Vocinti Adverse Reactions

The following convention is used for the classification of the frequency of an adverse drug reaction (ADR) and is based on the Council for International Organizations of Medical Sciences (CIOMS) guidelines: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Clinical Trials: Clinical trial data for expected adverse events is based on pooled safety analysis from the following studies: EE healing (CCT-001 and CCT-002), EE maintenance therapy (CCT-003 and OCT-001), GU healing (CCT-101), DU healing (CCT-102), prevention of recurrence of peptic ulcer associated with NSAID use (CCT-301, OCT-301 and OCT-303) and prevention of recurrence of peptic ulcer associated with LDA use (CCT-302, OCT-302 and OCT-304). (See Table 15.)


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Postmarketing: Following is a list of ADRs which have been observed in postmarketing and are not included previously: See Table 16.


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