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 @ 9:31 PM
Ignite Modification Date: 2025-12-25 @ 7:16 PM
NCT ID: NCT03063632
Description: None
Frequency Threshold: 0
Time Frame: Adverse event data collected from the first administration of the study drug until 30 days after the last dose of trial treatment, up to 2 years and 1 month
Study: NCT03063632
Study Brief: Testing the Combination of Two Experimental Drugs MK-3475 (Pembrolizumab) and Interferon-gamma for the Treatment of Mycosis Fungoides and Sézary Syndrome and Advanced Synovial Sarcoma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Group I (Pembrolizumab, Interferon Gamma-1b) Patients with Mycosis Fungoides and Sezary Syndrome receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 2 years in the absence of disease progression or unexpected toxicity. Patients also receive interferon gamma-1b SC 3 times per week for 12 weeks, and then follow 3 weeks on and 3 weeks off schedule for up to 2 years in the absence of disease progression or unexpected toxicity. Interferon Gamma-1b: Given SC Laboratory Biomarker Analysis: Ancillary studies Pembrolizumab: Given IV 4 None 4 16 15 16 View
Group II (Pembrolizumab, Interferon Gamma-1b) Patients with advanced synovial sarcoma receive pembrolizumab IV over 30 minutes on day 1 of each cycle, and interferon gamma-1b SC once a week. Cycles repeat every 3 weeks for up to 2 years in the absence of disease progression or unexpected toxicity. Interferon Gamma-1b: Given SC Laboratory Biomarker Analysis: Ancillary studies Pembrolizumab: Given IV 6 None 5 12 12 12 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Soft tissue infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE View
Bone infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE View
Urinary tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE View
Hypercalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE View
Pericardial tamponade SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders CTCAE View
Disease progression SYSTEMATIC_ASSESSMENT General disorders CTCAE View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE View
Tumor pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) CTCAE View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE View
Spinal cord compression SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE View
Allergic rhinitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE View
Bladder infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE View
Blood and lymphatic system disorders - Other, specify SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE View
Concentration impairment SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE View
Cardiac troponin I increased SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations CTCAE View
Chills SYSTEMATIC_ASSESSMENT General disorders CTCAE View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE View
Cholesterol high SYSTEMATIC_ASSESSMENT Investigations CTCAE View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE View
Edema face SYSTEMATIC_ASSESSMENT General disorders CTCAE View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders CTCAE View
Erythroderma SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE View
Gastrointestinal disorders - Other, specify SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE View
General disorders and administration site conditions - Other, specify SYSTEMATIC_ASSESSMENT General disorders CTCAE View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE View
Hiccups SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE View
Hypercalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE View
Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE View
Hypernatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE View
Hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders CTCAE View
INR increased SYSTEMATIC_ASSESSMENT Investigations CTCAE View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE View
Respiratory, thoracic and mediastinal disorders - Other SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE View
Skin hypopigmentation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE View
Skin papilloma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) CTCAE View
Surgical and medical procedures - Other SYSTEMATIC_ASSESSMENT Surgical and medical procedures CTCAE View
Tooth infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE View
Urinary incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE View
Weight loss SYSTEMATIC_ASSESSMENT Investigations CTCAE View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations CTCAE View
Blood lactate dehydrogenase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE View
Eye infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE View
Flu like symptoms SYSTEMATIC_ASSESSMENT General disorders CTCAE View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE View
Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE View
Gait disturbance SYSTEMATIC_ASSESSMENT General disorders CTCAE View
Investigations - Other SYSTEMATIC_ASSESSMENT Investigations CTCAE View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE View
Neuralgia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders CTCAE View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE View
Tumor pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) CTCAE View
Thromboembolic event SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE View
Urinary tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE View
Skin and subcutaneous tissue disorders - Other SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE View
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) CTCAE View
Nervous system disorders - Other SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE View
Keratitis SYSTEMATIC_ASSESSMENT Eye disorders CTCAE View
Malaise SYSTEMATIC_ASSESSMENT General disorders CTCAE View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE View
Muscle weakness upper limb SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE View
Infections and Infestations, Other SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE View