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In this study, trial conclusion is defined as the point in time when a patient has completed the planned course of treatment or they were withdrawn due to unacceptable toxicity or lack of response.
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An interim analysis was planned when at least 50% of the required patients had completed the planned treatment, to verify whether or not it was feasible to administer high doses of Interferon only intravenously without significantly increasing the toxicity.
This is an ongoing prospective study where not all the children have completed the planned visits.
Fourteen patients (54%) discontinued the study after they had completed the planned six cycles of treatment.
Overall, 16 or 62% of the cohort had completed the planned therapy duration (i.e., 11 weeks) without a chemotherapy dose interruption.
Final data analysis was carried out in March 2009 after all patients entered had completed the planned six cycles of chemotherapy or had interrupted treatment as a result of disease progression or unacceptable toxicity.
Final data analysis was carried-out in September 2010, after all patients entered had completed the planned six cycles of chemotherapy or interrupted treatment as a result of disease progression or unacceptable toxicity.
The local architect Des Ewing has completed the first of six planned houses that he calls The Iceberg at Knightsbridge Park in south Belfast.
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An independent Data Safety and Monitoring Committee (DSMC), comprising of experts in clinical trials, biostatistics and rehabilitation will be established to review data on adverse events after 300 study participants (half the planned study sample) have completed the six-month follow-up assessment.
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