Exact(6)
Safety data from each completed dose cohort is reviewed by a Data Safety Monitoring Board.
Of participants who completed dose optimization, 75.2% remained responders and 65.7% remained in remission in the 12-month study.
A total of 327 participants completed dose titration, entered the maintenance phase of the study, and had evaluable maintenance-phase data; 191 participants completed the trial.
The percent of participants optimized to each LDX dose, among participants who completed dose optimization (n=327) are illustrated in Figure 3.
Of the 327 participants who completed dose titration, 315 participants continued into the third month or thereafter and were evaluable for a subsequent change in dose.
During testing, two critical use errors occurred, both of which were in the FN group (Table 2): one related to setting the dose (37.5 IU instead of 75 IU) and the other to completing an incomplete dose (completed dose used was original dose instead of remaining dose).
Similar(54)
All 16 subjects completed dosing and the Day 9 follow-up visit.
The average duration of IFN therapy was 143±136 days, and the average number of completed doses was 57±50 (Table 2).
Twelve patients from the 15-min infusion group received 2- to 5-min infusions on day 8, and all completed dosing and follow-up through day 38.
Of these patients, 95 completed dosing through day 7 (15-min infusion: n = 53; and 30-min infusion: n = 42), and 93 completed through day 38 (15-min infusion: n = 51; and 30-min infusion: n = 42).
Twelve (12) studies reported inappropriate drug use; not completing dose (6/12) and sharing of medicines (4/12).
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