Table 4.
AEs. a
| Category |
RESOLVE 15 |
RESOLVE II 16 |
Pooled Analysis |
|||
|---|---|---|---|---|---|---|
| Treatment (n = 53) | Control (n = 47) | Treatment (n = 201) | Control (n = 99) | Treatment (n = 254) | Control (n = 146) | |
| Patients with any AE | 33 (62.3) | 33 (70.2) | 91 (45.3) | 37 (37.4) | 124 (48.8) | 70 (47.9) |
| Patients with AE resulting in discontinuation | 0 | 0 | 0 | 0 | 0 | 0 |
| Patients with most common AEs (> 1% incidence rate in any group that occurred more commonly in the treatment group) | ||||||
| Nervous system disorders | 6 (11.3) | 5 (10.6) | 11 (5.5) | 3 (3.0) | 17 (6.7) | 8 (5.5) |
| Headache | 3 (5.7) | 2 (4.3) | 6 (3.0) | 3 (3.0) | 9 (3.5) | 5 (3.4) |
| Presyncope | 2 (3.8) | 3 (6.4) | 4 (2.0) | 0 | 6 (2.4) | 3 (2.1) |
| Respiratory, thoracic, and mediastinal disorders | 7 (13.2) | 5 (10.6) | 24 (11.9) | 9 (9.1) | 31 (12.2) | 14 (9.6) |
| Asthma (worsening) | 2 (3.8) | 2 (4.3) | 10 (5.0) | 4 (4.0) | 12 (4.7) | 6 (4.1) |
| Epistaxis | 3 (5.7) | 2 (4.3) | 3 (1.5) | 0 | 6 (2.4) | 2 (1.4) |
| Patients with any implant-related AE (>1% incidence rate) | 5 (9.4) | 0 | 10 (5.0) | 0 | 15 (5.9) | 0 |
| Epistaxis | 3 (5.7) | 0 | 1 (0.5) | 0 | 4 (1.6) | 0 |
| Nasal discomfort | 1 (8.3) | 0 | 2 (1.0) | 0 | 3 (1.2) | 0 |
| Patients with any SAE | 0 | 0 | 2 (1.0) | 1 (1.0) | 2 (0.8) | 1 (0.7) |
| Implant-related epistaxis | 0 | 0 | 1 (0.5) | 0 | 1 (0.4) | 0 |
Abbreviations: AE, adverse event; MedDRA, Medical Dictionary for Regulatory Activities; SAE, serious AE; PT, preferred term.
a
Values represent patient counts and percentages. Each AE was coded using MedDRA. A patient reporting more than 1 AE for a particular MedDRA PT is counted only once. A patient reporting several AEs with different PTs is counted under each term. Implant-related AEs comprise all AEs related to device, study drug, and/or implant procedure.