Extension Study definition

Extension Study means the ongoing extension study of CDZ173 sponsored by Novartis or its Affiliate entitled, “An Open-label, Non-randomized Extension Study to Evaluate the Long Term Safety, Tolerability, Efficacy and Pharmacokinetics of CDZ173 in Patients With APDS/PASLI (Activated Phosphoinositide 3-kinase Delta Syndrome/p110d-activating Mutation Causing Senescent T Cells, Lymphadenopathy and Immunodeficiency)” designated by ▇▇▇▇▇▇▇▇▇▇▇▇▇▇.▇▇▇ Identifier: NCT02859727 and sometimes referred to by Novartis as “CDZ173X2201E01.”
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Examples of Extension Study in a sentence

  • Data will be summarized and tabulated based on the enrolled population for this Extension Study.

  • The analysis performed at six months of this Extension Study will be used as a follow-up to the 18 month fracture endpoint for Study BA058-05-003.

  • The subject has read, understood, and signed the written informed consent form for the Extension Study.

  • The fracture incidence; either clinically or radiologically determined, based on clinical events or protocol-directed vertebral x-rays at Month 6 of this Extension Study; will be analyzed.

  • In the month between Visit 9 and Visit 10 (between months 18 and 19 of Study BA058-05-003), the Investigator will consider the results of the assessments performed at Visit 9, including a local review of BMD, and determine if alendronate is appropriate for the subject, as part of this Extension Study.

  • All subjects enrolled in the Extension Study will be included in the safety analysis that will be performed on the following parameters: · Incidence and severity of AEs; · Pathological changes in hematology, chemistry and urinalysis data based on normal ranges supplied by the clinical laboratory, if applicable; Safety assessments for changes in physical examination, ▇▇▇▇▇ ▇▇▇▇▇, ECG, and laboratory tests will be descriptively summarized by treatment and study periods.

  • All subjects enrolled in the Extension Study will be included in the safety analysis that will be performed on the following parameters: · Incidence and severity of AEs. · Pathological changes in hematology, chemistry and urinalysis data based on normal ranges supplied by the clinical laboratory, if applicable.

  • The fracture incidence; either clinically or radiologically determined, based on clinical events or protocol-directed vertebral x-rays at Month 6 of this Extension Study; will be tabulated.

  • Patients eligible to continue in the Extension Study will not undergo the End-of-Study Visit and will transition into the Extension Study during the Follow-up Period.

  • The Parties agree that Rigel shall continue to conduct such Open Label Extension Study on behalf of AZ [ * ] following the Effective Date and for a period of [ * ] following such date (the end of such [ * ] period, the “Open Label Extension Study Transfer Date”), notwithstanding the date of transfer to AZ.