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Exact(10)
One healthy subject was discontinued from the GMAD study in accordance with the FEV1 discontinuation criterion ("a fall in FEV1 ≥ 30% compared with the pre-dose value within 4 h after administration of investigational product").
Discontinuation criterion was difficult foetal delivery defined as uterine incision-to-delivery interval >3 min.
Three patients developed serum IgG levels below the protocol-defined discontinuation criterion.
However, as two of the patients had met their individual FEV1 discontinuation criterion, the study discontinuation criterion "Two or more subjects, who receive AZD9164, have other clinically significant changes in laboratory values or other safety parameters" was also met.
Progression of delirium is not a discontinuation criterion, as the trajectories are variable and impossible to predict.
The related overall study discontinuation criterion was 'Two or more subjects, who receive AZD9164, have other clinically significant changes in laboratory values or other safety parameters'.
Similar(50)
Sixteen subjects in the colesevelam group and 39 in the placebo group discontinued due to protocol-specified discontinuation criteria (FPG >260 mg/dl [14.4 mmol/l], A1C ≥10.0%, or change in antidiabetes regimen).
Of these 106 patients, 36 discontinued the extension study because of hyperglycemia: 7 withdrew consent, 6 were withdrawn due to investigator judgment, 20 met protocol-specified discontinuation criteria, and 3 were discontinued for various other hyperglycemia considerations.
The lower dropout rate with colesevelam (27.8%) compared with placebo (39.0%) was likely related to treatment failure, as many patients discontinued in the placebo group due to meeting protocol-specified discontinuation criteria, attesting to the efficacy of colesevelam.
Among these patients, treatment was discontinued in 54 patients by the AEs listed in the discontinuation criteria of the protocol, in 34 by physician's decision for other than protocol criteria, and in 44 by patient's refusal related to AEs of the S-1 group, and in 67, 34, 41 of the UFT/LV group, respectively.
Patients received treatment with ridaforolimus until disease progression or other discontinuation criteria were met.
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