Vay-R維智寧

Vay-R Adverse Reactions

Manufacturer:

Enzymotec

Distributor:

KLN Medical

Marketer:

KLN Pharma
Full Prescribing Info
Adverse Reactions
The adverse events of Vay-R were evaluated in a randomized, double blind, placebo-controlled study of 15 weeks followed by an open label extension of an additional 15 weeks.
Adverse events reported during the course of the double-blind phase (table 2): 12 participants from the Vay-R group and 5 participants from the placebo group were classified by the study physicians as suffering from treatment related, or probably related, adverse events (13 and 5 adverse events, respectively). There were no significant differences between the study groups in either the incidence or number of adverse events recorded (p = 0.848 and p = 0.982, respectively).
Adverse events reported during the course of the open-label extension (table 2): 5 participants reported 7 adverse events that were classified by the study physicians as related or probably related to the study treatment. (See Table 2.)

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