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 @ 2:38 PM
Ignite Modification Date: 2025-12-25 @ 1:10 PM
NCT ID: NCT02964559
Description: None
Frequency Threshold: 5
Time Frame: 1 year after treatment discontinuation (max treatment duration of 3 years)
Study: NCT02964559
Study Brief: Pembrolizumab in Patients With Locally Advanced or Metastatic Skin 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 receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. 0 None 6 11 11 11 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Edema cerebral NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Fall NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
General disorders and administration site conditions - Other, specify NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hematoma NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hydrocephalus NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hypotension NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Meningitis NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pneumonitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Seizure NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Supraventricular tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Presyncope NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hyperglycemia NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Hyponatremia NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Creatinine increased NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Activated partial thromboplastin time prolonged NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Blood bilirubin increased NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Alkaline phosphatase increased NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Dry mouth NON_SYSTEMATIC_ASSESSMENT General disorders None View
Dyspnea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hyperkalemia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hypertension NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hyperuricemia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hypoalbuminemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hypocalcemia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hypoglycemia NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Hypomagnesemia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Anorexia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Bruising NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cough NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Dysphagia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Fall NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Flu like symptoms NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
General disorders and administration site conditions - Other, specify NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hemoglobin increased NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hypermagnesemia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hypokalemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hypothyroidism NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Metabolism and nutrition disorders - Other, specify NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Non-cardiac chest pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Platelet count decreased NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Pneumonitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rash maculo-papular NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Urine discoloration NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Adrenal insufficiency NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Allergic reaction NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Aspiration NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Blood and lymphatic system disorders - Other, specify NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Blurred vision NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Chills NON_SYSTEMATIC_ASSESSMENT General disorders None View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT General disorders None View
Edema cerebral NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Edema limbs NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Fever NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Flushing NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Gastrointestinal disorders - Other, specify NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hematoma NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hydrocephalus NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hypercalcemia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hypernatremia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hypophosphatemia NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View
Hypotension NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Infections and infestations - Other, specify NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Investigations - Other, specify NON_SYSTEMATIC_ASSESSMENT General disorders None View
Laryngeal hemorrhage NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Laryngeal inflammation NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Meningitis NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Movements involuntary NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Palpitations NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Papulopustular rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Paresthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Peripheral motor neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Postnasal drip NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Presyncope NON_SYSTEMATIC_ASSESSMENT General disorders None View
Seizure NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Skin and subcutaneous tissue disorders - Other, specify NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin ulceration NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Supraventricular tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Thromboembolic event NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Vaginal hemorrhage NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Vascular disorders - Other, specify NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Ventricular arrhythmia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Weight loss NON_SYSTEMATIC_ASSESSMENT General disorders None View
White blood cell decreased NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View