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 @ 11:28 PM
Ignite Modification Date: 2025-12-25 @ 9:15 PM
NCT ID: NCT02704156
Description: None
Frequency Threshold: 5
Time Frame: 3 years
Study: NCT02704156
Study Brief: SBRT Plus Pembrolizumab and Trametinib for 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
SBRT Plus Gemcitabine Patients with locally recurrent pancreatic cancer were randomly allocated to SBRT plus Pembrolizumab and Trametinib or SBRT plus Gemcitabine. Cyberknife plus Gemcitabine: Radiation therapy plus drug 85 None 21 85 85 85 View
SBRT Plus Pembrolizumab and Trametinib Patients with locally recurrent pancreatic cancer were randomly allocated to SBRT plus Pembrolizumab and Trametinib or SBRT plus Gemcitabine. Cyberknife plus Pembrolizumab and Trametinib: Radiation therapy plus drug 83 None 29 85 85 85 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Grade 3 pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
Grade 3 vomitting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Grade 3 and 4 increased ALT or AST SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Grade 3 stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Grade 3 rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Grade 3 and 4 neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Grade 3 thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Grade 3 increased blood bilirubin SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Grade 3 hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Grade 3 hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Grade 3 pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Grade 3 hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Grade 1-2 Nausea and vomitting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Grade 1-2 diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Grade 1-2 increased ALT or AST SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Grade 1-2 stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Grade 1-2 rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Grade 1-2 neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Grade 1-2 thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Grade 1-2 proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View