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 @ 11:10 AM
Ignite Modification Date: 2025-12-26 @ 11:10 AM
NCT ID: NCT03518112
Description: None
Frequency Threshold: 5
Time Frame: Time from the first day of treatment assessed up to 3 years, 1 month
Study: NCT03518112
Study Brief: Low-Intensity Chemotherapy and Blinatumomab in Treating Patients With Philadelphia Chromosome Negative Relapsed or Refractory Acute Lymphoblastic Leukemia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treatment (Blinatumomab, Combination Chemotherapy) See detailed description. Blinatumomab: Given IV Cyclophosphamide: Given IV Cytarabine: Given IT or IV Dexamethasone: PO or IV Filgrastim: Given SC Laboratory Biomarker Analysis: Correlative studies Leucovorin Calcium: Given IV Mercaptopurine: Given PO Methotrexate: Given IT or IV Pegfilgrastim: Given SC Rituximab: Given IV Vincristine Sulfate: Given IV 1 None 0 6 5 6 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Headache SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (4.0) View
Concentration Impairment SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Night Sweats SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Edema Legs SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Infusion Related Reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE (4.0) View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Neutopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Muscle Spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Chills SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Decreased White Blood Count SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Cytokine Release Syndrome SYSTEMATIC_ASSESSMENT Immune system disorders CTCAE (4.0) View
Ventricular Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (4.0) View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Alanine Aminotransferase Increased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Febrile Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (4.0) View
Mucositis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Steroid Myopathy SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (4.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View