All ADRs listed in the CDS are presented by MedDRA SOC. Within each frequency category, the ADRs are presented in the order of seriousness. Seriousness of the ADRs was determined by clinical importance. (See Table 3.)
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CIOMS III/V categories: Common ≥ 1/100 to < 1/10 (≥ 1% and < 10%); Uncommon ≥ 1/1000 to < 1/100 (≥ 0.1% and < 1%); Rare ≥ 1/10000 to < 1/1000 (≥ 0.01% and < 0.1%); Not known: frequency cannot be estimated from available data.
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