Table 2.
Summary of adverse events, safety population
| Preferred term, n (%) | <75 years | ≥75 years | ||
|---|---|---|---|---|
| Placebo (n = 272) | G-GR (n = 259) | Placebo (n = 92) | G-GR (n = 100) | |
| Patients with ≥1 AE | 112 (41.2) | 139 (53.7) | 44 (47.8) | 56 (56.0) |
| ≥1 AE leading to study discontinuation | 26 (10.0) | 17 (6.3) | 5 (5.4) | 9 (9.0) |
| ≥1 SAEs | 8 (2.9) | 6 (2.3) | 3 (3.3) | 2 (2.0) |
| AEsa | ||||
| Dizziness | 5 (1.8) | 27 (10.4) | 3 (3.3) | 12 (12.0) |
| Nausea | 8 (2.9) | 11 (4.2) | 1 (1.0) | 5 (5.4) |
| Headache | 11 (4.0) | 14 (5.4) | 4 (4.3) | 1 (1.0) |
| Somnolence | 10 (3.7) | 11 (4.2) | 0 | 5 (5.0) |
| Diarrhea | 8 (2.9) | 7 (2.7) | 2 (2.2) | 5 (5.0) |
| Edema, peripheral | 1 (0.4) | 10 (3.9) | 0 | 4 (4.0) |
| Dry mouth | 4 (1.5) | 8 (3.1) | 1 (1.1) | 2 (2.0) |
| Urinary tract infection | 2 (0.7) | 3 (1.2) | 0 | 3 (3.0) |
| Nasopharyngitis | 8 (2.9) | 7 (2.7) | 1 (1.1) | 2 (2.0) |
| Weight increased | 1 (0.4) | 7 (2.7) | 1 (1.1) | 0 |
| Constipation | 1 (0.4) | 3 (1.2) | 0 | 2 (2.0) |
| Herpes zoster | 3 (1.1) | 2 (0.8) | 1 (1.1) | 2 (2.0) |
| Pneumonia | 0 | 1 (0.4) | 0 | 2 (2.0) |
| Pain in extremity | 1 (0.4) | 5 (1.9) | 1 (1.1) | 2 (2.0) |
| Rash | 4 (1.5) | 1 (0.4) | 0 | 2 (2.0) |
| Blood urea increased | 0 | 0 | 0 | 2 (2.0) |
| Sedation | 0 | 0 | 0 | 2 (2.0) |
aIncludes events reported for ≥2 % of patients in any group
AE adverse event, G-GR gastroretentive gabapentin, SAE serious adverse event