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 @ 5:23 PM
Ignite Modification Date: 2025-12-25 @ 2:58 PM
NCT ID: NCT02728050
Description: None
Frequency Threshold: 0
Time Frame: From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.
Study: NCT02728050
Study Brief: Filgrastim, Cladribine, Cytarabine, and Mitoxantrone With Sorafenib in Treating Patients With Newly-Diagnosed, Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
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 1, Dose Level 1 Sorafenib 200mg PO BID days 10-19 Mitoxantrone 10mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m\^2 days 1-5 Cytarabine IV 2g/m\^2 days 1-5 2 None 2 6 6 6 View
Phase 1, Dose Level 2 Sorafenib 200mg PO BID days 10-19 Mitoxantrone 12mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m\^2 days 1-5 Cytarabine IV 2g/m\^2 days 1-5 2 None 2 6 6 6 View
Phase 1, Dose Level 6 Sorafenib 400mg PO BID days 10-19 Mitoxantrone 18mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m\^2 days 1-5 Cytarabine IV 2g/m\^2 days 1-5 0 None 5 7 6 7 View
Phase 2, Dose Level 6 Sorafenib 400mg PO BID days 10-19 Mitoxantrone 18mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m\^2 days 1-5 Cytarabine IV 2g/m\^2 days 1-5 10 None 22 37 27 37 View
Phase 1, Dose Level 3 Sorafenib 200mg PO BID days 10-19 Mitoxantrone 15mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m\^2 days 1-5 Cytarabine IV 2g/m\^2 days 1-5 2 None 4 11 10 11 View
Phase 1, Dose Level 4 Sorafenib 200mg PO BID days 10-19 Mitoxantrone 18mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m\^2 days 1-5 Cytarabine IV 2g/m\^2 days 1-5 4 None 4 8 8 8 View
Phase 1, Dose Level 5 Sorafenib 400mg AM, 200mg PM PO days 10-19 Mitoxantrone 18mg/m\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m\^2 days 1-5 Cytarabine IV 2g/m\^2 days 1-5 3 None 4 9 8 9 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Enterocolitis infectious SYSTEMATIC_ASSESSMENT Infections and infestations None View
Heart failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Left ventricular systolic dysfunction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pulmonary edema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rectal fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Restrictive cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Vascular access complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Line associated DVT SYSTEMATIC_ASSESSMENT Vascular disorders None View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Sweet's Syndrome SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
GI malignancy SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Perianal abscess SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Anal fissure SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Depressed SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sepsis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Infusion related reaction SYSTEMATIC_ASSESSMENT Investigations None View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Seizire SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Ventricular fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Bacteremia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Cellulitis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Fever SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Epistaxis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations None View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Lung infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Acute coronary syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Blurred vision SYSTEMATIC_ASSESSMENT Eye disorders None View
Cardiac troponin I increased SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Dental caries SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Edema face SYSTEMATIC_ASSESSMENT General disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Activated partial thromboplastin time prolonged SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Fibrinogen decreased SYSTEMATIC_ASSESSMENT Investigations None View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperuricemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Toe infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Infusion related reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders None View
Oral hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Palmar-plantar erythrodysesthesia syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rectal fissure SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Rectal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Vascular disorders None View
Tumor lysis syndrome SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Typhlitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vascular access complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Tongue infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
C.difficile infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Injury to jugular vein SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Intracranial hemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Paresthesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View