Your English writing platform
Discover LudwigExact(3)
Safety and tolerability (i.e., the maximum tolerated dose, MTD) will be assessed using a classical 3 + 3 dose-escalation design.
Two (0.9%) patients on ALA and one (0.7%) patient on placebo discontinued study treatment as a result of lack of tolerability (i.e., because of an adverse event with "likely" causal relationship to study medication as judged by the investigator).
But, at the time that her life is on the edge of tolerability, I do not see mention of taking in the sun for an hour each morning, an inviolate exercise regime, daily walks on the beaches or in the parks, playing games with friends or an orientation in therapy toward becoming a contributor to others' well-being to even a small degree rather than struggling merely not to be a burden.
Similar(57)
The efficacy and tolerability of i.a.a
In the regulatory context, the approach to collecting PROs for AEs may differ depending on whether the aim is a comparative tolerability claim (i.e. a product having a more favourable tolerability profile compared with another) or just general documentation of AEs.
62 In terms of safety and tolerability, phase I and II studies reported similar rates of all adverse and severe adverse events in placebo, denosumab, and alendronate groups.
Our main aim was to explore the safety and tolerability of i.v. ghrelin in such a clinical situation, in which the interpretation of (negative) efficacy data requires considerable caution.
CPH114527 was a phase 1, open label, dose characteristic study to investigate the pharmacokinetics, pharmacodynamics, safety, and tolerability of i.v. and s.c. doses of CPHPC in patients with systemic amyloidosis.
Oral topotecan has demonstrated activity and tolerability similar to i.v. topotecan in chemosensitive small-cell lung cancer (von Pawel et al, 2001) and relapsed epithelial ovarian cancer (Gore et al, 2002), and thus seems to offer patients a convenient alternative to i.v. therapy.
The results of this 'first-in-man' open-label Phase I tolerability study reported here demonstrate that GS-101 is well tolerated in healthy human subjects.
Explanation for the different tolerability in phase I versus phase II trial was a change in the dosing schedule.
Write better and faster with AI suggestions while staying true to your unique style.
Since I tried Ludwig back in 2017, I have been constantly using it in both editing and translation. Ever since, I suggest it to my translators at ProSciEditing.

Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com