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 @ 9:57 PM
Ignite Modification Date: 2025-12-25 @ 7:35 PM
NCT ID: NCT03831932
Description: None
Frequency Threshold: 5
Time Frame: Up to 2 years
Study: NCT03831932
Study Brief: Telaglenastat Hydrochloride and Osimertinib in Treating Patients With EGFR-Mutated Stage IV 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
Phase 1b 800mg Telaglenastat HCl Cohort Patients receive telaglenastat hydrochloride PO BID and osimertinib PO QD (starting cycle 1 day 16 of phase I). Patients undergo blood sample collection and may undergo x-ray imaging, CT scan, MRI, or PET scan throughout the study. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT scan Magnetic Resonance Elastography: Undergo MRI Osimertinib: Given PO Positron Emission Tomography: Undergo PET scan Telaglenastat Hydrochloride: Given PO X-Ray Imaging: Undergo x-ray imaging 0 None 2 6 6 6 View
Phase 1b 400mg Telaglenastat HCl Cohort Patients receive telaglenastat hydrochloride PO BID and osimertinib PO QD (starting cycle 1 day 16 of phase I). Patients undergo blood sample collection and may undergo x-ray imaging, CT scan, MRI, or PET scan throughout the study. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT scan Magnetic Resonance Elastography: Undergo MRI Osimertinib: Given PO Positron Emission Tomography: Undergo PET scan Telaglenastat Hydrochloride: Given PO X-Ray Imaging: Undergo x-ray imaging 1 None 2 3 3 3 View
Phase 1b 600mg Telaglenastat HCl Cohort Patients receive telaglenastat hydrochloride PO BID and osimertinib PO QD (starting cycle 1 day 16 of phase I). Patients undergo blood sample collection and may undergo x-ray imaging, CT scan, MRI, or PET scan throughout the study. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT scan Magnetic Resonance Elastography: Undergo MRI Osimertinib: Given PO Positron Emission Tomography: Undergo PET scan Telaglenastat Hydrochloride: Given PO X-Ray Imaging: Undergo x-ray imaging 2 None 2 3 3 3 View
Phase 2 Expansion Cohort Patients receive telaglenastat hydrochloride PO BID and osimertinib PO QD (starting cycle 1 day 16 of phase I). Patients undergo blood sample collection and may undergo x-ray imaging, CT scan, MRI, or PET scan throughout the study. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT scan Magnetic Resonance Elastography: Undergo MRI Osimertinib: Given PO Positron Emission Tomography: Undergo PET scan Telaglenastat Hydrochloride: Given PO X-Ray Imaging: Undergo x-ray imaging 2 None 1 10 10 10 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Disease progression SYSTEMATIC_ASSESSMENT General disorders CTCAE v.5.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v.5.0 View
Bile duct stenosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE v.5.0 View
Biliary duct dilation SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE v.5.0 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Blood lactate dehydrogenase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v.5.0 View
Failure to thrive SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v.5.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE v.5.0 View
Gamma-Glutamyl Transferase (GGT) increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v.5.0 View
Thromboembolic event SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE v.5.0 View
Lung Infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v.5.0 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE v.5.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders CTCAE v.5.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders CTCAE v.5.0 View
Stroke SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v.5.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Activated partial thromboplastin time prolonged SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system 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
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Blood lactate dehydrogenase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Blurred vision SYSTEMATIC_ASSESSMENT Eye disorders CTCAE v.5.0 View
Cardiac troponin I increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Chest wall pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v.5.0 View
Cholesterol high SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v.5.0 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Diplopia 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
Floaters SYSTEMATIC_ASSESSMENT Eye disorders CTCAE v.5.0 View
Gait disturbance SYSTEMATIC_ASSESSMENT General disorders CTCAE v.5.0 View
Dry heaves SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Hallucinations SYSTEMATIC_ASSESSMENT Psychiatric 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
Hyperphosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition 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
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v.5.0 View
Hypomagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v.5.0 View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v.5.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE v.5.0 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders CTCAE v.5.0 View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE v.5.0 View
Photophobia SYSTEMATIC_ASSESSMENT Eye disorders CTCAE v.5.0 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE v.5.0 View
Thromboembolic event SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE v.5.0 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v.5.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Weight gain SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders CTCAE v.5.0 View
Muscle weakness upper limb SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v.5.0 View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE v.5.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE v.5.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Bloating SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Chest pain - cardiac SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE v.5.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 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
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v.5.0 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v.5.0 View
Electrocardiogram QT corrected interval prolonged SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Flashing Lights during first dose SYSTEMATIC_ASSESSMENT Eye disorders CTCAE v.5.0 View
Flank pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v.5.0 View
Flashing lights SYSTEMATIC_ASSESSMENT Eye disorders CTCAE v.5.0 View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v.5.0 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v.5.0 View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v.5.0 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v.5.0 View
Lipase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Nail changes SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v.5.0 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v.5.0 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v.5.0 View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v.5.0 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v.5.0 View
Skin ulceration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v.5.0 View
Bronchial infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v.5.0 View
Generalized muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE v.5.0 View
Gastroesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v.5.0 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v.5.0 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE v.5.0 View
Bruising SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE v.5.0 View
Concentration impairment SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE v.5.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Costolchondritis SYSTEMATIC_ASSESSMENT General disorders CTCAE v.5.0 View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Flu like symptoms SYSTEMATIC_ASSESSMENT General disorders CTCAE v.5.0 View
Gum infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v.5.0 View
Gum sensitivity SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Hypernatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v.5.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE v.5.0 View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v.5.0 View
Iron deficiency SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE v.5.0 View
Paronychia SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v.5.0 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v.5.0 View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE v.5.0 View
Pulmonary infiltrates SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v.5.0 View
Rash acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v.5.0 View
Sensitive to light SYSTEMATIC_ASSESSMENT Eye disorders CTCAE v.5.0 View
Sinus Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v.5.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE v.5.0 View
Abdominal flutter SYSTEMATIC_ASSESSMENT General disorders CTCAE v.5.0 View
altered mental status (intermittent) SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE v.5.0 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Cjills SYSTEMATIC_ASSESSMENT General disorders CTCAE v.5.0 View
creatine phosphokinase (CPK) increased SYSTEMATIC_ASSESSMENT Investigations CTCAE v.5.0 View
Dry nares SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE v.5.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v.5.0 View
Fecal incontnence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE v.5.0 View
Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE v.5.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE v.5.0 View
Laryngeal inflammation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v.5.0 View
mouth ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE v.5.0 View
Muscle weakness lower limb SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue 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
Thrush SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v.5.0 View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE v.5.0 View
Urinary frequency SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE v.5.0 View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE v.5.0 View