Table 3.
Adverse Events*
| Adverse Event | Isradipine (n = 170) | Placebo (n = 166) |
|---|---|---|
| Any adverse event | 163 (95.9) | 156 (94.0) |
| Any serious adverse event† | 27 (15.9) | 28 (16.9) |
| Death | 2 (1) | 1 (1) |
| Discontinuation due to adverse event | 7 (4.1)‡ | 3 (1.8)§ |
| Adverse events occurring in ≥5% of patients | ||
| Dizziness | 42 (24.7) | 26 (15.7) |
| Nausea | 26 (15.3) | 32 (19.3) |
| Headache | 28 (16.5) | 17 (10.2) |
| Nasopharyngitis | 23 (13.5) | 22 (13.3) |
| Constipation | 23 (13.5) | 21 (12.7) |
| Fatigue | 23 (13.5) | 20 (12.0) |
| Edema | 31 (18.2) | 9 (5.4) |
| Arthralgia | 17 (10.0) | 21 (12.7) |
| Insomnia | 19 (11.2) | 19 (11.4) |
| Back pain | 18 (10.6) | 16 (9.6) |
| Anxiety | 20 (11.8) | 13 (7.8) |
| Depression | 20 (11.8) | 13 (7.8) |
| Musculoskeletal pain | 12 (7.1) | 15 (9.0) |
| Muscle spasms | 11 (6.5) | 13 (7.8) |
| Upper respiratory tract infection | 12 (7.1) | 11 (6.6) |
| Fall | 7 (4.1) | 15 (9.0) |
| Pain in extremity | 11 (6.5) | 9 (5.4) |
| Sinusitis | 7 (4.1) | 13 (7.8) |
| Joint swelling | 12 (7.1) | 7 (4.2) |
| Cough | 9 (5.3) | 9 (5.4) |
| Somnolence | 10 (5.9) | 8 (4.8) |
| Sleep disorder | 9 (5.3) | 8 (4.8) |
*
Values are presented as numbers (percentages) of participants experiencing the event at least once.
†
Defined as any adverse event that occurred at any dose and resulted in death, a life-threatening adverse event, inpatient hospitalization or prolongation of an existing hospitalization, persistent or significant disability/incapacity, or a congenital anomaly.
‡
Fatigue, leg edema (n = 2), muscle weakness, joint swelling, spinal fracture, and muscle spasm.
§
Myocardial infarction, orthostatic hypotension, and gastroesophageal reflux.