Table I.
Patient Disposition
| Lisinopril Monotherapy (n=130) | Carvedilol CR Monotherapy (n=131) | Carvedilol CR + Lisinopril Combination Therapy (n=393) | Total (N=654) | |
|---|---|---|---|---|
| Withdrawn, No. (%) | 19 (15) | 26 (20) | 58 (15) | 103 (16) |
| Primary reason for withdrawal, No. (%) | ||||
| Adverse event | 3 (2) | 7 (5) | 18 (5) | 28 (4)a |
| Lost to follow‐up | 0 | 4 (3) | 5 (1) | 9 (1) |
| Protocol violation | 6 (5) | 5 (4) | 4 (1) | 15 (2) |
| Patient decision to withdraw | 3 (2) | 7 (5) | 14 (4) | 24 (4) |
| Lack of efficacy | 5 (4) | 2 (2) | 2 (<1) | 9 (1) |
| Other | 2 (2) | 1 (<1) | 15 (4) | 18 (3) |
aBased on the end‐of‐study status clinical report form. Three additional participants had at least 1 adverse event with an action of “withdrew IP”; however, they each had a study conclusion status of “not withdrawn” from the study. They are included in the section that describes patients with adverse events leading to withdrawal of the investigational product.