This program will be initiated after the commercial availability of PraxbindTM in India. It will include patients administered with PraxbindTM into the surveillance program after commercial availability in 2 years at selected centres approved by the regulatory authority.
Study Type
OBSERVATIONAL
Enrollment
5
Drug
Mazumdar Shaw Medical centre
Bangalore, India
Columbia Asia Referral Hospital
Bengaluru, India
Care Hospital
Hyderabad, India
Number of Participants With Suspected Adverse Drug Reactions (ADRs) and Fatal Adverse Events (AEs)
Number of participants with suspected adverse drug reactions (ADRs) and fatal adverse events (AEs) occurring within 7 days after Praxbind® administration.
Time frame: Up to 7 days following treatment.
Percentage of Patients Who Received Praxbind® Either for Emergency Surgery/Urgent Procedures or for Life-threatening or Uncontrolled Bleeding
Percentage of patients who received Praxbind® either for emergency surgery/urgent procedures or for life-threatening or uncontrolled bleeding.
Time frame: Data collected from patients who had been treated with Praxbind® within 2 years of the commercial availability of Praxbind®.
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