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From discontinuation day forward patients were assigned 0% improvement.
The clinical evaluations took place at visit 1, at any premature discontinuation (day 1 to day 3), and at the TOC visit.
Baseline study assessments prior to initiating dasatinib and docetaxel treatment (day 0), at docetaxel discontinuation (day 341), and at the last assessment on single-agent dasatinib therapy (day 1319) are summarized in Table 1.
After the inclusion visit, participants attended three visits: after 1 week of treatment (day 7), at the end of the treatment period (day 28) and 1 week after treatment discontinuation (day 35).
Baseline study assessments prior to initiating dasatinib and docetaxel treatment (day 0), at docetaxel discontinuation (day 190), and at the last assessment on single-agent dasatinib (day 1373) are summarized in Table 1.
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Antiparkinsonism drugs were allowed only if necessary, and were otherwise tapered to discontinuation 1 day before the screening or washout phase.
Two of the three patients with grade IV acute GVHD (SPN 3704 and 3783) required sirolimus discontinuation by day 9 post-HCT due to severe SOS and progressive altered mental status, respectively.
One retrospective study has compared rATG induction (6.0 mg/kg) versus IL-2RA induction with basiliximab in 99 kidney transplant patients for whom early steroid discontinuation on day 6 was planned [ 118].
End-of-treatment examinations were performed 28 days after the day of discontinuation or within 7 days before the initiation of a post-study treatment, whichever came first in each patient.
Originally this had been classed as "continuation phase" drop out, but we moved it to "30 day discontinuation" period.
A total of 274 patients were treated and had post-baseline efficacy data recorded (three patients were randomized but not treated due to study discontinuation on the day of randomization).
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