Table 2.
Patient characteristics with potential relevance for cardiac events and frequency of symptoms by subgroup
| Overall population | Patients with bradycardia | Patients with second-degree AV block | Patients with AE | Patients with symptoms suggestive of cardiac events at visit 2 | Patients who discontinued study drug due to AE | |
|---|---|---|---|---|---|---|
| N = 3951 | N = 31 | N = 62a | N = 1350 | N = 120 | N = 38 | |
| Demographics | ||||||
| Age (years), mean ± SD | 39.3 ± 10.4 | 42.1 ± 10.9 | 40.4 ± 11.7 | 39.3 ± 10.4 | 39.6 ± 10.4 | 42.3 ± 12.4 |
| Female, n (%) | 2779 (70.3) | 14 (45.2) | 57 (91.9) | 1023 (75.8) | 96 (80.0) | 29 (76.3) |
| Concomitant medication known to prolong QT interval: | ||||||
| SSRI n (%) | 339 (10.1) | 1 (3.2) | 4 (6.5) | 152 (11.3) | 17 (14.2) | 6 (15.8) |
| TCA n (%) | 92 (2.3) | 0 | 0 | 38 (2.8) | 2 (1.7) | 1 (2.6) |
| Amantadin n (%) | 42 (1.1) | 0 | 0 | 18 (1.3) | 2 (1.7) | 0 |
| Carbamazepin n (%) | 29 (0.7) | 0 | 1 (1.6) | 14 (1.0) | 3 (2.5) | 1 (2.6) |
| Fampridine n (%) | 299 (7.6) | 3 (9.7) | 5 (8.1) | 81 (6.0) | 8 (6.7) | 1 (2.6) |
| Heart rate at visit 2 pre-dose | ||||||
| Heart rate (bpm), mean ± SD | 73.9 ± 10.4 | 59.5 ± 8.0 | 75.0 ± 8.5 | 73.4 ± 10.4 | 73.3 ± 11.6 | 75.8 ± 10.6 |
| Blood pressure at visit 2 pre-dose | ||||||
| Systolic (mmHg), mean ± SD | 121.8 ± 14.0 | 125.7 ± 20.3 | 117.5 ± 13.7 | 122.0 ± 14.1 | 123.9 ± 14.5 | 120.4 ± 15.4 |
| Diastolic (mmHg), mean ± SD | 78.5 ± 9.7 | 78.1 ± 13.1 | 75.7 ± 9.0 | 78.7 ± 9.8 | 79.9 ± 10.0 | 76.1 ± 11.1 |
| Potassium levels at visit 2 | ||||||
| < 3.5 mmol/L | 13 (0.3) | 0 | 0 | 5 (0.4) | 0 | 0 |
| ≥ 3.5–5.5 mmol/L | 3853 (98.3) | 31 (100) | 61 (98.4) | 1320 (98.5) | 119 (99.2) | 38 (100.0) |
| > 5.5 mmol/L | 54 (1.4) | 0 | 1 (1.6) | 15 (1.1) | 1 (0.8) | 0 |
| Symptoms suggestive of cardiac eventsb during 6 h first-dose observation | ||||||
| Patients with symptoms, n (%) | 120 (3.0) | 1 (3.2)c | 1 (1.6)d | 120 (8.9) | 120 (100.0) | 1 (2.6) |
aOne of the patients had both, bradycardia and second-degree AV block and is therefore included in both groups
bCardiac symptoms are defined as the following MedDRA preferred terms: Angina pectoris, chest discomfort, dizziness, dyspnoea, dyspnoe exertional, fatigue, palpitations, syncope, vertigo, vertigo positional, blurred vision
cFatigue and chest discomfort
dPalpitations