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 @ 4:16 PM
Ignite Modification Date: 2025-12-25 @ 2:14 PM
NCT ID: NCT05718466
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT05718466
Study Brief: Stereotactic Radiology Versus Chemotherapy for Recurrent/Progressive Glioblastoma After Second-Line Chemotherapy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Fractionated Radiosurgery and Bevacizumab FRS and Bev followed by Bev combined either Irinotecan or Temozolamide or Carboplatin or Etoposide until progression Bevacizumab Chemotherapy Fractionated radiosurgery 15 None 5 18 0 18 View
Bev With Chemo Bev combined either Irinotecan or Temozolomide or Carboplatin or Etoposide until progression Bevacizumab Chemotherapy 14 None 4 17 0 17 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pulmonary Embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Nausea/Vomiting SYSTEMATIC_ASSESSMENT General disorders None View
New Onset Weakness SYSTEMATIC_ASSESSMENT General disorders None View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cerebral Edema SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Altered Mental Status SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Intratumoral Hemorrhage SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Other Events(If Any):