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 @ 12:03 AM
Ignite Modification Date: 2025-12-25 @ 10:01 PM
NCT ID: NCT02243358
Description: None
Frequency Threshold: 5
Time Frame: Consent to 1 year post completion of protocol therapy
Study: NCT02243358
Study Brief: Phase II Study of Chemo-Radiotherapy in Patients With Resectable and Borderline Resectable 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
Neoadjuvant Chemo-Radiotherapy and Resection 2 cycles - FOLFOX6 (1 month) Gemcitabine/RT (5-6 weeks) Rest period 2 weeks Re-staging evaluation (CT scan to be done during the 2 weeks of rest) Surgery (To be performed no later than 6 weeks after completion of chemo-radiation) Folfox6 Gemcitabine Radiation Therapy Pancreaticoduodenectomy with retroperitoneal lymphadenectomy 0 None 0 24 21 24 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Mucositis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Hypomagnesemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Cold intolerance NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Fatigue NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Decreased appetite NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Hypokalemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View