STUDY END Sample Clauses

STUDY END. The end of the study is defined as last patient last visit. In case of an ongoing serious adverse event (SAE), patients will continue to be monitored until resolution or until the outcome of the event is known and stable, beyond the defined study end, as necessary.
Sample 1
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STUDY END. The end of the study is defined as the last visit of the last patient. The last visit of a patient should occur, at the latest, 4 weeks after the last administration of NI-0501, except for patients continuing NI-0501 treatment beyond Week 8 (see paragraph below). In case of an ongoing serious adverse event (SAE), the patient will continue to be monitored until resolution or until the outcome of the event is known and stable, beyond the defined study end as necessary. In the event that additional NI-0501 concentration monitoring is not performed in the context of the NI-0501-05 study, this monitoring will continue beyond the 4 week follow-up period, until a measurable concentration of NI-0501 is no longer detectable. This measurement should occur not less than every two weeks. In this study, no further treatment beyond Week 8 is planned. However, in the event that an appropriate donor has not been identified by Week 8 or in case of the need to delay the schedule of HSCT for reasons unrelated to the administration of NI-0501, NI-0501 treatment can be continued beyond this time upon the request of the Investigator, in the context of an open label safety extension long term follow-up study, providing a favourable benefit/risk has been established. For these patients, end of study NI-0501-04 is defined as their last visit (i.e. three days after the last infusion administered in the context of NI-0501-04 study).
Sample 1

Related to STUDY END

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