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 @ 7:50 PM
Ignite Modification Date: 2025-12-25 @ 5:26 PM
NCT ID: NCT03264404
Description: None
Frequency Threshold: 0
Time Frame: 24 months
Study: NCT03264404
Study Brief: Azacitidine and Pembrolizumab in 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
Pembrolizumab Patients with advanced pancreatic cancer will receive pembrolizumab with the hypomethylating agent azacitidine. Pembrolizumab: Pembrolizumab 200 mg IV every 3 weeks until progression Azacitidine: 50 mg/m2 subcutaneous daily for 5 days every 28 days 26 None 9 36 36 36 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Gastric hemorrhage SYSTEMATIC_ASSESSMENT General disorders None View
Endocrine disorders SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Nervous system disorders SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Stroke SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Myocarditis SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hepatobiliary disorders SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Vascular disorders SYSTEMATIC_ASSESSMENT Vascular disorders None View
Gastroparesis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hepatic hemorrhage SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Thromboembolic event SYSTEMATIC_ASSESSMENT Vascular disorders None View
Portal vein thrombosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Urinary tract pain SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypokalemia SYSTEMATIC_ASSESSMENT Investigations None View
Skin and subcutaneous tissue disorder SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Chest wall pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Anal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vaginal dryness SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Hoarseness SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Infections and infestations SYSTEMATIC_ASSESSMENT Infections and infestations None View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Weight loss SYSTEMATIC_ASSESSMENT Investigations None View
Metabolism and nutrition disorders SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Sore throat SYSTEMATIC_ASSESSMENT General disorders None View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Gastrointestinal disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Confusion SYSTEMATIC_ASSESSMENT General disorders None View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Ear and labyrinth disorders SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Watering eyes SYSTEMATIC_ASSESSMENT Eye disorders None View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Thromboembolic event SYSTEMATIC_ASSESSMENT Vascular disorders None View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Portal hypertension SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hypernatremia SYSTEMATIC_ASSESSMENT Investigations None View
Endocrine disorders SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Injury, poisoning and procedural complications SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Bruising SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders None View
Hallucinations SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Musculoskeletal and connective tissue disorder SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Cardiac troponin T increased SYSTEMATIC_ASSESSMENT Investigations None View
Generalized muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Weight gain SYSTEMATIC_ASSESSMENT Investigations None View
Edema, Limbs SYSTEMATIC_ASSESSMENT General disorders None View
Hot flashes SYSTEMATIC_ASSESSMENT General disorders None View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Stroke SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Hypocalcemia SYSTEMATIC_ASSESSMENT Investigations None View
Hypomagnesemia SYSTEMATIC_ASSESSMENT Investigations None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Alanine aminotransferase increase SYSTEMATIC_ASSESSMENT Investigations None View
International Normalized Ratio (INR) Increased SYSTEMATIC_ASSESSMENT Investigations None View
Hyponatremia SYSTEMATIC_ASSESSMENT Investigations None View
Hypercalcemia SYSTEMATIC_ASSESSMENT Investigations None View
Creatinine Increased SYSTEMATIC_ASSESSMENT Investigations None View
Hyperkalemia SYSTEMATIC_ASSESSMENT Investigations None View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Investigations None View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Chills SYSTEMATIC_ASSESSMENT General disorders None View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Skin hyperpigmentation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations None View
Bloating SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hepatobiliary disorder SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Cough SYSTEMATIC_ASSESSMENT General disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Flu like symptoms SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View