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Patients were individually randomised according to a 2∶1 (DHA-PQP∶AL) scheme, so as to have more patients in the DHA-PQP arm to provide better estimates for its cure rates and more cases for the integrated safety data base.
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However, the safety data based on RA studies should only be cautiously compared between other indications such as moderate to severe plaque psoriasis, due to differences in co-morbidities and patient populations.
Dose escalations required acceptable safety data based on blinded review of safety data at a dose-level review meeting following completion of the day 15/week 3 visit by the final patient in each cohort and when six or more patients in a cohort had been administered at least three doses of brodalumab (cohorts 1, 2, 3 and 5).
Analyses and summaries of safety data were based on the actual treatment received.
The reported safety data are based on all subjects that received any study medications (n = 103).
Unlike efficacy data (analyzed based on assigned treatment group), safety data were analyzed based on actual treatment and included all patients who had received at least one dose of ustekinumab.
Efficacy and safety data were evaluated based on an intention to treat analysis including all participants who were randomised to continue or discontinue co-trimoxazole prophylaxis.
It was a general framework that is used to validate safety information based on local sensor data to detect Sybil node attackers.
All safety data were summarised descriptively based on the safety population.
Similar to active pharmaceutical ingredients, in most instances the safety data of excipients is based on adult exposure.
The board will monitor the trial data, in particular the safety data, and makes recommendations based on the periodically reviewed data.
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