Patient Withdrawal Criteria Sample Clauses

Patient Withdrawal Criteria. Any patient can decide to withdraw from study participation at any time for any reason. In addition, the study Sponsor may decide to stop the study participation of any patient as deemed necessary. The Investigator may also stop the study participation of any patient at any time. Reasons for study withdrawal include but are not limited to: • The patient was erroneously included in the study (i.e., was found to have not met the eligibility criteria). • The patient experiences an intolerable or unacceptable AE. • The patient is unable to comply with the requirements of the protocol. • The patient participates in another investigational study without the prior written authorization of the Sponsor. The Investigator or study staff will document the reason(s) for treatment discontinuation on the case report form (CRF). Patients who received at least 1 dose of IP who discontinue from treatment within 4 weeks after a functional assessment visit will be asked to return for an End of Study visit within 4 weeks of their last visit. Patients who received at least one (1) dose of IP who discontinue treatment more than 4 weeks after a functional assessment visit will be asked to complete all Early Termination (Week 96) assessments within 30 days of discontinuation and a subsequent End of Study visit within 4 weeks of the Early Termination (ET) visit. Following Week 96, patients may continue to receive eteplirsen for up to an additional 48 weeks and be followed as described in the Safety Extension portion of Section 2, Table 3 (Safety Extension Schedule of Events). They may receive weekly infusions of eteplirsen at the same dose, with continuous monitoring of adverse events and concomitant medications, while undergoing physical examination and safety laboratory assessments every 24 weeks. If patients discontinue eteplirsen during the Safety Extension, they will be asked to return for an End of Study visit 4 weeks after their final dose. Patients who discontinue eteplirsen dosing in the Safety Extension Period in order to transition onto commercial drug or into a separate eteplirsen study do not require an End of Study visit.
Sample 1
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