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: 2025-12-26 @ 5:23 PM
Ignite Modification Date: 2025-12-26 @ 5:23 PM
NCT ID: NCT03089606
Description: Adverse events were collected from day one of the study drug administration to 30 days after completion of treatment.
Frequency Threshold: 0
Time Frame: Up to 114 days.
Study: NCT03089606
Study Brief: Pembrolizumab TX-naive Distant Mets Melanoma and Use of (C11-AMT) PET at Baseline as Imaging Biomarker
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Single Arm This is a single arm study. All participants completed the study interventions which are pembrolizumab treatment, FDG PET, C11-AMT PET and CT scans. 9 None 5 27 27 27 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Neoplasms benign, malignant and unspecified NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) CTCAEv4.03 View
Rash maculo-papular NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAEv4.03 View
Neutrophil count decreased NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv4.03 View
Retinal detachment NON_SYSTEMATIC_ASSESSMENT Eye disorders CTCAEv4.03 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAEv4.03 View
Cardiac disorders - Other, specify NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAEv4.03 View
Chest pain - cardiac NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAEv4.03 View
Hearing impaired NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAEv4.03 View
Vertigo NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAEv4.03 View
Endocrine disorders - Other, specify NON_SYSTEMATIC_ASSESSMENT Endocrine disorders CTCAEv4.03 View
Hyperthyroidism NON_SYSTEMATIC_ASSESSMENT Endocrine disorders CTCAEv4.03 View
Hypothyroidism NON_SYSTEMATIC_ASSESSMENT Endocrine disorders CTCAEv4.03 View
Blurred vision NON_SYSTEMATIC_ASSESSMENT Eye disorders CTCAEv4.03 View
Eye disorders - Other, specify NON_SYSTEMATIC_ASSESSMENT Eye disorders CTCAEv4.03 View
Floaters NON_SYSTEMATIC_ASSESSMENT Eye disorders CTCAEv4.03 View
Retinal detachment NON_SYSTEMATIC_ASSESSMENT Eye disorders CTCAEv4.03 View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv4.03 View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv4.03 View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv4.03 View
Dry mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv4.03 View
Gastrointestinal disorders - Other, specify SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv4.03 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv4.03 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAEv4.03 View
Edema limbs NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv4.03 View
Facial pain NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv4.03 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv4.03 View
Flu like symptoms NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv4.03 View
Localized edema NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv4.03 View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders CTCAEv4.03 View
Hepatic pain NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAEv4.03 View
Immune system disorders - Other, specify NON_SYSTEMATIC_ASSESSMENT Immune system disorders CTCAEv4.03 View
Infections and infestations - Other, specify NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAEv4.03 View
Papulopustular rash NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAEv4.03 View
Seroma NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAEv4.03 View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv4.03 View
Alkaline phosphatase increased NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv4.03 View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv4.03 View
Blood bilirubin increased NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv4.03 View
Creatinine increased NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv4.03 View
Investigations - Other, specify NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv4.03 View
Lymphocyte count decreased NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv4.03 View
Neutrophil count decreased NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv4.03 View
Platelet count decreased NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv4.03 View
White blood cell decreased NON_SYSTEMATIC_ASSESSMENT Investigations CTCAEv4.03 View
Anorexia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAEv4.03 View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAEv4.03 View
Hypercalcemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAEv4.03 View
Hyperglycemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAEv4.03 View
Hyperkalemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAEv4.03 View
Hypertriglyceridemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAEv4.03 View
Hypoalbuminemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAEv4.03 View
Hyponatremia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAEv4.03 View
Metabolism and nutrition disorders - Other, specify NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAEv4.03 View
Obesity NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAEv4.03 View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAEv4.03 View
Arthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAEv4.03 View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAEv4.03 View
Bone pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAEv4.03 View
Generalized muscle weakness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAEv4.03 View
Musculoskeletal and connective tissue disorder - Other, specify NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAEv4.03 View
Neck pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAEv4.03 View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAEv4.03 View
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) CTCAEv4.03 View
Tumor pain NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) CTCAEv4.03 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAEv4.03 View
Dysesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAEv4.03 View
Dysgeusia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAEv4.03 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAEv4.03 View
Ischemia cerebrovascular NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAEv4.03 View
Paresthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAEv4.03 View
Peripheral sensory neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAEv4.03 View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAEv4.03 View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAEv4.03 View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAEv4.03 View
Psychiatric disorders - Other, specify NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAEv4.03 View
Chronic kidney disease NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAEv4.03 View
Renal and urinary disorders - Other, specify NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAEv4.03 View
Urinary frequency NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAEv4.03 View
Reproductive system and breast disorders - Other, specify NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAEv4.03 View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEv4.03 View
Dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEv4.03 View
Nasal congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEv4.03 View
Respiratory, thoracic and mediastinal disorders - Other, specify NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEv4.03 View
Sinus disorder NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEv4.03 View
Sleep apnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEv4.03 View
Wheezing NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAEv4.03 View
Dry skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAEv4.03 View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAEv4.03 View
Rash acneiform NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAEv4.03 View
Rash maculo-papular NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAEv4.03 View
Scalp pain NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAEv4.03 View
Skin and subcutaneous tissue disorders - Other, specify NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAEv4.03 View
Skin hypopigmentation NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAEv4.03 View
Surgical and medical procedures - Other, specify NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures CTCAEv4.03 View
Hot flashes NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAEv4.03 View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAEv4.03 View
Lymphedema NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAEv4.03 View