TABLE 3.
Compliance rate | Total (n = 381) | TEL/AML/CHTD, (n = 192) | TEL/AML, (n = 189) | p |
---|---|---|---|---|
Baseline – weeks 2 | 98.0 ± 5.8 | 97.9 ± 5.2 | 98.1 ± 6.3 | NS |
Week 2 – weeks 4 | 98.8 ± 4.7 | 98.8 ± 5.3 | 98.7 ± 4.0 | NS |
Week 4 – weeks 8 | 98.7 ± 4.7 | 98.7 ± 4.6 | 98.7 ± 4.7 | NS |
Total period | 98.2 ± 4.2 | 98.0 ± 4.5 | 98.4 ± 3.8 | NS |
Adverse events | Total (n = 381) | TEL/AML/CHTD (n = 192) | TEL/AML (n = 189) | p |
---|---|---|---|---|
TEAE, n(%) | 48(12.6) | 30(15.6) | 18(9.5) | .0728 |
Treatment related AEs, n(%) | 30(7.9) | 20(10.4) | 10(5.3) | .0633 |
SAEs, n(%) | 2(0.5) | 1 (0.5) | 1 (0.5) | 1.000 |
Treatment‐related SAEs, n(%) | 0(0) | 0(0) | 0(0) | |
Discontinued due to AE | 0(0) | 0(0) | 0(0) |
Abbreviations: AEs, TEAEs which have the relationship with IP such as ‘Certainly’, ‘Probably’, ‘Possibly’, ‘Unlikely’ or ‘Unassessable/Unclassifiable; TEAE, Treatment emergent adverse event; SAE, Serious adverse event Treatment‐Related; TEL/AML, telmisartan/amlodipine; TEL/AML/CHTD, telmisartan/amlodipine/chlorthalidone.