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 @ 11:50 PM
Ignite Modification Date: 2025-12-25 @ 9:44 PM
NCT ID: NCT04533451
Description: None
Frequency Threshold: 0
Time Frame: Up to 3 years
Study: NCT04533451
Study Brief: Testing the Effects of MK-3475 (Pembrolizumab) With or Without the Usual Chemotherapy Treatment for Patients 70 Years of Age and Older With Advanced Non-small Cell Lung 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
Group A (Pembrolizumab) Quality-of-Life Assessment: Ancillary studies 8 None 8 43 43 43 View
Group B (Pembrolizumab, Pemetrexed, Carboplatin) Quality-of-Life Assessment: Ancillary studies 6 None 6 54 53 54 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Heart failure SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE 5 View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5 View
Death NOS SYSTEMATIC_ASSESSMENT General disorders CTCAE 5 View
Disease progression SYSTEMATIC_ASSESSMENT General disorders CTCAE 5 View
Neoplasms benign, mal, uncpec - Oth spec SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) CTCAE 5 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE 5 View
Blood and lymph sys disorders - Oth Spec SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE 5 View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE 5 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE 5 View
Chest pain - cardiac SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE 5 View
Sinus bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE 5 View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE 5 View
Ventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE 5 View
Ear and labyrinth disorders - Oth spec SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAE 5 View
Ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAE 5 View
Hearing impaired SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAE 5 View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAE 5 View
Adrenal insufficiency SYSTEMATIC_ASSESSMENT Endocrine disorders CTCAE 5 View
Hyperthyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders CTCAE 5 View
Hypophysitis SYSTEMATIC_ASSESSMENT Endocrine disorders CTCAE 5 View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders CTCAE 5 View
Blurred vision SYSTEMATIC_ASSESSMENT Eye disorders CTCAE 5 View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders CTCAE 5 View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders CTCAE 5 View
Eye disorders - Other, specify SYSTEMATIC_ASSESSMENT Eye disorders CTCAE 5 View
Flashing lights SYSTEMATIC_ASSESSMENT Eye disorders CTCAE 5 View
Watering eyes SYSTEMATIC_ASSESSMENT Eye disorders CTCAE 5 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5 View
Belching SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5 View
Duodenal ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5 View
Esophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5 View
Gastroesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5 View
Gastrointestinal disorders - Oth spec SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5 View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5 View
Oral pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5 View
Chills SYSTEMATIC_ASSESSMENT General disorders CTCAE 5 View
Edema face SYSTEMATIC_ASSESSMENT General disorders CTCAE 5 View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders CTCAE 5 View
Facial pain SYSTEMATIC_ASSESSMENT General disorders CTCAE 5 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE 5 View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE 5 View
Gait disturbance SYSTEMATIC_ASSESSMENT General disorders CTCAE 5 View
Gen disord and admin site conds-Oth spec SYSTEMATIC_ASSESSMENT General disorders CTCAE 5 View
Generalized edema SYSTEMATIC_ASSESSMENT General disorders CTCAE 5 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders CTCAE 5 View
Pain SYSTEMATIC_ASSESSMENT General disorders CTCAE 5 View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE 5 View
Hepatobiliary disorders - Other, specify SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE 5 View
Allergic reaction SYSTEMATIC_ASSESSMENT Immune system disorders CTCAE 5 View
Infections and infestations - Oth spec SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 5 View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 5 View
Rash pustular SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 5 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 5 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 5 View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 5 View
Soft tissue infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 5 View
Thrush SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 5 View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 5 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 5 View
Wound infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 5 View
Bruising SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE 5 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE 5 View
Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE 5 View
Hip fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE 5 View
Infusion related reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE 5 View
Inj, pois and proced complic - Oth spec SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE 5 View
Radiation recall reaction (dermatologic) SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE 5 View
Spinal fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE 5 View
Vascular access complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE 5 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 5 View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 5 View
Cardiac troponin I increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 5 View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 5 View
Investigations - Other, specify SYSTEMATIC_ASSESSMENT Investigations CTCAE 5 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 5 View
Lymphocyte count increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 5 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 5 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 5 View
Thyroid stimulating hormone increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 5 View
Weight loss SYSTEMATIC_ASSESSMENT Investigations CTCAE 5 View
White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 5 View
Acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 5 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 5 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 5 View
Glucose intolerance SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 5 View
Hypercalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 5 View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 5 View
Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 5 View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 5 View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 5 View
Hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 5 View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 5 View
Hypomagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 5 View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 5 View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 5 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 5 View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 5 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 5 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 5 View
Chest wall pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 5 View
Flank pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 5 View
Generalized muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 5 View
Muscle cramp SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 5 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 5 View
Neoplasms benign, mal, uncpec - Oth spec SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) CTCAE 5 View
Tumor pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) CTCAE 5 View
Concentration impairment SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 5 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 5 View
Dysarthria SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 5 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 5 View
Dysphasia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 5 View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 5 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 5 View
Memory impairment SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 5 View
Muscle weakness left-sided SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 5 View
Muscle weakness right-sided SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 5 View
Paresthesia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 5 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 5 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 5 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 5 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE 5 View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE 5 View
Delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE 5 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE 5 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE 5 View
Restlessness SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE 5 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE 5 View
Chronic kidney disease SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE 5 View
Dysuria (painful urination) SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE 5 View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE 5 View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE 5 View
Renal and urinary disorders - Oth spec SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE 5 View
Urinary frequency SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE 5 View
Urinary incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE 5 View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE 5 View
Allergic rhinitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 5 View
Aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 5 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 5 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 5 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 5 View
Hiccups SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 5 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 5 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 5 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 5 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 5 View
Postnasal drip SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 5 View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 5 View
Resp, thoracic, mediastinal - Oth spec SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 5 View
Rhinorrhea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 5 View
Sinus pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 5 View
Sore throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 5 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 5 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 5 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 5 View
Rash acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 5 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 5 View
Skin and subcut tissue disord - Oth spec SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 5 View
Skin ulceration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 5 View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE 5 View
Hot flashes SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE 5 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE 5 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE 5 View
Phlebitis SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE 5 View
Thromboembolic event SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE 5 View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 5 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 5 View
Eosinophilia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE 5 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 5 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 5 View
Blood lactate dehydrogenase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 5 View
CPK increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 5 View
Hyperlipidemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 5 View
Hypernatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 5 View
Muscle weakness lower limb SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 5 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 5 View
Myositis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 5 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 5 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 5 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 5 View
Urinary tract pain SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE 5 View
Urinary urgency SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE 5 View
Vaginal dryness SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE 5 View