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 @ 5:12 AM
Ignite Modification Date: 2025-12-26 @ 4:17 AM
NCT ID: NCT03872427
Description: None
Frequency Threshold: 0
Time Frame: 4 years
Study: NCT03872427
Study Brief: Testing Whether Cancers With Specific Mutations Respond Better to Glutaminase Inhibitor, Telaglenastat Hydrochloride, Anti-Cancer Treatment, BeGIN Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cohort 1 NF1 mutant malignant peripheral nerve sheath tumors (MPNST) 7 None 5 9 9 9 View
Cohort 2 NF1 mutant other cancers 20 None 7 26 24 26 View
Cohort 3 KEAP1/NRF2 mutant cancers 6 None 4 9 8 9 View
Cohort 4 STK11/LKB1 mutant cancers 8 None 6 10 10 10 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Bacteremia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Esophageal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Gait disturbance SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Generalized muscle weakness SYSTEMATIC_ASSESSMENT General disorders None View
Hyponatremia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Resp, thoracic & mediast - Other - Hemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Tracheal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Acute kidney injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Appendicitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Chest wall pain SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Colonic obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Death NOS SYSTEMATIC_ASSESSMENT General disorders None View
General and admin site - Other - Failure To Thrive SYSTEMATIC_ASSESSMENT General disorders None View
Generalized edema SYSTEMATIC_ASSESSMENT General disorders None View
Hypercalcemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoxia SYSTEMATIC_ASSESSMENT General disorders None View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Nervous system - Other - L5 Lumbar Lesion Compress Nerve Route SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Tumor pain SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
ALT increased SYSTEMATIC_ASSESSMENT Investigations None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Concentration impairment SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations None View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dysgeusia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Ear and Labyrinth - Other - Decreased Hearing SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Edema face SYSTEMATIC_ASSESSMENT General disorders None View
Eye disorders - Other, specify - Sty SYSTEMATIC_ASSESSMENT Eye disorders None View
Fall SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
General and admin site - Other - Migraine SYSTEMATIC_ASSESSMENT General disorders None View
General and admin site - Other - Sleep Disorder SYSTEMATIC_ASSESSMENT General disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hypercalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Infections & infestations - Other - Covid SYSTEMATIC_ASSESSMENT Infections and infestations None View
Infections & infestations - Other - Covid-19 SYSTEMATIC_ASSESSMENT Infections and infestations None View
Injury/poison/procedure - Other - Dislocation Of Rib (Left) SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Irregular menstruation SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Memory impairment SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Metabolism and nutrition - Other - Positive For Appetite Change SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Muscle cramp SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Musculoskel/connect tissue -Other - Right Hip Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Musculoskel/connect tissue -Other - Shaking At Night SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Musculoskel/connect tissue -Other - Tumor Pain (Back) SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Peripheral motor neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Reproductive and breast - Other - Abnormal Image Finding SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Reproductive and breast - Other - Sclerosing Intraductal Papilloma Without Atypia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Skin & subcutaneous tissue -Other - Cellulitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin & subcutaneous tissue -Other - Joint Swelling SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin & subcutaneous tissue -Other - Skin Infection (Cut/Right Foot Wound) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin papilloma SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Trismus SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Tumor pain SYSTEMATIC_ASSESSMENT General disorders None View
Voice alteration SYSTEMATIC_ASSESSMENT General disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Weight gain SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Weight loss SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations None View
AST increased SYSTEMATIC_ASSESSMENT Investigations None View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Activated PTT prolonged SYSTEMATIC_ASSESSMENT Investigations None View
Allergic reaction SYSTEMATIC_ASSESSMENT General disorders None View
Bacteremia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Blood/Lymph - Other - Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Bronchial infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cholecystitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Dry eye 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
Ear and Labyrinth - Other - Hyperacusis SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders None View
Elevated LDH SYSTEMATIC_ASSESSMENT Investigations None View
Eye disorders - Other, specify - Visual Disturbance SYSTEMATIC_ASSESSMENT Eye disorders None View
Floaters SYSTEMATIC_ASSESSMENT Eye disorders None View
GI disorders - Other, specify - Heartburn SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastroesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Generalized muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hiccups SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Metabolism and nutrition - Other - Lactic Acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Metabolism and nutrition - Other - Metabolic Acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nervous system - Other - Numbness To Bilateral Foot R>L SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neuralgia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Oral dysesthesia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pain in extremity SYSTEMATIC_ASSESSMENT General disorders None View
Paresthesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Periorbital edema SYSTEMATIC_ASSESSMENT General disorders None View
Photophobia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rhinorrhea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Serum amylase increased SYSTEMATIC_ASSESSMENT Investigations None View
Shingles SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Skin & subcutaneous tissue -Other - Itching SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Stomach pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Tremor SYSTEMATIC_ASSESSMENT General disorders None View
Urinary frequency SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Confusion SYSTEMATIC_ASSESSMENT Nervous system disorders None View
INR increased SYSTEMATIC_ASSESSMENT Investigations None View
Muscle weakness lower limb SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Rectal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Renal & urinary disorders - Other - Difficulty Urination SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Adrenal insufficiency SYSTEMATIC_ASSESSMENT General disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Delirium SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hoarseness SYSTEMATIC_ASSESSMENT General disorders None View
Hypoxia SYSTEMATIC_ASSESSMENT General disorders None View
Investigations - Other, specify - Ldh Increase SYSTEMATIC_ASSESSMENT Investigations None View
Localized edema SYSTEMATIC_ASSESSMENT General disorders None View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Resp, thoracic & mediast - Other - Hypoxemia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Resp, thoracic & mediast - Other - Pulmonary Opacities SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Seroma SYSTEMATIC_ASSESSMENT General disorders None View
Bladder infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bruising SYSTEMATIC_ASSESSMENT General disorders None View
Chest wall pain SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Chills SYSTEMATIC_ASSESSMENT General disorders None View
Cholesterol high SYSTEMATIC_ASSESSMENT Investigations None View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypomagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Infections & infestations - Other - Covid19 Positive SYSTEMATIC_ASSESSMENT Infections and infestations None View
Lipase increased SYSTEMATIC_ASSESSMENT Investigations None View
Malaise SYSTEMATIC_ASSESSMENT General disorders None View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rash acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View