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: 2025-12-25 @ 2:04 AM
Ignite Modification Date: 2025-12-26 @ 12:29 AM
NCT ID: NCT03749460
Description: Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
Frequency Threshold: 0
Time Frame: Up to 4 years
Study: NCT03749460
Study Brief: Nivolumab and Ipilimumab and Stereotactic Body Radiation Therapy in Treating Patients With Salivary Gland Cancers
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treatment (Nivolumab, Ipilimumab, SBRT) Patients receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 2 weeks for up to 12 courses and then every 4 weeks for an additional 8 courses in the absence of disease progression or unacceptable toxicity. Patients also receive ipilimumab IV over 60 minutes on day 1. Treatment repeats every 6 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. Beginning week 3, patients undergo 3 fractions of stereotactic body radiation therapy every other day in the absence of disease progression or unacceptable toxicity. Nivolumab: Given IV Ipilimumab: Given IV Stereotactic Body Radiation Therapy: Undergo SBRT 9 None 3 20 20 20 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Right Rib Fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Right Coracoid Fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Adrenal Insufficiency SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Oral Bleeding SYSTEMATIC_ASSESSMENT General disorders None View
Lung Infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Adrenal Insufficiency SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Allergic Reaction SYSTEMATIC_ASSESSMENT Immune system disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Aspirational Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hyperthyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Bilateral Upper Extremity Edema SYSTEMATIC_ASSESSMENT General disorders None View
Non-Cardiac Chest Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Chills SYSTEMATIC_ASSESSMENT General disorders None View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Conjuctival Erythema SYSTEMATIC_ASSESSMENT Infections and infestations None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Drooling SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dry Eyes SYSTEMATIC_ASSESSMENT Eye disorders None View
Dry Mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dry Skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Ear Fullness SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Alkaline Phosphate Increased SYSTEMATIC_ASSESSMENT Investigations None View
Aspartate Aminotransferase Increased SYSTEMATIC_ASSESSMENT Investigations None View
Alanine Aminotransferase Increased SYSTEMATIC_ASSESSMENT Investigations None View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal 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
Erythematous-Pustular Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Fistula Tract SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Flu Like Symptoms SYSTEMATIC_ASSESSMENT General disorders None View
Fungal Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
GERD SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hair Loss SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hallucinations SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Head/Neck Swelling SYSTEMATIC_ASSESSMENT General disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hearing Loss SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Heartburn SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hemoptysis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hot Flashes SYSTEMATIC_ASSESSMENT General disorders None View
Hyperpigmented Skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Increased Spine Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Worsening Trismus SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Swollen Neck Sore SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Infusion Related Reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Intermittent Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Intermittent Abdominal Cramping SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Intermittent Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Intermittent Facial Swelling SYSTEMATIC_ASSESSMENT General disorders None View
Intermittent Hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Intermittent Maculopapular Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Intermittent Nasal Congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Intermittent Rhinitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Joint Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Ear Bleeding SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Facial Neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Left Neck Discomfort SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Neck Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Lower Extremity Edema SYSTEMATIC_ASSESSMENT Vascular disorders None View
Lung Infection (Pneumonia) SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Lymphedema SYSTEMATIC_ASSESSMENT Vascular disorders None View
Maculopapular Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Mania SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Mental Fogginess SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Microcytic Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Mucositis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pustular Skin Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Muscle Spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscle Weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Myalgias SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Neck Tightness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Night Sweats SYSTEMATIC_ASSESSMENT General disorders None View
Non Pruritic Cheek Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Otorrhea SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Skin Pain SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Facial Pain SYSTEMATIC_ASSESSMENT General disorders None View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Renal Insufficiency SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Respiratory Infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Itchy Eyes SYSTEMATIC_ASSESSMENT Eye disorders None View
Eye Pain SYSTEMATIC_ASSESSMENT Eye disorders None View
Foot Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Right Knee Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Foot Edema SYSTEMATIC_ASSESSMENT General disorders None View
Periorbital Edema SYSTEMATIC_ASSESSMENT General disorders None View
Thoracic Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Rhinorrhea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cancer Related Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Right Leg Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Sinus Congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Skin Infection SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Sore Throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Swollen Joints SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Taste Changes SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Upper Respiratory Infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Urinary Frequency SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Vision Changes SYSTEMATIC_ASSESSMENT Eye disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Weight Loss SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hoarseness SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Xerostomia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View