Clinical Trial: French Observational Xagrid (FOX) Study In Adult Patients With Essential Thrombocythemia

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: A Phase 4, Observational Study to Explore How Different Treatment Regimens Affect Continuation With Treatment in the First 6 Months Following Initiation of XAGRID Into Adult Patients'

  • Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: Withdrawal of Previous Cytoreductive Therapy Before Anagrelide Hydrochloride Initiation [ Time Frame: 6 months ]

    Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when Anagrelide Hydrochloride treatment was initiated, using the following variables:

    •Withdrawal of previous cytoreductive therapy:

    • Before: if a stop date of previous cytoreductive therapy was prior to the date of Anagrelide Hydrochloride initiation
    • After: if a stop date of previous cytoreductive therapy was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up
    • Not Withdrawn: in all other cases
  • Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: Withdrawal of Previous Cytoreductive Therapy After Anagrelide Hydrochloride Initiation [ Time Frame: 6 months ]

    Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when Anagrelide Hydrochloride treatment was initiated, using the following variables:

    •Withdrawal of previous cytoreductive therapy:

    • Before: if a stop date of previous cytoreductive therapy was prior to the date of Anagreli

      Original Primary Outcome: To determine how different treatment regimens, during the initiation of XAGRID into a patient's essential thrombocythemia (ET) therapy, affect continuation with treatment in the first 6 months. [ Time Frame: 6 months ]

      Current Secondary Outcome:

      • Percentage of Subjects With Anagrelide Hydrochloride Starting Doses [ Time Frame: 6 months ]
      • Number of Subjects With Anagrelide Hydrochloride Titration Modifcations- First Modification Only [ Time Frame: 6 months ]
      • Summary of Adverse Drug Reactions (ADR): Withdrawal of Previous Cytoreductive Therapy Before Anagrelide Hydrochloride Initiation [ Time Frame: 6 months ]

        Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when Anagrelide Hydrochloride treatment was initiated, using the following variables:

        •Withdrawal of previous cytoreductive therapy:

        • Before: if a stop date of previous cytoreductive therapy was prior to the date of Anagrelide Hydrochloride initiation
        • After: if a stop date of previous cytoreductive therapy was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up
        • Not Withdrawn: in all other cases
      • Summary of Adverse Drug Reactions: Withdrawal of Previous Cytoreductive Therapy After Anagrelide Hydrochloride Initiation [ Time Frame: 6 months ]

        Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when Anagrelide Hydrochloride treatment was initiated, using the following variables:

        •Withdrawal of previous cytoreductive therapy:

        • Before: if a stop date of previous cytoreductive therapy was prior to the date of Anagrelide Hydrochloride initiation
        • After: if a stop date of previous cytoreductive therapy was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up
        • Not Withdrawn: in all other cases
      • Summary of Adverse Drug Reactions: No Withdrawal of Previous Cytoreductive Therapy [ Time Frame: 6 months ]

        Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when Anagrelide Hydrochloride treatment was initiated, using the following variables:

        •Withdrawal of previous cytoreductive therapy:

        • Before: if a stop date of previous cytoreductive therapy was prior to the date of Anagrelide Hydrochloride initiation
        • After: if a stop date of previous cytoreductive therapy was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up
        • Not Withdrawn: in all other cases
      • Summary of Adverse Drug Reactions: When the Dosing Was Consistent With the Summary of Product Characteristics (SmPC) [ Time Frame: 6 months ]

        Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when XAGRID treatment was initiated, using the following variables:

        • Initiation of XAGRID dosing consistent with the Summary of Product Characteristics (SmPC):
        • Consistent if:

          • The starting dose was <=1 mg/day, AND
          • Any increase in dose was no more than 0.5mg/day, AND
          • Any increase in dose was made at least 7 days after first initiation or at least 7 days after any previous modification (up or down), AND
          • The maximum dose did not exceed 10 mg/day at any stage.
        • Inconsistent: in all other cases
      • Summary of Adverse Drug Reactions: When the Dosing Was Inconsistent With the Summary of Product Characteristics (SmPC) [ Time Frame: 6 months ]

        Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when XAGRID treatment was initiated, using the following variables:

        • Initiation of XAGRID dosing consistent with the Summary of Product Characteristics (SmPC):
        • Consistent if:

          • The starting dose was <=1 mg/day, AND
          • Any increase in dose was no more than 0.5mg/day, AND
          • Any increase in dose was made at least 7 days after first initiation or at least 7 da

            Original Secondary Outcome:

            Information By: Shire

            Dates:
            Date Received: August 26, 2010
            Date Started: September 2010
            Date Completion:
            Last Updated: February 14, 2014
            Last Verified: February 2014