Safety
The frequencies of patients reporting ≥1 AE during the double-blind treatment phase were similar across treatment groups, ranging from 45% to 48%. The majority of AEs were categorized as mild to moderate in intensity. The most frequently reported AEs were peripheral edema (5.7%), headache (5.4%), and dizziness (5.2%; Table 3). Dizziness occurred more frequently with triple therapy (7.7%) and Val/HCTZ (7.0%) than with Aml/Val (2.3%) or Aml/HCTZ (3.9%). Peripheral edema occurred less frequently with triple therapy (4.5%) and Val/HCTZ (0.9%) compared with Aml/HCTZ (8.9%) or Aml/Val (8.5%). Overall, there was a low incidence of other AEs related to, or potentially related to, low BP across treatment groups, eg, hypotension (≤1.5%), syncope (