Table 2 Adverse Events Documented During Double-Blind Treatment
From: Integrated analysis of droxidopa trials for neurogenic orthostatic hypotension
Variable | Pooled Studies NOH301 and NOH302 | Study NOH306 | ||
|---|---|---|---|---|
Droxidopa | Placebo | Droxidopa | Placebo | |
N | 131 | 132 | 114 | 108 |
Duration, wk | 1–2 | 8–10 | ||
Any AE, n (%) | 30 (22.9) | 31 (23.5) | 91 (79.8) | 87 (80.6) |
Any severe AE, n (%) | 0 | 2 (1.5) | 10 (8.8) | 9 (8.3) |
Any AE leading to study drug discontinuation, n (%) | 0 | 2 (1.5) | 12 (10.5) | 5 (4.6) |
AE type,a n (%) | ||||
Headache | 8 (6.1) | 4 (3.0) | 15 (13.2) | 8 (7.4) |
Dizziness | 5 (3.8) | 2 (1.5) | 11 (9.6) | 5 (4.6) |
Urinary tract infection | 4 (3.1) | 2 (1.5) | 4 (3.5) | 5 (4.6) |
Decreased appetite | 2 (1.5) | 1 (0.8) | 1 (0.9) | 0 |
Fatigue | 2 (1.5) | 3 (2.3) | 8 (7.0) | 6 (5.6) |
Feeling abnormal | 2 (1.5) | 0 | 2 (1.8) | 1 (0.9) |
Hypertension | 2 (1.5) | 0 | 8 (7.0) | 1 (0.9) |
Nausea | 2 (1.5) | 2 (1.5) | 10 (8.8) | 5 (4.6) |
Pyrexia | 2 (1.5) | 0 | ||
Rhinorrhea | 2 (1.5) | 0 | ||
Syncope | 2 (1.5) | 1 (0.8) | 1 (0.9) | 4 (3.7) |
Falls | 1 (0.8) | 9 (6.8) | NAb | NAb |
Edema peripheral | 0 | 2 (1.5) | 5 (4.4) | 6 (5.6) |
Loss of consciousness | 0 | 3 (2.3) | ||
Vision blurred | 0 | 2 (1.5) | 1 (0.9) | 1 (0.9) |