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 @ 2:11 AM
Ignite Modification Date: 2025-12-26 @ 12:39 AM
NCT ID: NCT04434560
Description: No participants were enrolled in the Neoadjuvant Immunotherapy group.
Frequency Threshold: 0
Time Frame: Approximately 10 days
Study: NCT04434560
Study Brief: Neoadjuvant Immunotherapy in Brain Metastases
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Standard of Care (no Neoadjuvant Immunotherapy) Patients will proceed to surgical resection with no nivolumab/ipilimumab given prior to surgery. 0 None 1 1 1 1 View
Neoadjuvant Immunotherapy Patients will receive a single dose of neoadjuvant nivolumab and ipilimumab 7 days (± 3 days) prior to surgical resection. Nivolumab: Nivolumab will be given at the FDA-approved dose of 3 mg/kg. Ipilimumab: Ipilimumab will be given at the FDA-approved dose of 1 mg/kg. 0 None 0 0 0 0 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pyramidal tract syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders CTCAE (4.0) View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Hypomagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Concentration impairment SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Dysphasia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Paresthesia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Pyramidal tract syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View