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 @ 12:37 AM
Ignite Modification Date: 2025-12-25 @ 10:47 PM
NCT ID: NCT04233567
Description: None
Frequency Threshold: 5
Time Frame: Up to 5 years
Study: NCT04233567
Study Brief: Infigratinib for the Treatment of Advanced or Metastatic Solid Tumors in Patients With FGFR Gene Mutations
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 (Infigratinib) Patients receive infigratinib PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Infigratinib: Given PO 13 None 4 17 17 17 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Covid-19 SYSTEMATIC_ASSESSMENT Immune system disorders CTCAE v.5.0 View
Gasteroenteritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Bone Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v.5.0 View
Metavirus SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v.5.0 View
Small Intestinal Obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Teeth Extraction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Abdominal Cramping SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Alanine Aminotransferase Increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Alkaline Phosphatase Increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Allergic Reaction SYSTEMATIC_ASSESSMENT Immune system disorders CTCAE v.5.0 View
Allergic Rhinitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v.5.0 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v.5.0 View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE v.5.0 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v.5.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE v.5.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v.5.0 View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v.5.0 View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v.5.0 View
Bacteremia SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v.5.0 View
Belching SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Bloating SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Hypoxemia Post Monoclonal Antibody Infusion SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE v.5.0 View
Blurred Vision SYSTEMATIC_ASSESSMENT Eye disorders CTCAE v.5.0 View
Body Aches SYSTEMATIC_ASSESSMENT General disorders CTCAE v.5.0 View
Bone Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v.5.0 View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders CTCAE v.5.0 View
Cheilitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Cholesterol High SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Chronic Kidney Disease SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE v.5.0 View
Nasal Congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v.5.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Corneal Ulcer SYSTEMATIC_ASSESSMENT Eye disorders CTCAE v.5.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v.5.0 View
Productive Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v.5.0 View
Creatinine Increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Platelet Count Decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v.5.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE v.5.0 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v.5.0 View
Dry Eye SYSTEMATIC_ASSESSMENT Eye disorders CTCAE v.5.0 View
Dry Mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Dry Skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v.5.0 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v.5.0 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v.5.0 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE v.5.0 View
Ear Pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAE v.5.0 View
Edema Limbs SYSTEMATIC_ASSESSMENT General disorders CTCAE v.5.0 View
Edema Trunk SYSTEMATIC_ASSESSMENT General disorders CTCAE v.5.0 View
Edema Face SYSTEMATIC_ASSESSMENT General disorders CTCAE v.5.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v.5.0 View
Eye Redness SYSTEMATIC_ASSESSMENT Eye disorders CTCAE v.5.0 View
Burning Eyes SYSTEMATIC_ASSESSMENT Eye disorders CTCAE v.5.0 View
Choroid Mild Tortuosity SYSTEMATIC_ASSESSMENT Eye disorders CTCAE v.5.0 View
Trichiasis SYSTEMATIC_ASSESSMENT Eye disorders CTCAE v.5.0 View
Corneal Abrasion SYSTEMATIC_ASSESSMENT Eye disorders CTCAE v.5.0 View
Cotton Wool Spot SYSTEMATIC_ASSESSMENT Eye disorders CTCAE v.5.0 View
Diplopia SYSTEMATIC_ASSESSMENT Eye disorders CTCAE v.5.0 View
Punctate Keratopathy SYSTEMATIC_ASSESSMENT Eye disorders CTCAE v.5.0 View
Gritty Eyes SYSTEMATIC_ASSESSMENT Eye disorders CTCAE v.5.0 View
Posterior Vitreous Detachment SYSTEMATIC_ASSESSMENT Eye disorders CTCAE v.5.0 View
Retinal Hemorrhage SYSTEMATIC_ASSESSMENT Eye disorders CTCAE v.5.0 View
Trichomegaly SYSTEMATIC_ASSESSMENT Eye disorders CTCAE v.5.0 View
Blepharitis SYSTEMATIC_ASSESSMENT Eye disorders CTCAE v.5.0 View
Constant Eye Pressure SYSTEMATIC_ASSESSMENT Eye disorders CTCAE v.5.0 View
Pseudophakia SYSTEMATIC_ASSESSMENT Eye disorders CTCAE v.5.0 View
Presbyopia SYSTEMATIC_ASSESSMENT Eye disorders CTCAE v.5.0 View
Dermatochalasis SYSTEMATIC_ASSESSMENT Eye disorders CTCAE v.5.0 View
Keratopathy SYSTEMATIC_ASSESSMENT Eye disorders CTCAE v.5.0 View
Eye Infection SYSTEMATIC_ASSESSMENT Eye disorders CTCAE v.5.0 View
Eyelash Epilation SYSTEMATIC_ASSESSMENT Eye disorders CTCAE v.5.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE v.5.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE v.5.0 View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE v.5.0 View
Flank Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v.5.0 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Floaters SYSTEMATIC_ASSESSMENT Eye disorders CTCAE v.5.0 View
Flu Like Symptoms SYSTEMATIC_ASSESSMENT General disorders CTCAE v.5.0 View
Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE v.5.0 View
Gait Distrubance SYSTEMATIC_ASSESSMENT General disorders CTCAE v.5.0 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Gastroesophageal Reflux Disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Dry Nose SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Rectovaginal Fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Dry Throat SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Epigastric Discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Gastrointestinal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Gastrointestinal Reflux Disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Generalized Weakness SYSTEMATIC_ASSESSMENT General disorders CTCAE v.5.0 View
Glaucoma SYSTEMATIC_ASSESSMENT Eye disorders CTCAE v.5.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v.5.0 View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE v.5.0 View
Hemorrhoidal Hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Anal Hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Hoarseness SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v.5.0 View
Hypercalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v.5.0 View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v.5.0 View
Hyperphosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v.5.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE v.5.0 View
Hypertrichosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v.5.0 View
Hypertriglyceridemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v.5.0 View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v.5.0 View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v.5.0 View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v.5.0 View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v.5.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE v.5.0 View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders CTCAE v.5.0 View
Covid-19 SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v.5.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE v.5.0 View
Intermittent Phlegm SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v.5.0 View
Keratitis SYSTEMATIC_ASSESSMENT Eye disorders CTCAE v.5.0 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v.5.0 View
Lipase Increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Localized Edema SYSTEMATIC_ASSESSMENT General disorders CTCAE v.5.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v.5.0 View
Lymphocyte Count Decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Melena SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Memory Impairment SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v.5.0 View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Muscle Cramp SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v.5.0 View
Muscle Aches SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v.5.0 View
Trochanteric Bursitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v.5.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v.5.0 View
Nail Changes SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v.5.0 View
Nail Discoloration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v.5.0 View
Nail Lifting SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v.5.0 View
Nail Loss SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v.5.0 View
Nail Ridges SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v.5.0 View
Nasal Sores SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v.5.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Neck Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v.5.0 View
Non-cardiac Chest Pain SYSTEMATIC_ASSESSMENT General disorders CTCAE v.5.0 View
Non-neurovascular Age Related Macular Degeneration SYSTEMATIC_ASSESSMENT Eye disorders CTCAE v.5.0 View
Onychauxis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v.5.0 View
Oral Dysesthesia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Oral Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Otitis Externa SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v.5.0 View
Overactive Bladder SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE v.5.0 View
Pain of Skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v.5.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders CTCAE v.5.0 View
Pain in Extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v.5.0 View
Palmar-plantar Erythrodysesthesia Syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v.5.0 View
Paresthesia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v.5.0 View
Paronychia SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v.5.0 View
Pelvic pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE v.5.0 View
Periorbital Edema SYSTEMATIC_ASSESSMENT Eye disorders CTCAE v.5.0 View
Peripheral Motor Neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v.5.0 View
Peripheral Sensory Neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v.5.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v.5.0 View
Rash Maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v.5.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v.5.0 View
Port Site Redness SYSTEMATIC_ASSESSMENT General disorders CTCAE v.5.0 View
Rhinitis Sicca SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v.5.0 View
Retinal Vascular Disorder SYSTEMATIC_ASSESSMENT Eye disorders CTCAE v.5.0 View
Retinopathy SYSTEMATIC_ASSESSMENT Eye disorders CTCAE v.5.0 View
Shingles SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v.5.0 View
Sinus Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE v.5.0 View
Lip Blister SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v.5.0 View
Crawling Sensation on Skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v.5.0 View
Callus Tenderness SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v.5.0 View
Corners of Mouth Cracking Open SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v.5.0 View
Nasal Mucosa Irritation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v.5.0 View
Toe Intermittent Drainage SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v.5.0 View
Sore Throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v.5.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v.5.0 View
Thromboembolic Event SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE v.5.0 View
Thrush SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v.5.0 View
Tooth Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v.5.0 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v.5.0 View
Vaginal Discharge SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE v.5.0 View
Vaginal Pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE v.5.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Watering Eyes SYSTEMATIC_ASSESSMENT Eye disorders CTCAE v.5.0 View
Weight Gain SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Weight Loss SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v.5.0 View