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 @ 12:44 AM
Ignite Modification Date: 2025-12-25 @ 10:57 PM
NCT ID: NCT02513667
Description: None
Frequency Threshold: 0
Time Frame: Baseline until date of first observed disease progression or death, an average of 12 months
Study: NCT02513667
Study Brief: Ceritinib in Combination With Stereotactic Ablative Radiation Metastatic Lung Adenocarcinoma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
ALK-inhibitor Naive Patients Patients will receive ceritinib at a dose of 750 mg (150 mg capsules times 5 capsules once a day) for 10 weeks. Patient will stop taking Ceritinib 72 hours before SABR (Stereotactic ablative body radiation). They could get 1, 3 ,or 5 treatments on consecutive days with 18 hours between each treatment or every other day (doctor's determination). The patient may start taking Ceritinib again 72 hours after radiation is complete. Patient will continue to take certinib for up to 8 months. At Follow-Up treatment, patients will be contacted every 3 months for 9 months. Ceritinib: Patients will receive ceritinib at a dose of 750 mg (150 mg capsules times 5 capsules once a day) for 10 weeks. Patient will stop taking Ceritinib 72 hours before SABR radiation. The patient may start taking Ceritinib again 72 hours after radiation is complete. Patient will continue to take certinib for up to 8 months. Stereotactic ablative body radiation: Patients will receive study drug for 10 weeks. They could get 1, 3 ,or 5 treatments on consecutive days with 18 hours between each treatment or every other day (doctor's determination). 0 None 1 8 8 8 View
Patients Recieved Prior ALK Inhibitor Patients will receive ceritinib at a dose of 750 mg (150 mg capsules times 5 capsules once a day) for 10 weeks. Patient will stop taking Ceritinib 72 hours before SABR (Stereotactic ablative body radiation). They could get 1, 3 ,or 5 treatments on consecutive days with 18 hours between each treatment or every other day (doctor's determination). The patient may start taking Ceritinib again 72 hours after radiation is complete. Patient will continue to take certinib for up to 8 months. At Follow-Up treatment, patients will be contacted every 3 months for 9 months. Ceritinib: Patients will receive ceritinib at a dose of 750 mg (150 mg capsules times 5 capsules once a day) for 10 weeks. Patient will stop taking Ceritinib 72 hours before SABR radiation. The patient may start taking Ceritinib again 72 hours after radiation is complete. Patient will continue to take certinib for up to 8 months. Stereotactic ablative body radiation: Patients will receive study drug for 10 weeks. They could get 1, 3 ,or 5 treatments on consecutive days with 18 hours between each treatment or every other day (doctor's determination). 0 None 2 5 5 5 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v.4 View
hyperbilirubinemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE v.4 View
Altered Mental Status SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE v.4 View
influenza SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v.4 View
pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v.4 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal Pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.4 View
Acid Reflux SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.4 View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v.4 View
Increased ALT SYSTEMATIC_ASSESSMENT Investigations CTCAE v.4 View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE v.4 View
Appetite Change (dysgeusia, anorexia, decreased appetite) SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v.4 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE v.4 View
Increased AST SYSTEMATIC_ASSESSMENT Investigations CTCAE v.4 View
Pain - Back SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE v.4 View
Benign Familial Tremmors SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders CTCAE v.4 View
Pain - BL Foot SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE v.4 View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE v.4 View
Burning sensation SYSTEMATIC_ASSESSMENT General disorders CTCAE v.4 View
Chest Pain SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE v.4 View
Claustrophobia SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE v.4 View
cold SYSTEMATIC_ASSESSMENT General disorders CTCAE v.4 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.4 View
Hypertnesion SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE v.4 View
Hypercholesterolemia SYSTEMATIC_ASSESSMENT Investigations CTCAE v.4 View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v.4 View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v.4 View
Increased Creatinine SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE v.4 View
cough SYSTEMATIC_ASSESSMENT General disorders CTCAE v.4 View
intraoperative ear injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE v.4 View
Decreased ANC SYSTEMATIC_ASSESSMENT General disorders CTCAE v.4 View
Decreased calcium SYSTEMATIC_ASSESSMENT General disorders CTCAE v.4 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE v.4 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.4 View
Impaired Balance SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE v.4 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v.4 View
Disequilibrium SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v.4 View
Discomfort in the sciatic nerve right leg SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v.4 View
Discomfort left side of rib cage SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v.4 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v.4 View
Increased GGT SYSTEMATIC_ASSESSMENT Investigations CTCAE v.4 View
Increased Lipase SYSTEMATIC_ASSESSMENT Investigations CTCAE v.4 View
Erectile dysfunction SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE v.4 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE v.4 View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE v.4 View
Flu like symptoms (achy,warm) SYSTEMATIC_ASSESSMENT General disorders CTCAE v.4 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v.4 View
Heartburn SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.4 View
Herpes Simplex SYSTEMATIC_ASSESSMENT Immune system disorders CTCAE v.4 View
Increased amylase SYSTEMATIC_ASSESSMENT Investigations CTCAE v.4 View
Increased blood bilirubin SYSTEMATIC_ASSESSMENT Investigations CTCAE v.4 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE v.4 View
Increased lymphocyte SYSTEMATIC_ASSESSMENT Investigations CTCAE v.4 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE v.4 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.4 View
Vomitting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.4 View
Intermittent bloating SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.4 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v.4 View
Pain- Knee SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v.4 View
Intermittent hand and finger spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v.4 View
Rash SYSTEMATIC_ASSESSMENT Immune system disorders CTCAE v.4 View
stomach cramps SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.4 View
Itching SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v.4 View
Latent tuberculosis SYSTEMATIC_ASSESSMENT General disorders CTCAE v.4 View
Tooth Infection SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.4 View
Low albumin SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v.4 View
Malignant pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE v.4 View
Neck Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v.4 View
Orthostatic hypotension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE v.4 View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v.4 View
Pain - right lung, shoulder SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v.4 View
Right Leg/Hip Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v.4 View
Right shoulder pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v.4 View
Pain - General SYSTEMATIC_ASSESSMENT General disorders CTCAE v.4 View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE v.4 View
Pleural Effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v.4 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v.4 View
Prolonged QT SYSTEMATIC_ASSESSMENT Investigations CTCAE v.4 View
Prostatitis SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE v.4 View
Pruritus (hands) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v.4 View
Seasonal allergies SYSTEMATIC_ASSESSMENT Immune system disorders CTCAE v.4 View
Sinus Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v.4 View
Skin infections: shingles SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v.4 View
Snoring SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v.4 View
Sore throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v.4 View
T wave abnormality SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE v.4 View
Tachycardia SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE v.4 View
Tranaminatis SYSTEMATIC_ASSESSMENT General disorders CTCAE v.4 View
Trapped Lung SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v.4 View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v.4 View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v.4 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAE v.4 View
Weight loss SYSTEMATIC_ASSESSMENT Investigations CTCAE v.4 View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v.4 View
Worsening Allergies SYSTEMATIC_ASSESSMENT Investigations CTCAE v.4 View
Edema SYSTEMATIC_ASSESSMENT General disorders CTCAE v.4 View
Blurred Vision SYSTEMATIC_ASSESSMENT Eye disorders CTCAE v.4 View