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 treatment of non-erosive reflux disease (NERD; CCT-201). Although the study in patients with NERD has the placebo arm and is considered as the best data, the number of patients (N=449 and 278 for TAK-438 and placebo, respectively) is relatively small compared to the number of patients of all other active-comparator studies combined (N=3162 and 1392 for TAK-438 and AG-1749 [Lansoprazole], respectively). Therefore, the pooled safety data of active-comparator studies are used for the primary analysis. The safety data of CCT-201 study are analyzed separately. (Note: AG-1749 (Lansoprazole) is the only comparator used in the comparator studies.) (See Table 4.)

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Postmarketing: Following is a list of ADRs which have been observed in postmarketing and are not included in the table previously: (See Table 5.)

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