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: 2025-12-26 @ 10:17 PM
Ignite Modification Date: 2025-12-26 @ 10:17 PM
NCT ID: NCT04175912
Description: All treated patients are included in this analysis.
Frequency Threshold: 5
Time Frame: Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years
Study: NCT04175912
Study Brief: Testing the Combination of Pevonedistat With Chemotherapy for Bile Duct Cancer of the Liver
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Arm A (Pevonedistat) Patients receive pevonedistat IV over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. 17 None 8 17 17 17 View
Arm B (Pevonedistat, Paclitaxel, Carboplatin) Patients receive pevonedistat IV over 1 hour on days 1, 3, and 5, paclitaxel IV over 3 hours on day 1, and carboplatin IV over 15-60 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Starting cycle 5, patients may receive pevonedistat monotherapy at the discretion of treating physician. 15 None 12 17 17 17 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE 5.0 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE 5.0 View
Death NOS SYSTEMATIC_ASSESSMENT General disorders CTCAE 5.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE 5.0 View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE 5.0 View
Disease progression SYSTEMATIC_ASSESSMENT General disorders CTCAE 5.0 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5.0 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5.0 View
Colonic perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5.0 View
Gastroparesis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5.0 View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5.0 View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE 5.0 View
Hepatobiliary disorders - Other, specify SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE 5.0 View
Biliary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 5.0 View
Hepatic infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 5.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 5.0 View
Infections and infestations - Other, specify SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 5.0 View
INR increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 5.0 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 5.0 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 5.0 View
White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 5.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 5.0 View
Hypercalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 5.0 View
Hypomagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 5.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 5.0 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 5.0 View
Edema cerebral SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 5.0 View
Intracranial hemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 5.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 5.0 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 5.0 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 5.0 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 5.0 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 5.0 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE 5.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE 5.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE 5.0 View
Superior vena cava syndrome SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE 5.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hearing impaired SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAE 5.0 View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAE 5.0 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAE 5.0 View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE 5.0 View
Disseminated intravascular coagulation SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE 5.0 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE 5.0 View
Blood and lymphatic system disorders - Other, specify SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE 5.0 View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE 5.0 View
Sinus bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE 5.0 View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE 5.0 View
Cardiac disorders - Other, specify SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE 5.0 View
Chills SYSTEMATIC_ASSESSMENT General disorders CTCAE 5.0 View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders CTCAE 5.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE 5.0 View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE 5.0 View
Flu like symptoms SYSTEMATIC_ASSESSMENT General disorders CTCAE 5.0 View
Infusion related reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE 5.0 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders CTCAE 5.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders CTCAE 5.0 View
General disorders and administration site conditions - Other, specify SYSTEMATIC_ASSESSMENT General disorders CTCAE 5.0 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 5.0 View
Bullous dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 5.0 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 5.0 View
Erythema multiforme SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 5.0 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 5.0 View
Nail discoloration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 5.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 5.0 View
Rash acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 5.0 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 5.0 View
Skin ulceration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 5.0 View
Skin and subcutaneous tissue disorders - Other, specify SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE 5.0 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5.0 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5.0 View
Bloating SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5.0 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5.0 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5.0 View
Fecal incontinence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5.0 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5.0 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5.0 View
Gastroesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5.0 View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5.0 View
Stomach pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5.0 View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5.0 View
Gastrointestinal disorders - Other, specify SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 5.0 View
Hepatobiliary disorders - Other, specify SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE 5.0 View
Hepatic infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 5.0 View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 5.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 5.0 View
Herpes simplex reactivation SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 5.0 View
Thrush SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE 5.0 View
Bruising SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE 5.0 View
Activated partial thromboplastin time prolonged SYSTEMATIC_ASSESSMENT Investigations CTCAE 5.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 5.0 View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 5.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 5.0 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 5.0 View
Cardiac troponin I increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 5.0 View
Cholesterol high SYSTEMATIC_ASSESSMENT Investigations CTCAE 5.0 View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 5.0 View
GGT increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 5.0 View
INR increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 5.0 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 5.0 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 5.0 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 5.0 View
Weight loss SYSTEMATIC_ASSESSMENT Investigations CTCAE 5.0 View
White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 5.0 View
Blood bicarbonate decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE 5.0 View
Blood lactate dehydrogenase increased SYSTEMATIC_ASSESSMENT Investigations CTCAE 5.0 View
Investigations - Other, specify SYSTEMATIC_ASSESSMENT Investigations CTCAE 5.0 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 5.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 5.0 View
Hypercalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 5.0 View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 5.0 View
Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 5.0 View
Hypernatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 5.0 View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 5.0 View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 5.0 View
Hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 5.0 View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 5.0 View
Hypomagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 5.0 View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 5.0 View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 5.0 View
Hyperphosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE 5.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 5.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 5.0 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 5.0 View
Flank pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 5.0 View
Generalized muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 5.0 View
Muscle weakness lower limb SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 5.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 5.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 5.0 View
Musculoskeletal and connective tissue disorder - Other, specify SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE 5.0 View
Concentration impairment SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 5.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 5.0 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 5.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 5.0 View
Paresthesia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 5.0 View
Peripheral motor neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 5.0 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE 5.0 View
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) CTCAE 5.0 View
Eye disorders - Other, specify SYSTEMATIC_ASSESSMENT Eye disorders CTCAE 5.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE 5.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE 5.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE 5.0 View
Allergic rhinitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 5.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 5.0 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 5.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 5.0 View
Hiccups SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 5.0 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 5.0 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 5.0 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 5.0 View
Postnasal drip SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 5.0 View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 5.0 View
Sleep apnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 5.0 View
Sore throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 5.0 View
Chronic kidney disease SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE 5.0 View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE 5.0 View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE 5.0 View
Urinary frequency SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE 5.0 View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE 5.0 View
Urine discoloration SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE 5.0 View
Glucosuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE 5.0 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE 5.0 View
Renal and urinary disorders - Other, specify SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE 5.0 View
Pelvic pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE 5.0 View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE 5.0 View
Hot flashes SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE 5.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE 5.0 View
Thromboembolic event SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE 5.0 View