Table 4.
Adverse drug reactions.
| Patients Number (%) (Event No) | Olme/Amlo/Rosu (n = 105) |
Olme/Rosu) (n = 106) |
Olme/Amlo (n = 54) |
Total (n = 265) |
|---|---|---|---|---|
| Subjects with ADRs | 11 (10.48) | 6 (5.66) | 2 (3.70) | 19 (7.17) |
| 95% Confidence Interval | (4.62, 16.33) | (1.26, 10.06) | (0.00, 8.74) | (4.06, 10.28) |
| p-value * | 0.2163 (c) | |||
| Severity | ||||
| Mild | 14 | 6 | 2 | 22 |
| Moderate | 0 | 2 | 0 | 2 |
| Severe | 0 | 0 | 0 | 0 |
| Relationship with drugs | ||||
| Certain | 0 | 0 | 0 | 0 |
| Probable/Likely | 0 | 2 | 1 | 3 |
| Possible | 7 | 3 | 0 | 10 |
| Unlikely | 7 | 3 | 1 | 11 |
| Not related | 0 | 0 | 0 | 0 |
| Unassessable/Unclassifiable | 0 | 0 | 0 | 0 |
| Subjects with Serious ADRs | 0 | 0 | 0 | 0 |
| Exact 95% Confidence Interval | (0.00, 3.45) | (0.00, 3.42) | (0.00, 6.60) | (0.00, 1.38) |
| p-value * | NC | |||
| Subjects with ADRs Leading to drug Discontinuation | 1 (0.95) (2) | 0 | 0 | 1 (0.38) (2) |
| Exact 95% Confidence Interval | (0.02, 5.19) | (0.00, 3.42) | (0.00, 6.60) | (0.01, 2.08) |
| p-value * | 0.6000 (f) | |||
| Subjects with ADRs Leading to Fatal circumstances | 0 | 0 | 0 | 0 |
| Exact 95% Confidence Interval | (0.00, 3.45) | (0.00, 3.42) | (0.00, 6.60) | (0.00, 1.38) |
| p-value * | NC |
Olme, Olmesartan; Amlo, Amlodipine; Rosu, Rosuvastatin; ADR, adverse drug reaction; NC, not calculated. * Testing for difference among treatment groups, chi-square test (c) or Fisher’s exact test (f). Note: Denominator of percentage is the number of subjects in each group. Severity and relationship are displayed as ‘number of events’ and others are displayed as ‘number of subjects (percentage of subjects) (number of events)’. ADR is the adverse event whose relationship to the study drug is ‘Certain’, ‘Probable/Likely’, ‘Possible’, ‘Unlikely’, ‘Unassessable/Unclassifiable’.