Table 5.
Summary of AEs (ITT population)
| Number (%) of patients reporting event | ||||||
|---|---|---|---|---|---|---|
| Titration period | Maintenance period | Treatment phase | ||||
| Placebo, N = 66 | GSK239512, N = 65 | Placebo, N = 66 | GSK239512, N = 65 | Placebo, N = 66 | GSK239512, N = 65 | |
| Any common event | 23 (35) | 34 (52) | 44 (67) | 43 (66) | 50 (76) | 48 (74) |
| AEs rated by intensity | ||||||
| Mild | 17 (26) | 20 (31) | 17 (26) | 19 (29) | 19 (29) | 18 (28) |
| Moderate | 6 (9) | 14 (22) | 24 (36) | 21 (32) | 28 (42) | 27 (42) |
| Severe | 0 | 0 | 3 (5) | 3 (5) | 3 (5) | 3 (5) |
| Treatment-related AEs | 6 (9) | 23 (35) | 2 (3) | 7 (11) | 8 (12) | 27 (42) |
| SAEs | 0 | 0 | 1 (2) | 2 (3) | 1 (2) | 2 (3) |
| AEs Leading to withdrawal | 0 | 1 (2)a | 0 | 6 (9) | 0 | 7 (11) |
| Common AEs ≥ 5% patients | ||||||
| Insomnia | 6 (9) | 20 (31) | 1 (2) | 4 (6) | 7 (11) | 22 (34) |
| Middle insomnia | 0 | 2 (3) | 1 (2) | 3 (5) | 1 (2) | 5 (8) |
| Nightmare | 0 | 4 (6) | 0 | 2 (3) | 0 | 5 (8) |
| Headache | 6 (9) | 8 (12) | 7 (11) | 10 (15) | 11 (17) | 16 (25) |
| Dizziness | 2 (3) | 2 (3) | 1 (2) | 4 (6) | 3 (5) | 6 (9) |
| Fatigue | 0 | 1 (2) | 4 (6) | 0 | 4 (6) | 1 (2) |
| Pyrexia | 1 (2) | 0 | 3 (5) | 1 (2) | 4 (6) | 1 (2) |
| Nausea | 4 (6) | 1 (2) | 3 (5) | 2 (3) | 6 (9) | 2 (3) |
| Diarrhoea | 0 | 3 (5) | 3 (5) | 0 | 3 (5) | 3 (5) |
| Nasopharyngitis | 3 (5) | 1 (2) | 12 (18) | 10 (15) | 14 (21) | 11 (17) |
| Vertigo | 0 | 3 (5) | 1 (2) | 1 (2) | 1 (2) | 3 (5) |
| Palpitations | 0 | 3 (5) | 0 | 0 | 0 | 3 (5) |
| Influenza | 0 | 0 | 4 (6) | 5 (8) | 4 (6) | 5 (8) |
| UTI | 1 (2) | 2 (3) | 1 (2) | 4 (6) | 2 (3) | 5 (8) |
| Bronchitis | 0 | 0 | 3 (5) | 0 | 3 (5) | 0 |
| Cystitis | 0 | 0 | 0 | 3 (5) | 0 | 3 (5) |
| Neck pain | 1 (2) | 1 (2) | 4 (6) | 2 (3) | 4 (6) | 3 (5) |
| Arthralgia | 0 | 0 | 4 (6) | 0 | 4 (6) | 0 |
ITT population is the same population as the safety population
AE adverse event, ITT intent-to-treat, SAE serious AE (defined as any AE or adverse reaction that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect), UTI urinary tract infection
aAE leading to withdrawal started during the titration period but the patient did not withdraw until the maintenance phase