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This study was terminated early as interim analysis identified no significant clinical benefit.
In addition, a phase III study of SU11248 monotherapy in patients with imatinib-resistant/imatinib-intolerant GIST has recently been halted ahead of schedule as interim analysis clearly demonstrated the efficacy benefits of this approach.
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As in a prospective trial at interim analysis, Phase 2 was performed for each of the five-year cohort periods after one year of follow-up.
As expected, tumour scores at killing were higher than those at interim analysis, but with the same pattern.
Data from surgical patients will be presented as soon as the interim analysis in that group is completed.
The study was terminated early as this interim analysis revealed a clearly statistically significant result.
The only randomised trial, – published as an interim analysis at the ASCO meeting 2006, included a total of 35 patients and used (i) induction chemotherapy with CapOx and CapIri and (ii) very high doses of irinotecan during radiochemotherapy (180 mg m−2), which might not be suited to exploit the radiosensitizing properties of irinotecan (Privitera et al, 2006).
Preliminary results from these two trials have recently been presented as an interim analysis in abstract form, showing the drug's ability to maintain long-term remission and to reinduce clinical response in "withdrawal" patients (Sandborn et al 2007c; Schreiber et al. 2007c).
However, despite the consistent evidence of efficacy in preclinical settings and the favorable tolerability profile, the development of bifeprunox has been discontinued, as an interim analysis showed inadequate efficacy of the compound (see http://www.clinicaltrials.gov/ct2/show/NCT00658645) and the US FDA had refused approval for marketing.
However, after a patient experienced complications during sedation interruption, the Data Safety Monitoring Board (DSMB) chose to closely follow all reported adverse events and perform an interim analysis as necessary based on clinical expertise and safety concerns.
In CORE, the ADMC will not apply the stopping rules and interim analysis as per a clinical trial because (A) the intervention is not therapeutic and (B) the stepped wedge design does not allow for interim analysis since all clusters will not have received the intervention.
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CEO of Professional Science Editing for Scientists @ prosciediting.com