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Thereafter escalation steps were ⩽50%.
Dose escalation steps of 33% were planned.
Table 1 shows an overview about the dose escalation steps and the treatment duration.
This may yield situations where dose escalation steps may be larger than originally anticipated.
Should DLT be observed in one out of six patients and dose escalation continued, escalation steps were ⩽35%.
Mitomycin C was administrated as bolus injection in three dose escalation steps of 6, 8 and 10 mg m−2 on days 1 and 22.
Similar(49)
At reaching 50% lethality upon long-time exposure, the addition of cisplatin was paused and cells were allowed to recover over three passages until the next dose escalation step (Wang et al, 1980; Port et al, 2011).
The inclusion of six patients per dose group in each escalation step provided an 80% probability that at least one patient would report an adverse event that has an underlying incidence rate of 24%.
Only when efficacy is formally demonstrated by controlled studies balancing the acute risks of HSCT vs the toxicity of chronic immunosuppressive treatment will HSCT be perceived as an alternative to, or reasonable escalation step after failure of standard treatment.
The trial reported here is the next in a series of age de-escalation steps towards the EPI age range, contributing to adjuvant and schedule selection.
As part of an age de-escalation step in the RTS,S clinical vaccine development plan, we conducted a phase II, randomized, double-blind study to assess the safety and immunogenicity of RTS,S/AS01E and RTS,S/AS02D in children aged 18 months to 4 years living in Gabon.
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