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Excessive toxicity and disease progression were responsible for the study discontinuation of four patients (8%) each.
However, as two of the patients had met their individual FEV1 discontinuation criterion, the study discontinuation criterion "Two or more subjects, who receive AZD9164, have other clinically significant changes in laboratory values or other safety parameters" was also met.
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The choice of the endpoint of this study, discontinuation of non-ergoline DA treatment, which encompasses both efficacy and tolerability, is also open to discussion.
Additionally, these studies employed both inpatient and outpatient treatment settings which may have influenced the overall study discontinuation rates.
If vitamin D dose was missing at the end of the EAP due to early study discontinuation, the vitamin D dose at the time of discontinuation was used.
In spite of the high attrition rate, the reasons for study discontinuation were balanced between groups and the resulting analysis set was representative of the study population.
In the case of premature study discontinuation, the last data value recorded in the patient diary was assigned according to the principle of last observation carried forward (LOCF).
The EP allows subjects who are currently receiving oral azacitidine and who are demonstrating clinical benefit as assessed by the Investigator, to continue receive oral azacitidine after unblinding by Sponsor (Celgene Corporation) until the subject meets the criteria for study discontinuation or until oral azacytidine becomes commercially available and reimbursed.
Finally, the rate of study discontinuation due to AEs for the G-GR group was very similar for older and younger patients (~9.5 %).
Administrative/investigator decisions were responsible for the most study discontinuations; the most frequent reasons given were cessation of chemotherapy and lack of response to the study dose of darbepoetin alfa.
This paper outlines the rationale, design and information learned at the time of study discontinuation.
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CEO of Professional Science Editing for Scientists @ prosciediting.com