PrCa Adverse Events including Skeletal-related Events (SREs)


This example shows a CRF used to collect information on adverse events, including skeletal-related events (SREs).


A skeletal event (SRE) is defined as: a pathologic fracture, spinal cord compression, necessity for radiation to bone (for pain or impending fracture) or surgery to bone. Sometimes a change in antineoplastic therapy to treat bone pain is considered an SRE. The team considered two approaches to developing an example CRF for skeletal events based on CRFs provided by sponsors. One approach collects all skeletal events in a single form, but requires reconciliation of some data with other forms, while another approach collects adverse experiences, procedures (i.e., radiation and surgery), and medications in separate forms, but with items to allow identification of those that are skeletal-related events. The "multiple CRF forms" approach was chosen as being more convenient for sites, and requiring less overall reconciliation among forms. This approach also organizes the data by the appropriate SDTM domain.

For this CRF, adverse events and procedures (i.e., radiation and surgery) are collected in separate forms, but with items to allow identification of those events that are considered skeletal-related events. In this example, investigators categorized adverse events as skeletal-related or not skeletal related based on definitions provided in the protocol. If an event was skeletal-related, the investigator indicated what type of skeletal-related event occurred. Spinal cord compression and pathological fracture were protocol-defined SREs, while "Other Skeletal-Related Events" were potential SREs. The category "Other Skeletal-Related Event" was used to reconcile the AE information with the information collected on radiation and surgery to bone. Also, the use of this "Other" category avoids potential confusion with "blank" responses. The CDASH variable PRAENO was used on the Radiation Procedures and Procedures (excluding Radiation Therapy) CRFs to link any radiation to bone for pain management, and any surgery to bone to reported AEs.


Adverse Events including SREs
AEs including SREs
Were any adverse events experienced? Yes  No  
What is the adverse event identifier?
What is the adverse event term?
What is the category of the adverse event? SRE-related  Not SRE-related  
If SRE-related, Indicate type of event
What is the best description of the cause of the fracture?
What is the toxicity grade of the adverse event?
Start Date
 01 Jan 2000
What is the anatomical location of the adverse event?
What is the side of the anatomical location of the adverse event? Right  Left  Bilateral  
Is the adverse event still ongoing? Yes  No  
End Date
 01 Jan 2000
Was the adverse event serious? Yes  No  
Did the adverse event result in death? Yes  No  
Death Date
 01 Jan 2000
Was the adverse event life threatening? Yes  No  
Did the adverse event result in initial or prolonged hospitalization for the subject? Yes  No  
Did the adverse event result in disability or permanent damage? Yes  No  
Was the adverse event associated with a congenital anomaly or birth defect? Yes  No  
Was the adverse event a medically important event not covered by other serious criteria? Yes  No  
Was this adverse event related to study treatment? Yes  No  
What action was taken with study treatment?
What is the outcome of this adverse event?
* Mandatory field

Package(s)
PrCa_AEs_including_SREs_2023-01-31.zip