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At the 2015 ASCO annual meeting, researchers reported the safety data of a phase I dose-escalation study (NCT01840566) in 8 patients with poor-risk R/R aggressive B-NHL who received BEAM-conditioned HDT-ASCT followed by infusion of anti-CD19 28ζ CAR-T cells at 1 of 3 dose levels (5 × 106, 1 × 107 or 2 × 107 CAR+ T cells/kg) at days +2 and +3 (Sauter et al., 2015).
Preliminary data of a phase III trial may also confirm this with Panitumumab plus FOLFOX4 [ 31].
The survival data of a phase I trial combining irinotecan with mitomycin C for HIPEC is not yet available [ 19].
Data of a phase II trial in patients with advanced chronic lymphocytic leukemia was reported in 2009 (Blum et al. 2009).
Data of a phase II trial in patients with relapsed or progressive multiple myeloma was reported by Galli et al. (2010).
The choice of these concentrations is based on pharmacokinetic data of a phase 3 randomised study following 3- and 24-h infusions of paclitaxel at dose levels of 135 and 175 mg m−2.
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Based on the promising preclinical data of BNP7787, a phase I clinical study was performed in patients with solid tumours treated with a fixed dose of cisplatin every 3 weeks preceded by BNP7787 in escalating doses.
In an interim data review of a phase III clinical trial, the drug appeared safe but not effective enough to continue the study.
To report the mature data of a prospective Phase II trial designed to evaluate the efficacy of an epidermal growth factor receptor inhibitor cetuximab (CTX) added to the concurrent therapy of weekly paclitaxel/carboplatin (PC) and daily radiation therapy (RT).
Simulation study and application of EID to the data of a real Phase I trial demonstrate that EID can always estimate a more accurate maximum tolerated dose (MTD) according to the exact toxicity profile under any toxicity profiles without additional cost or length of the trial.
Cronbach's alpha was calculated from the data of an unpublished phase III trial of afamelanotide in PP.
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