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 @ 5:46 PM
Ignite Modification Date: 2025-12-25 @ 3:13 PM
NCT ID: NCT04098068
Description: None
Frequency Threshold: 5
Time Frame: Serious and Other Adverse Events assessed for up to 28 months. All-Cause Mortality assessed for up to 80 months.
Study: NCT04098068
Study Brief: Study of MK-3475 (Pembrolizumab) in Patients With Microsatellite Unstable (MSI) Tumors (Cohort D)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
MSI (Microsatellite Unstable) Negative With Mutator Phenotype MK-3475 (pembrolizumab): MK-3475 200 mg flat dose every 21 days 4 None 6 12 5 12 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Opioid use disorder SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Diffuse large B cell lymphoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Congestive heart failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Disease progression SYSTEMATIC_ASSESSMENT General disorders None View
Plasma cell myeloma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Thromboembolic event SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Anorexia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cellulitis SYSTEMATIC_ASSESSMENT Immune system disorders None View
Chills SYSTEMATIC_ASSESSMENT General disorders None View
Conjunctival erythema SYSTEMATIC_ASSESSMENT Eye disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
COVID infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Dehydration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diabetes mellitus SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders None View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Edema SYSTEMATIC_ASSESSMENT General disorders None View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Esophageal dysmotility SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Esophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Ganglion cyst SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastroesophageal reflux SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hernia SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hyperbilirubinemia SYSTEMATIC_ASSESSMENT Investigations None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Lymphadenopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Metrorrhagia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders None View
Nocturia SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Oral thrush SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pelvic pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pruritis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Sinus pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Small bowel obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Sweating SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Thromboembolic event SYSTEMATIC_ASSESSMENT Vascular disorders None View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract pain SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Vaginal hemorrhage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Watering eyes SYSTEMATIC_ASSESSMENT Eye disorders None View
Weight loss SYSTEMATIC_ASSESSMENT Investigations None View
Dental pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View