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Seven patients were still alive at study closure and survival was censored for these patients at a common date (April 8 , 2015.
At study closure, six patients with MCL continued receiving lenalidomide.
However, the ethics of debriefing ('disclosing'unmaskinging'unblindinging'), at study closure has been overlooked.
At study closure, 78.8% of patients who started biologics were still receiving them.
Approximately 40% of the individuals with a baseline HbA1c of 8.3% attained HbA1c values ≤7% at study closure.
At study closure, 19 patients (34%) were alive, with no evidence of disease in 9 cases (16%).
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All patients were recalled for further evaluation at the time of study closure.
At 18 months after study closure, and with median 35 months potential follow-up, 11 (20%) patients remain alive.
However, there was no significant difference between groups in the median overall survival at the date of study closure.
Since this event did not reach 50% at the time of study closure, the time median could not be estimated.
Only 6 patients (3 per group) had not recovered from severe neutropenia in Induction 1 at the time of study closure; these patients were permitted to receive open-label filgrastim treatment (2 patients in total received additional filgrastim therapy).
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