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The final treatment feasibility and safety would be approved if the incidence of predefined severe grade 3/4 toxicities (NCI-CTC) would be no higher than 20% as well as the incidence of predefined severe, life threatening bleeding events would be no higher than 20% in a minimum of 15 patients under treatment duration of at least 12 weeks.
The primary safety measures were the incidence of predefined GI adverse events (AEs) and peripheral oedema.
The determination of the sample size was based on the key primary safety variable, the incidence of predefined GI AEs.
Hematology, liver function, renal function, and electrolyte laboratory parameters were evaluated for the incidence of predefined, clinically significant abnormalities, and for median and mean changes from baseline to last follow-up visit.
The primary end point was the incidence of predefined adjudicated upper GI events as previously reported.
The incidence of predefined AEs of special interest, i.e. those that were likely to be LABA related or ICS related, was greatest in the FF/VI 800/100 μg regimen, with palpitations (15 vs. 1 5%), oropharyngeal pain (8 vs. 0 1%) and tremor (8 vs. 0%) being the most frequently reported.
Similar(53)
The incidence of individual predefined GI AEs and their severity was also comparable between the treatment groups.
In the univariate analysis advanced age (P = 0.02) and existence of liver cirrhosis (P < 0.01) were both associated with incidence of a predefined SAE.
The primary end point was the incidence of a predefined comprehensive composite primary end point of both upper and lower GI events, including clinically significant decreases in haemoglobin (≥2 g/dL) and/or haematocrit (≥10%), as previously reported.
29 For clinical outcomes such as the incidence of MACE (predefined clinical scenarios; death, myocardial infarction, re-admission for heart failure or revascularisation), Kaplan-Meier curves displaying the pattern of events during the 6-month and 12-month follow-up period are drawn.
Pathak, R. K. & Dhar, S. A nanoparticle cocktail: temporal release of predefined drug combinations.
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