
Pnuemonitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 4.0 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.0 View